The Medicines Co. v. Mylan, Inc.

Case Name: The Medicines Co. v. Mylan, Inc., Civ. No. 11-cv-1285, 2013 U.S. Dist. LEXIS 176269 (N.D. Ill. December 16, 2013) (St. Eve, J.) (When a claim element in a product-by-process patent require “efficient mixing” and the ANDA product is formulated by “inefficient mixing,” the ANDA product cannot infringe as a matter of law. Filing of an ANDA, in the absence of any other activities on the part of the Defendant, could not support a finding of willful infringement.) 

Drug Product and Patent(s)-in-Suit: Angiomax^® (bivalirudin); U.S. Patent Nos. 7,582,727 (“the ’727 patent”) and 7,598,343 (“the ’343 patent”) 

Nature of the Case and Issue(s) Presented: The asserted patents claim pharmaceutical formulations of bivalirudin and the process for making bivalirudin. Specifically, the ’727 patent is a product patent, while the ’343 patent is a product-by-process patent. Bivalirudin is the active ingredient in The Medicines Co.’s (“TMC”) branded drug product Angiomax. Angiomax is an injectable anticoagulant used to prevent blood clotting during coronary procedures.

Mylan filed an ANDA seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of a generic version of TMC’s Angiomax. In response, TMC filed suit against Mylan alleging infringement of the ’727 and ’343 patents. Mylan moved for summary judgment, asking the Court to find that TMC’s patents were not infringed, or in the alternative, that they were invalid. Additionally, Mylan sought summary judgment with respect to TMC’s allegation of willful infringement of the patents-in-suit. The court granted Mylan’s motion for summary judgment that the ’343 patent was not infringed and denied Mylan’s motion for summary judgment that the ’727 was not infringed. The court denied Mylan’s motion for summary judgment with respect to invalidity due to lack of written description or enablement. Finally, the court granted Mylan’s motion for summary judgment that its alleged infringement was not willful.

Why Mylan Partially Prevailed:  Concerning Mylan’s argument that its proposed ANDA drug did not infringe the ’343 patent, the court focused on the construction of two terms in the specification: “efficient mixing” and “inefficient mixing.” The specification described examples of both types of mixing, and each of the asserted claims included “efficient mixing” as a claim limitation. Mylan’s argued that its generic drug did not infringe because it used inefficient mixing in its formulation. In fact, Mylan argued that the mixing it used to formulate the ANDA product was even more inefficient than the examples of inefficient mixing that were disclosed in the specification of the ’343 patent. The court agreed. Mylan’s compounding process used one paddle mixer rather than two, and its mixer operated at a lower speed than the mixers described in the specification. Additionally, Mylan’s compounding process always added a pH-adjusting solution all at once instead of all at once or rapidly in multiple portions, as is disclosed in the specification. The court rejected TMC’s argument that there was at least a genuine issue of material fact related to the scale and concentration of mannitol and pH-adjusting solutions used by Mylan in its generic formulation. Moreover, the court rejected TMC’s argument that there was infringement under the doctrine of equivalents. TMC argued that a Mylan employee admitted that it was using efficient mixing to make its generic version, but the court rejected the argument as inadmissible hearsay, and also because the employee’s use of the term “efficient mixing” was not the same as the specialized meaning of the term used in the patent.

Regarding its motion for summary judgment of non-infringement of the ’727 patent, Mylan again argued that TMC’s inability to show that Mylan was using efficient mixing to formulate its ANDA product was fatal to TMC’s infringement claim. However, because none of the asserted claims of the ’727 patent included the “efficient mixing” limitation, the court disagreed. TMC argued that summary judgment was inappropriate because the batch data that Mylan submitted to the FDA contained a level of impurities less than the 0.6% level claimed in the patent. Mylan argued that a single batch result could not reliably predict the results of future batches, and that future batches could have impurity levels above the claimed 0.6% scope. The court rejected Mylan’s argument, noting that TMC had offered sufficient evidence to establish a genuine issue of material fact.

Mylan next argued that the ’727 patent was invalid for lack of written description and lack of enablement.  Mylan’s position was that if the ’727 patent encompassed pharmaceutical batches generated using inefficient mixing in addition to batches using efficient mixing, the patent had to be invalid for failing to enable the full scope of the claimed invention. The court rejected Mylan’s argument because the ‘727 patent was a product patent, not a product-by-process patent. Accordingly, the process used to generate the claimed drug was immaterial and largely irrelevant and could not be relied upon as a basis to render the claims invalid for lack of enablement.

Lastly, Mylan argued that TMC could not prove willful infringement because the mere filing of an ANDA does not support a finding of willful infringement, and TMC could not show that Mylan’s actions were objectively unreasonable. The court agreed, finding that TMC’s allegations that Mylan would infringe if Mylan manufactures, uses, sells, offers to sell or imports its generic bivalirudin product in the future, was wholly speculative. It noted that TMC failed to cite to any type of legal authority for the proposition that the mere filing of an ANDA in the absence of any other activities on the part of the Defendant could support a finding of willful infringement. The motion for summary judgment finding that Mylan did not willfully infringe TMC’s patents was granted.