On January 14, 2016, a PTAB panel denied institution of petitions for inter partes review of two patents owned by AbbVie and alleged by AbbVie to cover the pharmaceutical product HUMIRA®, the best-selling brand-name drug of 2015. The petitions, filed by Amgen, preceded the company’s submission of a Biologics License Application for a biosimilar alternative to HUMIRA®. According to the Board, the petitions challenging the patentability of the claims of U.S. Patent Nos. 8,916,157 and 8,916,158 failed to show “that there [was] a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition[s]” as required under 35 U.S.C. § 314. Petitioner challenged claims in both patents under 35 U.S.C. § 103(a) as obvious over two sets of prior art references and the state of the art at the time of the inventions. The Board was not persuaded in either instance, and determined that the first set of references did not provide “sufficient guidance such that a skilled artisan would have had a reasonable expectation of success…” The Board further found the combination of the references to “be exercises in impermissible hindsight reconstruction,” citing to Grain Processing Corp. v. Am.-Maize prods. Co., 840 F.2d 902, 907 (Fed. Cir. 1988). In also rejecting the patentability arguments over the second set of references, the Board agreed with the Patent Owner that a “lack of teachings . . . would have left one of ordinary skill in the art ‘with an utter lack of guidance…’” After determining that Petitioner had “not established a reasonable likelihood of prevailing with respect to” the challenged independent claims, the petitions were denied and no trial was instituted.
Amgen, Inc. v. AbbVie Biotechnology LTD., IPR2015-01514 (PTAB January 14, 2015)[Elluru (opinion), Hulse, LaVier].
Amgen, Inc. v. AbbVie Biotechnology LTD., IPR2015-01517 (PTAB January 14, 2015)[LaVier (opinion), Elluru, Hulse].