Posts Tagged: "biologics"

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.

New Dance Moves? Purple Book Amendments Require Public Disclosure of ‘Patent Dance’ Patent Lists

Innovator (or “reference”) biologic drug makers and small-molecule drug makers face differing legal obligations with respect to public patent disclosures. Under the Hatch-Waxman Act, reference small-molecule drug makers are required to provide to the U.S. Food and Drug Administration (FDA) a list of the patents covering the active ingredients, compositions, formulations, and methods of treatment for their approved reference drug products, which the FDA in turn is required to publish in its “Orange Book.”  21 U.S.C. § 355(b)(1), (c)(2). The publication of such patents in the FDA Orange Book thus gives all generic drug applicants advance notice of the patents to be asserted by a reference drug maker in future Hatch-Waxman litigation.

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.

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.

USMCA Takes Another Step Forward in 25-3 Senate Committee Vote

The United States Senate Finance Committee today considered the U.S.-Mexico-Canada Agreement (USMCA) in an Open Executive Session and voted 25 to 3 to move the bill forward.

The USMCA enjoys wide bipartisan support, but Senators Pat Toomey (R-PA), Bill Cassidy (R-LA) and Sheldon Whitehouse (D-RI) voted against the bill. Toomey and Cassidy objected largely to process issues, as the Committee was not allowed to present amendments under a fast-track process, while Whitehouse was critical of the agreement’s lack of urgency on climate change. President Donald Trump and House Speaker Nancy Pelosi reached agreement on the USMCA, which would, if ratified, replace the North American Free Trade Agreement (NAFTA), on December 10. Notably for the IP community, the new version struck down provisions that would have expanded regulatory data protection for biologics inventions from five years in Mexico and eight years in Canada to 10 years in both countries.