Director – Intellectual Property - Cipla
co-founder - ipEssentia
Dr. Alka is currently associated with ipEssentia as Co-Founder since August 2020. Alka recently worked at Alkem Laboratories Limited as Global Head IP (from Jan 2019- May 2020). Alka is based in Mumbai, India.
In her previous assignments, she’s worked for Lupin Limited, as Head, IP (Formulations) leading a team of 38+ professionals. Prior to that, she’d worked with Cipla limited as Head, IP Department (was leading a team of 30+professionals, been responsible for setting up the same single-handedly from scratch).
Dr. Alka obtained her bachelor’s degree in pharmacy from Mumbai, followed by Master’s and Doctoral degree in pharmaceutics. She then went on to obtain Bachelor’s in Law and a Post-graduate Certificate in Intellectual Property Law and Practice (PGDPLP) from University of Mumbai. She’s also received CPVA (Certified Patent Valuation Analyst from Business Academy, USA) to her credit. She’s admitted to practice before Indian Patent Office. Most recently, she’s completed her Doctoral studies in Pharmaceutical law.
Dr. Alka started her career in Research department post her doctoral studies and after few years changed to Intellectual Property field. In her Industry tenure of almost 25 years, Alka has worked in different departments of pharmaceutical companies viz. Research, regulatory, IP, etc.
Dr. Alka’s responsibility with Alkem was to manage Alkem’s IP department- protecting and defending Alkem’s IP rights worldwide covering ALL of patent issues across Alkem’s offices worldwide.
In her tenure with Cipla, the company received many IP accreditations (viz “Best Case award” by Managing IP group in Hong Kong and Platinum award for patents by IPA in Sept 2015). India Business Law Journal published her views about Indian Patent law in their September 2015 issue.
Alka is a regular speaker on Patents matters.She also teaches in premier Pharmacy and Patent Institutes in Mumbai and is also examiner to post-graduate pharmacy and IP students at Mumbai and NMIMS University. Alka was designated as IP star in 2015 by Managing IP forum. She was also nominated as distinguished IP Counsel (Female) category in the year 2018 by Legal Era and was recognized amongst “Top 100 Powerful Women in Law” by World Intellectual Property Forum (in 2017 and in 2021).
Vice President- Global IP Head - Intas Pharmaceuticals Ltd.
Dr. Alpesh Pathak is currently Vice President - Global IP Head at Intas Pharmaceuticals Ltd.
Dr. Alpesh has also written two books Entitled “Protecting Patent Fundamentals” and
“Understanding Global patent litigations through landmark judgements – A litigation ready reckoner”
which is well appreciated in patent professionals and major universities wherein patent is one of the
value-added subject in the respective technical discipline. The second book is just published.
Dr. Alpesh Pathak has received an international award for the Top 50 In-house counsel in Singapore
and also received several other awards for his contribution in the field of Intellectual Property since
last more than two decades.
Having spent more than two decade in the field of IP, he works on a variety of intellectual property
matters at Intas at Global Level, including IP due diligence of Biosimilar, IP activities for 351(k) filing,
FTF Para IV filing, handling patent litigations across the globe and related activities, drafting and
prosecution of patent applications, drafting and negotiation of intellectual property agreements with
third parties, and due diligence analyses in supporting in-licensing and out-licensing activities.
Prior to joining Intas, Dr. Alpesh has worked with some of the leading pharmaceutical companies
like Alembic Ltd, Lupin Ltd., Zydus Cadila and Cadila Pharmaceuticals. Alpesh holds a PhD degree
from The Sardar Patel University. Dr. Alpesh Pathak is a registered Patent agent. Besides having
PG diploma in Patent Law degree from Nalsar Uni, Hyderabad, he has undergone various
specialized courses on US litigations and European patent practices. He has completed Masters
from the Sardar Patel University, and a B.Sc. from the Same University with specialization in organic
chemistry. Dr. Alpesh is also active in certain knowledge development programs for creating IP
awareness by conducting lectures in various universities and conferences in India and abroad. He
also currently a visiting faculty at Sardar Patel University and Gujarat Technical University (GTU).
Dr. Alpesh Pathak has contributed as speaker in more than 90 leading IP
conferences/Seminars/workshop across the globe.
Managing Associate - Simmons & Simmons
Amy is a Managing Associate in Simmons & Simmons’ patent litigation group in London. She has a technical background in biochemistry and her notable experience includes numerous high-profile monoclonal antibody patent cases in the UK courts, as well as coordinating multi-jurisdictional litigation and supporting EPO opposition proceedings.
She has extensive experience of biosimilar litigation, in particular acting for Samsung Bioepis in relation to its adalimumab biosimilar; including the widely reported litigation against AbbVie (which resulted in so called “Arrow” declaratory relief being granted for the first time by the UK courts) and subsequent disputes concerning adalimumab formulation patents in multiple European jurisdictions concerning patents and utility models held by Fresenius Gedeon Richter. She has also worked on innovator vs innovator disputes for Eli Lilly (in relation to its anti-A? candidate for Alzheimer’s disease, Solanezumab), Merck Sharpe & Dohme (in relation to its ground breaking anit-PD1 cancer therapy, Keytruda) and UCB (in relation to its anti-IL-17 antibody therapy).
Amy is an editor of the EPLAW patent blog, organises and lectures on the IP module of the University of Cambridge’s MPhil in Bioscience Enterprise and is a founding member of the London leadership committee of the ChIPs network, an organisation focused on advancing and connecting women in technology, law and policy.
Founder - Appropriate IP Services
Senior Vice President of Intellectual Property - Fresenius Kabi
Dr Corinna Sundermannis Senior Vice President of Intellectual Property at Fresenius Kabi. Her responsibilities include the IP aspect of generic launches, but also IP protection of Fresenius Kabi’s business in clinical nutrition, pharmaceuticals, standard solutions, and medical devices. She has built up Fresenius IP department starting in 2008, including an active in-house European opposition team. Dr. Sundermann started her career in the innovator industry, holds a diploma in chemistry (Frankfurt am Main) and a Ph.D. from the University of Jena.
Partner - Siqueria Castro Advogados
Over 20 years of work in the Intellectual Property area, Eduardo focuses on trademark registration, anti-piracy measures and border measures.He graduated from Paulista University Law School (UNIP), with Extension Course in Industrial Property from Getúlio Vargas Foundation, Specialization in In Intellectual Property from Getúlio Vargas Foundation, Program at Franklin Pierce Law Center (University of New Hampshire, USA) and Class of Intellectual Property from the University of São Paulo Law School (USP). Eduardo Augusto is a member of Brazilian Intellectual Property Association (ABPI), former Vice-President of Association for Defense of Intellectual Property in Portuguese-Speaking Countries (APILOP) and former President of the special Association for Defense of Intellectual Property of OAB/SP.
Founding Partner - Pergament & Cepeda LLP
Edward Pergament litigates patent infringement actions and drafts patent opinions for a variety of pharmaceutical clients from India, China, Russia, and North America. His primary expertise is in positioning pharmaceutical assets versus patent portfolios, both offensively and defensively, by any means available under the law, including patent litigation, patent strategy considerations, and patent procurement. Edward has a broad legal, business and technical expertise in pharmaceutical and cosmetic industry. At present, His practice is focused mainly on pharmaceutical patent litigation and establishing litigation positions for generic pharmaceutical companies, and on counseling brand side clients in pharmaceutical and chemical industries with respect to life cycle management and other strategic issues, including portfolio management. Edward Pergament was a scientist, an attorney, and an executive with several major pharmaceutical companies, and he has hand-on understanding of legal, business, and technical issues facing a broad range of pharmaceutical products, including NCEs, specialty, generics, formulations, and pharmaceutical solids.
Admissions: New York, 2000, New Jersey, 2001; U.S. Court of Appeals for the Federal Circuit; registered to practice before U.S. Patent and Trademark Office (1997).
Education: University of Odessa, former USSR (B.Sc., Chemistry/Organic Chemistry, 1985); Case Western Reserve University (M.Sc., Chemistry/Organic Chemistry, 1993); Rutgers School of Law, cum laude, Order of the Coif (J.D., 1999).
Practice Areas: Pharmaceutical Patent Litigation, Pharmaceutical Patent Law, and Counseling
Joint Secretary- Department of Justice Ministry of Law and Justice - Government of India
G.R.Raghavender is a civil servant from Central Secretariat Service (CSS) 1988. At present he is Joint Secretary, Department of Justice, Ministry of Law & Justice since January 2017. He is Mission Director for the National Mission for Justice Delivery and legal reforms. He is driving policy reforms for improving Enforcing Contracts parameter under the Ease of Doing Business and eCourts Project. Earlier, he was Joint Secretary in Department of Industrial Policy and Promotion, Ministry of Commerce & Industry,Government of India, New Delhi. There,he also held additional charge of Director General, National Productivity Council (NPC) from Dec.2015 to May 2016. He is former Registrar of Copyrights of the Indian Copyright office. He played a key role in introduction of the recent amendments to the Copyright Act in 2012 and the Copyright Rules, 2013 . He attended many WIPO SCCR meetings and FTA negotiations as a member of Indian delegation. He made significant contributions to recently concluded two WIPO treaties namely, 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 in revision of the copyright legislations of Bhutan, Kampuchia, Myanmar and Nepal as a copyright expert. As a resource person he gives lectures/talks on Copyrights and Related Rights in various International and National seminars and workshops organized by WIPO and by several Law Schools, Universities and Institutes all over India.
At present he is pursuing PhD(IPRs) from GGSIP University, New Delhi.He holds several degrees and post graduate degrees namely, M.A . Development Studies (Public Policy& Management) from Institute of Social Studies (ISS), the Hague, the Netherlands. M.A.(Gold medallist) &M.Phil (Ancient History.& Archaeology) from Osmania University, Hyderabad. He was a JRF Scholar of UGC as well. He holds a LLB degree from Delhi University and LL.M (IPRs) from GGSIP University, New Delhi.He also holdsbachelor's degree in Library and Information sciences (B.L.Sc.) and B.Sc degree from Osmania University,Hyderabad.
Head - IPM& Patent Counsel - Unichem Laboratories Limited
Gautam Bakshi, is an IP Attorney, currently working asHEAD - Intellectual Property Management & Patent Counsel with an Indian Multinational Pharmaceutical Company,Unichem Laboratories Limited.
Gautam is an experienced Intellectual Property Management professional with a demonstrated history of working in the Management position in the Pharmaceutical industry with proven track record. Skilled in Strategy, Management & Enforcement of IP coupled with strong Leadership capabilities nurtured with Management Development Programmes focused in Leadership Excellence from Top B-schools like Indian Institute of Management (IIM-C), XLRI & MDI.
He has rich expertise in the field of IP. His main areas of interest include Identification, Analysis and Management of IP. He is also well versed with the art and skill of IP Prosecution, Litigation. Licensing, Settlements and subsequent procedures thereof.
He has previously worked as Head IP for:
He was also associated in past with Dr. Reddy's Laboratories & Torrent Pharma.
Gautam Bakshi holds a Master’s Degree in Pharmaceutical Sciences (M. Pharmacy) as well as Master’s Degree in Business & Corporate Laws (LL.M.) alongwith several certifications/degrees/diplomas in IP.
He has several Patent Applications as an inventor to his credit filed globally. He has number of publications, has been Guest Faculty for many Institutes,been a panelist and an expert speaker in large number of seminars and workshops on IP rights and education, in India and overseas organized by:
General Manager and Head - Global IP - Panacea Biotec
Partner - Goodwin Procter LLP
Huiya Wu, a partner in Goodwin's Intellectual Property Litigation practice, is an intellectual property litigator who has spent more than 20 years litigating and trying cases in both federal and state courts, and has appeared before the Patent and Trademark Office (PTO), the Patent Trial and Appeal Board (PTAB), as well as the International Trade Commission (ITC). She has represented clients in a wide range of technologies, including pharmaceuticals, analytical devices, medical devices, automotive parts, and internet business methods, and has particular expertise in litigation under the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act.
Assistant Managing Counsel - Merck Sharp & Dohme Corp.
James Horgan is Assistant Managing Counsel at Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. He heads the European Patent Department based in the United Kingdom. He has a degree in chemistry and has practiced extensively in the pharmaceutical, vaccine and biotechnological fields for 25 years supporting research sites in England and Italy. He has wide experience of prosecuting applications before the EPO where he appears in ex parte and inter partes Oral Proceedings. James has filed and prosecuted a large number of SPCs. He has been involved in major multi-jurisdictional litigation in cases relating to Vioxx, Fosamax, Cosopt, Propecia, Rebetol, Isentress and Inegy with major successes before the Dutch, Irish and Malaysian Supreme Courts in cases relating to second medical use claims, the standards for preliminary injunctions and the judicial assessment of subclaims, as well as before the CJEU and EFTA courts in cases relating to parallel imports and negative term SPCs. He is involved in IP policy issues via the IP Federation, where he was President in 2017-18, EFPIA, IFPMA and Business Europe. James Horgan has been included in the IAM list of the World’s 300 Leading IP Strategists employed in industry since its inception in 2015, and is also one of Managing Intellectual Property’s Corporate IP Stars.
Partner - Schiff Hardin
United States Intellectual Property Counselor for South Asia - USPTO
Working through the U.S. embassy in Delhi, India, Mr. Cabeca is the U.S. Intellectual Property (IP) Counselor for South Asia and serves as the principal officer within the U.S. embassies and consulates throughout South Asia on matters related to intellectual property policy and the protection and enforcement of IP rights. A veteran of the U.S. Department of Commerce for over 30 years, he has dedicated his career to working across the innovation ecosystem at all levels to carry out the strategic direction on IP policy while relentlessly advocating for the needs of IP stakeholders.
Senior Associate - Bristows LLP
Katie Cambrook is a Senior Associate at Bristows LLP in London. She has over 10 years’ experience in patent litigation. Katie has worked on a wide variety of life sciences patent matters including both small molecule pharmaceuticals and biologic/biosimilar medicines. Her work involves litigation in the UK courts but she has also worked closely with attorneys across much of the world to co-ordinate global life sciences litigation.
Director IP and Product Portfolio - Kashiv BioSciences LLC
Sr. Vice President - IPM and Licensing - Global Quality and Compliance, Merck
Partner - Rakoczy Molino Mazzochi Siwik LLP.
Lara Fitzsimmons is a partner at Rakoczy Molino Mazzochi Siwik LLP. She works with clients on issues where business and legal needs intersect, including navigating the statutory and regulatory hurdles relating to the review and approval of new and abbreviated drug and biosimilar applications before the FDA, as well as negotiating favorable settlement and licensing arrangements, joint development agreements, manufacturing, supply and distribution agreements, and authorized generic agreements. Ms. FitzSimmons also works with the Association for Accessible Medicines and the Biosimilars Council on filing amicus curiae briefs, including with the U.S. Supreme Court. Ms. FitzSimmons received her J.D. from George Washington University Law School and her B.S. from Northwestern University.
Vice President - IPM - Glenmark Pharmaceuticals
Dr. Mahalaxmi Andheria brings with her an experience of more than 25 years in the Pharma &
Biotech Industry. She has been actively involved in Formulation R&D for 5 years before she
decided to switch to IPR and thereafter IPR has been her primary area of focus. Dr. Andheria is a
PhD in Pharmaceutics from ICT (former UDCT, Mumbai) and a Post-Doctorate from University
of Cincinnati, USA.
In the IPR field, she has been associated with Sun Pharma, Panacea Biotec, Ajanta Pharma and
now with Glenmark Pharmaceuticals.
During her IPR carrier span, she has been instrumental in establishing/managing the IPR
Department consisting of specialists in diverse fields including, pharmaceutical, synthetic
chemistry & biological (vaccines and biosimilars) areas, assessing and strategizing all patent
related activities across various geographies (US, EP, Domestic and ROW markets). She has
established a seamless collaboration with Business Development and R&D expanding the
horizon of her Department beyond traditional IPR by broadening the outlook into portfolio
planning, strategizing innovation and business challenges through creative interdepartmental
Dr. Andheria actively engages in dialogue with policy makers in an effort to contribute towards
the development of a robust and balanced IP Policy in India. She is a member of IP Committee at
CII and FICCI. She enjoys sharing her experience in conferences and workshops and has
authored IPR related review articles in journals and books.
DGM-IPM - Macleods Pharmaceuticals Ltd.
Partner - BarentsKrans
Dr. Marleen is a partner in the IP & Technology department of BarentsKrans. She is head of the firm’s Healthcare & Life Sciences Industry Group. She has over 25 years of experience in litigating and coordinating multi-jurisdictional patent cases. She is internationally renowned for having successfully represented clients in many patent disputes in all fields of technology: mechanical engineering, life sciences, chemistry and high tech/telecoms. Dr. Marleen has acted as lead counsel in patent/SPC and regulatory proceedings and has advised clients in respect of many blockbuster molecules, like (es)omeprazole, alendronate, (es)citalopram, glatiramer acetate, trastuzumab, rivastigmine, zoledronate, imatinib, lenalidomide, rituximab, tadalafil, ezetimibe/simvastatin,CRISPR-Cas9 technology, dasatinib, pemetrexed, everolimus and, in the last year, cinacalcet, sitagliptin, bevacizumab and cabazitaxel.
In regulatory matters, Marleen has advised clients regarding clinical trials, orphan drug issues, disputes with the Dutch Medicines Evaluation Board (CBG) on marketing authorizations and the naming of products, questions concerning new active substances, line extensions and data & market exclusivity. She assists clients in negotiating and drafting licenses, technology transfer and distribution agreements.
Dr. Marleen is recognized as a Leading Individual in Patents and in Healthcare & Life Sciences by Legal 500, having an in depth knowledge of the sector as a whole. She is the recipient of the Clients Choice Award 2018 for Healthcare and Life Sciences. According to Legal 500 she is a ‘highly skilled litigator’ with ‘creative and commercially sound suggestions’. IAM 1000 patents 2021 reports: Van den Horst has a similar penchant for advanced technologies and complicated cases, particularly in the life sciences. “In addition to the expertise she brings, I am also very impressed by the quality of Marleen’s efforts and her motivation to continuously support us in realising our dream,” reports one client. “We fought our case in multiple jurisdictions and Marleen’s defence was tried, tested and true.”
Dr. Marleen holds a Doctorate from VU University Amsterdam; she is a frequent speaker at (inter)national conferences on patent/SPC topics, like EPLAW (Febr. 2021), ERA’s annual EU Pharmaceutical law Conference (March 2021), Fordham University’s annual IP Conference in New York (April 2021), World IP Forum (May 2021) and LESI Annual Conference (May 2021).
Counsel and Vice Chair, Pharmaceutical Litigation Practice - Cantor Colburn LLP
Nicholas Geiger has significant experience litigating patent and trademark infringement matters, as well as false advertising, false marking, trade secret and unfair trade practice matters. He has significant experience taking high-stakes cases to trial, obtaining positive results for his clients in numerous jury and bench trials in federal district court. He represents clients in a diverse array of industries covering a wide variety of technologies, including pharmaceuticals, medical devices, petrochemicals, fashion manufacturing and retail, materials science, and database software. He also counsels’ clients in FDA matters, seeking to harmonize clients' regulatory and litigation strategy to effectuate their business goals. Nicholas also has extensive experience managing complex matters and the devising and implementing of strategies to control the scope and cost of voluminous electronic discovery. Nicholas. Geiger has completed his J.D from Harvard Law School.
Partner - Ashurst
Nina Fitzgerald specialises in all aspects of contentious and commercial intellectual property matters. Nina has extensive life sciences experience and assists her clients with all aspects of their business including navigating the Australian regulatory system, agreements (including, supply, distribution, joint venture, research and collaboration agreements), trade marks, freedom to operate advice, oppositions, interlocutory injunctions, trials, appeals and damages claims. She is regularly involved in precedent setting pharmaceutical patent matters in the Federal Court of Australia, the Full Federal Court and High Court of Australia.
Nina is a Patent Star – Managing IP 2021, Leading Lawyer in Intellectual Property Law – Best Lawyers, Australia 2019 - 2021; Bronze ranked individual for Patent Litigation - IAM Patent 1000, 2019 – 2021 and Finalist for the Mentor of the Year Award (winner yet to be announced) – Lawyers Weekly Awards 2021. Nina is admitted to practice law in Australia and Hong Kong.
Managing and Founding Partner - Rakoczy Molino Mazzochi Siwik (RMMS)
RMMS is a team of over 30 attorneys focused exclusively on life sciences patent and regulatory counseling, patent litigation under Hatch-Waxman and the BPCIA, as well as post-grant review before the PTAB. RMMS attorneys embrace the science of a case, and have made it an integral part of our strategy in the over 300 pharmaceutical litigation matters clients have entrusted to us.
We understand that patent litigation is rarely an end-game, and that business decisions made throughout the product development, regulatory review, litigation, and commercialization process are equally critical to the company’s strategic plans involving any one product or a product portfolio.
Founder - ipEssentia
Dr. Poonam Raghuvanshi has 21+ years leading the Intellectual Property and Patent teams in multinational Pharma companies (Dr. Reddy’s, Ranbaxy, Dabur) & International research institutes (ICGEB). She has 7+ years in Product Development and Research with leading Pharma research organizations.
She has been recognized as “WIPF Powerful Women in IP - INDIA 2021” by World intellectual property forum. Dr. Raghuvanshi has led a large tribe of IP experts responsible for API, Formulation & NCE. She was a team member for 3 Iconic patent infringement/invalidation cases in Generic product history, Atorvastatin, Esomeprazole and Valganciclovir. She has contributed to build multi-Billion-dollar global product portfolio and devised invention review board to effectively manage the Patent Portfolio. She has ensured no unknown 3rd Party IP risk to the Product portfolio and conceptualized effective IP risk mitigation strategy across the globe. Dr. Poonam Raghuvanshi has completed her M. Pharm and PhD in Pharmaceutical Chemistry
Senior Director (Head) - IPM - Fresenius Kabi Oncology Ltd.
Dr. Prachi Tiwari is doctorate in Organic Chemistry, MBA and Law graduate. She is a Registered Indian Patent Agent with about 20 Years of experience in Leading Pharmaceutical Companies like Alembic, Ranbaxy (Presently Sun), Teva Pharmaceuticals and Fresenius Kabi Oncology Ltd.Dr. Prachi have more than 18 Years of experience as a Patent Professional and handled a wide sphere of Technological Areas of Patents – Chemistry, Polymorph, Formulations, Drug Delivery Systems, Indication, Biotechnology & Biosimilars, Medical devices and Nutrition.Currently she is responsible for all the Patent matters globally by supporting and Advising to the Research & Development, Business and Allied Functions of the Organization by ensuring hassle free product launch. Also exploring early market entry opportunities by designing around and challenging Road block Patents/applications. Dr. Prachi has handled drafting and prosecution of more than 200 Patent Applications. She is successfully involved in Indian opposition and Litigation of Patent matters. Dr. Prachi has worked on identification of new and potential products, for the inclusion in product portfolio grid.
Associate - Director KPMG
Priyanka Gupta leads a team of ~30 Intellectual property professional supporting 80+ clients across the globe for their patent, trademark, copyright protection and assertion, with the following key metrics:
Intellectual Property identification & protection – Patents, Copyrights, & Trademarks in India, US, UK, Europe, South Africa, Indonesia, and GCC
Open-source compliance & policy review – Copyleft licensing with specific requirements on several packages used under GPLV2/V3, EPL V2, Apache, BSD etc. through tool-based analytics
Technology commercialization & licensing - Buying/selling portfolios and/or negotiating the licensing agreements in the domain of 4G/5G, hybrid hydraulic excavators, hydrogen catalyst, and the like
Merger & Acquisition – Contract review, Trade secret identification, source code review, and/or appropriation of related intellectual property assets, IP taxation during assignment
Brand protection – Offline and online counterfeiting through market intelligence and tool-based analytics.
Patent analytics - Patentability searches, invalidation, infringement analysis, patent ranking, Claim/ EoU charting, state of art searches and freedom to operate searches
IP audit – Review of IP policies, budget, R&D versus IP conversion, Confidential information framework etc.
Financial In charge - Net revenue reporting, billing & collections, provisions, working capital and income statement for the business unit.
Connected cars, cloud computing, Artificial intelligence (OCR, data assessment, financial predictions, job assessment, question paper assessment), IoT, wireless communication/4G, software encoding/decoding solutions, block chain and few aspects of chemical additives etc.
Managing Partner - Gemini
Partner and Co-Chair – Intellectual Property Group - Schiff Hardin
Sailesh K. Patel co-chairs Schiff Hardin’s Intellectual Property Group and its Pharmaceuticals and Biologics Patent Litigation Team. Mr. Patel has over twenty years of experience representing pharmaceutical companies in well over 100 Hatch-Waxman and biosimilar matters. He is passionate about implementing creative and scientifically sound arguments for his clients, which have resulted in several legal precedent-setting cases. Sailesh has received numerous awards and recognitions for his work in the Hatch-Waxman area. He is ranked by Chambers & Partners and has been recognized by the US News & World Report as a Best Lawyer in IP, Legal 500, Leading IP Lawyer, Super-Lawyer and an IP Star. He is a thought-leader in the intellectual property area and is a frequent writer, speaker and media commentator on legal issues relating to the generics drug industry.
Principal - Lassman Law+Policy
Scott M. Lassman is the Principal at Lassman Law+Policy, a boutique law firm located in Washington, D.C. that focuses on solving its clients’ most complicated FDA-related problems. Scott provides strategic advice and advocacy to small, mid-size and large pharmaceutical, biotechnology and medical device companies, as well as the trade associations that represent them and the investors who fund them. His practice covers all aspects of FDA regulatory law, with a special focus on exclusivity, biosimilars, product approval and policy matters.
Scott also has extensive experience with the FDA Citizen Petition process and, when necessary, litigating FDA disputes in federal court. He has successfully protected his clients’ interests through litigation in a wide variety of matters, including Hatch-Waxman exclusivity, 180-day exclusivity, pediatric exclusivity, user fees, and approval requirements. Scott is author of the Exclusivity Rules blog, which focuses on the written and unwritten rules governing FDA’s exclusivity decisions. The blog is available at: www.lassmanfdalaw.com/blog/.
Before starting Lassman Law+Policy, Scott was the Chair of the FDA Practice Group at a leading, international law firm, a partner at a well-regarded FDA boutique, and the head FDA regulatory attorney at a major pharmaceutical trade association. Scott graduated from Yale University (B.A.), the University of Texas at Austin (M.A.), and the University of Virginia School of Law (J.D.).
Director - Dispute Resolution - Regeneron
General Manager- IPM - Glenmark Pharmaceuticals Ltd
Shradha Saraf is currently with Glenmark Pharmaceuticals limited. Prior to Glenmark, she was associated with Lupin Pharma and Sun Pharma.Shradha’s background combines a post graduate degree in pharmaceutics from NIPER (National Institute of Pharmaceutical Education & Research), Mohali with more than 17 years of industry experience.
Among other things Shradha’s key area of focus includes FTO assessment& design IP strategies across various Regulated and Semi regulated markets with primary focus on North American market. She has IPR experience in both innovative and generic segments which includes small molecules, biologicals, drug device, respiratory, oncology and all kind of generic, complex generic or super generics. Her expertise also includes managing Hatch Waxman litigations in collaboration with the Counsel.
Co-Chair Pharmaceutical Practice, Co-Chair Litigation Practice , - Cantor Colburn LLP
Steve Coyle is a Partner and co-chairs the firm's Litigation Department. He is a trial lawyer with more than 25 years' experience litigating and trying complex disputed matters, and specializes in patent and all varieties of intellectual property litigation. Steve’s areas of focus include ANDA and Hatch-Waxman litigation, where he has represented the rights of generic drug manufacturers and helped them to bring products to market. Steve also counsels’ clients in FDA matters and is the Chair of Cantor Colburn’s Pharmaceutical Litigation Practice. Steve represents clients as both plaintiffs and defendants in a variety of other patent matters, including software, cybersecurity, fiber optics, lighting, circuit boards, robotics, telecommunications, piping systems, and consumer goods. Steve has substantial experience litigating trademark, copyright, and trade secret matters as well. He has litigated in courts throughout the country, and he has represented clients in alternative dispute resolution forums such as arbitrations and mediations. Steve has also handled multiple appeals, including before the Federal Circuit. In all of his cases, Steve strives to develop and follow a pragmatic strategy that advances not only his clients’ short term litigation goals but also their long-term business needs.
Senior Patent Attorney & Senior IP Consultant - Indoco Remedies
Swati is an accomplished IP expert. In her career spanning over 27 years, she has been
involved in strategic patent portfolio management; drafting and prosecuting over 500 world-
wide patent applications; providing legal opinions on patentability, patent infringement, FTO
analysis and validity issues, and devising strategies for patent litigation.
Currently, in her role as Senior Patent Attorney & Senior IP Consultant at Indoco Remedies
Ltd., Swati provides strategic expertise on a broad range of IP issues, advises senior
management on IP issues that have legal implications, prepares opinions and deals with IP
litigations. Prior to joining Indoco, Swati served as In-House Patent Counsel and Head of
Patents Dept. at Piramal Healthcare Ltd. overlooking protection of inventions in Drug
Discovery Research, process chemistry and formulations. During her tenure, Piramal won
Pharmexcil “Platinum Patent Award” in 2014, for securing the most number of patents under
overall category. She has also worked as patent professional for leading Indian
Pharmaceuticals including Sun Pharma. and Lupin..
Swati is a frequent speaker on emerging areas of patent law at various events. Recognised
among “Powerful Women in IP - India 2021” by World Intellectual Property Forum. In the
year 2019, Swati received recognition as “IP Star Woman of the Year” from Legal Era
Magazine. Also, received recognition amongst “Top 100 Powerful Women in Law” by World
Intellectual Property Forum in the year 2017.
Patent Attorney - Tee & Howe Intellectual Property Attorneys
Vice President - Intellectual Property and Portfolio Management - Hetero Labs Limited
Vice President - IPR/Legal/Portfolio Management - RK Pharma group
Dr. Vure Prasad comes with an overall experience of close to 20 years. Currentlyworking as Vice President –IPR/Legal/Portfolio Management for RK Pharma group. He also worked for various pharmaceutical industries like Granules, Virchow Group, Lupin, Hikmaand Dr. Reddy’s Laboratories.
He has earned the doctoral degree in Pharmaceutics from Central Drug Research Institute- Jawaharlal Nehru University, New Delhi, Mastersin Pharmaceutical Sciencesfrom Nagpur University; University campus. He also earned Master’s in Business Administrationfrom the SMS, JNTU, and Hyderabad. In addition to this he hascompletedLL.B and LL.M in Corporate Securities Law from Osmania University. He is also aCertified Patent/Trademark agent by Indian Patent/Trademark office respectively.
He has anenriched experience in development of Simple/Complex formulations, also dealing with intellectual property and regulatory subject matter of the same&also been part of dealing with litigations in US, Europe, India and other non regulated countries. During this tenure he credited with more than 45publications; and he is also an inventor of70 patents/patent applications. He is also an author of some chapters in a couple of books. His fields of interest areIntellectual property rights, Product selection and dosage form technology. He has attended and presented Papers in various symposiums and workshops at the national and international level.He also delivered ‘Guest Lectures’ at various universities in the fields of Dosage form Technology & Intellectual Property/Regulatory affairs.
Partner - Formosa Transnational
Frank Lu is a partner in Formosa Transnational. In addition to anattorneyat law, he also qualifies as a patent agent in Taiwan and the U.S.He graduated with an IP LLM from University of Washington and with an MS in Biochemistry from National Taiwan University. He focuses his practice in the areas of IP litigation, IP licensing, management of corporate IP portfolios, and data protection. He has counseled on and handled a wide range of IP enforcement and management matters for many high-tech companies in Taiwan, Japan, the United States, and many other countries.
Representative Legal Matters
Performed IP due diligence on several acquisitions;
Advising on IP rights applications, prosecutions,licensing, and collaborative developments, to protect clients’ IP portfolios;
Successfully defended clients (various kinds of technical fields) against IP infringement lawsuits; and represented clients to enforce their IP rights.
My major works as a patent attorney in Formosa Transnational Attorney at Law are as follows.
Patent Filing and Strategies
I regularly assist my client in preparing strategies to maximize the potential of pending patent applications. I guide individuals and corporations through the steps needed to protect valuable intellectual property in the manner that most closely suits their short- and long-term goals.
One strategy for a Taiwanese client who is willing to file patent application in major industrial countries is to consider the speed and cost. It is beneficial for Taiwanese companies to enter PCT through China because our team can discuss and communicate directly with the inventor(s) and draft patent specifications for filing. However, if the company has a branch in the U.S. or one of the inventors has the U.S. citizenship, another option is to enter PCT through the U.S., the benefit of which is the advertising effect: the public investors like a US patent. Please note that as Taiwan is not a PCT member, if an application is filed through PCT, it still needs to be filed in Taiwan within 12 months from the PCT filing date.
I handled more than 70 patent litigations during the past 10 years. I am not discussing my exaggerating winning rate, but share what I have learned through those exact cases. The experience in the patent litigation helps me to reconsider the claim drafting in each patent applications to reduce the possibility that the claim at issue is held invalid but still cover the infringing product. In addition to the patent litigation, I also dealt with hundreds of IP litigations, including trademark, copyright, and trade secret.
In addition, the warranty and indemnification clausesare necessary in the agreement with suppliers to hold clients harmless especially from the lawsuits related to the IP infringement.
Contract Review and Corporate Compliance
A part of my works relates to the review of contracts, including licensing agreement, non-disclosure agreement, cooperation and developmentagreement, etc.I advise clients regarding webpage contents in terms of privacy statements, data usage statements, the use of personal information, account terms and conditions, clearance of intellectual property issues, and corporate social responsibility (CSR) and assist them to comply with the related laws and regulations.