IPR challenges must rely on prior art “patents or printed publications” as the basis for invalidating US patents. But what if a useful prior art reference is not a typical printed publication such as a scientific literature reference or industry journal report? We explored the subject of what constitutes a prior art printed publication in a recent post; now we’ll take a closer look at this issue as it relates to digital content. Two related IPR decisions, Coalition for Affordable Drugs VIII, LLC v. The Trustees of the University of Pennsylvania (IPR2015-01835, Paper 56 and IPR2015-01836, Paper 58), demonstrate that it can sometimes be challenging to prove that a reference qualifies as a printed publication … leaving the petitioner wishing they could hop in the DeLorean to go back and change the prior art.
In IPRs, secondary considerations such as unexpected results can play a determinative role in evaluating obviousness, particularly when there is a clear nexus with the claimed invention. In general, ‘differences in degree’ of a known and expected property are not as persuasive in rebutting obviousness as ‘differences in kind’ (for example, a new property dissimilar to the known property). Such was the case in Coalition for Affordable Drugs v. Pozen, Inc. (IPR2015-01718), in a decision that may leave some feeling queasy.
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).
If a patent claim recites a range of 2-6 units, and a prior art reference recites a range of up to 4 units, do those two ranges overlap such that the patent claim is not novel? If so, how important are the ranges when it comes to establishing the novelty of the claim, and whose job is it to make that argument? These questions of overlapping ranges arose in Dermira, Inc. v. Purepharm, Inc. (IPR2015-01593). In this IPR decision, the PTAB affirmed that when a reference discloses an overlapping range with the challenged patent’s claims, the patent holder has the burden of showing the criticality of the claimed range to establish novelty.
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.
You can’t prepare for something that you can’t see. Newly recognized properties of previous discoveries or other inherent features not appreciated at the time of filing can sneak up on you after patent prosecution has ended, as was the case in the recent decision in Pharmacosmos A/S, v. Luitpold Pharmaceuticals, Inc. (IPR2015-01490).
The immune system is said to be a double-edged sword: On one hand, it protects us from foreign invaders such as bacteria and viruses. On the other, it can recognize its host as the enemy, causing autoimmune disorders like rheumatoid arthritis. A similar double-edged sword principle holds true for prior art references. In a recent decision in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company (IPR2015-01537), prior art cited by Momenta in a § 103 challenge to Bristol-Myers Squibb’s CTLA4Ig formulation patent turned out to be the very instrument that killed its case.
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.