Blog Big Molecule Watch June 04, 2020

PTAB Issues Final Written Decisions Finding Most Claims of Sanofi’s Lantus Patents Invalid

As we previously reported, Mylan filed a number of IPR petitions challenging a total of seven of Sanofi-Aventis’s patents related to Lantus® (insulin glargine injection).  On May 29, 2020, the PTAB issued Final Written Decisions in eight of Mylan’s pending petitions concerning four patents finding most of the challenged claims invalid.  However, in IPR2018-01684, the PTAB held that Mylan did not meet its burden to prove that claims 3 and 11 of U.S. Patent No. 9,604,008 are invalid.

The results of Mylan’s Lantus®-related IPRs thus far are as follows:

  • IPR2018-1670: claim 1 of U.S. Patent No. 8,679,069 (sole challenged claim) is invalid for obviousness (Final Written Decision issued April 2, 2020);
  • IPR2018-01675 and IPR2018-01676: claims 11, 14, 15, 18, and 19 of U.S. Patent No. 8,603,044 (all challenged claims) are invalid for obviousness (Final Written Decisions issued May 29, 2020);
  • IPR2018-01678, IPR2018-01679, and IPR2019-00122: claims 1–6, 12–18, 20, 23, 26–30, 32, 33, 36, 38-40, and 51-57 of U.S. Patent No. 8,992,486 (all challenged claims) are invalid for anticipation (claims 51-57) and obviousness (all remaining challenged claims) (Final Written Decisions issued May 29, 2020);
  • IPR2018-01680 and IPR2018-01682: claims 21-30 of U.S. Patent No. 9,526,844 (all challenged claims) are invalid for anticipation (claims 21-24 and 26-28) and obviousness (claims 21-30) (Final Written Decisions issued May 29, 2020);
  • IPR2018-01684: claims 1, 7, 8, and 17 of U.S. Patent No. 9,604,008 are invalid for obviousness, but Petitioner did not meet its burden to show unpatentability of claims 3 and 11 (Final Written Decision issued May 29, 2020);
  • IPR2017-01526: claims 1-25 of U.S. Patent No. 7,476,652 (all challenged claims) are invalid for obviousness (Final Written Decision issued December 12, 2018; previously reported)
  • IPR2017-01528: claims 1-20 of U.S. Patent No. 7,713,930 (all challenged claims) are invalid for obviousness (Final Written Decision issued December 12, 2018; previously reported)

As we previously reported, Sanofi has appealed the decisions in IPR2017-01526 and IPR2017-01527 finding the challenged claims of U.S. Patent Nos. 7,476,652 and 7,713,930 invalid to the U.S. Court of Appeals for the Federal Circuit.  Sanofi has now also filed a notice of appeal in IPR2018-01670 concerning U.S. Patent No. 8,679,069.

Furthermore, on March 9, 2020, the Federal District Court for the District of New Jersey held, following a bench trial, that claims 21, 22, 25, and 30 of U.S. Patent No. 9,526,844 are not infringed by Mylan’s proposed insulin glargine pen and are invalid for lack of written description under 35 U.S.C. § 112.

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