Bill would curb anti-competitive abuses of the patent system by the pharmaceutical drug industry that restrict access to generic and biosimilar drugs
WASHINGTON– U.S. Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT) introduced the Affordable Prescriptions for Patients Act which would curb major drug companies’ anti-competitive use of patents to protect their prescription drugs and prevent generic and biosimilar competition from coming to market. The bill is designed to encourage competition and give patients greater access to prescription drugs at a cheaper cost without stifling innovation or infringing on patent rights.
“Drug companies have taken advantage of the patent system to maintain their monopoly on certain drugs and prevent generics from coming to market,” Sen. Cornyn said. “These tactics mean Americans are forced to pay more for the life-saving medications they need. This bill puts patients first and reforms the system to encourage the availability of cheaper generics.”
“Using practices that would make the robber barons of the gilded age blush, Big Pharma has crushed competition and stifled access to cheaper generic drugs to squeeze billions out of families, businesses, and the government,” Sen. Blumenthal said. “Through common sense reforms, this bipartisan bill will empower the FTC to fight back against drug companies’ most egregious and monopolistic practices. It represents an important step in reining in Big Pharma’s greed and puts the industry on notice—enough is enough.”
Pharmaceutical manufacturers have been deliberately abusing the patent system to extend their monopolies and to prevent potential competitors from entering the marketplace through tactics like product hopping and patent thicketing.
Product hopping is a tactic used to get around pharmacy-level generic substation laws. Pharmaceutical manufacturers will often make new versions of their drug, with minor reformulations, or will introduce a new version altogether, preventing pharmacists from switching patients to lower-cost generics and forcing patients to the new version.
Patent thicketing is a tactic used by manufactures to deploy multiple patents strategically in order to prevent competition. Manufactures will file for numerous patents on one drug – methods of manufacture, formulations, devices, uses, as well as composition of matter patents – to create a patent thicket in order to extend their exclusivity on the market. Generic or biosimilar manufacturers are forced to fight through the patent thicket before getting their drug approved, which is costly to these would-be competitors and puts them at risk of losing the chance to sell their drug.
These behaviors are intentional and problematic, and they result in higher drug prices for consumers. To help prevent drug companies from deliberately abusing the patent system, the Affordable Prescriptions for Patients Act would codify definitions of product hopping and patent thicketing within the Federal Trade Commission (FTC) Act. This would empower the FTC to challenge them as anti-competitive and enable the FTC to bring antitrust suits against companies who attempt to capitalize on their abuse of the system.
The Affordable Prescriptions for Patients Act is supported by Patients for Affordable Drugs, Coalition for Affordable Prescription Drugs, Campaign for Sustainable Rx Pricing, Vizient, Prime Therapeutics, and Mylan.