October 5, 2016
The Patent Trials and Appeals Board issued a final written decision upholding the validity of U.S. Patent No. 6,773,720, which is listed in the Orange Book for Shire’s Lialda® mesalamine delayed-release tablet product. In April 2015, Coalition for Affordable Drugs II LLC filed a petition for inter partes review of claims 1-4 of the ’720 patent and the Board instituted the proceedings in light of the Leslie and Groenendaal references. The petition against the ’720 patent is one of many filed by CFAD against innovator pharmaceutical and biotechnology company patents. CFAD is backed by billionaire hedge fund manager Kyle Bass. This decision is the first final written decision issued by the Board in a CFAD inter partes review.
The Board’s decision showed that claim construction can play a major role in an inter partes review proceeding. In this case, the Patent Owner and Petitioner disputed the meaning of the term “waxes.” Petitioner argued that “waxes” would encompass any substance having “waxy” or “wax-like” characteristics, and thereby would include the fatty alcohols disclosed in the Leslie patent. Patent Owner contended that “waxes” should be construed chemically as an ester, which would exclude the fatty alcohols in Leslie. The Board agreed with Patent Owner, determining that Petitioner’s construction of “waxes” was unreasonably broad. In particular, the Board noted that other members of the recited class of lipophilic substances exhibited waxy or wax-like properties. Further, the Board found that Patent Owner’s construction was amply supported by both the intrinsic and extrinsic record. Consequently, the Board determined that the combination of references would fail to teach all of the limitations of claim 1 (i.e., a claim 1(a) substance).
The Board’s decision also demonstrated that presenting a rigorous analysis of the complexity of the relevant art can expose significant failures of proof for motivation to combine. For example, the Board credited Patent Owner’s argument that Petitioner failed to account for the extraordinary variety of pH-independent dosage forms, much less the formulation in Leslie. The Board characterized Petitioner’s analysis as “throw[ing] metaphorical darts at a board” as compared to picking “known options” from a “finite number of identified, predictable solutions.” The Board also acknowledged the “very large number” of active ingredients that fell within the genus salicylates and criticized Petitioner’s failure to provide any reason to “improve” the 5-ASA compositions in Groenendaal. The Board was persuaded that a POSA would have taken into consideration numerous factors, such as such as dose size, compressibility, flowability, aqueous solubility, partition coefficient, drug stability, interaction with excipients, and chemical structure and weight.
Despite rarely crediting evidence of secondary considerations in pharmaceutical patent cases, the Board also found that evidence of secondary considerations were “not insubstantial” here. The Board found that evidence of a long-felt but unsolved need was particularly compelling. The Board observed that it was undisputed that researchers had been motivated for many years to create pills containing a very large percentage of mesalamine while minimizing the amount of pills necessary for administration. On commercial success, the Board found that both parties agreed that Lialda fell within the claims and that scientific literature evinced widespread praise. The Board found this evidence to be “relevant and favorable” to the obviousness analysis, especially in conjunction with long-felt need evidence.