Biosimilar Litigation 2025 – Lessons from UPC, UK, Europe & India
Agenda
- Amgen v. Sanofi (Repatha): UPC’s perspective on second-medical-use claims.
- Alexion v. Samsung Bioepis/Amgen: Eculizumab across UPC & UK/EPO.
- Stelara (ustekinumab) – Janssen v. Samsung Bioepis: Skinny labels, national courts,
and contractual claims. - Roche v. Zydus (Pertuzumab, India): Process claims, disclosure, and Section 104A analysis.
- Second-medical-use and skinny-label strategies.
- Manufacturing/process patents and injunction practices.
- Forum selection: UPC vs UK, EPO oppositions vs national enforcement.
- Freedom-to-operate checks, invalidation strategies, and regulatory interplay.
- Label design and defensive portfolio management.
Launch tactics, confidentiality and reverse disclosure (India), damages, settlement vs
litigation.
Our Speakers
DR. MALATHI LAKSHMIKUMARAN
Executive Director and Practice Head – Life Sciences, New Delhi.
With over 30 years of experience in biochemistry and molecular biology, Dr. Malathi Lakshmikumaran leads the Life Sciences Group at Lakshmikumaran & Sridharan’s IP division.
A registered patent agent, she handles patent drafting, filing, prosecution, and litigation in pharmaceuticals, chemicals, and biotechnology.
Her expertise extends to plant variety protection, biodiversity, and traditional knowledge. Previously, she headed the Centre for Bioresource & Biotechnology Division at TERI for 17 years.
Dr. Lakshmikumaran has supervised several Ph.D. students and authored over 100 international publications.
Education: Ph.D. in Biochemistry, Pune University.
Honors: National Young Women Scientist Awar (DBT, 2000); Fogarty Fellowship, NIH, USA; National Science Talent Scholarship.
VINDHYA S. MANI
Partner – Technology Law Division, Bengaluru.
Vindhya is a registered advocate with the Delhi Bar Council, focusing on IP opposition and litigation before the Patent and Trademark offices, PVP Registry, IPAB, High Courts, and the Supreme Court.
She also advises clients on environmental law and biodiversity compliance.
Vindhya holds a B.Sc. (Hons.) in Biological Sciences from Sri Venkateswara College, an LL.B. from Delhi University, a Post Graduate Diploma in IPR from NLSIU, Bangalore, and a BCL from the University of Oxford.