By Oren Langer and Christy May
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:
- Exelixis, Inc. v. MSN Labs. Private Ltd.
Cabometyx® (cabozantinib (L)-malate)
Judgment that asserted claims covering crystalline cabozantinib (L)-malate salts were adequately supported by written description affirmed; appeal concerning separate impurity patent dismissed as moot and underlying judgment vacated. - Norwich Pharms., Inc. v. Kennedy, Jr.
Xifaxan® (rifaximin)
FDA correctly concluded that Actavis had not forfeited its 180-day exclusivity for failure to market, but applied the wrong causation standard in determining that Actavis had not forfeited exclusivity for failure to obtain tentative approval. - Scilex Pharms. Inc. v. Aveva Drug Delivery Systems, Inc.
ZTlido® (lidocaine topical patch)
Judgment of noninfringement affirmed where the district court correctly construed the term “dissolving agent” to require that it both dissolve lidocaine and maintain it in a dissolved state, precluding infringement under the doctrine of equivalents. - Otsuka America Pharm., Inc. v. Hetero Labs Ltd.
Nuedexta® (dextromethorphan hydrobromide / quinidine sulfate)
Preliminary injunction largely affirmed where the district court correctly construed claim terms governing a weight-to-weight ratio limitation, but the Federal Circuit vacated the district court’s waiver of the Rule 65(c) bond requirement. - United Therapeutics Corp. v. Liquidia Techs., Inc.
Tyvaso® and Tyvaso DPI® (treprostinil)
Following a bench trial, the court: found infringement of method-of-treatment claims covering inhaled treprostinil for PH-ILD and rejected Defendant’s obviousness, on-sale-bar, and inherent-anticipation defenses; and also held that certain dependent claims reciting treatment outcomes were not entitled to patentable weight. - Vanda Pharms. Inc. v. Teva Pharms. USA, Inc.
Hetlioz® (tasimelteon)
Granting summary judgment of noninfringement where generic tasimelteon labels did not affirmatively encourage prescribers to discontinue beta blockers before administering tasimelteon and the generic products had substantial non-infringing uses. - Vertex Pharms. Inc. v. Lupin Ltd.
Kalydeco® (ivacaftor)
Following trial, judgment of noninfringement entered where Lupin’s generic contained approximately 74.26% ivacaftor and Vertex’s asserted claims required either 80% or “about 80%” ivacaftor. - Jazz Pharms. Ireland Ltd. v. Tris Pharma, Inc.
Xywav® (calcium, magnesium, potassium, and sodium oxybates oral solution)
Motion to dismiss denied where Hatch-Waxman complaint plausibly alleged infringement based on defendant’s original Paragraph IV certifications and the court declined to consider defendant’s post-filing amendments to its NDA.
Relevant ANDA Updates highlighted in this issue:
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