On October 27, 2014, District Court Judge Amy J. St. Eve of the Northern District of Illinois found in an 80 page opinion that Mylan’s proposed generic drug product infringes all of the asserted claims of The Medicines Company’s U.S. Patent No. 7,582,727 (the “’727 patent”). She further held that the same claims of the ’727 patent were not invalid or unenforceable. The ’727 patent is listed in the FDA’s Orange Book as covering The Medicines Company’s drug product, Angiomax®, which is indicated for use as an anticoagulant during coronary angioplasty procedures.

The Court’s decision follows a June 2014 bench trial in The Medicines Company v. Mylan Inc. With respect to infringement, the Court found that “Mylan’s ANDA specification clearly describes a product that meets the limitations of the asserted claims, [the Federal Circuit’s precedent in] Sunovion is directly on point and establishes that Mylan’s proposed drug product infringes [the asserted claims] of the ’727 patent as a matter of law.”

The Court rejected all of Mylan’s allegations of invalidity and unenforceability. Specifically, the Court found that the asserted claims of the ’727 patent were not invalid due to anticipation, obviousness, or nonenablement. Regarding anticipation, the Court found that “Mylan has failed to prove that the Original Angiomax® batches alleged by it to meet the on-sale bar under § 102(b) meet each and every limitation of the claim,[] and thus Mylan has not established that the claimed invention was the subject of a commercial offer for sale by clear and convincing evidence and therefore cannot establish invalidity of the ’727 patent claims due to an on-sale bar.” With respect to obviousness, the Court found that “Mylan’s argument is fraught with unsupported assumptions,” “Mylan has little to no evidentiary support for its obviousness argument,” and “[a]fter a thorough analysis . . . the Court finds there is no motivation for a person . . . to combine the teachings of the prior art and arrive at the claimed invention with a reasonable expectation of success.” With respect to enablement, the Court found that Mylan failed to show that the claims “would be inoperable and failed to provide evidence that a person of ordinary skill in the art would have been unable to practice the asserted claims without resorting to any experimentation, let alone undue experimentation.” The Court also rejected Mylan’s allegations that the asserted claims were unenforceable due to inequitable conduct and found, for example, that the “credibility of Dr. Musso’s and Dr. Krishna’s testimony at trial and the evidence corroborating their testimony. . . weighs against a finding of intent to deceive the PTO.”

The Court’s ruling prevents Mylan from obtaining FDA approval of its generic drug product and launching the product until the earlier of a successful appeal or expiration of the ’727 patent in 2028. Mylan must overturn the Court’s rulings on each of the asserted claims in order to succeed on appeal.

The Medicines Company is represented by Porter F. Fleming, Angus Chen, Jason Lief, David Zwally, Laura Krawczyk, Sam Desai, Jason Kanter, Erika Selli, and Jonathan Herstoff of Frommer Lawrence & Haug LLP, and Patricia Smart of Smart & Bostjancich.