Asenapine - USA

On Aug 06, 2019, Delaware court denied each motion filed by Forest & Sigmapharm to enter final judgment after trial based on a post-trial amendment to ANDA specification.

The current controversy in this ongoing Hatch-Waxman case involves a motion by defendant Sigmapharm to vacate a finding of infringement pursuant to Fed. R. Civ. P. 60(b) based on a post-trial amendment to its ANDA. Plaintiffs Forest oppose Sigmapharm’s motion and filed a cross motion to enter final judgment.

During litigation Forest asserted that the defendants infringed claim 1 of U.S. Patent No. 5,763,476; which requires that the pharmaceutical composition “disintegrate within 30 seconds in water at 37° C.”

Sigmapharm’s first ANDA, filed in August 2013, had a disintegration specification of “not more than 5 minutes”—Specification 1. 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 (RLD).

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.

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.

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.’” On October 13, 2016, Judge Robinson granted Forest’s request and trial on infringement as to Sigmapharm was stayed & to be proceeded with other defendants.

In response to the FDA’s September 2016 Complete Response, Sigmapharm again amended its disintegration specification in March 2017—Specification 4.  Sigmapharm changed the single disintegration test to two separate tests and lowered the upper time limit to under a minute. 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 Nov 16, 2018, Court issued a post-trial opinion finding that Sigmapharm literally infringed claim 1 of the ’476 patent. Court found that Sigmapharm’s product “disintegrate within 30 seconds in water at 37° C.” based upon the testimony of Forest’s expert, Dr. Adam Myers, who, based upon testing consistent with USP <701>, opined that Sigmapharm’s Specification 4 infringed Claim 1. 

Sigmapharm took the position that the two disintegration tests in Specification 4—the 30-Second Test and the 55-Second Test—precluded infringement. Sigmapharm equated “failing” USP <701> with proof that a batch of tablets would not disintegrate within 30 seconds. But court rejected this approach as it was not consistent with the “words of the claim(s).” Court found that a “fail” result would unreliably allow too many tablets to disintegrate within 30 seconds to conclusively show that a batch would not disintegrate within that time.

After this opinion, instead of submitting a proposed form of final judgment, Sigmapharm amended its ANDA by adopting - Specification 5, and filed a motion pursuant to Fed. R. Civ. P. 60(b) asking court to change infringement finding to non-infringement and enter final judgment in its favor. According to Sigmapharm, Specification 5 changed the acceptance criteria under Sigmapharm’s 30-Second Test such that a batch of its tablets would not disintegrate within 30 seconds. In other words, Sigmapharm now posits no more than 0/6 tablets will disintegrate within 30 seconds on stage 1 and 2/18 tablets on stage 2.  According to Sigmapharm, the FDA approved Specification 5 by default.

Sigmapharm sought relief from judgment pursuant to Fed. R. Civ. P. 60(b)(2), 60(b)(5), and 60(b)(6).

Court denied motion under Rule 60(b)(2) because  as per this rule “newly discovered evidence is evidence of facts should be in existence at the time of trial”. Here Specification 5 was not in existence at the time of trial. Instead, Sigmapharm created Specification 5 after trial, in response to court’s finding of infringement.

Court denied motion under Rule 60(b)(5) because this rule only “provides for relief from injunction or consent decrees.” Here, Sigmapharm is not seeking modification to an injunction or consent decree, but a change to legal conclusions. Accordingly, Rule 60(b)(5) is not the proper grounds to grant the relief Sigmapharm seeks.

Court also denied motion under Rule 60(b)(6) because Sigmapharm failed to show that it is an exceptional circumstances.

Court said that the “Ferring” [Ferring B.V. v. Watson Laboratories, Inc., 764 F.3d 1382 (Fed. Cir. 2014)] case cited by Sigmapharm is entirely distinguishable from the facts before it. First, unlike in Ferring, court’s finding of infringement was not based solely on the ANDA, but also on actual testing of Sigmapharm’s generic product. Second, there was no discussion at the trial before court suggesting that Sigmapharm would or should amend its ANDA to moot the issue of infringement. Third, the Ferring court found no prejudice because, among other reasons, Ferring never requested that the district court reopen the record to address infringement by the amended ANDA.

Thus court declined to enter a final judgment in Sigmapharm’s favor based on Specification 5.

Court also declined to enter a final judgment in Forest’s favor based on Specification 4 because Specification 4 is no longer operative now. In addition, Sigmapharm asserts that, due to the changes made by Specification 5, “[t]he batches tested by [Forest], some of which were found to infringe, are no longer representative, in terms of disintegration characteristics, of the products that Sigmapharm will manufacture and market.” Court further said that nothing precludes it from disregarding Specification 5 and entering final judgment as to Specification 4 based on the findings set forth in the November 18, 2018 trial opinion. But if Sigmapharm wants the opportunity to prove that Specification 5 does not infringe the ’476 patent,  court willing to provide that opportunity.

Therefore, Sigmapharm has two options:

(1) have a final judgment entered based on the November 16, 2018 opinion addressing Specification 4 and appeal that judgment to the United States Court of Appeals for the Federal Circuit, or

(2) request that court reinstate the discovery and litigation process with respect to Specification 5.