WASHINGTON - U.S. Senator Amy Klobuchar (D-MN) sent letters to six pharmaceutical companies, Abbvie, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Mylan-Viatris, and Teva, requesting the removal of all patents identified by the Federal Trade Commission (FTC) as improperly or inaccurately listed in the FDA Orange Book by the end of the month. In November, the FTC sent warning letters to 10 pharmaceutical companies identifying more than 100 patents that the recipients improperly listed on the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book). The Orange Book identifies approved drug products and patents covering them. Improperly listing patents in the Orange Book can prevent generic - often less expensive - drugs from entering the market. A number of pharmaceutical companies have removed these patents from the Orange Book in response to the FTC’s warning letters, but most have failed to act. The FTC found that improperly listing patents in the FDA Orange Book to deter generic competition can violate antitrust laws.

“As you know, improperly listing a patent in the Orange Book can harm consumers, raise prices, and stifle competition by preventing cheaper generic drugs from entering the market for up to 30 months, and drives up the cost of entry by generic drug manufacturers by pushing them into expensive litigation before entering the market,” wrote Klobuchar.

Klobuchar continued, “While your inventions that benefit consumers deserve strong patent protections, those patents should not be used to box out generic drug competition long after legitimate patent protections have expired. I urge you to remove all remaining patents identified in the FTC’s November 7 letter as quickly as possible.”

The full text of the letters can be found HERE.

In February 2023, two of Klobuchar’s bipartisan bills with Senator Chuck Grassley (R-IA) to promote competition and reduce drug prices - the Preserving Access to Affordable Generics and Biosimilars Act and the Stop STALLING Act - passed the Senate Judiciary Committee. Like Klobuchar’s letters demanding pharmaceutical companies remove improperly listed patents from the Orange book, these bills too would remove barriers to competition from generic drugs.

The Preserving Access to Affordable Generics and Biosimilars Act would limit anticompetitive “pay-for-delay” deals that prevent or delay the introduction of affordable follow-on versions of branded pharmaceuticals. Pay-for-delay deals happen when pharmaceutical drug companies pay brand name companies to delay the introduction of cheaper substitutes – increasing the cost of prescriptions and imposing significant costs on our healthcare system. The legislation covers pay-for-delay deals affecting biosimilar and interchangeable biologics in addition to generic drugs.

The Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics  (Stop STALLING) Act would deter pharmaceutical companies from filing sham petitions with the FDA in order to interfere with the approval of generic and biosimilar medicines that compete with their own brand products, a tactic that delays patient access to affordable medications. The bill would also give the FTC enhanced authority to take action against those who file sham petitions. 

In February 2023, the Klobuchar-supported Affordable Prescriptions for Patients Act also passed the Senate Judiciary Committee. The bill would help lower drug prices by preventing bad actors from using patents to block generic and biosimilar competition from coming to market.