Achieved a complete trial victory in the U.S. District Court for the District of New Jersey for clients Eisai and Merck, successfully defending Eisai’s patent covering its life-saving Lenvima® cancer drug product.
Eisai Co., Ltd., Eisai Inc., MSD Oncology Holdings Ltd., et al. v. Shilpa Medicare Ltd.
Bruce served a lead counsel to Eisai as the petitioner defending a threat of infringement of Eisai’s lemborexant sleep drug product by successfully invalidating the patent in suit at the PTAB in a Post Grant Proceeding, on the ground of inherent anticipation.
Eisai Inc. v. Crystal Pharmaceutical (Suzhou) Co., Ltd.
Bruce currently serves as lead counsel to BioNTech defending claims of patent infringement by Moderna in the U.S. District Court for the District of Massachusetts involving the COVID-19 vaccine.
ModernaTX Inc. et al. v. BioNTech SE and Pfizer Inc.
Bruce served as lead counsel to Actelion, a Johnson & Johnson company, and Nippon Shinyaku in patent litigation against Zydus related to their blockbuster drug product Uptravi®, used in the treatment of pulmonary arterial hypertension to delay disease progression and hospitalization. After litigating through fact and expert discovery, Zydus agreed to a consent judgement that affirmed the asserted claims of the patent-in-suit are valid and enforceable, and the case was resolved with a favorable settlement for the client.
Actelion Pharmaceuticals Ltd. and Nippon Shinyaku Co., Ltd. v. Zydus Worldwide DMCC, et al.
Bruce currently serves as lead counsel to BioNTech in a declaratory judgment action in the U.S. District Court for the Eastern District of Virginia relating to threats of infringement by CureVac involving the COVID-19 vaccine.
BioNTech SE and Pfizer Inc. v. CureVac AG
Bruce served as lead counsel for COVID-19 vaccine developer BioNTech SE in patent infringement litigation in the U.S. District Court for the Southern District of California involving artificial fluorescent protein assay technology. Bruce achieved a favorable resolution of the matter on behalf of BioNTech.
Allele Biotechnology and Pharmaceuticals, Inc. v. BioNTech SE and Pfizer Inc.
Bruce was lead counsel for Actelion, a Johnson & Johnson company, in patent infringement lawsuits in the U.S. District Court for the District of New Jersey against Zydus Pharmaceuticals, Amneal Pharmaceuticals, and Aurobindo Pharma related to Opsumit®, a drug used to treat pulmonary arterial hypertension to delay disease progression and hospitalization. The defendants ultimately entered into consent judgments following a powerful defense of the inventors and devastating deposition examination of defendants’ experts.
Actelion Pharmaceuticals Ltd. v. Zydus Pharmaceuticals. (USA) et al.
Bruce was lead counsel for Boehringer Ingelheim in the U.S. District Court for the District of Delaware in connection with Biologics Price Competition and Innovation Act (BPCIA) litigation relating to Boehringer’s FDA request to market Cyltezo®, a biosimilar of Humira®. The case involved a “patent dance” with thousands of pages of detailed statements, claim construction hearings, over 90 depositions, over 20 significant discovery disputes. The matter also involved parallel IPR petitions resulting in rulings that method-of-treatment claims covering the drug product Humira® were invalid, later affirmed on appeal.
AbbVie Inc. et al. v. Boehringer Ingelheim International GMBH et al.
Bruce was lead counsel for Boehringer Ingelheim in Hatch-Waxman litigation in the U.S. District Court for the District of New Jersey, securing victories in multi-defendant litigation involving the blockbuster life-saving blood thinner used by patients at risk of stroke, Pradaxa®, resulting in walkaways from six separate generic defendants. Bruce argued and won from the bench critical Markman issues, which had significant implications for the infringement and validity issues in the case.
Boehringer Ingelheim Pharma GMBH & Co. KG et al. v. Teva Pharmaceuticals USA, Inc. et al.
Bruce represented Orexigen in a complete trial victory in the U.S. District Court for the District of Delaware in a patent litigation relating to Orexigen’s weight loss drug Contrave® against Actavis Laboratories (now part of Teva Pharmaceuticals). At trial, Bruce successfully cross-examined the generic’s surprise fact witness who claimed to be a prior inventor and the generic’s lead expert witness after the generic sought to alter strategy the night before his testimony. The Federal Circuit affirmed the trial victory on the longest running patent, citing, among other things, Bruce’s cross-examination at trial.
Orexigen Therapeutics, Inc. v. Actavis Laboratories FL, Inc.
Bruce was lead counsel for Adamas Pharma LLC in Hatch-Waxman litigation against Sandoz involving patents with method of treatment claims to protect Gocovri™, its flagship product and the first FDA-approved medicine for treating dyskinesia in Parkinson''s disease patients receiving levodopa-based therapy, with or without concomitant dopaminergic medications. After successfully litigating into claim construction briefing, Adamas obtained a favorable settlement.
Adamas Pharma LLC v. Sandoz
Bruce was lead counsel for Merck in achieving a successful outcome in a generic challenge to Entereg® (alvimopan), an innovative treatment used for post-operative ileus, a potentially deadly condition following abdominal surgery. Bruce prevailed in Markman proceedings where Teva sought to invalidate the patent based on indefiniteness.
Merck Sharp & Dohme Corp. v. Teva Pharmaceuticals USA, Inc.
Bruce was lead counsel for Eisai and Arena in numerous generic challenges to Belviq® (lorcaserin), an innovative treatment for weight loss. After litigation into expert discovery and successful cross-examination of the generics’ experts, the case settled including stipulations of infringement.
Arena Pharmaceuticals Inc. et al. v. Lupin Ltd. et al.
Bruce was lead counsel for Merck in achieving a complete trial victory in patent infringement litigation relating to Merck’s Emend® for Injection, an important drug for the prevention of chemotherapy-induced nausea and vomiting. After a six-day bench trial, Judge Sheridan of the District of New Jersey entered judgment in favor of Merck on all aspects of Sandoz’s invalidity defenses, resulting in a successful outcome for Merck. In the course of the Court’s 80-page opinion finding in Merck’s favor, the Court noted the lack of credibility of Sandoz’s key expert witness who had been cross-examined by Bruce at trial.
Merck Sharp & Dohme Corp. v. Sandoz Inc. et al.
Bruce was lead counsel for Eli Lilly & Co. in litigation with Sanofi regarding Eli Lilly’s request to market its insulin glargine drug product Basaglar®. Sanofi brought suit on five patents, relating to a pharmaceutical composition and injector pen device, listed in the FDA Orange Book for Sanofi’s Lantus® and Lantus SoloStar® insulin glargine products. Bruce successfully led the case through fact and expert discovery, including live-witness Markman proceedings. The case settled on the eve of trial in late 2015 with the press reporting Eli Lilly’s ability to launch Basaglar® the following year.
Sanofi-Aventis US LLC et al. v. Eli Lilly & Co.
Bruce was lead counsel for Eisai in litigation with five generic defendant groups involving the patents directed to a crystalline form of rufinamide, the active ingredient in Eisai’s drug product, Banzel®, an important drug in the treatment of epilepsy. After successfully litigating through fact and expert discovery, Bruce obtained a victory in Markman proceedings having significant implications for the infringement and validity issues in the case. Bruce also convinced the Court, during the final pretrial conference, to exclude certain purported testing evidence by the defendants offered in support of their invalidity defense. An hour before opening argument at trial, the case settled on favorable terms.
Eisai v. Glenmark Generics, Ltd. et al.
While district court litigation was ongoing with other generic drug companies, generic drug company Apotex filed a petition for Inter Partes Review (IPR) at the U.S. Patent and Trademark Office seeking to invalidate the patent protecting Merck’s Emend® for Injection drug product. Bruce obtained a successful ruling from the PTO rejecting Apotex’s invalidity attack and refusing to institute review, and this ruling was subsequently reaffirmed on Apotex’s petition for rehearing.
Merck Sharp & Dohme Corp. v. Apotex Inc.
Bruce was lead counsel for Boehringer Ingelheim in this appeal involving the patent protecting Mirapex®, a key drug in the treatment of Parkinson’s disease. Bruce was hired to handle the appeal after another firm had received an adverse ruling at trial. Bruce argued and won a complete reversal from the Federal Circuit, with the Court declaring the patent to be valid. The appeal established important precedent concerning the scope of the double patenting safe harbor provision, 35 U.S.C. § 121.
Boehringer Ingelheim International GmbH et al. v. Mylan Pharmaceuticals, Inc.
Bruce was lead counsel for Boehringer Ingelheim in its counterclaim action for patent infringement against Sandoz. Bruce argued and won a preliminary injunction ruling, delivered from the bench, preventing Sandoz from launching a generic version of Mirapex®. The court was persuaded to grant the injunction on a patent that had been subject to a license and which would be expiring in several months. The Judge deciding this case in the Middle District of Florida had, in his immediately preceding patent case, refused both preliminary and permanent injunctive relief in part on the ground that the patentee had previously licensed the patent. Bruce subsequently negotiated a stipulation continuing the injunction through patent expiration.
Sandoz Inc. v. Boehringer Ingelheim International GmbH et al.
Bruce was lead trial counsel for Takeda in two actions enforcing Takeda’s patent for its anti-insomnia drug Rozerem® against challenge by generic drug companies Teva and Watson. After two years of litigation through fact and expert discovery, Bruce obtained a favorable settlement dismissing both companies’ patent challenges.
Takeda Pharmaceutical Company Ltd. et al. v. Teva Pharmaceuticals USA, Inc. et al.
Bruce was lead trial counsel for Eisai in an action defending Eisai’s patent protecting Aricept®, the market leading drug for the treatment of Alzheimer’s disease, having sales of some $2 billion/year. Bruce obtained a preliminary injunction against Teva’s threatened launch of a generic version of the drug. Bruce ensured continued exclusivity of the patent through patent expiration, and successfully defended attempts by Teva to trigger and run out the regulatory exclusivity of a first-filing generic drug applicant.
Eisai Co., Ltd. et al. v. Teva Pharmaceuticals USA, Inc.
Bruce was lead trial counsel for Merck in an action enforcing Merck’s patents protecting its oral anti-emetic drug product, Emend®. Bruce ultimately obtained a consent judgment for his client that included an injunction prohibiting Sandoz from infringement through patent expiration.
Merck & Co., Inc. v. Sandoz Inc.
Bruce was co-lead trial counsel to Eisai in litigation defending Eisai’s patent covering Aciphex®, an acid reflux drug with annual U.S. sales in excess of $1 billion. Eisai initially won summary judgment of patent validity, followed by a successful trial win on a defense of inequitable conduct. The judgments were then affirmed on appeal. The case established helpful precedent for innovator pharmaceutical companies with respect to the standards for judging obviousness of a compound patent. The case also established the benrishi-client privilege protecting from discovery communications between Japanese patent agents and their clients.
Eisai Co., Ltd. and Eisai Inc. v. Teva Pharmaceuticals USA, Dr. Reddy’s Laboratories and Mylan Laboratories
Bruce represented Wyeth (acquired by Pfizer) and Altana Pharma AG (acquired by Nycomed) in a jury trial against three generic pharmaceutical companies regarding the companies’ $2 billion per year ulcer drug Protonix®. Bruce successfully examined the inventor of omeprazole, who was also serving as an expert. The jury upheld the validity of the patent, permitting the plaintiffs to seek a damages claim of billions of dollars.
Nycomed v. Teva Pharmaceuticals USA, Inc.
Bruce represented Pfizer (Warner-Lambert Company) during a successful bench trial against Teva involving Pfizer’s formulation patent covering its highly successful cardiovascular drug Accupril®. Bruce elicited critical trial testimony from Pfizer’s formulation expert, including refutation of new evidence presented for the first time by the generic’s expert at trial. In its decision, the Court found the patent was not invalid for lack of enablement, despite the breadth of the claims.
Warner-Lambert Company v. Teva Pharmaceuticals USA, Inc.
