Mind + Muscle

technical minds + legal muscle


dig deep

IPR: A 2nd Bite At The Apple For Hatch-Waxman Litigants

  • 03.11.14
  • Dennies Varughese, Pharm.D., Joshua N. Mitchell, & H. Keeto Sabharwal
  • IP Law360

With the advent of inter partes review, Congress authorized a second and parallel adjudicatory proceeding for generic pharmaceutical companies to challenge the validity of Orange Book-listed patents. The first option, of course, was in litigation before a United States district court. Congress intended the IPR to offer a cheaper, more streamlined avenue to challenge patents than in district court. But having parallel proceedings makes the most sense if there’s some binding effect that runs from one venue to the other.

Recent decisions by the Federal Circuit and the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board illustrate that the binding effect runs in one direction only, favoring a PTAB’s unpatentability determination over any contrary decision by the district court upholding the validity of the same claims. The absence of a reciprocal binding effect that runs from the district court to the PTO means that generic litigants get a separate and distinct opportunity to attack Orange Book patents in an IPR irrespective of what happens in any parallel district court action — a “second bite at the apple.”

To read the full article, download the attached PDF.

Sort By Media Type

Sort By Media Type
  • AlertAlert
  • BriefsBriefs
  • Comments to USPTOComments to USPTO
  • Design Patent Case DigestDesign Patent Case Digest
  • MultimediaMultimedia
  • News & ArticlesNews & Articles
  • Press ReleasePress Release
  • VideoVideo
  • WebinarWebinar

Unsolicited e-mails and information sent to Sterne, Kessler, Goldstein & Fox P.L.L.C. will not be considered confidential or privileged, may be disclosed to others, may not receive a response, and do not create an attorney-client relationship with Sterne Kessler.  If you are not already a client of Sterne Kessler, do not include any confidential information in this message.