By Myles Starr
The Federal Trade Commission (FTC) sent warning letters last November to several pharmaceutical companies cautioning them that more than 100 patents were improperly or inaccurately listed on the Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). On Jan. 18, Sen. Amy Klobuchar (D-Minn.) sent letters to six pharmaceutical companies identified in the letter that failed to act: AbbVie, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Mylan-Viatris and Teva.
“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 Sen. Klobuchar.
While the senator’s letter did acknowledge that the drug companies provide a valuable service and “inventions that benefit consumers deserve strong patent protections,” it warned that “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.”
On Jan. 29, Sen. Tammy Baldwin (D-Wis.) also sent a letter to AstraZeneca, Boehringer Ingelheim, GSK and Teva calling on the companies “to stop improperly listing patents for inhalers in the Orange Book and stifling competition.”
However, AstraZeneca, Boehringer Ingelheim and GSK, in statements to Endpoints News, defended their use of the Orange Book and stated that they believe they are in compliance with all relevant statutes.
Whether or not the January letters have the teeth to bring about changes in the Orange Book, Sen. Klobuchar has taken several actions against the inflated price of prescription drug costs. As the chairwoman of the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights, alongside Sen. Chuck Grassley (R-Iowa), she introduced two bills that have passed the Senate Judiciary Committee:
The Preserve Access to Affordable Generics and Biosimilars Act authorizes the FTC to “initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product.” It is intended to limit anticompetitive “pay-for-delay” deals that prevent or delay the introduction of affordable versions of branded pharmaceuticals to the market. If passed in its current form, the bill would impose penalties on manufacturers who violate its statutes, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.
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 to interfere with the approval of generic and biosimilar medicines that compete with their own brand’s products. If passed in its current form, the bill would authorize the FTC to sue an individual or entity that submits such a petition to the FDA. A party found liable in such a lawsuit would be subject to civil penalties, such as a fine of up to $50,000 for each day that the FDA spent reviewing the baseless petition.
Neither bill has come up yet for a vote.
