During the week of June 18-22, 2018, the Patent Trial and Appeal Board issued two decisions in Tech Center 1600 denying institution of IPR petitions. The petitions were filed by Samsung Bioepis Co. Ltd. (“Bioepis”) against Genentech, Inc. (“Genentech”), and Initiative for Medicines, Access & Knowledge (I-MAK), Inc. (“I-MAK”) against Gilead Pharmasset LLC (“Gilead”), respectively. The decisions follow.
Samsung Bioepis Co. Ltd. v. Genentech, Inc., No. IPR2018-00192 (Decision Entered June 18, 2018). In this Petition, Bioepis challenged U.S. Patent No. 7,846,441 (“the ’441 patent”) on obviousness grounds based on five prior art references: Lottery, Hayes, Baselga ’94, Baselga ’96, and Gelmon. Genentech filed a preliminary response to the Petition. The claims at issue are directed to a combination therapy for HER2-positive cancers using an anti-ErbB2 antibody that binds to epitope 4D5, and a taxoid, in the absence of an anthracycline derivative.
The Board exercised its discretion to deny the Petition under 35 U.S.C. § 325(d) because the same or substantially the same prior art or arguments were presented in several previously instituted IPRs involving the same claims of the ’441 patent. Prior to this IPR, Pfizer, Inc. and Celltrion, Inc. challenged the same claims of the ’441 patent over the combination of, inter alia, Baselga ’96, and Baselga ’94. Although Lottery, Hayes, and Gelmon were not asserted in the previous IPRs, the Board agreed with Genentech that Bioepis’s arguments based on the newly asserted references were substantially the same as those in the earlier IPRs, and therefore denied Bioepis’s petition.
Initiative for Medicines, Access & Knowledge (I-MAK), Inc. v. Gilead Pharmasset LLC, No. IPR2018-00211 (Decision Entered June 20, 2018). In this Petition, I-MAK challenged U.S. Patent No. 9,393,256 (“the ’256 patent”) on anticipation and obviousness grounds based on a reference by Legrand-Abravanel, an anticipation ground based on a reference by Delaney, and an obviousness ground based on references by Sofia and Guo. Gilead filed a preliminary response to the Petition. The claims at issue recite an interferon-free combination therapy of two compounds (designated Compounds 6 and 10) for HCV infection in humans. Gilead asserted that neither Legrand-Abravanel nor Delaney disclosed the claimed combination of Compounds 6 and 10.
The Board agreed with Gilead and found that Legrand-Abravanel and Delaney at most disclosed a genus of the claimed combination, respectively: 1) Legrand-Abravanel disclosed combinations of an NS5B inhibitor (such as Compound 10) and a genus covering Compound 6; and 2) Delaney disclosed combinations of a list of compounds (such as Compound 6) and a genus covering Compound 10. The Board denied institution on the anticipation ground based on Legrand-Abravanel or Delaney because I-MAK failed to explain whether or how a person of ordinary skill in the art (POSA) would “at once envisage each member of the genus” disclosed in Legrand-Abravanel or Delaney to establish the anticipation of the claimed species by the disclosed genus. The Board denied institution on the obviousness ground based on Legrand-Abravanel, or Sofia and Guo because I-MAK failed to show sufficiently whether or why a POSA would have had a reasonable expectation of success in arriving at the claimed combination from the teachings of the prior art. The Board found that I-MAK failed to provide any analysis of the reasonable expectation requirement for the obviousness ground over Legrand-Abravanel, and further explained that the “general approach and guidance to a field of experimentation” as taught by Legrand-Abravanel is insufficient to establish the requisite reasonable expectation of success. Finally, the Board found I-MAK’s conclusory statement that a POSA would “have also been motivated to test such compound combinations with or without an interferon” was insufficient to render obvious the claim limitation of “wherein the method does not include administering interferon,” in view of Sofia and Guo.