Source: https://www.robinskaplan.com/Resources/Newsletters/GENERICally-Speaking-Hatch-Waxman-Bulletin/GENERICally-Speaking-Winter-2019
Timestamp: 2019-04-20 19:18:35+00:00

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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.
Novartis Pharms. Corp v. Breckenridge Pharm. Inc.
A post-URAA patent that issues after, and expires before, a pre-URAA patent does not qualify as a double-patenting reference against the pre-URAA patent.
“Effectively” extending the term of a second patent was not a violation of 35 U.S.C. § 156.
Tris Pharma Inc. v. Actavis Labs. Fl, Inc.
On appeal, the Federal Circuit found that the district court’s conclusions of law related to its obviousness findings were based on inadequate factual findings, and therefore vacated and remanded.
Indivior Inc. v. Dr. Reddy’s Labs. S.A.
District court’s finding that plaintiff demonstrated a likelihood of success on the merits was reversed on the basis of (i) specification disclaimer and (ii) issue preclusion.
Teva Pharms. USA, Inc. v. Sandoz Inc.
The Federal Circuit concluded that the district court did not err in invalidating all asserted claims of the Copaxone patents as obvious.
Patent-in-suit is invalid because certain limitations are inherent in the prior art.
Takeda Pharms., U.S.A., Inc. v. West-Ward Pharm. Corp.
The court disagreed with Plaintiff’s argument that the labeling, promotional materials, and samples related to Defendants’ product showed intent to induce infringement, and granted summary judgment in Defendants’ favor.
Impax Labs. V. Zydus Pharms. USA, Inc.
(udgment on the pleadings was appropriate where plaintiff’s Answer to counterclaims conceded non-infringement at the time of the counterclaim.
Horizon Pharma, Inc. v. Dr. Reddy’s Labs., Inc.
The word “target,” appearing twice in each of the independent asserted claims is indefinite, thereby rendering the patents-in-suit invalid on summary judgment.
Plaintiff’s testing of representative ANDA products demonstrated literal infringement.
The claims of the patent-in-suit were infringed, and though adequately described, they were found invalid as obvious.
Bristol-Myers Squibb Co. v. Aurobindo Pharma USA Inc.
After limited discovery on plaintiffs’ alter-ego theory, the court granted defendant’s motion to dismiss for lack of personal jurisdiction.

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