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Articles 1 - 7 of 7
Full-Text Articles in Law
Is The Chemical Genus Claim Really “Dead” At The Federal Circuit?: Part Ii, Christopher M. Holman
Is The Chemical Genus Claim Really “Dead” At The Federal Circuit?: Part Ii, Christopher M. Holman
Faculty Works
A 2020 law review article entitled The Death of the Genus Claim (“Death”) purports to document a dramatic shift in the Federal Circuit’s interpretation of 35 U.S.C. 112(a)’s enablement and written description requirements, particularly as applied to chemical genus claims. According to the authors of Death, it has become nearly impossible to obtain a chemical genus claim that will be upheld as valid in the face of a challenge for overbreadth under Section 112(a). Death was cited extensively in Amgens’s successful petition for certiorari in Amgen v. Sanofi, a case asking the Supreme Court to overturn the Federal Circuit’s decision …
The Data Exclusivity Debate In India: Time For A Rethink?, Prashant Reddy T.
The Data Exclusivity Debate In India: Time For A Rethink?, Prashant Reddy T.
Indian Journal of Law and Technology
Data exclusivity or regulatory marketing exclusivity is a concept that has been subject to much debate in the Indian context – with specific reference to the Indian pharmaceutical and agro-chemical industries. This debate has been carried on in the backdrop of obligations under the TRIPS as well as the Indo-EU Free Trade Agreement. In this paper, the author discusses the concept of data exclusivity in the light of the existing regulatory regime for pharmaceuticals and agro-chemicals in India. He also examines various Committee reports to glean the Indian stance on data exclusivity for agro-chemicals as well as pharmaceuticals and the …
Is The National Pharmaceutical Policy, 2012 Really Cheering The Pharma?, Dipika Jain
Is The National Pharmaceutical Policy, 2012 Really Cheering The Pharma?, Dipika Jain
Indian Journal of Law and Technology
The National Pharmaceutical Policy was approved by the Cabinet and notified in 2012. Based on this policy, a new Drugs Price Control Order was notified in May, 2013. As a result, several drugs will come within the ambit of price control under the National list of Essential Medicines (NLEM). The primary purpose of NLEM is to facilitate the rational use of medicines which will allow for cost effective, safe and drugs with efficacy. This paper critically evaluates the provision on exclusion of patented drugs in the recent National Pharmaceutical Policy, 2012 from the Drug Pricing Policy for five years. The …
India’S Tryst With Trips: The Patents (Amendment) Act, 2005, Shamnad Basheer
India’S Tryst With Trips: The Patents (Amendment) Act, 2005, Shamnad Basheer
Indian Journal of Law and Technology
The Patents (Amendment) Act, 2005 introduces pharmaceutical product patents in India for the first time. This Act attempts to balance out competing interests of a variety of stakeholders, including domestic generic medicine producers, foreign multinational pharmaceutical companies and civil society groups concerned with access to medicines. Although this dexterous manoeuvring around competing interests deserves praise, the net result of such a compromise has been a lack of clarity in the law. While highlighting the key aspects of the 2005 amendments and this lack of clarity, this article also focuses on the vexed issue of the likely impact of the new …
Race And Regulation Podcast Episode 6 - Race, Social Inequalities, And Clinical Drug Trials, Jill A. Fisher
Race And Regulation Podcast Episode 6 - Race, Social Inequalities, And Clinical Drug Trials, Jill A. Fisher
Penn Program on Regulation Podcasts
As mandated by the U.S. Food and Drug Administration, clinical trials for new pharmaceuticals enroll healthy people as paid research participants to test for drug safety and tolerability. But the social injustices from these trials are too often overlooked. Drawing on her award-winning book, Adverse Events, Jill Fisher of UNC-Chapel Hill’s Center for Bioethics explains how clinical drug trials attract disproportionate participation by racial and ethnic minorities who then disproportionately assume risks of participating in these trials, often just to stay financially afloat.
Beefing Up Skinny Labels: Induced Infringement As A Question Of Law, Garrett T. Potter
Beefing Up Skinny Labels: Induced Infringement As A Question Of Law, Garrett T. Potter
Notre Dame Law Review
This Note proposes a novel argument for improving the application of induced infringement by splitting its elements into separate questions of fact and law, incorporating the relevant perception and reasoning of both judge and jury. Part I provides a primer of the Hatch-Waxman Act and interactions (and lack thereof) between the USPTO and FDA in regulating pharmaceutical compositions. Part II assesses the historical landscape that led to the codification of induced infringement. Part III concludes by proposing an alternate approach by treating an element of induced infringement as a question of law, rather than a question of fact, and sets …
Eviscerating Patent Scope, Shahrokh Falati
Eviscerating Patent Scope, Shahrokh Falati
Articles & Chapters
The scope of patent claims directed to inventions in the field of pharmaceuticals and biotechnology has been stumped by the Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112. Specifically, the application of a heightened test for enablement of claims to a genus of compounds with functional limitations or a genus of therapeutic antibodies, coupled with an increasingly broader application of the written description doctrine, has resulted in considerable uncertainty in the biopharmaceutical industry. The Federal Circuit’s shift in interpreting 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by splitting the singular …