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.

Swati is an accomplished IP expert, and a qualified Indian Patent Attorney with an experience spanning over 27 years in dealing with all the aspects of the Patents field ranging from strategic patent portfolio management, drafting and prosecuting over 500 domestic & global patent applications, providing legal opinions on patentability, patent infringement, FTO analysis and patent validity issues. She has extensive experience in devising pharma patent litigation strategies as well as "clearing the way" strategies in relation to pharmaceutical patents/published applications.

Currently, Swati is Head of IPM cell at Alivus Life Sciences Ltd. (Erstwhile Glenmark Life Sciences Ltd). She previously worked in the in-house IP dept. of Piramal Pharma, Sun Pharma, Lupin and Indoco Remedies.

Being highly experienced in the IP field, Swati is a frequent speaker on emerging areas of patent law at various events. Also, she is recognised among “Powerful & Influential women in IP “ in the years 2021 & 2023 by World Intellectual Property Forum (WIPF). In the year 2019, she received recognition as “IP Star Woman of the Year” from Legal Era Magazine. In 2024, Swati received recognition as “The great Indian Women IPR Icon” from Transformance Forums.

I hold an M. Pharm from BITS Pilani and currently serve as Deputy General Manager - Legal & IPR at Reliance Life Sciences in Navi Mumbai. In this role, I am playing a crucial role in establishing a robust IP strategy that aligns with the company's business objectives and regulatory requirements. I am deeply involved in strategic decision-making and ensuring compliance with both intellectual property and legal frameworks across the organization.

With over 19 years of experience in Intellectual Property (IP) within the Pharmaceutical and Life Sciences Industries, I specialize in Patent searching, Analysis, Patentability Assessments, Freedom to Operate (FTO), and Patent Drafting. My in-depth expertise spans a wide range of therapeutic areas, including Pharma, Bio-Pharma, Peptides, Oligonucleotides, Innovative Therapies (Gene Therapy, mRNA, LNP) and associated patent issues.

I bring a unique blend of business development and IP management, having worked extensively in R&D, strategy, operations, and support to regulatory affairs. My ability to identify, manage, and support projects from strategy through conception to launch has led to successful business outcomes in an increasingly competitive global market.

A key area of focus has been devising Non-infringement strategies that enable early market entry in critical markets such as India, US, and EU. Through cost-effective management of IP portfolios and supervision of outside counsel, I help companies navigate complex patent landscapes and safeguard their innovations.

Additionally, my expertise extends into Legal compliance auditing for ISO 14001:2015 (Environmental Management) and ISO 45001:2018 (Occupational Health & Safety). I conduct thorough audits to assess the effectiveness of the Environmental Management System (EMS), identify non-compliance issues, recommend corrective actions, and ensure the organization remains up-to-date with evolving regulatory standards. My efforts in this area help the organization avoid legal penalties, enhance its reputation, and stay aligned with statutory changes.

As part of my role, I actively support mergers and acquisitions (M&A), due diligence, and collateral management with competitor institutions. I work closely with both internal and external stakeholders to drive strategic initiatives and ensure seamless execution. Furthermore, I advocate for and implement IP policies that foster innovation and maintain confidentiality.

I am an energetic and results-driven professional who believes in continuous learning and fostering a high-performance culture. My approach to problem-solving blends analytical rigor with strategic vision, enabling effective decision-making even in high-pressure, fast-paced environments. I am driven by a desire to excel and to inspire others, balancing a big-picture perspective with a meticulous focus on detail. With strong communication skills, a deep sense of integrity, and a collaborative mindset, I am committed to driving innovation, regulatory compliance, and organizational success.

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Key Areas of Expertise

• Intellectual Property Management: Patent portfolio management, FTO, non-infringement strategies, patentability assessments, and litigation support.
• Business Development & Strategy: Identification and management of strategic IP initiatives across R&D, operations, and commercialization.
• Legal Compliance: ISO 14001:2015 and ISO 45001:2018 legal compliance audits, risk assessment, regulatory adherence, and statutory updates.
• Mergers & Acquisitions (M&A): Due diligence, legal negotiations, integration, and IP management during M&A processes.
• IP Policy Development: Formulating and implementing policies to promote innovation and protect IP assets within and outside the organization.
• Team Leadership & Collaboration: Dealing with cross-functional teams, fostering a high-performance culture, and managing projects to successful outcomes.

Ajendu Sohani is an accomplished IP expert, currently working as HEAD - Intellectual Property Rights Formulation and In-house Counsel at Indoco Remedies Ltd. He has done Masters in Pharmacognosy Phytochemistry from Principal K.M. Kundnani College of Pharmacy and is also a registered Indian Patent Agent. He brings with him close to eighteen years of rich experience from various giants in the Pharmaceuticals industry. He is not only informed about Intellectual property but is also well versed with the drug regulatory procedures.

In his current role, he is responsible for building IP strategy for various products of the company, Providing IP clearance, executing IP agreements, managing patent portfolio, drafting and prosecuting patent applications, preparing legal opinion on patentability, patent infringement, FTO analysis and validity issues and recommending, effectively managing ediscovery processes for Para IV products, suggesting new molecules for development to the Portfolio Team. He is also well versed with the art and skill of IP prosecution, litigation. Licensing, settlements and subsequent procedures thereof. He has been invited as a speaker and as a panellist for discussion in various IP forums.

Prior to joining Indoco, he was associated with Encube, Cipla, Ajanta Pharma, Unichem Laboratories Limited, J.B. chemicals & pharmaceuticals Ltd and Dr. Reddy’s Laboratories.

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.

Avi Garg is Masters in Applied Chemistry (Gold Medallist) and Bachelor of Science (Chemistry Honours) (University Topper). He has earned his law degree from Faculty of Law, University of Delhi. He also holds a Postgraduate Diploma in Intellectual Property Rights Laws (PGDIPRL) from NLSIU, Bangalore. Avi is a registered Patent Agent with Indian Patent Office. Avi is also a member of the Bar Council of Delhi. Avi has more than 17 years of experience in IP.

His areas of expertise include medicinal chemistry, pharmaceutical, chemical, petrochemical, natural chemistry, biochemistry and allied sciences. He is actively involved in drafting, filing and prosecuting patent applications at different forums like Indian Patent Office, International Bureau (WIPO), USPTO, EPO etc. He is also involved in pre-grant & post-grant oppositions and revocation matters. He has been attending hearings for prosecution, opposition at all branches of the Indian Patent Office, and appeal and revocation matters before the High Court.

Avi is also providing opinions on different technical and legal issues related to Patent Laws. He is assisting clients in Freedom-to-operate (FTO), patentability, invalidation, patent landscape etc. He is also involved in filing and prosecuting design applications in India, handling cancellation proceedings and providing opinions to client regarding various aspects of Designs law in India. He has written many articles on various issues of IPR. He is an avid speaker and has delivered many talks on IPR.

Overview

Coy Stull is an intellectual property attorney with experience in all stages of federal court litigation, including trials and appeals. Coy provides strategic counseling to clients at all stages of the business cycle — from the formation of new ventures to the ongoing commercial operation of established businesses.

Coy works with clients in a wide variety of technological areas, including software applications, blockchain, consumer products, industrial processes, nanomaterials, pharmaceutical compositions, methods of treatment, small molecules, natural products, medical diagnostic devices, and veterinary products. Coy has extensive experience in life science technologies, including pharmaceutical litigation related to the Hatch-Waxman Act.

A registered Patent and Trademark Office attorney, Coy advises clients regarding filing and prosecution of patent and trademark applications, as well as inter partes review (IPR) and ex parte reexaminations.

Coy also advises clients in all manner of transactions involving the use, sale, licensing, and transfer of technology and intellectual property.

Coy handles trademark, copyright, and trade secret disputes, including litigation, opposition and cancellation proceedings before the Trademark Trial and Appeal Board, and UDRP proceedings.

Outside of his intellectual property practice, Coy devotes a significant amount of time to pro bono matters. He has represented several veterans seeking service-related disability benefits before the

U.S. Court of Appeals for Veterans Claims. Coy is also a volunteer for Bay Area Legal Services and has represented family law clients in the Tampa Bay area.

Coy is board certified in Intellectual Property Law by The Florida Bar. He is a currently appointed member of The Florida Bar’s Intellectual Property Law Certification Committee and the Federal Circuit Bar Association’s Patent Litigation Committee.

Experience

• Verifone in Mesa Digital, LLC v. Verifone, Inc., a patent infringement litigation in the Southern District of Florida concerning point-of-sale devices.
• Alfasigma USA in Alfasigma USA, Inc. v. Westminster Pharmaceuticals, LLC, a tortious interference litigation in the Middle District of Florida.
• Belcher Pharmaceuticals in Belcher Pharmaceuticals, LLC v. Rubin, a litigation concerning the ownership of patents in the Thirteenth Circuit in Hillsborough County, Florida.
• Big Daddy Enterprises Inc. and Wide Open Enterprises LLC in Rare Breed Triggers, LLC v. Big Daddy Enterprises, Inc., a patent infringement litigation in the Northern District of Florida concerning firearm triggers.
• Bionpharma Inc. in Azurity Pharmaceuticals, Inc. v. CoreRX, Inc., a patent infringement litigation in the Middle District of Florida involving an enalapril maleate pharmaceutical product.
• Creed Monarch Inc. in Automatic Equipment Manufacturing Co. v. Danko Manufacturing, LLC, a patent infringement litigation in the District of Nebraska involving brakes for towed vehicles.
• TracFone Wireless Inc. in Precis Group LLC v. TracFone Wireless, Inc., a patent infringement litigation in the Southern District of Florida and the Federal Circuit concerning methods of payment.
• HNA LH OD in HNA LH OD, LLC v. Local House International, Inc., a false advertising litigation in the Southern District of Florida.
• Brubaker HomeShopping Inc. in Brubaker HomeShopping, Inc. v. USA Supreme Distributions, a trade secrets litigation in the Middle District of Florida concerning database theft.
• EZSTAX LLC in EZSTAX, LLC v. Aldi, Inc., a patent infringement litigation in the Middle District of Florida concerning organization systems.
• Nichia Corp. in Nichia Corp. v. Lighting Science Group in a patent infringement litigation in the Middle District of Florida concerning semiconductor light-emitting devices.
• Dr. Reddy’s Laboratories in Indivior Inc. v. Dr. Reddy’s Laboratories, S.A., Hatch-Waxman patent infringement litigations in the District of Delaware, the District of New Jersey, and the Federal Circuit involving patents listed in the Orange Book for Suboxone® (buprenorphine/naloxone sublingual film).
• Dr. Reddy’s Laboratories in inter partes review proceedings involving an Orange Book patent for Suboxone® (IPR2019-00328, IPR2019-00329).
• Fresenius Kabi USA in Shire Orphan Therapies LLC v. Fresenius Kabi USA, LLC, a Hatch-Waxman patent infringement litigation in the District of Delaware and the Federal Circuit involving a patent listed in the Orange Book for Firazyr® (icatibant acetate).
• Ceva Santé Animale and Horizon Valley Generics in Merial Inc. v. Ceva Santé Animale S.A., a contract and Lanham Act litigation in the Middle District of Georgia involving fiproniI/methoprene veterinary products.
• West-Ward Pharmaceuticals and Eurohealth International in Spectrum Pharmaceuticals Inc. v. Eurohealth International Sarl, a Hatch-Waxman patent infringement litigation in the District of Nevada involving an Orange Book patent listed for Fusilev® (Ievoleucovorin).
• Respondent Enzymotec in Omega-3 Extracts From Marine or Aquatic Biomass and Products Containing the Same (ITC Inv. No. 337-TA-877).
• Watson Laboratories and Actavis Laboratories in Bayer Pharma AG v. Watson Laboratories Inc., Hatch-Waxman patent infringement litigations in the District of Delaware and the District of New Jersey involving patents listed in the Orange Book for Staxyn® (vardenafil).
• Watson Laboratories in Pfizer Inc. v. Watson Pharmaceuticals Inc., a Hatch-Waxman patent infringement litigation in the District of Delaware involving a patent listed in the Orange Book for Rapamune® (sirolimus).
• Impax Laboratories Inc. in Purdue Pharma Products LP v. Impax Laboratories Inc. and In re Tramadol Hydrochloride Extended-Release Tablets Patent Litigation, Hatch-Waxman patent infringement litigations in the District of Delaware involving patents listed in the Orange Book for Ultram ER (extended-release tramadol hydrochloride).

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Areas of Focus

Practices

• Intellectual Property
• Administrative Litigation and Appeals
• Appellate & Trial Support
• Business Transactions
• Digital and E-Commerce Engagement andInnovation
• Distressed Health Care
• Government Law & Consulting
• Health Care
• Intellectual Property Litigation

Industries

• Health Care
• Technology

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Insights

05.30.2023
U.S. Supreme Court Unanimously Upholds the Federal Circuit’s Enablement Inquiry for Patent Claims

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06.08.2022
Amgen, Juno And The Fate Of Functional Genus Claims
Law360

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03.02.2020
Canna We Talk Cannabis? Not So Patently Obvious: Patent Infringement in the Cannabis Industry

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News

12.13.2023
Coy Stull Quoted in Law360: “The Biggest Patent Rulings of 2023”

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03.14.2023
Coy Stull Quoted in Tampa Bay Business Journal: “Crystal Lagoon Creators Allege Local LicenseesStole Its Proprietary Technology”

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03.09.2023
Carlton Fields Joins Florida Blockchain Business Association

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06.08.2022
Carlton Fields IP Attorneys Author Article for Law360: Amgen, Juno And The Fate Of FunctionalGenus Claims

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11.01.2021
The Collective Spotlight: J. Coy Stull

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11.12.2020
Carlton Fields’ J. Coy Stull Earns Board Certification from The Florida Bar

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01.24.2019
Carlton Fields Adds Experienced Intellectual Property Litigator J. Coy Stull

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Professional & Community Involvement

• Federal Bar Association, Tampa Bay Chapter
• Federal Circuit Bar Association
• Vice Chair, Patent Litigation Committee
• Co-Chair, Hatch-Waxman/BPCIA Subcommittee
• The Florida Bar
• Vice Chair, Intellectual Property Law Certification Committee (2021–present)
• Hillsborough County Bar Association
• Bay Area Legal Services
• Collective Member and Volunteer (2019–present)
• Great American Teach-In
• Volunteer (2022)
• Palma Ceia Little League
• Coach (2019–present)
• Tampa Bay United Soccer League
• Coach (2019–present)

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Speaking Engagements

• “Recent Developments in Pharmaceutical Patent Litigation,” Federal Circuit Bar Association,Patent Litigation Committee (March 17, 2022)
• “Appellate Advocacy Before the U.S. Court of Appeals for Veterans Claims,” Veterans ConsortiumPro Bono Program (November 11, 2021)
• "Skinny Labels, Enablement, Venue, and More: Recent Developments in Hatch-WaxmanLitigation," Federal Circuit Bar Association, Patent Litigation Committee (May 11, 2021)
• “Brexit and Beyond – The Top IP Issues,” Hillsborough County Bar Association, IntellectualProperty Section (February 4, 2021)

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Pro Bono

• Lead counsel for veterans in benefits appeals at the U.S. Court of Appeals for Veterans Claims.
• Lead counsel for client in child custody case in Hillsborough County, Florida.
• Lead counsel for tenants in a housing conditions and eviction case in the Superior Court of theDistrict of Columbia.
• Lead counsel for homeless client in a child custody and protective order case in the SuperiorCourt of the District of Columbia.
• Volunteer at D.C. Bar Pro Bono Center Landlord Tenant Resource Center and small business clinic.
• Volunteer at CARECEN citizenship clinics.

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Credentials

• University of Miami School of Law (J.D., cumlaude, 2005)
• University of Florida (B.S., with honors, 2002)

• District of Columbia
• Florida
• U.S. Patent and Trademark Office

• Intellectual Property Law

• U.S. Supreme Court
• U.S. Court of Appeals, Federal Circuit
• U.S. Court of Appeals for Veterans Claims
• U.S. Court of Appeals, Eleventh Circuit
• U.S. District Court, District of Columbia
• U.S. District Court, Middle District of Florida
• U.S. District Court, Northern District of Florida
• U.S. District Court, Southern District of Florida

Ms. Nilam Gadani is Senior Patent Attorney and Head of Patent Department at H K Acharya & Company with more than nineteen years of patent law experience.

Her area of expertise includes Indicting patent applications, litigation and prosecution detailing conclusions on patent issues for national and international clients. She prompts the company's clients on the issues identified with licenses. She is likewise engaged with investigating the patentability of new inventions and rendering opinions with deference thereto and, to be sure, all major parts of the act of Intellectual Property Law. She has been a speaker at different Domestic and International seminars and meetings.

Vidya Subramanian, a results-driven professional with about 25 years of experience in Intellectual Property (IP) portfolio management within the Pharmaceutical and Biotech sectors, currently working with Reliance Life Sciences Pvt. Ltd. She specializes in strategic IP management aligned with corporate business objectives, focusing on enhancing the protection of new inventions and driving the growth of IP assets. She possesses a strong background in understanding the technical aspects of inventions and translating them into robust IP protection strategies. Her expertise spans patent search, filings, prosecution in India, and effective management of foreign filings in collaboration with attorneys worldwide. She has a proven track record of developing IP reporting formats, implementing efficient procedures, and making significant contributions to business growth and IP protection

Core Expertise:

• Strategic IP management to align with corporate goals and business development
• IP portfolio management, including patent and trademark strategy, clearance, and prosecution
• Extensive experience in coordinating with R&D teams and scientists for timely provision of data to secure new IP.
• Development of IP budgets, database systems, and customized reporting formats.
• Expertise in patent search, non-infringement analysis, competitor monitoring, and IP clearance reports
• Managing relationships with external patent attorneys and ensuring cost-effective foreign filings and prosecution.
• Strong negotiation skills and adept at reviewing IP clauses in agreements and contracts.
• Establishing framework for ISO compliance frameworks (ISO 45001:2018 & ISO 14001:2015) which includes identifying and tracking applicable laws, and ensuring legal compliance.

As a strategic leader, she is committed to fostering a positive work environment that supports team performance and drives results. Her strong communication and negotiation skills have helped me successfully navigate complex IP matters while supporting business goals.

Overview

Dr. Jayashree Mitra focuses on patent litigation, including Hatch-Waxman patent litigation. She represents clients in federal court and before the Patent Trial and Appeal Board and the International Trade Commission in a full range of patent litigation, including Hatch-Waxman actions, inter partes review, post-grant review proceedings, and trade secret disputes. She also advises clients in the cannabis industry and psychedelic industry on regulatory compliance, helping them align their IP strategies to comply with FDA and DEA regulations and guidance.

Jayashree is well known for her detailed understanding of the pharmaceutical, biotechnology, cannabis, psychedelics, and emerging technology sectors. A former neuropharmaceutical researcher at Yale University, Jayashree's technical knowledge extends to small molecules, protein therapeutics, protein conjugates, vaccines, injectables, biologics, and biosimilars, as well as blockchain and data privacy. She has particular insight into the science underlying innovative cannabis technology products and psychedelics. Her research in neuropharmacology at Yale specifically involved analyzing the effects of psychoactive substances on the developing brain.

She also has experience handling antitrust matters, as well as intellectual property due diligence and technology agreements for mergers, acquisitions, and other corporate transactions.

Jayashree engages in extensive pro bono work, including criminal appeals and death penalty cases.

Experience

• Represented a manufacturer of devices for the cannabis industry in federal court in litigationinvolving enforcement of patent concerning vape-filling technology.
• Represented clients in the cannabis industry in developing intellectual property portfolios.
• Represented clients in the cannabis industry on regulatory compliance and FDA regulations.
• Represented a global pharmaceutical company in federal court in litigation involving enforcementof patents covering the client's drug for treating pain and epilepsy, achieving victory at trial inwhich the patents were held valid and infringed.
• Represented a global pharmaceutical company in federal court in litigation involving patentsrelated to a drug for treatment of depression.
• Advised a global pharmaceutical company in multiple patent litigations across multipleinternational jurisdictions on patents for a drug used in treating epilepsy and pain.
• Represented a major pharmaceutical company in a lawsuit filed by a state attorney generalinvolving Sherman Act, antitrust, and consumer protection claims.
• Represented major pharmaceutical company in federal class action antitrust litigations accusingthe company of delaying entry of generic competition through alleged fraud on the U.S. patentoffice and sham patent litigation.

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Areas of Focus

• Intellectual Property
• Cybersecurity and Privacy
• Technology

• Technology

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News

10.19.2023
Jayashree Mitra Mentioned in Law.com: “Cops and Cannabis/Carlton Fields' New Partner/Suit Targets Lyvly/Firm's Defamation Suit”

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10.17.2023
Carlton Fields Expands Intellectual Property Practice With Patent Litigator Jayashree Mitra

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10.17.2023
Jayashree Mitra Mentioned in Attorney At Law Magazine: “Carlton Fields Expands Intellectual Property Practice”

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10.17.2023
Jayashree Mitra Featured in Bloomberg Law: “Carlton Fields Brings on Jayashree Mitra as IP Shareholder in NY”'

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10.17.2023
Jayashree Mitra Featured in Law360: “Carlton Fields Adds Fox Rothschild Patent Law Atty in NY” Speaking Engagements

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Speaking Engagements

• “IP Litigation and Administrative Proceedings: A Global Overview of Managing Cannabis Conflicts,” 2023 Global Cannabis Intellectual Property Symposium, International Cannabis Bar Association (September 29, 2023)

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Credentials

• Northwestern Pritzker School of Law (J.D.,2008)
• Northwestern University Law Review
• Yale University (Ph.D., 2003)
• All India Institute of Medical Sciences (M.S.,1996)
• Rammohan College, University of Calcutta(B.S., with honors, 1994)

• New York

• Bengali
• Hindi

• U.S. Supreme Court
• U.S. Court of Appeals, Fourth Circuit
• U.S. District Court, Eastern District of New York
• U.S. District Court, Southern District of NewYork

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Background

• Partner, Fox Rothschild LLP, New York, NY (2021–2023)
• Partner , Zuber Lawler, New York, NY (2018–2021)
• Intellectual Property Litigation and Antitrust Associate, White & Case LLP, New York, NY (2008–2018)

Professional/ Research Experience:

Sekhmet Pharmaventures/ Optimus (currently working) Director – IPR & & Legal

BDR Group of Companies (6/2023 – 8/2024) Deputy General Manager – Lead_IP/ Portfolio Evaluating inventions by correlating business impact; Portfolio/ Pipeline Strategy management; Creating IP strategies for First-to-Market/ FTF launches; Reviewing FTO & Patentability reports; Competitive IP intelligence; Patent Drafting/ Filing/ Prosecution response/ Hearing with Examiners/ Maintenance; Working Closely with Legal Team; IP contracts/ Due diligence

Aurobindo Pharma Limited (9/2016 – 05/2023) Assistant General Manager Product Selection support; Market/ Financial forecasting; Identifying Early Launch Opportunities/ Global IP strategies/ IP risks for intended launches (Designing around Process/ Polymorph/ Composition); Prior-art Search; Understanding the inventions, identification of key issues, differentiation; PIV/ Litigation support

Cadila Pharmaceuticals Limited (03/2012 – 08/2016) Manager Evaluation of Clinical Data for Novel DPP-IV; End-to-End Product Development Monitoring; Opposition Drafts; SOPs for IPR; IPR Policy support & Litigation support.

Aptuit Laurus (18/07/2011 to 29/02/2012) Assistant Manager Neutraceutical molecules’ evaluation

PharmaZell (India) Pvt. Ltd (02/01/08 to 14/07/11) Assistant Manager Literature evaluation; Patent NI Analysis/ FTO; Patent Drafting/ Filing/ Prosecution/ FER reply/ maintenance

Scitech Patent Art services pvt ltd (06/07/04 to 27/12/07) Senior Knowledge Scientist White Space Analysis/ Total Solutions/ Patent search

Qualifications:

Ph.D. – Chemistry from GITAM University in 2021 RP-HPLC method for the simultaneous determination of selective drug substances in pharmaceutical composition

MBA – Operations research from IGNOU in 2008

PG Diploma in Regulatory from Bio Informatics Institute in 2008

PG Diploma in Patents Law from NALSAR University in 2007

MSc – Industrial Organic Chemistry from JNTU in 2004.

Research Publications:

1. Title: RP-HPLC method development and validation for the estimation of Emtricitabine, Bictegravir and Tenofovir alafenamide in bulk and pharmaceutical dosage form. Journal: Journal of Taibah University for Science, 13:1, 1137-1146; Published onNovember 12, 2019 (DOI: 10.1080/16583655.2019.1689601)
2. Title: Stability indicating RP-HPLC method development and validation for the Estimation of Sofosbuvir, Velpatasvir and Voxilaprevir in bulk and pharmaceutical dosage form. Journal: Research J. Pharm. and Tech., 2020, 13(11), 5063-5071; Published in November 2020 (DOI: 10.5958/0974-360X.2020.00887.2)
3. Title: A simple alternative and improved HPLC method for the estimation of Doravirine, Lamivudine and Tenofovir disoproxil fumarate in solid oral dosage form. (DOI: 10.1002/bmc.5121) Journal: Biomedical Chromatography, 2021;e5121; Published in March 2021
4. Title: Surfactant assisted copper (II) oxide nanoparticles for the adsorption of dyesRhodamine B and Methylene blue. Journal: Research Journal of Chemistry and Environment, 2019, 23(12), 68-77; Published in December, 2019

Participation(s) as Speaker:

• Great Indian IPR Summit & Awards, 2024 – Panel discussion – Speaker
• 5^th elets Pharma Leadership summit & Awards, 203 – Panel discussion – SPEAKER
• 8^th IIPSS - SPEAKER