Biotechnology/Pharma Patents: Immune to Post Grant Challenges?
Recent reports shown less than 6% of petitions filed in post-grant proceedings are in the biotechnology/pharmaceutical field. At first glance, this number appears surprisingly low; and the question as to why this number is not higher, similar to mechanical patents or electrical patents, arises. Questions relating to who is the typical petitioner, types of arguments made, types of claims being challenged, and the like further come to mind. What could possibly be the reason that these challenges are not more commonly brought against patents in fields that are so highly innovative?
A closer look at recent petitions may provide a little insight. Under 35 U.S.C. §§ 311-315, claims of a granted patent may only be challenged in an inter partes review proceeding under 35 U.S.C. §102 or 35 U.S.C. § 103. For patent practitioners prosecuting applications in the biotechnology/pharmaceutical fields, these grounds of rejection have historically been made, however, minor amendments and/or arguments typically can be made to overcome these rejections. Particularly in light of KSR International Co. v. Teleflex, Inc., the Graham inquiries can readily by satisfied in many of these applications by including unexpected results. Further, many arguments against obviousness are successful simply due to the recognized unpredictability in these technology areas. Accordingly, it may be possible that potential petitioners are not willing to invest expense into proceedings without more certainty regarding the outcomes.
Further, in view of recent decisions such as in Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., and Mayo v. Prometheus, validity under 35 U.S.C. §101, and thus, enforceability, of the claims in these biotechnology applications may be questionable. Until recently, patent practitioners simply did not see these invalidity grounds against their claims. And, despite the release of the USPTO’s Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products, claims have been inconsistently scrutinize by patent examiners, and how claims will survive ultimate scrutiny in view of the Court’s decisions remains unclear.
With the coming of the Post Grant Review proceedings, however, patent owners in these fields may see an increase in challenges to their patented claims. Under 35 U.S.C. §§ 321-325, Post Grant Review allows for challenges to claims on any invalidity ground, including 35 U.S.C. §101 and 35 U.S.C. §112. Accordingly, although it appears that post grant proceedings have been of little concern to patent owners in the biotechnology/pharmaceutical arts to date, these patent owners should be on alert that they will not be so immune for long.