Shashank Upadhye, a partner at Upadhye Tang LLP, is one of the most recognized leaders in the U.S. pharmaceutical and FDA space. For almost 30 years, he has focused on pharmaceutical law, with an emphasis on IP and FDA issues. He spent many years as the Chief of legal/IP/FDA counsel at Apotex (Toronto), Sandoz (New Jersey and Germany), and Eon Labs (NY), so he brings key business savvy to pharma clients. Shashank has significant C-suite experience, handling budgets exceeding $60 million.

His specialty is patent strategy, patent litigation, FDA counseling, and administrative law litigation. He represents clients in all aspects of federal court litigation from trial through appeals. Shashank also works with or against the FDA to move product approvals along. He has litigated many cases against the FDA when the FDA acts outside of statutes and regulations. He advises clients on FDA’s Good Manufacturing Practices (GMP) compliance.

He is a prolific speaker and recognized leader in the Hatch Waxman/Para. IV field. Shashank authors the key legal book on pharmaceutical and FDA law, called Generic Pharmaceutical Patent and FDA Law (15th 2024-25 Edition), available here: https://tinyurl.com/Generic-Pharma-Book. He has published 100+ articles, been interviewed for dozens of news agencies; and has presented at 100+ conferences.

He is active in the Boy Scouts as a Merit Badge Counselor, Eagle Scout coach, and troop leader. He is also a USA Ice Hockey Level 4 referee and trains junior referees.

Dr. Amar Desai, Global IP: Zydus Lifesciences Limited

Dr. Amar Desai is leading the team of IP Professionals as Sr. General Manager - Global IP at Zydus Lifesciences Ltd. (ZLL). He has 19 years of rich experience of various facets of Intellectual Property. He has drafted and prosecuted more than 410 patent applications worldwide and has secured grants of more than 100 patents to his credit.

He holds a doctorate degree from Veer Narmad South Gujarat University, Surat and is a registered Indian Patent agent. He has completed PG Diploma (PGD-IPM) in Patent Law from Nalsar University and has Bachelor of Law (LL.B.) from The Sardar Patel University, Vallabhvidhya Nagar, Anand. He has a natural ability to connect with the audience and puts a lot of effort into preparing his material. His presentation always leaves a lasting impression. He has delivered talks and presentations to various academic institutions as well as business events at Surat, Ahmedabad, Mumbai, Bengaluru, Delhi, Vadodara, etc. He has been appointed as Advisory Member to IPR law & Research Centre at Manipal Law School, Bengaluru and 14^th Pharma IPR during Mar-2025 organized by Informa Marketing in Mumbai. He has been on the advisory board of various academic institutions for designing curriculum related to courses for future industrial needs.

His deep understanding of his core areas allows for effective problem-solving. Expertise in these subjects is highly valued in today’s market. His expertise includes infringement analysis, Freedom To Operate (FTO), Polymorphism, litigation, patent drafting and prosecutions, due diligence, regulatory filings and responses, etc. to list a few. He delivered talks at 11^th and 12^th Pharma IPR events on multi-disciplinary topics, at World Intellectual Property Forum (WIPF) on Artificial Intelligence (AI) and its importance in Biopharmaceuticals, etc. His work includes various aspects of Intellectual Property including FTOs, Para IV filings, filing and prosecution of patent applications, litigation discovery, IP due diligence, interactions with third parties etc.

Mr. Raju Sharma is an accomplished IP expert and a qualified Indian Patent agent. He holds a Master's degree in Organic Chemistry and a Diploma in IPR from Pune University along with a Certificate course in IPR Law (CCIPR) from the Federation of Indian Chambers of Commerce & Industry (FICCI).

In his career spanning over 15 years, he has worked in the in-house IP department of prominent Indian Pharma Companies including Torrent Pharmaceuticals Ltd, IPCA Laboratories Ltd, Hikal Ltd, Enaltec Labs Private Ltd, and Ind-swift Laboratories Pvt. Ltd, where he has worked on all aspects of patents, ranging from strategic patent portfolio management, drafting and prosecution of domestic & global patent applications, providing legal opinions on patentability, patent infringement, FTO analysis, due diligence, validity issues, and devising strategies for patent litigation.

Currently, he is working as Head of the IPR department at Ami Lifesciences Private Ltd, where he oversees the global IP front. He provides strategic expertise on a broad range of IP and advises senior management on IP issues that have legal implications. He works closely with cross-functional groups like BD, R&D, Regulatory, and Marketing.

Dr. Dinesh Kumar Sarwal, Senior Director (IPR), Jubilant Pharmova Ltd.

Overview: Chief IPR Strategist with key role in managing and facilitating nurture Innovation culture, Ideation, designing, IP protection, IP compliance and support on commercialization of product and technologies of business interest. Work experience in R&D departments of pharmaceutical companies like Sun Pharma Advanced Research Centre (SPARC), Panacea Biotech Ltd and Ranbaxy Research Lab and presently spearheads IPR department of Jubilant Pharmova and Jubilant Radiopharma

Pharmaceutical Technologies: NCE, API, Intermediates, Generics (Solid Oral, Liquid, NDDS, Drug Device, Opthalmic, Injectable, Drug Device), Biologicals (Peptide, Allergenic extract), Veterinary Dosage, Medical Devices and Artificial Intelligence (AI) technologies

Para IV ANDA: 50+ successful Para IV USA ANDA filings (including FTF)

Patent Opposition: Successful track record in USA (successful Inter Partes Review Patent opposition), EU (Successful Post-Grant Opposition), India (Post-Grant Patent opposition), and PCT 3rd party observations

Patent Litigation Management: Favorable court decisions in USA (District Court, CAFC and International Trade Commission), Europe, Canada, Australia and other ROW markets

IP Award for Organization: Successfully led Jubilant Pharmova IPR team and secured 2023 CII Special National IPR Award under Life Sciences Category (Due to IP compliance policies and IP based commercial technologies)

Individual and Team Awards: winner of prestigious 20+ Jubilant Pharmova Chairmen awards on Leadership and successful R&D projects (Change Master of Year, Extramiler of the Year, Tranzformer of the Year, Pioneer of the Year)

Patent Publications (Inventor): 10+ (including granted USA Patents on USFDA approved dosage forms like Solid Oral, Injectable and Radiopharmaceutical technologies and products)

Research Publications: 170+ (Research papers and Book Chapter) in international Journal of repute on innovative pharma products and technologies

IPR Publications: 1. Co-author of CII white Paper on “IPR Issues with Respect to Pharmaceutical Sector-2023” and 2. Co-author of Book chapters published in “CII Book on IP FOR START-UPs AND MSMEs-2023”

IPR and Pharma Technology Policy Expert: 1. Member of CII National Committee on Intellectual Property Rights (FY: 2015-FY 2025) 2. Member of CII Expert Group (2023) to develop a scale on Technology Readiness Levels (TRL) 3. Member CII National Task Force on Genomics (2023)

G20/B20 Technology, Innovation, R&D Task Force Member (2023): 1. Member of B20 task force 2023 (under the ambit of G20, held in India) on Technology, Innovation, R&D 2. Co-lead International and national Pharma and life Sciences companies representative consortium and drafted a white paper on Technology, Innovation, R&D sub-group on Cancer detection and Cure techniques

Education: Pharm, M. Pharm., Ph.D, from University Institute Pharmaceutical Sciences (UIPS), Panjab University, Chandigarh

• Recipient of open fellowship from UGC and CSIR during doctoral research work at Panjab University
• Registered Indian Patent Agent (IN/PA 5535)
• Certificate course on IPR Valuation

DR PRAVIN SHEJUL

Pravin, a distinguished figure in the field of Intellectual Property (IP), serves as the Director (Head) and In-house IP Counsel at OmniActive Health Technologies Ltd. With a robust techno-legal background, he holds a Ph.D. in Medicinal Chemistry from the University of Aberdeen, UK, and an LL.B. from Mumbai University. His 17+ years of experience, including as an in-house Counsel, Indian patent and trademark agent, and member of the Bar Council of India, set him apart in the industry.

He has vast experience in the Chemical, Pharmaceutical, and Life science fields like GSK, Glenmark, Janssen, and Wanbury on IP-related matters, including litigation globally. He has during his tenure with these said organizations handled patent-related and legal matters pertaining to multiple businesses globally such as API, formulation (solid oral forms and injectables), new chemical entities, herbal, medical devices, critical care, OTC products, the key strengths being drafting and filing of robust patent applications worldwide; prosecuting patent applications worldwide to obtain patent grants; providing non-infringement, patentability, freedom to operate, invalidity and other legal opinions; IP due diligence, competitive intelligence and landscaping; out-licensing; strategizing on non-infringing/invalidation strategies in PIV and other IP litigations; and product selection for portfolio management.

Currently Pravin is working with OmniActive and handling IP and legal matters globally pertaining to multiple businesses globally in the Nutraceutical sector.

Pravin is an expert in Biodiversity matters and represents the company before the National Biodiversity Authority, including drafting, filing, prosecuting, and submitting writ petitions before the Competent authorities for Biodiversity matters and managing Biodiversity matter compliance.

Timothy H. Kratz is a veteran complex trial lawyer, with over 35 years of first-chair courtroom experience. He leads or has led litigation teams in numerous large, complex matters, including cases in the fields of patents and other forms of intellectual property, technology licenses and development, trade and competition, healthcare, securities, professional malpractice and all aspects of business litigation. For the past 20 years, he has built and led teams focused on Hatch-Waxman litigation, serving as lead counsel in all phases of numerous ANDA cases for leading generic pharmaceutical companies. He has significant experience in this field, including serving as lead counsel on more than 100 ANDA applications with Paragraph IV challenges.

Timothy is a recognized international speaker on topical issues pertinent to the life sciences industry and patent litigation, having presented at industry conferences throughout the United States, and in South Korea and on numerous occasions in India. He has been tendered and qualified as an expert in an international litigation matter in the field of U.S. patent litigation procedures. He was also his prior firm’s chair of the life sciences industry team, serving in this firm management position for more than two years. As such, he has coordinated multi-disciplinary and multi-office teams of lawyers serving the life sciences industry.

Timothy has a depth of experience in the management of high stakes, high profile commercial litigation. He has tried many cases to verdict in a variety of jurisdictions and argued several appeals before federal and state appellate courts and in fact has been selected on multiple occasions from joint-defense group counsel to argue an appeal on behalf of multiple leading companies in the field. He has also taught trial advocacy skills to both law students and lawyers in several states. He has been a member of the Georgia bar since 1989.