Board Adjudicates First AIA Pharmaceutical Decisions Upholding Patentability on Claim Construction Positions Requested at Oral Hearing

The wait is over for the first pharmaceutical AIA post-grant review final written decisions. Last December, the Board instituted inter partes review (IPR) trials for select claims in three patents listed in the Orange Book for Oracea®, a pharmaceutical approved to treat rosacea. Seeking to market a generic version of the brand name drug, Amneal Pharmaceuticals submitted an ANDA to the FDA with Paragraph IV certifications sparking Hatch Waxman litigation against Galderma Laboratories and Supernus Pharmaceuticals over four Orange Book-listed patents, including U.S. Patent No. 8,206,740. Galderma Labs. Inc. v. Amneal Pharm., LLC, C.A. No. 11-1106-LPS, D.I. 222 (D. Del. May 16, 2014).

This December, the Board declined to find challenged claims of the ’740 patent and its children, U.S. Patent Nos. 8,394,405 and 8,394,406, unpatentable. Amneal Pharm., LLC v. Supernus Pharm., Inc., IPR2013-00368, Paper 94 (Dec. 9, 2014); IPR2013-00371, Paper 96 (Dec. 9, 2014); IPR-2013-00372, Paper 92 (Dec. 9, 2014).

Each claim at issue concerned a composition with a ratio of immediate release formulation to delayed release formulation (IR:DR). The Board’s decisions rested on its claim construction of the term “delayed release,” which neither party construed directly in briefings. At the oral hearing, Judge Kamholz asked counsel for a precise list with pinpoint citations to record evidence relied on for the plain meaning of “delayed release.” IPR2013-00368, Paper 92 at 48:7-49:6. Attorneys provided the requested citations towards the end of the oral hearing. IPR2013-00368, Paper 92 at 70:7-72:2, 80:11-81:20.

The Board, agreeing with the petitioner’s asserted broadest reasonable interpretation, construed “delayed release” to mean “release of a drug at a time other than immediately following oral administration,” using language from an FDA document submitted as an exhibit by the patent owner. Despite adopting the petitioner’s proposed construction for “delayed release,” the petitioner did not ultimately prevail. The Board, applying the same interpretation of “delayed release” to the cited references (Ashley ’932 and Sheth), concluded that the petitioner had not proved obviousness by a preponderance of the evidence.

Specifically, though noting the Sheth reference uses the words “delayed release,” the Board credited expert declaration testimony that Sheth’s second portion concerned release of a drug promptly after administration and the same expert’s deposition testimony that, although there might be some lag, it would not be considered a delay. Viewing the petitioner’s argument, then, as premised on an incorrect assumption that Sheth allegedly disclosed a “delayed release” second portion, the Board rejected the petitioner’s position that the claimed ratios were known or could have been reached through routine experimentation, finding this position untenable and unwarranted.

The Board’s final written decision did not decide all disputed issues. For example, the Board did not address the patent owner’s alternative arguments that certain references were not prior art. IPR2013-00368, Papers 83 and 86. Also, the petitioner’s motion to exclude particular exhibits was dismissed as moot, because the Board’s final written decision did not cite those exhibits.