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