Shannon M. Bloodworth

Mylan Pharmaceuticals Inc. v. Allergan, Inc.; Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc.

Patent Trial and Appeal Board; Federal Circuit
Convinced the PTAB and the Federal Circuit that the St. Regis Mohawk Tribe was not entitled to assert tribal sovereign immunity to inter partes review of patents covering Restasis®, a treatment for dry-eye. Shortly before the IPR hearing, original patent owner Allergan assigned the patents to the Tribe and paid the Tribe a substantial sum of money in exchange for the Tribe’s assertion of sovereign immunity and an exclusive license back to Allergan. The PTAB denied the Tribe’s motion to terminate the IPRs, holding that tribal sovereign immunity was not a defense to cancellation proceedings, that Allergan all substantial ownership rights, and that the Tribe was not a necessary and indispensable party in any event. On appeal, the Federal Circuit affirmed that Allergan and the Tribe could not invoke tribal sovereign immunity to bar the PTAB from reconsidering patentability.

In re Copaxone 40 mg

Federal Circuit; Patent Trial and Appeal Board; District of Delaware
Federal Circuit affirmed separate decisions by a Delaware federal judge and the PTAB that patents on Teva Pharmaceuticals' blockbuster multiple sclerosis drug Copaxone are invalid. The Federal Circuit's decisions put an end to Mylan's high-stakes and long-running patent battle against Teva, as these were the last remaining patent infringement cases Mylan was defending in the U.S. relating to Glatiramer Acetate Injection 40mg/mL, a generic version of Copaxone. The patents would have blocked low-cost generic competition until 2030.

Mylan Pharmaceuticals Inc. v. Janssen Oncology, Inc.; BTG International Ltd. et al v. Actavis Laboratories FL, Inc. et al.

Patent Trial and Appeal Board; District of New Jersey
Secured a final written decision from the PTAB finding all claims of the only Orange Book-listed patent covering Janssen’s Zytiga® (abiraterone acetate) product unpatentable. Demonstrated the obviousness of combining a corticosteroid like prednisone with abiraterone acetate in treating patients suffering from metastatic castration-resistant prostate cancer. Achieved another victory for Mylan in a parallel case in the District of New Jersey when the court invalidated the patent, following a bench trial.

In re Copaxone ’775 Patent Litigation

U.S. District Court for the District of Delaware
Represented Mylan in patent infringement litigation concerning method of manufacturing glatiramer acetate (Copaxone®), a treatment for multiple sclerosis. Plaintiffs agreed to dismiss all claims after Mylan obtained a favorable claim construction ruling.

AstraZeneca AB, et al. v. Mylan Laboratories Ltd.

U.S. Court of Appeals for the Federal Circuit
U.S. District Court for the District of New Jersey
Lead trial counsel for Mylan in Hatch-Waxman litigation over patent rights to esomeprazole (Nexium®). Defeated motion for a preliminary injunction in the district court and on appeal, allowing Mylan to market a generic esomeprazole product.

Teva Pharmaceuticals USA v. United States Food & Drug Administration, et al.

U.S. District Court for the District of Columbia
Represented Intervenor-Defendant Mylan Pharmaceuticals Inc. in a suit brought by Teva Pharmaceuticals against the FDA under the Administrative Procedure Act. Teva sought to force FDA to reclassify the multiple sclerosis drug Copaxone as a biologic product in order to frustrate generic competition. Successfully obtained summary judgment against Teva on all claims.

Teva Pharmaceuticals USA Inc., et al. v. Mylan Pharmaceuticals Inc., et al.

U.S. Supreme Court
U.S. Court of Appeals for the Federal Circuit
U.S. District Court for the Southern District of New York
Lead counsel and trial counsel for Mylan in various suits venued domestically (e.g., the Southern District of New York, Federal Circuit, and United States Supreme Court) and abroad related to alleged infringement of patents on a copolymer of amino acids for the treatment of multiple sclerosis (Copaxone®). In the domestic case, a decision by the United States Supreme Court resulted in a favorable invalidity ruling Federal Circuit. International litigation ongoing.

Apotex, Inc. v. Daiichi Sankyo, Inc., et. al.

U.S. District Court for the Northern District of Illinois
Representing intervenor Mylan in a dispute regarding Mylan’s 180-day exclusivity rights to market generic Benicar®. Litigation ongoing.

Janssen Biotech, Inc. v. Mylan Inc.

U.S. District Court for the District of New Jersey
U.S. District Court for the Northern District of West Virginia
Representing Mylan in the District of New Jersey and the Northern District of West Virginia in Hatch-Waxman litigation over patent rights to abiraterone acetate (Zytiga®). Case is ongoing.

AstraZeneca Pharmaceuticals LP v. Agila Specialties Inc.

U.S. District Court for the District of New Jersey
Representing Agila in the District of New Jersey in Hatch-Waxman litigation over patent rights to fulvestrant injection (Faslodex®). Case is ongoing.

Teva Pharmaceuticals USA Inc., et al. v. Mylan Pharmaceuticals Inc., et al.

U.S. District Court for the District of Delaware
Lead counsel Mylan in Hatch-Waxman litigation in the District of Delaware over patent rights to the 40mg dose of Copaxone®, a copolymer of amino acids used to treat multiple sclerosis. Case is ongoing.

Flip To, LLC v. Fandealio, Inc.

U.S. District Court for the Middle District of Florida
Representing internet company and defendant Fandealio, Inc. in a trademark dispute in the Middle District of Florida.

The Medicines Company v. Mylan Inc.

U.S. District Court for the Northern District of Illinois
Lead trial and appellate counsel for Mylan in Hatch-Waxman litigation over patent rights to bivalirudin (Angiomax®). The district found that Mylan infringed only one of two patents. The Federal Circuit reversed the finding of infringement, holding that Mylan infringed neither asserted patent.

Mylan Inc. v. Smithkline Beecham Corporation

U.S. District Court for the District of New Jersey
Represented Mylan Inc. in litigation involving breach of a patent settlement agreement related to the depression medication Paxil® (paroxetine). Case resulted in a jury verdict in Mylan’s favor exceeding $100 million.

Mylan Pharmaceuticals Inc. v. Novartis AG

U.S. Patent and Trademark Office
Representing Mylan in inter partes review before the United States Patent and Trademark Office related to fingolimod (Gilenya®). IPR is ongoing.

Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd.

U.S. Patent and Trademark Office
Representing Mylan in multiple inter partes reviews before the United States Patent and Trademark Office related to a method of treatment with glatiramer acetate (Copaxone®). IPR is ongoing.

In re ’808 Patent

U.S. Patent and Trademark Office
Represented Mylan in challenging reissue patent application in the United States Patent and Trademark Office after the patent had been declared invalid by the Federal Circuit. Reissue was abandoned.

Hospira, Inc., et al. v. Sylvia Matthews Burwell, et al.

U.S. Court of Appeals for the Fourth Circuit
U.S. District Court for the District of Maryland
Lead counsel for intervenor-defendant Mylan Institutional LLC in a suit brought by Hospira in the District of Maryland against the U.S. Food and Drug Administration to rescind approval of Mylan’s generic Precedex® (Dexmedetomidine) product. Successfully obtained summary judgment, allowing Mylan to market its product. After Hospira appealed to Fourth Circuit, negotiated a successful settlement agreement.

Teva Neuroscience, Inc., et al. v. Mylan Inc., et al.

U.S. District Court for the District of New Jersey
Lead trial and appellate counsel for Mylan in a Hatch-Waxman litigation over patent rights to rasagiline mesylate (Azilect®), a drug approved for the treatment of Parkinson’s disease. Negotiated a success settlement agreement.

Teva Pharmaceuticals USA Inc., et al. v. Mylan Pharmaceuticals Inc., et al.

U.S. District Court for the Southern District of New York
Lead counsel Mylan in the Southern District of New York related to alleged infringement of patents related to molecular weight markers related to the manufacture of glatiramer acetate (Copaxone®). We were successful In the domestic case, a decision by the United States Supreme Court resulted in a favorable invalidity ruling Federal Circuit. The Southern District of New York dismissed the case on our motion to dismiss.

Novo Nordisk Inc. v. Mylan Pharmaceuticals Inc., et al.

U.S. District Court for the District of New Jersey
Successfully defended Mylan, a generic pharmaceutical company, in Hatch-Waxman litigation relating to repaglinide (Prandin®), a diabetes treatment. Case was dismissed and Mylan was able to market its generic product upon FDA approval.

Pfizer Inc., et al. v. Mylan Inc., et al.

U.S. District Court for the District of Delaware
Lead counsel for Mylan in Hatch-Waxman litigation over patent rights to atorvastatin calcium (Lipitor®). Negotiated a success settlement agreement allowing Mylan to market its generic Lipitor® product.

Medicis Pharmaceutical Corporation v. Mylan Inc., et al.

U.S. District Court for the District of Delaware
Lead counsel for Mylan in Hatch-Waxman litigation over patent rights to the acne medication minocycline hydrochloride extended release tablets (Solodyn®). Negotiated a successful settlement agreement following Mylan’s launch of its generic minocycline product.

Watson Laboratories, Inc. v. Sebelius, et al.

U.S. District Court for the District of Columbia
Represented Mylan Pharmaceuticals Inc. as an Intervenor-Defendant in Hatch-Waxman related litigation regarding generic exclusivity rights relating to the diabetes treatment pioglitazone hydrochloride (Actos®). Defended against competitors’ temporary restraining order and injunction motion permitting Mylan to market its generic pioglitazone hydrochloride product.

Boehringer Ingelheim International GmbH, et al. v. Mylan Pharmaceuticals Inc.

U.S. Court of Appeals for the Federal Circuit
U.S. District Court for the District of Delaware
Lead and appellate counsel for Mylan prevailing in a bench trial finding invalid the patent rights to pramipexole dihydrochloride (Mirapex®), a Parkinson’s disease treatment.

Daiichi Sankyo Company Ltd., et al. v. Mylan Pharmaceuticals Inc.

U.S. District Court for the District of New Jersey
Represented Mylan in three-week court trial in the District of New Jersey involving claimed structural obviousness of chemical compound for the treatment of hypertension (Benicar®).

Pfizer Inc. v. Mylan Laboratories Inc., et al.*

U.S. Court of Appeals for the Federal Circuit
U.S. District Court for the Western District of Pennsylvania
Successfully obtained stay of district court injunction from the Federal Circuit, leading to generic launch of amlodipine; successfully obtained temporary restraining order in related litigation in the D.C. district and appellate courts over entitlement to and extent of generic exclusivity.

Innogenetics N.V. v. Abbott Laboratories*

U.S. Court of Appeals for the Federal Circuit
U.S. District Court for the Western District of Wisconsin
Represented Innogenetics in an action for patent infringement against Abbott Laboratories on Innogenetics’ patent for a method of genotyping the hepatitis C virus. Innogenetics obtained summary judgment of no unenforceability, a directed infringement verdict on the three asserted claims, and jury verdicts that the patent was not invalid and awarding damages. On appeal, the Federal Circuit affirmed the findings of infringement and validity of two of the asserted claims and affirmed the jury’s damages award. 512 F.3d 1363. (Fed Cir. 2008)

Manders v. McGhan Medical Corporation, et al.*

U.S. District Court for the Western District of Pennsylvania
Obtained a favorable settlement on behalf of medical device company in patent infringement action involving patent on medical prosthesis.

* Prior Experience