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
- Roxane Labs., Inc. v. Camber Pharms. Inc.
In view of Plaintiff’s prosecution arguments, including one of the inventor’s declarations, the district court’s claim construction was affirmed as was its final judgment of non-infringement; transfer of venue was proper and the district court did not abuse its discretion in so holding. - Endo Pharms. Inc. v. Actavis Labs. UT, Inc.
Obviousness finding was appropriate where there were unpredictable results with each possible proposed combination. - Bayer Pharma AG v. Watson Labs., Inc.
After a ruling of patent validity and infringement, the court did not impose a permanent injunction where patentee, given its highly speculative arguments of a premature ANDA product launch, failed to show irreparable harm and lack of an adequate remedy at law. - Roxane Labs., Inc. v. Vanda Pharms., Inc.
Listing Orange-Book patents is not a tortious act as it is required by law, therefore, no specific jurisdiction exists under Ohio’s long-arm statute. - Aptalis Pharamtech, Inc. v. Apotex Inc.
Plaintiffs met their burden of proof in showing that defendants’ drug particles are embedded in sufficient polymer particles for the resulting formulation to be described as drug particles “covered by” or “surrounded” in line with the court’s claim construction. - Mylan Institutional LLC v. Aurobindo Phama Ltd
After a showing of a likelihood of success on the merits and irreparable harm, plaintiff was granted a preliminary injunction preventing defendants from importing isosulfan blue into the US. - Orexo AB v. Actavis Elizabeth LLC
While the product patent-in-suit was found to be invalid as obvious, the process patent improving bioavailability of buprenorphine was held valid and infringed. - Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc.
Testing expired samples and conducting “uncontrolled experiments” on non-expired samples lead to a finding of non-infringement. - Merck Sharp & Dohme Corp. v. Hospira Inc.
Because a first patent directed to a stable ertapenem composition and a method of stabilizing ertapenem was found valid and infringed, a second patent directed to the creation of the carbamate adduct of ertapenem using routine techniques was invalid as obvious: it contained no inventive concept that was not disclosed in the other patent. - Endo Pharms. Inc. v. Amneal Pharms. LLC
The two prior-art references relied on by Defendants to prove obviousness did not give a POSA a reasonable expectation of success at making the claimed invention; and Teva’s implied license defense was rejected by the court.