WASHINGTON – U.S. Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT) introduced the Affordable Prescriptions for Patients Act, which would help lower drug prices by preventing bad actors’ anti-competitive use of patents to block generic and biosimilar competition from coming to market:

“Texans shouldn’t have to pay more at the pharmacy counter because of bad actors who game the patent system and prevent cheaper generics from coming to market,” said Sen. Cornyn. “This bipartisan legislation would help target these anti-competitive practices and ensure access to lower-cost alternatives.”

“The pharmaceutical industry’s shameless abuse of the patent system has driven costs sky-high for consumers by keeping generics off the market and stifling innovation,” said Sen. Blumenthal. “Our common sense reforms will protect competition and reduce prices at the pharmacy. I’m proud to join Senator Cornyn in this bipartisan effort to ensure patients can afford critical medicine. We’re stopping the music for pharma’s patent dance.”

This legislation is cosponsored by Senators Ted Cruz (R-TX), Dick Durbin (D-IL), Chuck Grassley (R-IA), and Amy Klobuchar (D-MN).

Background:

Some pharmaceutical manufacturers have been deliberately abusing the patent system to prevent potential competitors from entering the marketplace through tactics like “product hopping” and abuse of the “patent dance” process.

The Affordable Prescriptions for Patients Act puts an end to practices that prioritize profits for pharmaceutical companies ahead of Americans’ health. By stopping abuses of our patent system, this legislation will pave the way for generics and biosimilars to compete with branded drugs and aggressively lower drug prices for consumers in the process.

Product Hopping: Product hopping is a practice that bad actors in the pharmaceutical industry engage in when their exclusive right to a drug is about to expire, but they do not want to compete with generic alternatives. Rather than simply competing on the merits with their old drug and any generic alternative, companies manipulate the market to move patients off the old drug and onto the new. They “hop” patients from branded product to branded product by engaging in a variety of practices to disadvantage their old drug, including destroying the inventory of their old drug, pulling it from the market, aggressively raising the price, badmouthing their old drug, or even diminishing its safety.  Then, when the market protections for the earlier drug expire and a generic or biosimilar alternative comes to market, it is difficult to switch patients to the cheaper generic or biosimilar. As a result of this abuse of the patent system, patients are stuck paying high costs for a drug that is substantially similar to their old one for many years to come.

The bill puts an end to this practice. It prohibits branded drug manufacturers from engaging in anticompetitive product hopping and facilitates entry to the market for generics and biosimilars, driving down drug costs.

 Patent Dance: Biosimilars are to biologics what generic drugs are to branded drugs. In 2010, Congress enacted a law designed to resolve any patent litigation quickly before a biosimilar is introduced to the market, creating a patent dispute resolution process known as the “patent dance.” Under current law, however, there are no limits on the number of patents that a branded manufacturer of biologics can assert during the patent dance – leading some companies to abuse a process designed to facilitate biosimilar entry, not hinder it.

This bill places a reasonable limit on the number of patents a manufacturer can contest, preventing a “patent thicket.” This will help deter branded manufacturers of biologics from gaming the system to increase the number of patents they assert, while preserving the incentives provided by the patent system to encourage the core innovation that produces new biologic treatments in the first place.