PTAB EXTENDS TIME FOR INSULIN GLARGINE IPR DECISION

We previously covered the Patent Trial and Appeal Board’s (the “Board”) institution of inter partes reviews filed by Mylan challenging the validity of various Sanofi patents relating to devices for administering insulin glargine: IPR2018-01675, IPR2018-01676 (Patent 8,603,044 B2); IPR2018-01678, IPR2018-01679, IPR2019-00122 (Patent 8,992,486); IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2); and IPR2018-01684 (Patent 9,604,008).  On March 25, 2020, the Board entered an order adjusting the deadline for issuance of decisions in each of these proceedings by almost two months, and shall now issue a Final Written Decision no later than May 29, 2020.

The Board had instituted inter partes review on April 2, 2019 in IPR2018-01675 and IPR2018-01676, and on April 3, 2019 in the remaining proceedings.  On August 15, 2019, the Board joined Pfizer Inc. to each of the proceedings.  The Board justified its extension of the Final Written Decision deadline in view of that jointer by reasoning that, although under 35 U.S.C. § 316(a)(11) a final determination is required within one year of the institution decision, the Board has the authority to adjust this timeline in the case of joinder.

 

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