This bill amends patent infringement laws to promote competition and reduce prescription drug costs by allowing more patent challenges and increasing the number of patents a reference product sponsor can assert in an infringement action.
John Cornyn
Senator
TX
The "Affordable Prescriptions for Patients Act" amends patent infringement laws to include patents related to the manufacturing of biological products. It sets limits on the number of patents a reference product sponsor can assert in an infringement action against a biological product applicant, with exceptions for certain circumstances and types of patents. These changes aim to balance patent protection with the goal of increasing access to affordable biological medications. The amendments apply to applications submitted after the enactment of this act.
Affordable Prescriptions Act Sets 20-Patent Limit for Biologic Lawsuits, But Loopholes May Persist
This part of the Affordable Prescriptions for Patients Act tweaks the rules for patent disputes involving biologic drugs – complex medications often used for serious conditions – and their more affordable counterparts, known as biosimilars. Specifically, Section 2 amends U.S. patent law (35 U.S.C. § 271(e)) to generally limit the original drug maker (the reference product sponsor) to asserting a maximum of 20 patents when suing a company seeking approval for a biosimilar version (under 42 U.S.C. § 262(k)). This change applies to biosimilar applications filed after the Act becomes effective.
Cracking Open the Patent Playbook
The core idea here involves the complex legal process often called the 'patent dance' between makers of original biologics and companies developing biosimilars. Biologics are expensive, and bringing cheaper biosimilars to market hinges on navigating the original drug's patents. This bill attempts to streamline that by capping the number of patents an original manufacturer can initially use in an infringement lawsuit at 20, provided they meet certain criteria (like being listed correctly and not filed too long after the original drug's approval). It also slightly broadens what counts as infringement related to the biosimilar application itself. The goal seems to be preventing 'patent thickets' – overwhelming biosimilar developers with dozens or hundreds of patents to delay competition.
The Fine Print: Exceptions and Hurdles
While a 20-patent cap sounds straightforward, the details matter. The bill includes several escape hatches allowing a court to permit more than 20 patents in a lawsuit. This can happen if the court decides it's 'in the interest of justice,' if the biosimilar applicant hasn't provided required information (under 42 U.S.C. § 262(l)), or if there are significant delays in the patent office issuing patents. For instance, if a biosimilar company trying to launch a lower-cost arthritis treatment doesn't perfectly follow the complex information exchange rules, the original drug maker could potentially get court permission to assert more than the initial 20 patents, adding complexity and cost back into the process. Notably, patents covering how a drug is used therapeutically are exempt from this limit altogether.
Real-World Ripple Effects: Costs and Access
Ultimately, these changes could impact how quickly lower-cost biosimilars reach patients. While the 20-patent limit could reduce overwhelming litigation tactics, the exceptions create uncertainty. If manufacturers can still find ways to assert numerous patents through these exceptions, the lengthy and expensive legal battles that currently delay biosimilar entry might continue. This means potential delays in access to more affordable versions of critical biologic medicines used for conditions like cancer, autoimmune disorders, and diabetes. The effectiveness of this section hinges on how strictly courts interpret the 'interest of justice' and other exceptions, determining whether it truly streamlines biosimilar competition or just rearranges the hurdles.