H.R. 2884 – The Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Judiciary Subcommittee on Courts, Intellectual Property and the Internet Chairman Rep. Hank Johnson (GA) issued the following opening statement during a full Judiciary Committee markup on September 29, 2021.
I move to strike the last word.
The cost of prescription drugs has soared too high for too long in this country. We spend more on prescription medications than residents of any other developed nation. The fact is that affordable health care is simply out of reach for most Americans.
That is why I introduced H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021, along with my friend from California, Mr. Issa. This bill’s name may be long, but its purpose is simple: it seeks to bring down medical costs by streamlining the pathway for alternatives to expensive, brand-name biological drugs, known as biologics, to get to consumers.
Improving access to these alternatives, which are called “biosimilars,” is critical to lowering medical costs. In 2010, Congress created a streamlined application process for biosimilars to reach the market through the Biologics Price Competition and Innovation Act, or the BPCIA. The benefit of having more biosimilars available is tangible. For example, one report estimates that over the next five years, global pharmaceutical spending will be approximately 160 billion dollars lower than it would have been had biosimilars not reached the market.
Although the BPCIA created a robust application process for biosimilars to get to the market quickly, it has not been able to reach its full potential.
H.R. 2884 addresses one clog in the current system—patent thicketing. Brand-name biologics have kept their exclusive hold on the market by improperly using the patent system to fend off their biosimilar competition for far longer than contemplated.
These efforts include building up a portfolio of late-filed patents, which circumstances suggest may be obtained more with a view to block competition than to actually advance medicine. These filings are often timed to keep the brand-name drug’s exclusivity alive just as the drug’s earlier patents begin to expire.
The manufacturer of the branded biologic will assert these patents in litigation against the biosimilar applicant, and in the meantime get to retain their exclusive hold on the market and, consequently, their hold on Americans’ wallets.
H.R. 2884 strengthens the BPCIA by encouraging both the brand-name manufacturer and the biosimilar applicant to engage more completely in the BPCIA’s process and by addressing manufacturers’ patent-thicketing tactics.
To be sure, H.R. 2884 does not intend to discourage brand-name manufacturers from identifying new diseases their biologics can treat. That is why patents that claim certain methods of use, such as an indication or method of treatment, are limited.
By streamlining and simplifying the patent litigation process, we hope to help make these important and life-saving biologics more affordable for American consumers and more accessible in the marketplace. We should not have to accept high-priced healthcare as an inescapable American burden. This legislation is another bold step in the Committee’s efforts to lower the costs of staying healthy. I encourage everyone to support this legislation and I yield back.