Aside from a quick termination of IPR proceedings pending settlement in Argentum Pharmaceuticals LLC v. Cipla Ltd., No. IPR2017-00807 (Decision Entered May 21, 2018), the Board entered four decisions in TC 1600 during the week of May 21, all denying institution of IPR petitions filed by Initiative for Medicines, Access & Knowledge (I-MAK), Inc. (“I-MAK”) against Gilead Pharmasset LLC. (“Gilead”). Those decisions are as follows:
Initiative for Medicines, Access & Knowledge (I-MAK), Inc. v. Gilead Pharmasset LLC, No. IPR2018-00121 (Decision Entered May 21, 2018). In its petition, I-MAK challenged U.S. Patent No. 8,334,270 (“the ’270 patent”) on anticipation and obviousness grounds based on references by Sofia, Ma, and Perrone. Gilead filed a preliminary response to the petition. The ’270 patent claims priority to two provisional applications, including application 60/909,315 (“the ’315 provisional”). I-MAK alleged that the primary references—Sofia and Ma—qualify as prior art because the ’270 patent is not entitled to the benefit of priority to the ’315 provisional. The Board disagreed, finding that the ’315 provisional discloses the very compound relied on in I-MAK’s grounds of anticipation and obviousness, and that I-MAK failed to sufficiently demonstrate that the ’270 patent is not entitled to claim priority to the ’315 provisional. Consequently, the Board denied institution of inter partes review because Sofia and Ma were found to be unavailable as prior art.
Initiative for Medicines, Access & Knowledge (I-MAK), Inc. v. Gilead Pharmasset LLC, No. IPR2018-00122 (Decision Entered May 21, 2018). In its petition, I-MAK challenged the ’270 patent on two grounds of obviousness based on two primary references by Clark and two secondary references, Perrone and McGuigan. Gilead filed a preliminary response to the petition. Although the claims at issue recite a Markush group of phosphoramidate nucleoside derivatives, I-MAK’s challenge was limited to just one specific uridine analog—2’-deoxy-2’-fluoro-2′-C-methyluridine—with one specific phosphoramidate moiety—(phenyl)(isopropyl-L-alaninyl)phosphate. The Board denied institution of inter partes review because I-MAK failed to establish that one skilled in the art (i) would have selected 2’-deoxy-2’-fluoro-2’-C-methyluridine as a lead compound, (ii) would have modified 2’-deoxy-2’-fluoro-2’-C-methyluridine to achieve the claimed invention based on the teaching of Perrone, or (iii) would have reason to combine the teaching of 2’-deoxy-2’-fluoro-2’-C-methyluridine in the Clark references in view of the teaching of phophoramidate prodrug moieties in Perrone or McGuigan to achieve the claimed invention.
Initiative for Medicines, Access & Knowledge (I-MAK), Inc. v. Gilead Pharmasset LLC, No. IPR2018-00125 (Decision Entered May 24, 2018). In its petition, I-MAK challenged U.S. Patent No. 8,633,309 (“the ’309 patent”) on three grounds based on references by Sofia, Clark, and Congiatu. Gilead filed a preliminary response to the petition. The claims at issue relate to phosphoramidate nucleoside compounds having a specific purity of Sp and Rp stereoisomers. The Board denied institution of the first ground—anticipation by Sofia—because I-MAK failed to establish that a mixture of diastereomer compounds disclosed by Sofia expressly or inherently disclose the claimed compounds. For the second ground based on Sofia and Congiatu, the Board exercised its discretion to deny institution under 35 U.S.C. § 325(d) because the same or substantially the same prior art or arguments related to the Sofia reference were previously presented to the Office during prosecution of the ’309 patent. The third ground based on Clark and Congiatu was denied because I-MAK failed to establish (i) that the Clark reference expressly or inherently teaches the claimed formula or its required purity, (ii) that the Congiatu reference establishes a lack of unexpected results related to the purity of the claimed formula that Congiatu disclosed, or (iii) any persuasive reason to combine the teachings of the Clark and Congiatu references.
Initiative for Medicines, Access & Knowledge (I-MAK), Inc. v. Gilead Pharmasset LLC, No. IPR2018-00126 (Decision Entered May 24, 2018). In its petition, I-MAK challenged U.S. Patent No. 9,284,342 (“the ’342 patent”) on three grounds of obviousness based on references by Sofia, Clark, and Ma. Gilead filed a preliminary response to the petition. The claims at issue require a crystalline compound “having XRPD 2ϴ-reflections (°) at about: 6.1 and 12.7.” The Board denied institution of all three grounds because I-MAK disregarded the crystalline structure limitations required by the claims, and failed to establish any suggestion that one skilled in the art would have been motivated to make the combinations or modifications of the cited references to arrive at the claimed crystalline compounds.