Stefan M. Miller

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 and appellate review by the Federal Circuit
• Representing individual inventor in 11-year, multi-district patent litigation involving video laryngoscopes
• Representing pharmaceutical company in a “bet-the-company” patent & contract litigation alleging billions in damages
• Representing pharmaceutical company in appellate proceedings before the USPTO and pre-litigation strategy
• As part of his pro bono work, Stefan recently led a trial team in the Manhattan Criminal Court to successfully secure the immediate release of an inmate by way of a writ of habeas corpus

Other Representative Matters

• Representied 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
• 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 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 alleged 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
• In collaboration with Kirkland’s Shanghai office, counseled Chinese pharmaceutical and organic food companies to provide U.S. regulatory and FDA compliance advice
• 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

Stefan was previously an associate at the New York office of Kaye Scholer LLP and has been a registered patent agent/attorney before the USPTO since 2005.