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
This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.
A) Study in detail about Para - IV filing. B) Case studies for Para - IV Filing.Aakashdeep Raval
This document discusses paragraph IV (P-IV) filings under the Hatch-Waxman Act. It provides details on:
1) P-IV filings allow generic drug companies to file an Abbreviated New Drug Application (ANDA) to challenge a patent before it expires.
2) If the original drug company sues for patent infringement within 45 days, approval is automatically stayed for 30 months.
3) The first generic company to file a successful P-IV challenge receives 180 days of market exclusivity prior to other generics entering.
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 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.
1) When filing an ANDA application, an applicant must provide information on any patents listed for the reference drug in the Orange Book.
2) In its application, a generic applicant must submit one of four certifications regarding the patents: that there are no patents (Paragraph I); any patents have expired (Paragraph II); any patents will expire on a specific date (Paragraph III); or the generic product does not infringe on or the patents are invalid (Paragraph IV).
3) A Paragraph I or II certification allows immediate approval, while a Paragraph III approval is effective after patent expiration. A Paragraph IV certification requires notifying the innovator and may allow early generic entry.
Anda submission and paragraph IV certificationRichaTrivedi16
Anda submission and paragraph IV certification covers topic goals of anda , innovator/generic difference ,hatch waxman act , ANDA certification clauses , Anda review pathway , comparison of diffirent pathway
The document discusses generic drugs and the Abbreviated New Drug Application (ANDA) process. It explains that an ANDA contains data to review and approve a generic drug as a safe and effective alternative to the original brand name drug. It provides details on the Hatch-Waxman Act which established the modern generic drug approval pathway and allows generics to reference clinical data from the branded version. The document also outlines the requirements for generic drugs to be approved as well as the various certification pathways in the ANDA process.
The Hatch-Waxman Act established an abbreviated approval pathway for generic drugs that relies on the safety and efficacy evidence of the branded reference drug. It aims to balance incentives for innovation and generic competition. The Act created ANDAs that allow generics to enter the market after patents and exclusivities expire. It also provides the branded drug up to 30 months to litigate patents against Paragraph IV ANDA challenges and restores some patent term lost during regulatory review.
This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.
A) Study in detail about Para - IV filing. B) Case studies for Para - IV Filing.Aakashdeep Raval
This document discusses paragraph IV (P-IV) filings under the Hatch-Waxman Act. It provides details on:
1) P-IV filings allow generic drug companies to file an Abbreviated New Drug Application (ANDA) to challenge a patent before it expires.
2) If the original drug company sues for patent infringement within 45 days, approval is automatically stayed for 30 months.
3) The first generic company to file a successful P-IV challenge receives 180 days of market exclusivity prior to other generics entering.
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 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.
1) When filing an ANDA application, an applicant must provide information on any patents listed for the reference drug in the Orange Book.
2) In its application, a generic applicant must submit one of four certifications regarding the patents: that there are no patents (Paragraph I); any patents have expired (Paragraph II); any patents will expire on a specific date (Paragraph III); or the generic product does not infringe on or the patents are invalid (Paragraph IV).
3) A Paragraph I or II certification allows immediate approval, while a Paragraph III approval is effective after patent expiration. A Paragraph IV certification requires notifying the innovator and may allow early generic entry.
Anda submission and paragraph IV certificationRichaTrivedi16
Anda submission and paragraph IV certification covers topic goals of anda , innovator/generic difference ,hatch waxman act , ANDA certification clauses , Anda review pathway , comparison of diffirent pathway
The document discusses generic drugs and the Abbreviated New Drug Application (ANDA) process. It explains that an ANDA contains data to review and approve a generic drug as a safe and effective alternative to the original brand name drug. It provides details on the Hatch-Waxman Act which established the modern generic drug approval pathway and allows generics to reference clinical data from the branded version. The document also outlines the requirements for generic drugs to be approved as well as the various certification pathways in the ANDA process.
The Hatch-Waxman Act established an abbreviated approval pathway for generic drugs that relies on the safety and efficacy evidence of the branded reference drug. It aims to balance incentives for innovation and generic competition. The Act created ANDAs that allow generics to enter the market after patents and exclusivities expire. It also provides the branded drug up to 30 months to litigate patents against Paragraph IV ANDA challenges and restores some patent term lost during regulatory review.
The Hatch-Waxman Act established regulations for generic drugs in the US to facilitate generic competition. It created an Abbreviated New Drug Application process for generics to gain approval more quickly by showing bioequivalence to branded drugs. The first generic to challenge a patent via Paragraph IV certification gains 180 days of marketing exclusivity. The Act also allows patent term extensions for branded drugs to compensate for regulatory approval times. While increasing generic competition, it provides benefits to branded manufacturers such as data and market exclusivities as well as patent dispute resolutions.
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 presentation aims at a students focussed perspective of Abbreviated New Drug Application filing with premier regulatory body like USFDA, the eCTD is followed worldwide for drug submission aimed for gaining particular market approvals.When submitted with FDA it is evaluated by CDER. eCTD is further a mandatory submission for ANDAs with FDA and for NDAs with EU and Japan.
Yuvraj Regmi on Hatch-Waxman Act and Amendments and CFRYUVRAJ REGMI
VERY USEFUL PPT FOR UNDERSTANDING HACTH WAXMAN ACT AND CODE OF FEDERAL REGULATION.
THIS PPT HAS BEEN PREPARED FROM VARIOUS SOURCES AVAILABLE ON INTERNET.
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.
This document summarizes the Hatch-Waxman Act, which established regulations for generic drugs in the US. It facilitated generic drug approval through the ANDA process and provided incentives for innovation by granting patent term extensions and periods of market exclusivity. However, it also created loopholes like authorized generics that brand name drugs could exploit to extend their market monopoly. Overall, the Act sought to balance increased generic competition with continued incentives for pharmaceutical innovation.
The document discusses the Abbreviated New Drug Application (ANDA) process for generic drugs. It provides background on the Hatch-Waxman Act of 1984 which established the ANDA pathway. The key points are:
1. The Hatch-Waxman Act aimed to balance innovation and access to medicines by providing incentives for brand and generic drug companies. It allowed generics to rely on brand safety data and established bioequivalence standards.
2. ANDAs contain data to demonstrate a generic drug is bioequivalent to the brand version. This allows generics to enter the market without duplicative clinical trials, lowering costs.
3. The FDA approves ANDAs if generics meet quality standards and their
Abriviated new drug application 505(j) fillingshahnawazQuadir
An abbreviated new drug application (ANDA) allows generic drug manufacturers to file for FDA approval of a generic drug. The ANDA relies on the safety and efficacy data of an approved innovator drug and must demonstrate bioequivalence through bioavailability/bioequivalence studies. There are different types of ANDA applications including Paragraph I, II, III, and IV, with Paragraph IV applications being used when a generic applicant is attempting to enter the market before patent expiration by claiming the patents are invalid or would not be infringed by the generic product. The ANDA review process involves a 30 month stay if the innovator sues for patent infringement within 45 days, during which time the first approved generic receives 180 days of market
This presentation will address Refuse to Receive standards when Submitting ANDAs and Prior approval supplements (PASs) to ANDAs. The presentation highlights deficiencies that may cause FDA to refuse-to-receive an ANDA.
NDA and ANDA regulatory approval processNilesh Gawade
This document discusses the regulatory approval processes for new drug applications (NDAs) and abbreviated new drug applications (ANDAs) in the United States. It explains that an NDA contains extensive clinical and non-clinical data submitted by an innovator company to obtain approval for a new drug. An ANDA contains similar data to demonstrate equivalence to an already approved drug for generic versions after patents have expired. The document provides details on the requirements, review processes, and certification pathways for both NDAs and ANDAs.
The document discusses key aspects of Abbreviated New Drug Applications (ANDAs), including:
1. ANDAs contain data submitted to FDA for review and approval of generic drug products. Once approved, generics can be marketed as lower-cost alternatives.
2. Guidelines provide formats for ANDA sections including chemistry, manufacturing, and bioequivalence data. Electronic submissions are encouraged for consistency and rapid review.
3. Manufacturing and control requirements are important for ANDA approval. From 1977-1992, 105 applications were not approved due to issues in this area.
4. The Hatch-Waxman Act established 180 days of generic marketing exclusivity for the first ANDA applicant challenging a patent
An ANDA contains data submitted to the FDA to review and approve a generic drug product. Once approved, a generic manufacturer can produce and market a safe, low-cost alternative to the innovator drug. All approved drugs are listed in the Orange Book. ANDAs have four types of submissions: Paragraph I for drugs with no listed patents allowing immediate approval; Paragraph II for off-patent drugs; Paragraph III where generics agree not to market until patents expire; and Paragraph IV for generics believing patents are invalid allowing earlier market entry. The examples show drugs with Paragraph III certifications and their patent expiration dates.
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.
ANVISA is the regulatory body for health surveillance in Brazil. It was established in 1999 to protect public health by regulating products and services under health surveillance. ANVISA's mission is to protect and promote health by ensuring hygiene, safety of products and services, and facilitating access. The agency is responsible for surveillance of areas like drugs, cosmetics, food, medical devices, and more. It coordinates the National Health Surveillance System and establishes standards. ANVISA's website provides information on regulations, registered products, permits and more.
This document summarizes the Hatch-Waxman Act, which established the modern system for regulating generic drugs in the US. The Act aims to make generic drugs more accessible by streamlining the approval process for generics while also providing incentives to brand name drug companies. It allows generics to challenge drug patents and grants exclusivity periods to first generic applicants and brand name drugs for new chemical entities. The Orange Book lists approved drug products and related patent information.
International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11
Abstract:
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.
cmc [ chemistry manufacturing control ]Akshay Patil
This document provides information about Chemistry, Manufacturing and Controls (CMC) regulatory affairs. It discusses the responsibilities of CMC regulatory affairs in providing leadership, strategy and regulatory knowledge to achieve approval of pharmaceutical products. It also summarizes key elements included in CMC regulatory submissions like manufacturing sites, analytical methods and quality testing data. The document further discusses post-approval regulatory requirements including post-approval studies and safety surveillance. It provides examples of combination products and medical device regulations. It introduces the Common Technical Document (CTD) format for registration applications and its electronic version (eCTD). Finally, it summarizes some key ICH guidelines.
Regarding the objectives of the act , drug approval that includes both the branded drug and the generic drug approval, new drug exclusivity, about the challenging patent exclusivity, patent term extension and patent litigation under the act ,and the benefits of branded manufacturers will be discussed here .
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
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
The Hatch-Waxman Act established regulations for generic drugs in the US to facilitate generic competition. It created an Abbreviated New Drug Application process for generics to gain approval more quickly by showing bioequivalence to branded drugs. The first generic to challenge a patent via Paragraph IV certification gains 180 days of marketing exclusivity. The Act also allows patent term extensions for branded drugs to compensate for regulatory approval times. While increasing generic competition, it provides benefits to branded manufacturers such as data and market exclusivities as well as patent dispute resolutions.
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 presentation aims at a students focussed perspective of Abbreviated New Drug Application filing with premier regulatory body like USFDA, the eCTD is followed worldwide for drug submission aimed for gaining particular market approvals.When submitted with FDA it is evaluated by CDER. eCTD is further a mandatory submission for ANDAs with FDA and for NDAs with EU and Japan.
Yuvraj Regmi on Hatch-Waxman Act and Amendments and CFRYUVRAJ REGMI
VERY USEFUL PPT FOR UNDERSTANDING HACTH WAXMAN ACT AND CODE OF FEDERAL REGULATION.
THIS PPT HAS BEEN PREPARED FROM VARIOUS SOURCES AVAILABLE ON INTERNET.
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.
This document summarizes the Hatch-Waxman Act, which established regulations for generic drugs in the US. It facilitated generic drug approval through the ANDA process and provided incentives for innovation by granting patent term extensions and periods of market exclusivity. However, it also created loopholes like authorized generics that brand name drugs could exploit to extend their market monopoly. Overall, the Act sought to balance increased generic competition with continued incentives for pharmaceutical innovation.
The document discusses the Abbreviated New Drug Application (ANDA) process for generic drugs. It provides background on the Hatch-Waxman Act of 1984 which established the ANDA pathway. The key points are:
1. The Hatch-Waxman Act aimed to balance innovation and access to medicines by providing incentives for brand and generic drug companies. It allowed generics to rely on brand safety data and established bioequivalence standards.
2. ANDAs contain data to demonstrate a generic drug is bioequivalent to the brand version. This allows generics to enter the market without duplicative clinical trials, lowering costs.
3. The FDA approves ANDAs if generics meet quality standards and their
Abriviated new drug application 505(j) fillingshahnawazQuadir
An abbreviated new drug application (ANDA) allows generic drug manufacturers to file for FDA approval of a generic drug. The ANDA relies on the safety and efficacy data of an approved innovator drug and must demonstrate bioequivalence through bioavailability/bioequivalence studies. There are different types of ANDA applications including Paragraph I, II, III, and IV, with Paragraph IV applications being used when a generic applicant is attempting to enter the market before patent expiration by claiming the patents are invalid or would not be infringed by the generic product. The ANDA review process involves a 30 month stay if the innovator sues for patent infringement within 45 days, during which time the first approved generic receives 180 days of market
This presentation will address Refuse to Receive standards when Submitting ANDAs and Prior approval supplements (PASs) to ANDAs. The presentation highlights deficiencies that may cause FDA to refuse-to-receive an ANDA.
NDA and ANDA regulatory approval processNilesh Gawade
This document discusses the regulatory approval processes for new drug applications (NDAs) and abbreviated new drug applications (ANDAs) in the United States. It explains that an NDA contains extensive clinical and non-clinical data submitted by an innovator company to obtain approval for a new drug. An ANDA contains similar data to demonstrate equivalence to an already approved drug for generic versions after patents have expired. The document provides details on the requirements, review processes, and certification pathways for both NDAs and ANDAs.
The document discusses key aspects of Abbreviated New Drug Applications (ANDAs), including:
1. ANDAs contain data submitted to FDA for review and approval of generic drug products. Once approved, generics can be marketed as lower-cost alternatives.
2. Guidelines provide formats for ANDA sections including chemistry, manufacturing, and bioequivalence data. Electronic submissions are encouraged for consistency and rapid review.
3. Manufacturing and control requirements are important for ANDA approval. From 1977-1992, 105 applications were not approved due to issues in this area.
4. The Hatch-Waxman Act established 180 days of generic marketing exclusivity for the first ANDA applicant challenging a patent
An ANDA contains data submitted to the FDA to review and approve a generic drug product. Once approved, a generic manufacturer can produce and market a safe, low-cost alternative to the innovator drug. All approved drugs are listed in the Orange Book. ANDAs have four types of submissions: Paragraph I for drugs with no listed patents allowing immediate approval; Paragraph II for off-patent drugs; Paragraph III where generics agree not to market until patents expire; and Paragraph IV for generics believing patents are invalid allowing earlier market entry. The examples show drugs with Paragraph III certifications and their patent expiration dates.
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.
ANVISA is the regulatory body for health surveillance in Brazil. It was established in 1999 to protect public health by regulating products and services under health surveillance. ANVISA's mission is to protect and promote health by ensuring hygiene, safety of products and services, and facilitating access. The agency is responsible for surveillance of areas like drugs, cosmetics, food, medical devices, and more. It coordinates the National Health Surveillance System and establishes standards. ANVISA's website provides information on regulations, registered products, permits and more.
This document summarizes the Hatch-Waxman Act, which established the modern system for regulating generic drugs in the US. The Act aims to make generic drugs more accessible by streamlining the approval process for generics while also providing incentives to brand name drug companies. It allows generics to challenge drug patents and grants exclusivity periods to first generic applicants and brand name drugs for new chemical entities. The Orange Book lists approved drug products and related patent information.
International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11
Abstract:
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.
cmc [ chemistry manufacturing control ]Akshay Patil
This document provides information about Chemistry, Manufacturing and Controls (CMC) regulatory affairs. It discusses the responsibilities of CMC regulatory affairs in providing leadership, strategy and regulatory knowledge to achieve approval of pharmaceutical products. It also summarizes key elements included in CMC regulatory submissions like manufacturing sites, analytical methods and quality testing data. The document further discusses post-approval regulatory requirements including post-approval studies and safety surveillance. It provides examples of combination products and medical device regulations. It introduces the Common Technical Document (CTD) format for registration applications and its electronic version (eCTD). Finally, it summarizes some key ICH guidelines.
Regarding the objectives of the act , drug approval that includes both the branded drug and the generic drug approval, new drug exclusivity, about the challenging patent exclusivity, patent term extension and patent litigation under the act ,and the benefits of branded manufacturers will be discussed here .
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
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
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
The document discusses regulations around Abbreviated New Drug Applications (ANDAs) for generic drugs in the US. It notes that ANDAs must include a patent certification stating that the generic drug will not infringe on patents listed for the branded drug. There are four types of certifications, with Paragraph IV certification asserting a listed patent is invalid or will not be infringed. Filing a Paragraph IV certification allows the first generic to receive 180 days of market exclusivity upon approval. The branded company then has 45 days to sue the generic for patent infringement and trigger a 30-month stay of FDA approval while the case is litigated.
This generally deals with ANDA litigation in United states with Paragraph iv litigation generally. It also emphasizes on Cost involved in ANDA litigation with different methods for reducing the cost.and how many million or billion at stake when Generic and Branded drugs. It also covers the litigation part of District New Jersey that how and in what manner litigation with respect to Hatch-waxman act an is done along with the timelines and CAFC timelines.
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.
ANDAs – Key Regulatory and Legislative IssuesMichael Swit
This document summarizes key regulatory and legislative issues regarding ANDAs. It discusses various market protections available to brand drugs, including patents, statutory exclusivities under the Hatch-Waxman Act, and strategies for defending generic competition. It also outlines recent FDA rules and proposed legislation aimed at preventing anti-competitive behavior between brand and generic drug companies in patent litigation settlements. The document concludes by discussing challenges in developing a pathway for approving generic biologics.
Introduction to the Legal Basis for Generic Drug ApprovalsMichael Swit
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, August 2013. New Brunswick, NJ., with a focus on how the 1984 Hatch-Waxman Act came to be enacted.
Understanding pharmaceutical patents and their intersection with the FDA. Insights into the patent process, from filing to issuance, with a focus on the particularities of pharmaceutical patents, for both small molecules and biologics. Learn how to structure your filings for success, and peer into the complex but valuable interaction between your patents and the FDA regulatory procedure.
This document discusses biosimilars regulation in the United States. It provides background on biosimilars and the Biologics Price Competition and Innovation Act (BPCIA) that established an approval pathway for biosimilars. The BPCIA requires biosimilars to be "highly similar" to an FDA-approved biologic and created provisions for resolving patent disputes between innovators and biosimilar applicants known as the "patent dance." A key case, Amgen v. Sandoz, addressed whether biosimilar applicants must follow the patent dance and provide notice of commercial marketing after FDA approval. The U.S. Solicitor General recommended the Supreme Court review issues in the case that will impact
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.
An Abbreviated New Drug Application (ANDA) allows generic drug manufacturers to file an application to obtain approval for a generic version of an approved drug. The ANDA contains data to demonstrate the generic drug is bioequivalent to the reference listed drug. If approved, the generic drug can provide a safe, effective, and lower-cost alternative to patients. The ANDA process helps expedite approval of generic drugs and increase competition in the pharmaceutical market.
Intellectual property is the product or creation of the mind. It is different from other properties in term that it is “intangible”. Hence it needs some different way for its protection.
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 discusses key provisions of the Hatch-Waxman Act, which established the modern system of regulating generic drugs in the US. It aims to balance the interests of branded drug companies, generic companies, and consumers. Some key points covered include:
- It allows generic companies to submit abbreviated new drug applications without repeating clinical trials by proving bioequivalence.
- It provides patent term extensions for branded drugs and 180-day exclusivity periods for first generic applicants challenging a patent.
- It established a pathway for early experimental use of patented drugs and a 30-month stay on generic approvals if patents are challenged.
This document discusses distribution records and the Hatch-Waxman Act. It defines distribution records as written data related to the distribution of drug products from manufacturers to distributors. It notes distribution records should include information like product name, strength, recipient details, and quantities. The document also summarizes the key aspects of the Hatch-Waxman Act, including that it established the Abbreviated New Drug Application process for generics and aimed to balance interests of brand and generic drug companies as well as consumers.
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
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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.
Presentation on Critical Legal Issues Facing GMP ComplianceMichael Swit
August 27, 2018 Presentation to the 23rd Annual GMP by the Sea Conference in Cambridge, Maryland, focusing on the potential legal consequences faced by companies that violate FDA's requirements on Good Manufacturing Practices (GMPs) for drugs and biologics
Overview of FDA Drug Manufacturing RequirementsMichael Swit
Presentation on FDA Regulation of Drug Manufacturing to the Introduction to Drug Law Course sponsored by the Food & Drug Law Institute (FDLI) on July 25, 2018 in San Francisco.
Combination Products, Orphan Drugs, and OTC DrugsMichael Swit
Presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Exam review course on FDA regulation of combination products, orphan drugs, and OTC drugs.
Latest Developments in and the Future of the Regulatory Landscape for Approv...Michael Swit
Presentation on "Latest Developments in and the Future of the
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for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference.
June 25, 2018. San Diego, CA.
Guide on the use of Artificial Intelligence-based tools by lawyers and law fi...Massimo Talia
This guide aims to provide information on how lawyers will be able to use the opportunities provided by AI tools and how such tools could help the business processes of small firms. Its objective is to provide lawyers with some background to understand what they can and cannot realistically expect from these products. This guide aims to give a reference point for small law practices in the EU
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Synopsis On Annual General Meeting/Extra Ordinary General Meeting With Ordinary And Special Businesses And Ordinary And Special Resolutions with Companies (Postal Ballot) Regulations, 2018
Lifting the Corporate Veil. Power Point Presentationseri bangash
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Here are some common scenarios in which courts might lift the corporate veil:
Fraud or Illegality: If shareholders or members use the corporate structure to perpetrate fraud, evade legal obligations, or engage in illegal activities, courts may disregard the corporate entity and hold those individuals personally liable.
Undercapitalization: If a corporation is formed with insufficient capital to conduct its intended business and meet its foreseeable liabilities, and this lack of capitalization results in harm to creditors or other parties, courts may lift the corporate veil to hold shareholders or members liable.
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.
Alter Ego: If there is such a unity of interest and ownership between the corporation and its shareholders or members that the separate personalities of the corporation and the individuals no longer exist, courts may treat the corporation as the alter ego of its owners and hold them personally liable.
Group Enterprises: In some cases, where multiple corporations are closely related or form part of a single economic unit, courts may pierce the corporate veil to achieve equity, particularly if one corporation's actions harm creditors or other stakeholders and the corporate structure is being used to shield culpable parties from liability.
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>.
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2. www.duanemorris.com2
Generic Firm’s Duties, Triggered By
Patents
• Be Aware Of Patent Status
– Infringement = triple damages
– Search Orange Book and PTO
• Patent Certification, 21 CFR 314.94(a)(12)
• Amend Patent Cert. Until ANDA Approval
• Lack of “Duty of Care” Risks Payment of
Attorney’s Fees
3. www.duanemorris.com3
Safe Harbor for ANDA R&D on Patent-
Protected RLD
• History: Court Held “Patent Infringement” Includes Pre-
commercial Testing of Product (Roche v. Bolar, Federal Circuit,
1984)
• Waxman Hatch Act -- Overturned the Court Decision,
Specifically Declaring that Precommercial Testing Is NOT an
Infringement (35 USC Section 271(e)(1))
• Statute Language: Person May Make, Use or Sell a Patented
Drug During the Patent Life If Solely for Uses Reasonably
Related to the Development and Submission of Information
under a Federal Law Which Regulates the Manufacture, Use or
Sale of Drugs
4. www.duanemorris.com4
Safe Harbor for ANDA R&D on
Patent-Protected RLD
• Safe Harbor Applies to Innovator and Generic Firms
(Bristol-Myers Squibb v. Rhone-Poulenc Rorer, S.D.N.Y.
2001, aff’d, 3rd Circuit, 2003)
• “Reasonably Related” Means Having a Decent Prospect that
the “Use” Would Generate the Kind of Information Relevant
to FDA Approval Requirements
– (Intermedics v. Ventritex, N.D.Ca. 1991, aff’d, Federal Circuit, 1993 – clinical
trials on intermediates, yes)
– (Integra Life Sciences v. Merck, Sup. Ct., 2005 – preclinical research to identify
future candidate, yes)
5. www.duanemorris.com5
ANDA Patent Certifications
No -- Orange Book Patent
• Paragraph 1 – Patent
information not submitted to
FDA
• Paragraph 2 – Patent has
expired
• No Relevant Patents
Statement – No Patents exist
Yes -- Orange Book Patent
• Paragraph 3 – Will not market
until patent expires
• Paragraph 4 – Challenging the
patent as invalid, unenforceable
or not infringed
• Little viii Statement – Patent
not infringed because not
seeking approval for that use;
use will not be on label (Method
of Use Carve-Out)
6. www.duanemorris.com6
Labeling Carve-Outs (“Little viii”
Statement)
• Authorized by FFDCA, Sec. 505(j)(2)(A)(v)
– Generic drug must have same labeling as RLD, except for
changes required because of different manufacturers
• Preferred by FDA, 21 CFR 314.94(a)(7), (8)
– Generic labeling may omit an indication or other labeled aspect
that is protected by patent or exclusivity
• Upheld by Courts
– “The statute expresses the legislature's concern that the new generic be safe and
effective for each indication that will appear on its label; whether the label for
the new generic lists every indication approved for the use of the pioneer is a
matter of indifference.“ Bristol Myers Squibb Co. v. Shalala, 91 F.3d 1493, 1500
(D.C. Cir. 1996).
– Sigma-Tau Pharmaceuticals, Inc. v. Schwetz, 288 F .3d 141 (4th Cir. 2002) (orphan
drug exclusivity).
7. www.duanemorris.com7
Labeling Carve-Outs (“Little viii”
Statement)
• Differences must not render the proposed product less safe or
effective than the RLD for all remaining, non-protected
conditions of use. 21 CFR 314.127(a)(7)
• Rapamune (sirolimus) – Carve-out Denied
– 3-yr Excl. for cyclosporine withdrawal regimen, extensive info from
clinical study throughout labeling, protected labeling info essential
to safe and effective use of the drug
– FDA: Labeling contains extensive, critical prescribing info that
doctors should receive to determine treatment for any indication.
Sept. 20, 2004, Docket FDA-2003-P-00002.
• Oxandrin (oxandrolone) – Carve-out Upheld
– 3-yr Excl. for geriatric use, clinical study info in labeling
– FDA: all S&E issues within general adult population are adequately
addressed in labeling without geriatric-specific info. Dec. 1, 2006,
Docket FDA-2005-P-0368.
8. www.duanemorris.com8
Para. IV Patent Certification
• Submit Completed ANDA
• Receive FDA Letter That ANDA Has Been
Received
• Send Notice To NDA Sponsor/Patent Holder
• Notice Must Contain:
- ANDA No. - Drug Info.
- Patent No. - Expiry Date
- Scientific Rationale why no infringement/invalid
- Offer to Provide Access to ANDA, if no infringement
- Legal Brief supporting position
9. www.duanemorris.com9
Para. IV Patent Certification
• Amend ANDA to Inform FDA of Notice
• Get Receipt of Delivery Confirmation and Submit
to FDA, 21 CFR 314.95
• NDA Sponsor Has 45 Days to Sue, Starting Day
After Notice is Received
• Suit Triggers 30-month Stay Against ANDA
Approval
• Amend ANDA “Immediately” to Inform FDA of
Suit
10. www.duanemorris.com10
30-Month Stay Rules
• FDA Is Prohibited From Approving The
ANDA For A Period Of:
– Either 30 Months Counted From Day of NDA
Holder’s Receipt of Notice
– Or Until the Day of a Favorable Court Decision
– Whichever Occurs First
11. www.duanemorris.com11
30-Month Stay Rules
• Definition of “Favorable Court Decision” Is
Date-Dependent
• Before March 2000: Appellate Court, per FDA
Policy
• From March 2000 to Dec. 8, 2003: District
Court, per Court Ruling
• After Dec. 8, 2003, Any of the Following:
– District Court Judgment or Settlement Order
– Appellate Court Judgment or Settlement Order
12. www.duanemorris.com12
30-Month Stay Rules
• FDA Amendments Act of 2007
• Signed September 27, 2007
• 30-Month Stay Can Be Extended if FDA Decides
that a Pending Citizen Petition Must Cause a
Necessary Delay in the ANDA Approval
• Extension Equals Length of Time from FDA’s
Receipt of Petition to FDA’s Grant/Denial of
Petition
13. www.duanemorris.com13
Later-Listed Patents
• Definition: Patents Listed With FDA After An
ANDA Is Filed With FDA
• Whether They Trigger 30-Month Stay
Depends On Before/After Aug. 18, 2003
• Old FDA Regulation: Submit Patent Cert. To
Later-Listed Patents & Notice To NDA Holder.
Effect Is Multiple 30-Month Stays
• MMA: After Para. IV ANDA Is Filed, Submit
Patent Cert. & Notice, But 45-Day Clock & 30-
Month Stay Are NOT Triggered
14. www.duanemorris.com14
180-Day Exclusivity
• Available To ANDAs That Contain a Paragraph
IV Patent Certification
• Awarded For Challenging a Patent (Regardless
Of Success)
• Affect On ANDAs:
– Affects Only Subsequently-Filed ANDAs with
Paragraph IV Patent Certifications
– May Be Filed With FDA, And Reviewed, But Will
Not Be Approved Until Exclusivity Expires
– Results In A Tentative Approval Letter
– May Stop/Restart Due to Pediatric Exclusivity
15. www.duanemorris.com15
Requirements for ANDA Exclusivity
• First Person to Submit Complete ANDA
(“First to File”)
• Containing a Paragraph IV Certification
• Challenging a Patent as Invalid or Not
Infringed
• Notice to Patent Holder and NDA Holder
• Eligible for 180 Days of Exclusivity
16. www.duanemorris.com16
Medicare Modernization Act of 2003
• Rules Governing 180-Day Exclusivity are
Now Date Dependent
– Para. IV ANDAs filed before Dec. 8, 2003 are under “old”
pre-MMA rules
– Para. IV ANDAs filed after Dec. 8, 2003 are under “new”
MMA rules
– For 2nd and 3rd ANDA Filers, “old” pre-MMA rules apply
if First-to-File was Before Dec. 8, 2003
17. www.duanemorris.com17
Medicare Modernization Act of 2003
• Timing of Notice to NDA/Patent Holder
– Before Aug. 18, 2003:
At ANDA Applicant’s Discretion
– After Aug. 18, 2003:
Within 20 Days After ANDA Applicant Receives
Word From FDA That ANDA Is Acceptable to
Be Received
18. www.duanemorris.com18
Medicare Modernization Act of 2003
• Trigger for Start of Exclusivity
– Before Aug. 18, 2003:
Earlier of Date of Favorable Court Decision
in a Patent Lawsuit, or Date of First-to-File’s
First Commercial Marketing
– After Aug. 18, 2003:
First-to-File’s First Commercial Marketing (Only); Includes
Authorized Generic
19. www.duanemorris.com19
Forfeiture of 180-Day Exclusivity
• After December 8, 2003, via Medicare Modernization Act
• New Section 505(j)(5)(D)
• By the Following Actions
– Withdrawal of ANDA
– Amendment or Withdrawal of Paragraph IV Cert.
– Failure to obtain Tentative Approval within 30 Months after
submission of ANDA
– Agreement with another ANDA Applicant, NDA Holder or
Patent Owner, where FTC files a complaint and successfully
argues the agreement violates antitrust laws
– Expiration of all patents that had Para. IV certs.
20. www.duanemorris.com20
Forfeiture of 180-Day Exclusivity …
• By Failure to Market the ANDA Drug by the Later of 2 Dates:
– Date 1: The earlier of the date that is
75 days after ANDA approval, or
30 months after ANDA submission
– Date 2:
75 days after
Final Ct. Decision that patent is invalid or not infringed
Lawsuit Settlement where Court enters final judgment that
states patent is invalid or not infringed
Patent is withdrawn from Orange Book by NDA Holder
For all patents with Para. IV Certs.
By any Para. IV ANDA applicant with Tentative Approval
21. www.duanemorris.com21
Historical Controversies Over 180-Day
Exclusivity
• Must First Filer Be Sued?
• What is a “Court Decision” That Triggers 180-Day
Exclusivity?
– 1999: FDA Regulation Said Appellate Court
– 1997-2000: Court Rulings Said Trial Court
– 2000: FDA Guidance Said First Court That Decides the
Patent Is Invalid, Unenforceable or Not Infringed
– After Aug. 18, 2003: No Court (Only Trigger Is First Filer’s
First Commercial Marketing)
22. www.duanemorris.com22
Problems Interpreting 180-Day
Exclusivity
• Does Later Filer Ever Get ANDA Exclusivity?
• What About Patents Not Filed Promptly With FDA
(“Late Listed” Patents)?
• Can There Be “Shared” Exclusivity?
– Based on Differing Product Characteristics
– Based on Multiple Patents
– Based on Same-Day Filing of ANDAs
• Can the ANDA Applicant Force a Patent Infringement
Suit?
– Possibly, via Declaratory Judgment Action
23. www.duanemorris.com23
Problems Interpreting 180-Day
Exclusivity
• Can exclusivity be “sold”?
• What Are the Potential Consequences of Settling the
Patent Lawsuit?
– Risk of Lawsuit by Plaintiff’s Lawyers, Patient Groups,
Shareholders, Competing Generic Companies, FTC, State
Attorney General
– After Jan. 4, 2004: Must Notify FTC & DOJ Within 10
Business Days of Settlement
– Forfeiture of 180-Day Exclusivity, if settlement “converts”
cert to Para. III