Case 1:14-cv-01118-GMS
(1) Actavis' proposed ANDA products infringe all of the asserted claims of the '096 patent; and
(2) Actavis' proposed ANDA products infringe all of the asserted claims of the '742 patent.
The district court properly dismissed Janis Carmona's complaint under the Rooker-Feldman doctrine. Janis sought to overturn state court decisions in federal district court, which does not have jurisdiction to review state court judgments. The Rooker-Feldman doctrine bars lower federal courts from reviewing state court decisions. Janis' only recourse was to appeal to the U.S. Supreme Court, which denied her petition for certiorari. The district court correctly determined it lacked subject matter jurisdiction over Janis' complaint seeking to invalidate the state court rulings.
Federal Judge's order of sanctions against Wal-Mart for its failure to preserve videotape in retaliation and discrimination lawsuit in Atlanta, Georgia.
Un juge fédéral Texan a interdit lundi au département américain de la Défense de punir un groupe de Navy Seals et d'autres membres des forces spéciales qui ont refusé les vaccins pour des motifs religieux.
The patent is for a system to manage and disseminate information from controlled environment facilities, such as jails or prisons. It involves storing resident and facility information in a database, selectively providing information to outside parties and professionals, and conducting reverse auctions for goods and services for residents. The system aims to reduce the administrative burden on facilities while selectively providing information to authorized individuals.
This document is an order from a federal district court ruling on motions in a product liability case involving a defective attic ladder. The court denied the defendant ladder manufacturer's motion to exclude the plaintiff's expert witness under Daubert. The court found that both the plaintiff's and defendant's experts were qualified and used reliable methodologies, even if they reached different conclusions. The court also granted in part and denied in part the defendant's motion for summary judgment, finding factual disputes remained that precluded full summary judgment.
Par JULIEN G. - Vendredi 12 novembre, dans une décision nationale, la Cour d’Appel fédérale du 5e circuit de la Nouvelle Orléans, a ordonné l’interruption de l’obligation vaccinale, imposée par l’administration Biden, dans le secteur privé. C’est un nouveau revers de taille pour Joe Biden, dont le seul recours possible est maintenant la Cour Suprême des États-Unis (SCOTUS)
Defendants reply brief in support of defendants’ motion to dismiss action for...Cocoselul Inaripat
This document is a reply brief filed by the defendants in support of their motion to dismiss the plaintiff's case for failure to appear at depositions. The defendants argue that the plaintiff has failed to provide any medical evidence that his medical conditions prevented him from attending the depositions. They note that he was able to attend a mediation shortly before one scheduled deposition and file court documents, contradicting his medical inability claims. As a result, the defendants believe the plaintiff's case should be dismissed due to his willful failure to comply with discovery obligations.
The district court properly dismissed Janis Carmona's complaint under the Rooker-Feldman doctrine. Janis sought to overturn state court decisions in federal district court, which does not have jurisdiction to review state court judgments. The Rooker-Feldman doctrine bars lower federal courts from reviewing state court decisions. Janis' only recourse was to appeal to the U.S. Supreme Court, which denied her petition for certiorari. The district court correctly determined it lacked subject matter jurisdiction over Janis' complaint seeking to invalidate the state court rulings.
Federal Judge's order of sanctions against Wal-Mart for its failure to preserve videotape in retaliation and discrimination lawsuit in Atlanta, Georgia.
Un juge fédéral Texan a interdit lundi au département américain de la Défense de punir un groupe de Navy Seals et d'autres membres des forces spéciales qui ont refusé les vaccins pour des motifs religieux.
The patent is for a system to manage and disseminate information from controlled environment facilities, such as jails or prisons. It involves storing resident and facility information in a database, selectively providing information to outside parties and professionals, and conducting reverse auctions for goods and services for residents. The system aims to reduce the administrative burden on facilities while selectively providing information to authorized individuals.
This document is an order from a federal district court ruling on motions in a product liability case involving a defective attic ladder. The court denied the defendant ladder manufacturer's motion to exclude the plaintiff's expert witness under Daubert. The court found that both the plaintiff's and defendant's experts were qualified and used reliable methodologies, even if they reached different conclusions. The court also granted in part and denied in part the defendant's motion for summary judgment, finding factual disputes remained that precluded full summary judgment.
Par JULIEN G. - Vendredi 12 novembre, dans une décision nationale, la Cour d’Appel fédérale du 5e circuit de la Nouvelle Orléans, a ordonné l’interruption de l’obligation vaccinale, imposée par l’administration Biden, dans le secteur privé. C’est un nouveau revers de taille pour Joe Biden, dont le seul recours possible est maintenant la Cour Suprême des États-Unis (SCOTUS)
Defendants reply brief in support of defendants’ motion to dismiss action for...Cocoselul Inaripat
This document is a reply brief filed by the defendants in support of their motion to dismiss the plaintiff's case for failure to appear at depositions. The defendants argue that the plaintiff has failed to provide any medical evidence that his medical conditions prevented him from attending the depositions. They note that he was able to attend a mediation shortly before one scheduled deposition and file court documents, contradicting his medical inability claims. As a result, the defendants believe the plaintiff's case should be dismissed due to his willful failure to comply with discovery obligations.
This document is a reply brief filed by the defendants in support of their motion to dismiss the plaintiff's case for failure to appear at depositions. The defendants argue that the plaintiff has failed to provide any medical evidence that his medical conditions prevented him from attending the depositions. They note that he was able to attend a mediation shortly before one scheduled deposition and file court documents, contradicting his medical inability claims. As a result, the defendants believe the plaintiff's case should be dismissed due to his willful failure to comply with discovery obligations.
The decision by U.S. District Judge John Copenhaver Jr. that a zoning ordinance passed by three liberal Democrat commissioners in Fayette County, WV that blocks oil & gas wastewater injection wells in the county is illegal and unenforceable.
Government’s response to defendant’s petition for review of magistrate’s repo...Cocoselul Inaripat
This document is the government's response to the defendant's petition for review of the magistrate's order denying bond and ordering pretrial detention. The government argues that the defendant has not demonstrated any new information warranting reopening of the detention hearing. It also argues the magistrate's findings that the defendant poses a flight risk were not clearly erroneous. The government asserts the defendant's petition should be denied.
This document is an order from a United States District Court regarding cross-motions for summary judgment in a case involving a plaintiff who was imprisoned at a halfway house operated by the defendant. The court provides background on the case, including that the plaintiff sued over alleged unlawful seizure of his property and constitutional violations. The court evaluates the motions using the standard for summary judgment, granting the defendant's motion and denying the plaintiff's motion.
This document is a report and recommendation from a United States District Court regarding a patent infringement case between Two-Way Media Ltd. and Verizon Communications Inc., Verizon Services Corp., and Verizon Online LLC. The court provides background on the parties, patents in question, plaintiff's allegations of infringement related to Verizon's TV Everywhere streaming services, and the standard for reviewing a motion to dismiss. The court will recommend granting Verizon's motion to dismiss for failure to state a claim of joint infringement under the requirements that all steps of a method patent be attributable to the same defendant.
This document outlines functions of the court that can and cannot be performed by a single justice of the peace in family court proceedings. It provides two tables listing specific rules and practice directions where a single justice is not authorized to perform certain functions, such as making final orders, adding or removing parties, or excluding people from hearings. The document clarifies that unless otherwise specified, a single justice cannot make final decisions of the magistrates' court.
Systems and methods for visual presentation and selection of IVR menuTal Lavian Ph.D.
Embodiments of the invention provide a system for generating an Interactive Voice Response (IVR) database, the system comprising a processor and a memory coupled to the processor. The memory comprising a list of telephone numbers associated with one or more destinations implementing IVR menus, wherein the one or more destinations are grouped based on a plurality of categories of the IVR menus. Further the memory includes instructions executable by said processor for automatically communicating with the one of more destinations, and receiving at least one customization record from said at least one destination to store in the IVR database.
U.S. District Court Judge Derrick Watson's Oct. 17 rulingHonolulu Civil Beat
This document is a court order granting a motion for a temporary restraining order to prohibit enforcement of sections of Executive Order 3 (EO-3). The order summarizes the background of EO-3 and previous executive orders restricting entry from certain countries. It finds that EO-3, like the previous orders, likely exceeds presidential authority and engages in unconstitutional nationality-based discrimination. On this basis, the court grants the motion to restrain enforcement of EO-3 until further review can be conducted.
This document provides discovery materials to the defendants in a criminal case involving charges related to exporting aircraft parts to Iran. It includes:
1) CDs and images of computer data seized from the defendants containing emails and files.
2) Reports of post-arrest interviews of the two defendants.
3) Notification that physical documents and items seized can be inspected by the defendants, and copies of documents ordered.
4) A request for reciprocal discovery from the defendants and commitment to provide ongoing discovery required by law, including Brady and Giglio materials.
This document is a bill request from the Code Reviser's Office concerning proposed amendments to Washington's law on the medical use of cannabis. The bill would amend several sections of RCW 69.51A relating to definitions, protections for medical use, possession limits, and valid documentation requirements. It removes references to the medical cannabis patient registry and makes other changes to clarify and update the law.
Procedures for Deposition of a Biological Sample to Overcome a 112 Enablement...Workman Nydegger
The document discusses procedures for making a biological deposit to overcome a 35 USC 112 enablement rejection from a patent examiner. It explains that a deposit can satisfy the written description and enablement requirements under 112 if access to the biological material is necessary. It provides details on following the deposit rules under 37 CFR 1.801-1.809, including depositing material before filing, using an acceptable depository, establishing viability, and including references to the deposit in the patent specification. The key steps are finding a suitable depository, depositing the material, submitting required forms to the patent office, and amending the specification.
Steven Duesing, Nicole Mathis v. The Attorney General of CanadaGuy Boulianne
This is an application for judicial review of a decision by the Minister of Health to quarantine asymptomatic Canadians in federal facilities without due process. The applicants, Steven Duesing and Nicole Mathis, seek an interlocutory injunction suspending mandatory confinement in federal facilities and releasing those currently confined. They also seek declarations that the decision violates sections of the Charter and is unreasonable as it does not balance rights and freedoms. The grounds for the application are that the federal government has not ensured there are no reasonable alternatives to detaining Canadians in facilities against their will.
Teva's Copaxone faced challenges from generic drug companies before its patents expired. In the US, Teva sued Sandoz and Mylan to block their generic versions, resulting in complex litigation that ultimately invalidated Teva's patents. In India, Teva sued Natco but the Delhi High Court dismissed the case due to lack of evidence. As generics prepared to enter the market, Teva developed a new long-acting Copaxone formulation and obtained additional patents to extend its market exclusivity. This allowed Teva to switch most patients to the new version before generics could significantly impact sales of the original drug. The case demonstrates Teva's strategic efforts to maximize revenue from Copaxone through patent litigation and new product development
Nancy S. Montinola versus Philippine Airlines. G.R. No. 198656. September 8, ...PoL Sangalang
Nancy S. Montinola versus Philippine Airlines. G.R. No. 198656. September 8, 2014. Supreme Court of the Philippines. Uploaded by Atty. Apollo X.C.S. Sangalang in relation to his lecture on "Company Policy: Elements of Administrative Investigation and Progressive Discipline" on October 15, 2014, at the Asian Institute of Management, Makati City, Philippines.
This document is a form used for small claims cases in the Philippines. It provides information about the plaintiff and defendant, including their personal details and addresses.
The plaintiff is claiming that the defendant owes them a certain amount of money. The details provided include when and how the debt occurred, and how the plaintiff calculated the amount owed.
The form also includes sections for the defendant to respond to the claim, allowing them to deny or partially deny the debt. The defendant can also file a counterclaim, stating that money is actually owed to them from the plaintiff. Spaces are provided for both parties to include details about any attempts to collect on the alleged debts, as well as proof to support their statements.
1. An assistant engineer visited TCT Engineering to learn about optical fiber systems as an alternative to improve his company's copper cable transmission system which suffers from interference issues.
2. He learned that optical fiber has a much higher capacity than copper cable and can transmit all types of data simultaneously without electrical interference. It also allows faster transmission while using lighter and less expensive materials.
3. Based on the knowledge gained, the engineer believes optical fiber will increase their competitiveness and recommends senior staff visit TCT to learn more about implementing such a system as Malaysia aims to fully digitalize telecommunications.
The document provides samples of basic legal forms used in Philippine courts, including captions, acknowledgments, affidavits, and negotiable instruments. It describes the types of courts established after the Judiciary Reorganization Act of 1980 and provides examples of captions for each court. It also provides templates for acknowledgments, jurats, affidavits, verifications, and certifications. Finally, it includes examples of promissory notes and bills of exchange as samples of negotiable instruments.
Special laws on children 8353, 9262, 9231, 7877, 7610, 920Omar Jacalne
The documents discuss several laws relating to women, children, and human trafficking in the Philippines. The PNP Reform and Reorganization Act of 1998 established women's desks in police stations and mandated the prioritization of women in police recruitment. The Anti-Child Abuse Law of 1990 defines a child and penalizes child prostitution, trafficking, and pornography. The Anti-Trafficking in Persons Act of 2003 defines and punishes trafficking and distinguishes it from human smuggling. Child labor is regulated under the Child Labor Law, which prescribes minimum ages and limits on work hours.
Case studies presentation_Patent Research AESAN PATEL
Infringement: A term which is very common in patent research and law forms. i.e. the action of breaking the terms of a law, agreement, etc.; violation.
PruvIt Ventures VS ForeverGreen International Lawsuit filedPruvit
http://meta.pruvitnow.com Pruvit Ventures has filed a lawsuit against ForeverGreen International. Pruvit is shipping product today. For detailed info check Troy Dooly's post and video: http://mlmhelpdesk.com/breaking-mlm-news-pruvit-ventures-files-federal-lawsuit-against-forevergreen-aka-fg-express/
C5 second medical_use_patents_presentation_29_january_2014Dr Duncan Curley
The document summarizes a presentation on enforcing second medical use patents against generic drug manufacturers. It discusses how including a patented indication on a generic drug's label can infringe the patent, even if the label is "skinny labeled" to remove reference to the indication. Case law suggests this may establish contributory infringement if some doctors are likely to prescribe the drug for the patented use. The presentation analyzes cases where labeling was found to not prove direct infringement but may have with different evidence. It concludes that second medical use patents will likely become more important for research companies to defend given advancing clinical research.
This document is a reply brief filed by the defendants in support of their motion to dismiss the plaintiff's case for failure to appear at depositions. The defendants argue that the plaintiff has failed to provide any medical evidence that his medical conditions prevented him from attending the depositions. They note that he was able to attend a mediation shortly before one scheduled deposition and file court documents, contradicting his medical inability claims. As a result, the defendants believe the plaintiff's case should be dismissed due to his willful failure to comply with discovery obligations.
The decision by U.S. District Judge John Copenhaver Jr. that a zoning ordinance passed by three liberal Democrat commissioners in Fayette County, WV that blocks oil & gas wastewater injection wells in the county is illegal and unenforceable.
Government’s response to defendant’s petition for review of magistrate’s repo...Cocoselul Inaripat
This document is the government's response to the defendant's petition for review of the magistrate's order denying bond and ordering pretrial detention. The government argues that the defendant has not demonstrated any new information warranting reopening of the detention hearing. It also argues the magistrate's findings that the defendant poses a flight risk were not clearly erroneous. The government asserts the defendant's petition should be denied.
This document is an order from a United States District Court regarding cross-motions for summary judgment in a case involving a plaintiff who was imprisoned at a halfway house operated by the defendant. The court provides background on the case, including that the plaintiff sued over alleged unlawful seizure of his property and constitutional violations. The court evaluates the motions using the standard for summary judgment, granting the defendant's motion and denying the plaintiff's motion.
This document is a report and recommendation from a United States District Court regarding a patent infringement case between Two-Way Media Ltd. and Verizon Communications Inc., Verizon Services Corp., and Verizon Online LLC. The court provides background on the parties, patents in question, plaintiff's allegations of infringement related to Verizon's TV Everywhere streaming services, and the standard for reviewing a motion to dismiss. The court will recommend granting Verizon's motion to dismiss for failure to state a claim of joint infringement under the requirements that all steps of a method patent be attributable to the same defendant.
This document outlines functions of the court that can and cannot be performed by a single justice of the peace in family court proceedings. It provides two tables listing specific rules and practice directions where a single justice is not authorized to perform certain functions, such as making final orders, adding or removing parties, or excluding people from hearings. The document clarifies that unless otherwise specified, a single justice cannot make final decisions of the magistrates' court.
Systems and methods for visual presentation and selection of IVR menuTal Lavian Ph.D.
Embodiments of the invention provide a system for generating an Interactive Voice Response (IVR) database, the system comprising a processor and a memory coupled to the processor. The memory comprising a list of telephone numbers associated with one or more destinations implementing IVR menus, wherein the one or more destinations are grouped based on a plurality of categories of the IVR menus. Further the memory includes instructions executable by said processor for automatically communicating with the one of more destinations, and receiving at least one customization record from said at least one destination to store in the IVR database.
U.S. District Court Judge Derrick Watson's Oct. 17 rulingHonolulu Civil Beat
This document is a court order granting a motion for a temporary restraining order to prohibit enforcement of sections of Executive Order 3 (EO-3). The order summarizes the background of EO-3 and previous executive orders restricting entry from certain countries. It finds that EO-3, like the previous orders, likely exceeds presidential authority and engages in unconstitutional nationality-based discrimination. On this basis, the court grants the motion to restrain enforcement of EO-3 until further review can be conducted.
This document provides discovery materials to the defendants in a criminal case involving charges related to exporting aircraft parts to Iran. It includes:
1) CDs and images of computer data seized from the defendants containing emails and files.
2) Reports of post-arrest interviews of the two defendants.
3) Notification that physical documents and items seized can be inspected by the defendants, and copies of documents ordered.
4) A request for reciprocal discovery from the defendants and commitment to provide ongoing discovery required by law, including Brady and Giglio materials.
This document is a bill request from the Code Reviser's Office concerning proposed amendments to Washington's law on the medical use of cannabis. The bill would amend several sections of RCW 69.51A relating to definitions, protections for medical use, possession limits, and valid documentation requirements. It removes references to the medical cannabis patient registry and makes other changes to clarify and update the law.
Procedures for Deposition of a Biological Sample to Overcome a 112 Enablement...Workman Nydegger
The document discusses procedures for making a biological deposit to overcome a 35 USC 112 enablement rejection from a patent examiner. It explains that a deposit can satisfy the written description and enablement requirements under 112 if access to the biological material is necessary. It provides details on following the deposit rules under 37 CFR 1.801-1.809, including depositing material before filing, using an acceptable depository, establishing viability, and including references to the deposit in the patent specification. The key steps are finding a suitable depository, depositing the material, submitting required forms to the patent office, and amending the specification.
Steven Duesing, Nicole Mathis v. The Attorney General of CanadaGuy Boulianne
This is an application for judicial review of a decision by the Minister of Health to quarantine asymptomatic Canadians in federal facilities without due process. The applicants, Steven Duesing and Nicole Mathis, seek an interlocutory injunction suspending mandatory confinement in federal facilities and releasing those currently confined. They also seek declarations that the decision violates sections of the Charter and is unreasonable as it does not balance rights and freedoms. The grounds for the application are that the federal government has not ensured there are no reasonable alternatives to detaining Canadians in facilities against their will.
Teva's Copaxone faced challenges from generic drug companies before its patents expired. In the US, Teva sued Sandoz and Mylan to block their generic versions, resulting in complex litigation that ultimately invalidated Teva's patents. In India, Teva sued Natco but the Delhi High Court dismissed the case due to lack of evidence. As generics prepared to enter the market, Teva developed a new long-acting Copaxone formulation and obtained additional patents to extend its market exclusivity. This allowed Teva to switch most patients to the new version before generics could significantly impact sales of the original drug. The case demonstrates Teva's strategic efforts to maximize revenue from Copaxone through patent litigation and new product development
Nancy S. Montinola versus Philippine Airlines. G.R. No. 198656. September 8, ...PoL Sangalang
Nancy S. Montinola versus Philippine Airlines. G.R. No. 198656. September 8, 2014. Supreme Court of the Philippines. Uploaded by Atty. Apollo X.C.S. Sangalang in relation to his lecture on "Company Policy: Elements of Administrative Investigation and Progressive Discipline" on October 15, 2014, at the Asian Institute of Management, Makati City, Philippines.
This document is a form used for small claims cases in the Philippines. It provides information about the plaintiff and defendant, including their personal details and addresses.
The plaintiff is claiming that the defendant owes them a certain amount of money. The details provided include when and how the debt occurred, and how the plaintiff calculated the amount owed.
The form also includes sections for the defendant to respond to the claim, allowing them to deny or partially deny the debt. The defendant can also file a counterclaim, stating that money is actually owed to them from the plaintiff. Spaces are provided for both parties to include details about any attempts to collect on the alleged debts, as well as proof to support their statements.
1. An assistant engineer visited TCT Engineering to learn about optical fiber systems as an alternative to improve his company's copper cable transmission system which suffers from interference issues.
2. He learned that optical fiber has a much higher capacity than copper cable and can transmit all types of data simultaneously without electrical interference. It also allows faster transmission while using lighter and less expensive materials.
3. Based on the knowledge gained, the engineer believes optical fiber will increase their competitiveness and recommends senior staff visit TCT to learn more about implementing such a system as Malaysia aims to fully digitalize telecommunications.
The document provides samples of basic legal forms used in Philippine courts, including captions, acknowledgments, affidavits, and negotiable instruments. It describes the types of courts established after the Judiciary Reorganization Act of 1980 and provides examples of captions for each court. It also provides templates for acknowledgments, jurats, affidavits, verifications, and certifications. Finally, it includes examples of promissory notes and bills of exchange as samples of negotiable instruments.
Special laws on children 8353, 9262, 9231, 7877, 7610, 920Omar Jacalne
The documents discuss several laws relating to women, children, and human trafficking in the Philippines. The PNP Reform and Reorganization Act of 1998 established women's desks in police stations and mandated the prioritization of women in police recruitment. The Anti-Child Abuse Law of 1990 defines a child and penalizes child prostitution, trafficking, and pornography. The Anti-Trafficking in Persons Act of 2003 defines and punishes trafficking and distinguishes it from human smuggling. Child labor is regulated under the Child Labor Law, which prescribes minimum ages and limits on work hours.
Case studies presentation_Patent Research AESAN PATEL
Infringement: A term which is very common in patent research and law forms. i.e. the action of breaking the terms of a law, agreement, etc.; violation.
PruvIt Ventures VS ForeverGreen International Lawsuit filedPruvit
http://meta.pruvitnow.com Pruvit Ventures has filed a lawsuit against ForeverGreen International. Pruvit is shipping product today. For detailed info check Troy Dooly's post and video: http://mlmhelpdesk.com/breaking-mlm-news-pruvit-ventures-files-federal-lawsuit-against-forevergreen-aka-fg-express/
C5 second medical_use_patents_presentation_29_january_2014Dr Duncan Curley
The document summarizes a presentation on enforcing second medical use patents against generic drug manufacturers. It discusses how including a patented indication on a generic drug's label can infringe the patent, even if the label is "skinny labeled" to remove reference to the indication. Case law suggests this may establish contributory infringement if some doctors are likely to prescribe the drug for the patented use. The presentation analyzes cases where labeling was found to not prove direct infringement but may have with different evidence. It concludes that second medical use patents will likely become more important for research companies to defend given advancing clinical research.
The document discusses patentability requirements in the US, including utility, novelty, and non-obviousness. It provides details on the types of subject matter that can be patented, conditions for novelty like anticipation and statutory bars, and considerations for non-obviousness. It also discusses the European patent regime and takes questions.
Roche sued Cipla for patent infringement over Cipla's generic version of Roche's cancer drug erlotinib. The single judge ruled in favor of Cipla, noting that Cipla's cheaper generic provided important public access to this life-saving drug. However, the division bench overturned this, finding that Roche's patent was for a mixture of polymorphs while Cipla's drug contained only polymorph B, which was not patented. The court criticized Roche for not properly describing the invention and not providing data to show Cipla's drug infringed the patent. Ultimately, Cipla was found not to infringe Roche's erlotinib patent.
This document provides information on key players in the medical device sector in India, with a focus on cardiac stents. It lists several granted patents and pending patent applications related to cardiac stent technologies filed by companies and institutions in India. It summarizes details of some exemplary granted patents, including the invention title, filing date, assigned patent classification codes. It also provides tables listing patent application numbers, titles, filing dates and current status of numerous pending applications related to cardiac stents and other medical devices.
This document summarizes a legal article examining how the Supreme Court's 2014 decision in Daimler AG v. Bauman affects personal jurisdiction in patent cases involving pharmaceutical companies. Specifically, it discusses:
1) How the decision may impact jurisdiction in cases arising under the Biologics Price Competition and Innovation Act (BPCIA), which established an abbreviated pathway for regulatory approval of biosimilar drugs.
2) Key aspects of the BPCIA, including its requirement that biosimilar applicants and reference product sponsors engage in a "patent dance" process to identify and potentially litigate relevant patent rights.
3) How the Federal Circuit's ruling in Amgen v. Sandoz, the first case to
Maximizing Pharmaceutical Patent Life Cycles: Strategies to Avoid Obviousness...Rachel Hamilton
For over a decade, American Conference Institute’s (ACI’s) Maximizing Pharmaceutical Patent Life Cycles and Biotech Patents conferences have brought you up-to –the minute legal, regulatory, and policy information concerning small and large molecule drug products. In deference to the legacy of these iconic events and your revered opinion, ACI proudly presents this new program on Pharmaceutical and Biotechnology Patent Life Cycles and Portfolio Strategies. This conference will give you a comprehensive and thorough picture of how small and large molecule products—as well as diagnostics—operate in a world not only governed by PTO and FDA-related laws and regulations, but also against the backdrop of Hatch-Waxman, BPCIA, iconoclast Supreme Court decisions affecting the future life sciences IP, and Health Care Reform. Our stellar faculty will provide you with insights and strategies relative to life cycle management, portfolio strategies, brand optimization and new product development as well as the thoughtful and targeted commentary and in-depth analysis that you have come to expect from ACI’s industry-leading life sciences IP conferences.
This order from the United States District Court for the Northern District of Georgia addresses sanctions against Hi-Tech Pharmaceuticals, Inc., Jared Wheat, Sean Smith, and Dr. Terrell Mark Wright for contempt of previous court orders. The court had previously found the defendants in contempt for making unsubstantiated advertising claims about weight loss products in violation of injunctions against deceptive marketing practices. At an evidentiary hearing, the court considered evidence to determine the appropriate nature and amount of sanctions. In this order, the court issues findings of fact regarding the defendants' roles and responsibilities at Hi-Tech, and reserves judgment to issue conclusions of law on the sanctions imposed.
The document summarizes a court case in India regarding an appeal against the acquittal of respondents charged under the Prevention of Food Adulteration Act for selling atta (wheat flour) found to contain living and dead insects. The trial court had convicted the respondents, but the additional sessions judge acquitted them, noting that the atta met standards under the act. The state appealed, arguing the judge did not properly consider evidence. The court discussed principles for appeals against acquittal, noting appellate courts have full power to review evidence and reach their own conclusions. It dismissed the appeal, finding no grounds to reverse the acquittal.
The document provides information on how a product is developed, including literature searches, sources for information on innovators and patents, and criteria for procuring active pharmaceutical ingredients (APIs). It discusses preformulation studies including stress testing APIs under various conditions like heat, humidity, acids, bases and metals. The document also covers topics like therapeutic equivalence codes, national drug codes, drug master files, exclusivity, and types of patents listed in the Orange Book.
Report and Recommendation of US Magistrate Judge Todd Spodek
The United States Magistrate Judge submitted a Report and Recommendation to the District Court regarding the case of the United States of America vs. Raul Gonzalez-Torres. The defendant pled guilty to conspiracy to possess with intent to distribute more than 500 grams of cocaine. The Magistrate Judge found that the defendant entered the plea freely and voluntarily with an understanding of the charges and penalties. The Magistrate Judge recommended that the District Court accept the guilty plea and, after reviewing the pre-sentence investigation report, enter a final judgment of guilty against the defendant.
This document is a settlement agreement between Sharon Logan, Paw Protectors Inc. and Orange County Animal Care regarding a lawsuit concerning OCAC's animal impoundment policies and practices. Key terms of the settlement include: OCAC will not euthanize animals within statutory holding periods except under specific circumstances; OCAC will release animals to rescue groups prior to euthanasia under certain conditions; OCAC will amend some of its internal policies; OCAC will provide monthly documentation on euthanized animals to Plaintiffs for review; and the court will retain jurisdiction to enforce the settlement until November 2017. Both parties agree to dismiss the lawsuit and release all claims against each other regarding the matters in the complaint.
This document is a settlement agreement between Sharon Logan, Paw Protectors Inc. and Orange County Animal Care regarding a lawsuit concerning OCAC's animal impoundment policies and practices. Key terms of the settlement include: 1) OCAC will not euthanize animals within statutory holding periods except under specific circumstances; 2) OCAC will release stray animals to rescue groups prior to euthanasia under certain conditions; and 3) OCAC will amend some of its policies per the parties' agreement. The agreement also establishes procedures for Plaintiffs to review OCAC records regarding euthanized animals and allows the court to retain jurisdiction to enforce the settlement until October 2017.
Patent amendment before the Federal Court in AustraliaWayne Condon
This document discusses a 2012 Federal Court of Australia case (Bayer v Generic Health) regarding a patent amendment application under Section 105 of the Patents Act. In the case, Bayer sought to amend claims in its oral contraceptive (Yazmin) patent related to dosage, form, and dissolution testing after commencing infringement proceedings against Generic Health. The Court allowed the amendments, finding that Bayer did not improperly delay amendment, assert claims it knew needed amending ("covetous claiming"), or gain unfair advantage from the unamended claims. The discretion under Section 105 favors patentees as long as they have not engaged in blatantly disentitling conduct regarding the Australian patent.
This order grants the plaintiffs' motion for summary judgment on two claims in their lawsuit against the County of Hawaii. The order finds that the County's Ordinance 13-121, which restricts open-air cultivation and testing of genetically engineered crops, is preempted by both federal and state law. Specifically, the order concludes that the ordinance is preempted in part by the federal Plant Protection Act and is fully preempted by Hawaii state law. Therefore, the court declares the ordinance to be invalid.
WOLLSCHLAEGER v. GOVERNOR OF THE STATE OF FLORIDANo. 12-14009..docxambersalomon88660
WOLLSCHLAEGER v. GOVERNOR OF THE STATE OF FLORIDA
No. 12-14009.
814 F.3d 1159 (2015)
The Governor of the State of Florida, other Florida officials, and members of the Board of Medicine of the Florida Department of Health (collectively, the "State"), appeal from the District Court's grant of summary judgment and an injunction in favor of a group of physicians and physician-advocacy groups (collectively, "Plaintiffs") enjoining enforcement of Florida's Firearm Owners Privacy Act1 (the "Act") on First and Fourteenth Amendment grounds.
The Act seeks to protect patient privacy by restricting irrelevant inquiry and record-keeping by physicians on the sensitive issue of firearm ownership and by prohibiting harassment and discrimination on the basis of firearm ownership. The Act does not prevent physicians from speaking with patients about firearms generally. Nor does it prohibit specific inquiry or record-keeping about a patient's firearm-ownership status when the physician determines in good faith, based on the circumstances of that patient's case, that such information is relevant to the patient's medical care or safety, or the safety of others.
Society has traditionally accorded physicians a high degree of deference due to their superior knowledge, educational pedigree, position of prestige, and "charismatic authority," resulting from their "symbolic role as conquerors of disease and death." Paula Berg, Toward A First Amendment Theory of Doctor-Patient Discourse and the Right to Receive Unbiased Medical Advice, 74 B.U. L.Rev. 201, 226 (1994). This deference reaches its apex in the examination room where patients are in a position of relative powerlessness. Patients must place their trust in the physicians' guidance and submit to the physicians' authority.
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In doing so, the Act plays an important role in protecting what gets into a patient's record, thereby protecting the patient from having that information disclosed, whether deliberately or inadvertently. The Act closes a small but important hole in Florida's larger patient-privacy-protection scheme. Given this understanding of the Act, and in light of the longstanding authority of States to define the boundaries of good medical practice, we hold that the Act is, on its face, a permissible restriction of physician speech. Physicians remain free—as they have always been—to asser.
Partner Michael Fuller wrote an article for the Bloomberg BNA - Pharmaceutical Law & Industry Report discussing how the PTAB may be taking a more balanced approach in biotech and pharmaceutical IPRs.
The Federal Circuit Review is a monthly newsletter featuring the latest case summaries handed down from the U.S. Court of Appeals for the Federal Circuit.
In this Issue:
Cancellation of Claims by PTO Binding on District Court
Claims Reciting Method Free of an Agent is Invalid Where Patent Does Not Mention Agent
Defendant Did Not Have Proper Notice of Products Accused of Infringement
The qualifications proposed by the parties are not material to determining infringement
in this case.
Infringement of the ’096 PatentC.
9. Claim 1 of the ’096 patent recites:
1. A pharmaceutical composition comprising:
a plurality of extended release beads comprising a gelling agent and an active ingredient,
wherein said gelling agent is present in an amount sufficient to impart a gelling effect to the
composition when the composition is subjected to a physical stress.
Case 1:14-cv-01118-GMS Document 131 Filed 11/14/16 Page 9 of 43 PageID #: 2696
4
10. Actavis’s ANDA products contain
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This document contains Recro's proposed post-trial findings of fact and conclusions of law regarding its infringement suit against Actavis Laboratories FL, Inc. Recro alleges that Actavis's generic versions of the extended-release hydrocodone product Zohydro ER infringe Recro's U.S. Patent Nos. 9,132,096 and 6,902,742. Specifically, Recro argues that Actavis's ethylcellulose-based coating is equivalent to the claimed polyacrylic coatings of the '096 patent, and that Actavis's active-ingredient containing pellets deliver hydrocodone in a pulsatile manner as required by the '742 patent. Recro seeks a finding that Actavis
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The parties stipulate to dismiss the case Recro Gainesville LLC v. Alvogen Malta Operations Ltd. without prejudice. The dismissal is pursuant to Rules 41(a)(1)(A)(ii) and 41(c) of the Federal Rules of Civil Procedure and without costs, disbursements, or attorneys' fees to any party. The stipulation also states that the dismissal shall not prohibit or restrict the defendant from maintaining or filing certifications for ANDA No. 206986 under relevant law nor prohibit or restrict the FDA from reviewing or approving that ANDA.
Lifting the Corporate Veil. Power Point Presentationseri bangash
"Lifting the Corporate Veil" is a legal concept that refers to the judicial act of disregarding the separate legal personality of a corporation or limited liability company (LLC). Normally, a corporation is considered a legal entity separate from its shareholders or members, meaning that the personal assets of shareholders or members are protected from the liabilities of the corporation. However, there are certain situations where courts may decide to "pierce" or "lift" the corporate veil, holding shareholders or members personally liable for the debts or actions of the corporation.
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Failure to Observe Corporate Formalities: Corporations and LLCs are required to observe certain formalities, such as holding regular meetings, maintaining separate financial records, and avoiding commingling of personal and corporate assets. If these formalities are not observed and the corporate structure is used as a mere façade, courts may disregard the corporate entity.
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Recro vs Actavis Zohydro Case Memorandum - Filed 02/22/17
1. IN THE UNITED STATES DISTRICT COURT
. FOR THE DISTRICT OF DELAWARE
RECRO GAINESVILLE LLC, .
Plaintiff,
v.
Civil Action No. 14-1118-GMS
CONSOLIDATED
ACTAVIS LABORATORIES FL, INC.,
)
)
)
)
)
)
)
)
)
)Defendant.
MEMORANDUM
I. INTRODUCTION
In this patent infringement action, Plaintiff Recro Gainesville LLC ("Recro") alleges
infringement by Actavis Laboratories FL;·Inc. of U.S. Patent No. ·9,132,096 ("the '096 patent")
and U.S. Patent No. 6,902,742 ("the '742 patent").1
The court held a three-day bench trial in this
matter on October 3, 4 and 7 of2016. (D.I. 133-135). Presently before the court are the parties'
post-trial proposed findings offact and conclusions oflaw concerning infringement ofthe patents-
in-suit. (D.I. 125, 126).
Pursuant to Federal Rule of Civil Procedure 52(a), and after having considered the entire
record in this case and the applicable law, the court concludes that: (1) Actavis' proposed ANDA
products infringe all of the asserted claims of the '096 patent; and (2) Actavis' proposed ANDA
products infringe all of the asserted claims of the '742 patent. These findings of fact and
conclusions oflaw are set forth in further detail below.
1
Recro and Actavis submitted a Stipulated Dismissal of Claims and Counterclaims with Respect to U.S. Patent No..
6,228,398. (D.I. 111 at 1)..
Case 1:14-cv-01118-GMS Document 138 Filed 02/22/17 Page 1 of 29 PageID #: 2812
2. II. FINDINGS OF FACT2
A. The Parties
l. PlaintiffRecro Gainesville LLC ("Recro") is a Massachusetts limited liability company
having its principal place ofbusiness at 1300 Gould Dr., Gainesville, GA 30504.
2. D.efendant Actavis Laboratories FL, Inc. ("Actavis") is a Florida corporation having its
,principal place ofbusiness at 2945 W. Corporate Lakes Blvd, Weston, FL.
3. The court has subject matter jurisdiction, as well as personal jurisdiction over all parties.
B. Background
4. Recro has alleged infringement ofU.S. Patent Nos. 6,902,742 ("the '742 patent") and
9,132,096 (''the '096 patent") against Actavis under 35 U.S.C. § 271(e)(2)(A).
5. Actavis asserted a defense ofnon-infringement of both the '096 and '742 patent.
C. The Patents-in-Suit
6. · The '742 patent, entitled "Multiparticulate Modified Release Composition," issued on
June 7, 2005, to Dr. Devane, Dr. Stark, Mr. Fanning, and Dr. Rekhi as named inventors. The face
ofthe '742 patent claims priority to U.S. Patent Application No. 60/106,726, filed on November
2, 1998. According to the Orange Book, the expiration date ofthe '742 patent is November 1,
2019.
7. "The '096 patent, entitled "Abuse Resistant Pharmaceutical Compositions," issued on
Septe~ber 15, 2015, naming Dr. Rekhi and Dr. Richard Sidwell as inventors. The face ofthe
'096 patent claims priority to September 12, 2014. According to the Orange Book, the expiration
date ofthe '096 patent is September 12, 2034.
1. The Asserted Claims
a. '096 Patent, Claims 1, 4, and 5
Claim 1, 4, and 5 ofthe '096 patent read:
1. An oral pharmaceutical composition comprising a first population ofbeads and a second
population ofbeads; said first bead population comprising a pharmaceutically active ingredient
2 Prior to trial, the parties submitted an exhibit of uncontested facts in conjunction with their Pretrial Order.
(D.I. 114, Ex. 1.) The court takes most of its findings of fact from the parties' uncontested facts. The court has also
reordered and renumbered some paragraphs, corrected some formatting errors, and made minor edits for the purpose
ofconcision and clarity that it does not believe alters the meaning ofthe paragraphs from the Pretrial Order. Otherwise,
any differences between this section and the parties' statement of uncontested facts are unintentional.
The court's findings of fact with respect to matters that were the subject of dispute between the parties are
included in Part III of this opinion ("Discussion and Conclusions of Law"), preceded by the phrase "the court finds"
or "the court concludes."
2
Case 1:14-cv-01118-GMS Document 138 Filed 02/22/17 Page 2 of 29 PageID #: 2813
3. selected from the group consisting ofhydrocodone and pharmaceutically acceptable salts thereof,
wherein said first bead population is substantially free ofpolyethylene oxide; and said second
bead population comprising polyethylene oxide and a permeable or semi-permeable coating
selected from the group consisting of an ammonio methacrylate copolymer, a methacrylic acid
copolymer and a mixture thereof, wherein said second bead population is substantially free of
any pharmaceutically active ingredient.
4. The composition according claim 1, wherein the pharmaceutically active ingredient is
hydrocodone bitartrate.
5. The composition according to claim 4, wherein the hydrocodone bitartrate is present in an
amount offrom 5 to 250 mg.
b. '742 Patent, Claims 1, 6, 13, 14, 16, and 19
Claims 1, 6, 13, 14, 16, and 19 ofthe '610 Patent read:
1. A multiparticulate modified release composition comprising a first population of active
ingredient-containing particles and at least one subsequent population of active ingredient-
containing particles, the active ingredient contained in the first population being an opiate and
the active ingredient in the subsequent population being an opiate or non-opiate, wherein the
subsequent population of active ingredient-containing particles further comprise a modified
release coating or, alternatively or additionally, a modified.release matrix material, such that the
composition following oral delivery to a subject delivers the active ingredients ofthe first and
subsequent populations in a pulsatile manner.
6. The composition according to claim 1, wherein the subsequent population comprises opiate-
containing particles.
13. The composition according to claim 6, wherein at least one ofthe active ingredients ofthe
first and subsequent populations comprises hydrocodone or a pharmaceutically acceptable salt
thereof, an enantiomer or mixtures thereof, or mixtures thereof.
14. The composition according to claim 1, wherein the first and subsequent populations have
different in vitro dissolution profiles.
16. The composition according to claim 15, which in operation releases substantially all ofthe
active ingredient from the first population prior to release ofthe active ingredient from the
subsequent population.
19. The composition according to claim 16, wherein the mean in vitro dissolution profile in an
aqueous medium is such that substantially all ofthe active ingredient ofthe first population is .
released within about two hours.
3
Case 1:14-cv-01118-GMS Document 138 Filed 02/22/17 Page 3 of 29 PageID #: 2814
4. D. Zohydro® ER
8. Zohydro® ER extended-release capsules contain hydrocodone bitartrate and are
indicated "for the management ofpain severe enough to require daily, around-the-clock, long-
term opioid treatment and for which alternative treatment options are inadequate." Recro licenses
the '742 and '096 patents to Pernix Therapeutics Holdings, Inc. ("Pernix") and Pernix markets
and sells Zohydro® ER capsules in the United States.
9. The '742 and '096 patents have been listed in the Orange Book in connection with
Zohydro® ER capsules.
E. Actavis' ANDA
10. Actavis submitted ANDA No. 206952 to the FDA seeking approval to market
hydrocodone bitartrate extended-release capsules in the 10, 15, 20, 30, 40, and 50 mg strengths.
11. By letter dated August 12, 2014, Actavis advised Recro's predecessor that it had
submitted ANDA No. 206952 to the FDA seeking approval to manufacture, use, or sell generic
hydrocodone bitartrate extended-release capsules in the 10, 15, 20, 30, 40, and 50 mg strengths
prior to the expiration ofthe '742 patent.
12. By letter dated April 6, 2015, Actavis advised Recro that it had submitted an amendment
to ANDA No. 206952 seeking approval to manufacture, use, or sell generic hydrocodone
bitartrate extended-release capsules in the 10, 15, 20, 30, 40, and 50 mg strengths prior to the
expiration ofthe'742 patent.
13. By letter dated November 10, 2015, Actavis advised Recro that it had submitted ANDA
No. 206952 to the FDA seeking approval to manufacture, use, or sell generic hydrocodone
bitartrate extended-release capsules in the 10, 15, 20, 30, 40, and 50 mg strengths prior to the
expiration ofthe '096 patent.
14. . Recro asserts infringement ofthe following claims against Actavis: claims 1-4, 6, 9, 13-
14, 16 and 19 ofthe '742 patent; and claims 1-2 and 4-5 ofthe '096 patent.
15. C.A. No. 14-1118-GMS commenced on September 3, 2014, before the expiration of45
days :from receipt of Actavis's August 12, 2014 notice letter. C.A. No. 15-413-GMS commenced
on May 21, 2015, before the expiration of45 days :from receipt of Actavis's April 6, 2015 notice
letter. C.A. No. 15-1196-GMS commenced on December 23, 2015, before the expiration of45
days from Recro's receipt ofActavis's November 10, 2015 notice letter. The 30-month stay
deadline against Actavis is February 12, 201 7.
III. DISCUSSION AND CONCLUSIONS OF LAW
The court has jurisdiction over the subject matter of this action pursuant to 28 U.S.C. §§
1331 and 1338(a). Venue is proper under 28 U.S.C. §§ 1391(b), (c), and (d), and 1400 (b). After
4
Case 1:14-cv-01118-GMS Document 138 Filed 02/22/17 Page 4 of 29 PageID #: 2815
5. .having considered the entire record in this case, the substantial evidence in the record, the parties'
post-trial submissions, and the applicable law, the court concludes thatActavis' proposed products
infringe the asserted claims ofthe '096, but do not infringe the asserted claims ofthe '742 patents.
The court's reasoning follows.
A. Infringement
1. The Legal Standard
The determination ofwhether an accused method infringes a claim in a patent has two
steps: (1) construction ofthe claim to determine its meaning and scope; and (2) comparison of
the properly construed claim to the method at issue. See Tanabe Seiyaku Co. v. United States
Int'] Trade Comm 'n, 109 F.3d 726, 731 (Fed. Cir. 1997) (citing Markman v. Westview
Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en bane), ajf'd 5)7 U.S. 370 (1996)). The
patent owner has the burden ofproving by a preponderance ofthe evidence that "every limitation
ofthe patent claim asserted to be infringed is found in the accused [method], either literally or by
equivalent." SmithKline Diag., Inc. v. Helena Lab. C01p., 859 F.2d 878, 889 (Fed. Cir. 1988).
Under this standard, a patent owner does not have to produce "definite" proof of infringement,
but must instead demonstrate that "infringement was more likely than not to have occurred." See
Warner-Lambert Co. v. Teva Pharms., USA, Inc., 418 F.3d 1326, 1341 n.15 (Fed. Cir. 2005)
(citing Advanced Cardiovascular Sys., Inc. v. Scimed Life Sys., Inc., 261 F.3d 1329, 1336 (Fed.
Cir. 2001)). The application of a patent claim to an accused product is a fact-specific inquiry.
See Kustom Signals, Inc. v. Applied Concepts, Inc., 264 F.3d 1326, 1332 (Fed. Cir. 2001).
Even if an accused product differs enough from the claimed product to preclude literal
infringement, the patent owner can establish infringement under the doctrine of equivalents.
Zelinski v. Brunswick Corp., 185 F.3d 1311, 1316 (Fed. Cir. 1999). The doctrine of equivalents
5
Case 1:14-cv-01118-GMS Document 138 Filed 02/22/17 Page 5 of 29 PageID #: 2816
6. analysis seeks to determine "ifthere is equivalence between those elements ofthe accused
product and the claimed limitations ofthe patented invention that are not literally infringed." Id.
Elements ofthe allegedly infringing device and the claimed device are considered equivalent if
the differences between the elements are insubstantial. Id. "One test used to determine
'insubstantiality' is whether the element performs substantially the same function in substantially
the same way to obtain substantially the same result as the claim limitation." Id. at 1316-17.
In the ANDA context, 35 U.S.C. § 271(e)(2)(A) provides that it shall be an "artificial" act
ofinfringement to submit an ANDA "ifthe purpose of such submission is to obtain approval ...
to engage in the commercial manufacture, use, or sale of a drug ... claimed in a patent or the use
ofwhich is claimed in a patent before the expiration of such patent." 35 U.S.C. § 271(e)(2)(A).
The filing of an ANDA only constitutes ~technical act ofinfringement for "purposes of creating
case or controversy jurisdiction." Perring B. V v. Watson Labs., Inc.-Florida, 764 F.3d 1401,
1408 (Fed. Cir. 2014). Once jurisdiction is established, the ultimate infringement inquiry is
determined by traditional patent law principles, requiring "a comparison ofthe asserted patent
claims against the product that is likely to' be sold following ANDA approval." Id.
2. The '096 Patent
Recro asserts that Actavis' ANDA products infringe claims 1, 4, and 5 ofthe '096 patent.
The focus ofthe dispute concerns one claim limitation: "a permeable or semi-permeable coating
selected from the group consisting ofan ammonio methacrylate copolymer, a methacrylic acid
copolymer and a mixture thereof." JTX3, col 3011. 8-12. Recro argues that Actavis'
ethylcellulose-based coating is equivalent to the claimed polyacrylic coatings-"ammonio
methacrylate copolymer, a methacrylic acid copolymer and mixtures thereof." Id.; D.I. 126 at
20. Actavis contends that not only does their ethylcellulose-based coating fail to satisfy the
6
Case 1:14-cv-01118-GMS Document 138 Filed 02/22/17 Page 6 of 29 PageID #: 2817
7. function-way-result test, see Zelinski, 185 F.3d at 1316-17, it also includes a cellulosic polymer
that Recro dedicated to the public and other excipients not permitted by the claims. (D.I. 125 at
8-13).
a. Dedication to the Public
Actavis maintains that Recro dedicated ethylcellulose to the public because cellulosic
polymers were disclosed in the specification, but not claimed. (D.I. 125 at 8). Disclosure
dedication occurs when the patentee "discloses but declines to claim subject matter." Johnson &
JohnstonAssocs. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1054 (Fed. Cir. 2002). Allowing the
patent holder to then recapture that subject matter under the doctrine of equivalents conflicts with
a patent claim's purpose to clearly define the scope ofthe patentee's right. Id. The Federal
Circuit has h.eld, however, that the written description's disclosure of alternatives to the claimed
subject matter does not always dedicate those alternatives to the public. See id. ("This
'disclosure-dedication' rule does not mean that any generic reference in a written specification
necessarily dedicates all members ofthat particular genus to the public."). The disclosure in the
specification inust be specific enough that a skilled artisan "could identify the subject matter that
has been disclosed and not claimed." Id. The court does not find that the disclosure of cellulosic
polymers dedicates ethylcellulose to the public.
The court heard testimony that ethylcellulose is one ofmany cellulosic polymers known
to those having ordinary skill in the art. Dr. Siepmann testified that there are many thousands of
cellulosic polymers in existence, and several dozen that are commonly used in pharmaceutical
formulations. Trial Tr. 113:19-114:2. After mentioning that suitable coating materials include
cellulosic polymers generally, the patent lists types ofthose polymers "such as cellulose acetates,
cellulose alkanylates and cellulose acrylates." JTX3, col. 5 11. 13-15. Dr. Felton, Actavis'
7
Case 1:14-cv-01118-GMS Document 138 Filed 02/22/17 Page 7 of 29 PageID #: 2818
8. expert, stated that ethylcellulose would not fall into any ofthe subcategories listed after the
disclosure of general cellulosic polymers." Trial Tr. 364:1-365:5. The court is therefore
persuaded by Recro's point that, though those having skill in the art might recognize
ethylcellulose as one choice of cellulosic polymer, the specification actually leads one away from
that choice. (D.I. 126 at 9).
The written description and the claims provide notice to the public "as to the subject
matter ofthe patent," and "the scope ofthe invention," respectively. PSC Computer Prod., Inc.
v. Foxconn Int'!, In,c., 355 F.3d 1353, 1358 (Fed. Cir. 2004). The quintessence of such public
notice is the ability to determine what has been taught by the specification and what has been
claimed. See id. at 1360. The court finds that a person skilled in the art would not have been
able to clearly identify that ethylcellulose was disclosed and not claimed, given the generality of
the phrase "cellulosic polymers." The court finds, therefore, that ethylcellulose was not
dedicated to the public.
b. Doctrine of Equivalents
Recro concedes that the Actavis does not literally infringe the asserted claims ofthe '096
patent. (D.I. 126 at 5). Instead, Recro contends that Actavis' ethylcellulose-based coating "is
equivalent to the claimed coatings 'consisting of an ammonio methacrylate copolymer, a
methacrylic acid copolymer and mixtures thereof."' (D.I. 126 at 4 (citing JTX3, col. 30 11. 8-
12)). The court finds Recro's argument persuasive because the ethylcellulose-based coating
performs substantially the same function, in substantially the same way, to obtain the same
result. See Zelinski, 185 F.3d at 1316-17.
The specification ofthe '096 patent explicitly states that the functions ofthe placebo bead
coating are to "provide a physical barrier essentially separating or sequestering the gelling agent
8
Case 1:14-cv-01118-GMS Document 138 Filed 02/22/17 Page 8 of 29 PageID #: 2819
9. from the other components ofthe composition" and to "control (i.e. delay or otherwise limit) the
ingress ofwater into the second bead population, thus restraining the gelling action ofthe gelling
agent." JTX3, col. 4, 1. 66-col. 5, 1. 6. Defendants' expert, Dr. Felton, testified that
ethylcellulose "is the semipermeable membrane that controls the water ingress into the bead."
Trial Tr. 296:20-22. Defendants ANDA also characterizes ethylcellulose as a polymer "widely
used in oral pharmaceutical formulations as a binder, extended release polymer and hydrophobic
coating agent for tablets and granules." JTX35 at 31. Additionally, in discussing the effect of
the pH ofthe dissolution medium on drug release, Actavis explained to the FDA that
ethylcellulose was selected as the "release controlling polymer" because, in the presence of
liquid, it exhibits "pH independent swelling and permeating of drug molecules across the
membrane." JTX35 at 21. The court finds that Defendants statements in the ANDA and Dr.
Felton's testimony support Plaintiffs' assertion that the ethylcellulose-based coating performs the
same function as the claimed polyacrylic coatings. See Bayer AG v. Elan Pharm. Research
Corp., 212 F.3d 1241, 1248 (Fed. Cir. 2000) (holding that courts can consider statements made
in the ANDA to instruct their infringement analysis).
The claimed polyacrylic coating behaves differently depending on how it is used. When
the claimed composition is administered orally and intact the "[w]ater from the surrounding
environment is absorbed through the coating ofthe gelling agent-containing beads which, upon
contact with the gelling agent, causes the beads to swell." JTX3, col. 911. 33-36. Eventually,
the swelling ofthe beads causes the coating to rupture. Id. ll. 36-38. Though rupture ofthe
gelling-agent containing beads causes the gelling agent to form a viscous mass, the gel does not
interfere with the release ofthe drug from the active ingredient-containing beads when taken as
directed. Id. 11. 45--49. This is due to how the bead population disperses along the
9
Case 1:14-cv-01118-GMS Document 138 Filed 02/22/17 Page 9 of 29 PageID #: 2820
10. gastrointestinal tract. Id. II. 31-33. When the claimed composition is crushed or dissolved in a
small amount ofwater, however, the gelling agent creates a viscous mass, trapping the active
ingredient, and assuring that it cannot be drawn up into a syringe. Id. II. 50-55.
Defendant's expert, Dr. Felton, testified that ethylcellulose in Actavis' placebo beads
functions to restrict the ingress offluid into the bead and is often used in the preparation of
pharmaceutical coatings capable ofrupture. Trial Tr. 355:17-25. The rupturable nature ofthe
ethylcellulose-based coating is clear from the examples adduced at trial demonstrating the
"rupture sequence" of both an ethylcellulose based coating and the methacrylate coating. PTX
56 (methacrylate coating); PTX 68 (ethylcellulose coating). The sequences appear substantially
similar, ifnot identical.
Dr. Felton explained that the way Actavis' product works is that ifit. is ingested as a
capsule, "the capsule [will] dissolve, and the individual beads, both drug containing bead and
placebo, a gelling bead, will separate, and as long as they separate sufficiently far away from
each other, then they won't interfere with the release ofthe active ingredient." Trial Tr. 354:19-
25. Dr. Felton agreed with Plaintiff's counsel that Actavis' product has abus·e deterrent
properties without changing the in vitro release ofhydrocodone when the product is used as
intended. Trial Tr. 355:1-5. The Addendum to Product Development Report for Actavis'
generic product supports Dr. Felton's testimony, attesting to the fact that "[t]he presence of
placebo beads is not intended to alter the drug sequence." JTX35 at 20. The court finds that the
combination ofthe statements in the ANDA along with Dr. Felton's testimony is enough to
conclude that Actavis' ethylcellulose-based coating functions in substantially the same way as
the claimed coating.
10
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11. Lastly, the result ofthe polyacrylic coating in the placebo bead is that it deters abuse
when the product is crushed or dissolved in a small amount ofwater. See Trial Tr. 111:11-13.
When taken as directed, however, it allows the patient to receive the same in vivo active-
ingredient exposure as they would without the coating. Id. Dr. Felton testified that Actavis'
placebo beads achieve the same result. See Trial Tr. 355:1-5.
Defendants argue Plaintiffs failed to prove infringement under the doctrine of equivalents
because Plaintiff's expert, Dr. Siepmann, did not properly account for the excipients in Actavis'
coating. (D.I. .125 at 11). Defendants contend that because the claim language requires the
coating be "selected from the group consisting of an ammonio methacrylate copolymer, a
methacrylic acid copolymer and a mixture thereof," the presence of any other excipients is
explicitly excluded. Id. The court is not persu~ded.
The court finds that excipients are not excluded by the language of claim 1 ofthe '096
patent. In Warner Chilcott Co., LLCv. Zydus Pharmaceuticals (USA) Inc., No. CA 11-1105-
RGA, 2013 WL 1729383 (D. Del. Apr. 22, 2013.), Judge Andrews confronted a very similar
issue to the one the court faces here-does a Markush group limit "the entirety ofthe 'inner
coating layer' to the specifically listed polymers?" Id. at *5. Judge Andrews concluded that a
· person having ordinary skill in the art would not find excipients excluded from the Markush
claim because excipients, solvents, and carriers are "naturally associated with pharmaceutical
formulations." Id. Excipients, therefore, could be understood to be unrelated to the actual
invention because they were not used in a novel fashion. Id. The court finds that identical
reasoning can be applied here.
Although the claim phrase "consisting of' is ordinarily found to signify exclusion, in the
'096 patent, "consisting of' only serves to limit the universe ofpolymers that can be present in
11
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12. the coating. The phrase does not limit the presence of excipients, solvents or carriers ubiquitous .
to pharmaceutical preparations. Dr. Felton testified that triethyl citrate was a common excipient
in drug coatings. Trial Tr. 360:7-8. The '096 patent itself also states that "[t]he coating may
further comprise plasticizers, pore forming agents, anti-adherents or other excipients." JTX3,
col. 5 11. 24--26. The court thus finds that excipients like talc and triethyl citrate are not excluded
by Markush claim style.
Defendants maintain that because triethyl citrate is a pore former, its presence in Actavis'
placebo bead coating could impact its function, undermining the doctrine of equivalents analysis.
(D.I. 125 at 11-12). The court finds Defendant's argument unconvincing given its statements in
the ANDA. Defendants acknowledged that triethyl citrate could alter the permeability
characteristics oftl~.e coating. JTX030 at 51. They represented to the FDA, however, that "the
risk of [t]riethyl [c]itrate affecting dissolution is low because it's [sic] level ofuse in the current
formulation is fixed at 10 weight percent ofthe ER." Id. In fact, Defendants explicitly stated
that both triethyl citrate and talc have a "negligible effect on drug dissolution." Id. at 56. As a
result, the court finds that the presence of excipients in Actavis' coating does nothing to
undermine the doctrine of equivalents analysis.
c. Dependent Claims 4 and 5
There is really no dispute that Actavis' ANDA product meets the limitations of
dependent claims 4 and 5. Claim 4 discloses "[t]he composition according to claim 1, wherein
the pharmaceutically active ingredient is hydrocodone bitartrate." JTX3, col. 30 11. 19-20.
Claim 5 requires a "composition according to claim 4, wherein the hydrocodone bitartrate is
present in an amount of from [sic] 5 to 250 mg." JTX3, col. 30 11. 21-23.
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13. Actavis' ANDA document discloses a "[q]uality [t]arget [p]roduct [p]rofile (QTPP) for
[h]ydrocodone [b]itartrate ER [c]apsules" where the dosage strength is 10, 15, 20, 30, 40, and 50
milligrams. JTX30 at 4, 16-17. The court thus finds that Actavis' ANDA product infringes
dependent claims 4 and 5 in addition to independent claim 1.
3. The '742 Patent
Recro asserts that Actavis' product infringes claims 1, 6, 13, 14, 16, and 19 ofthe '742
patent. The dispute centers around two claim limitations: (1) "comprising a first population of
active ingredient-containing particles and at least one subsequent population of active ingredient-
containing particles," JTX2 col. 15 11. 61-64; and (2) "delivers the active ingredients ofthe first
and subsequent populations in a pulsatile manner." Id. col. 1611. 4-5. Recro argues that
Actavis' products literally infringe both claim limitations, and alternatively that Actavis' product
infringes the first claim limitation under the doctrine of equivalents. (D.I. 126 at 12-15).
a. A first and subsequent population of active ingredient-
containing particles
The '742 patent specification lists a multitude ofmultiparticulate modified release
compositions. The patent states that typically, "the dosage form may be a blend of different
populations of active ingredient containing particles which make up the immediate release and
the modified release components, the blend being filled into suitable capsules." JTX2, col. 1011.
38--42. The patent also explains that the different populations of active ingredient-containing
particles can be compressed into "mini-tablets," or further, formed into a multilayer tablet. Id. 11.
43--48.
The evidence presented at trial demonstrated that Actavis' active ingredient-containing
beads do not comprise a first and subsequent population of active ingredient containing particles.
Instead, Actavis' product can be described as a multilayer tablet. Dr. Felton described a tablet
13
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14. where a drug layer, containing hydrocodone, polyethylene glycol, and water, is layered on top of
a sugar sphere. Trial Tr. 309:21-312:25. A release controlling barrier is subsequently layered
on top ofthe drug layer, and on top ofthe barrier layer, there is another drug layer, again with
hydrocodone bitartrate, polyethylene glycol, and water. Id. Recro argues that Actavis' product
still falls within the scope ofthe claim because the specification explicitly allows for a multilayer
tablet. The patent makes clear, however, that the first and second population ofparticles are
different from each other-"the subsequent population ofactive ingredient-containing particles
further comprises a modified release coating or, alternatively or additionally, a modified release
matrix material." JTX2, col. 1511. 67-col. 1611. 3. As Dr. Felton stated, both active ingredient
layers are the same. The subsequent drug layer, as Dr. Felton called it, does not comprise a
modified release coating or a modified release material. The release-controlling barrier layer is
on top ofthe layer containing the active-ingredient.
Recro argues that Actavis' product does, in fact, have two populations of active
ingredient-containing particles-one with a sugar sphere, a drug layer, and an extended release
coat and another with just a sugar sphere and a drug layer. (D.I. 126 at 13-14). Dr. Siepmann,
Recro's expert, testified that what Actavis' essentially did was take the "particle" without the
extended release coat and put it on to the "particle" with the extended release coat. Trial Tr.
85:12-20. The court finds Recro's argument unpersuasive. The claim requires that the particles,
plural, comprise a modified release coating. JTX2, col. 1511. 67-col. 1611. 3. According to Dr.
Siepmann's testimony, there would only be one active ingredient-containing particle with an
extended release coating in each ofActavis' pellets. Thus, from a semantic perspective, a sugar
sphere with a drug layer and an extended release layer cannot be considered a subsequent
population of active ingredient-containing particles.
14
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15. In the alternative, Recro tries to argue that the active-ingredient-containing particles are
the individual particles ofhydrocodone contained in Actavis' pellets. Again, the court is not
persuaded. Hydrocodone bitartrate is present in the pellets as a crystal. Even Dr. Siepmann,
refers to the active ingredient as a drug crystal. Trial Tr. 91 :5-6. It is unclear to the court what
could be considered an active-ingredient containing particle in a layer that could more aptly be
described as a population ofpolyethylene glycol, water, and drug crystals. Moreover, claim 1 of
the '742 patent requires that the active ingredient-containing particles themselves comprise the
modified release coating or the modifie4 release matrix material. JTX3, col. 1611. 1-3. Recro
offers no arguments for how that is possible given their alternate construction for active
ingredient-containing particles.
Because the court concludes that Actavis does not literally infringe the first and
subsequent population of active ingredient-containing particles limitation, it must determine
whether Actavis infringes under the doctrine of equivalents. Recro maintains that, even
assuming Actavis' product does not contain a first and subsequent population ofactive
ingredient-containing particles, there is no substantial difference between Actavis' approach and
the claimed approach. (D.I. 126 at 14). Dr. Siepmann testified that the function and result of
both the one- and two-pellet approach are to "deliver the drug in a specific manner," i.e. a
pulsatile manner. Trial Tr. 87:8-10, 25-88:1. The court finds that the active ingredient in
Actavis' product, with first and subsequent active ingredient-containing layers separated by a
release-controlling barrier, is delivered in a pulsatile manner, see infra § III.A.3.b-c.
Accordingly, the court moves on to analyzing whether pulsatile delivery is achieved in the same
way by the claimed product and Actavis' product.
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16. The specification ofthe '742 patent makes clear that active ingredient is released from ·
the first population of active ingredient-containing particles, followed by a subsequent release of
active ingredient-containing from the second population of particles. JTX2, col. 411. 37-48. The
patent also allows for situations where the first population releases the active ingredient rapidly
and the second population releases the active ingredient over an extended period oftime. JTX2,
col.8 11. 35-44. The ANDA reveals a very similar mode of action. In Actavis' product, the
''two-stage coating" works by releasing twenty percent ofthe total dose immediately, followed
by the extended release of eighty percent ofthe dose. JTX20 at 20. So, regardless of whether
the first and subsequent releases of active ingredient come from different layers of one multilayer
tablet or different particles all together, the releases are achieved in the same way; the first
release occurs from the first population of particles or a first layer, and a subsequent release
occurs from a second population ofparticles or a second layer. Because the court finds that
Actavis' multilayer tablet differs insubstantially from Recro's claimed first and subsequent
population of active ingredient-containing particles, Actavis' product meets the first limitation of
claim 1.
The court wishes to note that the La Manna reference played no role in its analysis. It is
not clear to the court whether Actavis is trying to use the reference to assert a theory of
prosecution history estoppel or whether Actavis is simply trying to underscore its point that its
multilayer tablet with a discrete barrier layer would not be equivalent to the claimed dosage
form. (D.I. 125 at 14). Either way, the statements made to the Patent Office during the
prosecution ofthe La Manna application have no effect on Recro's ability to assert infringement
under the doctrine of equivalents. See Festa Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co.,
535 U.S. 722, 734 (2002) (explaining that ifthe original patent application once claimed the
16
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17. purported equivalent, but during patent prosecution the patentee narrowed the claim to obtain the
patent, the patentee cannot later recapture that subject matter through the doctrine of
equivalents).
The statements made with regard to the La Manna reference were made on January 11,
2007, long after the '742 patent issued on June 7, 2005. See id. at 724 ("Estoppel arises when an
amendment is made to secure the patent and the amendment narrows the patent's scope.").
Though prosecution history of a related application may limit application ofthe doctrine of
equivalents in a later filed patent, Al-Site Corp. v. VS! Int'!, Inc., 174 F.3d 1308, 1322 (Fed. Cir.
1999) (emphasis added), it can by no means affect the application ofthe doctrine of equivalents
in an earlier filed patent without vitiating the very purpose ofthe doctrine. Here, the statements
clearly were not made to secure the patent considering they were made after the '742 patent
issued. For that reason, the court declines to consider the statements made to the Patent Office
during prosecution ofthe La Manna patent.
b. Delivers the active ingredients of the first and
subsequent populations in a pulsatile manner
Claim I ofthe '742 patent requires that following oral delivery, the composition "delivers
the active ingredients ofthe first and subsequent populations in a pulsatile manner." JTX2, col.
1611. 4-5. The court's December 29, 2015, claim construction order construed the phrase to
mean "following oral delivery to a subject provides a first pulse of an active ingredient release,
followed by at least one subsequent pulse of active ingredient release, producing a plasma
concentration profile characterized by two or more peaks interspersed with low concentration
troughs." (D.I. 69 at 1-2).
Recro argues that Actavis' dissolution data disclosed in the ANDA demonstrated that the
release from its products involves two pulses of active ingredient. (D.I. 126 at 16). Actavis
17
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18. -
counters that the term "pulse" would be synonymous with "burst" to a person of skill in the art.
Trial Tr. 329:23-24. The court finds that regardless of what a person having ordinary skill in the
art would interpret the term "pulse" to mean, a "burst" of active ingredient is not required by the
patent or the court's claim construction. See Phillips v. AWHCorp., 415 F.3d 1303, 1313 (Fed.
Cir. 2005) ("[T]he person of ordinary skill in the art is deemed to read the claim term not only in
the context ofthe particular claim in which the disputed term appears, but in the context ofthe
entire patent, including the specification."). Accordingly, the court finds Actavis' argument
unpersuasive on this point.
The '742 patent explains that "[t]he number ofpulses in the profile ... in operation will
depend on the number of active ingredient containing components in the composition." JTX2,
col. 6 11. 16-19. Embodiments listed in the patent specification also allow for a number of
combinations of active ingredient-containing components. The first component can be an
immediate release or a time-delayed immediate release component. JTX2, col. 8 11. 5-10. The
second component can be a time-delayed immediate release, a time-delayed sustained release or
an extended release component. JTX2, col. 8 11. 11-16. Because the patent states that the
number ofpulses will depend on the number of active ingredient-containing components, and
such an interpretation does not interfere with the court's claim construction ruling, the court
finds that Actavis' product meets that limitation.
Actavis' ANDA states that the goal ofthe company's research and development efforts
was to create a dosage form that provided an initial rapid release followed by a sustained release.
JTX30 at 46. They achieved that goal by "loading 80% ofthe dose onto active pellets that were
coated with an ER coat" and then, on top ofthe ER coat, applying "an over-coat of
[h]ydrocodone [b]itartrate equivalent to 20% ofthe dose." Id The type of active ingredient-
18
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19. containing components used in Actavis' product-immediate and extended release
components-fall within the scope of claim 1 ofthe '742 patent. Interpreting the claim term
"pulse" in accordance with Dr. Felton's proposed construction--essentially requiring two
immediate-release components-would cause a preferred embodiment to fall outside ofthe
claim scope. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996)
(explaining that an interpretation that reads a preferred embodiment out ofthe claim scope is
rarely, if ever, correct). Because Actavis' product contains two active ingredient-containing
components falling within the scope of claim 1, as evidenced by its statements in the ANDA, the
court finds that Actavis product meets the first and subsequent pulse claim limitation in claim 1
ofthe '742 patent.
The applicant's discussion ofthe Paradissis reference during prosecution ofthe parent of
the '742 patent, U.S. Patent No. 6,228,398, does nothing to undermine the court's findings. The
Paradissis reference taught a pharmaceutical composition "comprising 0-50% of an immediate
release particle and up to 100% of an extended release particle capable of approaching a zero
order release rate of a drug during a 12 to at least 24 hour period." DTX512 at 5. The applicants
explained that a zero order release rate meant that the drug was released at a constant rate over
time. Id. The Applicants contrasted that release rate with the pulsatile release oftheir own drug,
which, they stated, "means a first pulse of active ingredient release is followed by a period of
negligible active ingredient release, the period of negligible active ingredient release is followed
by at least one second pulse of active ingredient release." DTX512 at 5-6.
Actavis tries to argue that the period of negligible release is somehow required by the
claims because ofthe applicant's statements with regard to this parent application. (D.I. 125 at
17). Actavis also interprets the term "zero-order release rate" to mean a "sustained release
19
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20. system designed to release the drug over an extended time frame." Id. First, the court's claim
construction does not require a negligible release ofactive-ingredient. (D.I. 69 at 1-2). Further,
the prosecution history establishes that Paradissis could be a one hundred percent extended
release particle with a constant release rate. Actavis' product is certainly not analogous to the
product disclosed in the Paradissis reference. Actavis' own ANDA states that the goal oftheir
research and development work was to "formulate a dosage form that provides an initial rapid
release followed by a sustained release," not a one hundred percent extended release particle.
JTX30 at 46. The Paradissis reference, therefore, has no effect on the court's infringement
analysis ofthe pulsatile release claim limitation.
c. Plasma concentration characterized by two- or more
peaks interspersed with low concentration troughs
As previously mentioned, the court construed claim 1 to require not just a first and
subsequent pulse of active ingredient, but also "a plasma concentration profile characterized by
two or more peaks interspersed with low concentration troughs." (D.I. 69 at 2). Actavis
contends that its three bioequivalence studies show no evidence that administering its product to
patients causes plasma concentration profiles that meet the court's construction. (D.I. 125 at 18-
19). Recro argues, however, that because some patients experienced plasma concentration
profiles characterized by two or more peaks interspersed with low concentration troughs,
Actavis' product meets the claim limitation. (D.I. 126 at 18). The court finds Recro's argument
persuasive.
It is well established that a finding of direct infringement can be predicated on
circumstantial evidence demonstrating that at least one person directly infringed an asserted
claim. See Toshiba Corp. v. Imation Corp., 681F.3d1358, 1364 (Fed. Cir. 2012); Lucent
Techs., Inc. v. Gateway, Inc., 580 F.3d 1301, 1317 (Fed. Cir. 2009); i4i Ltd. P'ship v. Microsoft
20
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21. Corp., 598 F.3d 831, 850 (Fed. Cir. 2010). Further, claim 1 ofthe '742 patent references "oral
delivery to a subject." The court construed "a subject" in accordance with its plain and ordinary
meaning. (D.I. 69 at n.1). The facts at issue here bear a striking resemblance to those analyzed
by ChiefJudge Stark in Research Found. ofState Univ. ofNY v. Mylan Pharm. Inc., 809 F.
Supp. 2d 296 (D. Del. 2011), vacated-in-part on other grounds, 531 F. App'x 1008 (Fed. Cir.
2013).
In Research Found., Mylan maintained that their generic drug did not infringe the
claimed drug because it did not meet the claim limitation requiring a "steady state blood
concentration of doxycycline of between 0.3 µg/ml to 0.8 µg/ml." Id. at 330. Mylan presented
evidence at trial that the mean minimum blood concentration value of 31 subjects was 0.164
µg/ml. Id. Chief Judge Stark found that the claims-at-issue were not directed to mean values,
however. The claims instead were directed to administering a single pill and treating a single
patient. Id. Accordingly, the court held that "even if only 1 of 31 subjects in the pivotal pK
study had a Cmin of 0.3 to 0.6 µg/ml, [that was] a sufficient basis from which to find
infringement." Id. at 330-31. The court finds Recro's analysis of individual subject's plasma
concentration profiles proper given Research Found and the claim limitation's focus on
administering the composition to a subject.
Here, Recro presented evidence that at least seven individuals in the ACT-15030
bioequivalence study had plasma profiles exhibiting two or more high concentration peaks
interspersed with low concentration troughs. JTX41 at 2-7. The 15030 study reported subject's
plasma concentration levels between zero and thirty hours after they were given ten milligrams
ofhydrocodone bitartrate extended release capsules. Id. Recro's expert, Dr. Fleckenstein,
showed that subject 1028 in the ACT-15030 study exhibited the claimed plasma concentration
21
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22. profile. Trial Tr. 205:17-206:1. Dr. Fleckenstein presented both the data from Actavis' 15030
clinical study report, JTX41 at 2, and his own graph ofthat data. PDX236. Dr. Fleckenstein
explained that subject 1028 exhibited a rapid absorption ofthe drug indicated by a sharp rise in
hydrocodone concentration in the subject's blood-from zero concentration upon administration
to 7.613 hydrocodone concentration after two hours. JTX41at2; Trial Tr. 205:17-22. At three
hours, subject 1028 had a hydrocodone plasma concentration level of 6.927, a drop from the
peak experienced at two hours. Dr. Fleckenstein explained that this was the low concentration
trough required by claim 1 because it was consistent with the dissolution data reported in
Actavis' ANDA. Trial Tr. 229:5-14.3
Dr. Fleckenstein summarized all of Actavis' in vitro dissolution tests found in Actavis'
ANDA. JTX45 at 51, 54, 57, 60, 63, 66, 117, 129, 141, 153, 165, 177; PDX223. The
dissolution data from the Clinical Summary section ofthe ANDA, for the six different dosage
forms (10mg-50mg), had sampling times at 0, 1, 2, 4, 6, 8, 10, 12, 14, and 16 hours. JTX45 at
51, 54, 57, 60, 63, 66. Dr. Fleckenstein testified that hydrocodone, being a highly soluble
compound, dissolves very rapidly. Trial Tr. 192:6-10. It was, therefore, important to have more
3
Dr. Fleckenstein also pointed to data in the Zohydro® New Drug Application ("NDA"), JTXlO at 93, to support
his testimony that Actavis' ANDA product likely had a "two to two and a halfhour lag time built in before release
ofthe second component." Trial Tr. 206:2-6. The court could not consider that data, however. "It is error for the
court to compare in its infringement analysis the accused product or process with the patentee's commercial
embodiment or other version ofthe product or process; the only proper comparison is with the claims ofthe patent."
Zenith Labs v. Bristol-Myers Squibb Co., 19 F.3d 1418, 1423 (Fed. Cir. 1994). There is an exception to that maxim
where the commercial embodiment meets all ofthe claim limitations. See Adams Respiratory Therapeutics, Inc. v.
Perrigo Co., 616 F.3d 1283, 1288 (Fed. Cir. 2010). Upon analysis ofthe Zohydro® NDA, the court realized that it
likely made an error in its Markman Opinion. See (D.I. 69 at 1-2). As previously mentioned, the court construed
"pulsatile manner" in claim 1 ofthe '742 patent to mean "producing a plasma concentration profile characterized by
two or more peaks interspersed with low concentration troughs." Id. After analyzing the NDA, it appears that
Zohydo®, for which the '096 patent is listed in the Orange Book, does not even meet the pulsatile release claim
limitation as construed by the court. Figure 45 in the NDA-a graphical representation ofthe in vitro mean plasma
concentration levels ofhydrocodone over time-shows no sign ofthe "low concentration trough" required by the
court's construction. During claim construction, the court did not have the benefit of the data disclosed in the NDA,
however. Accordingly, it would constitute clear error for the court to credit Dr. Fleckenstein's testimony comparing
Actavis' product to Zohydro®.
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23. frequent sampling times than each hour. More frequent sampling was specifically needed for at
least the first four hours because that is when the dissolution rates are rapidly changing due to the
combination of an extended release layer and immediate release layer in Actavis' product. Trial
Tr. 249:5-9. Dr. Fleckenstein used the control group data from Actavis' alcohol dose dumping
study to get more frequently sampled data for his analysis ofthe dissolution rate of Actavis'
product. Id. at 192:13-16.
The table that Dr. Fleckenstein created, using both the alcohol dose dumping control
group data and the general dissolution studies' mean data, demonstrates that in the first fifteen
minutes after administration ofthe ANDA product, nineteen percent ofthe hydrocodone
dissolved. PDX224; Trial Tr. 193:16-21. Over the next forty-five minutes, another nineteen
percent slowly dissolved. Trial Tr. 193:22-25. Between one and four percent dissolved every
fifteen minutes until the two-hour time-point. PDX224. Between two and four hours, and
additional twenty-five percent ofthe total hydrocodone dissolved. Id. Between the four- and
six-hour time-points, only another thirteen percent ofthe total hydrocodone dissolved. Id. The
court finds that Dr. Fleckenstein's analysis ofthe dissolution data shows an immediate release
between zero and fifteen minutes. Id. There is then a slower rate of release over the next hour
and forty-five minutes, where only another nineteen percent in total is released. Id. There is
. then another release somewhere between the two and four-hour time-points because the percent
dissolved increased during that two-hour window. Id. After the four-hour time-point, the
amount ofhydrocodone dissolved between each time-point slowly declined. Id. The court finds
that Dr. Fleckenstein's testimony, along with the dissolution data, support the assumption that
the dip in subject 1028's plasma profile actually reflects the low-concentration trough required
by the claims. Ifthere is another release of hydrocodone from the subsequent layer between two
23
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24. and four hours after administration, it follows that there would be a dip in the amount of
hydrocodone present in the subject's blood prior to that release because the body has
metabolized most ofthe initial release. See Trial Tr. 217:22-218:24.
Some subjects, like subject 1018, exhibited low concentration dips in their blood plasma
profiles after 4 hours. JTX41 at 2, 5. Dr. Fleckenstein distinguishes those dips from the actual
low concentration trough associated with Actavis' drug delivery system by explaining that,
according to the clinical protocol, the subjects were fed after four hours. Trial Tr. 208: 13-20.
Dr. Fleckenstein explained that food will "stimulate flow to the liver" and cause "variability in
the clearance ofthe drug." Id. The court finds Dr. Fleckenstein's testimony credible. It is also
buttressed by Actavis' own data stating that "[i]nter-assay precision ofthe assay was determined
by the% [coefficient of variation] ofthe [quality control] samples for Hydrocodone from all
acceptable batches and it ranged from 2.7 to 3.3%." JTX33 at 22. The high accuracy ofthe
assay employed directly contradicts Actavis' explanation for why the court must consider mean
subject plasma concentration data-"the assay that is used [] could contribute to variability."
(D.I. 125 at 21). The court thus finds that Actavis' product meets the plasma profile limitation of
claim 1 of the '742 patent because at least some patients exhibited the claimed profile.
Actavis suggests the court consider the mean values for the group of subjects because of
the variability in an individual's blood concentration over time. (D.I. 125 at 21); Trial Tr. 442:1-
8. Again, the court finds that argument unavailing. Dr. Fleckenstein testified that because ofthe
complicated absorption characteristics for hydrocodone, there will be a lot of intra-subject
variability-each subject will absorb and metabolize the drug slightly differently. Trial Tr.
217:22-218:24. If anything, the intra-subject variability underscores the importance of
analyzing individual data because, as Plaintiffs Expert, Dr. Fleckenstein, testified, "the use of
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25. mean values would 'average[] out' the variability and smooth out the profiles." (D.I. 126 at 18
(citing Trial Tr. 204:14-205:2)).
Actavis also takes issue with the fact that "Dr. Fleckenstein's conclusions rely on single-
point dips in blood plasma concentration levels in 16 out ofthe 112 subjects in the three studies
conducted." (D.I. 125 at 21). Recro persuasively points out, however, that the patent does not
require a particular curve shape with specific peak height and trough depths. (D.I. 126 at 19).
The patent explains that those in the art are aware that the plasma concentration curve will be
influenced by the active ingredient used, the delay in release ofthe active ingredient from each
component, the coatings used in or on the components, and the nature of release from the
components. JTX2, col. 8 11. 1-27. "Depending on the duration ofthe lag time between the
release of active ingredient from each component and the nature ofthe release ... the pulses in
the plasma profile may be well separated and clearly defined peaks ... or the pulses may be
.superimposed to a degree ...." JTX2, col. 8 11. 27-34. Neither the patent nor the court's claim
construction require a specific amount oftime for which a peak: or a trough must persist.
Actavis' arguments on this point do nothing to undermine the court's finding that Actavis'
product meets the claimed plasma profile limitation.
d. Dependent claims 6, 13, 14, 16, and 19
Dependent claim 6 ofthe '742 patent discloses the "composition according to claim 1,
wherein the subsequent population comprises opiate-containing particles." JTX2, col. 1611. 15-
17. Actavis' ANDA clearly states that the extended release layer comprises hydrocodone.
JTX35 at 28. Trial testimony established that hydrocodone bitartrate is an opioid. Trial Tr.
178:11-12. Actavis, therefore infringes claim 6 ofthe '742 patent.
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26. Claim 13 ofthe '742 patent requires "[t]he composition according to claim 6, wherein
at least one ofthe active ingredients ofthe first and subsequent populations comprises
hydrocodone or a pharmaceutically acceptable salt thereof." JTX2, col. 1611. 36-40. The
ANDA establishes that both layers-the immediate release and extended release layers--of
Actavis' product comprise hydrocodone. JTX35 at 28.
Claim 14 requires "[t]he composition according to claim 1, wherein the first and
subsequent populations have different in vitro dissolution profiles." JTX2, col. 16 11. 41-43.
The combination ofthe average dissolution data from Actavis' in vitro dissolution studies and
the more frequently sampled data from the alcohol dose dumping studies clearly indicate
different in vitro dissolution profiles for the immediate release and extended release components
ofActavis' product.
Actavis disclosed in its ANDA that the initial rapid release followed by a sustained
release was achieved "by loading 80% ofthe dose onto active pellets that were coated with an
ER coat," and then loading "[o]n top ofthe ER coat, an over-coat of [h]ydrocodone [b]itartrate
equivalent to 20% ofthe dose." JTX30 at 46. The average dissolution data that Dr. Fleckenstein
collated into a chart, PDX224, and a graph, PDX225, demonstrated that nineteen percent ofthe
hydrocodone in the product dissolved within the first 15 minutes of administration. JTX45 at
117, 129, 141, 153, 165, 177. Another nineteen percent dissolved over the next hour and forty-
five minutes. Id. At two hours, thirty-eight percent of hydrocodone had dissolved, and at four
hours sixty-three percent had dissolved. JTX45 at 51, 54, 57, 60, 63, 66. The amount dissolved
slowly decreased for the remaining time points-6, 8, 10, 12, 14, and 16. Id. The rate of
dissolution was never as high as it was in the first fifteen minutes. Trial Tr. 193:16-21. The
dissolution data that Dr. Fleckenstein presented at trial clearly matched the goals of Actavis'
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27. formulation as outlined in their ANDA. See JTX30 at 46. About twenty-percent ofthe drug
dissolved immediately, and the remaining eighty-percent ofhydrocodone that came from the
layer behind the extended-release coating, dissolved slowly over the remaining fifteen hours and
forty-five minutes. JTX45 at 51, 54, 57, 60, 63, 66, 117, 129, 141, 153, 165, 177.
Dr. Fleckenstein also presented evidence allowing the court to conclude that the
immediate release oftwenty-percent ofhydrocodone does, in fact, come from the first active
ingredient layer ofActavis' product, whereas the extended dissolution of eighty-percent of
Actavis' product comes from the subsequent active ingredient containing layer ofActavis'
product. PDX227. Dr. Fleckenstein analyzed the ANDA dissolution data for just the extended
release component of Actavis' drug., JTX43 at 2; JTX42 at 1. Dr. Fleckenstein testified that he
subtracted the dissolution percentage for the extended release form ofthe drug from the total
percentage dissolved at those time points disclosed in the in vitro dissolution studies. Trial Tr.
194:22-195:5. This analysis demonstrated that, in the first hour, most ofthe dissolution ofthe
drug comes from the first active-ingredient containing layer, with only an average ofnine-
percent ofthe extended release component contributing to the total amount dissolved. PDX227;
JTX43 at 1,2. Recro persuaded the court that it is more likely than not that Actavis' product
infringes claim 14 ofthe '742 patent.
Claim 16 discloses a form of the composition of claim 1 where "substantially all of the
active ingredient from the first population" is released "prior to release ofthe active ingredient
from the subsequent population." JTX2, col. 16 11. 48-51. As previously mentioned, Actavis
loaded twenty-percent ofthe hydrocodone dose in a layer on top ofthe extended release layer.
Actavis intended for the top active ingredient-containing layer to release immediately upon
administration to the subject. JTX30 at 46. Dr. Fleckenstein's chart, PDX229, summarizing the
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28. data disclosed in Actavis' ANDA, demonstrates that within the first fifteen minutes after
administration ofthe drug, nineteen-percent ofhydrocodone is dissolved. JTX45 at 117, 129,
141, 153, 165, and 177. The first active-ingredient containing layer in Actavis' product contains
twenty-percent ofthe total amount of hydrocodone. The data also demonstrates that only an
average ofnine-percent ofthe extended release component is released within the entire first
hour. JTX35 at 42; PDX227. Accordingly, the court finds that the first active ingredient layer
released substantially all ofthe active-ingredient prior to the release of active ingredient from the
subsequent layer found under the extended release coating.
Claim 19 requires that mean, in vitro dissolution profiles demonstrate that "substantially
all ofthe active ingredient ofthe first population is released within about two hours." JTX2, col.
1611. 64-67. For the reasons previously stated, this claim is clearly infringed by Actavis'
product. In fact, substantially all ofthe active ingredient is released from the first active
ingredient...containing layer within the first fifteen minutes after administration.
B. Remedies
Under 35 U.S.C. § 271(e)(4)(A), the effective date of any Food and Drug Administration
approval of Actavis' ANDA No. 20-6952 shall be a date not earlier than the later expiration date
of the '096 and '742 patents, including any extensions and marketing exclusivities (September
12, 2034). Pursuant to 35 U.S.C. § 271(e)(4)(B), the court finds that Actavis, its officers, agents,
attorneys, and employees, and those acting in privity or concert with any ofthem, should be
enjoined from engaging in the commercial manufacture, use, offer to sell, or sale with the United
States, or importation into the United States of Actavis' ANDA Product prior to the expiration of
the '096 and '742 patents.
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29. IV. CONCLUSION
In sum, the court finds infringement of all of the asserted claims of the '096 and '742
patents.
Dated: FebruaryJ.i-, 2017
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