MaryAnne Armstrong, Ph.D.

Partner

Birch, Stewart, Kolasch & Birch, LLP
Suite 100 East
8110 Gatehouse Road
Falls Church, VA 22042
USA
Telephone: +1-703-205-8000
Facsimile: +1-703-205-8050
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MaryAnne Armstrong has a bachelor’s degree in biochemistry from the Pennsylvania State University and a Ph.D. in biochemistry, with a master’s degree in immunology, both from Cornell University. Dr. Armstrong worked as a post-doctoral fellow in the Laboratory of Experimental Immunology, National Cancer Institute, NIH. She has practiced in the intellectual property field since 1995, working with both large and small companies and universities, for the preparation and prosecution of patent applications in the fields of immunology, pharmaceutical chemistry, biotechnology, vaccines, therapeutic antibodies, organic chemistry, assay and drug screening systems, medical devices and plant patents.

Dr. Armstrong is experienced in post-grant procedures, including inter partes review and interference practices. Dr. Armstrong successfully represented a third party requestor in the inter partes reexamination invalidation of a patent through the Court of Appeals for the Federal Circuit (CAFC) and successfully represented the petitioner in the invalidation of three biologics patents in IPR proceedings. Dr. Armstrong has considerable experience in counseling clients with regard to FTO opinions, based on infringement and/or validity analysis, as well as counseling clients with regard to patentability analyses and the preparation of license agreements and collaboration agreements. She is also experienced in FDA related procedures, including ANDAs and requests for Patent Term Extension.

Dr. Armstrong lectures around the world on patent and FDA matters and was named a Life Science Star by LMG Life Sciences in 2012, 2013 and 2015, an IP Star by Managing IP in 2013, 2014, 2015 and 2016, and a WIPR Leader in 2016 and 2017. She is the past Chair of the Chemistry & the Law (CHAL) Division of the American Chemical Society (ACS), and is currently a member of the CHAL Executive Committee and on the editorial board of Life Sciences IP Review.

Articles & Presentations

Speaking Engagements & Recognitions

Representative Matters

  • Genzyme Therapeutic Products Ltd. v. BioMarin Pharmaceutical Inc. [IPR Nos. 2013-00534 and -00537] 119 USPQ2d 1022 (Fed. Cir. 2016) – Enzyme Replacement Therapy for Pompe Disease
  • BioMarin Pharmaceutical, Inc. v. Duke University, IPR2013-00535 (PTAB 2015) – Enzyme Replacement Therapy for Pompe Disease
  • Chemi v. Kappos amd Fidia, Appeal No. 2010-1514, (Fed. Cir. 2011) – Process for purifying phosphatidylserine