IPR is a common way to challenge patents covering pharmaceutical compounds, often on grounds of obviousness. As illustrated in the recent decision in in Mylan Pharmaceuticals Inc. v. AstraZeneca (IPR2015-01340), such IPRs may rely on a “lead compound analysis” involving a two-prong inquiry that asks: (i) whether a structurally similar prior art compound would have been selected as a “lead compound” and (ii) whether there was motivation to modify that compound to arrive at the claimed compound.
It is not uncommon in the biotechnology and pharmaceutical fields to file new patent applications based on results of a clinical trial or discovery of a newly appreciated feature of a compound. However, results-based claim language, such as pharmacokinetic or drug release profiles, may not confer patentable weight, as shown in a recent IPR decision.
No matter whether you are the patent owner or petitioner in an IPR, expert witness testimony is an important aspect of building your case. The Board relies on expert witnesses to provide insight into the often highly technical aspects of a given case, and will inevitably choose to give more weight to the testimony of one side’s witness over the other. This can be especially true when the testimony of the opposing experts is in direct conflict. So how does the Board choose which expert testimony to give more weight? Sometimes it’s a question of timing, as in the recent decision in Mylan Pharmaceuticals Inc. v. AstraZeneca (IPR2015-01340).
Duck salad—not the tasty Asian dish, but rather a pesky aquatic weed that grows among rice crops—is the subject of the patent challenged in the recent IPR Aceto Agricultural Chemicals Corp. v. Gowan Company, LLC (IPR2016-00076). The Board’s final written decision illustrates a point that should not be overlooked: the broadest reasonable interpretation, which the Board applies to most claims in IPR, is not the broadest conceivable interpretation. The distinction made all the difference in this case.
In IPRs regarding the patents to pharmaceutical compounds, patentability often turns on the obviousness of taking a known compound and modifying it based on a known technique. This process is known as lead compound analysis. Argentum Pharmaceuticals, Inc. v. Research Corporation Technologies, Inc. (IPR2016-00204) illustrates that even when the lead compound and the modification technique are known, the basics of patent law cannot be ignored—especially with billions of dollars in sales at stake.
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.