Takeda Pharmaceuticals U.S.A. v. Alkem Laboratories Limited

 
APPEAL NO.
20-1545
OP. BELOW
DCT
OPINION
TBD
SUBJECT
Patent
AUTHOR
TBD

Issue(s) Presented

1. “Section 1.2(d) of the License Agreement at issue in this case permits Alkem to launch its generic Colcrys® product a specified time period ‘after the date of a Final Court Decision . . . holding that all unexpired claims of the Patents-in-Suit that were asserted and adjudicated against a Third Party are either (i) not infringed, or (ii) any combination of not infringed and/or invalid, unpatentable, or unenforceable[.]’ The district court held that Takeda is unlikely to succeed in its argument that Alkem was not entitled to launch its generic product. Did the district court err in concluding that Section 1.2(d) was likely triggered by a court decision that: (A) held only three out of the eight asserted patents to be not infringed; and (B) reached no determination regarding noninfringement, invalidity, unpatentability, or unenforceability with respect to the remaining five patents?”

2. “Based on the correct interpretation of the License Agreement, did the district court abuse its discretion in denying Takeda’s motion for a preliminary injunction?”

3. “Based on the correct interpretation of the License Agreement, did the district court abuse its discretion in finding that there was no irreparable harm based on Section 1.10 of the License Agreement which provides that Takeda ‘shall be entitled to immediate injunctive relief’ in the event of a breach, and that a breach by Alkem of the License Agreement, ‘would cause Takeda irreparable harm’”?