Some See Potential of Inter Partes Review to Clear the Way for Biosimilars

Even as the industry awaited news of the Supreme Court’s ruling in the case of Sandoz v Amgen, many legal experts at the 8th Annual Summit on Biosimilars earlier this month were focused on inter partes review (IPR) as an alternative to patent litigation under the contentious Biologics Price Competition and Innovation Act (BPCIA).

IPR is a trial proceeding before the Patent Trial and Appeal Board (PTAB), which provides for the review of patentability for 1 or more claims of a patent. The IPR process is a relatively new feature of US law, having become available in September 2012.

IPRs offer biosimilar and generic drug manufactures the benefit of challenging innovator patents with relative speed; if an IPR is instituted after showing that there is a reasonable likelihood that the petitioner challenging an innovator’s patent will prevail in at least 1 claim, the PTAB must make a final determination within 1 year (with a possible extension of 6 months for good cause). Patent litigation for small-molecule drugs under the Drug Price Competition and Patent Term Restoration Act of 1984 (commonly known as the Hatch-Waxman Act) can, by contrast, take multiple years, and BPCIA litigation, as Sandoz v Amgen demonstrated, can also be lengthy and expensive. IPRs have an additional benefit for petitioners insofar as they require a lower burden of proof than does federal court litigation.

However, the biopharmaceutical industry has been slow to embrace IPRs; the primary players engaging in IPR litigation thus far have been software and electronics industries. According to John J. Molenda, partner at Steptoe & Johnson LLP, of more than 2000 IPR petitions as of September of 2015, only 30 were for biologic drugs, though IPR petitions concerning biologics have ramped up in early 2017.

According to Molenda, the types of patents commonly challenged for biologics include manufacturing, method of treatment, composition of matter, and formulation, yet method-of-treatment challenges accounted for nearly half of such petitions. Challenges to formulation patents represented another quarter of petitions, though these petitions were instituted less than 15% of the time.

Among pharmaceutical IPR petitions, Molenda said, 33% were instituted by PTAB, 33% are pending, 18% were denied, and 16% were either terminated or settled. He cited 13 cases that had progressed to a final decision, among them cases related to glatiramer (Copaxone), a drug used in treating patients with multiple sclerosis, and alglucosidase alfa (Lumizyme), a so-called “orphan drug” used to treat Pompe disease.

It remains to be seen whether the Supreme Court’s decision that the BPCIA patent dance is optional will push more biosimilar manufacturers to opt to litigate under the BPCIA in the future rather than to pursue new inroads into this more recently developed arena. However, IPRs continue to provide an option for biosimilar manufactures who seek a faster alternative to BPCIA litigation, especially as the federal circuit courts work to address remaining questions of the patent dance that went unresolved in the Sandoz v Amgen ruling.