GENERICally Speaking

A Hatch-Waxman
Litigation Bulletin

This quarterly issue of the GENERICally Speaking campaign provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation.

In this issue:

• Janssen Pharms., Inc. v. Mylan Labs. Ltd.
  Invega Trinza® (paliperidone palmitate)
  The Federal Circuit affirmed findings of induced infringement and non-obviousness when generic manufacturer’s proposed label instructed doctors to act in accordance with the asserted claimed language when treating patients who missed doses.
• Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc.
  Bridion® (sugammadex)
  In the context of reissued patents, the reference to “the patent” in subsection 156(c) is to the original patent for purposes of calculating Patent Term Extension (“PTE”).
• In re Entresto
  Entresto® (valsartan/sacubitril)
  Because the district court erroneously conflated the issues of patentability and infringement, the Federal Circuit reversed its finding that the patent-in-suit was invalid for a lack of adequate written description.
• Liquidia Techs., Inc. v. FDA
  Yutrepia® (treprostinil inhalation powder)
  The district court affirmed FDA’s decision that plaintiff’s 505(b)(2) application not receive final approval.
• Janssen Prods., L.P. v. EVER Valinject GmbH
  Yondelis® (trabectedin)
  The district court made multiple rulings on motions to dismiss for lack of personal jurisdiction, improper venue, lack of subject matter jurisdiction, and failure to state a claim for which relief may be granted.
• Vanda Pharms., Inc. v. FDA
  Hetlioz® (tasimelteon)
  FDA’s decision to approve generic version of tasimelteon did not violate APA and was upheld in cross motions for summary judgment.
• Mallinckrodt Pharms. Ireland Ltd. v. Airgas Therapeutics LLC
  INOMax® (nitric oxide)
  Finding that plaintiff is not likely to succeed in its infringement claims, that one of the two patents-in-suit is susceptible to an invalidity defense, and no showing of irreparable harm, the court denied plaintiff’s motion for a preliminary injunction.
• Alcon Inc. v. Padagis Israel Pharms. Ltd.
  Simbrinza® (brinzolamide / brimonidine)
  The court rejected Plaintiff’s doctrine of equivalents infringement claim under both the function-way-result and the “insubstantial differences” tests.
• Taiho Pharma Co. v. MSN Labs Private Ltd.
  Lonsurf® (tipiracil)
  Because the term “purity” referred to polymorphic purity and not chemical purity, defendant did not infringe the asserted claims.
• Boehringer Ingelheim Pharms. Inc. v. Apotex Inc.
  Tradjenta® (linagliptin)
  The court denied defendants’ Rule 12(c) motion insofar as it sought judgment of no induced infringement as a matter of law and granted the motion insofar as it sought judgment of no contributory infringement as a matter of law.