Posts Tagged: "patent thickets"

The USPTO was actively working behind the scenes to revise sections of the Manual of Patent Examining Procedure pertaining to the subject of its recent Request for Comments, including policies and procedures relating to restriction, continuation, divisional, double patenting and terminal disclaimer practice. Three days after the RFC response period ended, the USPTO announced publication of a revised version of the MPEP in the Federal Register. The revised MPEP (Ninth edition, revision 07.2022) was made retroactive to July 2022…. An analysis of the revised MPEP reveals that it contains multiple changes that not only fail to address the President’s and Senators’ concerns [patent thickets], but instead actively facilitate more “restriction thickets”.

The U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) today jointly held an all-day listening session featuring speakers from patient advocacy and industry groups, academia, and brand and generic pharmaceutical companies who weighed in on the relationship between patents and affordable access to medicines. The session was announced via a Federal Register Notice and request for comments on the subject, published on November 7, 2022, stemming from a joint July 2022 announcement that the two agencies plan 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 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.

On June 8, a letter signed by a bipartisan group of U.S. senators was sent to U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal voicing concerns over the anti-competitive impacts of so-called “patent thickets,” especially in the drug industry. The senators’ letter urged Director Vidal to address issues of large numbers of patents granted to cover various aspects of a single pharmaceutical treatment, “primarily made up of continuation patents.” The letter, signed by Senators Patrick Leahy (D-VT), John Cornyn (R-TX), Richard Blumenthal (D-CT), Susan Collins (R-ME), Amy Klobuchar (D-MN) and Mike Braun (R-IL), advances a few claims about continuation filings that don’t come from any clear source.

On Thursday, May 9, the Affordable Prescriptions for Patients (APP) Act was introduced into the U.S. Senate by Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT). If passed by Congress and signed into law, the bill would modify the Federal Trade Commission (FTC) Act to give the FTC additional antitrust authority to challenge the anticompetitive nature of certain actions by pharmaceutical patent owners in the service of providing more consumer access to generic and biosimilar drugs.