THE MEDICINES COMPANY v. MYLAN: Apr. 6, 2017. Before Dyk, Wallach, Hughes


  • In ANDA case, the CAFC interprets batching limitation to require specific efficient mixing conditions, and reverses the district court’s finding of infringement based on this claim construction.

Procedural Posture:

The N.D. Ill. Held on summary judgment that the asserted claims of the ‘343 were not infringed, and those of the ‘727 were infringed. The CAFC affirmed-in-part and reversed-in-part.


  • Claim Construction: The district court erred by declining to interpret the claims of the ‘727 patent to require “efficient mixing” in producing the pharmaceutical batches. The CAFC held that based on the specification and the prosecution history, the batch limitation required the use of a compounding process that achieves batch consistency, and that this compounding process must use efficient mixing. The specification and prosecution history confirmed that achieving batch consistency required efficient mixing. The CAFC held that this efficient mixing required using the efficient mixing conditions of Example 5.
  • Infringement: The CAFC reversed the district court’s judgment that ‘727 was infringed. To infringe either patent, the accused batches must be compounded using a process that employs the efficient mixing conditions of Example 5. Mylan’s ANDA did not infringe the asserted claims since it was “undisputed” that Mylan did not use multiple mixing devices as required by Example 5.