On July 11, the Senate voted to approve legislation that will limit the ability of pharmaceutical companies’ patent thickets to slow biosimilar competition. The outlook for this legislation, called the Affordable Prescriptions for Patients Act (Senate Bill 150), is by no means assured.
Patent thickets have been a bane of biosimilar manufacturers from the implementation of the BPCIA. Companies file for and accrue patents that cover everything from new drug formulations, uses in new indications, new production methodology, and drug delivery routes. The act, which was sponsored by US senators John Cornyn (R-TX) and Richard Blumenthal (D-CT), would limit the number of patents that a reference manufacturer may claim under the patent dance.
Senator Cornyn stated in a press release “Anti-competitive practices from companies abusing the patent system have caused Texans’ costs at the pharmacy counter to skyrocket. This long-overdue legislation would promote competition and lower prices for patients without standing in the way of innovation, and I urge my colleagues in the house to pass it as soon as possible.”
The legislation seemingly has broad bipartisan support. This will not guarantee passage through the House and its Republican majority. A similar legislative proposal was first introduced in 2019 and was reformulated and introduced in 2023 by Senators Cornyn and Blumenthal. Whether broad bipartisan support for this type of action exists in the House is unknown at this time.
The argument against passage is that the proposal will have a detrimental effect on intellectual property rights. However, better guardrails are needed to ease the path for biosimilar competition after the expiration of a biologic’s marketing exclusivity.
Patent thickets are an abuse of the patent system, which force biosimilar manufacturers into excessive and unnecessary legal proceedings in an effort to weed out duplicative and insignificant patents that stand in the way of competition. Patent thickets have been blamed for the delayed release of several biologic products including adalimumab and etanercept, the latter now gaining up to 30 years of marketing exclusivity. The patent thickets have also played a role in the proliferation of biosimilar licensing agreements, which are designed to halt any ongoing patent litigation and allow a biosimilar to finally reached the market (with a royalty or licensing fee paid back to the reference manufacturer).