Generic Versions of AstraZeneca’s Pulmicort Respules Enjoined from Launch Pending Appeal in Patent Infringement Case

In a non-precedential opinion addressing a request for injunctive relief in the context of generic pharmaceuticals, the U.S. Court of Appeals for the Federal Circuit granted an injunction to prevent generic versions of AstraZeneca’s PULMICORT RESPULES®(budesonide inhalation suspension) from launching, pending AstraZeneca’s appeal of a judgment of invalidity of one patent and non-infringement of another and on the condition of posting a $72 million bond.  AstraZeneca LP et al. v. Breath Ltd., Case Nos. 13-1312, -1352 (Fed. Cir., May 24, 2013) (Linn J.).

AstraZeneca sought to enjoin Breath Limited, Watson Laboratories, Inc., Apotex Corp., Apotex, Inc. and Sandoz, Inc. (collectively, the Generics) from launching their accused generic products during the pendency of this appeal. Breath Limited, Watson Laboratories, Inc. and Sandoz, Inc. opposed.  Teva Pharmaceuticals USA, Inc., a licensee of AstraZeneca, moved without opposition for leave to file anamicus curiae brief regarding the motion for an injunction.

The Federal Circuit, relying on Rule 8(a)(2) of the Federal Rules of Appellate Procedure for authority to grant an injunction pending appeal, considered the four factors from Hilton v. Braunskill in determining whether to grant the injunction: (1) whether AstraZeneca would be irreparably harmed without the injunction; (2) whether the defendant-appellees would be substantially harmed by the grant of the injunction; (3) whether AstraZeneca is likely to succeed on the merits; and (4) the public interest.

The Federal Circuit found that AstraZeneca had established that it was entitled to the relief of enjoining the Generics from launching their accused generic products during the pendency of AstraZeneca’s appeal.  The Court granted AstraZeneca’s motion on the condition that AstraZeneca post a $72 million bond with the district court within seven days of the date of the order.  The Federal Circuit also granted Teva’s motion for leave to file an amicus curiae brief.

In the briefing, AstraZeneca argued that it would be irreparably harmed by the “premature” launch of the generic products. Teva Pharmaceuticals, AstraZeneca’s sole licensee, made the same argument in its motion for leave to file an amicus curiae brief. Breath and Watson argued that the harm to AstraZeneca would be small and, in any event, quantifiable.

AstraZeneca further argued in its brief that the defendant-appellees would not be harmed by the injunction, pointing specifically to Apotex’s failure to oppose the motion, Sandoz’s lack of FDA approval for its generic and the protection afforded to the other appellees by a bond. Watson counter-argued that it is substantially harmed because it is ready to launch and is missing out on a lucrative opportunity to participate in a market that currently only has two players.

AstraZeneca argued that it has a high likelihood of success on the merits because the district court misapplied the obviousness standard in finding invalidity and erred in finding non-infringement after misconstruing the term “heat sterilized.”

Finally, AstraZeneca’s public interest argument focused on the need for strong patent protection to encourage pharmaceutical innovation. Breath and Watson responded by arguing that the purpose of Hatch-Waxman is “to get generic drugs into the hands of patients at reasonable prices-fast.”

 

http://www.natlawreview.com/article/generic-versions-astrazeneca-s-pulmicort-respules-enjoined-launch-pending-appeal-pat

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