Starting February 1, 2022, the U.S. Patent and Trademark Office (USPTO) will begin inviting selected applicants to participate in a pilot program to defer subject matter eligibility examination until final disposition of the application or all other rejections have been addressed. The theory behind …›
The increasing presence of data-driven solutions in the healthcare and life sciences sector is apparent from the rise in numbers of patents and patent applications. The number of published bioinformatics patents and patent applications in the last decade has nearly doubled. Bioinformatics …›
The Federal Circuit continues to tighten the standards for written description of functional claims, particularly in the biologics realm, which is putting patent applicants in the position of having to pursue narrow claims directed to specific sequences. At the same time, reliance on the …›
By: Meghan McLean Poon and Kelsey J Roberts Kingman
Genus claims have long been an important component of patent strategy, extending coverage around a lead compound to stop would-be competitors. Recent decisions from the Federal Circuit, however, highlight a tightening standard for written description and enablement of genus claims for biologic inventions, leading …›
10/27/2021 Update: The adopted regulation ((EU) 2021/1873) is now officially published in the Journal of the EU.
In accordance with the vote of the Council of the European Union on October 5, 2021, the European Union has adopted a new regulation aimed at extending the …›
Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a “Comprehensive Plan for Addressing High Drug Prices.” The HHS Report—issued …›
In recent years, there have been various antitrust investigations in the pharmaceutical sector resulting in decisions of the European Commission (EC) and the European Courts.[1] In two recent rulings – “Lundbeck”[2] and “Paroxetine”[3] – the European Court of Justice (ECJ) dealt with settlement agreements …›
Session 11 of the GSAS Harvard Biotech Club and Morrison & Foerster course on Legal Topics for Scientists, Entrepreneurs, and Start Ups was led by Life Sciences Transactions + Licensing partner Wolfgang Schoenig focusing on key EU Intellectual Property. Wolfgang discussed Intellectual Property Rights, …›
Matthew Chivvis, life sciences IP litigation partner in Morrison & Foerster’s San Francisco office led session 5 of our course on Legal Topics for Scientists, Entrepreneurs, and Start Ups. Matthew discussed the Hatch-Waxman and Biologics Price Competition and Innovation Act for generics and biosimilars. …›
Nina Schäfer and Jin Ito contributed to this article.
On November 25, 2020, the European Commission (the “Commission”) published its “Pharmaceutical Strategy for Europe” which outlines the Commission’s multi-year vision for a more patient-centered pharmaceutical system. The strategy aims to achieve various goals through …›
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