WASHINGTON – U.S. Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT) released the following statements after their Affordable Prescriptions for Patients Act, which would help lower drug prices by preventing bad actors in the pharmaceutical industry from deliberately abusing the patent system, passed the Senate Judiciary Committee unanimously: 

“Anti-competitive behaviors from some companies who abuse the patent system are driving up prices and preventing Texans from accessing cheaper generics,” said Sen. Cornyn. “This legislation would ensure bad actors can’t game the system to keep lower-cost prescription drugs from coming to market, and I look forward to it coming to the Senate floor soon.”

“Today brings us one step closer to lowering Americans’ prescriptions drug costs,” said Sen. Blumenthal. “Big Pharma’s abuses of our patent system have crushed competition and stifled innovation – leaving countless families to foot the bill while the industry pads their profits. Our bipartisan, common sense measure is needed to cut out-of-pocket expenses and help patients access their critical medications. I look forward to championing our bill in the Senate. ”

This legislation is cosponsored by Senate Judiciary Committee Chairman Dick Durbin (D-IL), Ranking Member Chuck Grassley (R-IA), and Senators Ted Cruz (R-TX) 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.