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Joint Secretary, Department of JusticeMinistry of Law & Justice Government of India
Joint Secretary, Department of Justice
Ministry of Law & Justice Government of India
Mr. 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. Mr. Raghavender is a 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. Mr. G.R. Raghavender holds a LLB degree from Delhi University and LL.M (IPRs) from GGSIP University, New Delhi.
Global IP HeadIntas Pharmaceuticals Limited
Vice President & Head – Intellectual PropertyDr. Reddy’s Laboratories
Vice President – IPMMacleods Pharamceuticals Limited
Global IP Head
Intas Pharmaceuticals Limited
Vice President & Head – Intellectual Property
Dr. Reddy’s Laboratories
Dr. Poonam Raghuvanshi, M.Pharm Ph.D is the Vice-President & Head, Intellectual Property, at Dr. Reddy’s. She has more than 25 years of Industrial experience in Pharma Research and intellectual Property. Her areas of interest are: Aligning IP strategy with business objectives; Finding opportunities to grow new markets, Spreading Awareness on IP Rights; Assessing Consequences and implications of IP Infringement; Implementing strategies to protect the intangible asset.
Running innovation initiative, the objective was to invite new ideas for product development (life extension or new product (not NCE) ideas), select the ideas which align with business needs & unmet patient needs, support the scientist in bringing the idea to a proof of concept (PoC) stage, as a physical product, create Intellectual property around it before introducing for complete product development.
Identifying IP based generic assets through screening, identification of gaps, opportunities, Whites spaces or legal loop holes. Spear heading the global IP strategy, with current focus on India, China & Emerging markets; from identifying the opportunity to deciding & successfully implementing the litigation strategy.
Vice President – IPM
Macleods Pharamceuticals Limited
Member and Registered Patent AttorneyCozen O’Connor
PartnerLocke Lord LLP
Managing AssociateKrishna & Saurastri Associates LLP.
Co-Chair, Intellectual Property LitigationCozen O’Connor
FounderAppropriate IP Services
Co-Chair Hatch-Waxman and Biologics Litigation Group, Registered Patent AttorneyCozen O'Connor
PartnerMaynard Cooper and Gale
PartnerSterne, Kessler, Goldstein & Fox P.L.L.C.
PartnerGreen, Griffith & Borg-Breen LLP
General Manager - Intellectual Property CellSun Pharmaceutical Industries Ltd
Head - IPM & Patent CounselUnichem Laboratories Limited
Vice President | Shareholder | Pharmaceutical Practice Co-ChairXact Data Discovery
PartnerArent Fox LLP
United States District Court
Associate DirectorKashiv Biosciences Pvt. Limited, Formerly Adello Biologics
Japanese Patent Attorney - HeadKuzuwa & Partners
General Manager, IPR – LegalMylan Laboratories Limited
Head of Law and PartnerHGF Limited
PartnerGreenblum & Bernstein, P.L.C., USA
Director (Head) - IPM Fresenius Kabi Oncology Ltd
Patent DirectorHGF Limited
PartnerRemfry & Sagar
PartnerTaft, Stettinius and Hollister
Partner and Co-chair, Intellectual Property PracticeGoldberg Segalla
Partner Executive Committee Member Practice Group Co-Leader, Hatch-Waxman and Biosimilars - Diversity Committee Co-ChairSchiff Hardin
Vice President | Shareholder | Pharmaceutical Practice SMEPharmaceutical Practice SME
PartnerUpadhye Cwik LLP.
Partner and Litigation Department Co-ChairCantor Colburn LLP
Senior In-House Patent AttorneyIndoco Remedies Limited
Partner Lerner David
Associate Vice President – IP & Portfolio Management Hetero Labs Ltd.
CounselMaynard Cooper and Gale
Member and Registered Patent Attorney
Aaron Lukas is a registered patent attorney who concentrates his practice on complex patent cases for clients in the pharmaceutical, biotechnology, and semiconductor industries. Aaron has handled all aspects of cases including pre-suit investigations, fact and expert discovery, dispositive motions, and trial. He also has experience in IPR matters at the PTAB on behalf of both patent owners and challengers. In addition to patent litigation, his practice includes representing clients seeking patentability, infringement, and invalidity analyses, as well as developing strategic plans for clients seeking to protect their intellectual property around the world. Aaron has worked with clients in a wide range of high technology fields, including nanotechnology, semiconductor devices, display technologies, gene synthesis, recombinant DNA technology, diagnostic assays, and pharmaceuticals.
Aaron Eckenthal has specialized in all varieties of intellectual property litigation from the outset of his career. One area of focus includes ANDA and Hatch-Waxman litigation where he has represented several generic drug companies. In addition to life science based litigation, Aaron has litigated other cases that involve complex patent, trademark and copyright issues. His work spans a variety of technical areas including chemical, pharmaceutical, food science, medical device, and biotechnology.Aaron is also active in inter partes review (IPR) proceedings. He has extensive experience with patent and trademark procurement and has assisted clients in developing strong patent and trademark portfolios in an effort to achieve business and intellectual property goals. Some of Aaron’s success for clients can be attributed to his strong business acumen – his focus on big picture business goals to create a meaningful business strategy through intellectual property that will accomplish the overall objective for a client. Aaron obtained hisMasters in Biology from Rutgers University, after studying Bacteriology and Genetics at the University of Wisconsin. AaronEckenthal was recently recognized as a
Rising Star in Intellectual Property by New Jersey Super Lawyers Magazine.
Locke Lord LLP
Alan Clement is the Chair of the Intellectual Property Group of Locke Lord LLP and is a Partner in the New York Office. Alan holds a B.S. in Chemical Engineering with a concentration in polymer engineering from the University of Massachusetts and a J.D. from Pace University. For over 20 years, Alan has been intimately involved in a number of multi-patent, complex Hatch-Waxman pharmaceutical patent infringement litigations, including acting as lead trial and appellate counsel. He is a frequent speaker at major conferences in the pharmaceutical and other industries on current intellectual property trends and concerns. Alan Clement has also authored numerous published articles addressing and analyzing legal issues.
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” (just published) which is well appreciated in patent professionals and major universities wherein patent is one of the value-added subjects in the respective technical discipline.
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. He is also responsible for 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. Pathak has worked with some of the leading pharmaceutical companies like Alembic Ltd, Lupin Ltd., Zydus Cadila and Cadila Pharmaceuticals. He holds a PhD degree from The Sardar Patel University. He 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 and Bachelors in Science from the Sardar Patel 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 is 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.
Andy Camenisch specialises primarily in patents in the fields of pharmaceuticals and chemistry on inventions relating to new chemical entities (NCEs), pharmaceutical formulations, methods of treatment, dosing regimens, medical devices, methods of manufacture, food and beverage products, materials chemistry and cosmetics products. In addition to drafting and prosecuting patent applications, he is also experienced in pharmaceutical patent litigation, having been involved in revocation proceedings at the UK High Court and in the coordination of the pan-European revocation of several European patents covering pharmaceutical formulations and drug combinations.
Andy also manages the delivery of due diligence projects, requiring the formulation of complex prior art and FTO search strategies and advising on issues relating to patent term extensions, SPCs, regulatory data exclusivity, the enforceability of the patent portfolio (e.g. in terms of its patentability) and freedom to operate. Andy’s client base includes International pharmaceutical companies, cosmetic companies and bulk chemical companies and UK Universities.
Krishna & Saurastri Associates LLP.
Anshul Sunil Saurastri is a Managing Associate and Patent Attorney at Krishna & Saurastri Associates LLP. His practice areas include IP prosecution, oppositions, litigation and transactions. Earlier, he worked at an Indian law firm, a U.S. based investment firm and a U.S. based laboratory. Anshul is recognized as a scholarly author in the journal Blood. Holding degrees in the sciences, engineering and law and training in legal, strategic and technical areas, he has amassed cross-functional expertise. He holds a Master’s in Engineering and a Bachelor’s in Applied Sciences from USA and a Degree of Law from India. Anshul Saurastri is registered with the Bar Council of India and Indian Patent Office.
Co-Chair, Intellectual Property Litigation
Barry Golob focuses his practice on complex patent litigation. He is an experienced first-chair trial attorney with extensive federal jury and bench trial experience, having led trial teams in more than 90 cases, many of which were tried to verdict. Although Barry has represented clients at all levels of litigation in various fields of technology, including computer software, medical devices, office furniture, the Internet, insurance, manufacturing, LEDs and telecommunications, he presently focuses on consumer electronics and Hatch-Waxman litigation. In addition to handling complex jury and bench trials nationwide and appeals before the
States Court of Appeals for the Federal Circuit
, he has participated in all aspects of alternative dispute resolution, including arbitrations and mediations. In this regard, Barry Golob has also developed innovative approaches and strategies to resolve significant disputes to avoid costly litigation, and often lectures on these topics.
Appropriate IP Services
Dr. Bharati Nadkarni has 20 years of experience with:
Dr. Nadkarni joined Sun Pharmaceutical Industries Limited as an executive of IP Cell and later as Global Vice President - IP and Portfolio Planning. She was responsible forproduct identificationin the regulated markets, and IP strategy &litigation for all markets. She provided support across functions for filing and launch of products in view of IP strategy. Recently he has founded a firm Appropriate IP Services to provide IP and Business development consultancy to pharma industry clients. The firm works closely with the client, as an extension of their in-house teams, to provide inputs on product identification and IP strategy. We have experience in the areas of IP, Business development and Regulatory science, and provide a unique value to the client in working from product identification to product launch, and everything in between.
Co-Chair Hatch-Waxman and Biologics Litigation Group, Registered Patent Attorney
Blake Coblentz focuses his practice on patent litigation and counseling for clients in the biotechnology and pharmaceutical industries. A registered patent attorney, Blake has deep subject-matter knowledge in the areas of biochemistry, molecular and cellular biology, gene synthesis, recombinant DNA technology, immunology, pharmaceuticals, therapeutic methods, diagnostic assays, and vaccines. He counsels pharmaceutical companies in the areas of Paragraph IV design strategies, Hatch-Waxman litigation, and biosimilar market opportunities. Blake is not just a litigator; he’s a trial lawyer. His ability to bring clarity to complex issues through effective depositions and examinations of witnesses have led to significant victories for his clients. Blake’s notable trial wins in the pharmaceutical sector include a favorable decision of non-infringement in the first ever case to go to trial under the Biologics Price Competition and Innovation Act and the only successful defense to date of patents
on a transdermal testosterone product. Blake also represents patent owners and challengers in inter partes reviews before the Patent Trial and Appeal Board.
Maynard Cooper and Gale
Brandon Stroy is a partner in the Firm’s Intellectual Property & Technology practice. His practice is centered on intellectual property counseling, litigation, and diligence. Brandon’s background in Electrical and Biomedical Engineering enables him to advise clients across a range of complex technological areas. He has tried patent cases relating to pharmaceuticals, medical devices, computers, and software. He also advises clients on strategic and business issues related to intellectual property, including portfolio management and valuation and licensing. Over the course of his career, Brandon has defended some of Silicon Valley’s most prominent technology companies on patent matters. He has successfully represented clients in a variety of intellectual property matters including the Internet, data networking, encryption technologies, telecommunications, electrochemical sensors, semiconductors, medical devices, and automotive technologies. He also has extensive experience litigating intellectual property cases for life sciences companies, including Hatch-Waxman/ANDA litigation.
Brandon has also represented clients in matters before the United States Patent and Trademark Office, including post-grant proceedings under the America Invents Act. He was named a Northern California Rising Star for Intellectual Property and Intellectual Property Litigation by Super Lawyers in 2016 and 2017. Brandon Stroy received his J.D. from Columbia University along with M.E.M. and a B.S from Duke University.
Sterne, Kessler, Goldstein & Fox P.L.L.C.
Chandrika Vira is a director in Sterne Kessler’s Trial & Appellate and Biotechnology & Chemical Practice Groups. She represents clients in complex patent litigations in federal district courts, in contested proceedings before the Patent Trial and Appeal Board, and before the Federal Circuit on appeal.She has litigated cases involving a broad range of technologies in the pharmaceutical, biotechnological arts, and electrical arts. Chandrika Vira focuses her practice on litigating cases involving small-molecule pharmaceuticals under the Hatch-Waxman Act and biologics and biosimilars under the Biologics Price Competition and Innovation Act (BPCIA).
Green, Griffith & Borg-Breen LLP
Christopher Griffith is a seasoned IP trial lawyer with over 30 years of experience exclusively in pharmaceuticals, chemicals, medical devices and biotechnology. He has been lead counsel in trials and appeals in contentious issues in the US District Courts and the Federal Circuit, and is a former adjunct professor of patent law. Chris and his team also have experience in IPRs before the PTAB.
As a recognized expert, he provides strategic formulation, IP portfolio preparation, prosecution and development, pre-litigation counseling concerning IP and related FDA issues affecting 505(b)(1), 505(b)(2), ANDA products (Hatch-Waxman) as well as biologic products (BPCIA), including PIV certifications, Orange Book issues, and related FDA issues. Due diligence and opinions (validity, freedom-to-operate), whether involving API/excipient selection, trade dress, formulation attributes, or labeling, are also part of his practice. He is also sought after for his expertise in prosecution and portfolio management.
Christopher Griffith has been recognized as a “Global IP Star” by LMG Life Sciences, a “Life Sciences Star” by Managing IP, an “IAM Patent 1000” litigation attorney, and an Illinois “Super Lawyer,” among other honors.
General Manager - Intellectual Property Cell
Sun Pharmaceutical Industries Ltd
Dr. Gaurav Sahal is a qualified, registered Indian Patent Agent currently heading global patent filing, prosecution and product life-cycle management for Sun Pharma. More than 16 years of professional experience with a proven track record in managing in-house and acquired IP assets, strategizing patent prosecution across jurisdictions, analysing market opportunities for both small molecule and biological drugs, and providing business-oriented IP inputs to senior management. A team leader who is focused on promoting synergy across R&D and business units to align the IP strategies with the business goals to maximize the profitability and to bring cost efficiency. Dr. Gaurav Sahal’s key areas of expertise include: Pharmaceuticals & Biologicals/Biosimilars, Patentability & Validity Assessment, IP Asset Management and IP Licensing, Mergers & Acquisitions.
Head - IPM & Patent Counsel
Unichem Laboratories Limited
Mr. Gautam Bakshi, is an IP Attorney, currently working as HEAD - Intellectual Property Management & Patent Counsel with an Indian Multinational Pharmaceutical Company, Unichem Laboratories Limited.
He 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.
Mr. Bakshi 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.
Mr. Gautam has previously worked as Head IP for:
He was also associated in past with Dr. Reddy's Laboratories & Torrent Pharma.
He has several Patent Applications as an inventor to his credit filed globally. Mr. Gautam Bakshi 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.
Hugh Balsam is a partner in the Chicago office of Locke Lord LLP. Hugh holds a M.M. from the Kellogg School of Management, Northwestern University and a J.D. from John Marshall Law School. He argues appeals in all areas of the law, including commercial litigation, intellectual property law, insurance liability, bankruptcy law, employment law, constitutional law, foreclosure law, product liability, medical litigation, and state and federal procedural law. His practice is nationwide, in both state and federal courts. He has handled matters in the United States Supreme Court and has extensive experience in the United States Courts of Appeals for the Federal Circuit and for the Seventh Circuit. Hugh authored a well-received article in Verdict, the journal of the Trial Section of the American Bar Association, entitled “How to Make Technical Briefs Understandable for Generalist Judges” . Following up on that publication, ?Hugh Balsam has given frequent presentations at legal seminars, bar association meetings, and law schools across the country on the topic of simplifying complex and technical subject matter.
Vice President | Shareholder | Pharmaceutical Practice Co-Chair
Xact Data Discovery
Jane Funk is a trained litigation attorney with 13 years of litigation and discovery experience in the pharmaceutical industry. She has supported corporate legal departments and law firms with 500+ matters. Jane Funk is former VP of National Accounts at Robert Half.
Areas of Expertise:
Arent Fox LLP
Janine Carlan is a patent litigator with more than 20 years of experience. She has expertise in representing pharmaceutical companies in patent disputes, including Hatch-Waxman cases between brand and generic pharmaceutical companies. She also represents companies in International Trade Commission (ITC)Section 337 cases, cases defending against claims by Non-Practicing Entities (NPE), as well as in proceedings before the Patent Trial and Appeal Board (PTAB), including filing petitions for Inter Partes Review (IPR). She has been lead trial counsel on patent and trade secret cases covering diverse areas of technology, including pharmaceuticals, medical devices, electronics, software, Internet content delivery, automotive parts, chemicals, manufacturing processes, furniture, and plastics processing.
Prior to becoming an attorney‚ Janine Carlan worked as a chemical engineer at FMC Pharmaceuticals‚ McNeil Consumer Products and Astra Zeneca in the areas of regulatory affairs‚ research and development‚ and pharmaceutical manufacturing.
Dr. John Hanish is a Shareholder in Maynard Cooper’s New York office and a member of the firm’s Intellectual Property Litigation and Intellectual Property Protection practice groups. He started his legal career at Fish & Neave and has 18 years of experience in the trial and appeal of patent licensing and infringement matters in the federal courts, International Trade Commission and arbitration. He also practices in the U.S. Patent and Trademark Office with respect to filing petitions and conducting proceedings for post-grant review, inter partes review and the transitional program for covered business method patent review. He also assists clients with patent prosecution and opinions regarding patent infringement and validity.
Dr. John’s doctorate and research experience help him assist clients with patent issues in the life sciences. He also has extensive experience with medical device, consumer product, technology and software patents. Before he attended law school, Dr. John Hanish was a Winston Fellow at The Rockefeller University and a Research Scientist at the Sloan-Kettering Institute.
Judge Roy Payne is presently a judge in the United States District Court for the Eastern District of Texas. He previously served as a judge in the United States District Court for the Western District of Louisiana. According to Docket Navigator, Judge Payne has construed the most patent claim terms (over 5,550 terms as of 2019) out of any federal judge ever. Judge Payne also ranks among the top five federal judges who have conducted the most Markman hearings of all time. Also, he ranks among the top judges in number of patent cases filed before him. In 2017 alone, Judge Payne had 327 new patent cases filed before him. As an acknowledged thought leader, Judge Payne lectures nationally on litigation and patent cases, including Hatch-Waxman and biosimilar patent litigations.
Kashiv Biosciences Pvt. Limited, Formerly Adello Biologics
Japanese Patent Attorney - Head
Kuzuwa & Partners
Just after graduating from Tokyo University of Agriculture and Technology, Kiyoshi Kuzuwa started his career at the Japan Patent Office (JPO), during which he served as a patent examiner/appeal examiner in the field of polymer processing, applied chemistry, textile technology, medical science etc., Deputy director of Examination Standards Office, a professional member of IP Legislative Affairs Office and an exchange patent examiner at the USPTO. In the meantime, he studied German Patent Law and European Patent Law at the University of Munich and the Max-Planck-Institute in Germany. After resigning from the JPO, he joined a Swiss chemical company in 1992, and worked as a member of the IP department there and as Head of Japan region corporations until he established KUZUWA & PARTNERS in 1995. He is a registered Japanese patent attorney since 1992 and admitted to practice before Infringement Courts as a registered IP infringement litigator since 2004. He has been writing several books and articles in the IP field, and often gives lectures at Japanese universities and international IP fora. Kiyoshi Kuzuwa was also Professor of Chiba University for 2004 - 2005, a member of a committee of JPO IP Project for 2005 - 2006, and is now a member of INTA, AIPPI, FICPI, APAA, AEA and PTMG.
Lawrence is a Partner in our Chemistry, Biotechnology and Pharmaceuticals patent department. Lawrence previously worked in-house within the Intellectual Property Department of GlaxoSmithKline for eight years, and is particularly valued by clients for his understanding of the role of in-house counsel and the commercial application of intellectual property in the life sciences field. Lawrence’s existing practice includes drafting and prosecuting patent applications for a broad range of technologies on a worldwide basis. Lawrence also has considerable experience of providing strategic advice in respect of patent infringement and validity, handling patent opposition matters, and undertaking due diligence assessments of third party IP for licensing and acquisition purposes.
A selection of Lawrence’s key clients include:
Lawrence was recently described in Legal 500 UK as being “very knowledgeable both in Chemistry and in IP law”.
Dr. Mahalaxmi Andheria brings with her an experience of more than 20 years in the Pharma & Biotech Industry. She has been actively involved in formulation R&D for 5 years and thereon worked on IPR. Dr. Andheria is a PhD in Pharmaceutics from ICT (former UDCT, Mumbai) and a Post-Doctorate from University of Cincinnati, USA. She started her IPR career with Sun Pharma, while her association with Panacea Biotec for 13 years was instrumental in forming and managing the IPR Department consisting of specialists in diverse fields including biological (vaccines and biosimilars), pharmaceutical & synthetic chemistry area. During her tenure at Panacea, she established a seamless collaboration with Business Development and R&D expanding the horizon of traditional IPR by broadening the outlook into portfolio planning, strategizing innovation and business challenges through creative interdepartmental collaborations. Currently she has taken the realms of IPR at Ajanta Pharma, contributing towards the goals and aspirations of this fastest growing Specialty Pharmaceutical Company.
Dr. Andheria finds it extremely satisfying to share her understanding of this field and takeaways from her experience with students, inventors and business professionals interested in understanding the impact of IPR on their business decisions. She regularly speaks in conferences, summits, workshops. In addition she actively engages in dialogue with policy makers in an effort to contribute towards the development of a robust and balanced National IP Policy. Dr. Mahalaxmi Andheria is a Committee Member of the CII National Committee on Intellectual Property.
General Manager, IPR – Legal
Mylan Laboratories Limited
Head of Law and Partner
Martyn advises clients on all aspects of contentious and non-contentious intellectual property law with a focus on intellectual property litigation. He has been involved in numerous High Court actions in the fields of patents, trademarks, copyright, design rights and misuse of confidential information. He regularly acts for clients at all stages of litigation from pre-action issues right through to trial and appeal. Martyn’s work often has an international aspect and he has considerable experience of co-ordinating legal teams in various jurisdictions.
Martyn’s clients are drawn from all sectors and include multinational companies, Universities and SMEs. He has extensive experience of the Intellectual Property Enterprise Court and in 2013 successfully acted for the defendants in the first trial before the new court (Manvers Engineering v Lubetech). Martyn Fish also has experience of entitlement, revocation and ownership disputes before the UK Intellectual Property Office.
Miyoka “Miki” Goodin is a Partner based in the Chicago office of Locke Lord LLP and is a member of the Firm’s Executive Committee. Miki holds a Bachelor’s degree in Molecular and Cellular Biology from the University of California at Berkeley and obtained her law degree from the University of Southern California Gould School of Law. Miki focuses her practice on complex intellectual property litigation matters with a primary emphasis on disputes involving the Hatch-Waxman provisions of the Patent Act and the Federal Food, Drug and Cosmetic Act. Miki Goodin has advised clients on regulatory issues before the U.S. Food and Drug Administration, has counseled and represented clients on various antitrust-related matters, including those relating to patent enforcement and settlement, and helps clients develop strategies for filing abbreviated or 505(b)(2) new drug applications.
Greenblum & Bernstein, P.L.C., USA
Dr. Paul Braier is a shareholder at G&B, and a member of the Pharmaceutical; Biotechnology; Litigation and Trial; and Client Counseling practice groups of Greenblum & Bernstein. His work in these groups includes preparing and supervising preparation of infringement and validity opinions, Notice Letters, litigation, and FDA citizen petitions, as well as general counseling, particularly in the pharmaceutical, chemical, and medical arts. He is involved extensively in the firm's pharmaceutical practice, and advises drug companies (primarily generics) on strategic planning and new product introduction. He works extensively with Hatch-Waxman issues and the interface of patent and FDA law. Dr. Paul is a regular panelist in seminars given in association with the annual conferences of the Pharma IPR India conferences, and has spoken regularly at the International Generic Pharmaceutical Association and the European Generics Association and other conferences. He is an editor for the Journal of Generic Medicines and regularly contributes articles on patent law and generic drugs.
Dr. Braier received a Bachelor of Science in Chemistry with high honors from the College of William and Mary in 1986, a Ph.D. in Chemistry from the University of Chicago in 1992, and a Juris Doctor degree from the Georgetown University Law Center in 1998. While at Georgetown University, he was a staff member of the Journal of Legal Ethics.
Dr. Paul is admitted to the Virginia State Bar, the U.S. District Court and Bankruptcy Courts for the District of Columbia, and the Court of Appeals for the Federal Circuit, and is registered to practice before the United States Patent and Trademark Office. Dr. Paul Braier is a member of the American Intellectual Property Law Association, the American Bar Association, and the American Chemical Society.
Director (Head) - IPM
Fresenius Kabi Oncology Ltd
Dr. Prachi Tiwari is adoctorate in Organic Chemistry, MBA and Law graduate with several PG courses in IPR. She is a registered Indian Patent Agent with about 19 years of experience in leading pharmaceutical companies like Alembic, Ranbaxy (Presently Sun), Teva Pharma and Fresenius Kabi Oncology Ltd.
Dr. Tiwari has more than 16 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 and nutrition.
Currently Dr. Prachi is responsible for all the patent matters globally by supporting and advising to the Research & Development, Business and Allied Functions of the Organization. She ensures hassle free product launch and exploring early market entry opportunities by designing around and challenging road block patents/applications. She handles drafting and prosecution of more than 200 patent applications. She is successfully involved in Indian opposition / litigation of Patents/applications. Dr Prachi Tiwari workson identification of new and potential products, for the inclusion in product portfolio grid.
Specialising in the fields of biotechnology and chemistry, Punita has a broad range of experience, handling subject matter including novel genes and peptides, genetic based therapies and diagnostics, and point of care assays and devices.
Her practice encompasses drafting patent applications and overseeing their prosecution in the UK, Europe and overseas, opposing and defending granted patents before the European Patent Office, advising on infringement and validity issues and handling pre-flotation or licence agreement related due diligence. Over the years Punita Shah has worked closely with universities and a small start-up companies and is highly experienced in providing advice on patent portfolio management and filing strategies. She also works with large international corporations and foreign attorneys.
Dr. Ramani V Marakani has 15 years of experience in patent preparation and prosecution. She was working as a Senior Director with Clairvolex Knowledge Process Pvt. Ltd. She was mentoring patent engineers and supervising the patent development team in Bangalore to ensure high quality of patent applications. Prior to this she was a Director at Intellectual Ventures. In this role, she was responsible working with inventors from prominent Indian universities in the areas of material science, polymer chemistry and other related chemical sciences. Dr. Ramani was an Associate with Schwegman Lundberg & Woessner, Minneapolis prior
to IV. She held the positions of an IP Counsel with Philips Electronics India Ltd., and a Lead Scientist with John F Welch Technology Centre, Bangalore. Before moving to IP and R&D, she was an Assistant Professor at one of the engineering colleges in Bangalore. She received her B. Tech and M.Tech in Chemical Engineering from Osmania University, Hyderabad. She received her PhD from IISc, Bangalore. Dr. Ramani Marakani received her JD and LLM from the then Franklin Pierce Law Centre (now University of New Hampshire School of Law).
Remfry & Sagar
Enrolled at the Bar in 1992, Ranjna Mehta-Dutt is a prominent face of the Indian IP fraternity and leads the Life Sciences practice of the Firm. Well versed in the intricacies of patent law, she is skilled at formulating strategy for developing and managing patent portfolios, particularly when it comes to pharmaceutical, biotech and chemical patents, with a special focus on appeals and contentious matters. Her experience also extends to the protection of designs and plant varieties. Recognised as a leading IP attorney in India, Ranjna Mehta-Duttlectures often on IP law and also assists the government with policy making.
Taft, Stettinius and Hollister
Richard Ruzich is an internationally recognized patent attorney who focuses on complex patent litigation, representing generic pharmaceutical companies in ANDA litigation under the Hatch-Waxman statutory framework. An accomplished trial and appellate advocate, registered patent attorney and frequent lecturer and author, he is known worldwide for his legal work on behalf of his generic clients, including biosimilar sponsors. Richard Ruzich experience covers the entire lifecycle spectrum from product selection, Paragraph IV development and through to market entry, including at-risk launches.
Partner and Co-chair, Intellectual Property Practice
Ron Daignault, partner and co-chair of Goldberg Segalla's Intellectual Property Practice, is a trial attorney with over 25 years of experience and an intellectual property litigator. Widely respected as a pharmaceutical Hatch-Waxman and Abbreviated New Drug Application (ANDA) litigator for both generic and branded drug companies. Ron has guided clients through litigation involving dozens of patents, products, formulations & designs, and methods of use. Ron has been involved in numerous bench, jury trials and
evidentiary hearings, serving as lead counsel or second chair in most of them, and has also argued before several U.S. Courts of Appeals and the New York State Appellate Division.
A frequent writer and speaker on topics in the field of intellectual property, he has held a spot on the New York Metro Super Lawyers list consistently since 2012, and Managing Intellectual Property has recognized him as a “Star” in both Life Sciences and Intellectual Property every year since 2013. Ron Diagnault currently serves as an Advisory Board member of Bloomberg/BNA's Life Sciences Lawand Industry Report and an Amicus Committee member of the New York Intellectual Property Law Association.
Roshan Shrestha focuses his practice on all aspects of intellectual property law, including patent litigation, prosecution and opinion work in the chemical, pharmaceutical and electronic material arts. He has a broad scope of pharmaceutical and life sciences capabilities, including Hatch-Waxman litigation and inter partes review proceedings at the USPTO. Shrestha has been recognized by Super Lawyers as a Rising Star since 2014. In 2016, he was named to Law Bulletin’s “40 Illinois Attorneys Under 40 to Watch.” Before practicing law, Roshan Shrestha was a research scientist at Los Alamos National Laboratory in New Mexico, where his investigation on materials for hydrogen storage technology received several patents.
Partner Executive Committee Member Practice Group Co-Leader, Hatch-Waxman and Biosimilars - Diversity Committee Co-Chair
International and Fortune 500 clients know who to turn to when facing complex patent litigation. As co-leader of Schiff Hardin’s Intellectual Property Group, Sailesh (Sal) K. Patel also co-chairs the firm’s Pharmaceuticals and Biologics Patent Litigation Team and serves on the firm’s executive committee. 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 has resulted in legal precedent-setting cases. He has served as lead counsel on numerous patent infringement litigation matters. With a background in chemical and biomedical engineering, he has completed his Chemical Engineering from Northwestern University (1996) and Juris Doctor Degree from Boston College of Law (1999). Defense against patent infringement requires subject matter experts; he is skilled at aligning the best experts to successfully defend his clients’ interests.
Sailesh 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. He also assists companies in Paragraph IV and biosimilars design strategies, helping his clients protect their scientific discoveries. He has significant experience in preparing and prosecuting patent applications in a variety of technologies. Sal has represented clients in cases involving Hatch-Waxman litigation, biosimilars, wind and solar technology, medical devices, life science, food processing, automotive components, and software, among other sectors. In addition to his legal practice, Sailesh Patel also co-chairs the firm’s Diversity Committee.
Sasha Rao is Chair of Maynard Cooper & Gale’s nationwide Intellectual Property Practice, which includes an experienced team of IP lawyers and professionals located in San Francisco, New York, Huntsville, and Birmingham. She is a seasoned IP lawyer and regularly leads intellectual property and commercial litigation for her clients, including cases involving patents, trademarks, copyrights, trade secrets, unfair competition, and complex commercial disputes. Her strong science background in physics has enabled her to develop effective courtroom strategies for cases involving technologies ranging from pharmaceuticals, medical devices, and biotechnology to computers, Internet, and software. In the realm of life sciences, Sasha has extensive experience in Hatch-Waxman/ANDA litigation and has represented generic and branded pharmaceutical companies in numerous patent cases.
Sasha also advises clients on corporate, transactional, policy and regulatory matters, including IP aspects of mergers and acquisitions. Her enthusiasm for cutting-edge technologies has led to her being recognized as one of the leading practitioners in the emerging ?eld of autonomy and robotics systems. She is registered to practice in the United States Patent and Trademark Office. She also represents clients in Patent Office trials, including Covered Business Method (CBM) and Inter Partes Review (IPR) post-grant invalidity challenges available under the America Invents Act.
Sasha was selected as an Intellectual Property Trailblazer for 2019 by the National Law Journal. She was also named by the Daily Journal in 2019 as one of California’s Top Women Lawyers, Top Artificial Intelligence Lawyers, and one of California’s Top Intellectual Property Lawyers. Sasha’s success and talents in the IP ?eld have also earned her recognition by The Best Lawyers in America© in the area of Litigation: Intellectual Property (2017-present). The Recorder has recognized her 4 times as one of the “Women Leaders in Tech Law.” Sasha Rao was also recognized as a “Trailblazer” by the South Asian Bar Association – Northern California (2016); an “IP Star” by Managing IP magazine (2013–2018); one of the “Top 250 Women in IP” by IP Stars (2013–2018).
Vice President | Shareholder | Pharmaceutical Practice SME
Pharmaceutical Practice SME
Scott Polus has 12 years of experience in Digital Forensics and 14 years eDiscovery Operations. He has vast 20 years of experience in Information Technology. He is a recognized CCE: Certified Computer Examiner, International Society of Forensic Computer Examiners (#1753) and ACE: AccessData Certified Examiner. Magnet Forensics: Internet Evidence Finder Essentials (IEF), Version 6.x . Scott Polus has Private Investigator Licenses: Texas (A18625), Michigan (3701206570)
Upadhye Cwik LLP.
Shashank Upadhye is one of the most recognized leader in the US pharmaceutical and FDA space. For 20+ years, he has focused on pharmaceutical law, with an emphasis on IP and FDA issues. He also spent many years as the chief of legal/IP/FDA counsel at Apotex, Sandoz, and Eon Labs, so he brings key business savvy to clients. Because of that in-house experience, he creates innovative strategies on product development, litigation strategy, and verdicts/settlements. He is a prolific speaker and recognized leader in the Hatch Waxman/Para. IV field. Shashank writes the key legal book on pharmaceutical and FDA law, called Generic Pharmaceutical Patent and FDA Law.
He counsels both brand companies [505(b)(2) applicants] seeking to strategically patent and launch their brand name products in the long term. He helps pharmaceutical clients with the 505(b)(2) NDA process, with an emphasis on creating savvy business and legal strategies around intellectual property, FDA, and supply chain. He can assist 505(b)(2) applicants to interpret the “innovative change” and “conditions of approval” standards and whether a 505(b)(2) will be blocked by an exclusivity.
Shashank provides legal support to generic companies seeking to challenge patents (opinions and litigation) and maximize 180-day exclusivity. He provides input at every stage of the product lifecycle from product selection, R&D, regulatory affairs, product launch, and ongoing marketing/sales. We are routinely called upon to represent clients in sole first-to-file cases.
Shashank also works with or against FDA to move product approvals along. We help to overcome changes in approval standards, Guidance & USP changes, exclusivity fights, and product launches. He advises client on FDA compliance relating to Form 483’s, Warning Letter responses, and enforcement. He helps clients with resolving import alerts and with compliance training. GMP compliance is also a practice focus for Shashank.
Simon is a Partner in our litigation department. Prior to joining AA Thornton Simon worked in the patent litigation department of a London based IP boutique law firm and also in-house within the legal Department of Eli Lilly. Simon’s in-house experience is particularly valued by clients because it allows him to understand the commercial drivers affecting their businesses. Simon’s practice includes life sciences and pharmaceutical patent litigation across a broad range of technologies. Simon also has considerable experience of providing strategic advice in respect of product life cycle management, freedom to operate, and Supplementary Protection Certificates.
A selection of Simon’s key contentious matters include:
Partner and Litigation Department Co-Chair
Cantor Colburn LLP
Senior In-House Patent Attorney
Indoco Remedies Limited
Taylor has 12 Years of litigation and discovery experience in the pharmaceutical industry. He has supported corporate legal departments and law firms with 500+ matters Taylor Judd was former Senior VP at Orange Legal Technologies
Tedd Van Buskirk, a partner with Lerner David, is a business-minded and result-driven intellectual property litigator with a life sciences focus, serving clients in the pharmaceutical, medical device, and biotechnology industries. Over the past 25 years, he has earned a reputation for his ability to absorb the scientific, legal, and business implications and nuances of virtually any technologyspecifically for his knack in making them understandable to non-technical audiences, especially in the courtroom. He has a track record of success helping clients navigate the complex intersection of the patent and FDA laws relating to the Hatch-Waxman Amendments. From the earliest blockbusters to the multi-defendant FTF cases of today, Tedd has litigating ANDA cases and prosecuted parallel inter partes review (IPR) proceedingsfrom filing through trial and appeal from A to Z (ALOXI®, ANDROGEL®, CLARITIN®, EFFIENT®, INVOKANA®/INVOKAMET®, LIDODERM®, NEURONTIN®, OXYCONTIN®, PREVACID®, PRECEDEX®, PRILOSEC®, TRINTELLIX®, ZANTAC®, and ZOFRAN®, among others).Prior to joining Lerner David, he was a partner in several AmLaw 100 firms.Tedd Van Buskirk is a frequent panelist and speaker on Hatch-Waxman matters and is often quoted in the press and published on issues affecting the pharmaceutical industry.
Associate Vice President – IP & Portfolio Management
Hetero Labs Ltd.
Vijay Nasare is Associate Vice President – IP & Portfolio Management at Hetero Labs Ltd. He is responsible for devising and implementing IP strategies at Hetero. He handles patent litigations and settlement at Hetero and performs key role in developing Hetero’s internal and external pipeline. Prior to joining Hetero, he worked with Glenmark Pharmaceuticals Inc USA, where he was mainly responsible for patent litigation and product launch management. Prior to Glenmark, he worked at Dr Reddy’s Laboratories Ltd and FDC limited. He is Post graduate in Pharmaceutical Sciences and he has earned his Degree of Law from the University of Mumbai. Vijay Nasare has also done PGDM (Executive) from Narsee Monjee institute of Management Studies.
For 40 years, Edward Bailey has focused his practice on intellectual property litigation including patents, trademarks and copyrights. He is an experienced trial lawyer, having tried cases (both jury and bench trials) in numerous jurisdictions. Ed also has had experience in the United States Court of Federal Claims and the International Trade Commission. He is registered to practice in the United States Patent & Trademark Office and has represented clients in contested proceedings in that office.