In an attempt to increase the availability of biosimilars, on July 11, 2024, the Senate passed the Affordable Prescriptions for Patients Act, which was introduced in the House on July 19, 2024. The bill sets a cap of 20 patents in certain categories that can be asserted by a Reference Product Sponsor (RPS) in BPCIA litigation. Despite the often large numbers of patents a RPS will include in its original patent list during the patent dance, a RPS often asserts less than 20 patents in BPCIA litigation. As such, this bill is unlikely to have much practical effect even if it were to become law.
Previous versions of the Affordable Prescriptions for Patients Act in the Senate were much more focused on prohibiting product hopping to avoid competition by generic and biosimilar applicants, with the BPCIA patent caps being a small part of the bill. The product-hopping provisions were removed from the bill when it passed the Senate in July and subsequently was introduced into the House. To the extent the Congressional Budget Office analyzed the patent-cap provisions, it analyzed “lists of patents that sponsors of original biological products have indicated might reasonably be asserted against biosimilar competitors”, concluding that the bill would accelerate biosimilar competition by about two years, reducing the price of affected biological products by about 20 percent.
However, the bill does not limit the patents that can be exchanged in patent lists. Rather, it limits the patents that can be asserted in BPCIA litigation. Specifically, it defines a group of patents that (i) claim the biological product subject to the biosimilar application or a method or product used in making that biological product; (ii) were included on the RPS’s paragraph (3)(A) patent list; and (iii) have an actual filing date more than 4 years after the date on which the RPS was approved or include a claim to a method in a manufacturing process that is not used by the RPS. The bill would amend 35 U.S.C. § 271(e)(7)(A) to limit an infringement action by a RPS against a biosimilar applicant (BSA) to no more than 20 patents from this group of patents.
While several of the categories within this proposed group of patents have been identified as potentially contributing to problematic “patent thickets” inhibiting biosimilar competition, the bill does not limit the number of patents a RPS can include in its paragraph 3(A) patent list during the patent dance. These lists often have many more patents than what are actually asserted in litigation, both because the failure of an RPS to include a patent in its patent list precludes including the patent in BPCIA litigation and because the patent dance provides the BSA with an opportunity to provide facts regarding noninfringement and invalidity, often leading to a narrowing of the case. The bill does not limit the number of patents that can be listed and thus does not reduce the effort required to fully engage in the patent dance.
Instead, the bill limits the number of patents that can be asserted in BPCIA litigation—the actual complaint for patent infringement, not the RPS’s patent list that kicks off the patent dance. Not only are fewer patents often asserted in BPCIA complaints than on the RPS’s paragraph 3(A) patent lists, but less than 40% of BPCIA complaints assert more than 20 patents of any kind. Thus, fully 60% percent of BPCIA complaints would not even be subject to the 20-patent cap proposed by the Affordable Prescriptions for Patients Act, not even considering whether the patents fall within the group of patents defined by the bill. And, it is generally the case that fewer than five patents are litigated in the preliminary injunction phase of a case.
Perhaps the 20-patent cap would have more effect if it were somehow keyed to the much larger number of patents identified for products subject to high profile discussions about patent thickets—like HUMIRA (adalimumab)—or even the reduced set of patents identified in an RPS’s paragraph 3(A) patent list—as the CBO report discussed. But it is unlikely to have much effect in bringing biosimilar products to market more quickly and cheaply as it would affect few litigations and could make actual BPCIA litigation even more complicated as the parties litigate the contours of yet another provision.
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