A partner in Goodwin’s Life Sciences group and Intellectual Property practice, Michael Siekman focuses his practice on intellectual property matters, including patent prosecution, licensing and post-grant proceedings and litigation. Leveraging over 25 years of experience, Michael has built in-depth patent portfolios, particularly advising clients in the biotechnology and pharmaceutical industries.
Michael keeps clients’ business goals in mind as he regularly provides legal counsel in the litigation matters, including Hatch-Waxman matters, and post-grant solutions for biosimilars. He has successfully led matters before the Patent Trial and Appeal Board (PTAB) and the European Patent Office. His transactional practice involves licensing agreements, collaboration agreements, and IP-related aspects of mergers, acquisitions, IPOs and other financings.
Michael has extensive experience with biosimilars and has written and presented often on the topic. One of his biosimilar articles has been cited in three amicus briefs to the Supreme Court in two cases involving the PTAB.
As a parent of a child with Type 1 diabetes, Michael particularly enjoys working with biopharma and device companies in that space.
Experience
Michael’s representative experience includes:
- Obtained key HIV-1 and HIV-2 diagnostic patents for Institut Pasteur to support their licensing program*
- Obtained the first nonviral, ex vivo gene therapy patents for TKT in US and abroad*
- Obtained key phage display of antibody patents for Dyax, reinvigorating licensing program*
- Obtained yeast display of double-chain antibody patents for Dyax, attracting more interest in licensing program*
- Obtained patents covering the production of any therapeutic protein in the milk of any transgenic mammal for Genzyme*
- Obtained patent covering BTG’s CroFab® antibody product, using appeal to the PTAB, appeal to the Federal Circuit, and a § 145 action to obtain patent used in litigation to delay competitor and obtain royalty*
- Obtained patents covering Dyax’s Takhzyro® antibody product*
- Obtained patents covering GTC Biotherapeutic’s ATryn® transgenic product*
- Obtained patents covering rebaudiosides contained in Bestevia® and related methods for Conagen*
- Obtained RNAi patents for Dicerna targeting a competitor, leading to a favorable cross-licensing deal*
- Coordinated Alnylam’s prosecution of lipid nanoparticle patents asserted in litigation* against COVID-19 vaccines*
- Served as an expert on US patent law in several EPO opposition proceedings*
*Denotes experience prior to joining Goodwin
- Lead counsel in two IPRs defending BTG International’s patent covering its CroFab® antibody product. Obtained termination of first IPR via favorable settlement and denial of institution of subsequent IPR filed by second petitioner*
- Lead counsel in four IPRs defending four Cold Spring Harbor Laboratory patents relating to short hairpin RNA (shRNA). Obtained denial of institution of all four IPRs, preserving Cold Spring Harbor’s widely licensed shRNA patent portfolio*
- Represented Straumann in two IPRs challenging Zircore’s patents regarding dental prosthetics and systems for manufacturing them, resulting in favorable settlement*
- Lead counsel in patent interference for Dyax against Adimab relating to yest display of antibodies. Invalidated Adimab’s patent and obtained patent to same invention for Dyax by proving 11 months of diligence*
- Lead counsel in patent interference for Barber Foods, successfully prevailing against Best Foods division of Unilever for deriving patent from collaboration with Barber Foods*
- Backup counsel for TKT in the first ex vivo gene therapy interference, leading the final settlement negotiations of this 5-way interference*
*Denotes experience prior to joining Goodwin
- Obtained Patent Term Extension for Organon’s Domitor® (medetomidine)*
- Obtained Patent Term Extension for Organon’s Anitisedan® (atipamezole hydrochloride)*
- Obtained Patent Term Extension for Shire’s Elaprase® (idursulfase)*
- Obtained Patent Term Extension for GTC’s ATryn® (Antithrombin (Recombinant))*
- Consulted on Patent Term Extension strategy for Lantheus’s Ablavar® (gadofosveset trisodium)*
- Consulted on Patent Term Extension strategy for Dyax’s Kalbitor® (ecallantide)*
- Obtained Patent Term Extension for Dyax’s Takhzyro® (lanadelumab-flyo)*
- Consulted on Patent Term Extension strategy for LFB’s Sevenfact® (coagulation factor Vila (recombinant)-jncw (eptacog beta))*
*Denotes experience prior to joining Goodwin
- Led IP diligence and drafting regarding Merck KGaA’s $780 million acquisition of Exelead, a CDMO focusing on lipid nanoparticle formulations*
- Led IP diligence, negotiations, and drafting regarding the $475 million sale of a controlling interest by Compagnie Générale des Établissements Michelin SCA in its Solesis biomaterials subsidiary to Altaris Capital Partners*
- Led IP diligence and drafting regarding Cleveland Clinic’s $33 million series B equity investment in Centerline Biomedical*
- Led IP diligence and drafting regarding Mullen Automotive’s $148.2 million acquisition of a controlling interest in Bollinger Motors*
- Led IP diligence, negotiations, and drafting regarding Portage Biotech’s acquisition of Tarus Therapeutics*
- Led IP diligence, negotiations, and drafting regarding Pasithea Therapeutics’ acquisition of Alpha-5 Integrin LLC*
- Led IP diligence, negotiations, and drafting regarding Pasithea Therapeutics’ acquisition of Alpha-5 Integrin LLC*
- Represented Ginkgo Bioworks regarding IP aspects of synthetic biology Collaboration Agreement with Amyris valued at over $300 million*
- Led IP diligence for Ginkgo Bioworks regarding synthetic biology cannabinoid Partnership Agreement with Cronos Group valued at $100 million*
- Defended IP diligence for Ginkgo Bioworks regarding bioindustrial strain improvements in support of Collaboration Agreement with Cargill*
- Defended IP diligence for Ginkgo Bioworks in support of $100 million Series A launch of Joyn Bio agricultural synthetic biology joint venture with Bayer*
- Defended IP diligence for Ginkgo Bioworks in support of $90M Series A launch of Motif FoodWorks*
- Defended IP diligence for Dyax in acquisition by Shire valued at $6.5 billion*
- Supported all aspects of Dyax’s Licensed and Funded Research Program, one of the most widely licensed biotechnology patent portfolios, with projected milestones and royalties of several hundred million dollars per year*
*Denotes experience prior to joining Goodwin
- Represented BTG in ITC litigation against Bioclon regarding Fab compositions targeting snake venoms, delaying competitor from entering the market and obtaining royalty upon competitor’s launch*
- Defended Straumann in patent litigation asserted by Zircore regarding dental prosthetics and systems for manufacturing them, resulting in favorable settlement*
- Defended Straumann in patent litigation asserted by D’Alise regarding dental components, resulting in favorable settlement*
- Represented Citius in Hatch-Waxman litigation against Zydus regarding phentermine formulation*
- Represented Cold Spring Harbor Laboratory in patent litigation against Invitrogen regarding CSHL’s deoR- E. coli cell lines*
- Represented Wyeth in Hatch-Waxman litigation against Teva regarding venlafaxine*
- Defended Immunex in patent litigation asserted by ZymoGenetics regarding fusion proteins*
- Defended Organon in International Chamber of Commerce arbitration proceeding asserting infringement of patent regarding GnRH antagonist*
- Defended SmithKline Beecham in patent litigation asserted by Connaught regarding OspA, the active ingredient in Lyme disease vaccine*
- Defended SmithKline Beecham in patent litigation asserted by Connaught regarding the purification of pertactin, an active ingredient in DTP vaccine*
*Denotes experience prior to joining Goodwin
Areas of Practice
Professional Activities
- American Intellectual Property Law Association – PTAB Trial Committee
- Boston Patent Law Association
- Juvenile Diabetes Research Foundation (JDRF)
- New England Chapter, Corporate Development Committee, 2022-present
- New England Chapter, Nominating and Governance Committee, 2018 – 2022
- New England Chapter, Board of Directors, 2013 – 2016
- Diabetes Innovation Fund, Board of Directors, 2011-2012
Professional Experience
Prior to joining Goodwin, Michael was a partner at McDermott Will & Emery. Previously, he was chair of the practice group leaders and co-chair of the Biotechnology practice group of a large intellectual property law firm.
Credentials
Education
JD1995
Boston University School of Law
(concentration in Intellectual Property, with Honors)
BSBiology1990
Bates College
Admissions
Bars
- Massachusetts
- District of Columbia
Courts
- Federal Circuit Court of Appeals
- U.S. Patent and Trademark Office
Recognition & Awards
- IAM Patent 1000 – The World’s Leading Patent Practitioners, 2022 – 2024
- Legal 500 USA, Recommended Lawyer, 2022 – 2023
- Massachusetts Super Lawyer – Intellectual Property, 2011 – 2019
- Boston University Journal of Science & Technology Law, Articles Editor
- National Science Foundation, Research Experiences for Undergraduates Award
Publications
Michael’s representative publications include:
- Lead Author, “Patent Term Extension Strategies for Biosimilars,” Intellectual Property & Technology Law Journal, December 20, 2023
- Lead Author, “Pharma Sector Should Push Manufacturing Patents for Biologics,” Bloomberg Law, October 3, 2023
- Lead Author, “Biopharma IPR Trends,” Life Science Leader, May 11, 2017
- Lead Author, "Impact of Post-Grant Proceedings on Biologics and Biosimilars,” BioProcess International, January 19, 2017
- Lead Author, “Impact of Post-Grant Proceedings on Biologics and Biosimilars,” Bloomberg BNA · April 15, 2016
- Lead Author, “PTAB Surprises Some by Using Its Standard Operating Procedures to Assert Control of Its Case Law,” BNA’s Patent, Trademark & Copyright Journal, April 3, 2015
- Lead Author, “To Predict How the Board Will Decide Issues in Inter Partes Review Proceedings, Look to Prior Board Decisions in Contested Cases,” Bloomberg BNA February 1, 2014
- Lead Author, “Recovering Patent Life with Patent Term Extension,” BioPharma, December 1, 2013
- Lead Author, “Third Party Submissions in Pending Patents,” Today's General Counsel, March 15, 2013
- Lead Author, “Post-grant review under America Invents Act,” Intellectual Property Magazine, January 1, 2012
- Lead Author, "Post-Grant Oppositions Under Patent Reform,” Intellectual Property Watch-Inside Views, November 14, 2011
- Co-author, “Be Prepared for Biosimilars,” Managing Intellectual Property, November 1, 2010