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
- Spectrum Pharms., Inc. v. Burwell
DC Circuit affirms district court’s summary judgment that the FDA’s ANDA approval for one indication was proper even though branded company enjoyed exclusivity on same product for treatment of another indication.
- Intendis GMBH et al. v. Glenmark Pharms. Inc., USA
Affirming district court’s application of the doctrine of equivalents, in part, on the basis of Defendants’ representations to the FDA in their ANDA.
- Merck & Cie v. Watson Labs., Inc.
Because a fax containing essential price, delivery, and payment terms to sell the covered product was a premature commercial exploitation of the claimed invention, the asserted claim was invalid under the on-sale bar.
- In Re Bendamustine Consolidated Cases
The asserted claims of the patents-in-suit were not obvious because a POSA would not have been motivated to improve the prior art in line with the inventions claimed.
- Reckitt Benckiser Pharms, Inc. v. Watson Labs., Inc.
One of Plaintiffs’ patents was valid and infringed while the remaining patents-in-suit were either invalid or not infringed.
- Ferring B.V. v. Actavis, Inc.
Dismissal of “artificial” § 271(e)(2)(A) claim is warranted when patent holder can bring actual infringement claims against Defendants under § 271(a).
- Takeda Pharms. U.S.A., Inc. v. West-ward Pharm. Corp.
A product label that does not encourage direct infringement cannot be the basis for an induced infringement claim.
- Genzyme Corp. v. Dr. Reddy’s Labs., Ltd.
Validity of patent-in-suit upheld in light of art determined to be non-analogous by patent examiner.
- Bayer Pharma AG v. Watson Labs., Inc.
A proposed combination will not render a patent obvious wherein the proposed combination includes changing the core structure of the lead compound.
- Endo Pharm. Inc. v. Amneal Pharms. LLC
Plaintiff is awarded injunctive relief following analysis of the eBay factors, but said relief cannot be awarded under § 271(e)(4)(A) because the patents-in-suit issued after Defendants’ ANDAs were filed.
- Bayer Pharma AG v. Watson Labs., Inc.
A proposed combination will not render a patent obvious wherein the proposed combination improperly relies on hindsight.
- Pfizer Inc. v. Sandoz Inc.
Post-hoc expert conclusions were not sufficient to contradict prior-art publications relating to obviousness.
- Allergan, Inc. v. Teva Pharmaceuticals USA, Inc.
Specific jurisdiction is present in any state where the generic manufacture may sell its ANDA product after FDA approval.
- Otsuka Phama. Co., Ltd. v. Zydus Pharms. USA, Inc., et al.
Allowing certification for appeal of patent with severable invention from remaining patents in suit.
- Helsinn Healthcare S.A. v. Hospira, Inc.
Applying the Federal Circuit’s recent decision in Acorda Therapeutics, the court denied defendants’ motion to dismiss on grounds of lack of personal jurisdiction, and also denied defendants’ Rule 12(b)(6) motion because § 271(e)(2) does not explicitly require an entity to sign the ANDA in order for it to be a properly-named defendant.
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