U.S. Senate Passes Affordable Prescriptions for Patients Act of 2023 to Limit Number, Nature of Patents in Biosimilar Litigation

Under the Biologics Price Competition and Innovation Act (BPCIA), the innovator of a biologic drug approved by the U.S. Food and Drug Administration (FDA) can sue the manufacturer of a biosimilar version of that drug for patent infringement based on the biosimilar’s filing of its application for FDA approval. In July 2024, the U.S. Senate unanimously passed a bipartisan bill titled Affordable Prescriptions for Patients Act of 2023 that could affect BPCIA patent infringement suits in the future. If enacted, the bill would limit the number of certain types of patents that the biologic innovator can assert against the biosimilar applicant in such litigation. The bill, however, permits certain exceptions and expansions to its imposed limit.

The bill would affect only BPCIA litigation. Cases filed by branded pharmaceutical companies against generic drug manufacturers under the Hatch-Waxman Act are not implicated.

If passed into law, these would be the bill’s key takeaways for BPCIA litigation:

• A biologic innovator may sue only on 20 patents that were filed four years after its biologic drug was approved or that cover a manufacturing process not used by the biologic innovator.
  • No more than 10 of the above 20 patents may have issued after the biologic innovator serves its initial list of patents during the BPCIA’s presuit information exchange.
  • There is no limit on the number of other types of patents (e.g., method of treatment patents or patents filed earlier than or within four years of the innovator’s biologic getting FDA approved) that can be asserted.
• Even if the above limits apply, courts may increase the number of these patents in the interest of justice or for good cause shown.
• The above limits will not apply if the biosimilar applicant fails to complete all required presuit actions under the BPCIA.

The bill was originally introduced by Sens. John Cornyn, Republican of Texas, and Richard Blumenthal, Democrat of Connecticut. Its stated purpose is to “impose limitations on patent litigation involving biological products.”¹  According to the sponsors, the bill will lower drug pricing by accelerating biosimilar entry onto the market. In other words, the lawmakers’ proposed solution to high drug prices is to limit the enforcement of patents by a biologic innovator.

This bill is the latest in a series of proposed legislation that targets drug patents and life sciences litigation in the purported interest of increasing competition and decreasing drug prices. Other bills introduced in 2023 proposed changes to the FDA approval process for newly submitted or approved drug applications and are described here. 

Current Regime

The BPCIA creates an abbreviated pathway for the approval of biosimilar versions of existing biologic drugs. The biosimilar can seek FDA approval using the biologic innovator’s drug as a reference product.² The Patent Act deems a biosimilar’s FDA filing to be an artificial act of infringement.³   

The BPCIA also includes the option of a presuit information exchange between the biosimilar applicant and biologic innovator designed to streamline the patent issues and resolve them in BPCIA litigation before the biosimilar comes to market. The information exchange, sometimes referred to as the “patent dance,” starts when the biosimilar applicant elects to share a copy of its FDA application with the biologic innovator. Then the parties can exchange lists of the biologic innovators’ patents for which a claim of infringement can be asserted as well as their respective positions on infringement, validity, and enforceability of those patents. Finally, both sides can negotiate the final list of patents for BPCIA patent litigation. A biosimilar applicant is not required to participate in this presuit information exchange. But if it fails to do so, the biologic innovator can file suit against the biosimilar on any patents that cover the biosimilar or its use.

Currently, there is no limit to the number of patents that can be asserted against a biosimilar applicant in BPCIA litigation.

Proposed Limits on Number of Patents and Exceptions

The major focus of the bill is limiting the assertion of patents by date and type when a BPCIA suit is filed. It would do so by amending § 271(e) of the Patent Act. The proposed amendment states that the biologic innovator may assert no more than 20 patents that (i) claim its reference biologic product or its method of manufacture with an actual filing date four years after the reference product is FDA approved or (ii) claim a manufacturing process not used by the reference product sponsor. The logic behind the filing date limit appears to be that later-filed patents will presumably have later expiration dates that might be used to block biosimilar entry. The limit on the type of manufacturing patents appears directed to reducing the number of patents that the biologic innovator itself is not using.

The proposed 20-patent cap would not affect the presuit information exchange before the biologic innovator files an action for patent infringement. But while the cap does not limit the number of patents a biologic innovator may include on its initial patent list during the presuit exchange, the bill does use the timing of that initial patent list as yet another date cutoff. It states that no more than 10 of the 20 patents asserted in BPCIA litigation can have issued or been acquired by the biologic innovator after that initial patent list is exchanged. 

There are certain types of patents to which the 20-patent limit does not apply. The bill explicitly states that the limit shall not apply to patents which claim a method of using the biologic “in therapy, diagnosis, or prophylaxis, such as an indication or method of treatment or other condition of use.” Also outside the 20-patent limit are earlier-filed patents: those filed less than four years after the innovator biologic’s FDA approval. The bill imposes no limits on assertion of these method of use and earlier filed patents. Regulated industry should begin to assess various litigation strategies in light of the proposed bill on a case-by-case basis.

Expansion of the Proposed Limits

Courts can increase the 20-patent limit if the biologic innovator promptly requests such an expansion, if the expansion is in the interest of justice, or good cause is shown. The bill does not provide any further guidance on what constitutes an interest of justice, but it does give examples of good cause. 

The bill provides that good cause “shall be established” if the biosimilar applicant fails to provide all the presuit information outlined in the BPCIA. The bill may thus give an additional incentive for a biosimilar to participate fully in the presuit exchange to invoke its limits.

The bill describes other examples of good cause in permissive terms. It states that good cause “may” be established if there is a material change in the biosimilar applicant’s product or manufacturing process or if a patent would have issued before the biologic innovator serves its initial patent list but for Patent Office delays. The bill states that the court may also consider whether the biosimilar applicant provided sufficient information to the biologic innovator during the presuit exchange to assert additional patents. It shifts the burden here to the biologic innovator to provide a “reasonable description of the identity and relevance of any information” beyond the biosimilar’s FDA application that would be “necessary to enable the court to form a belief with respect to whether a claim of infringement” could reasonably be asserted.

Other Potential Impacts and Next Steps

Ultimately, the downstream effects of the proposed bill on litigation and drug pricing remain to be seen. As an initial matter, its limits apply only to suits for infringement under § 271(e) of the Patent Act — where the biosimilar’s filing of its application for FDA approval constitutes the statutory act of infringement. That raises questions about whether and how it would affect suits based on actual or anticipated sales brought under other subsections of the Patent Act. And in some ways, this has a counterintuitive effect of potentially limiting the intended benefits of early litigation relying on § 271(e): If an early suit can be brought only on a subset of relevant patents, that may delay the parties’ ability to obtain clarity as to whether the proposed biosimilar’s introduction into the market would infringe the biologic innovator’s patents. Even in the § 271(e) context, the bill’s practical effect is hard to predict in light of the exceptions, which might capture a substantial portion of cases in which more than 20 patents would be asserted under existing law. The effects of the proposed patent litigation limits on drug pricing are even more attenuated, given the complexity of the systems behind pricing and access.

It is unclear when, if at all, the bill is expected become law. The bill passed the Senate on July 11 and arrived at the House of Representatives on July 15. As of now, no actions on this bill have occurred in the House, and the earliest it may be addressed is the week of September 9. If the bill passes the House, it will then go to the President to be signed into law.