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.

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. G.R. Raghavender is Senior Consultant (IPR) in the Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce & Industry, and a retired civil servant from the Central Secretariat Service (CSS) 1988. He worked as Joint Secretary, Department of Justice, Ministry of Law & Justice since January 2017. He was also Mission Director for the National Mission for Justice Delivery and legal reforms. He worked on implementing policy reforms for improving Enforcing Contracts parameters under the Ease of Doing Business and eCourts Project. Earlier, he was Joint Secretary in the Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce & Industry, Government of India, New Delhi, where he contributed to various FTA negotiations and RCEP agreements. Additionally, he held the charge of Director General, National Productivity Council (NPC) from December 2015 to May 2016.

He is an Intellectual Property Rights law expert focusing on IPR protection and emerging new technologies, Competition Law, and International Treaties and conventions. As a former Registrar of Copyrights of the Indian Copyright Office, he played a key role in the introduction of recent amendments to the Copyright Act in 2012 and the Copyright Rules in 2013. He attended many WIPO SCCR meetings and FTA negotiations as a member of the Indian delegation. He contributed significantly to the recently concluded WIPO treaties, namely, the Beijing Treaty on Audiovisual Performances (2012) and the Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired, or Otherwise Print Disabled (2013). He has contributed to revising the copyright legislation of Bhutan, Kampuchea, Myanmar, and Nepal as a copyright expert.

As a resource person, he delivers lectures and talks on Copyrights and Related Rights in various International and National seminars and workshops organized by WIPO and several Law Schools, Universities, and Institutes across India.

He has recently been awarded a Ph.D. (IPRs) from GGSIP University, New Delhi. He holds several degrees and postgraduate qualifications, including an M.A. in Development Studies (Public Policy & Management) from the Institute of Social Studies (ISS), The Hague, Netherlands, an M.A. (Gold Medalist), and an M.Phil in Ancient History & Archaeology from Osmania University, Hyderabad. He was also a JRF Scholar of UGC. Additionally, he holds an LLB degree from Delhi University and an LL.M. (IPRs) from GGSIP University, New Delhi. He completed his Bachelor's degree in Library and Information Sciences (B.L.Sc.) and a B.Sc. degree from Osmania University, Hyderabad.

Ajendu Sohani is an accomplished IP expert, currently working as HEAD -Intellectual Property Rights Formulation and In-house Counsel at Inventia Healthcare Limited. 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 Inventia, he was associated with Indoco, Encube, Cipla, Ajanta Pharma, Unichem Laboratories Limited, J.B. chemicals & pharmaceuticals Ltd and Dr. Reddy’s Laboratories.

Dr Alok Tripathi have over 25 years of experience in Intellectual property, Product Portfolio Management, Project Management and Business development across renowned organization such as Zydus Cadila, Glenmark, Ranbaxy, Macleods and presently serving as Senior Vice President at Centaur Pharmaceutical.

Dr Alok holds PhD degree in Organic Chemistry and registered as "Patent Agent" with India Patent Office and named as an inventor in more than 100 Patents/Patent Applications filed/granted in various territories.

Anand is AVP & Head of IP at Reliance Consumer Products, Bangalore R&D. He has the task of setting-up and implementing holistic IP Strategy for the company’s FMCG business and of end-to-end IP management.

He is an organic chemist, law graduate and Indian Patent Agent with over 2 decades of experience in patents and designs with India’s reputed multinational company, HUL where he was senior inhouse Patent Counsel in Patent Group India, Mumbai. Anand has successfully completed an international stint with Unilever Patent Group Shanghai.

He is well-versed with global patent and designs law and practice, including in India, PCT, EPO and EUIPO. His core skills include drafting, prosecution, formalities, training and mentoring, enforcement, litigation, oppositions, design cancellation and dispute resolution. He has drafted over 200 patent specifications for variety of FMCG products.

Since 2022, Anand has been actively involved with the Global IP Commission of International Chamber of Commerce (ICC) as Vice Chair & Regional Representative for India, and Chair of Working Group on Designs.

As a leadership member of the commission, Anand has been working with ICC to represent the voice of business at institutions including WIPO, EUIPO and OECD.

Anand was a visiting faculty member at Institute of Intellectual Property Studies (IIPS) Mumbai for over 4 years.

He has one patent to his credit as an inventor, and has co-authored an article on designs in Intellectual Property Magazine.

Dr. Khanna heads the Patent Department and is in-charge of both patent prosecution and litigation at the firm. She has more than 21 years of work experience with 17 years in the field of patents. Dr. Khanna oversees and handles work in different technology domains including chemistry, pharmaceutical, medical devices, electrical and mechanical inventions, telecommunication to name a few. She engages with her clients in strategizing protection and enforcement of patent rights in India. She is actively involved with the Patent Office and the Department for Promotion of Industry and Internal Trade (DPIIT) and organizations like the Confederation of Indian Industry (CII) and Invest India etc. in policy decision making and regularly engages with them in this regard. A few examples of such engagements are participation in commenting and contributing towards CRI guidelines, pharmaceutical inventions’ guidelines, working statement requirements, SEP (Standard Essential Patents) paper (issued by the DPIIT) etc. Dr. Khanna is a member of the IP Committee of the CII. She is a regular speaker at conferences and avidly supports reform in patent laws to encourage innovation in the country. Dr. Khanna is a member of APAA, INTA, AIPPI and IPO association.

I am currently working with Emcure Pharmaceuticals Ltd, Pune as AVP & Head - Global IP. Broadly my role is to provide IP support to R&D at every stage of Generic product development and also work closely with BD/Marketing teams for identification of IP driven new product opportunities.

The R&D profile includes technical evaluation of patents and pending applications, performing infringement and invalidity analysis, filing and prosecuting patent applications for novel technologies, addressing polymorph related issues, devising patent litigation strategy and providing technical support to external attorneys during litigation process (Opinions, Notice Letters, Discovery), actively involving in settlement discussions to secure early launch dates.

The BD profile includes IP support for In-Licensing product deals, launch planning, applying innovative approaches to identify niche products, computing and providing relevant market entry information, tracking NCE approvals, novel technology IP due diligence, monitoring PIV filings and subsequent litigations, settlements if any, reviewing Innovator annual reports and Financial statements.

Overall, my industrial experience of 20+ years involved working with organizations like Dr. Reddy’s, Torrent, Lupin, Wockhardt and IPCA.

With 28.5 years of versatile & diverse working experience in basic and applied research in drug delivery system design and intellectual property management & business strategy, Dr. Archna Roy holds a Ph.D. in Novel Drug Delivery Design, Masters Diploma in Business Administration (MDBA) in Marketing, Master of Pharmacy, and Bachelor of Pharmacy (Hons) degrees.

As Senior Director and Head of Global IPM and core member of the organizational Business Strategy team at Novugen Pharma and Novugen Oncology at Malaysia, she is responsible for framing, aligning & overseeing all IP related activities globally, including new product identification, product portfolio management, and launch support for both finished dosage forms (FPs) & APIs, IP due diligences for in-licensing & out-licensing and/or mergers and acquisitions, patent portfolio management, R&D clearances, pre-litigation & litigation activities, and regulatory filings and approvals support across all geographies, She has resolved multiple PIV, first-to-file & first to market products’ litigations with successful outcomes in US, EU, JP, MY, IN & ROW.

Prior to joining Novugen, Dr. Archna held key leadership & academician roles in Lupin Ltd., BITS-Pilani, and Mesco Pharm. Ltd., India. She has many research publications in peer-reviewed journals, conducted several workshops & trainings, delivered multiple presentations & invited lectures/talks in various forums, and has supervised many Masters’ & Ph.D. thesis work. Further, she has received many professional awards and recognitions throughout her career.

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.

Bishram Singh Chauhan is heading the global branded portfolio-IP at Sun Pharmaceutical Industries Ltd. He has rich experience of seventeen years in the field of IPR and is qualified Indian Patent Agent. He pursued Doctorate in Pharmacy from the Maharaja Sayajirao University, Baroda, with Senior Research Fellowship granted by Indian Council of Medical Research. He started his professional career as medicinal chemist and after working couple of years in medicinal research he moved to the field of Intellectual Property. He had association with major Indian pharma company like Zydus, Alembic, Wokhardt, IPCA Labs and Dr Reddy’s Lab where he was responsible for IP related to APIs, NCEs and formulations. He is associated with Sun for last 10 years with various responsibilities.

In his current role, he is responsible for controlling the global IP for branded products including NCEs and 505(b)(2) products. He is also responsible for developing the LCM strategies for the Brands which include measures to increase the market exclusivity. He also looks after the due-diligence activity for in-licensing, out-licensing and transactions on asset purchases.

On personal front, he loves to play sports with Badminton, cricket and swimming being his favorite games. He also loves to listen to music.

Bradford's practice includes the full spectrum of patent law, with a special focus on patent litigation as well as Hatch-Waxman litigation. He has represented a variety of pharmaceutical clients in matters involving various drugs, including antihistamines, analgesics, oral contraceptives, and chemotherapy agents. He has experience preparing and prosecuting patent applications in a wide variety of technical fields, including small and large molecule pharmaceuticals, software, mechanical devices, catalytic chemistry, polymer chemistry, and pharmaceutical formulations. Bradford also has experience in IP counseling for clients, including devising patent portfolio development strategies, as well as providing opinions on non-infringement, validity, and enforceability of patents, and on patentability of inventions.

Previous Work

Prior to joining ArentFox Schiff, Bradford worked at a mid-size intellectual property boutique firm in Washington, DC.

• Bradford has been recognized by Managing Intellectual Property’s “IP Stars.”

Industries

• Life Sciences

Practices

• Complex Litigation
• Appellate Patent Litigation
• Hatch-Waxman Litigation
• Litigation: District Court & ITC Litigation
• Post-Grant Proceedings
• Food, Drug, Medical Device & Cosmetic
• Drugs & Biologics
• Medical Devices Patent
• Chemical & Life Sciences

Bar & Court Admissions

• District of Columbi
• US Patent and Trademark Office
• US District Court, District of Columbia
• US Court of Federal Claims
• US Court of Appeals, Federal Circuit
• US District Court, Eastern District of Wisconsin

Education

• Georgetown University Law Center, JD, 2008
• Dartmouth College, AB, 2005 (magna cum laude, Chemistry w/ department honors)

Bethan Hopewell is a Partner at Powell Gilbert (www.powellgilbert.com), a specialist European IP firm, a Solicitor of England & Wales, an Irish Solicitor and UPC Representative.

Bethan Hopewell has a background in molecular biology, which has led her to specialize in advising clients in the life sciences sector. Bethan represented clients on some of the leading patent cases in the fields of pharmaceutics, molecular diagnostics and biotechnology. This includes two cases before the Supreme Court which remain the key UK authorities on the law of industrial application and on the infringement and validity of second medical use patents. A significant aspect of Bethan’s practice involves the strategic coordination of multi-jurisdictional patent disputes. She frequently spearheads the coordination of large-scale litigation programs advising in respect of parallel actions before the European Patent Office and national courts in Europe, the US and beyond. This multijurisdictional angle to her work also now includes advising clients on actions before the Unified Patent Court.

Chad A. Landmon chairs the Hatch-Waxman & Biologics practice group at Polsinelli. Chad's practice uniquely combines his litigation experience with a deep understanding of navigating the complex FDA regulatory landscape. He serves as first chair trial counsel in patent disputes while also handling FDA citizen petitions and litigations involving marketing exclusivities, patent listings, bioequivalence, labeling and other critical FDA approval issues. He works with clients spanning pharmaceuticals, biologics, medical devices and human tissue products with billions of dollars in annual sales. Chad also manages cases involving the cross-section of antitrust and patent law, particularly those arising from settlements of patent disputes and Hatch-Waxman Act exclusivity disputes. Chad is recognized among the world’s leading patent litigators by IAM Patent 1000, Benchmark Litigation and Law360. Chad graduated, with honors, from the University of Connecticut School of Law and is admitted to the Connecticut and District of Columbia Bar.

Overview

J. Coy Stull is an Of Counsel 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).

Areas of Focus

• 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

• Health Care
• Technology

Insights

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

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

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

News

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

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

03.09.2023
Carlton Fields Joins Florida Blockchain Business Association

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

11.01.2021
The Collective Spotlight: J. Coy Stull

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

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

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)

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)

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.

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

Jaimin Shah is an intellectual property litigator focusing on patent, trademark, and trade secret cases in federal courts across the country. His patent litigation practice is industry-agnostic, spanning diverse technology areas such as pharmaceuticals, automobile accessories, smokeless firepits, smartphone messaging apps, digital data compression systems, and LED luminaires.

Overview

Jeremy Lowe represents clients in high-stakes patent trials and appeals and other complex litigation matters with a focus on pharmaceuticals and medical devices. Boasting more than 24 years of experience as a trial and appellate attorney, he works with both plaintiffs and defendants in state and federal courts to consistently achieve favorable outcomes.

Recognized for his exceptional legal acumen, Jeremy has successfully represented clients before multiple U.S. district courts, the U.S. Patent and Trademark Office, the U.S. Court of Appeals for the Federal Circuit, and the U.S. Supreme Court. His notable victories include defending a multibillion-dollar jury trial and achieving a landmark ruling that reshaped 150 years of double patenting law.

Jeremy’s undergraduate degree in chemical engineering and capacity to understand high-level STEM materials have laid the foundation for exceptional legal services and outcomes. He prioritizes honest and transparent communication with clients, proactive and ethical legal strategies, professional relationship maintenance with opposing counsel, and winning by all means necessary.

Education

• Washington University in St. Louis School of Law, 1999 (J.D.)
• University of Missouri – Columbia, 1996 (B.S.)

Bar Admissions

• Missouri
• Illinois
• Connecticut
• New York
• U.S. Patent and Trademark Office

Court Admissions

• U.S. Supreme Court
• U.S. Court of Appeals for the Federal Circuit

Community Involvement

• Girls and boys youth athletics and team sports, head coach

Distinctions

• Litigation Counsel of America, Order of Certus, Barrister
• Martindale-Hubbell Peer Review, AV Preeminent
• University of Missouri, Academy of Distinguished Alumni, Chemical Engineering, Fellow
• Chambers USA, Recognized Practitioner, 2016
• Hartford Business Journal, Top 40 Under 40 Business Leaders, 2013
• Connecticut Law Tribune, New Leaders in the Law, 2012
• Connecticut Magazine, Top 40 Under 40 People, 2012

Memberships

• Trial Law Institute
• Diversity Law Institute

Presentations and Publications

• “Dissecting the Obviousness-Type Double Patenting Debate,” Law360, November 2024

Related Experience

• Successfully defended a leading industry client in a $100 million+ patent infringement trial against a top film manufacturer involving photosensitive films.
• Represented a global pharmaceutical company in a multibillion-dollar patent infringement trial over anti-seizure medications.
• Secured a summary judgment of patent infringement for a pharmaceutical company in a sleep medication dispute.
• Defended a Fortune 100 company in a $30 million+ antitrust and patent infringement trial involving respirator technology.
• Represented a global pharmaceutical company in a patent infringement trial concerning sterile solution formulations.
• Advocated for an international pharmaceutical company in a patent infringement case involving gastric retention formulations.
• Represented a global pharmaceutical company in a patent infringement trial over oral film technologies.
• Represented an international pharmaceutical company in a trial before the Patent Trial and Appeal Board involving anti-fungal compounds.
• Secured summary judgment in a patent infringement case for an international pharmaceutical company regarding anti-viral medications.
• Successfully negotiated settlement in a patent infringement matter involving cancer treatment drugs for a global pharmaceutical company.
• Represented a Fortune 50 company at the Federal Circuit in a case involving medical implant technologies.
• Advocated for a pharmaceutical company at the Federal Circuit in a landmark anti-viral medication case reshaping 150 years of double patenting law.
• Represented a global pharmaceutical company at the Federal Circuit in an appeal involving sleep medication patents.
• Defended a pharmaceutical company at the Federal Circuit in a case over oral film formulations.
• Represented international clients as amici in three Federal Circuit appeals addressing double patenting law.
• Represented international client at the Supreme Court in response to a cert. petition.

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. Dnyaneshwar Shelke has over 17 + years of experience in Pharma industries in the field as Medicinal chemist, intellectual property, and portfolio management professional and currently is a Head intellectual property & product portfolio management at Unichem laboratories based in Mumbai, Maharashtra. Previously, Dr. Dnyaneshwar was an AGM Intellectual Property management at Alkem Laboratories and held positions at Mankind Pharmaceutical, Macleods Pharmaceuticals, Glenmark Pharmaceuticals and Calyx chemical and Pharmaceutical. Dr. Dnyaneshwar received a Doctorate in Medicinal Chemistry from Mumbai University, Mumbai and a Master of Science degree in Organic Chemistry from the University of Pune.

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.

Areas of Focus

• Intellectual Property
• Cybersecurity and Privacy
• Technology

• Technology

News

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

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

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

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

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

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)

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

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)

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.

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.

Mr. Kaushal Joshi is an experienced IP & Legal professional with expertise in Pharma/Biopharma Patents & corporate legal. He is heading IP of Kashiv Biosciences. His practice focuses on Life sciences patent issues, Biosimilar litigation, Biosimilar pre-litigation strategy, IP generation, IP filing strategy, prosecution, IP due diligence & other legal issue impacting the pharmaceutical and Biotech industries.

Mr. Kaushal’s expertise lies in designing of IP strategy for Biosimilars (first and second wave biosimilars), new biologics (Antibody, vaccine) prosecution & Litigation. He has participated in litigation, opposition proceeding in India, Europe and USA including BPCIA litigation. He has drafted more than 100 patent applications & prosecuted several applications pertaining to biologics & small molecules in several jurisdictions

He has filed more than 150 patent applications since 2019 in current organization.

He has a hands-on laboratory experience in protein purification & vaccine which makes him more competent to creates comprehensive road-map of scientific technology, solving legal & scientific issues and device fruitful IP strategy to meet business objective.

He worked in Cadila Healthcare, Glenmark and Lupin Pharma before joining the Kashiv.

Madhav D Trivedi, an accomplished Intellectual property professional with over 17 years of experience in pharmaceutical industry, specializing in API, formulation, and biosimilar. With a strong academic foundation, including Master’s degree in Organic Chemistry, LL.M. in intellectual property rights and post Graduate diploma in IPR, Mr. Trivedi has expertise in patent laws, infringement analysis and strategic IP management for global market especially India, USA, Europe and other regulated markets. He has successfully developed IP strategies for more than 300 molecules, filed 150+ patents and played a pivotal role in cross-functional collaboration across multiple jurisdiction. He has worked with the companies like Zydus Lifesciences, Piramal enterprises, Pharmathen SA, Strides Arcolab and currently heading IP department in BDR pharmaceutical. Renowned as a speaker at international IP conferences and in universities, he is recognized for his innovative contributions and leadership in the IP domain.

Manisha Chhabra is the Global Lead-Intellectual Property for FTO Formulations at UPL, a prominent global provider of sustainable crop protection and food production solutions. With over 17 years of experience in the pharmaceuticals and agrochemicals industry, she holds a Master of Pharmacy, a Bachelor of Laws, a Post Graduate Diploma in Patents Law, and is a registered patent agent with the Indian Patent Office. In her current role, she oversees global IP strategy and operations for UPL's formulation products, ensuring compliance, innovation, and value creation. She has conducted comprehensive FTO analyses, patent searches, risk assessments, and contributed to the development and filing of supplementary protection certificates. Additionally, she has resolved IP disputes, enhancing UPL's IP assets and competitive edge. Prior to UPL, she worked in the IPR departments of Macleods, Jubilant Generics, and Mankind Pharma

Marc Lauzeral is a lawyer at the Paris Bar. Counsel at specialist patent litigation firm Schertenleib Avocats in Paris, France, Marc’s practice is focused on complex cross-border patent, SPC, and trade secrets disputes. Marc has extensive experience at every stage of litigation, from preliminary injunction to final hearing and appeal before French Courts and the Unified Patent Court. In addition to previous experiences in international law firms, Marc was a law clerk for the intellectual property judges of the Lyon Court of First Instance which allowed him to prepare and attend over fifty hearings, and to draft decisions. Marc is a member of the UPC Standing Committee of the AIPPI.

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.

• Seasoned Pharma IP professional having 22+ years of experience in Pharma Research, and IP & Portfolio Management.
• Currently associated with Sun Pharma, Mumbai as Sr. General Manager - IP Management.
• Has completed Ph. D. (Pharma Sciences), Law graduation (L.L.B.) and Leadership Development Program (IIM, Ahmedabad).
• Has worked at various leadership positions in past with Wockhardt Ltd., Glenmark Pharma Ltd., and Dr Reddy’s Ltd.

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.

A seasoned pharmaceutical professional with diverse & well-rounded IP experience of 19 plus years. Currently Heading the IP Group at Amneal Pharmaceuticals, wherein he works towards aligning the IP strategy with business objective. Devising IP invalidation/design around strategies, Paragraph IV strategies, claim chart, FLBs/notice letters, assisting litigation by closely working with in-house and/or external counsel to enable IP based launches. Providing end-to-end IP guidance to relevant stakeholders on API, Finished product, Device & other matters including trademark. His interactive & collaborative approach, enviable perspective on business intelligence and ability to connect the dots has helped the organization achieve strategic business goals or identify new business/ growth opportunities. Purab offers a unique blend of science, patent law & ANDA strategy for handling and advising on complex generics product development.

Areas of focus are:

• Finding early launch opportunities via IP based design around or invalidation
• Ensuring creative, business-focused solutions to resolve IP disputes/Litigation
• Partner with Portfolio team in identifying new products & joint ideation opportunity
• IP creation & patent filing by capturing the white space for 505(b)2 projects
• Provide strategic IP support for BD activities - Due diligence, M&A & other partnering opportunities
• Ensure alignment of IP, BD, RA and R&D strategies
• Advising on exclusivity matters, critical FDA letters & collaborating with Regulatory affairs
• IP strategies for new geographies – Enabling expansion in India & International markets
• Advising business, commercial & marketing teams on Trademark strategies for India & International markets

Prior to joining Amneal, He was associated with Dr. Reddy’s Laboratories & Wockhardt Research Centre. He holds Master’s degree in pharmaceutical sciences from BITS Pilani, Rajasthan. He is a registered patent agent with the Indian patent office and holds a diploma in patents law from the NALSAR University, Hyderabad.

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.

Rakesh Satpathy, Director of Legal & Technology Solutions at Epiq is a seasoned sales and business development professional with more than 12 years of experience helping corporates, agencies and top-notch law firms (India and Am law) in forensics, litigation support, investigations, eDiscovery & IP infringement matters. An expert in eDiscovery and forensics technology, believe and passionate about problem solving and providing solutions. My technical background with legal business acumen makes me an ideal candidate for the business consulting in legal & forensics domain. Currently, working as a sales leader for APAC-India region contributing for revenue and positioning Epiq in India.

Roshan Shrestha focuses his practice on intellectual property law, including patent litigation, prosecution, and opinion work in the chemical, pharmaceutical, and electronic material arts. He has broad litigation experience, including district court litigation, contested AIA proceedings, e.g., Re-examination and Inter Partes Review (IPR) at the Patent Trial and Appeal Board (PTAB) in the United States Patent and Trademark Office (USPTO), International Trade Commission (ITC), and appellate matters.

Sal Patel co-chairs ArentFox Schiff’s Intellectual Property Litigation practice. Sal is a seasoned trial attorney and has first-chaired more than 10 trials and appeals. He is passionate about implementing creative and scientifically sound arguments for his clients, which have resulted in legal precedent-setting cases.

Sal has served as lead counsel on numerous patent infringement litigation matters, trademark infringement litigation matters, and other commercial disputes.

Sal is effective both in trials and in negotiating favorable settlements for his clients. There are many moving parts in patent litigation, and he is skilled at coordinating multiple parties, experts, and arguments into coherent and persuasive cases. In cases where there are multiple defendants, he represents his clients in a way that makes them stand out from the rest, leading to more favorable results. He also assists companies in Paragraph IV and biosimilars design strategies, helping his clients protect their scientific discoveries.

Sal has represented pharmaceutical companies in many cases involving Paragraph IV disputes and counsels clients on biosimilars. He has also represented clients in patent litigation involving wind and solar technology, medical devices, life sciences, food processing, automotive components, and software, among other sectors.

With a background in chemical engineering, he has significant experience in preparing and prosecuting patent applications in a variety of technologies. Sal also has significant experience with patent and trademark proceedings in the U.S. Patent and Trademark Office.

Clients rely on Sal for intellectual property transactions and licensing, including contracts involving patent, trademark, copyright, and computer and technology law.

In addition to his legal practice, Sal chairs the firm’s Diversity, Equity, and Inclusion Committee.

Client Work

• Pfizer v. Aurobindo (D. Del. 2021) Representing Aurobindo in palbociclib, Ibrance®, ANDA litigation
• Eagle Pharmaceuticals v. Aurobindo (D. Del. 2020) Representing Aurobindo in bendamustine, Bendeka®, ANDA litigation
• Allergan v. Akorn (E.D. Tex. 2017) Successfully defended Akorn at trial in the E.D. Texas invalidating Allergan’s patent covering Restasis®, a billion dollar ophthalmic product
• Allergan v. Aurobindo Pharma (D. Del. 2018) Lead counsel for Aurobindo in linaclotide, Linzess®, ANDA litigation
• The Medicines Company v. Aurobindo (D.N.J. 2017) Lead counsel for Aurobindo in bivalirudin ANDA litigation
• Horizon v. Lupin (D.N.J. 2017 and Fed. Cir.) Lead counsel for Lupin in Vimovo® ANDA litigation
• Mylan Institutional v. Aurobindo (E.D. Tex. 2017 and Fed. Cir.) Lead counsel for Aurobindo in patent litigation involving isosulfan blue
• Eli Lilly v. Ajanta and Aurobindo (E.D. Va. 2017) Lead counsel for Aurobindo and Ajanta pharmaceuticals in litigation involving tadalafil, Cialis®
• The Medicines Company v. Aurobindo (D.N.J. 2017) Lead counsel for Aurobindo in bivalirudin, Angiomax®, ANDA litigation
• Allergan v. Akorn (M.D.N.C. 2016 and Fed. Cir.) Lead counsel for Akorn on bimatoprost, Latisse® and Lumigan®, ANDA litigation
• Depomed v. Alkem (D.N.J. 2016 and Fed. Cir.) Represented Alkem in tapentadol, Nucynta®, ANDA litigation
• Pfizer v. Fresenius Kabi (D. Del. 2016) Represented FK in tigecycline 505(b)(2) trial
• Otsuka v. Ajanta and Orchid (D.N.J. 2016) Lead counsel for Ajanta and Aurobindo in aripiprazole, Abilify®, ANDA litigation
• Acorda Therapeutics v. Aurobindo, Accord and Alkem (D. Del. 2016) Representing Aurobindo, Alkem and Accord in dalfampridine, Ampyra®, ANDA litigation
• Dexcel v. Sun (D.N.J. 2017) Represented Sun Pharmaceuticals in omeprazole delayed release litigation
• Pfizer v. Aurobindo (D.N.J. 2015) Lead counsel for Aurobindo in linezolid ANDA litigation
• Janssen v. Aurobindo (D.N.J. 2015) Lead counsel for Aurobindo in galantamine ANDA litigation
• Forest v. Sun Pharmaceuticals (D.Del. 2014) Lead counsel for Sun Pharmaceuticals Ltd. in ANDA litigation of the Alzheimer drug Namenda®,memantine XR
• AstraZeneca v. Aurobindo (D. Del. 2016 and Fed. Cir.) Lead counsel for Aurobindo in ANDA litigation of diabetes drug Onglyza® (saxagliptin)
• Cephalon v. Glenmark (D. Del. 2014) Lead counsel for Glenmark in bendamustine ANDA litigation
• Teva Women’s Health v. Lupin (D.N.J. 2012 and Fed. Cir.) Lead counsel for Lupin in ANDA litigation for birth control drugs Seasonique and Loseasonique
• Teva Women’s Health v. Lupin (D.N.J.) Represented Lupin in Seasonale® ANDA litigation
• Warner-Chilcott v. Lupin (D.N.J.) Represented Lupin in Loestrin and Femcon ANDA litigation
• Sciele Pharma v. Lupin (D. Del.) Represented Lupin in metformin, Fortamet, ANDA litigation
• Shire v. Mylan (D. Del.) Represented Mylan in lanthanum carbonate ANDA litigation
• Abbott Laboratories v. Mylan Inc. (N.D. Ill.) Represented Mylan in lopinavir/ritonavir ANDA litigation
• AstraZeneca v. Sandoz (D.N.J.) Represented Sandoz in quetiapine ANDA litigation
• AstraZeneca v. Lupin (D.N.J.) Represented Lupin in esomeprazole ANDA litigation
• Sepracor v. Lupin (D.N.J.) Represented Lupin in eszopiclone ANDA litigation
• AstraZeneca v. Lek and Sandoz (S.D.N.Y.) Represented Lek and Sandoz in omeprazole litigation. Obtained a finding of non-infringement opening the U.S. market for a generic version of Prilosec

• Rosco, Inc. v. Safety Vision (S.D. Tex. 2020) Lead counsel representing Safety Vision in patent litigation involving vehicle mirror/monitor systems
• Estech v. Houston Wire & Cable (W.D. Tex. 2020) Lead counsel representing Houston Wire & Cable in patent litigation involving VoIP systems
• MillerCoors v. HCL Technologies (N.D. Ill. 2018) Representing HCL in SAP software implementation dispute
• Rosco Inc. v. Velvac Inc. (S.D.N.Y 2015) Lead counsel for Velvac in patent litigation involving fender mounted mirror assemblies
• Kodak v. DR Systems (S.D. Cal. 2009) Represented Kodak in patent litigation involving MRI imaging systems
• Schreiber Foods v. Saputo Foods (N.D. Ill.) Represented Schreiber in patent litigation involving imitation cheese
• Continental Can v. Orexo (N.D. Ill.) Represented Continental Can in patent litigation involving oxygen barrier films

• Joseph Legat v. Legat Architects, Inc. (N.D. Ill. 2021) Representing Legat Architects in trademark infringement litigation
• Purepecha Enterprises Inc. v. El Matador Adobos, et al. (N.D. Ill. 2012) Representing El Matador Adobos in trademark infringement dispute
• Sal has also handled many inter partes review petitions in the USPTO relating to LED lighting patents, pharmaceuticals, and internet technology

Boards, Memberships & Certifications

• American Bar Association
• Asian American Bar Association of Chicago, Honorary Board Member
• Indian-American Bar Association of Chicago, Advisory Council, Past President
• North American South Asian Bar Association, Former Board of Directors, Intellectual Property Section, Former Chair
• Intellectual Property Law Association of Chicago, Past Board of Managers

Professional Activities

• Chicago-Kent College of Law, Pharmaceutical Patent Law, Adjunct Professor

Publications, Presentations & Recognitions

• “R&D Using the Metaverse and Digital Twins," Applied Clinical Trials Magazine (Aug. 11, 2022)
• “The Supreme Court’s Mayo v. Prometheus Decision: The Implications for Biotechnology," (co-author) The National Law Review (Mar. 23, 2012)
• “There Is No Orange Book: The Coming Wave of Biological Therapeutics,” (co- author) Oxford University Journal of Intellectual Property Law & Practice (2011)
• “Inequitable Conduct: Therasense En Banc,” SpicyIP Blog, (India) (Mar. 27, 2011)
• “Northern Ill.’s New Local Patent Rules,” Law360 (Nov. 6, 2009)
• “Federal Circuit Review of Markman Issues (2002),” Litigation Committee, Intellectual Property Law Association of Chicago (IPLAC) (Dec. 2003)
• “Federal Circuit Review of Markman Issues (2001),” Litigation Committee, Intellectual Property Law Association of Chicago (IPLAC) (Dec. 2002)

• "Overcoming IP Issues Relating to the Metaverse and Augmented Reality," 6th World Legal Tech Summit, Luxatia International, Conference (Sept. 8, 2023)
• “Patenting AI: Navigating National & Regional Differences, Protecting Inventions and Outputs,” Global IP ConfEx Collaborative Roundtable Discussion, Conference (May 24, 2023)
• “Building a Robust Invention Harvesting Program - is there a Special Sauce?” IP & Secret Sauce - Virtual Round Table Discussion, Webinar (Apr. 28, 2023)
• “RVIA General Counsel Meeting,” RV Industry Association, Conference (Oct. 5, 2022)
• “Trends in Hatch-Waxman Litigation,” IPR Connexion, Webinar (Sep. 2, 2021)
• “Section 112 Considerations on Pharmaceutical Patents and Litigation,” IPR Connexion, Webinar (Sep. 1, 2021)
• “Diversity in the Legal Profession,” TerraLex 2020 Virtual Global Meeting, Webinar (Nov. 12, 2020)
• “Inherent Obviousness: A Case Study on a Less Known but Effective Defense”, 9th Annual Pharma IPR Conference 2020, Mumbai, India (Mar. 4, 2020)
• “Doctrine of Equivalents: Latest from the Federal Circuit,” Intellectual Property Owners Association, Webinar (Oct. 2, 2019)
• “Doctrine of Equivalents: Tips for Plaintiffs, Defendants, and Patent Prosecutors,” Intellectual Property Owners Association, Webinar (Jun. 18, 2019)
• “2018: A Year of Change for Post Issuance Proceedings,” 4th Annual IP Strategy Summit: Chicago, Chicago, Ill. (Jun. 5, 2018)
• “The On-Sale Bar and its implications in Hatch-Waxman Litigation,” Pharma IPR conference, Mumbai, India (Mar. 2018)
• “A View from the Bench: The Federal Judges Speak on Paragraph IV Litigation,” (moderator) Paragraph IV Disputes Master Symposium – ACI’s Hatch-Waxman Series, Chicago, Ill. (Oct. 3, 2017)
• “The State of the Asian American Attorney in Chicago Law Firms,” (panelist) The Chicago Committee, Chicago, Ill. (Jun. 3, 2015)
• “Takeaways from High-Profile Biosimilar Court Cases,” Business of Biosimilars Conference, Boston, Mass. (Oct. 21, 2014)
• “Perils of the Safe Harbor: Understanding How the Resetting of the Boundaries of 271(e)(1) in the Aftermath of Classen and Momenta Is Impacting Paragraph IV Litigation Strategies,” American Conference Institute, New York, N.Y. (Apr. 29, 2014)
• “Cost-Effective Litigation Management Strategies for Paragraph IV Litigation,” Pharma IP and Regulatory Conference, Mumbai, India (Feb. 26, 2014)
• “Formulating Assertions and Defenses in View of New Substantive and Procedural Developments in the Federal Courts and PTO,” Paragraph IV Disputes Master Symposium, American Conference Institute, Chicago, Ill. (Oct. 3, 2013)
• “Freedom to Operate Issues and Patent Litigation Considerations for Biosimilars,” Second International Conference on Biowaivers and Biosimilars, Raleigh, N.C. (Sep. 23, 2013)
• “Breaking Developments in Hatch-Waxman Litigation: Paragraph IV Disputes and Beyond,” Legal and Regulatory Summit on Generic Drugs, New York, N.Y. (Jul. 17, 2013)
• “Antitrust Concerns in Settlement of Paragraph IV Litigation,” Pharma IP and Regulatory Conference, Mumbai, India (Apr. 10, 2013)
• “Evaluating the Patentability Standards in the Pharmaceutical Industry to Mitigate the Risks Involved in Product Launches in Analyzing Freedom-to- Operate Issues,” Pharma IPR Conference, Mumbai, India (Feb. 1, 2012)
• “A Glimpse of the Future – US Biosimilars Litigation Considerations,” Biopractice.com, Webinar (Dec. 15, 2011)
• “Alleging and Defending Against Inequitable Conduct in a Paragraph IV Case: Legal and Ethical Considerations,” Paragraph IV Disputes, American Conference Institute, New York, NY (May 4, 2011)
• “IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trade Dress, and More,” Paragraph IV Disputes, American Conference Institute, New York, NY (May 2, 2011)
• “The Scientist: Discussing the ‘Invention’ History With an Eye Towards Distinguishing the Innovative Nature of the Generic Product and Proving Invalidity,” Paragraph IV On Trial, American Conference Institute, New York, NY (Nov. 13, 2009)

Recognitions

• IAM Patent 1000 – Patent Litigation, Illinois, (2019-2022)
• Life Sciences Star – Hatch-Waxman Patent Litigation, LMG Life Sciences (2018- 2022)
• The Best Lawyers in America, Best Lawyers (2019-2024)
• The Legal 500 United States – Patents: Litigation (2021-2023)
• Chambers USA – Intellectual Property, Illinois (2021 and 2023-2024)
• Illinois Super Lawyers, Thomson Reuters (2009, 2012-2014, 2018-2021)
• IP Star, Managing Intellectual Property (2013-2020)
• Illinois Leading Lawyer, Law Bulletin’s Illinois Leading Lawyers Network (2013- 2021)
• Nation’s Best – Midwest Region, Lawyers of Color (2019)
• Peer Reviewed AV® Preeminent™, Martindale-Hubbell (Since 2014)
• Named to The National Law Journal’s Chicago’s 40 Under 40 Attorneys List for 2013

Industries

• AI, Metaverse & Blockchain Beverage & Food
• Life Sciences

Practices

• Advertising & Promotions Complex Litigation Patent Litigation
• Hatch-Waxman Litigation
• Environmental, Social & Governance (ESG)
• Patent
• Chemical & Life Sciences
• Trade Secrets, Noncompetes & Employee Mobility

Bar & Court Admissions

• Illinois
• US Court of Appeals, Federal Circuit
• US District Court, Northern District of Illinois (Trial Bar)
• US District Court, Eastern District of Michigan
• US Patent and Trademark Office

Education

• Boston College Law School, JD, 1999
• Northwestern University, BS, 1996

Shirshendu holds a graduate degree in Pharmaceutical Sciences and a postgraduate degree in Pharmaceutical Chemistry from BIT, Mesra, Ranchi. After completing his master’s, he began his corporate journey at Zydus Research Centre, where he worked in the chemistry department as a Scientist and later as a Senior Chemist for three years.

Following his industry experience, he transitioned into academia and pursued a PhD. At the M S University of Baroda, supported by a scholarship from AICTE, under the mentorship of Prof. M R Yadav.

After earning his doctorate degree, Shirshendu entered the field of Intellectual Property. He gained initial IP experience at Torrent Pharmaceuticals. After Torrent, he joined Evalueserve, a consultancy firm, where he worked closely with major pharmaceutical companies on IP strategy and analytics.

In 2011, he joined Dr. Reddy’s Laboratories, where he has spent over 14 years handling multiple roles within the IP department. Currently serving as Head – Special Projects (API-IP) at Dr. Reddy’s Laboratories, he is responsible for generating IP-related revenues and driving strategic initiatives. His expertise includes patent strategy, IP analytics, freedom-to-operate assessments and revenue generation through intellectual property.

Sridevi Krishnan heads the Intellectual Property (IP) function at Piramal and is Piramal’s in-house patent & trademark attorney with a techno-legal background, having a Masters degree in Organic Chemistry and being a gold-medallist in law, at both levels of LL.B and LL.M. She has about 30 years of experience spaced out in Medicinal Chemistry and in Intellectual Property (IP). She is a certified Indian patent & trademark agent, has a Diploma in Patent Law, and a Diploma in International Business Development. Sridevi is responsible for providing patentable and non-infringing solutions; creating invalidation strategies as required and providing IP support to all businesses of Piramal in terms of handling patents, trademarks, copyrights, designs, product selection and IP litigations. She has during her tenure with Piramal handled patent and other IP related matters pertaining to multiple businesses globally such as API, formulation (solid oral forms and injectables), new chemical entities, herbal, medical devices, critical care, and OTC products. Sridevi has won several awards both individually and for her organisation such as “Powerful women in IP-WIPF-2021”, “Top 100 IP leaders of India-WIPF-2018”, “NITI Aayog Award-2020”, “Woman leader in Innovation-2019”, “Best Use of IP in Innovation to Piramal 2019”, “IP Gem of India 2018 & 2019,” “IDMA team award-2015-16 & 2026-17” and GIPC award for “Catalyst for social impact through IP”. She has been an invited speaker at several forums like the 3rd Annual IPR Asia Summit-Nov 2020, Pharma Patent, Portfolio Management-Oct 2020, 4th Annual Pharma Project & Portfolio Management Summit 2021, 10th Annual Pharma IPR 2021, WIPF-2023 & 2024, GIPC-2025; and a resource person at Colleges of Pharmacy for sessions on IP. She had also authored several informative articles in ‘The Pharma Review’ between 2016-2020.

Sudha Kannan is Vice President (IP & Statutory Compliance-R&D) at Advanced Materials-Aditya Birla Chemicals (Grasim Industries), part of Aditya Birla Group, Mumbai. She holds a master’s degree in chemistry and a PhD in Information Science. She additionally holds a diploma in Patent Law & Practice and is a registered Patent Agent with the Intellectual Property Office, India.

Beginning a career in the pharmaceutical industry, she worked with some of the largest libraries in Mumbai and moved to the area of patents and is currently leading the Patent and Regulatory & Compliance activities in Aditya Birla Chemicals – Advanced Materials (Grasim Industries). In a career spanning over three decades, she has worked in in various roles in R&D, IP and Regulatory and 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.

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

I have 28 years of IT industry experience at TCS, spanning across the entire gamut of Intellectual Property Management & Governance , Product Engineering, Presales, Business Strategy Planning, Program Management and Delivery, Practice Management, Alliance and Analyst Relations Management.

Currently as part of the TCS Corporate IP & Engineering Group, I am responsible for establishing corporate IP governance processes and systems for TCS IP, customer IP and third-party in IP products, platforms and solutions. I also work closely with different TCS business units to guide them on IP creation & protection, risk management and assetization; enabling them with IP and software engineering best practices and compliance to IP commitments, and establishing IP linkages in TCS offerings.

I regularly interact with global IP ecosystem stakeholders, including industry and professional bodies, government agencies and other organizations, to promote collaboration, policy interventions and ecosystem maturity in intellectual property. I have also represented TCS on the technical advisory board for the Indian Patent Office and have been associated with Licensing Executives Society International (LESI) since 2014.

Prior to this, I held leadership roles across TCS Life Sciences and Healthcare, Energy and Resources, Banking & Financial Services, Insurance, Manufacturing and Utilities and Travel & Hospitality units and also led the TCS Knowledge Management Practice.

I am a highly pro-active and result-oriented individual and bring high energy to the workplace and take complete ownership of initiatives I am involved in. I have strong networking skills and have excellent working relationships with customers/partners and within the organization at all levels. I have a good perspective of industry trends, customer business and technology challenges and mapping an organization’s services and offerings to the same.

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.

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.

• I am a senior professional in the field of pharmaceutical science and have 16 years of working experience in intellectual property, portfolio planning, and business development activities.
• I am currently heading global intellectual property and litigation activity along with portfolio management for Unison Pharmaceuticals Pvt. Ltd for global markets such as the US, Europe, Canada, Australia, New Zealand, India, and the rest of the world.
• Unison Pharmaceuticals is one of the fastest-growing pharmaceutical industries in India in generic/branded side business across the globe.
• Prior to joining Unison, I worked with various top 5 US-based MNCs such as Amneal Pharmaceuticals, Lupin Ltd, Zydus Cadila, and Alembic Pharmaceuticals Ltd.
• I have completed Master in Pharmacy from NMIMS, Mumbai, Master in Business Management (M.B.A) from NMIMS, Mumbai and a Pharmaceutical Doctoral (Ph.D.) Science from Gujarat University.
• I have also completed a postgraduate diploma in patent law from NALSAR University. I am a registered Indian Patent & Trademark attorney since 2013.

• Responsible for leading and managing global IP strategies such as patent prosecution, patent litigation, IP creation and valuation, enforcement of IP rights and patent litigation settlement activities.
• Handling global patent litigation for US, Europe, Canada, and India markets by discussion and strategy with in-house and outside attorneys/counsels.
• Handled more than 30 countries patent prosecution for successful grant of broad patent such as Japan, Canada, Australia, South Africa, China, Malaysia, Philippines, Thailand, Vietnam, Singapore, New Zealand, South Korea, Mexico, Brazil, Russia, Eurasian, USA, Europe, India, Central America, Taiwan, Argentina etc.
• Handled more than 30 products IP litigation for US and Europe markets along with settlement with brand companies for the organization.
• Leading the strategy and portfolio steering committee in prioritization of early/late- stage product pipeline to manage organization revenues.
• Interaction with US/European/Indian attorney’s for ongoing product IP filing strategy on regular basis.

• Pharma IPR 2024
• WIPF 2024
• Pharma & Biotech Litigation, Germany 2023
• Pharmaceutical Resource Planning and Portfolio Management, Philadelphia, USA 2022
• WIPF, Thailand – 2022
• IP, Pharma Project & Portfolio Management Summit, Mumbai – 2021
• IP Gorilla Conference, Singapore - 2021
• Pharma IPR, Mumbai - 2020
• IP Gorilla Conference, Dubai - 2020
• International Summit at Indian Patent Office, RGNIIPM, Nagpur -2019
• Department of Science & Technology (DST), Gandhinagar – 2019
• Gujarat Council of Science & Technology (GUJCOST), Gandhinagar - 2019
• Atal Innovation Mission, NITI Aayog Govt of India, Gujarat – 2017
• World Intellectual property Forum (WIPF), New Delhi - 2016
• Gujarat Technical University (GTU), Ahmedabad – 2015

Vishal Sudan is an accomplished leader in Intellectual Property (IP) management, currently serving as the Head of IP at Fresenius Kabi (GBS). With a strong academic foundation that includes an M.Sc. in Chemistry and an LLB, he is also recognized as an Indian Patent Agent. Vishal is an alumnus of the prestigious Indian Institute of Management (IIM), as well as Guru Nanak Dev University (GNDU) and Punjabi University.

His professional journey encompasses significant roles at leading organizations such as Sun Pharma, Evalueserve, and Panacea Biotec, where he honed his expertise in both synthetic chemistry and IP management. This diverse experience equips him with a unique perspective on navigating complex patent landscapes in the pharmaceutical industry.

Notably, Vishal actively representing Fresenius Kabi before the Indian Patent Office, and the Delhi High Court, demonstrating his proficiency in legal advocacy within the IP domain.

At Fresenius Kabi, Vishal is dedicated to advancing innovative IP strategies that align with global standards and best practices. His leadership not only enhances the company's IP framework but also contributes to fostering a culture of innovation and growth within the organization….”