On May 5, 2021, the Biden Administration announced its support for waiving intellectual property protections for COVID-19 vaccines. Understandably, the news made headlines and stirred passionate reactions from the medical community and IP holders alike. But actually bringing about that
The Patent Playbook
Key Insights on Trends and Legal Developments in Patent Law
The Patent Playbook, published by Proskauer Rose LLP, focuses on issues related to patent law and intellectual property strategy. It covers topics such as patent litigation, inter partes review (IPR) proceedings, patent validity and enforceability, inventorship especially in the context of AI-assisted inventions, venue considerations in patent disputes, and the alignment of patent claims with regulatory approvals. The blog also addresses emerging technologies including artificial intelligence and blockchain, and their impact on patent eligibility and innovation policies. It provides analysis of recent court decisions, government initiatives, and regulatory guidance affecting patent prosecution and enforcement strategies.
Latest from The Patent Playbook - Page 8
Delaware High Court Allows Licensee To Stop Royalty Payments By Disclaiming Patent Claims
In an opinion issued on March 3, 2021, the Supreme Court of Delaware, one of the top commercial courts in the country, overturned a jury verdict that Glaxo Group Limited and Human Genome Sciences, Inc. (collectively, “GSK”) breached the implied…
“Advancing Education on Biosimilars”: Game Changer or More of the Same?
The presidential administration may have changed, but the legislative branch remains focused on issues relating to patient access to drugs. One of these efforts includes P.L. 117-8, the Advancing Education on Biosimilars Act of 2021. Formerly S.164, it was…
When Is Less Really More for a Patent Licensee?
In Apple v. Qualcomm, Federal Circuit Finds No Standing to Challenge Validity of a Few Patents When Many Were Licensed
The development timeline for small-molecule drugs and biologics is lengthy, estimated to take between 10 and 15 years. As a result,…
Induced Infringement of Method of Treatment Claims: Looking to the Label and Beyond
Reference product sponsors often obtain patents claiming methods of using a known drug to treat a condition or disease. Because generic and biosimilar developers typically do not treat patients, and thus do not directly infringe the claims, plaintiffs must sue…
The Impact of the Ensuring Innovation Act on NCE Exclusivity
The Ensuring Innovation Act recently became law after passing in the Senate with unanimous, bipartisan support. According to one Senator, the intent of the legislation was to “close loopholes to prevent awarding market exclusivity to products that do not present…
Generic Competition for Withdrawn Drug Products
By Sarah Cork
When a pharmaceutical company withdraws a product from the market, the basis for the withdrawal can affect whether a competitor can commercialize a generic version of that product. A generic cannot be approved if, in the FDA’s view, the product…
CAFC Tightens Enablement Standard for Functional Claiming of Antibodies
In the recent case of Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit affirmed the district court’s invalidation of certain of Amgen’s antibody patent claims, concluding that the claims were not “enable[d]” under 35 U.S.C. § 112. This decision establishes…
I’ve Been Sued for Patent Infringement… Is an IPR Worthwhile?
By Sarah Cork
Recent Precedential Decisions Applying Fintiv
When a company is sued for patent infringement, often one early strategic consideration is whether to counterattack the patent’s validity at the Patent Trial and Appeal Board (PTAB) in a parallel post-grant proceeding such as inter partes review…