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Forest Laboratories, LLC v. Sigmapharm Laboratories, LLC

United States District Court, D. Delaware

August 6, 2019



          GOLDBERG, J.

         The current controversy in this ongoing Hatch-Waxman case involves a motion by defendant Sigmapharm Laboratories, LLC (“Sigmapharm”) to vacate a finding of infringement pursuant to Fed.R.Civ.P. 60(b) based on a post-trial amendment to its Abbreviated New Drug Applications (“ANDA”). (D.I. 411). Plaintiffs Forest Laboratories LLC, Forest Laboratories Holdings, Ltd., and Allergan Pharmaceuticals International Ltd. (collectively, “Forest”) oppose Sigmapharm's motion and have filed a cross motion to enter final judgment. (D.I. 413). For the reasons stated below, Sigmapharm's motion will be denied and Forest's motion will be denied without prejudice.


         A. The Consolidated Case

         In September 2014, Forest initiated several patent infringement actions against companies that had filed ANDAs under the Hatch-Waxman Act, 21 U.S.C. § 355, seeking FDA approval to market generic versions of Saphris®, an asenapine maleate tablet. Among other issues raised, Forest asserted that the defendants infringed claim 1 of U.S. Patent No. 5, 763, 476 (“the '476 patent”), which requires that the pharmaceutical composition “disintegrate[] within 30 seconds in water at 37° C.” (D.I. 409 at 5, 7). These actions were consolidated and originally overseen by the Honorable Sue L. Robinson, now retired. (Id. at 3).

         B. Specifications 1-4

         Sigmapharm's first ANDA, filed in August 2013, had a disintegration specification of “not more than 5 minutes”-Specification 1. (PTX 525 at 9). In August 2015, the FDA issued a Complete Response, rejecting Specification 1 because the disintegration time was not “within seconds” as required by the Reference Listed Drug. (PTX 414 at 2). Because disintegration times directly implicated the issue of infringement, Forest sought emergency relief from Judge Robinson's scheduling order “to avoid prejudice to Forest and a waste of resources by the Court.” (D.I. 419-1, Ex. A at 1).

         On January 29, 2016, Judge Robinson issued an order, stating:

[F]or this case to go forward with some semblance of certainty, Sigmapharm must provide a declaration from one of its executives (binding Sigmapharm) stating that Sigmapharm will not reformulate its product and that Sigmapharm risks the costs of litigation if it does.


         In response, Sigmapharm submitted a declaration from its CEO, Spiridon Spireas, Ph.D. stating that it will not “reformulate its ANDA products.” (D.I. 157-1). There was some discussion at a subsequent status conference as to what the term “reformulate” would cover. (D.I. 419-1, Ex. B at 7:7-11:25). Judge Robinson made clear that any definition of reformulation created by Sigmapharm was not binding on her “so that if there are changes that hold up the case that in my mind constitute a reformulation, then I am saying that Sigmapharm is at risk for whatever costs that entailed.” (Id. at 10:15-21). Sigmapharm acknowledged Judge Robinson's pronouncement and noted that it was only trying to exclude from the binding declaration “some small change that has nothing to do with disintegration.” (Id. at 11:17-25).

         One month later, in February of 2016, Sigmapharm responded to the FDA's rejection of Specification 1 by amending its disintegration specification to “not more than 75 seconds”- Specification 2.[1] (PTX 416 at 1, 13). Based on Specification 2, Forest prepared and served its opening expert reports, which included testing of lots PD 54:33 and 54:34. (See D.I. 409 at 11).

         In May 2016, three months before trial was scheduled to start before Judge Robinson, Sigmapharm again amended its disintegration specification from “not more than 75 seconds” to “35 to 75 seconds”-Specification 3. (PTX 632 at 2). Forest again sought relief from Judge Robinson, asserting that if the FDA accepted Sigmapharm's Specification 3, Forest would need additional fact and expert discovery. (D.I. 419-1, Ex. C). Sigmapharm took the position that no further discovery was needed. (Id.). According to Sigmapharm, “It is impossible for Forest to prove literal infringement because the specification precludes it.” (Id.). Judge Robinson was understandably troubled by Sigmapharm's position that “everything that that happened before this is not relevant anymore, because you changed your label on your specification.” (D.I. 419-1, Ex. D at 28:15-18). In reference to Sigmapharm's tactics, she noted that “maybe you've wasted a lot of time here and a lot of money.” (Id. at 29:23-24). In order to give Forest time to take additional discovery regarding Sigmapharm's Specification 3, the trial date for all defendants was moved from August 2016 to October 2016. (D.I. 419-1, Ex. E at 5-6, 9:9-12).

         In September 2016, the FDA rejected Sigmapharm's Specification 3, reiterating its recommendation that Sigmapharm reformulate its drug product so that it demonstrated “a disintegration time that is in-line with the labeling requirement of ‘within seconds.'” (D.I. 384-1, Ex. 1 at ¶ 32; PTX 629 at 2). With trial set to commence in less than a month, Forest requested that any infringement issues as to Sigmapharm be stayed in order “to avoid prejudice to Forest and waste of the Court's and Forest's resources trying infringement of a product the FDA has twice not approved.” (D.I. 419-1, Ex. G). On October 13, 2016, Judge Robinson granted Forest's request and trial on infringement as to Sigmapharm was stayed. (Id.). Meanwhile, Judge Robinson proceeded to trial in October 2016 on infringement as to the remaining defendants and validity as to all defendants. (Id.).

         In response to the FDA's September 2016 Complete Response, Sigmapharm again amended its disintegration specification in March 2017-Specification 4. (D.I. 384-1, Ex. 1 at ¶ 33). Sigmapharm changed the single disintegration test to two separate tests and lowered the upper time limit to under a minute. (PTX 630 at 15). Thus, the “35 seconds to 75 seconds” became:

(1) at 30 seconds “fail” USP <701> (the “30-Second Test”), and
(2) at 55 seconds “pass” USP <701> (the “55-Second Test”).


         On July 25, 2017, having been designated as a visiting judge to assist with the Delaware Court's docket, I was assigned this case. I rejected Sigmapharm's motion to lift the stay in November 2017, because there was not enough certainty as to whether there would be further changes to Sigmapharm's specification. (D.I. 341; D.I. 349; D.I. 351). But in January of 2018, I granted a renewed motion to lift the stay after Sigmapharm received correspondence from the FDA classifying any remaining deficiencies in its ANDA as “minor.” (D.I. 353; D.I. 358). I also granted Forest's request for additional fact discovery and supplemental expert reports on Specification 4, and the parties proceeded to trial before me in June 2018. (D.I. 356).

         C. The Infringement Trial

         At trial, Forest asserted that Sigmapharm infringed claims 1-2, 4-6, and 9-10 of the '476 patent. (D.I. 384-1, Ex. 4). The parties agreed that Sigmapharm's infringement of claims 2, 5, and 6 rose and fell with infringement of claim 1. (D.I. 362 at ¶ 3). The parties further agreed that infringement of claims 4, 9, and 10 would be resolved by applying to Sigmapharm any findings of infringement or non-infringement made against two other defendants in the consolidated case.[2] (Id. at ¶ 4). Given these agreements, the sole issue before me at the infringement trial was whether Sigmapharm infringed claim 1 of the '476 patent either literally or under the doctrine of equivalents. (Id. at ¶ 3).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;D. The ...

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