Michael Stramiello, Ph.D., is an intellectual property litigation associate in Washington, DC. His practice focuses on the life sciences industry. He has handled patent disputes before the U.S. Patent & Trademark Office's Patent Trial & Appeal Board (PTAB), U.S. District Courts, the Federal Circuit, and the American Arbitration Association (AAA). His litigation experience includes:
developing strategies on validity and infringement;
leading work with expert and fact witnesses as they prepare to provide written and oral testimony;
taking and defending expert depositions;
drafting briefs and contentions; and
second-chairing oral arguments.
Dr. Stramiello also provides strategic counseling to biotechnology clients with respect to patent portfolio development, licensing and enforcement strategies, and inventorship issues. In addition, he has experience drafting and prosecuting biotechnology patent applications. Dr. Stramiello has handled matters involving various compositions (e.g., AAV, baculoviral, and lentiviral vectors, antibodies, antibody-drug conjugates, atypical antipsychotics, cannabinoids, CAR T cells, drug discovery platforms, hormones, microfluidics, nitrogen-scavenging drugs, NMDA receptor antagonists, norepinephrine-serotonin reuptake inhibitors, oligonucleotides, opioids, phosphodiesterase type-5 inhibitors, potassium channel antagonists, prodrugs, recombinant DNA, RNA-guided nucleases, selective serotonin reuptake inhibitors, thrombin inhibitors, vaccines, and virus-like particles), routes of administration (e.g., epicutaneous, injectable, oral, and sublingual), and methods (e.g., additive manufacturing, disease treatment, genome editing, protein purification, and transfection).
During law school, Dr. Stramiello trained in examination of biotechnology patent applications at the United States Patent & Trademark Office, externed at the U.S. District Court for the Northern District of Alabama, and worked as a commercialization analyst at the University of Alabama Office for Technology Transfer, where he analyzed invention disclosures, identified licensing opportunities, and assisted in contract negotiations. Before law school, he conducted graduate research on learning and memory disorders. His work involved pharmacological and electrophysiological characterizations of dopaminergic, GABAergic, glutamatergic, and serotonergic activity in the hippocampus.
Accolades and Recognitions
Certificate in Biologic Therapeutic Drug Development, University of Wisconsin-Madison Division of Pharmacy Professional Development, 2020
ABA Section of IP Law Recognition of Outstanding Leadership, 2018
Capital Pro Bono High Honor Roll, 2016
Bert W. Levit Essay Award for innovative research and writing in lawyers' professional liability, 2013
ABA-BNA Award for Excellence in the Study of IP Law, 2013
CALI Excellence for the Future Award for highest grades in Litigation Drafting, 2011
ARCS Award for accomplishment in biomedical research, 2009
UGA Dissertation Completion Award for academic performance, research achievement, and community service, 2009
Full-tuition academic scholarships for undergraduate, graduate, and legal education
University of Alabama School of Law, J.D.
University of Georgia, Ph.D.
University of Georgia, B.S. (cum laude)
Quoted, on how biotechnology startups can protect their IP, byLabiotech, July 19, 2021.
Deputy Editor-in-Chief. Landslide® magazine, ABA Section of Intellectual Property Law, Volume 13, 2020-2021.
Acquisitions/Intake Editor. Landslide® magazine, ABA Section of Intellectual Property Law, Volume 12, 2019-2020.
Sole author. "What Proposed PTAB Rule Change Means for Patent Owners," Law360, June 12, 2020.
Lead Issue Editor. Landslide® magazine, ABA Section of Intellectual Property Law, Volume 12, Issue 2, Nov./Dec. 2019.
Sole author. "Reflections on the § 315(a) Bar in Light of New PTAB Precedent," Lexology, Sept. 3, 2019.
Quoted, on proposed motions in the second Broad v. UC interference proceeding regarding CRISPR-Cas9, bySTAT, July 31, 2019.
Quoted, on a petition to the USPTO seeking a parallel interference proceeding on the use of CRISPR-Cas9 in eukaryotes, byLaw360, July 25, 2019.
Panelist, on trends driving change in biopharmaceutical innovation, hosted by PhRMA in Washington, DC, Apr. 29, 2019.
Quoted, on proxy-CRISPR and navigating the evolving CRISPR IP landscape, bySTAT, Feb. 19, 2019.
Lead Issue Editor. Landslide® magazine, ABA Section of Intellectual Property Law, Volume 11, Issue 2, Nov./Dec. 2018.
Quoted, on what the UC v. Broad interference outcome means for companies looking to access CRISPR IP, byBioCentury, Oct. 4, 2018.
Quoted, on the outcome of the UC v. Broad CAFC appeal regarding CRISPR-Cas9, byBloomberg,Law360,BioCentury,National Law Journal,New York Law Journal,The Recorder,IP Wire,Farm Futures, andBloombergQuint. Sept. 10-11, 2018.
Quoted, on a petition for PGR regarding CRISPR-Cpf1, bySTAT. July 17, 2018.
Coauthor. "Key Takeaways on Changing Claim Construction Standards at the PTAB," Bloomberg Law, June 19, 2018.
Coauthor. "USPTO Proposes Changing Claim Construction Standard for IPRs, PGRs, and CBMs," Lexology, May 10, 2018.
Quoted, on oral arguments in the UC v. Broad CAFC appeal regarding CRISPR-Cas9, byBloomberg,STAT,The Scientist,BioCentury,The Mercury News,The National Law Journal,KQED (San Francisco NPR affiliate),East Bay Times,Santa Cruz Sentinel,California Healthline,BloombergQuint,Monterey County Herald,The Reporter,Chico Enterprise-Record,Red Bluff Daily News,Daily Democrat,Vallejo Times-Herald,Oroville Mercury Register, andEureka Times-Standard. Apr. 29-May 3, 2018.
Coauthor. "A Divided Supreme Court Upholds Inter Partes Review's Constitutionality but Constrains the Patent Office's Authority," Lexology, Apr. 25, 2018.
Sole Author. "CRISPR: The New Frontier in Biotechnology Innovation," Landslide® magazine digital feature, Feb. 14, 2018.
Lead Author. "Learning the Ropes of PTAB Depositions," Boston Patent Law Association Newsletter, Feb. 14, 2018.
Quoted, on revocation in the Broad EPO opposition proceeding regarding CRISPR-Cas9, byLaw.com's Skilled in the Art briefing, Jan. 22, 2018.
Lead Issue Editor. Landslide® magazine, ABA Section of Intellectual Property Law, Volume 10, Issue 3, Jan./Feb. 2018.
Lead Author. "Navigating a PTAB Deposition," BNA's Patent, Trademark & Copyright Journal, Dec. 1, 2017.
Lead Author. "Planning for a PTAB Deposition," BNA's Patent, Trademark & Copyright Journal, Oct. 27, 2017.
Speaker. "Life Sciences at the PTAB: Statistics and Insights," Paul Hastings CLE Program, June 15, 2017.
Coauthor. "PTAB Upholds Acorda's Ampyra® Patents, Rejecting Challenges Based on Inventors' Own Work," Lexology, Mar. 15, 2017.
Lead Issue Editor. Landslide® magazine, ABA Section of Intellectual Property Law, Volume 9, Issue 4, Mar./Apr. 2017.
Coauthor. "Give Your PTAB Record the Nutrition It Needs to Fight for You: Techniques for Discovery and Success Before the PTAB and the Federal Circuit," AIPLA Mid-Winter Institute, Feb. 3, 2017.
Lead Author. "Use of PTAB Decisions in District Court Litigation," IP Watchdog, Sept. 18, 2016.
Coauthor. "Five Years In: The AIA's Effects on Patent Litigation," Bloomberg Big Law Business, Sept. 8, 2016.
Lead Issue Editor. Landslide® magazine, ABA Section of Intellectual Property Law, Volume 8, Issue 6, July/Aug. 2016.
Coauthor. "Some Fed. Circ. Guidance on Procedural Safeguards for PTAB," Law360, June 30, 2016.
Coauthor. "Federal Circuit Provides Guidance on the APA's Procedural Safeguards for PTAB Proceedings," Lexology and myCorporateResource.com, June 16, 2016.
Lead Author. "More Rule Changes for PTAB Proceedings," Lexology, Apr. 5, 2016.
Coauthor. "Navigating the Limitations on Discovery in AIA Post-Grant Proceedings," Buffalo Intellectual Property Law Journal, Dec. 3, 2015.
Lead Author. "Important Things You Should Know about the Patent Office's New Guidance Regarding PTAB Proceedings," Lexology and myCorporateResource.com, Aug. 26, 2015.
Coauthor. "Impact of America Invents Act on Biotech Intellectual Property," Cold Spring Harbor Perspectives in Medicine, Apr. 28, 2015.
Coauthor. "Introduction to Intellectual Property: A U.S. Perspective," Cold Spring Harbor Perspectives in Medicine, Mar. 27, 2015.
Coauthor. "2013 Patent Law Decisions of the Federal Circuit," American University Law Review, June 23, 2014.
Lead Author. "Momenta Pharms., Inc. v. Amphastar Pharms, Inc.," AIPLA Biotech Buzz, Aug. 15, 2012.
Chapter Editor (Student). Annual Review of Intellectual Property Law Developments 2011, American Bar Association, 2012.
Coauthor. "Transgenic Mouse Model for the Formation of Hirano Bodies," BMC Neuroscience, Oct. 6, 2011.
Lead Author. "Cocaine Enhancement of Long-Term Potentiation in the CA1 Region of Rat Hippocampus: Lamina-Specific Mechanisms of Action," Synapse, Aug. 2010.
Lead Author. "D1/5 Receptor Mediated Enhancement of LTP Requires PKA, Src Family Kinases, and NR2B-Containing NMDARs," Neuropharmacology, July 3, 2008.
Coauthor. "Postsynaptic Dopamine D3 Receptor Modulation of Evoked IPSCs via GABAA Receptor Endocytosis in Rat Hippocampus," Hippocampus, Jan. 31, 2008.
Coauthor. "The Effects of Extinction Training in Reducing the Reinstatement of Drug-Seeking Behavior: Involvement of NMDA Receptors," Behavioural Brain Research, Aug. 6, 2007.
Landslide® Magazine Board: served as Deputy Editor-in-Chief (2020-present), Acquisitions/Intake Editor (2019-2020), Issue Editor (2015-2018), and Column Editor (2012-2014)
PTAB Bar Association: Selected for Law Journal Editorial Board (2019-present); appointed as Vice Chair of the Program Committee (2019-present), as one of seven members of the Nominations Committee (2018 & 2019), and as Chair of the Young Lawyers & Agents Committee (2016-2017)
Law360: Selected for Life Sciences Editorial Advisory Board (2017)
Daiichi Sankyo, in pursuing multiple PGRs against Seagen
Daiichi Sankyo, in declaratory judgment action against Seagen
Alkermes Pharma, in ANDA litigation
Global pharmaceutical company, in arbitration regarding biotechnology IP
BioMarin Pharmaceutical, in strategic counseling regarding biotechnology IP
Alkermes Pharma, in defending against an IPR filed by Amneal
Bluebird Bio, in strategic counseling regarding biotechnology IP
Adamas Pharmaceuticals, in ANDA litigation
Insys Therapeutics, in ANDA litigation
Sunovion Pharmaceuticals and Sumitomo Dainippon Pharma, in defending against an IPR filed by Par Pharmaceutical
Horizon Therapeutics, in an appeal to the Federal Circuit regarding an IPR final decision
BioMarin Pharmaceutical, in multiple appeals to the Federal Circuit regarding interference decisions
Acorda Therapeutics, in defending against multiple IPRs filed by Coalition For Affordable Drugs (ADROCA)
Helsinn Healthcare, in defending against multiple PGRs and IPRs filed by Dr. Reddy's Laboratories
Insys Pharma, in defending against multiple IPRs filed by Coalition For Affordable Drugs XI
AbbVie, in asserting multiple patents against Centocor
Eli Lilly & Company, in pursuing multiple IPRs against LA BioMed
Note: this is a partial list.