Posts Tagged: "biotech"

Claim Drafting Issues for Biotech, Chemical and Pharma Patent Applications, Part II: From Indefiniteness to Negative Claim Limitations, Know Best Practices

In our previous blog post, we covered claim construction, Markush Groups, and dependent claim invalidation. As stated previously, while it is impossible to cover all of the various issues related to claim drafting for biotech, chemical and pharma patent applications, in Part II we will highlight some more of the most common issues that may come up, including changes to the law around indefiniteness; product-by-process and means plus function claims; and negative claim limitations.

Report Reveals Danger of Proposed Price Fixing to U.S. Biopharma Innovation

Recently published research conducted by Vital Transformation shows legislative provisions similar to those found in the Inflation Reduction Act of 2022, which allows the U.S. Government to “negotiate” drug prices under a set framework based upon the amount of time a drug has spent on the market, would have significant, negative effects on patient access to new therapies because funding would be severely curtailed for research and development. According to Vital Transformation, the reduction of net earnings due to government price fixing would substantially reduce the amount of research and development of small biotech firms, which would negatively impact future drug discovery and development. The model used in the study estimates that with government price fixing “only 6 of 110 previously approved therapies would be considered ‘not at risk’ of being cancelled, or at very least divested.”

Two Pharma and Biotech Cases to Watch in 2022

As we enter the second month of 2022, the old saying, “If at first you don’t succeed, try, try again” and the famous line, “I’m not dead,” from Monty Python and the Holy Grail, come to mind to describe two issues we’ll be watching closely this year relating to litigation involving small and large molecule therapies. In the first instance, Amgen recently petitioned the Supreme Court to review the Federal Circuit’s affirmance invalidating several patent claims based on the lack of enablement for genus claims. This case comes on the heels of the Supreme Court’s denial of cert. in Idenix Pharms. LLC v. Gilead Sci. Inc., 941 F.3d 1149 (Fed. Cir. 2019) on similar issues. Amgen now hopes for a better result.

CAFC Denies Amgen Petition to Reconsider Enablement Test for Biotech Patents

On June 21, the United States Court of Appeals for the Federal Circuit (CAFC) denied a petition for rehearing and rehearing en banc filed by Amgen Inc., Amgen Manufacturing, Limited, and Amgen USA, Inc. (Amgen) in their case against Sanofi, Aventisub LLC, FKA Aventis Pharmaceuticals Inc., Regeneron Pharmaceuticals Inc., and Sanofi-Aventis U.S. LLC (Sanofi). Judge Lourie was joined by Judges Prost and Hughes in a separate opinion on the denial of the petition for panel rehearing. A group of intellectual property professors; GlaxoSmithKline plc; and Biogen Inc., Bristol-Myers Squibb Company, Corning Incorporated, and Merck Sharp & Dohme Corp. filed amicus briefs.

TRIPS IP Waiver Could Establish Dangerous Precedent for Climate Change and Other Biotech Sectors

While the discussions around waiving intellectual property (IP) rights set forth in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) are currently (and somewhat amorphously) limited to COVID-19 related drug and medical products, it is probably shortsighted to ignore the implications for other technologies critical to sustaining our environment and advancing a more healthful world. In fact, if we want to ensure continued investment in these technologies, we should be very concerned about the message conveyed by the international political tide: if you overcome a challenging scientific problem and your solution has the potential to save lives, be prepared to be subjected to intense political pressure and to potentially hand over your technology without compensation and regardless of the consequences.