USPTO Launches Program to Defer Subject Matter Eligibility Responses

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 …›

Traversing Higher Hurdles for Functional Limitations Under Section 112

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 …›

Pay-for-Delay has a tough (antitrust) time at EU Top Court

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 …›

The European Commission’s New Pharmaceutical Strategy for Europe

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 …›