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
- Acorda Therapeutics Inc. v. Mylan Pharms. Inc.
The act of filing an ANDA, coupled with intent to market a generic drug in Delaware, was sufficient basis to establish specific personal jurisdiction in Delaware.
- Warner Chilcott Co., LLC v. Teva Pharms. USA, Inc.
One of skill in the art would be motivated to obtain the logical goal of a drug to have bioavailability that is affected by coadministration with food.
- Purdue Pharma L.P. v. Epic Pharma, LLC
In affirming judgment of invalidity, the Federal Circuit credited the district court’s findings concerning the disclosure of the prior art and the adequacy and reliability of Defendants’ expert’s testing results and methodology.
- Shire Development, LLC v. Watson Pharms., Inc.
Applying the Federal Circuit’s claim construction on remand, the district court found that Defendant’s’ ANDA product will infringe the asserted claims of the patent-in-suit.
- Braintree Labs. Inc. v. Breckenridge Pharm., Inc.
Because the ANDA product does not satisfy the claimed volume limitation of the patent and the use claimed in the patent is not FDA-approved, the ANDA product does not infringe the patent-in-suit.
- Helsinn Healthcare, S.A. v. Dr. Reddy’s Labs. Ltd.
The district court applied the law of on-sale bar and the written description requirement to support findings that defendant did not meet its burden to show patent invalidity.
- Supernus Pharms., Inc. v. Actavis Inc.
Based on the court’s claim construction, two of the three patents-in-suit were found infringed, and all three were not invalid.
- Amarin Pharma, Inc. v. Apotex, Inc.
ANDA must be “received” by FDA for district court litigation to proceed.
- Apotex, Inc. v. Daiichi Sankyo, Inc.
All that was required to constitute standing by ANDA filer was to show that a patent’s listing constituted an independent barrier to entry into the drug market and that a judicial decision could remove that barrier.
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