Biologics & Biosimilar Litigation 2026: Lessons from India, the UPC, Europe and the US
Agenda
- Patent cliffs for nivolumab, semaglutide, aflibercept and pembrolizumab, and India’s role as a launch market and export hub.
- Zydus v. E.R. Squibb: biosimilarity versus infringement, product-to-claim mapping, and prosecution history.
- Novo v. Dr. Reddy’s: export manufacturing, genus versus species obviousness, and late-life injunctions.
- Update on Roche v. Zydus.
- The aflibercept saga: equivalence in Munich, London and The Hague, and cross-border relief.
- Genentech v. Organon: when filing a marketing authorisation application means imminent infringement.
- The Brussels bioequivalence ruling.
- Halozyme v. MSD: formulation and enzyme patents as lifecycle tools.
- Hikma v. Amarin on skinny labels.
- ITC exposure for Indian biosimilar manufacturers.
Our Speakers
DR. MALATHI LAKSHMIKUMARAN, Ph.D., FNASc
Executive Director and Practice Head, Lakshmikumaran & Sridharan, Attorneys.
Dr. Malathi serves as an Executive Director and heads life science group at the IP division of the firm. She has more than 30 years of experience in the field of biochemistry and molecular biology with an expertise in genomics, DNA fingerprinting and genetic transformation. She mainly works on pharmaceutical, chemical, and biotechnological patent applications. She is a registered patent agent and has been actively engaged in preparing, filing and prosecuting of patent applications, both in India and abroad. She advises clients on patentability, invalidity, and Freedom to Operate projects while also conducting patent landscape projects. She is actively involved in advising clients on plant variety protection/registration, and compliance of Biological Diversity Act.
Malathi undertakes extensive work for start-ups especially with incubators at C-CAMP, BBC, IKP, IISc, and IIT Delhi, advising them on the importance of Patent protection. v
She was a content writer for a Course on “Intellectual Property and Genetic Resources in the Life Sciences” (DL-427) by WIPO Academy and WIPO TK division. She has delivered talks for the DL 427 course and mentored the trainees. She was the main content writer for a WIPO booklet on “IP, Innovation in the Lifesciences for Women in Science”. She was the nodal person for conducting a Leadership Course on “Intellectual property, Science, and Innovation for Women Scientists and Innovators” from April 25 to 28, 2023 at WIPO Headquarters, Geneva. This course was organized by the WIPO Academy in collaboration with United Nations Educational, Scientific and Cultural Organization (UNESCO), and Republic of Korea (South Korea). In addition, Malathi conducted and moderated a session on “Women in Science – Shaping the future” on April 26, 2023, at WIPO Headquarters on World IP day. She is also a voracious speaker and delivered several talks on IP at various fora including GIPC, WIPF, BIRAC, Legal Era, IIT Delhi, IIT Kharagpur, Delhi University, CCAMP, and IKP.
PAST EXPERIENCE
Prior to joining the firm, she served as the Head, Centre for Bioresource & Biotechnology Division in The Energy and Resource Institute (TERI) from 1985 until 2002. She has also actively worked with national and international organizations as well as several academic institutions. Malathi has successfully supervised several Ph.D. students in Plant Molecular Biology. She has more than 100 publications to her credit in various international and Indian journals. Malathi has served as a task force member on several DBT (Department of Biotechnology) and DST committees. She has evaluated several projects as a task force member of DBT.
EDUCATION
- Bachelor of Science – Pune University
- Masters (Chemistry)- Pune University
- PhD in Biochemistry – Pune University
- Fellow of the National Academy of Sciences
MEMBERSHIP OF PROFESSIONAL ASSOCIATIONS
- Member of AIPPI
- Member of FICPI
- Member of APPA
- Member of INTA
AWARDS
- Recipient of National science talent scholarship
- Recipient of the prestigious Fogarty Visiting Research Associate ship from National Institute of Health, Bethesda, USA
- Recipient of the National Young Women Scientist Award by Department of Biotechnology in March 2000
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.