With Democrats now controlling the legislative agenda in Washington, the debate over a federal regulatory approval pathway for biosimilars or follow-on-biologics (“biosimilars”) seems inevitably leading to major amendments to 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 biologicals. Aside from attempts to propose a legislation which parallels the current abbreviated pathway for the small molecules, the innovator biopharma companies must secure patent term provisions that would allow effective extension of their patents directed to the manufacturing process of their novel therapeutic biologics.
Reviewing the evolution of patent term extension jurisprudence sets the stage for an intense debate as to the boundaries of any patent term extension provision on any biosimilars legislation. The patent term authority in the current version of 35 U.S.C. Section 156 finds its origin in the Drug Price Competition and Patent Term Restoration Act of 1984 (“the Hatch-Waxman Act”), codified under 35 U.S.C. Section 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. The Hatch-Waxman Act allows 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. However, the Hatch-Waxman Act did not amend the Public Health Service Act, under which therapeutic biologics are approved. Therefore, currently there is no abbreviated pathway for the approval of therapeutic biologics.
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