Stephen B. Maebius

Partner

Drawing upon over 30 years of experience, Stephen (Steve) Maebius helps clients protect their innovation and transact business involving intellectual property assets.

Steve is a partner with Foley & Lardner LLP and leads teams handling a variety of IP work, including IP due diligence reviews, opinions, patent portfolio creation and management, licensing, inter partes proceedings involving patents and litigation, and pharmaceutical patent term extensions. He is a former member of the firm’s Management Committee and past chair of the IP Practice. Prior to becoming a lawyer, he was a patent examiner in the Biotechnology Group of the U.S. Patent and Trademark Office, gaining experience examining small molecule drugs as well as biologics.

スティーヴ・メビウスは、フォーリー&ラードナーLLPの知的財産権法部門のパートナーである。当法律事務所の前マネージメント・コミッティーのメンバーであ り、知的財産権グループの前代表パートナーである。また、医薬品・バイオテクノロジー・化学製品プラクティスグループにも所属している。弁護士登録をする以前は、米国特許商標庁で特許審査官を務め、バイオテクノロジー関連の業務を担当していた。現在は、知的財産権 (IP) に関連する業務を幅広く取り扱って おり、例えば、IPデリジェンスレビュー、法律意見書作成、国際的な特許ポートフォリオ管理、ライセンシング、訴訟、再審査(inter parters review, reexamination)、特許期間延長、インターフェアレンスに関連する業務を手掛ける。

代表的事件

  • 主任弁護士として、オレンジブック記載の10億ドル以上の売上げを有する製薬の特許ファミリーに対するジェネリック企業を相手方申立人とする6件のinter partes review (並行するハッチワックスマン訴訟を伴う)で、被申立人側を代理して防御に成功した。PTABは最終判断において全てのクレームの特許性を認め、申立人の主張を全て退けた。(IPR2013-00368, IPR-2013-00371, IPR2013-00372)
  • オレンジブック記載のプロダクト・バイ・プロダクト特許出願を担当。同特許はUnited Therapeutics v. Sandoz訴訟(2014年) にて有効とされかつ特許侵害が認められた
  • LED関連企業を代理し、同企業に対して提起された特許侵害訴訟への対抗策として、共同代理人としてIPRを申し立て、特許無効の判断を導いた
  • 武田薬品工業株式会社 対 米国特許商標庁長官 (Jon W. Dudas) 事件 (D.D.C. 2007) – 共同代理人として特許再審査から生じた二重特許を理由とする拒絶査定を取り消す決定を下したサマリジャジメントを獲得し、クライアントを勝利に導いた(事件は控訴中)
  • Goldenberg & Immunomedics v. Cytogen & C.R. Bard (Fed. Cir. 2004) – 判事の判断が2対1に分かれた困難な事件で、共同代理人として、均等論を根拠とするサマリジャッジメントを取り消す決定を獲得し、クライアントを勝利に導いた
  • 年間総売上が15億ドルにも及ぶ医薬品を対象とする2件の特許の再審査事件を担当し、 1年足らずの内にすべてのクレームの特許権取得可能性を支持する決定を獲得した
  • ライセンスの初期支払金額が1億ドルにものぼるバイオテクノロジー創薬のライセンシングに関係する案件で、買収側企業を代理して IPデリジェンスを実施し、また関連契約書の作成にあたった

役職・所属団体等

知的財産権分野において、教育活動や執筆活動に積極的に取り組んでいる。” Due Diligence for Intellectual Property: Valuing Assets in a Transaction” (Law Journal Press出版) の中心的著者であり、東京大学先端科学技術研究センターの客員准教授、ジョージワシントン大学ロースクールで非常勤教授の職を歴任してきた。ジョージワシントン大学ロースクールでは、比較・国際特許法の講座を担当した。東京オフィスのメンバーと連携しながら、定期的に日本を訪れて法律業務を行っている。2002年には、連邦取引委員会/司法省 (FTC/DOJ) 合同で開催されたImplications of Competition and Patent Law and Policyと題された公聴会で、再審査の実務について証言を行った。

ナノテクノロジー分野における活躍としては、業界団体であるNanoBusiness Allianceの設立、そしてNanotechnology Law & Business 誌の創刊に尽力した。現在に至るまで Nanotechnology Law & Business 誌の編集委員を務めている。

受賞

  • IAM Patent 1000 – The World’s Leading Patent Practitioners, recognized for post-grant patent procedures (2012-2013) and prosecution and transactions (2014)
  • Chambers Global Intellectual Property – USA and Japan (2012 – 2015)
  • Chambers USA for the District of Columbia in intellectual property and patent prosecution (2012 – 2014)
  • The Legal 500 for patent licensing and patent prosecution (2010 – 2013) and for patent licensing and transactional (2014)
  • The Best Lawyers in America® in the areas of biotechnology law, patent litigation, and patent law (since 2007) and intellectual property (since 2009)
  • Washingtonian’s Best Lawyers in Washington for Intellectual Property (2013 – 2014)
  • Peer Review Rated as AV® Preeminent™, the highest performance rating in Martindale-Hubbell’s peer review rating system

学歴・経歴

コーネル大学(理学学士号(生物学専攻)、1989年)およびジョージワシントン大学ロースクール(法学博士、1994年)卒業。

資格

コロンビア特別区およびバージニア州の弁護士資格を有する。連邦控訴裁判所連邦巡回区裁判所、連邦最高裁判所および米国特許商標庁で弁論を行う資格を有する。

著書・論文等

  • “CAFC Partially Relaxes Idle Free Requirements for Amendments During IPR“, PTAB Trial Insights Blog (https://www.ptabtrialinsights.com/2016/02/cafc-partially-relaxes-idlefree-requirements-for-amendments-during-ipr/), 2016
  • “Lessons Learned From the 1st Successful Pharmaceutical IPR Defense of Orange Book Listed Patents”, PTAB Trial Insights Blog (https://www.ptabtrialinsights.com/2015/08/lessons-learned-from-the-1st-successful-pharmaceutical-ipr-defense-of-orange-book-listed-patents/), 2015
  • “Does Spike in IPR Settlements Signify Petitioner Success?” PTAB Trial Insights Blog (http://www.ptabtrialinsights.com/2015/08/does-spike-in-ipr-settlements-signify-petitioner-success/), 2015
  • “Patenting Risk Evaluation & Mitigation Strategies for Pharmaceuticals: A New Life Cycle Management Target for Patents?” Pharmaceutical Law & Industry, 7(1): 1-3, 2009 (co-author)
  • “Bayer Highlights Debate on Research Method Use (Patent Won’t Cover Fruit of Offshore Research Not Made with the Method),” National Law Journal, 2001 (co-author)
  • “Extending Process Claims From Intermediate to Final Product: Avoiding the Trap of Eli Lilly v. American Cyanamid,” Journal of the Patent & Trademark Office Society, 1998

Representative Experience

  • Assisted biotech client with building patent portfolio and presenting IP strategy to VC investors during fundraising, followed by successful IPO.
  • Co-counsel in the successful defense of a Post-Grant Review filed against a CRISPR Cpf1 patent (PGR2018-00072).
  • Lead counsel in the successful defense of six inter partes reviews filed by generic petitioners against a family of Orange Book-listed pharmaceutical patents covering a US $1bn controlled release product with parallel Hatch-Waxman litigation (IPR2013-00368, IPR2013-00371, and IPR2013-00372 – all claims found patentable in final written decision; IPR2015-01777, IPR2015-01778, and IPR2015-01782 – not instituted).
  • Prosecuted a portfolio of product-by-process patents listed in the Orange Book and upheld as valid in subsequent litigation.
  • Takeda Pharmaceutical Co. Ltd. v. John Doll (Fed. Cir. 2009) – co-counsel in a precedential 2-1 decision remanding a double patenting rejection arising from patent reexamination (all claims confirmed to be patentable upon remand).
  • Licensing of a biotechnology drug with an up-front payment of US $100m – represented the acquiring company in IP diligence and drafting transaction agreements.

Awards and Recognition

  • IAM Patent 1000 – The World’s Leading Patent Practitioners
    •  Post-Grant Patent Procedures (2012-2013, 2020)
    • Prosecution and Transactions (2014-2016, 2020-2021)
  • Chambers Global Intellectual Property – USA and Japan (2012-2015)
  • Chambers USA for the District of Columbia – Intellectual Property and Patent Prosecution (2012-2014)
  • Washington, D.C. Super Lawyers® – Intellectual Property (2014-2020, 2022-2023)
  • The Legal 500 
    • Patent Licensing and Patent Prosecution (2010-2013)
    • Patent Licensing and Transactional (2014 and 2015)
    • Intellectual Property – Patent Prosecution – Utility and Design Patents (2015 and 2016)
    • Healthcare – Life Sciences (2015 and 2016)
  • The Best Lawyers in America®
    • Biotechnology and Life Sciences (2007-2024)
    • Litigation – Patent (2012-2024)
    • Patent Law (2012-2024)
    • Intellectual Property (2007-2010)
  • Washingtonian’s Best Lawyers in Washington for Intellectual Property (2013-2014)
  • Peer review rated as AV Preeminent®, the highest performance rating in the Martindale-Hubbell® Peer Review Ratings™ system
  • Managing Intellectual Property – IP Star (2015)
  • Two IP transactions in which Steve participated received Licensing Executives Society’s “Deal of Distinction”

Presentations and Publications

  • Co-author, “Next-Generation Bioprinted Products: Products of Nature or Patentable Innovation?” IEEE Pulse (March 28, 2023)
  • Co-author, “PTAB’s Motion to Amend Pilot Program: Review of Initial Results,” PTAB Trial Insights Blog (Aug. 19, 2020)
  • Co-author, “PTAB – 2019 Year in Review,” PTAB Trial Insights Blog (Jan. 23, 2020)
  • Author, “District Court Sheds Light on Scope of IPR Estoppel,” PTAB Trial Insights Blog (Sept. 12, 2019)
  • Author, “Revamped PTAB Trial Practice Guide Holds Surprises,” PTAB Trial Insights Blog (Aug. 13, 2018)

Thought Leadership

  • Principal author, Due Diligence for Intellectual Property: Valuing Assets in a Transaction, published by Law Journal Press
  • Visiting associate professor of intellectual property law, Tokyo University’s Research Center for Advanced Science and Technology
  • Faculty adjunct professor of comparative and international patent law, George Washington University Law School Testified about post-grant patent proceedings during the FTC/DOJ hearings on the “Implications of Competition and Patent Law and Policy,” which preceded the landmark patent legislation known as the America Invents Act
  • Co-founder, NanoBusiness Commercialization Association
  • Co-founder and associate editor, Nanotechnology Law & Business journal
17 November 2023 PharmaPatents

Revisiting FDA’s Original Guidance on Orange Book Listability in Light of Heightened FTC Scrutiny

The listing of many types of patents in the FDA’s Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is fairly straightforward
17 August 2023 Honors and Awards

Foley Attorneys Recognized in 2024 Best Lawyers in America

Foley & Lardner LLP proudly announced today that 236 of the firm’s attorneys across 20 U.S. offices have received recognition in the 2024 edition of The Best Lawyers in America©.
25 May 2023

Spring 2023 JIPA Seminar Series: U.S. Intellectual Property Law Update

Foley is pleased to once again partner with the Japan Intellectual Property Association, the country’s largest private organization concerned with intellectual property rights, to present its members with a biannual update on intellectual property developments in the United States.
24 April 2023 Honors and Awards

Foley Attorneys Named to 2023 Washington, D.C. Super Lawyers and Rising Stars Lists

Foley & Lardner LLP is pleased to announce that four of its attorneys have been named to the 2023 Washington, D.C. Super Lawyers and Rising Stars lists.
14 March 2023 In the News

Stephen Maebius and Jennie Zheng Contribute to Article on Next-Gen Bioprinted Products

Foley & Lardner LLP Partner Stephen Maebius and Patent Agent Jennie Zheng contributed to an article in IEEE Pulse titled, “Next Generation Bioprinted Products: Products of Nature or Patentable Innovation?” in Volume 14, Issue 1 of the publication.
27 February 2023 Health Care Law Today

Health Care & Life Sciences Sector Top Trends for 2023

Foley is primed to strategically advise health care and life sciences companies through every step of their journey and all stages of their lifecycle.