By Oren Langer, Patrick Griffin, 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:
- Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc.
Invega Korlym® (mifepristone tablets)
Appeal from D.N.J., Bumb, J.) (Although the generic product’s proposed label may contain instructions recommending an infringing use, a district court may rely on outside-the-label evidence, like physician testimony, to find no direct infringement. - Astellas Pharma Inc. v. Ascent Pharms., Inc.
Myrbetriq® (mirabegron extended-release tablets)
After a bench trial, the court found the patents-in-suit, directed to pharmaceutical compositions containing mirabegron and methods of treating overactive bladder, infringed and not invalid. - In re Entresto (sacubitril/valsartan) Patent Litigation (Novartis Pharms. Corp. v. MSN Labs. Private Ltd.)
Entresto® (sacubitril/valsartan)
Given an earlier case involving the same patent-in-suit, parties, and accused product, the court granted plaintiff’s motion for summary judgment of infringement, validity and to prevent relitigating claim construction on the basis of claim/issue preclusion. - BioDelivery Sciences Int’l, Inc. v. Alvogen PB Research & Development LLC
Belbuca® (buprenorphine)
Because injunctions are enforced through the district court’s civil contempt power, the court dismissed plaintiff’s motion to enforce judgment when it should have filed a contempt motion instead.
Relevant ANDA Updates highlighted in this issue:
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