Posts Tagged: "biosimilars"

Seventh Circuit Throws Out Antitrust Suit Against AbbVie in Welcome Victory for Patent Rights

The U.S. Court of Appeals for the Seventh Circuit agreed with a district court earlier this week that neither a settlement agreement between AbbVie and a number of generic biologics companies, nor the 132 patents owned by Abbvie covering its blockbuster drug, Humira, violate the Sherman Antitrust Act. This holding, which is significant in its own right, also has broader implications for patent-antitrust analysis.

USPTO to Crack Down on ‘Incremental’ Patents in Response to Biden Executive Order’s Drug Pricing Mandate

The U.S. Patent and Trademark Office (USPTO) yesterday announced in a joint blog post with the Food and Drug Administration (FDA) that the Office plans to execute a number of initiatives aimed at lowering drug prices, as directed in July 2021 by President Joe Biden’s “Executive Order on Promoting Competition in the American Economy.” The announcement came via a blog post jointly authored by USPTO Director Kathi Vidal and Food and Drug Administration (FDA) Commissioner Robert M. Califf. Biden’s Executive Order in part encouraged curbing some pharmaceutical companies’ practices, such as so-called pay-for-delay settlement agreements between brand pharmaceutical companies and generics manufacturers. The Order called for the USPTO and the FDA “to leverage [their] collective expertise in promoting innovation, competition, and the approval and regulation of safe and effective drugs to help provide relief to American families at the pharmacy.”

Bills to Lower Prescription Drug Costs and Boost Biosimilars Sent to Biden’s Desk

The U.S. House of Representatives yesterday approved two bills meant to lower prescription drug prices and sent them on to President Joe Biden for approval. The Advancing Education on Biosimilars Act and the Ensuring Innovation Act were introduced by U.S. Senator Bill Cassidy, M.D. (R-LA) and broadly aim to improve the current market for cheaper generic drugs.

Hatch-Waxman and BPCIA Cases and Trends to Watch in 2021

As we turn the page to 2021, we expect at least two major cases to be resolved that could have long-lasting effects on where and how Hatch-Waxman and Biologics Price Competition and Innovation Act (BPCIA) cases are litigated. Specifically, the future of skinny labels is in doubt, and available venues for Plaintiffs could be significantly narrowed. The number of new drugs eligible for generic competition will also rebound in 2021, but only time will tell if the global pandemic affects the overall number of generic filings. While there are many more Hatch-Waxman and BPCIA developments to watch this year, these are a few that we will be following closely.

Federal Circuit Upholds Patent for Biologic Drug Enbrel; Judge Reyna Dissents

On July 1, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a holding of the U.S. District Court for the District of New Jersey in Immunex Corporation, Amgen Manufacturing, Limited, Hoffman-La Roche Inc. v. Sandoz, Inc., Sandoz International GMBH, Sandoz GMBH, holding that Sandoz failed to prove that the asserted claims were invalid for obviousness-type double patenting (ODP), failure to meet the written description requirement, and obviousness for lack of motivation to combine the prior art references. The ruling for now blocks Sandoz from marketing its biosimilar version (Erelzi) of the popular rheumatoid arthritis drug, Enbrel. Judge Reyna dissented, arguing that certain clauses of the licensing agreement were illusory, thereby rendering the agreement an effective assignment for purposes of ODP.