SCOTUS Hears Case That Could End IPRs for Biosimilar Developers

This week, the Supreme Court of the United States heard oral arguments in Oil States Energy Services, LLC v Greene’s Energy Group, LLC, a case that asks the court to decide whether inter partes review (IPR), a proceeding before the US Patent Trial and Appeal Board that provides for the review of 1 or more claims of a patent, is constitutional.

While the case in question arises from a dispute over a patent held by an oilfield service company on equipment used in hydraulic fracturing, the court’s decision will have far-reaching implications for biosimilar stakeholders; the IPR process is regularly used by biosimilar developers to challenge patents for reference biologics, especially such blockbuster drugs as Rituxan (rituximab) and Herceptin (trastuzumab).

Counsel for Oil States, Allyson Ho, argued that patents can only be revoked by a federal court decision, and that IPR proceedings, which were established by Congress as part of the America Invents Act as a means to address patent reviews, violate an entity’s constitutional right to have challenges heard before a federal jury.

Arguing for Greene’s Energy Group, Christopher Kise argued that IPRs simply reexamine whether a patent should have been issued initially, and that IPRs do not involve the exercise of judicial power.

Big Molecule Watch reported that the outcome of the case is difficult to predict (some justices asked numerous questions while others asked none at all), and suggested that Justice Kennedy’s vote in the matter may be significant to the eventual decision.

Biosimilars stakeholders will be watching the case closely in the coming days; in a recent interview, attorney Robert Cerwinski told The Center for Biosimilars^® that “IPRs have been one of the main tools in the tool kit of biosimilar applicants to try to clear a path for biosimilars to market.” He added, “The upshot is, if in fact the law that created IPRs is governed to be unconstitutional, Congress is going to have to take another shot at either modifying or redoing the statute that created IPRs. So, the potential impact on biosimilar applicants from having the IPR scheme eliminated entirely will be quite significant…there is a risk that the IPR world as we know it could change in the near term.”