Medicines Co. v. Mylan Inc.

257 F. Supp. 3d 1023
CourtDistrict Court, N.D. Illinois
DecidedJune 28, 2017
DocketNo. 11-cv-1285
StatusPublished
Cited by1 cases

This text of 257 F. Supp. 3d 1023 (Medicines Co. v. Mylan Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Medicines Co. v. Mylan Inc., 257 F. Supp. 3d 1023 (N.D. Ill. 2017).

Opinion

MEMORANDUM OPINION AND ORDER

AMY J. ST. EVE, District Court Judge:

Defendants Mylan Inc., Mylan Pharmaceuticals Inc., and Bioniche Pharma USA, LLC (collectively, “Defendants”) have moved to amend the Court’s Amended Final Judgment in light of the United States Court of Appeals for the Federal Circuit’s recent opinion in this case. (R. 676.) Plaintiff The Medicines Company (“TMC”) opposes Defendants’ motion and also moves for a new trial. (R. 682; R. 684.) For the following reasons, the Court grants Defendants’ motion and denies TMC’s motion.

BACKGROUND

I. The Patents-in-Suit

The Court assumes the parties’ familiarity with this case, but summarizes the [1025]*1025relevant facts and procedural history. TMC is the owner of U.S. Patent Nos. 7,582,727 (“the ’727 Patent”) and 7,598,343 (“the ’343 Patent”). Meds. Co. v. Mylan, Inc., 853 F.3d 1296, 1298 (Fed. Cir. 2017). The patents-in-suit concern “pharmaceutical formulations — or ‘batches’ — of the drug bivalirudin.” Id. Bivalirudin is .a well-known drug covered by a different TMC patent that expired in 2015. Id. It is typically distributed as a dry powder that “must be compounded with a base, before being reconstituted in a clinical setting and administered to a patient as an intravenous injection.” Id. Reconstituting bivaliru-din involves dissolving the drug in powder form in an aqueous solvent. Id. Because dissolving bivalirudin without a base results in an acidic solution that is not suitable for injection into humans, commercial forms of bivalirudin compound the drug with a base to increase the pH of the reconstituted drug to render it acceptable for injection. Id. The claimed inventions of the patents-in-suit “are directed to minimizing impurities in batches of bivalirudin that have been compounded with a base.” Id.

The claimed inventions arose out of a problem TMC encountered when manufacturing Angiomax — a base-compounded bivalirudin drug product. The Food & Drug Administration (“FDA”) “required TMC to limit the level of ‘Asp9-bivalirudin’ — an impurity generated during the compounding process that shortens bivalirudin’s shelf life — to less than 1.5 percent.” Id. at 1299. Between 2001 and 2005, TMC produced Angiomax with Asp9 levels normally below 0.6%, but sometimes the process TMC used resulted in variable or high levels of Asp9. Id. After producing two batches in 2005 and 2006 with Asp9 levels above 1.5%, TMC investigated and identified the compounding process as the source of the problem. Id. One of the steps of compounding bivalirudin is mixing a bivaliru-din solution (the powder bivalirudin dissolved into an aqueous solvent) with a pH-adjusting solution containing a base. Id. As the patents-in-suit indicate, this mixing process can result in “hotspots” — that is, certain “concentrated sites in the compounding solution that have much higher pH levels.” Id. (quoting from the ’727 Patent as an example). These hotspots in turn “catalyzed the degradation of bivalirudin to Asp9-bivalirudin, resulting in the undesirable high Asp9 levels that TMC was at times experiencing.” Id.

The inventions at issue in the patents-in-suit concern an “efficient mixing” process for combining the pH-adjusting solution with the bivalirudin solution that limits the formation of hotspots. Id. at 1299-1300 (noting that the “batch consistency of biva-lirudin products compounded using ‘efficient mixing* is the invention disclosed and claimed by the patents in suit, which were filed on the same day and share nearly identical specifications”). This process resulted in batches with Asp9 levels consistently below the FDA-mandated limit of 1.5%. Id. at 1299. Indeed, TMC found that efficient mixing resulted in batches with Asp9 levels that never exceeded 0.6%. Id. Both the ’727 and the ’343 Patents have a common claim limitation (the “batches limitation”): “[pharmaceutical batches of a drug product comprising bivalirudin ... wherein the hatches have a maximum impurity level of Asp9-bivalirudin that does not exceed about 0.6%.” Id. at 1300 (quoting ’727 Patent, col. 25:56-64; ’343 Patent, col. 27:13-31). The patents-in-suit also defined the term “pharmaceutical batches” as follows:

As used here, “batch” or “pharmaceutical batch” refers to material produced by a single execution of a compounding process of various embodiments of the present invention; “Batches” or “pharmaceutical batches” as defined herein may include a single batch, wherein the single batch is representative of all commercial batches, and wherein the levels [1026]*1026of, 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. • :

Id. (citation omitted) (quoting ’727 Patent, col. 5:24-36; ’343 Patent, col. 5:24-36).

II. Defendants’ ANDA and the Litigation Before Appeal

Defendants submitted an ANDA to the FDA in 2010, seeking to market a generic version of Angiomax. Id. Defendants stated that they would limit the ASP9 level of its generic drug to less than 2% and certified either (1) that their product would not infringe the patents-in-suit, or (2) that the patents-in-suit were invalid. Id. TMC filed the current lawsuit asserting infringement of the ’727 and ’343 Patents , under 35 U.S.C. § 271(e)(2), and Defendants filed counterclaims seeking declaratory judgments of invalidity. Id. The parties disputed the claim terms “pharmaceutical batches” and “efficiently mixing,” Id. at 1300-01. With respect to the former, this Court’s claim construction — to which both parties consented — “clarif[ies] that the definition requires a particular process.” Id. at 1301. With respect to the latter disputed term, the Court looked to two examples set forth in the patents’ specifications comparing TMC’s “old compounding process,” which used “inefficient mixing conditions” (Example 4), with the new “efficient mixing” process (Example 5). Id. The Court ultimately concluded that TMC “had disclaimed the ‘inefficient mixing conditions’ of Example 4 and adopted Mylan’s proposed construction of ‘efficiently mixing’, to require ‘not using inefficient mixing conditions such as described in Example 4.’ ” Id. at 1301 (quoting (R. 119, Aug. 6, 2012 Op., 30)).

Based on the claim construction of “efficiently mixing,” the Court granted summary judgment of non-infringement to Defendants with respect to the ’343 Patent. (R. 309, Dec. 16, 2013 Op., 18); see also Meds. Co., 853 F.3d at 1301. Specifically, with respect to literal infringement, the Court explained that “[t]he only question is whether Mylan’s compounding process is as inefficient (or more inefficient) than the compounding process described in Example 4,” and “[t]he undisputed facts show that Mylan’s compounding process is more inefficient than the ‘inefficient mixing’ process described in Example 4.” (R. 309 at 19-20); see also Meds. Co., 853 F.3d at 1301.

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Bluebook (online)
257 F. Supp. 3d 1023, Counsel Stack Legal Research, https://law.counselstack.com/opinion/medicines-co-v-mylan-inc-ilnd-2017.