This document discusses several key intellectual property issues related to pharmaceutical products and business transactions. It addresses conducting freedom to operate analyses to identify third party patents, FDA exclusivity periods for drugs, dividing infringement standards, companion diagnostic patents, and ownership considerations regarding academic research partnerships. The document provides examples and case law discussions to illustrate these intellectual property concepts.
When do drug patents expire and when can generic drugs launch?thinkBiotech
From DrugPatentWatch.com - When do drug patents expire, and when can generic drugs launch? An overview of patents, non-patent regulatory exclusivities, and specific US and EU factors influencing generic drug launch.
How Patent and Regulatory Exclusivity can Protect Your Medical Device BusinessMichael Weickert, Ph.D
Medical Device patents are the principal asset around which business transactions are structured. They can help establish a monopoly around the invention or product. Patents should be structured to protect the Business; solving the problem, not just the invention. Regulatory barriers can also protect the business by extending the duration a product dominates a market. Some Combination products (drug plus device, like EpiPen or asthma inhalers) may have access to several important Regulatory exclusivity programs like Orphan, Clinical Investigation exclusivity and QDIP. The goal is to have Regulatory and Patents strategies that work together to strengthen your business by protecting your innovative products from competitors.
This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.
This document summarizes a presentation on navigating regulatory and development pathways for Abbreviated New Drug Applications (ANDAs) and 505(b)(2) New Drug Applications (NDAs) given by patent attorneys Stan Antolin and Walter Boyd. The presentation covers patents, patent infringement, the Hatch-Waxman Act, ANDAs, 505(b)(2) NDAs, and strategies for avoiding patent infringement. It also includes diagrams of typical patent and drug development cycles.
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
Lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focused on:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ cosmetic regulation
This document discusses various types of non-patent market exclusivities that provide legal protection from generic competition for pharmaceutical companies. It describes five types of exclusivities in the US including orphan drug exclusivity which provides 7 years of protection, new chemical entity exclusivity with 5 years, new clinical study exclusivity for 3 years, pediatric exclusivity which extends existing protections by 6 months, and 180 days of exclusivity for being the first generic applicant to challenge a patent. The document also discusses exclusivity regimes in Europe including supplementary protection certificates and India's framework which does not guarantee data exclusivity.
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, August 2013. New Brunswick, NJ., with a focus on the patent provisions of the 1984 Hatch-Waxman Act
In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs. But patents aren’t the whole story; regulatory agencies also offer different forms of exclusivity—enforced by the agencies themselves—to encourage different forms of innovation in the industry. This panel discussed actual and potential roles for those rewards in the context of developing new drugs, new uses for old drugs, and new ways to make drugs, in both the United States and the European Union.
When do drug patents expire and when can generic drugs launch?thinkBiotech
From DrugPatentWatch.com - When do drug patents expire, and when can generic drugs launch? An overview of patents, non-patent regulatory exclusivities, and specific US and EU factors influencing generic drug launch.
How Patent and Regulatory Exclusivity can Protect Your Medical Device BusinessMichael Weickert, Ph.D
Medical Device patents are the principal asset around which business transactions are structured. They can help establish a monopoly around the invention or product. Patents should be structured to protect the Business; solving the problem, not just the invention. Regulatory barriers can also protect the business by extending the duration a product dominates a market. Some Combination products (drug plus device, like EpiPen or asthma inhalers) may have access to several important Regulatory exclusivity programs like Orphan, Clinical Investigation exclusivity and QDIP. The goal is to have Regulatory and Patents strategies that work together to strengthen your business by protecting your innovative products from competitors.
This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.
This document summarizes a presentation on navigating regulatory and development pathways for Abbreviated New Drug Applications (ANDAs) and 505(b)(2) New Drug Applications (NDAs) given by patent attorneys Stan Antolin and Walter Boyd. The presentation covers patents, patent infringement, the Hatch-Waxman Act, ANDAs, 505(b)(2) NDAs, and strategies for avoiding patent infringement. It also includes diagrams of typical patent and drug development cycles.
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
Lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focused on:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ cosmetic regulation
This document discusses various types of non-patent market exclusivities that provide legal protection from generic competition for pharmaceutical companies. It describes five types of exclusivities in the US including orphan drug exclusivity which provides 7 years of protection, new chemical entity exclusivity with 5 years, new clinical study exclusivity for 3 years, pediatric exclusivity which extends existing protections by 6 months, and 180 days of exclusivity for being the first generic applicant to challenge a patent. The document also discusses exclusivity regimes in Europe including supplementary protection certificates and India's framework which does not guarantee data exclusivity.
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, August 2013. New Brunswick, NJ., with a focus on the patent provisions of the 1984 Hatch-Waxman Act
In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs. But patents aren’t the whole story; regulatory agencies also offer different forms of exclusivity—enforced by the agencies themselves—to encourage different forms of innovation in the industry. This panel discussed actual and potential roles for those rewards in the context of developing new drugs, new uses for old drugs, and new ways to make drugs, in both the United States and the European Union.
The document provides an overview of the Waxman-Hatch Act of 1984, which established the modern generic drug approval pathway in the United States. It discusses the reasons for its creation, key provisions such as bioequivalence standards and patent certification requirements, and subsequent amendments. The Act sought to balance increased availability of low-cost generic drugs with incentives for continued pharmaceutical innovation.
The document discusses the FDA's regulatory pathways for medical devices. The FDA uses a risk-based classification system to categorize devices as Class I, II, or III based on risk, with Class III devices posing the highest risk. Class I devices face the fewest regulatory requirements while Class III devices require a rigorous premarket approval process. The key pathways are 510(k) clearance for Class II devices and premarket approval (PMA) for Class III devices. The FDA aims to evaluate devices throughout their lifecycle from premarket through postmarket surveillance to ensure safety and effectiveness.
The Hatch Waxman Act established provisions to balance the interests of branded and generic drug manufacturers as well as consumers. It created the Abbreviated New Drug Application (ANDA) process to streamline generic approval. It also provides incentives like exclusivity periods and a 30 month stay on generic approval to encourage drug development while facilitating generic competition through the ANDA pathway. The Act aims to reduce drug costs over time through increased generic competition.
The document discusses various forms of intellectual property protection including patents, copyrights, trademarks, and trade secrets. Patents provide the strongest protection by giving owners the right to stop others from using their invention, but require public disclosure of how to practice the invention. Copyright and trademark protection have more limited scopes. Trade secrets do not require disclosure but can be lost if the secret becomes public. The document provides examples of intellectual property issues that commonly arise for biotech inventions and businesses.
This document provides an overview and comparison of post-grant review procedures for patents in the US, Europe, China, and Japan. It summarizes the key aspects of each system, including grounds for review, timing, fees, parties involved, estoppel provisions, and appeal processes. The document also analyzes some criticisms of different systems and compares features of the US Post-Grant Review (PGR) process to those of other countries. In particular, it suggests the PGR process addresses some issues seen in Japanese oppositions and avoids overlap problems of Chinese procedures.
medical device regulatory approval in USASuraj Pamadi
The document discusses the approval process for medical devices in the United States, including an overview of the classification system for medical devices (Class I, II, III), the requirements for each class (e.g. 510(k) notification or premarket approval), and the components required for a 510(k) premarket notification application to the FDA.
Patents, Competition, Antitrust and Generic Drugs: Resolving Hatch-Waxman IssuesKirby Drake
This document summarizes the Hatch-Waxman Act and related issues involving patents, competition, and generic drugs. It discusses the Bayer-Barr litigation over the drug Cipro and the resulting antitrust litigation. While private plaintiffs argued the settlement violated antitrust laws by delaying generic competition, courts found the settlement was within Bayer's patent rights as it did not prevent other challenges and fell within the exclusionary zone of the patent. However, conflicts remain around balancing patent and drug competition policies.
SKGF_Presentation_Antibodies, Patents and Freedom to Operate: The Monoclonal ...SterneKessler
This document discusses the importance of freedom to operate (FTO) analysis for companies developing therapeutic antibody technologies. It notes that the patent landscape for antibody technologies has become more complex, making a thorough FTO analysis essential to avoid infringing the patents of others. The document outlines key concepts of patentability and dominance, describes strategies for clearing FTO such as design-arounds, invalidity arguments, and licensing. It provides examples of important patents in antibody humanization, expression, display, and other areas, as well as emerging antibody technologies that may create new patenting opportunities and risks.
The document discusses the Hatch-Waxman Act and its role in facilitating generic drug approvals in the US. It introduced the Abbreviated New Drug Application (ANDA) process which allows generics to piggyback on the clinical trial data of branded drugs. The Act also established the Orange Book database which lists drug patents. Generic companies can file ANDAs with certifications (Paras I-IV) regarding the patents. Para IV filings are the most complex and involve claims of non-infringement or patent invalidity, often leading to litigation between generic and branded companies. The Act aimed to balance increased generic competition with incentives for continued drug innovation.
The Hatch-Waxman Act established an Abbreviated New Drug Application (ANDA) process that allows generic drug companies to piggyback on the safety and efficacy data of branded drugs. It provides incentives for generic drug development and challenges to drug patents. The Act requires patent information be listed in the Orange Book and ANDA applicants must make one of four certifications regarding patents. A Paragraph IV certification for patent invalidity or non-infringement can lead to a patent challenge and 30 month stay of FDA approval for generics. The Act benefits both branded and generic drug companies.
The Hatch-Waxman Act, passed in 1984, aims to balance incentives for drug innovators and generic companies. It established the modern framework for generic drug approval through the ANDA process. This streamlined process requires generics to show bioequivalence rather than repeating clinical trials, expediting market entry. The Act also provides incentives for generics by allowing challenges to drug patents and provisions for patent term extensions to innovators. It created a more efficient pathway for generics while continuing to reward pharmaceutical innovation.
NDA and ANDA regulatory approval processJagrutiKale1
This document provides an overview of New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA). It discusses the requirements and process for submitting both full NDAs for new drugs and ANDAs for generic drugs. The key aspects covered are the format and content of NDA submissions, the review process by the FDA, and the different types of approval letters. It also explains the goals and requirements of the ANDA pathway for generic drugs established by the Hatch-Waxman Act, including the necessary patent certifications and the review process.
What’s In a Name? FDA and Non-Proprietary Names for Biologics/BiosimilarsMichael Swit
April 20, 2018 Presentation to the 11th Biosimilars & Follow-On Biologics 2018 Americas conference on FDA's Policy on Non-proprietary names for Biosimilars
What is IP, Patents in Pharma Industry by Dr Anthony Crasto, a complete guide for patenting in drug synthesis, discovery, process, polymorphs, AN INSIGHT INTO PCT, DATES, CLAIMS, DEFINITIONS ETC, all you want to know about criteria, method mode, advantages etc, EMAIL ME amcrasto@gmail.com, call +91 9323115463
The document summarizes the Code of Federal Regulations Title 21 Part 822, which provides procedures and requirements for post-market surveillance of medical devices. It outlines the subparts which address general provisions, notification, post-market surveillance plans, FDA review and action, responsibilities of manufacturers, waivers and exemptions, and records and reports. The purpose is to implement post-market surveillance authority to maximize collection of useful safety data on medical devices after market release. Manufacturers must submit surveillance plans for FDA approval and are responsible for conducting approved plans to monitor devices and report data and issues.
The Hatch-Waxman Act established in 1984 aimed to make generic drugs more available and reduce costs. It allows generic companies to file Abbreviated New Drug Applications referencing approved branded drugs to expedite approval process. The Act also provides incentives for early patent challenges of branded drugs and compensates branded companies for regulatory approval time lost from patent term. It established a 180-day market exclusivity period for first generic to challenge a patent, but loopholes exist like authorized generics that negatively impact generic competition.
The document discusses key aspects of developing a global regulatory strategy for drug development and registration. It outlines the long development timeline and costs to bring a drug to market. It also describes the regulatory approval processes in the US, EU and Japan, including application formats, timelines and opportunities to expedite review of important new drugs. Developing an integrated global strategy from early research can help optimize the development plan and registration across regions.
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
Lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focused on:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ cosmetic regulation
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
June 24, 2015 lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focus:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ Cosmetic Regulation
The document provides an overview of the Waxman-Hatch Act of 1984, which established the modern generic drug approval pathway in the United States. It discusses the reasons for its creation, key provisions such as bioequivalence standards and patent certification requirements, and subsequent amendments. The Act sought to balance increased availability of low-cost generic drugs with incentives for continued pharmaceutical innovation.
The document discusses the FDA's regulatory pathways for medical devices. The FDA uses a risk-based classification system to categorize devices as Class I, II, or III based on risk, with Class III devices posing the highest risk. Class I devices face the fewest regulatory requirements while Class III devices require a rigorous premarket approval process. The key pathways are 510(k) clearance for Class II devices and premarket approval (PMA) for Class III devices. The FDA aims to evaluate devices throughout their lifecycle from premarket through postmarket surveillance to ensure safety and effectiveness.
The Hatch Waxman Act established provisions to balance the interests of branded and generic drug manufacturers as well as consumers. It created the Abbreviated New Drug Application (ANDA) process to streamline generic approval. It also provides incentives like exclusivity periods and a 30 month stay on generic approval to encourage drug development while facilitating generic competition through the ANDA pathway. The Act aims to reduce drug costs over time through increased generic competition.
The document discusses various forms of intellectual property protection including patents, copyrights, trademarks, and trade secrets. Patents provide the strongest protection by giving owners the right to stop others from using their invention, but require public disclosure of how to practice the invention. Copyright and trademark protection have more limited scopes. Trade secrets do not require disclosure but can be lost if the secret becomes public. The document provides examples of intellectual property issues that commonly arise for biotech inventions and businesses.
This document provides an overview and comparison of post-grant review procedures for patents in the US, Europe, China, and Japan. It summarizes the key aspects of each system, including grounds for review, timing, fees, parties involved, estoppel provisions, and appeal processes. The document also analyzes some criticisms of different systems and compares features of the US Post-Grant Review (PGR) process to those of other countries. In particular, it suggests the PGR process addresses some issues seen in Japanese oppositions and avoids overlap problems of Chinese procedures.
medical device regulatory approval in USASuraj Pamadi
The document discusses the approval process for medical devices in the United States, including an overview of the classification system for medical devices (Class I, II, III), the requirements for each class (e.g. 510(k) notification or premarket approval), and the components required for a 510(k) premarket notification application to the FDA.
Patents, Competition, Antitrust and Generic Drugs: Resolving Hatch-Waxman IssuesKirby Drake
This document summarizes the Hatch-Waxman Act and related issues involving patents, competition, and generic drugs. It discusses the Bayer-Barr litigation over the drug Cipro and the resulting antitrust litigation. While private plaintiffs argued the settlement violated antitrust laws by delaying generic competition, courts found the settlement was within Bayer's patent rights as it did not prevent other challenges and fell within the exclusionary zone of the patent. However, conflicts remain around balancing patent and drug competition policies.
SKGF_Presentation_Antibodies, Patents and Freedom to Operate: The Monoclonal ...SterneKessler
This document discusses the importance of freedom to operate (FTO) analysis for companies developing therapeutic antibody technologies. It notes that the patent landscape for antibody technologies has become more complex, making a thorough FTO analysis essential to avoid infringing the patents of others. The document outlines key concepts of patentability and dominance, describes strategies for clearing FTO such as design-arounds, invalidity arguments, and licensing. It provides examples of important patents in antibody humanization, expression, display, and other areas, as well as emerging antibody technologies that may create new patenting opportunities and risks.
The document discusses the Hatch-Waxman Act and its role in facilitating generic drug approvals in the US. It introduced the Abbreviated New Drug Application (ANDA) process which allows generics to piggyback on the clinical trial data of branded drugs. The Act also established the Orange Book database which lists drug patents. Generic companies can file ANDAs with certifications (Paras I-IV) regarding the patents. Para IV filings are the most complex and involve claims of non-infringement or patent invalidity, often leading to litigation between generic and branded companies. The Act aimed to balance increased generic competition with incentives for continued drug innovation.
The Hatch-Waxman Act established an Abbreviated New Drug Application (ANDA) process that allows generic drug companies to piggyback on the safety and efficacy data of branded drugs. It provides incentives for generic drug development and challenges to drug patents. The Act requires patent information be listed in the Orange Book and ANDA applicants must make one of four certifications regarding patents. A Paragraph IV certification for patent invalidity or non-infringement can lead to a patent challenge and 30 month stay of FDA approval for generics. The Act benefits both branded and generic drug companies.
The Hatch-Waxman Act, passed in 1984, aims to balance incentives for drug innovators and generic companies. It established the modern framework for generic drug approval through the ANDA process. This streamlined process requires generics to show bioequivalence rather than repeating clinical trials, expediting market entry. The Act also provides incentives for generics by allowing challenges to drug patents and provisions for patent term extensions to innovators. It created a more efficient pathway for generics while continuing to reward pharmaceutical innovation.
NDA and ANDA regulatory approval processJagrutiKale1
This document provides an overview of New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA). It discusses the requirements and process for submitting both full NDAs for new drugs and ANDAs for generic drugs. The key aspects covered are the format and content of NDA submissions, the review process by the FDA, and the different types of approval letters. It also explains the goals and requirements of the ANDA pathway for generic drugs established by the Hatch-Waxman Act, including the necessary patent certifications and the review process.
What’s In a Name? FDA and Non-Proprietary Names for Biologics/BiosimilarsMichael Swit
April 20, 2018 Presentation to the 11th Biosimilars & Follow-On Biologics 2018 Americas conference on FDA's Policy on Non-proprietary names for Biosimilars
What is IP, Patents in Pharma Industry by Dr Anthony Crasto, a complete guide for patenting in drug synthesis, discovery, process, polymorphs, AN INSIGHT INTO PCT, DATES, CLAIMS, DEFINITIONS ETC, all you want to know about criteria, method mode, advantages etc, EMAIL ME amcrasto@gmail.com, call +91 9323115463
The document summarizes the Code of Federal Regulations Title 21 Part 822, which provides procedures and requirements for post-market surveillance of medical devices. It outlines the subparts which address general provisions, notification, post-market surveillance plans, FDA review and action, responsibilities of manufacturers, waivers and exemptions, and records and reports. The purpose is to implement post-market surveillance authority to maximize collection of useful safety data on medical devices after market release. Manufacturers must submit surveillance plans for FDA approval and are responsible for conducting approved plans to monitor devices and report data and issues.
The Hatch-Waxman Act established in 1984 aimed to make generic drugs more available and reduce costs. It allows generic companies to file Abbreviated New Drug Applications referencing approved branded drugs to expedite approval process. The Act also provides incentives for early patent challenges of branded drugs and compensates branded companies for regulatory approval time lost from patent term. It established a 180-day market exclusivity period for first generic to challenge a patent, but loopholes exist like authorized generics that negatively impact generic competition.
The document discusses key aspects of developing a global regulatory strategy for drug development and registration. It outlines the long development timeline and costs to bring a drug to market. It also describes the regulatory approval processes in the US, EU and Japan, including application formats, timelines and opportunities to expedite review of important new drugs. Developing an integrated global strategy from early research can help optimize the development plan and registration across regions.
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
Lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focused on:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ cosmetic regulation
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
June 24, 2015 lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focus:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ Cosmetic Regulation
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
August 7, 2013 lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focused on:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ cosmetic regulation
On Saturday, May 4, 2013, the Sino-American Biomedical & Pharmaceutical Professionals Association (SABPA) held its 8th Annual Biomedical Forum. The forum focused on career development, entrepreneurship and the latest innovations in pharma/biotech and medical devices industries. The biomedical forum strives to provide an attractive platform for entrepreneurs, scientists, engineers, investors, executives, and policy makers to promote life sciences, biotech, medical device and alliances across the biomedical industry in Southern California and Asian countries. Knobbe Martens Partner Terry Tullis presented on “Commercialization and Patent Infringement.”
UNDERSTANDING GENERIC VS INNOVATOR BUSINESSKabin Maleku
This presentation includes the basic difference between generic and innovator medicines and outline about various filling pathways for US FDA and Exclusivity and few case studies
This document discusses managing relationships between sponsors and investigators in clinical trials. It outlines the objectives and responsibilities of both parties. The sponsor's objectives include continued study of the test article, meeting enrollment objectives, and obtaining valid data. The investigator's objectives include access to new therapies, prestige from publications, and supplemental income. The sponsor is responsible for developing the protocol, selecting qualified investigators, providing required documents, monitoring investigations, reviewing data, and notifying regulators of issues. The investigator is responsible for complying with all requirements, conducting the study properly, maintaining records, and reporting required information. The document notes potential issues like noncompliance, FDA enforcement actions, and congressional investigations. It provides recommendations to increase compliant collaboration like detailed agreements, training,
Premarket Notification The 510(k) ProcessMichael Swit
June 5, 2012 presentation to the Food & Drug Law Institute Introduction to Medical Device Law Conference, Palo Alto, CA, focusing on:
I.The Legal Framework For 510(k) Determinations
II.510(k) Preparation – From Planning to Content
A. Predicates: researching predicates, combination predicates, and pre-amendment predicates
B. Strategy: choosing the right claim and introducing new features
C. Assessing data requirements/pre-IDE meetings
III. Device Modifications - Choosing The Right Regulatory Mechanism
IV.The FDA Review
V.What To Do When Your Substantial Equivalence Argument Is Rejected
V. Special Topics: User Fees, Combination Products
VI. Lessons Learned: Seeing The 510(k) From The Reviewer’s Perspective
VII. Recent Trends, 510(k) Reform
VIII. Case Study
Intellectual Property Considerations During Nonclinical Drug DevelopmentMaryBreenSmith
Presentation provides a brief overview of regulatory and patent market exclusivities for new drugs. Presentation also covers the types of intellectual property typically arising out of preclinical studies.
Quality Considerations in Due Diligence for Pharmaceutical TransactionsMichael Swit
The document discusses quality considerations in due diligence for pharmaceutical transactions. It outlines general considerations for due diligence structure and challenges. It emphasizes that quality matters because drugs made in non-compliant facilities can be considered adulterated by the FDA and result in criminal and civil penalties. The document provides examples of problems to look for, including manufacturing, pharmacovigilance, compliance history, FDA inspection history, and audits. It discusses techniques for probing issues, including reviewing FDA correspondence and litigation. Special considerations are outlined for different drug development stages. Helpful charts on diligence issues by stage and analyzing identified issues are presented.
Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Suc...Michael Swit
June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.
Many emerging companies make the mistake of putting all of their resources into immediate needs, and often neglect longterm regulatory strategy concerns when it comes to submissions and approvals. Don’t neglect the strategy piece in your planning! This lunch will provide a deep-dive foundation of how to develop a regulatory strategy. Topics to be addressed include:
What are different types of regulatory submissions for devices?
What are current trends in regulatory agencies?
What regulations around devices affect your organization?
Attendees will have the opportunity to ask questions with their company’s needs in mind.
Join us and Halloran Consulting at M2D2 for this expert lunch. Food will be served.
This document summarizes information about biosimilars and the regulatory pathways for their approval in the United States and European Union. It discusses how biosimilars differ from traditional small-molecule generics due to biological molecules' larger size, greater complexity, and manufacturing dependence. The U.S. passed the Biologics Price Competition and Innovation Act in 2010 to create an approval pathway for follow-on biologics, requiring biosimilarity demonstration and possible interchangeability labeling. Upcoming FDA hearings will provide information to guide biosimilar approval requirements regarding analytical and clinical data needs. The E.U. has approved several biosimilars under its regulatory framework established in 2005.
Freedom to Operate in the Pharmaceutical SectorAdrian Bradley
This presentation covers the essential aspects of planning and executing a freedom to operate or patent clearance exercise in the pharmaceutical sector. It deals with the search phase, the analysis phase and the follow-up phase. It is relevant for in-house IP attorneys and development managers.
Market Exclusivity Under the Waxman-Hatch ActMichael Swit
March 19, 2007 presentation to the San Diego County Bar Association IP Section, with a focus on:
•Orphan Drug Exclusivity (Seven Years)
•Five-Year Exclusivity
•Three-Year Exclusivity
•Pediatric Exclusivity (Six Months)
•180-Day Exclusivity
This document summarizes key aspects of intellectual property (IP) management and technology transfer (TT) in the pharmaceutical industry. It discusses practical aspects of patent maintenance, infringement, and exceptions. It provides examples of patent infringement analysis. It also describes different types of TT, the TT process in drug development, facets and means of TT, IP policies at research institutions, and TT agencies in India. Finally, it discusses ethics and values in IP, including compulsory licensing and ethical issues in research and development.
Dr. Liz Wagstrom - Multiple challenges to antibiotic useJohn Blue
The document discusses multiple challenges to antibiotic use from legislative, regulatory, and legal perspectives, including proposed laws to ban non-medical uses of antibiotics also used in humans, new FDA guidance to phase out antibiotic growth promotion and require veterinary oversight for other uses, and a lawsuit challenging the FDA's failure to address safety risks of certain antibiotic uses. The FDA is implementing changes over the next 3-5 years that will likely end most non-medical antibiotic uses and require veterinary oversight through mechanisms like veterinary feed directives.
Sangyun Lee, 'Why Korea's Merger Control Occasionally Fails: A Public Choice ...Sangyun Lee
Presentation slides for a session held on June 4, 2024, at Kyoto University. This presentation is based on the presenter’s recent paper, coauthored with Hwang Lee, Professor, Korea University, with the same title, published in the Journal of Business Administration & Law, Volume 34, No. 2 (April 2024). The paper, written in Korean, is available at <https://shorturl.at/GCWcI>.
Genocide in International Criminal Law.pptxMasoudZamani13
Excited to share insights from my recent presentation on genocide! 💡 In light of ongoing debates, it's crucial to delve into the nuances of this grave crime.
Capital Punishment by Saif Javed (LLM)ppt.pptxOmGod1
This PowerPoint presentation, titled "Capital Punishment in India: Constitutionality and Rarest of Rare Principle," is a comprehensive exploration of the death penalty within the Indian criminal justice system. Authored by Saif Javed, an LL.M student specializing in Criminal Law and Criminology at Kazi Nazrul University, the presentation delves into the constitutional aspects and ethical debates surrounding capital punishment. It examines key legal provisions, significant case laws, and the specific categories of offenders excluded from the death penalty. The presentation also discusses recent recommendations by the Law Commission of India regarding the gradual abolishment of capital punishment, except for terrorism-related offenses. This detailed analysis aims to foster informed discussions on the future of the death penalty in India.
The presentation deals with the concept of Right to Default Bail laid down under Section 167 of the Code of Criminal Procedure 1973 and Section 187 of Bharatiya Nagarik Suraksha Sanhita 2023.
Business law for the students of undergraduate level. The presentation contains the summary of all the chapters under the syllabus of State University, Contract Act, Sale of Goods Act, Negotiable Instrument Act, Partnership Act, Limited Liability Act, Consumer Protection Act.
Corporate Governance : Scope and Legal Frameworkdevaki57
CORPORATE GOVERNANCE
MEANING
Corporate Governance refers to the way in which companies are governed and to what purpose. It identifies who has power and accountability, and who makes decisions. It is, in essence, a toolkit that enables management and the board to deal more effectively with the challenges of running a company.
सुप्रीम कोर्ट ने यह भी माना था कि मजिस्ट्रेट का यह कर्तव्य है कि वह सुनिश्चित करे कि अधिकारी पीएमएलए के तहत निर्धारित प्रक्रिया के साथ-साथ संवैधानिक सुरक्षा उपायों का भी उचित रूप से पालन करें।
Integrating Advocacy and Legal Tactics to Tackle Online Consumer Complaintsseoglobal20
Our company bridges the gap between registered users and experienced advocates, offering a user-friendly online platform for seamless interaction. This platform empowers users to voice their grievances, particularly regarding online consumer issues. We streamline support by utilizing our team of expert advocates to provide consultancy services and initiate appropriate legal actions.
Our Online Consumer Legal Forum offers comprehensive guidance to individuals and businesses facing consumer complaints. With a dedicated team, round-the-clock support, and efficient complaint management, we are the preferred solution for addressing consumer grievances.
Our intuitive online interface allows individuals to register complaints, seek legal advice, and pursue justice conveniently. Users can submit complaints via mobile devices and send legal notices to companies directly through our portal.
Safeguarding Against Financial Crime: AML Compliance Regulations DemystifiedPROF. PAUL ALLIEU KAMARA
To ensure the integrity of financial systems and combat illicit financial activities, understanding AML (Anti-Money Laundering) compliance regulations is crucial for financial institutions and businesses. AML compliance regulations are designed to prevent money laundering and the financing of terrorist activities by imposing specific requirements on financial institutions, including customer due diligence, monitoring, and reporting of suspicious activities (GitHub Docs).
Safeguarding Against Financial Crime: AML Compliance Regulations Demystified
IP business transaction slides
1. IP Issues In Business
Transactions
Marta E. Delsignore, Ph.D.
Keith A. Zullow
January 9, 2018
2. 1
• Are there any third party patents? – Freedom
To Operate (FTO)
• What is the product exclusivity period for my
pharmaceutical product?
IP Analysis For Pharmaceutical Products
3. Freedom To Operate
2
• Are there any problematic 3rd party
patents/published patent applications?
- Identify major competitor patents
- Is design around an option?
- Validity investigation
• Are there any government rights or rights
claimed by another institution (or party) that
need to be considered?
4. 3
Market exclusivity obtained by:
• Patent protection
• FDA exclusivities
The Impact Of Exclusivities
And Patent Protection
5. 4
• Patent protection, including patent term
extensions and patent term adjustment
• Patent term: 20 years from filing or 17 years
from issuance if filed before June 1995
• Extended by USPTO - patent term adjustment
• Extended by FDA - maximum 5 years
• Pediatric exclusivity - additional 6 months if
patent listed in FDA’s Orange Book
Patent Protection
6. 5
• Patents covering product and method of using
product listed in FDA Orange Book
• Lawsuit by patent owner triggers
- 30 month stay of FDA approval of a generic
product
• Coverage by a patent in Orange Book can
provide 7.5 years of protection from product
approval by FDA
Patents Covering Pharmaceutical Product And
Method Of Use Listed In FDA Orange Book
7. 6
• FDA exclusivities: new chemical entity (NCE);
orphan drug; new indication
• NCE - 5 year exclusivity
• Orphan Drug - 7 year exclusivity
• New clinical investigations - 3 year exclusivity
FDA Exclusivities
8. FTO And Ownership Considerations
7
• Can off-label uses be an issue?
• Are there multiple indications on a product
label?
9. FTO And Ownership Considerations
8
• Assess ownership issues
- Ensure that patent/patent application
assignments are in order
- Review agreements covering ownership of IP
- Who has the right to prosecute applications and
enforce patents?
- Any tax transfer issues?
10. FTO And Ownership Considerations
9
• Check for pending litigation challenging or
asserting patents, including post-grant review
proceedings
• Evaluate the scope of patents
- Do they cover the product?
- Is design around possible?
• Evaluate the strength of patents
11. FTO And Ownership Considerations
10
• Do any licenses/in-licenses impact the
potential field of use?
• Contract research organization
• Synthesis/manufacturing
• Supply and purchase agreement can be an on-
sale bar
12. FTO And Ownership Considerations
11
Helsinn v. Teva
• Helsinn agreements with MGI:
(1) license agreement with MGI
(2) supply and purchase agreement with MGI
• Agreement (1): MGI pays $11 M in initial
payments to Helsinn plus additional future
royalties upon product distribution in US
• If FDA did not approve product, Helsinn could
terminate agreement (1) which automatically
would terminate agreement (2)
14. FTO And Ownership Considerations:
Academic Institutions (BYU)
13
• Dr. Simmons of BYU discovered COX-2 enzyme/gene
which allows for screening COX-2 inhibitors
• BYU and Simmons entered a research agreement with
Monsanto (later Pfizer) relating to development of COX-2
inhibitors
• Pfizer ended the agreement
• Pfizer later developed and patented numerous COX-2
inhibitors
- Over 100 patents
- Commercial products, including Celebrex®, Bextra®,
Deramaxx®
15. FTO And Ownership Considerations:
Academic Institutions (BYU)
14
• BYU alleged
- Dr. Simmons should have been named an inventor
- BYU had rights to Pfizer COX-2 inhibitor patents
and products based on original research agreement
• Six year litigation ensues in which BYU sought
billions in damages
• Settlement
- BYU receives $450 million
- BYU establishes Dan Simmons Chair at BYU
16. FTO And Ownership Considerations:
Academic Institutions (Vanderbilt)
15
• Dr. Corbin and others at Vanderbilt University
were among first to discover PDE5 and were
actively researching cGMP analogs
• Dr. Corbin and Glaxo entered a three year
research agreement
- Glaxo underwrites Vanderbilt cGMP analog
research
- Vanderbilt retains ownership of IP
- Glaxo granted license to any discoveries
17. FTO And Ownership Considerations:
Academic Institutions (Vanderbilt)
16
• Dr. Corbin made additional proposals to Glaxo
regarding PDE5 inhibitors, which included
potential inhibitors
• Around the same time, Glaxo researchers
identified PDE5 inhibitors
• Glaxo later seeks and obtains patents,
including the Cialis® patent
18. FTO And Ownership Considerations:
Academic Institutions (Vanderbilt)
17
• Vanderbilt files suit and contends that:
- Glaxo used Vanderbilt information to identify
lead compound
- Glaxo’s patented compounds use the structure
provided by Vanderbilt
- Glaxo could not have identified Cialis® without
reliance on Vanderbilt work
- Dr. Corbin and other Vanderbilt scientists
should be named as inventors
19. FTO And Ownership Considerations:
Academic Institutions (Vanderbilt)
18
• Glaxo contends:
- Work on PDE5 inhibitors was conducted
independently of information from Vanderbilt
- Work on PDE5 inhibitors conducted in France
without use of information from Vanderbilt
• Court concludes that Vanderbilt does not have
any rights to Cialis®
20. FTO And Ownership Considerations:
Academic Institutions (Vanderbilt)
19
• Exemplifies potential issues that arise when
one party obtains information from another
party and seeks patents on alleged
refinements
- Sponsored research
- Licenses
- Contract/supplier discussions
- Other business relationships
21. Enforcement Considerations:
Divided Infringement
20
• Is divided infringement an issue?
- Impacts proof of infringement
- Patent has little value if there is no infringement
• Arises where claim requires multiple actors
- Doctor assesses / patient ingests drug
- Lab assesses / doctor prescribes
- More than one drug; doctor administers one,
patient self-administers the other
22. Enforcement Considerations:
Divided Infringement Standard
21
• Direct infringement requires all claim steps
performed by or attributable to a single entity
• If more than one actor, are acts of one
attributable to the other such that one entity is
responsible?
• One entity responsible for acts of other where:
- Entity directs or controls others’ performance
- Actors form a joint enterprise
23. Enforcement Considerations:
Divided Infringement Standard
22
• Consider traditional agency and contractual
concepts
• Liability also arises where alleged infringer
- Conditions participation in activity/receipt of
benefit on performance of step(s)
▪ Mere guidance or instruction not enough
- Establishes manner or timing of performance
24. Enforcement Considerations:
Divided Infringement Example
23
Eli Lilly v. Teva
• The claims had three steps
- Administer folic acid prior to first administration
of pemetrexed [patient]
- Administer vitamin B12 prior to first
administration of pemetrexed [doctor]
- Administer pemetrexed [doctor]
• Issue was whether the acts of the patient were
directed or controlled by the doctor
25. Enforcement Considerations:
Divided Infringement Example
24
Eli Lilly v. Teva
• Infringement liability found
• Physicians condition pemetrexed treatment on
administration of folic acid and Vitamin B12
- Prescribing information provided support
- Experts provided support
- If patient does not take folic acid as directed,
doctor need not provide pemetrexed
- Verification not required
- Legal obligation not required
26. Enforcement Considerations:
Companion Diagnostics
25
• FDA definition of companion diagnostic: In
vitro diagnostic device that provides
information essential for safe and effective use
of corresponding therapeutic product
• Could be essential to:
- Identify patients most likely to benefit from drug
- Identify patients likely to be at increased risk
- Monitor response so adjustments (e.g.,
schedule, dose) can be made to improve
safety/effectiveness
- Identify patients for whom the therapeutic
product has been adequately studied
27. Enforcement Considerations:
Companion Diagnostics
26
• Companion diagnostic could impact potential
for generic competition
- Generic labeling must reference use of
companion diagnostic
- Carve-out not permitted
• Patents that claim diagnostics often face
validity challenges based on patent eligibility
28. Enforcement Considerations:
Companion Diagnostics – Patentability
27
35 U.S.C. § 101 - Inventions patentable.
Whoever invents or discovers any new and useful
process, machine, manufacture, or composition of
matter, or any new and useful improvement
thereof, may obtain a patent therefor, subject to
the conditions and requirements of this title.
Two part test:
• Step 1: Is the claim directed to a law of nature,
natural phenomenon, or abstract idea?
• Step 2: If yes, does the claim as a whole recite
significantly more than the ineligible subject
matter?
29. Enforcement Considerations:
Companion Diagnostics – Patentability
28
• Trend is for Supreme Court and Federal Circuit
to invalidate patents claiming companion
diagnostics
• Companion diagnostics claims are not per se
invalid
• More likely valid if claiming
- New diagnostic tool
- New combination of old tools that provides an
improvement
30. Enforcement Considerations:
Companion Diagnostics – Patentability
29
Things to look for when considering a patent that
claims a companion diagnostic
• Claims that merely instruct “applying” a newly
discovered correlation
• Characterization of invention in claims and
specification as a method of treatment
• Statements that techniques employed for
diagnostic purposes are “well-known” or
conventional
• Problematic prior art
31. Biologics
30
• Humira is top selling drug worldwide ($17.6B)
• 7 of top 10 selling drugs worldwide are
biologics
• Numerous biologic/biosimilar deals in 2017
- Aurobindo acquired four biosimilar products
from TL Biopharmaceutical
- Fresenius Kabi acquired Merck KGaA’s
biosimilars business
- Catalent agreed to purchase Cook Pharmica
- Agreements established marketing partners
32. Biologics
31
• 4 years of data exclusivity after approval
- No aBLA (biosimilars application) can be
submitted
• 12 years of marketing exclusivity after approval
- No aBLA can be approved
• Additional protection based on patent portfolios
covering antibodies, processes, methods of
use, and other things
33. Biologics – Due Diligence
32
• Broad patent protection
• Litigation is expensive and takes several years
- IPRs/PGRs at PTAB
- 1st wave biosimilars litigation
- 2nd wave biosimilars litigation
• RPS victory or settlement can impact
- When product can be launched
- Uses for which product can be launched
• Due diligence to predict end of exclusivity can
be extensive
34. Biologics – Example
Abbvie v. Amgen (Adalimumab)
33
• Approved 2002 (Abbvie)
• Amgen aBLA accepted by FDA: January 2016
• 1st wave biosimilars litigation
- August 2016
- 10 patents
• Potential 2nd wave biosimilars litigation: 51
additional patents identified
• 13 patents involved in IPR proceedings
35. Biologics – Example
Abbvie v. Amgen (Adalimumab)
34
• Settlement announced: September 2017
- Abbvie grants worldwide licenses on
country-by-country basis
- European launch: October 2018
- US launch: January 2023
36. Questions?
Marta E. Delsignore
Keith A. Zullow
Goodwin Procter LLP
The New York Times Building
620 Eighth Avenue
New York, NY 10018-1405
(212) 813-8800
MDelsignore@goodwinlaw.com
KZullow@goodwinlaw.com
January 9, 2018