Robert Cerwinski, JD, partner at Goodwin, discusses a petition before the Supreme Court challenging the constitutionality of inter partes review.
How does Oil States Energy Services v Greene’s Energy Group stand to change the IPR process in general?
It’s an interesting case in that there is a petition to the Supreme Court challenging the constitutionality of [inter partes reviews, IPRs]. 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. Everybody in the biosimilars world is watching this Supreme Court matter pretty closely. 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. I don’t think anyone really expects IPRs to go away forever, but this is one of those cases where even if folks are feeling pretty comfortable that IPRs are at least in some respect constitutional and are here to stay, there is a risk that the IPR world as we know it could change in the near term—so we are watching it closely.