During the week of November 5, 2018, the Board issued one decision granting institution of inter partes review.
Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited, IPR2018-00943 (Decision Granting Institution of IPR November 7, 2018). Petitioner Amneal challenged the patentability of claims 1-13 of United States Patent No. 7,919,499 (“the ᾽499 patent”) on two grounds of anticipation and four grounds of obviousness. IPR2018-00953 at 4. The ᾽499 patent is directed to methods for treating alcohol-dependent patients with a long-acting formulation of naltrexone. Id. at 3. Claim 1 includes a step of administering “a long acting formulation comprising about 310 mg to about 480 mg of naltrexone and a biocompatible polymer” in which “the serum AUC of naltrexone is about three times greater than that achieved by 50 mg/day oral administration.” Id. at 4-5.
Petitioner asserted two anticipation grounds: anticipation of claims 1, 3-5, and 10-12 by Comer as evidenced by Nuwayser and anticipation of claims 1, 3-5, 11, and 12 by Nuwayser. The Board found a reasonable likelihood of success that Petitioner would prevail on its asserted ground of anticipation by Comer, as evidenced by Nuwayser, because Comer teaches, either explicitly or inherently, every limitation of claim 1. Id. at 20-21. The Board disagreed with Patent Owner that Petitioner’s anticipation ground was improper because it relies on multiple references (i.e., Comer as evidenced by Nuwayser). Instead, the Board found that Nuwayser evidenced what a skilled artisan would have understood Comer’s reference to a specific drug to have meant; Nuwayser was not supplementing missing limitations in Comer. Id. at 23. The Board also questioned whether certain dependent claims were properly challenged as anticipated. However, in view of SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1355–56 (2018), the Board also instituted claims 3-5 and 10-12 as anticipated by Comer, as evidenced by Nuwayser. Id. at 25. Regarding the second ground of anticipation, the Board expressed “concern” with Petitioner’s “circular logic” to support its anticipation claim in view of Nuwayser alone, but nevertheless instituted IPR in view of SAS. Id. at 27.
Petitioner also asserted four obviousness grounds for claims 1-13 using different combinations of prior art references including Comer, Nuwayser, Rubio, Wright, Kranzler, Alkermes 10-K, and Vivitrex Specimen. Id. at 6. As the first two grounds included both Comer and Nuwayser, the Board found a reasonable likelihood of success that Petitioner would prevail with respect to showing that claims 1-13 are unpatentable over the two combinations. Id. at 33.
Regarding the last two obviousness grounds, the Board found that Petitioner failed to establish a reasonable likelihood of success that Petitioner would prevail on either asserted ground. Id. at 33 and 35. In particular, the Board found that Petitioner failed to show Alkermes 10-K qualifies as a printed publication because Petitioner did not demonstrate that a skilled artisan interested in preparing long-acting naltrexone formulations “would have known to locate the Alkermes 10-K.” Id. at 37. The Board also dismissed Petitioner’s reason to combine the Alkermes 10-K with Vivitrex Specimen, a trademark application for the drug Vivitrex. The Board found that Petitioner’s argument that a skilled artisan looking at the Alkermes 10-K reference would take a step to determine what trademark was pending to see what information was covered by the trademarked product “seems to us both haphazard and tenuous.” Id. at 38. Nevertheless, in view of SAS, the Board instituted IPR of all challenged claims. Id. at 34 and 38.