Stevens, Lauren L.
Global Patent Group
Executive Summary
The primary focus of my legal practice is to develop and implement global IP strategies with an emphasis on obtaining strong patent protection, assessing third party patent estates, and resolving potential issues related to enforceability, patentability, and validity.
- Extensive experience with approved drug products, including KEVEYIS®, CAMBIA®, INGREZZA®, ONGENTYS®, ORLISSA®, DUEXIS®, RAYOS®, VIMOVO®, PENNSAID® 2%, RAVICTI®, KRYSTEXXA®, ACTIMMUNE®, PROCYSBI®, and BELVIQ®, and many drugs prior to FDA approval, including roxadustat, etrasimod, ralinepag, temanogrel, tirasemtiv, and omecamtiv mecarbil.
- Strategic management of patent portfolio. Procured U.S. and foreign patents with an emphasis on small molecule pharmaceutical chemistry. Prepared Orange Book listability, patentability, validity, and infringement analyses and FDA patent listing forms.
- Oversight of US ANDA litigation, including document discovery, depositions, and trial strategy.
- Participated in >10 inter partes review proceedings, including drafting patent owner preliminary responses and patent owner responses, resulting in 6 denials of institution, 4 positive final written decisions, and 1 loss.
- Supervised IP legal due diligence for numerous financing, acquisitions and licensing transactions.
- Lecturer on practical aspects of chemical and pharmaceutical U.S. patent practices. Co-originator and instructor for the Patent Resources Group courses on Orange Book listing and strategies for inter partes review in the pharma context.
More than 25 years experience, including extensive corporate experience as a senior executive and general counsel.
Ph.D. in Organic Chemistry from Yale University; J.D. from Stanford University.
State Bar of California; 1992
U.S. Patent and Trademark Office; 1992