On January 19, 2016, the PTAB denied Coalition for Affordable Drugs V LLC’s (CFAD) request for rehearing following the Board’s decision denying institution of IPR. In IPR2015-01086, CFAD filed a petition requesting an IPR of claims 1–13 in Biogen International GmbH’s (Biogen) U.S. Patent No. 8,759,393. The Board denied the petition and CFAD filed a request for rehearing on the (same) grounds of anticipation and obviousness. As discussed below, the denial of the rehearing highlights the importance of supporting all conclusions in an expert declaration with reasoned explanations.
In its request for rehearing, CFAD had the burden of showing the decision should be modified by identifying all matters CFAD believes the Board misapprehended or overlooked. The Board then reviews the decision for an abuse of discretion. An abuse of discretion may be indicated if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors.
With respect to anticipation, CFAD argues that the Board’s construction of the term “microtablet” is not supported by substantial evidence. However, to support their construction that the term “microtablet” does not encompass “granulate” as asserted by CFAD, the Board notes that the specification distinguishes the terms by listing both terms in a list of preferred active ingredients. The Board thus was not persuaded that CFAD showed the Board misapprehended or overlooked any evidence or argument in construing the claim term “microtablets,” or in determining whether Petitioner had established a reasonable likelihood that the challenged claims are anticipated.
More interestingly, the Board found that CFAD’s declarant failed to explain why a person of ordinary skill in the art would combine the disclosures of two references with a reasonable expectation of success and thus failed to persuade the Board on the obviousness ground. This blog previously highlighted the importance of articulating for the Board the specific teachings of the prior art rather than, for example, merely pointing to particular prior art paragraphs.
The decision and denial reinforce that petitioners must be careful to support all opinions concerning the teachings of the prior art with reasoned statements and explanations
CFAD contends that their expert declarant explained why controlling the rate of release of powder-based oral pharmaceuticals was an obvious thing for a person of ordinary skill in the art to do, and one obvious way to control the rate of release of active ingredients is with wetting agents. In their decision denying institution of IPR, however, the Board found that the declaration failed to address the different properties of the different active ingredients, and instead offered a conclusory opinion that adding the wetting agents disclosed in one reference to the active ingredients disclosed in a second reference would have controlled the drug release rate and solved the gastrointestinal problems observed in the second reference. In the denial of the request for rehearing, the Board similarly concluded that the declarant
… fails to explain how adding wetting agents, which would increase the release rate of the drug, would improve … gastrointestinal complaints, which are already caused by rapid release of the drug in the stomach. Thus, without further explanation to the contrary, we are not persuaded that we misapprehended or overlooked any arguments or evidence that would alter our Decision.
The decision and denial reinforce that petitioners must be careful to support all opinions concerning the teachings of the prior art with reasoned statements and explanations. A simple formula of reciting various claim limitations, cross-referencing the claim limitations to particular paragraphs in the prior art, and offering a conclusion that a person of ordinary skill in the art would find the claims obvious in view of the prior art is not enough. Expert declarations in particular should supplement such a formula with explanations as to why a person of ordinary skill would combine the prior art, and why such a combination would predictably result in the desired (i.e., claimed) solution.