ANDA Infringement Analysis Must Focus on Likely or Actual Commercial Product: Federal Circuit | Practical Law

ANDA Infringement Analysis Must Focus on Likely or Actual Commercial Product: Federal Circuit | Practical Law

In Ferring B.V. v. Watson Laboratories, Inc.-Florida, the US Court of Appeals for the Federal Circuit held that two proposed generic versions of Lysteda do not infringe Ferring's patents, explaining that where the ANDA is silent on infringement, the accused infringer does not need to disprove infringement and the patent owner must establish that the likely or actual commercial product infringes.

ANDA Infringement Analysis Must Focus on Likely or Actual Commercial Product: Federal Circuit

by Practical Law Intellectual Property & Technology
Published on 26 Aug 2014 • USA (National/Federal)
In Ferring B.V. v. Watson Laboratories, Inc.-Florida, the US Court of Appeals for the Federal Circuit held that two proposed generic versions of Lysteda do not infringe Ferring's patents, explaining that where the ANDA is silent on infringement, the accused infringer does not need to disprove infringement and the patent owner must establish that the likely or actual commercial product infringes.
On August 22, 2014, in Ferring B.V. v. Watson Laboratories, Inc.-Florida, the US Court of Appeals for the Federal Circuit issued two opinions holding that proposed generic versions of Lysteda do not infringe Ferring's patents (No. 2014-1377, (Fed. Cir. Aug. 22, 2014); No. 2014-1416, (Fed. Cir. Aug. 22, 2014)). The Federal Circuit held that where an ANDA is silent as to infringement, the relevant inquiry is whether the patent owner has proven by a preponderance of the evidence that the accused infringer will likely market an infringing product.

Background

Ferring B.V. (Ferring) owns three patents directed to modified release formulations of tranexamic acid, which is the active ingredient in Ferring's Lysteda product. Ferring's patents claim, among other things, specific dissolution rates of the tranexamic acid after 15, 45, 90 and 120 minutes.
Watson Laboratories, Inc.-Florida (Watson), Apotex, Inc. and Apotex, Corp. (collectively Apotex) filed abbreviated new drug applications (ANDA) with the US Food and Drug Administration (FDA), seeking to market generic versions of Lysteda. Ferring filed infringement suits against Watson and Apotex under the Hatch-Waxman Act, and the cases were later consolidated.

Apotex's ANDA

Apotex filed its ANDA in 2010, including a dissolution specification for the generic tranexamic acid after 60 minutes. Apotex's ANDA did not include any dissolution specifications or relevant data for the time periods claimed in Ferring's patents. At trial, the US District Court for the District of Nevada concluded that the ANDA's dissolution specification established that Apotex's actual generic product did not infringe Ferring's patents. The district court concluded, however, that the ANDA's silence as to the other time periods permitted Apotex to infringe Ferring's patents.
Apotex agreed to amend its ANDA to include a specification for the tranexamic acid dissolution after 45 minutes that fell outside of Ferring's claimed range. Following a hearing on Apotex's amended ANDA, the district court:
  • Concluded that Apotex's 2010 ANDA infringed Ferring's patents but that the amended ANDA did not infringe.
  • Dismissed the case on the grounds that Apotex's amended ANDA rendered Ferring's complaint moot.
Ferring appealed the district court's dismissal.

Watson's ANDA

Watson's ANDA did not include any specifications about the dissolution of the tranexamic acid, but it did include data demonstrating that the dissolution rates after 90 and 120 minutes were outside of the ranges claimed in Ferring's patents. During discovery, both parties tested the dissolution rates of Watson's proposed generic product and the majority of the samples did not meet Ferring's claimed rates. At trial, Ferring also relied on Watson's internal test data for experimental, uncoated tranexamic acid cores as evidence of infringement.
After the bench trial, the court concluded that both Watson's generic products and its uncoated tranexamic acid cores infringed Ferring's patents. Following a suggestion by the court, Watson amended its ANDA to include only non-infringing tranexamic acid cores. The court, however, issued a final judgment based on Watson's submission of its original ANDA:
  • Enjoining the manufacture, use, sale or offer for sale of Watson's generic product.
  • Ordering the FDA to reset the approval date of Watson's ANDA to a date no earlier than the expiration of Ferring's patents.
Watson appealed the district court's infringement decision.

Outcome

On appeal, the Federal Circuit:
  • Affirmed the district court's dismissal of Ferring's complaint against Apotex on the grounds that Ferring did not establish that either Apotex's 2010 or 2014 ANDA infringes the asserted patents.
  • Reversed the district court's infringement finding against Watson and vacated the court's injunction and order resetting the FDA approval date of Watson's ANDA.
In reaching its non-infringement decisions, the Federal Circuit held that:
  • When an ANDA is silent as to infringement, the infringement analysis must focus on the product that is likely to be sold. The Federal Circuit explained that the burden does not shift to the ANDA filer to disprove infringement and the proper inquiry is whether the patent owner has proven by a preponderance of the evidence that the accused infringer will likely market an infringing product.
  • The district court may reconsider its infringement finding in light of an amended ANDA or other relevant information.

Apotex

The Federal Circuit rejected the district court's application of Sunovion Pharms., Inc. v. Teva Pharms., Inc. to find that Apotex's 2010 ANDA infringed Ferring's patents (731 F.3d 1271 (Fed. Cir. 2013)). The Federal Circuit explained that:
The Federal Circuit concluded that Ferring failed to establish that Apotex's 2010 ANDA infringed the asserted claims under the Glaxo analysis.
The Federal Circuit also affirmed the district court's dismissal based on Apotex's non-infringing amended ANDA, even though Apotex filed the amendment after the court found infringement based on the 2010 ANDA. The Federal Circuit explained that it is within the district court's discretion to allow an amendment before entering a resetting order under 35 U.S.C. § 271(e)(4).

Watson

In reversing the district court's infringement finding as to Watson's ANDA and proposed generic, the Federal Circuit first held that the district erred in concluding that Watson's act of filing an ANDA was an act of infringement in and of itself. The Federal Circuit explained that:
  • The filing of an ANDA is an artificial act of infringement under 35 U.S.C. § 271(e) that serves to create case or controversy jurisdiction.
  • Once jurisdiction is established, the infringement inquiry is focused on comparing the asserted claims to the product that is likely to be sold following ANDA approval.
The Federal Circuit held that the district court should have used the Glaxo analysis to determine whether Watson's proposed generic infringed Ferring's patents. The Federal Circuit explained that where the ANDA does not resolve the question of infringement, like Watson's ANDA in this case, the district court may refer to other relevant evidence, including biobatch data and actual samples of the proposed generic composition submitted to the FDA. The Federal Circuit held that the district court should have focused only on Watson's commercial tablets and should not have based its infringement decision on data relating to the uncoated cores. In particular, the Federal Circuit held that Watson's internal project document was irrelevant to infringement because it only contained data relating to the uncoated cores. Based on the errors in the district court's analysis, the Federal Circuit reversed the district court's infringement judgment and vacated the resetting order and permanent injunction.

Practical Implications

The Federal Circuit's decisions clarify the appropriate infringement analysis to be applied to cases filed under the Hatch-Waxman Act. In particular, the Federal Circuit's opinions make clear that where an ANDA does not include specifications or data addressing the asserted claim elements, the patent owner bears the burden to prove that the accused infringer is likely to market an infringing product. In cases where the ANDA filer can show bioequivalence without including data relating to each element of the asserted claims, it may be more difficult for patent owners to prove infringement.