Stefan M. Miller
Overview
Stefan Miller is a partner in the Intellectual Property Practice Group in Kirkland’s New York office. His practice focuses on patent litigation and counseling in the pharmaceutical, chemical and biochemical arts. He has extensive experience in all aspects of litigation including pre-litigation investigations, fact and expert discovery, depositions, oral argument, technical reports and analysis, Markman and summary judgment proceedings, brief writing and trial before the Patent & Trademark Office, ITC, and Federal District Courts. Stefan has also been a primary drafter of over fifty technical expert reports in a variety of technological fields including small-molecule compositions and formulations, biologics (including CAR-T technology), medical devices, and recombinant DNA technology. As part of his practice, he works closely with leading experts to scour the literature, identify the soundest technical foundations of a case, and ultimately “translate” complex scientific theories into simple, compelling themes resonating with judge and jury. Stefan has further advised on FDA regulations, including company best practices for regulatory compliance, import/export provisions for drugs and biologics, as well as FDA certification standards.
Stefan utilizes his first-hand experience with the prosecution of patent applications, bringing with him an inside look at the back and forth between patent applicant and the USPTO. Using his several years of prior patent prosecution and counseling experience, Stefan discovers weaknesses in patent families. When defending a client’s patents, he identifies the best defenses in protecting a client’s intellectual property, and when on the attack, leverages his insight into a patent’s file history to muster the best offense. He also routinely conducts expansive freedom-to-operate and other IP due diligence projects.
Stefan has an in-depth and broad-ranging technical background across several fields. He earned a Ph.D. in organic chemistry from Yale University, where he researched the synthesis of small-molecule drugs with applications in oncology, and has extensive experience in several additional technical fields during his past decade-plus of legal work.
Experience
Representative Matters
Recent Representative Matters
- Representing Microspherix in patent litigation involving Merck’s implantable contraceptive Nexplanon (etonogestrel implant); successfully defended client’s patent estate in Inter Partes Review proceedings before the USPTO
- Representing pharmaceutical company in potential litigation over blockbuster follow-on neurological drug
- Representing pharmaceutical company in arbitration proceedings regarding licensed patent estate for several blockbuster cancer drugs
- Represented Teva in ANDA patent litigation involving generic formulation of Entereg (alvimopan), a mu-opioid antagonist
- In collaboration with Kirkland’s Shanghai office, counseled Chinese pharmaceutical and organic food companies to provide U.S. regulatory compliance advice
- As part of his pro bono work, successfully obtained COM approval for Afghani-translator’s SIV application on appeal; currently representing inmate in criminal appeal to the New York Appellate courts
Other Representative Matters
- Represented AbbVie on technical analysis and due diligence for its $63 billion acquisition of Allergan
- Represented Impax Laboratories and AstraZeneca in ANDA patent litigation that resulted in a finding of infringement and patent validity of client’s patents directed to Zomig (zolmitriptan), a top-selling intranasal migraine drug
- Represented Pfizer in ongoing inter partes reviews (IPRs) of Genentech patents directed to various monoclonal antibody therapies including the breast cancer drug Herceptin (trastuzumab); obtained rare full reversal of PTAB denial leading to institution of all claims of challenged patent
- Represented Abbott in a complex multi-defendant action in the District of Delaware, in which plaintiff alleges infringement of patents related to DNA/RNA probes and fluorescent in situ hybridization “FISH” technology
- Represented Teva and Watson in ANDA patent litigation involving the blockbuster erectile dysfunction drug, Cialis
- Represented Teva in ANDA patent litigation involving an extended-release formulation of Trokendi XR (topiramate), an anti-seizure medication
- Represented Butamax Advanced Biofuels in multiple patent infringement actions, both as plaintiff and as defendant, relating to the production of the biofuel isobutanol using recombinant yeast DNA technology
- Represented client in successful, confidential arbitration proceeding involving potential blockbuster cancer drug
- Represented Baxter Int’l in ITC proceeding through trial and to favorable settlement against Ethicon and Ferrosan involving patents for hemostatic matrix compositions
- Represented large pharmaceutical company in contract dispute requiring technical analysis of immuno-oncology drug pipeline products
- Represented Gilead Sciences in ANDA patent litigation involving the anti-flu drug Tamiflu (oseltamivir phosphate)
- Represented pharmaceutical company in Citizen Petition to the FDA involving biosimilars
- Represented Pfizer in ANDA patent litigation involving Zyvox, a first-in-class antibiotic treating resistant bacterial infections
- Counseled clients and performed due diligence/technical analysis relating to patents and transactional matters for drug compositions and formulations including small-molecule drugs, antibodies and biologics, immune checkpoint regulators and immunomodulators, chimeric antigen receptor (CAR) T-cell technology, controlled-release compositions and delivery forms, antibiotics, PEGylated drugs, hematological agents, CNS drugs, nootropics and racetams, diabetes drugs, pain medications and neuropathic agents, nutraceuticals, vitamins and other supplements, as well as recombinant DNA and gene assembly technologies
- Drafted and successfully prosecuted numerous applications to issuance before the USPTO in the medical technology, biotechnology, pharmaceutical and biologics fields and worked in conjunction with foreign counsel to obtain the issuance of counterpart foreign applications in multiple jurisdictions
Prior Experience
Stefan was previously an associate at the New York office of Kaye Scholer LLP and has been a registered patent agent/attorney since 2005.
More
Thought Leadership
Publications
“Post-Grant Review of Patents: A Primer” by Stefan Miller and Greg Springsted in J Commer Biotechnol, August 2016
“Staking an Advantage in an AIA World: Practical Patent Tips for Biotechnology Companies” in J Commer Biotechnol, July 2014
"The Golden Rule of Biological Inventions and the Written Description Requirement” in Patent Strategy & Management, 2009
“Parallel Imports: Towards a Flexible Uniform Rule” in Journal of Commercial Biotechnology, 2009
Book Review: "Intellectual Property and Biotechnology: Biological Inventions" by Matthew Rimmer in J Commer Biotechnol, 2008
“Aggressive Intellectual Property Strategies” by Stefan Miller and Eugene Rzucidlo in Best Practices in Biotechnology Business Development, ed. Yali Friedman, Logos Press, 2008
“IP Branding: Adding Value to a Business” by Stefan Miller in Patent Strategy & Management, April 2007 and reprinted in The Intellectual Property Strategist, 2007
“Lessons from Purdue: Patent Practitioner Tips for Avoiding Inequitable Conduct Claims” by James DeZazzo and Stefan Miller in Patent Strategy & Management, 2006
“The Diastereoselective Pauson-Khand Cyclization of N-O, N-N Tethered Enynes and Progress Towards the Total Synthesis of the Axinellamines,” Yale University, 2005
“Amides and Derivatives; Polyamides and Peptides; Lactams; Synthesis from Aldehydes, Ketones and Derivatives” by Stefan M. Miller and David J. Austin in Science of Synthesis, 2005
“A Transient N-O Linked Pauson-Khand Strategy for the Synthesis of the Deschloro Carbocyclic Core of the Palau’amines and Styloguanidines” by Stefan Koenig, Stefan M. Miller et al. in Organic Letters, 2003
Press Mentions
"PTAB Reverses Course, Institutes Review Of Herceptin Patent," Law360, October 30, 2017
“Abbott Wins In Patent Case Over DNA Tech,” Chicago Daily Law Bulletin, August 23, 2017
“Lilly Settles Cialis Generic Patent Suit, Cuts Exclusivity,” Law360, July 13, 2017
“Impax, AstraZeneca Get Win In Generic Zomig Patent Case,” Law360, April 3, 2017
Seminars
“21st Century Therapies: Biologics and Biosimilars,” by Leora Ben-Ami, Patricia Carson, and Stefan Miller, Seminar, Kirkland & Ellis LLP, January 2016
“Recent Developments in BPCIA Suits,” by Amanda Hollis, Jeanna Wacker, Elizabeth Cutri, Stefan Miller, and James McConnell, Seminar, Pfizer Global IP Conference, May 2017
Recognition
Member of the Editorial Board, Journal of Commercial Biotechnology
Credentials
Admissions & Qualifications
- 2009, New York
- Registered to practice before the United States Patent and Trademark Office
Courts
- United States Court of Appeals for the Federal Circuit
Education
- New York University School of LawJ.D.2008
Intellectual Property Law Award
Full Tuition Scholarship
- Yale UniversityPh.D., Organic Chemistry2005Prize Teaching Fellow Award
- University of Texas at AustinB.S., Chemistrycum laude2000
Hoechst-Celanese Outstanding Chemistry Student
Full-Tuition Scholarship
National Merit Scholar