GENERICally Speaking Hatch Waxman Bulletin

The fourth quarter 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:

• Astellas US LLC v. Hospira, Inc.
  Lexiscan® (regadenoson)
  The district court did not abuse its discretion in excluding a new infringement theory and granting defendant’s motion to strike.
• Genentech, Inc. v. Sandoz Inc.
  Esbriet® (pirfenidone)
  Judgment of obviousness was affirmed on the basis that varying doses in response to the occurrence of side effects seems like a well-established practice, and judgment of non-infringement is affirmed when the district court did not clearly err in considering and weighing evidence of past physician practice against the instructions of the proposed generic label.
• Arius Two, Inc. v. Alvogen PB Rsch. & Dev. LLC
  Belbuca® (buprenorphine)
  Federal Circuit affirmed district court’s finding that certain patents-in-suit were not invalid and reversed the district court’s finding that certain patents-in-suit were invalid.
• Pharmacyclics LLC v. Alvogen, Inc.
  Imbruvica® (ibrutinib)
  Federal Circuit affirms trial court’s decision that all patents-in-suit are infringed and not invalid.
• Takeda Pharm. Co. Ltd. v. Norwich Pharms., Inc.
  Vyvanse® (1-lysine-d-amphetamine dimesylate)
  Asserted claims were not proven obvious or lacking enablement.
• Vanda Pharms., Inc. v. Teva Pharms. USA, Inc.
  Hetlioz® (tasimelteon)
  All of the asserted claims, related to methods of treating Non-24-hour sleep-wake disorder, are not infringed and obvious.
• Ferring Pharms. Inc. v. Fresenius Kabi USA, LLC
  Firmagon® (degarelix acetate)
  After a four-day bench trial, the court made various findings as to the infringement and invalidity of the patents-in-suit.
• Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd.
  Duobrii® (halobetasol propionate/tazarotene) and Bryhali® (halobetasol propionate)
  The court rejected ANDA filer’s obviousness and indefiniteness defenses in finding asserted patents not invalid.
• Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC
  Xyrem® (sodium oxybate);
  A patent claiming a computer-implemented system to address certain REMS conditions of using a drug was ordered delisted from the Orange Book.
• Novartis Pharms Corp. v. Crystal Pharm. (Suzhou) Co., Ltd.
  Entresto® (sacubitril/valsartan)
  After converting Paragraph IV certifications into a Section viii carve-out statement, thereby relying on a method not claimed by the patents-in-suit, the court no longer had subject matter jurisdiction and dismissal was appropriate.
• Allergan USA, Inc. v. Sun Pharm. Indus. Ltd.
  Viberzi® (eluxadoline)
  The court granted patentee’s Rule 12(c) motion dismissing ANDA filer’s unclean hands defense when it found that there was no misuse of ANDA filer’s confidential information used during ongoing patent prosecution.
• AstraZeneca AB v. Mylan Pharms. Inc.
  Symbicort® (budesonide/formoterol)
  Patents-in-suit are invalid for lack of adequate written description and non-enablement when the claims cover tens of thousands or millions of combinations of API and excipients, while the specification only teaches a limited subset of those embodiments.
• Horizon Medicines LLC v. Apotex Inc.,
  Pennsaid® 2% (diclofenac sodium)
  Because a patentee can grant a license to a future continuation patent that does not ultimately issue to the patentee, and instead issues to a third party, the license was valid and defendant was found not to infringe the patents-in-suit.
• Tolmar Therapeutics, Inc. v. Foresee Pharms. Co., Ltd.
  Eligard® (leuprolide)
  Defendants’ motion for judgment on the pleadings is denied because the court could not analyze the issue of infringement without claim construction and consideration of the asserted claim’s boundaries.

Relevant ANDA Updates highlighted in this issue:

• ANDA Approvals
• ANDA Litigation Settlements
• Generic Launches
• New ANDA Cases