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.
Post-grant review (PGR) is potentially more powerful than IPR, as it allows challenges to any requirement of patentability, while IPR is limited to claim validity in view of patents and printed publications. Accordingly, PGR, if available, may in some cases be a better option for petitioners. In one recent case, PGR might have been the better option—had the petitioner persuaded the PTAB that the patent at issue qualified for PGR.
In the last two weeks, the PTAB has invalidated three patents covering Copaxone®, a multiple sclerosis drug marketed by Teva with annual sales of over $3 billion. Challenged by generic manufacturers Mylan and Amneal, the patents specifically covered a long-acting form of Copaxone®, known as “3-times-a-week COPAXONE® 40 mg/ml,” which Teva developed when the original version of Copaxone® was coming off patent protection.
These IPR decisions highlight the usefulness of post-grant proceedings for generic and biosimilar manufacturers, particularly for challenging follow-on patents, such as those covering specific dose regimens, as we discussed in earlier posts.