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
- Shire LLC v. Amneal Pharms. LLC
Affirming finding of validity and infringement of patents-in-suit, but finding a supplier of components reasonably related to the submission of an ANDA falls within the safe harbor provision of 35 USC § 271(1) and is not liable for infringement
- Allergan, Inc., v. Sandoz Inc.
Trial court did not err when it found that there was no motivation to pursue modified concentration of existing drug and no reasonable expectation of success in doing so, and asserted claims met the Section 112 requirements for enablement and adequate written description.
- The Medicines Co. v. Hospira, Inc.
Claims held invalid based on application of on-sale bar when sale of manufacturing services was deemed a commercial offer for sale.
- Baxter Healthcare Corp. v. HQ Specialty Pharma Corp.
Patentee disavowed any meaning to claim term at issue other than that which was described in the specification, and in view of that construction, cross motions for summary judgment were denied.
- Endo Pharms. Inc. v. Actavis Inc.
The fact that the “bioavailability of oxymorphone is increased in people with impaired kidney function” is a natural law that is not subject to patent protection.
- Novartis Pharm. Corp. v. Noven Pharm., Inc.
Determining if compounds are similar for obviousness requires analysis of the entire structure.
- Merck & CIE v. Watson Labs., Inc.
Asserted claim was invalid and infringed after the court considered and rejected arguments related to on-sale bar, anticipation, obviousness, and lack of written description.
- Merck Sharp & Dohme Corp. v. Sandoz Inc
Lead compound analysis established that the asserted claims were not invalid as obvious.
- Eli Lilly & Co. v. Teva Parenteral Medicines, Inc.
Indirect infringement is present when the patient and prescribing information describe all claimed steps.
- Eli Lilly & Co. v. Nang Kuang Pharm.Co., Ltd.
Personal jurisdiction over defendants existed in Indiana when PIV Certification notice letter was sent to a corporation incorporated in that state.
- Millennium Pharms., Inc. v. Sandoz Inc.
The asserted claims were invalid as obvious when two of three elements were plainly in the prior art while the third element was an inherent result of the combination of the first two elements.
- Endo Pharms. Inc. v. Amneal Pharms. LLC
Controlled-release oxymorphone patents held infringed and valid while abuse-proof oxymorphone patent held infringed but invalid as obvious.
- Novartis Pharm. Corp. v. Zydus Noveltech Inc.
Personal jurisdiction does not exist when the only contact in the jurisdiction is plaintiff incorporation in the forum.
- Purdue Pharma L.P. v. Collegium Pharm., Inc.
There is no personal jurisdiction over defendant when PIV Certification notice letter was mailed to one state and defendants were headquartered in another state.
- Par Pharm., Inc. v. TWi Pharms., Inc.
On remand, asserted claims were obvious on the basis of inherency and the full scope of the claimed particle size range was not enabled; thus, the patent-in-suit was invalid.
- Intendis GMBH. v. Glenmark Pharms. Ltd.
Proposed ANDA formulation infringed the patent-in-suit under the doctrine of equivalents; defendants’ obviousness defense was also rejected.
- Pfizer Inc. v. Alkem Labs. Ltd.
Failure to raise a claim-construction issue precludes a party from arguing claim differentiation.
- Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc.
Motion to transfer denied when related litigation concerning the same patent was not co-pending and involved different accused products.
The articles on our Website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice.