WASHINGTON, DC] – Today U.S. Senators Richard Blumenthal (D-CT) and John Cornyn (R-TX) introduced the Affordable Prescriptions for Patients Actto help lower drug prices by preventing bad actors in the pharmaceutical industry from deliberately abusing the patent system.
The bipartisan legislation would curb drug companies’ anti-competitive use of patents to prevent generic and biosimilar competition from coming to market. The Blumenthal-Cornyn legislation specifically addresses an anti-competitive tactic known as “product hopping” and an abuse of the “patent dance” process for resolving patent infringement claims for biosimilars. Companion legislation addressing abuse of the “patent dance” process is being introduced in the House of Representatives today by U.S. Representatives Hank Johnson (D-GA) and Darrell Issa (R-CA). Companion legislation prohibiting “product hopping” is being introduced by U.S. Representative David Cicilline (D-RI) and Ken Buck (R-CO).
“We must stop bad actors in Big Pharma from abusing the patent system to crush competition and stifle access to cheaper generic drugs,” Blumenthal said. “These patent abuses go by colorful names, like product hopping and the patent dance, that obscure their very pernicious purpose: stifling competition from generics and keeping costs up. I’m proud to be partnering with Senator Cornyn on this bill to rein in some of the most egregious monopolistic and predatory tactics within the drug industry.”
“Texans struggling financially during the pandemic shouldn’t have to decide between paying the bills or their life-saving prescriptions,” said Cornyn. “This legislation would encourage competition to try and drive down the skyrocketing costs at the pharmacy.”
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 putting an end to abuses of our patent system, the Affordable Prescriptions for Patients Act 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 an anti-competitive tactic that some drug manufacturers engage in when their exclusive right to market a branded drug is about to expire. These companies use a variety of tactics to push patients to “hop” from a drug with a patent term that is ending to a similar drug with a long remaining period of exclusivity. Then, when the market protections for the earlier drug expire and a generic or biosimilar alternative comes to market, consumers struggle to access the cheaper generic or biosimilar. Instead, 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 employing 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. 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.
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