Since the implementation of the America Invents Act (AIA) and the creation of the inter partesreview (IPR) process, patent challengers have been using the Patent Trial and Appeal Board (PTAB) as an alternative or additional venue in patent disputes. In fact, the PTAB is currently the second most active venue for patent disputes. While the majority of IPR petitions filed to date have been in the electrical engineering or computer science arts, there has been a rise in the number of chemical or pharma requests (71 percent of electrical/computer IPR requests versus 13.3 percent for chemical/bio/pharma IPR requests). The use of IPRs in the pharmaceutical context, particularly in the context of ANDA litigation, presents some interesting and unique issues for patent holders, as well as first ANDA filers and follow-on generics. This article will discuss general strategies concerning the use of IPRs in the pharmaceutical context as well as special issues that may arise when there is a concurrent ANDA litigation proceeding.
While a full description of IPR is beyond the scope of this article, this relatively new procedure allows patent challengers to seek review of patents in the Patent and Trademark Office. Patentability may be challenged in an IPR only on a ground that could be raised under 35 U.S.C. §§ 102 (novelty) or 103 (obviousness), and only on the basis of prior art consisting of patents or printed publications. The PTAB will institute an IPR if it finds a reasonable likelihood that the petitioner would prevail with respect to at least one challenged patent claim, and a final determination by the PTAB will be issued within one year from institution (extendable for good cause by six months). IPR is available for a patent issued at any time but cannot be sought until after the later of: (1) nine months after the issuance or reissuance of the patent; or (2) termination of any post-grant review procedure (another relatively new procedure for challenging recently issued patents), and may no longer be sought after either of the following: (a) more than one year elapses after service of a complaint for infringement of the patent on the challenger, or (b) filing of a declaratory judgment action to invalidate the patent by the challenger (excluding counterclaims). Once a decision is made to institute an IPR, the parties are permitted to engage in some limited discovery. A more fulsome explanation of IPRs can be found in the article by Eric Hutchins, Mitchell Stockwell, and Wab Kabada, "Inter Partes Review: Rocket Docket Patent Validity Trials in the USPTO.