As we have reported here and here, over the past couple of years Mylan has filed a number of IPR petitions challenging a total of seven of Sanofi-Aventis’s patents related to Lantus® (insulin glargine injection). On April 2, 2019, the PTAB granted institution of two petitions (IPR2018-01675 and IPR2018-01676) challenging claims 11, 14, 15, 18, and 19 of U.S. Patent No. 8,603,044 on obviousness grounds. On April 3, 2019, the PTAB granted institution of seven additional petitions: IPR2018-01670 challenging claim 1 of U.S. Patent No. 8,679,069 on obviousness grounds; IPR2018-01678 and IPR2019-00122 challenging claims 1–6, 12–18, 20, 23, 26–30, 32, 33, 36, and 38–40 of U.S. Patent No. 8,992,486 on obviousness grounds; IPR2018-01679 challenging claims 51–57 of U.S. Patent No. 8,992,486 on anticipation and obviousness grounds; IPR2018-01680 and IPR2018-01682 challenging claims 21-30 of U.S. Patent No. 9,526,844 on anticipation and obviousness grounds; and IPR2018-01684 challenging claims 1, 3, 7, 8, 11, and 17 of U.S. Patent No. 9,604,008 on obviousness grounds. On April 3, the PTAB also denied institution of IPR2018-01696 challenging claims 21-30 of U.S. Patent No. 9,526,844 on obviousness grounds.
As we previously reported, this past December the PTAB issued Final Written Decisions finding claims 1-25 of U.S. Patent No. 7,476,652 (IPR2017-01526) and Claims 1-20 of U.S. Patent No. 7,713,930 (IPR2017-01528) unpatentable on obviousness grounds. Shortly thereafter, Sanofi-Aventis appealed to the Federal Circuit. On April 26, 2019, Sanofi-Aventis filed its opening appellate brief in the consolidated appeal to challenge the PTAB’s adverse decisions.
Sanofi has asserted the above patents against Mylan in a patent infringement suit in the District of New Jersey regarding Mylan’s proposed follow-on insulin glargine product. A Markman Hearing was held on April 12, 2019 and trial is set for January 2020 (subject to the Court’s availability).