Image: Bruce M Wexler

Bruce M Wexler

Partner, Litigation Department
New York
200 Park Avenue
New York, NY
10166
United States

Fax: 1(212) 230-7644

Overview

ブルース・M・ウェクスラーは、医薬品その他技術に関連する特許訴訟において豊富な経験を有する当事務所の訴訟専門パートナー。 これまでにも数百万ドルから数十億ドル規模の売上を誇る医薬品の特許侵害の弁護でクライアントを代理。医薬品、電子コンパス、感熱インク・ジェット・プリンター製品、車両用ミラー部品、車両用ガラス部品およびコンタクト・レンズ・ケア製品等の幅広い技術分野にわたる特許訴訟において主任弁護士又は共同主任弁護士として活躍。

2010年1月、クライアントであるベーリンガーインゲルハイム社を代理して米国連邦巡回控訴裁判所に控訴し勝訴 。ウェクスラー氏は当該控訴審の遂行のために起用され、地方裁判所が下した特許無効判断の取消を獲得。2008年3月には、ニュージャージー州地区合衆国連邦地方裁判所が差止仮処分を命じた、米国年間売上高約20億ドル規模の業界一のアルツハイマー病治療剤「アリセプト(Arcept® )」にかかる特許訴訟では、販売元のエーザイ株式会社を代理。2007年5月には、ファイザー社が販売するACE(アンジオテンシン変換酵素)阻害薬「アキュプリル(Accupril®)」の特許訴訟において、同社を代理し当該特許の有効性を維持。2007年3月には、米国年間売上高10億ドル以上の抗潰瘍剤「アシフェックス(Aciphex®)」の特許訴訟では、販売元のエーザイ株式会社を代理し勝訴。2006年10月にも特許の有効性をめぐりエーザイ株式会社を代理した訴訟で略式判決を勝ち取った。

Chambers USA 2009 は、同氏をニューヨーク州における知的財産専門弁護士の中で最も優れた弁護士の一人として評価。2008年および2009年のニューヨーク州「Super Lawyer」としても指名される。2007年からは毎年The Legal 500 US において、「特許訴訟部門のリーディング・ロイヤー」の評価を受けている。また、論文「Forum Shopping More Likely As A Result Of Narrowing Of Federal Circuit Jurisdiction in Vonado 」の功績から「2004年Burton賞(法律部門)」を受賞。さらに、マーティンデール・ハーバル(Martinedale-Hubbel)の弁護士評価調査では、法律的素養及び倫理規範に関して、最も高い評価である「AV® Peer Review」を受けている。 弁護士としての職務を開始する以前は、合衆国連邦巡回控訴裁判所の主席判事であるグレンL.アーチャーJr.(Glenn L. Archer, Jr.)付の裁判所書記官を務めた。 1992年ニューヨーク大学において法学博士号を取得(最優等-The Order of the Coif(米国優秀法学生会))。1989年レンセラー・ポリテクニーク・インスティテュート(Rensselaer Polytechnic Institute)物理学科を最優等で卒業 。同インスティテュートでは、Sigma Pi Sigmaのメンバーに選出される。

Education

  • New York University School of Law, J.D. (magna cum laude, Order of the Coif)

  • Rensselaer Polytechnic Institute, B.S. in Physics (summa cum laude, member - Sigma Pi Sigma honor society)

Speaking Engagements

  • Mr. Wexler's writing has been published in numerous journals, including Forbes, Law360, IP Magazine, Managing IP, and NYU's Journal of Intellectual Property and Entertainment Law.

  • He is a regular speaker at legal seminars, including ACI's Paragraph IV Disputes conference.

  • Mr. Wexler has been quoted frequently with regard to litigation and practice developments, including in the Wall Street Journal, Bloomberg News, Reuters, The Deal and The New York Times.

  • Mr. Wexler regularly provides his clients with in-house CLE presentations on a variety of topics of interest, and authors client alerts concerning important developments in the law.

Involvement

  • Mr. Wexler advised Congress and key stakeholders during the consideration and certain aspects surrounding the enactment of the America Invents Act.

  • He is a former judicial law clerk of the U.S. Court of Appeals for the Federal Circuit, where he served under Chief Judge Glenn L. Archer, Jr. He clerked for Chief Judge Archer during the Chief Judge's preparation of influential Federal Circuit decisions including Markman v. Westview.

Recent Representations

  • Allele Biotechnology and Pharmaceuticals, Inc. v. BioNTech SE and Pfizer

Mr. Wexler is lead counsel for BioNTech SE, which filed the world's first FDA application for a Covid-19 vaccine and an mRNA drug product.

  • Actelion Pharmaceuticals Ltd. v. Zydus Pharmaceuticals. (USA) et al.

Mr. Wexler was lead counsel for Actelion, a Johnson & Johnson company, in patent infringement lawsuits against Zydus Pharmaceuticals, Amneal Pharmaceuticals, and Aurobindo Pharma related to Actelion Opsumit®, a breakthrough 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.

  • Abbvie Inc. et al. v. Boehringer Ingelheim International GMBH et al.

Mr. Wexler was lead counsel for Boehringer Ingelheim 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.

  • Boehringer Ingelheim Pharma GMBH & Co. KG et al. v. Teva Pharmaceuticals USA, Inc. et al.

Mr. Wexler 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. Mr. Wexler argued and won from the bench critical Markman issues, which had significant implications for the infringement and validity issues in the case.

  • Orexigen Therapeutics, Inc. v. Actavis Laboratories FL, Inc.

Mr. Wexler represented Orexigen in a complete trial victory in a patent litigation relating to Orexigen's weight loss drug Contrave® against Actavis Laboratories (now part of Teva Pharmaceuticals). At trial, Mr. Wexler 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, Mr. Wexler's cross-examination at trial.

  • Adamas Pharma LLC v. Sandoz

Mr. Wexler 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.  

  • Merck Sharp & Dohme Corp. v. Teva Pharmaceuticals USA, Inc.

Mr. Wexler 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. Mr. Wexler prevailed in Markman proceedings where Teva sought to invalidate the patent based on indefiniteness.

  • Arena Pharmaceuticals Inc. et al. v. Lupin Ltd. et al.

Mr. Wexler 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.

  • Merck Sharp & Dohme Corp. v. Sandoz Inc. et al.

Mr. Wexler was lead counsel for Merck in patent infringement litigation defending Merck's patent protecting the active ingredient in 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 complete victory 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 Mr. Wexler at trial.

  • Sanofi-Aventis US LLC et al. v. Eli Lilly & Co.

Mr. Wexler 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. Mr. Wexler 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.

  • Eisai v. Glenmark Generics, Ltd. et al.

Mr. Wexler 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, Mr. Wexler obtained a victory in Markman proceedings having significant implications for the infringement and validity issues in the case. Mr. Wexler 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.

  • Merck Sharp & Dohme Corp. v. Apotex Inc.

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. Mr. Wexler 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.

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

Mr. Wexler was lead counsel for Boehringer Ingelheim in this appeal involving the patent protecting Mirapex®, a key drug in the treatment of Parkinson's disease. Mr. Wexler was hired to handle the appeal after another firm had received an adverse ruling at trial. Mr Wexler 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.

  • Sandoz Inc. v. Boehringer Ingelheim International GmbH et al.

Mr. Wexler was lead counsel for Boehringer Ingelheim in its counterclaim action for patent infringement against Sandoz. Mr. Wexler 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. Mr. Wexler subsequently negotiated a stipulation continuing the injunction through patent expiration. 

  • Takeda Pharmaceutical Company Ltd. et al. v. Teva Pharmaceuticals USA, Inc. et al.

Mr. Wexler 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, Mr. Wexler obtained a favorable settlement dismissing both companies' patent challenges.

  • Eisai Co., Ltd. et al. v. Teva Pharmaceuticals USA, Inc.

Mr. Wexler 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. Mr. Wexler obtained a preliminary injunction against Teva's threatened launch of a generic version of the drug. Mr. Wexler 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.

  • Merck & Co., Inc. v. Sandoz Inc.

Mr. Wexler was lead trial counsel for Merck in an action enforcing Merck's patents protecting its oral anti-emetic drug product, Emend®. Mr. Wexler ultimately obtained a consent judgment for his client that included an injunction prohibiting Sandoz from infringement through patent expiration.

  • Eisai Co., Ltd. and Eisai Inc. v. Teva Pharmaceuticals USA, Dr. Reddy's Laboratories and Mylan Laboratories

Mr. Wexler was co-lead trial counsel to Eisai in litigation defending Eisai's patent covering Aciphex®, an acid reflux drug with annual US sales in excess of $1 billion. Eisai initially won summary judgment of patent validity, followed by a successful trial win on the 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.

  • Nycomed v. Teva Pharmaceuticals USA, Inc.

Mr. Wexler 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®. Mr. Wexler 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.

  • Warner-Lambert Company v. Teva Pharmaceuticals USA, Inc.

Mr. Wexler represented Pfizer (Warner-Lambert Company) during a successful bench trial against Teva involving Pfizer's formulation patent covering its highly successful cardiovascular drug Accupril®. Mr. Wexler 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.

Practice Areas

Litigation
Patent Office
Patent Litigation
Intellectual Property
Life Sciences and Healthcare

Languages

英語

Admissions

New York Bar
United States Patent & Trademark Office

Education

New York University School of Law, J.D. 1992
Rensselaer Polytechnic Institute, B.S. 1989

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