Recent Cases and Trends in U.S. Patent Litigation
Agenda
Issue:
The Supreme Court’s denial of certiorari leaves standing the Federal Circuit’s obviousness ruling and its stringent “nexus” framework for secondary considerations.
Issue:
The Federal Circuit found “clinically proven effective” to be non-limiting, affirming obviousness for dosage regimen claims — potentially limiting the use of post hoc clinical data to support patentability.
Issue:
A precedential holding that after-arising technologies need not be described or enabled to fall within valid claim scope.
Issue:
Biogen was ordered to pay over $88 million in royalties for post-expiration sales, highlighting royalty obligations after patent expiry.
Issue:
The Delaware court denied transfer to New Jersey — a venue decision with strategic implications for ANDA litigation.
Issue:
The Federal Circuit’s narrow interpretation of “not an [element]” provides fresh guidance on claim construction and negative limitations.
Issue:
A consent judgment enjoined launch until patent expiry, with damages waived for pre August 2025 sales — a case study in negotiated remedies.
Issue:
The court granted judgment of non-infringement — a landmark skinny-label decision on inducement liability.
Our Speakers
DR. ROSHAN P. SHRESTHA
Dr. Roshan Shrestha specializes in patent litigation, prosecution, and IP counselling, particularly in pharmaceuticals, biosimilars, biotechnology, and chemical products. He has extensive experience in district court litigation, AIA proceedings (including IPRs), and appellate practice.
He has represented leading pharmaceutical companies in Hatch-Waxman litigations involving Vyvanse, Lyrica, Yaz, Nexium, Xarelto, and more.
Before law, Roshan worked as a research scientist at Los Alamos National Laboratory, earning patents in hydrogen storage technology.
He holds a Ph.D. in Chemistry from the University of North Carolina at Chapel Hill and a J.D. (cum laude) from Northwestern University. Recognized by Super Lawyers since 2014 and Leading Lawyers since 2017, he was also named one of “40 Illinois Attorneys Under 40 to Watch.”
STEPHEN R. AUSTEN
Steve leads Taft’s Pharmaceutical & Life Sciences Litigation practice area and is a widely recognized authority in Hatch-Waxman and biosimilar patent litigation. His practice focuses on Paragraph IV design strategies, Hatch-Waxman litigation, and biosimilar market opportunities.
He represents several leading generics, including first-to-file ANDA filers eligible for 180-day exclusivity. His current cases involve generic versions of ANGIOMAX®, AXIRON®, BELVIQ®, DALIRESP®, ELIQUIS®, FANAPT®, JEVTANA KIT®, KYPROLIS®, POMALYST®, STIVARGA®, TEFLARO®, VIIBRYD®, XARELTO®, and XELJANZ®.
A frequent author and editor of leading legal publications such as Pre-ANDA Litigation and ANDA Litigation: Strategies & Tactics, Steve has also contributed to Evidence in Patent Cases (Bloomberg BNA, 2019). He authors the LinkedIn blog “Hatch Waxman ANDA Litigation Forum (HALF)”, followed by over 14,000 members worldwide.
Before joining Taft, he served as Vice President and Head of Intellectual Property for North America at Sandoz Inc., where he was instrumental in shaping company strategy and achieving top litigation outcomes.
Steve is recognized by Chambers USA as a top IP attorney and has received distinctions from Best Lawyers in America, Illinois Leading Lawyers, Super Lawyers, and IAM Patent 1000.