Patent Term Extension for Manufacture of Follow-on-Biologics?

With Democrats now controlling the legislative agenda in Washington, the debate over a federal regulatory approval pathway for biosimilars or follow-on-biologics (“FOBs”) seems inevitable, leading to major amendments to both the Public Health Service Act, Food, Drug and Cosmetic Act and the Patent Act. A central issue in this debate turns on the extent of market exclusivity. Advocates for the generic industry will argue for limited exclusivity, while the innovator companies will push for legislation effectively extending the life cycle of their branded biologics. Any new legislation should contemplate both the eligibility requirement and the scope of the right extended to any branded biologic and offer viable life cycle strategies to the patent holders.

The statutory authority for patent term extension in the U.S. finds its origin in the Drug Price Competition and Patent Term Restoration Act of 1984 (“the Hatch-Waxman Act”), as codified under 35 U.S.C. § 156 (“§ 156”). The Hatch-Waxman Act was intended to strike a balance of incentives for the first entrants of pioneer small molecule drugs and the first entrants of generic drug makers on the market; allowing the owner of an approved pharmaceutical drug product to recover a portion of the time lost from the patent term which is spent during the regulatory review period regarding the patented drug product. During the regulatory review, the process of manufacturing a candidate biologic is subject to intense scrutiny by the Food Drug Administration (“FDA”). The process of perfecting these processes are important assets for innovator companies in maintaining their competitive edge. And given that the manufacturing process of a biological product might play a determinative role in immunogenicity, safety and efficacy of biologic, it is prudent for the innovative company to establish a strategy to maximize the term of their manufacturing patents covering the approved biologic. In fact, perhaps the most important negotiation for any patent authority in a FOB legislation should focus on authorization of patent term extension for manufacturing process claims, the scope of exclusivity granted to such process and the listing of such patents in the Approved Drug Products and Therapeutic Equivalence (“Orange Book”) or the like publications. Currently, under 35 U.S.C. § 156 (“§ 156”), a U.S. patent covering the method of manufacture (i.e., process for producing the biologic) is eligible for term extension, so long as the patented process covers the product, and the regulatory review represents the first permitted commercial marketing under the statute. However, unlike product and methods of use patents related to the approved product, patents covering relevant methods of manufacture are not currently subject to listing in the Orange Book.

Currently, there is a palpable level of uncertainty in defining the scope of the patent term extension available for claims covering an approved product, such as a small molecule. This confusion is in part rooted in the divergent and sometimes ambiguous interpretation of the terms ‘active ingredient’ and ‘active moiety’ by the United States Patent and Trademark Office (“USPTO”), the Food and Drug Administration (“FDA”) and the Federal Circuit when defining the eligibility of an approved product for patent term extension under § 156. In light of such ambiguities, innovator companies might work to maximize the life cycle of their branded biologics by lobbying for clear amendments to Section 156 calling for extending process of manufacture patent claims to mirror the importance of this intellectual property in the specific area of FOBs. Apart from the for availability of a patent term extension for the approved biologic product, any legislation covering federal regulatory approval for FOBs might also allow for a parallel patent term extension covering the method of manufacturing the approved product, or in the alternative consider legislation promoting reasonable patent term extension covering the method of manufacture for the branded company. Thus, Congress should consider a proactive role in the scope of any patent term extension(s) under any FOB legislation, but also emphasize clear eligibility criteria covering methods of manufacture.