The Medicines Co. v. Mylan Inc., No. 11 C 1285, Slip Op. (N.D. Ill. Aug. 6, 2012) (St. Eve, J.).
Judge St. Eve construed the claims in this patent case related to bivalirudin. Of particular note:
- “Pharmaceutical Batches” was construed as “may include a single batch, wherein the single batch is representative of all commercial batches (see generally, Manual of Policies and Procedures, Center for Drug Evaluation and Research, MAPP 5225.1, Guidance on the Packaging of test Batches at 1) made by a compounding process, and wherein the levels of, for example, Asp9 -bivalirudin, total impurities, and largest unknown impurity, and the reconstitution time represent levels for all potential batches made by said process. ‘Batches’ may also include all batches prepared by a same compounding process.”
- “Efficiently Mixing” was construed as “a pH-adjusting solution and the first solution are mixed not using inefficient mixing conditions such as described in Example 4.”
As usual, the Court very helpfully provided a glossary of constructions at the end of the opinion. Hopefully, this is a practice every judge will adopt.