For BioPharma patents, we were curious whether art that formed the basis for IPR institution was “newly discovered” prior art, or whether it was art that had previously been of record during prosecution. The answer to this question may help companies decide to take affirmative steps to discover and cite the most important art during prosecution of the patent application. If “newly discovered” prior art is generally used in IPR institution decisions, companies may be more likely to conduct affirmative prior art searches prior to prosecution to get all available art in front of the examiner. By conducting affirmative prior art searching, an examiner would possess the most important art, and theoretically the claims would be more resistant to an IPR. However, if art previously known during prosecution is generally used in IPRs, companies may feel justified in filing applications without conducting extensive prior art searches, believing that the presumption of the Examiner being aware of the prior art does not immunize the patent against a later IPR challenge.
To answer the question of whether art cited in BioPharma patents involved in IPRs was “newly discovered” prior art, we used the PTAB’s database to review the IPR institution decisions in the first 5 months of calendar year 2015 in Technical Center 1600. We then compared the art that formed the basis for IPR institution with the art cited on the patent’s face page. We did not determine whether the art was actually cited against the claims during prosecution, or whether the art was cited by the applicant or the examiner.
We found that most of the art that was the basis for IPR institutions was also made of record during prosecution of the patent. In all but one instance, at least one of the references in the IPR obviousness challenge was also before the examiner during prosecution. In each case, the primary reference used in the IPR obviousness challenge was before the examiner during prosecution. In each case of an IPR anticipation challenge, the art was also before the examiner during prosecution.
We concluded from our review of this small data set that challengers often need to look no further than the face page of the patent to find art sufficient to mount an IPR challenge. One big caveat to our conclusion is that our sample size was small (17 IPR decisions). Different patterns may emerge from a larger data set. Another reason for the prevalence of previously cited art in IPR challenges is that many (but not all) of the patents that were challenged were examined under the pre-KSR obviousness regime, but during IPRs are subject to the more liberal (from the challenger’s perspective) obviousness standard. Of course, another factor is the limited amount of time that the PTO has to examine patents allows some art to slip through the cracks.
Because art cited in the institution decisions of our study was not “newly discovered” prior art, it appears that the most relevant prior art is known by the examiner during prosecution. And the act of citing prior art to the examiner does not immunize the patent from IPRs. The patent owner must do their own, independent examination process using the prior art known to them and draft claims that are free of that art. For a patent application that covers an important invention, an exhaustive patentability analysis may be worth the expense. Certainly this won’t guarantee that a dedicated challenger won’t find better art, but it should minimize the risk.