Biologics litigation is evolving beyond classic biosimilar disputes, driven by higher-value products, an uptake in branded-vs-branded disputes, and growing injunction risk. This session brings together leading litigators and in-house counsel to examine how strategy is changing.
- How biologics disputes are starting earlier and outside traditional biosimilar timelines, (e.g. Novo Nordisk v. Eli Lilly), and what this means for launch and portfolio strategy.
- Examine the rise of branded-vs-branded cases like Alnylam Pharmaceuticals, Inc. v. Moderna, Inc., and how innovator enforcement and defence strategies are adapting.
- Review recent BPCIA cases and outcomes, including Hikma/Richter v. Amgen.
- Consider parallel proceedings in Europe and other jurisdictions and examine how they’re increasingly shaping U.S. biologics litigation decisions.
Alex Gloor
Nicole Clouse
Katie Nolan Stevaux
Arshad Jamil
Arshad Jamil is a senior Patent Attorney with extensive experience of more than 2 decades in the legal and IP rights fields. Arshad is the Chief IP counsel and Global head of IP rights at Biocon Biologics, where he is responsible for devising IP strategy and handling Global Patent litigation for Biosimilars and the Biocon Group’s patent and trademark filings and policy. Arshad manages Biocon group of companies IP portfolio of 1100+ global patents and 950+ global trademarks.
In his previous assignment, Arshad was a Senior Patent Attorney at Sun Pharma, where he handled ANDA litigations, including Hatch Waxman settlements. Arshad is an Engineer turned lawyer and have Bachelor of engineering (B.E.), Bachelor of Laws(LL.B.) and executive MBA degrees to his credit. Arshad is a distinguished speaker at National /International IP forums and recognised by IAM as The World’s leading IP strategists consecutively for 5 years 2017 , 2018, 2019, and 2020 and 2021 editions of IAM strategy 300.
Stan Fisher
Stan Fisher is a first-chair trial lawyer and counselor who focuses his practice primarily on issues that affect technology companies. Stan has tried numerous cases involving patent, FDA, and antitrust issues, as well as matters involving contracts, licensing, and business torts.
Stan has been consistently ranked as an “IP Star” by Managing Intellectual Property (2021-2024); and LMG Life Sciences Guide recognized him as a “Leading Life Science Star” since 2021. In 2022, LMG Life Sciences identified Stan among the finalists for the “General Patent Litigator of the Year (DC Metro)” award, and in 2023, he was a recognized as a finalist for “Hatch-Waxman Litigator of the Year (Branded)." IAM Patent 1000 has highlighted Stan as a “Leading Patent Litigation Attorney” in its guide since 2020. The 2020 publication noted Stan has “broad horizons as a trial lawyer and litigates with confidence and poise in diverse technical fields, across all areas of intellectual property and in regulatory, antitrust and contract disputes” and the 2022 edition emphasizes Stan’s standing as a “leading trial lawyer.” Both in September 2022 and May 2021, The American Lawyer recognized Stan as a “Litigator of the Week Runner Up” for successfully representing Merck in a major trial victory and IPR proceedings, respectively, concerning patents covering the blockbuster sitagliptin products: Januvia, Janumet, and Janumet XR.
In addition to Stan’s patent practice, he serves as Co-Chair of the firm’s Food and Drug Administration practice group. In this space, he focuses specifically on the intersection of FDA law, patent law, and antitrust law, advises on issues with the Orange Book, regulatory exclusivities, and other issues that are adjunct to pharmaceutical and biotech patent litigation. Stan’s experience litigating matters involving the FDA has been highlighted by IAM Patent 1000 with the publication describing Stan as a “top” FDA lawyer. The 2021 edition highlighted Stan's "vast biopharmaceutical experience” and explained that he “makes full use of his finely honed advocacy skills and intuitive understanding of Food and Drug Administration regulatory requirements and antitrust law." He also has an active practice litigating trade secrets, trademarks, and copyrights.
Stan serves as Professorial Lecturer in Law at The George Washington University Law School, where he teaches Chemical & Biotech Patent Law, a course Stan recently re-designed to focus on patent, regulatory, and antitrust issues arising in Hatch-Waxman, BPCIA, and other pharmaceutical and biotechnology patent matters.
Stan received his B.S. in Molecular Biophysics & Biochemistry from Yale College in 1997 and his J.D. from The George Washington University Law School in 2004, where he graduated with Highest Honors and served as Editor-in-Chief of The George Washington Law Review. He joined Williams & Connolly in March 2006 after clerking for Judge Richard Linn at the U.S. Court of Appeals for the Federal Circuit. Stan is a current member of the firm's Budget Committee and former member of the Hiring Committee. Stan is a Past President of the Giles S. Rich American Inn of Court, the Intellectual Property Inn of Court in Washington, D.C. generally affiliated with the U.S. Court of Appeals for the Federal Circuit.