Biologics, Patents, and Dances; the 2016 Election’s Unknown Effect
What does America’s November 8th choice between Hillary Clinton and Donald Trump have to do with the future of biologics, patents, and dances? Apparently a lot, because the outcome of this presidential election may affect how the Supreme Court will construe the “Patent Dance” of the Biologics Price Competition and Innovation Act (“BPCIA”).1
Biologics is the future of medicine.2 Unlike pharmaceutical drugs that are relatively simple and small chemical compounds chemicals synthesized through a set process, biologics are larger, more complex and manufactured by genetically modified living cells. These characteristics make biologics extremely effective but they also cause biologics to be awfully expensive to manufacture and bring safely to market.3 Consequently, biologics are exceptionally expensive and almost unaffordable to many consumers who need them. However, this issue of unaffordable medicine due to the high cost of research and development is not new and the same issue faced traditional pharmaceutical drugs. Therefore, in 1984, Congress sought to rectify the problem by passing the Drug Price Competition and Patent Term Restoration Act (“Hatch-Waxman Act”) which allowed generic drugs (not biologics) to piggy-back off of the research, development, and testing of the original drug maker.4 However, this solution was not as readily available for biologics due to its very nature. The relatively simple manufacturing process of pharmaceutical drugs allow for exact copies to be made by competitors. However, the complexity and the specific manufacturing process of biologics renders exact copies essentially impossible. Instead, generic biologics that are at least similar and have the same effect – hence the name Biosimilars – can be made. In 2010, Congress enacted the Biologics Price Competition and Innovation Act allowing a streamlined process, similar to the Hatch-Waxman Act’s, in which companies can use the information of the original biologics maker to manufacture biosimilars with the hope that the savings will be passed on to the consumers. Although the BPCIA employs the same concept as the Hatch-Waxman Act of allowing generic versions to use the information of the original, some specifics of the BPCIA is distinctly and purposely different. One of the big differences was the use of a process in which the two companies exchange patents that they believe need to be litigated from the onset. This process has been called the “patent dance” and its very nature is still unclear. Specifically, there is a debate, one that the Supreme Court will likely address, whether the patent dance is mandatory or optional.
In Amgen Inc. v. Sandoz Inc., the Federal Circuit, in a divisive opinion held that the patent dance is optional.5 The court recognized that the BPCIA is particularly complex and confusing, describing it as “a riddle wrapped in a mystery inside an enigma.”6 However, the court ultimately concluded that a biosimilar applicant may choose to not engage in the patent dance. The Court held that in such a scenario, the only remedy of the original biologic manufacturer is a traditional claim of patent infringement.
Both Amgen and Sandoz have petitioned for a writ of certiorari by the Supreme Court. On June 20, 2016, instead of deciding whether to grant certiorari in the biosimilar patent dance dispute between Amgen and Sandoz, the Supreme Court invited the Solicitor General “to file a brief in this case expressing the views of the United States.”7 However, The Solicitor General is unlikely to answer until after the change in administration.8 Biosimilars are not exactly buzzworthy and so, unsurprisingly, the positions of each candidate regarding this particular issue has not been offered. However, whoever is elected may impact the Solicitor General’s reply as to the view of the United States. Therefore, although Americans may be unaware, their November 8th choice may effect the very nature of the patent dance.
Patient Protection and Affordable Care Act, Pub. L. No. 111-148, § § 7001-03, 124 Stat. 119, 804-821 (2010) (enacting Biologics Price Competition and Innovation Act of 2009, H.R. 3590, 111th Cong. (2009)) (codified as amended in scattered sections of 28, 35 and 42 U.S.C.).↩
Carl J. Minniti III, Sandoz v. Amgen: Why Current Interpretation of the Biologic Price Competition and Innovation Act of 2009 Is Flawed and Jeopardizes Future Competition, 97 J. Pat. & Trademark Off. Socy. 172 (2015).↩
Drug Price Competition and Patent Term Restoration (Hatch-Waxman) Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984)(codified as amended in scattered sections of 21 and 35 U.S.C.).↩
794 F.3d 134, 1356 (Fed. Cir. 2015).↩
Amgen, 794 F.3d at 1351 n. 1.↩