- Home
- Books and Journals
- Full Court Press
- Regulation of Pharmaceutical Manufacturers
- Title
- CHAPTER 3 Intellectual Property Issues for Pharmaceutical Manufacturers
CHAPTER § 3.05 Patent Office Alternatives to Patent Litigation
Jurisdiction | United States |
§ 3.05 Patent Office Alternatives to Patent Litigation
[1] AIA Invalidation Proceedings
The AIA, which became law on September 16, 2011, created a new suite of invalidity challenges that can be raised against an issued U.S. patent. These new proceedings were designed to be a cost-effective alternative to district-court litigation. As such, the proceedings are inter partes, are decided primarily on the papers, integrate extremely narrow discovery, and conclude with a final oral hearing in front of a panel of three Administrative Patent Judges (APJs) of the Patent Trial and Appeal Board (PTAB). Since their introduction on September 16, 2012, PTAB invalidation proceedings have become an important tool for defendants in district court and ITC patent-enforcement actions.
Congress also designed the proceedings to have a definitive time frame. By statute, the PTAB must decide whether to institute a trial within approximately 6 months after a petition is filed and must issue a final written decision 1 year after the date of institution. Although the PTAB can extend this 1-year deadline for cause, it very rarely does so. Therefore, in almost every case, an instituted proceeding will be completed approximately 18 months after a petition is filed and no more than 24 months in the few exceptional cases with extensions. Because of the certainty of timing, district-court judges have been more willing to stay co-pending district-court cases during PTAB invalidation proceedings.
[a] Post-Grant Review
Post-Grant Review (PGR) proceedings are available only for patents having a filing date or claim with a priority date after March 16, 2013.390 In a PGR proceeding, a petitioner can challenge the validity of a claim based on any ground under 35 U.S.C. § 282(b)(2) or (3), including anticipation or obviousness based on patents or printed publications, prior public use, prior sale or offers for sale, non-statutory subject matter, lack of enablement, lack of written description, or indefiniteness.391
[b] Inter Partes Review
Inter partes review (IPR) proceedings permit any party, other than the owner of the patent, to challenge the validity of issued patent claims based on patents or printed publications.392 An IPR can be filed at any time after issuance for pre-AIA, first-to-invent patents.393 For AIA patents, an IPR cannot be filed within the first 9 months after issuance or during the pendency of a PGR filed against the patent.394 However, an IPR proceeding must be filed within 1-year after service of a complaint alleging infringement of the patent on the petitioner, the petitioner's real party in interest, or a privy of the petitioner.395 In addition, a petitioner is barred by statute from filing an IPR if the petitioner or the petitioner's real party in interest has already filed a civil action challenging...
To continue reading
Request your trial- Title
- CHAPTER 3 Intellectual Property Issues for Pharmaceutical Manufacturers
- CHAPTER § 3.01 Using Patents to Protect Pharmaceutical Research
- CHAPTER § 3.02 An Overview of Patent Enforcement Actions Under the Hatch-Waxman Act and Biologics Price Competition and Innovation Act
- CHAPTER § 3.03 Litigation Practices and Liability
- CHAPTER § 3.04 Protecting Other Intellectual Property
- CHAPTER § 3.05 Patent Office Alternatives to Patent Litigation
- CHAPTER § 3.06 Licensing Intellectual Property
Subscribers can access the reported version of this case.
You can sign up for a trial and make the most of our service including these benefits.
Why Sign-up to vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Subscribers are able to see a list of all the cited cases and legislation of a document.
You can sign up for a trial and make the most of our service including these benefits.
Why Sign-up to vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Subscribers are able to see a list of all the documents that have cited the case.
You can sign up for a trial and make the most of our service including these benefits.
Why Sign-up to vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Subscribers are able to see the revised versions of legislation with amendments.
You can sign up for a trial and make the most of our service including these benefits.
Why Sign-up to vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Subscribers are able to see any amendments made to the case.
You can sign up for a trial and make the most of our service including these benefits.
Why Sign-up to vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Subscribers are able to see a visualisation of a case and its relationships to other cases. An alternative to lists of cases, the Precedent Map makes it easier to establish which ones may be of most relevance to your research and prioritise further reading. You also get a useful overview of how the case was received.
Why Sign-up to vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.
Subscribers are able to see the list of results connected to your document through the topics and citations Vincent found.
You can sign up for a trial and make the most of our service including these benefits.
Why Sign-up to vLex?
-
Over 100 Countries
Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
-
Thousands of Data Sources
Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
-
Find What You Need, Quickly
Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
-
Over 2 million registered users
Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.