The court denies defendant’s motion for judgment of non-infringement in response to ANDA holder modification of its ANDA specification after trial.

Case Name: Forest Labs., LLC v. Sigmapharm Labs., LLC, No. 14-1119- MSG (consol.), 2019 U.S. Dist. LEXIS 131304 (D. Del. Aug. 6, 2019) (Goldberg, J.) 

Drug Product and Patent(s)-in-Suit: Saphris® (asenapine maleate); U.S. Patent No. 5,763,476 (“the ’476 patent”)

Nature of the Case and Issue(s) Presented: In September 2014, Forest initiated several lawsuits against ANDA holders alleging infringement of the ’476 patent, which requires that a pharmaceutical composition “disintegrate within 30 seconds in water at 37° C.” Sigmapharm’s first ANDA had a disintegration of “not more than 5 minutes” (0 .1. 409 at 5, 7). In August 2015, FDA rejected that specification because the disintegration time was not “within seconds” as required by the Saphris label. In February of 2016, Sigmapharm amended its disintegration specification to “not more than 75 seconds.” In May 2016, three months before trial was scheduled to start, Sigmapharm again amended its disintegration specification to “35 to 75 seconds.” In order to give Forest time to take additional discovery regarding Sigmapharm’s latest change, the trial date for all defendants was moved from August 2016 to October 2016. In September 2016, the FDA rejected Sigmapharm’s latest specification, 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 ,i 32; PTX 629 at 2). As a result, trial on infringement as to Sigmapharm was stayed. The court proceeded to trial in October 2016 on infringement as to the remaining defendants and validity as to all defendants. In March 2017, Sigmapharm amended its specification by changing the single disintegration test to two separate tests and lowered the upper time limit to under one minute: “(1) at 30 seconds ‘fail’ USP (“the 30-Second Test”), and (2) at 55 seconds ‘pass’ USP (“the 55-Second Test”).

The parties proceeded to trial in June 2018. On November 16, 2018, the court issued a trial decision finding that Sigmapharm’s ANDA product literally infringed the ’476 patent. Instead of submitting a proposed form of final judgment, Sigmapharm amended its ANDA specification again, and filed a motion pursuant to Fed. R. Civ. P. 60(b) asking me to change the court’s infringement finding to that of non-infringement and enter final judgment in its favor. (D.I. 411 , Ex. A at 21 ). According to Sigmapharm, its newest specification changes the acceptance criteria under the 30-Second Test such that a batch of its tablets would not disintegrate within 30 seconds. The court denied Sigmapharm’s motion.

Why Forest Prevailed: During claim construction, the Court found that the ’476 patent expressly provided a definition of the term “rapid disintegration” to mean “the pharmaceutical composition is disintegrated within 30 seconds in water at 37° C., and preferably within 10 seconds, as measured according to the procedure described in Remington's Pharmaceutical Sciences, 18th Edition (Ed. A. R. Genaro) 1990 pp 1640-1641; see also US Pharmacopeia, Chapter 1.” Given this construction, it was unreasonable for Sigmapharm to expect that “failing” USP was conclusive proof that its generic product would not literally infringe. For one thing, the aforementioned construction related to claim 9, not claim 1. In addition, the words “pass” or “fail” appear nowhere in the claim construction order.

The court was also mindful of the fact that the Federal circuit has in certain instances approved a district court’s finding of non-infringement based on an ANDA amended after trial. But those cases, in particular the Ferring B.V. v. Watson Labs., Inc. case, are distinguishable.

Finally, although the court declined to enter final judgment in Sigmapharm’s favor, it questioned the value of entering judgment in Forest’s favor given the fact that Sigmapharm’s fourth specification iteration was no longer operative and there hasn’t been a trial on its latest specification. Thus, Sigmapharm has two options: (i) have a final judgment entered based on the November 16, 2018 opinion addressing Specification 4 and appeal that judgment to the Federal Circuit, or (ii) request that the court reinstate discovery litigate the merits of its latest specification.