The Medicines Company v. Mylan, Inc. et al.

Docket No. 2015-1113, -1151, -1181

April 6, 2017

Brief Summary: DC’s finding of infringement of the ‘727 patent reversed based on FC’s reading its construction of “efficient mixing” into the claims, thereby requiring infringing batches to “be compounded using a process that employs the efficient mixing conditions of Example 5”, and no showing in Mylan’s ANDA that it does so. DC conclusion of noninfringement of the ‘343 patent (including the term “efficient mixing” and particular conditions) affirmed.

Summary: As background, the patents disputed here were previously held invalid under the § 102(b) on-sale bar (Medicines Co., FC 2015) but on rehearing en banc found not invalid (Medicines Co., FC 2016) since its “relationship with BVL did not give rise to an invalidating ‘commercial offer for sale’ under Pfaff” (US 1998). Here, the Medicines Company (MC) appealed DC holding on SJ that Mylan’s ANDA product did not satisfy the specific “efficient mixing” limitations of the claims of US 7,598,343 relating to bivalirudin (Angiomax®). The DC also found Mylan infringed the asserted claims of US 7,582,727 since its claims do not include the “efficient mixing” limitation. As discussed below, the FC panel concluded here that both patents “include a ‘batches’ limitation that requires batch consistency, which, according to the patents in suit, is achieved through efficient mixing” and therefore reversed the DC ‘727 infringement finding (i.e., the ‘727 patent effectively included the “efficient mixing” limitation).

The FC opinion explains that both patents “are directed to minimizing impurities in batches of bivalirudin that have been compounded with a base” which is required in commercial forms since, without a base (e.g., using only “an aqueous solvent such as water or saline”), it forms “an acidic solution not suitable for injection”. In its approval, MC was “required to reject any…batch determined to have an” Asp9-bivalirudin (an impurity) “level higher than 1.5 percent.” While MC could produce acceptable batches using its “old” process, the new process was found to result in batches that “consistently satisfied the FDA’s” requirement (the batches “never exceeded 0.6 percent” as claimed in the ‘727 and ‘343 patents). The FC panel opinion noted that the claim term “pharmaceutical batches” was defined by the patents’ specifications. MC and Mylan disputed the claim terms “pharmaceutical batches” (DC construction: “single batch…made by a compounding process” or “all batches prepared by a same compounding process”, limiting both patents) and “efficiently mixing” (DC construction: “not using inefficient mixing conditions such as described in Example 4”, determined not to be a limitation of the ‘727 patent). The FC panel pointed out that in the DC’s ‘727 infringement finding, it “appeared to assume that any batch with an Asp9 level below 0.6 percent would infringe the claims, even though the court had earlier determined that the prior art disclosed such batches.” It disagreed, explaining that “what the batches limitation requires is the use of a process that achieves batch consistency…between batches produced from the ‘same compounding process’”. MC “agree[d] that batch consistency is…what ‘distin[guishes] [them] from the prior art” but disagreed “that the claims…require use of a particular process that achieves batch consistency.” The FC panel disagreed with MC because that “interpretation…would yield an unworkable claim construction” since “proof of infringement would necessitate forward-looking assessments of whether an accused infringer’s production of future or ‘potential’ batches would be likely to generate Asp9 levels greater than ‘about 0.6%’” (e.g., if the defendant made 50 batches, he “would not know whether any of the batches infringed until all fifty batches had been produced” which would not provide “‘reasonable certainty’ regarding” claim scope (Nautilus, US 2014; Geneva Pharms., FC 2003)).

It also found MC’s interpretation to be inconsistent with the specification and prosecution history (e.g., in distinguishing pre-critical date sales, it stated that the batches were “prepared by the new process of the present invention” and admitted to the DC that the term “refers to the compounding processes described in the patents-in-suit”). And in its accelerated prosecution petitions, MC stated that the process of the invention “involves efficiently mixing the pH-adjusting solution and the dissolved bivalirudin solution, which is not performed in the Applicants’ prior compounding process.” The FC panel also wrote that MC’s “construction…amounts to a mere recitation of the results obtained from ‘efficient mixing’ rather than a definition of what the efficient mixing process is” and conceded this to the DC (MC “construe[d] the term functionally-i.e., by its intended result.”) Noting that “functional limitations…are not per se objectionable”, it explained that MC was attempting “to claim all solutions to the identified ‘impurities’ problem, without describing the entire range of solutions to that problem…efficient mixing must be defined in terms of the particular process or processes identified in the specification” (in this case, based on the patent’s Example 5 (“the only embodiment of ‘efficiently mixing’” (Johns Hopkins, FC 1998)) as the term does not “carr[y] an accepted meaning to one of ordinary skill in the art” (Ariad, FC2010 (en banc); Bayer, FC 2013; Phillips, FC 2005). Based on this construction, the FC panel concluded batches infringing the ‘727 patent, which does not include the term “efficient mixing” in the claims, must nevertheless “be compounded using a process that employs the efficient mixing conditions of Example 5” (Abbott Labs., FC 2009 (en banc)). And it was not shown that Mylan uses “efficient mixing” (“nothing in the ANDA speakes to whether Mylan uses” that process (Ferring, FC 2014 (“[w]hen an ANDA is silent…the correct analysis is…[whether] the ANDA applicant would likely sell an infringing product pursuant to the approved ANDA”)). The FC panel therefore reversed the DC’s finding of infringement of the ‘727 patent (affirmed noninfringement of the ‘343 patent).

This entry was posted in Claim Construction, Generics / ANDA. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.