The chairman and the ranking member of the Judiciary Subcommittee on Courts, Intellectual Property and the Internet in the House of Representatives, proposed a bipartisan bill to amend the patent dance in the Biologics Price Competition and Innovation Act (BPCIA) by capping the number of some types of patents that may be claimed by the maker of the reference product.
The chairman of the Judiciary Subcommittee on Courts, Intellectual Property and the Internet in the House of Representatives, along with a Republican congresswoman from Alabama, proposed a bipartisan bill to amend the patent dance in the Biologics Price Competition and Innovation Act (BPCIA).
In a statement, Representative Hank Johnson, D-Georgia, chair of the committee, and Ranking Member Martha Roby, R-Alabama, said the bill, HR 3991, the “Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act,” seeks to streamline the process by which biosimilar makers can get their drugs approved.
“By streamlining and simplifying the patent litigation process, we hope to help boost an already robust biosimilar application process and help to expeditiously make these life-saving drugs affordable to every consumer,” Johnson said.
According to a copy of the bill and additional information from Johnson’s office, HR 3991 would cap the number of a certain subset of patents claimed by the manufacturer of the reference product to 20, and limits 10 of those 20 to newly issued or licensed patents coming after the date the reference drug maker sends its initial list of patents allegedly infringed by the biosimilar applicant.
Patents that claim a method for using the product in therapy, diagnosis, or prophylaxis are not capped; patents that have an actual filing date of more than 4 years after the biological product is approved, or patents that include a claim to a method in a manufacturing process that isn’t practiced by the biologic manufacturer, are capped.
Reference manufacturers can request to have the number of patents increased, but the request “needs to be made without undue delay,” according to the bill. And a court may increase the number of patents that may be asserted either if “in the interests of justice so requires or for good cause.”
Good cause can be set if the biosimilar applicant does not provide enough information to the reference manufacturer; if there is a material change to the biological product; if the patent would have been issued except there was a failure within the United States Patent and Trademark Office; or for other reasons the court deems appropriate.
“Unfortunately, the BPCIA has not yet done for biosimilars what the 1984 Hatch-Waxman Act did for small-molecule drugs,” said Johnson. “And that is make it easier for generics to get the marketplace quicker and more efficiently and thereby make them more affordable at the pharmacy counter. My amendment seeks to strengthen the BPCIA, not undo or undermine it.”
He compared the current method for addressing competing patents with "a clogged artery."
"This legislation will help put an end to patent gamesmanship that prevents lower-priced generics from entering the market and bringing lower prices to consumers," said Roby.