Blog Big Molecule Watch May 02, 2019

PTAB Institutes Inter Partes Review of Five of Sanofi’s Lantus Patents

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).

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