The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the generics business, GENERICally Speaking: A Hatch-Waxman Litigation Bulletin.
Taking on an ANDA patent litigation requires significant corporate resources, time, and money. Staying on top of industry news and outcomes, following trends in the judiciary and the steps others are taking, and keeping informed of recently-enacted rules and legislation are critical.
This bulletin provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation. We hope you find it helpful.
Relevant Court Decisions
- Sunovion Pharma., Inc. v. Teva Pharms. USA, Inc. (Fed. Cir. Sept. 26, 2013)
Reversing district court decision of summary judgment of non-infringement and granting infringement as a matter of law.
- Pronova Biopharma Norge v. Teva Pharma. USA, Inc. (Fed. Cir. Sept. 12, 2013)
Shipping samples that are covered by the patent-in-suit without a confidentiality agreement, without a limitation on usage, and to a skilled artisan that is able to ascertain the claimed elements, is a public use under § 102(b).
- Teva Pharma. USA, Inc. v. Sandoz, Inc. (Fed. Cir. July 26, 2013)
The term "molecular weight" is indefinite because the claims do not indicate which average molecular weight measure is intended, and two different methods were relied on during prosecution to argue against/avoid rejection.
- Apotex, Inc. v. UCB, Inc.
"Egregious" misconduct on the part of the inventor—someone who is well versed in pharmaceutical formulations and the patent prosecution and enforcement processes—resulted in the Court's finding of inequitable conduct, laches, and disclaimer.
- GlaxoSmithKline LLC v. Banner Pharmacaps, Inc.
Defendants failed to meet their burden in showing that the asserted claims were invalid for not meeting the written description requirement and non-enablement.
- Senju Pharma. Co., LTO v. Lupin Ltd.
Finding that defendants infringe claims 6, 12-16 and that claims 6, 12-16 of the patent-in-suit are invalid for obviousness.
- Cephalon Inc. v. Mylan Pharma. Inc.
After construing certain disputed claim terms, the court found the asserted claims infringed and not invalid.
- Momenta Pharma., Inc. v. Amphastar Pharma., Inc.
Because all of defendant's activity fell under the safe harbor provision, it could not constitute patent infringement.
- Purdue Pharma L.P. v. Ranbaxy Inc.
An action by the FDA during the pendency of the instant actions rendered claims of infringement and the counterclaims asserting non-infringement moot, and the court declined to exercise jurisdiction over counterclaims asserting invalidity.
- Par Pharma., Inc. v. TWi Pharma., Inc.
Based on its claim construction, the court denied defendant's motion for summary judgment of non-infringement, and because the prior art failed to address the food effect that was the central innovation of the patent-in-suit, summary judgment of invalidity was denied.
- Dey, L.P. v. Teva Parental Medicines, Inc.
Plaintiffs' claim construction was adopted because defendants' proposed construction attempted to read a limitation into the claim and defendants could not prove that a construction in a related case had preclusive effect; as a result, court granted summary judgment of infringement.
- Teva Pharma. USA, Inc. v. Sandoz, Inc.
Granting motion to dismiss because Defendants' acts were protected by the safe harbor provision of §271(e)(1).
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