As we’ve written before, notwithstanding statutory limits restricting IPR challenges to novelty and obviousness, Section 112 challenges are possible in an IPR. In several proceedings, petitioners have asserted references that have required the Board to determine whether an earlier filing supports the challenged patent’s claims. The Board generally has addressed these issues at the institution stage. However, a recent decision involving Kyle Bass and his Coalition for Affordable Drugs demonstrates the Section 112 analysis may not be fully resolved until the trial stage, where it can play a determinative role.
The discovery of an optimum value of a “result-effective variable” in a known process is ordinarily considered within the skill of the art and obvious. But, if a patent owner shows that optimizing the variable resulted in benefits with a magnitude unexpected by one skilled in the art, the optimized variable may be found nonobvious, as in Coalition For Affordable Drugs v. Biogen Idec Inc. (IPR2015-01993).
Your IPR petition argues that a patent is obvious—but will those arguments even be fully considered? A recent decision in Affordable Drugs VII v. Pozen Inc. emphasizes the importance of providing evidence-based arguments within the appropriate documents that inform the Board’s investigation.
It is well established that objective evidence of nonobviousness (e.g., commercial success, long-felt but unresolved needs, unexpected results, etc.) must be taken into account when evaluating the obviousness of a claimed invention. This standard applies during patent prosecution, in proceedings before the PTAB, and in litigation. However, as demonstrated by a recent IPR decision involving Kyle Bass’s Coalition for Affordable Drugs (IPR2015-01776), it can be can be challenging to provide sufficient evidence of unexpected results and long-felt need.
In Coalition for Affordable Drugs v. Pozen, Inc. (IPR2015-01718), the Board instituted a trial despite a failure of the petition to show that a final “wherein” clause of a method claim was met by the prior art. Rather, the Board reasoned that the “wherein” clause was likely to actually be a “whereby” clause, just by another name. Because a “whereby” clause stating the intended result of performing a method is not a limitation on the claim, failure to show that the result was known or even occurred in the prior art was not a basis to deny institution.
Last week, in a decision that has surprised and worried some, the Board instituted one of the numerous IPRs for which Kyle Bass and the Coalition for Affordable Drugs (IPR2015-00988) filed petitions. Previously, the Board had been able to deny some of Bass’s petitions based on the petitions’ failure to demonstrate that references qualified as prior art (which we discussed here). However, the Board later declined to sanction Bass for abuse of process and misuse of proceedings in filing other similar petitions (which we discussed here).
Topics: Kyle Bass
Kyle Bass and the Coalition for Affordable Drugs have scored a big win in the multiple IPRs they filed to invalidate Celgene Corp.’s patents and ultimately profit by shorting its stock. The Board has ruled against imposing the sanctions Celgene requested against Bass for improper purpose and/or abuse of process, clearing the way for all of the IPRs to proceed. The reasons advanced in the ruling may open up the IPR process to entities well beyond those that have traditionally used procedures at the Patent Office to invalidate patents.
In the much-anticipated first Board decision to address the merits of an IPR petition filed by the Coalition for Affordable Drugs and Kyle Bass, the Board yesterday denied institution in IPR2015-00720. The reason for the denial was simpler than some of the arguments advanced by the patent owner, and serves as a reminder to petitioners of their burden to demonstrate that relied upon references are prior art.
Topics: Kyle Bass
Yesterday, Kyle Bass and his hedge funds opened a new front in their war against patent owners (on which we have reported previously) by filing three new IPR petitions. This time, the Bass Coalition has attacked U.S. Patent Nos. 7,582,621 (IPR2015-01776) and 7,767,657 (IPR2015-01780 and IPR2015-01785). Assigned to Anacor Pharmaceuticals, Inc., these patents cover KERYDIN® (tavaborole), which is an antifungal medication approved by the FDA for treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
On the same day in related IPR proceedings, Celgene responded to the Coalition’s defense of this unusual market manipulation strategy (see, for example, IPR2015-01103 Paper 19).
Topics: Kyle Bass
As we recently noted, patent owner Celgene moved for sanctions against Kyle Bass and his hedge funds, arguing that the funds are engaged in extortion and that they are abusing the IPR process. On August 11, 2015, the hedge funds responded with a full-throated defense of their practices (IPR2015-01103 Paper 15).