On April 6, 2017, the Federal Circuit reversed-in-part and affirmed-in-part the district court’s judgment of infringement and summary judgment for non-infringement of The Medicines Company’s (“MedCo”) patents-in-suit.  See The Medicines Company v. Mylan, Inc., 2015-1113 (Fed. Cir. 2017).  The patents-in-suit were U.S. Patent Nos. 7,582,727 (“the ’727 Patent) and 7,598,343 (“the ’343 Patent”). MedCo initiated a suit against Mylan, Inc. (“Mylan”) in response to Mylan submitting an Abbreviated New Drug Application (“ANDA”).  Through submitting an ANDA request, Mylan wished to obtain approval from the Food and Drug Administration (“FDA”) for a generic drug that would directly compete against MedCo’s ANGIOMAX® product.  To counter Mylan’s ANDA request, and keep their product exclusive, MedCo filed suit alleging that Mylan’s ANDA drug infringed claims in both the ’727 and ’343 Patents.

The district court held on summary judgment that Mylan’s drug did not satisfy the “efficient mixing” limitation of the ’343 Patent; however, following a 6-day bench trial found that Mylan’s drug did infringe the ’727 Patent because the asserted claims did not include an “efficient mixing” limitation.  Mylan argued on appeal that the district court erred by not including the “efficient mixing” limitation as part of the “batches” limitation in the ’727 Patent.

Claim 1 of the ’727 Patent recites a “batches” limitation, whereby both patents in suit share similar specifications pointing to “efficient mixing” with regard to “batches” of an active ingredient.  The Federal Circuit agreed with Mylan, that when properly construed, the “batches” limitation requires the use of a compounding process that achieves batch consistency, which “does not impermissibly add a process limitation to a product claim.”  See id. at 14.  The Court reasoned that Example 5 in the specification of the’727 Patent described the only clear meaning of the “efficient mixing” process:

We conclude that one or ordinary skill in the art would rely on Example 5 to ascertain the metes and bounds of ‘efficiently mixing.’  As the only embodiment of efficient mixing, Example 5 is ‘highly indicative of the scope of the claims.’  Example 5, however, is not merely the only disclosed embodiment of efficient mixing—it is the only description of efficient mixing in the patents in suit that casts light on what efficient mixing is and that enables one of ordinary skill in the art to achieve the objects of the claimed invention.

See id. at 22-23.  Although the ‘727 patent specification described Example 5 as “non-limiting,” the Court found it appropriate to limit “efficient mixing” to the sole description in the patent because no other portion therein otherwise taught what affirmative steps constitute efficient mixing.

After reviewing the District Court’s factual findings and legal conclusions de novo, the Court found that Mylan’s ANDA request did not infringe MedCo’s asserted patents.  Upon reading the “efficient mixing” limitation into the claims, the Court found for Mylan by finding that their proposed generic drug did not infringe MedCo’s asserted patents.

Anthony E. Faillaci is co-author od this article.