Critical Updates in U.S. Patent Litigation: Key Cases and Strategic Implications for Pharma & Biotech

Partners:

Taft Stettinius & Hollister LLP (www.taftlaw.com)

Webinar Date: 12th November 2024 | Timings: 9:30 AM IST

Agenda:

On-Sale Bar 

Case in Focus:

• Celanese Intl Corp v. ITC

Skinny Labeling & Carve-Outs 

Cases in Focus:

• Amarin Pharma Inc. v. Hikma Pharma
• Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc  

Clinical Trial Disclosures & Patent Validity 

Cases in Focus:

• Janssen v. Teva
• Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc

Written Description Requirements 

Cases in Focus:

• Amgen v. Sanofi
• Baxalta v. Genentech
• Medytox v. Galderma

Obviousness-Type Double Patenting (OTDP) 

Cases in Focus:

• In re Cellect
• Allergan USA Inc. v. MSN Labs. Pvt. Ltd.
• Acadia Pharms v. MSN Pharms

Our Speaker:

Roshan P. Shrestha, Ph.D. (rshrestha@taftlaw.com)

Dr. Roshan Shrestha’s practice encompasses intellectual property law, including patent litigation, prosecution, and opinion work in the chemical, pharmaceutical, and electronic material arts.

Dr. Shrestha has broad litigation experience, including district court litigation, contested AIA proceedings, e.g., Re-examination and Inter Partes Review (IPR) at the Patent Trial and Appeal Board (PTAB) in the United States Patent and Trademark Office (USPTO), International Trade Commission (ITC), and appellate matters.

He has particular experience on issues arising under the Hatch-Waxman Act. He has expertise in developing strategies on issues of patentability, infringement, validity and enforceability. He has represented prominent generic and brand pharmaceutical companies at both the trial and appellate levels. He also assists with the firm’s patent counseling and IP due diligence matters. He has extensive experience performing IP due diligence as part of corporate mergers and acquisitions, analyzing patent landscape and preparing patent non-infringement and invalidity opinions.

Numerous legal publications have recognized Dr. Shrestha as a preeminent Intellectual Property lawyer. He has been recognized as a Rising Star by Super Lawyers® since 2014, as a Best Lawyers® since 2020, and as a Leading Lawyers® since 2017. Law Bulletin, the publishers of Chicago Lawyer magazine, also recognized him as one of the “Forty under 40” attorneys.

Before practicing law, Dr. Shrestha was a research scientist at Los Alamos National Laboratory in New Mexico, where his investigation of materials for hydrogen storage technology received several patents. He received his J.D. from Northwestern University School of Law and his Ph.D. from the University of North Carolina at Chapel Hill.

Stephen R. Auten (sauten@taftlaw.com)

Steve is head of Taft’s Pharmaceutical & Life Sciences Litigation practice area and a member of Taft’s Executive Committee. Steve is a widely recognized and seasoned attorney in Hatch-Waxman and biosimilar matters, including related patent litigation, and is followed by key industry leaders (brand and generic alike), law firms, analysts, educators and others on his LinkedIn blog “Hatch Waxman ANDA Litigation Forum” or HALF, which has over 14,000 members worldwide.

He currently represents clients primarily in the areas of Paragraph IV design strategies, Hatch-Waxman litigation, and biosimilar market opportunities. He is currently counsel to several leading generics, including those who are first-to-file with an ANDA with a Paragraph IV Certification, and thus eligible for 180-days of market exclusivity.

Steve earned his J.D. from the Chicago-Kent College of Law and his Bachelor of Science in chemistry from the University of Illinois at Urbana-Champaign with high distinction, authoring a senior thesis on enantiomeric separation under the supervision of Dr. William H. Pirkle, a recognized pioneer in the field. Steve is recognized by Chambers USA as a top Intellectual Property attorney in Illinois. He is also recognized by his peers in The Best Lawyers in America for IP Litigation, as an Illinois Leading Lawyer, an Illinois Super Lawyer in IP Litigation, and as a “World’s Leading Patent Practitioner” by Intellectual Asset Management magazine.