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22 - 24 September 2021
Vice President – IPMMacleods Pharamceuticals Limited
Director & Head-Business Development, Portfolio & StrategyKashiv Biosciences Pvt. Ltd.
Vice President & Head – Intellectual PropertyDr. Reddy’s Laboratories
General Counsel and Vice President (Legal)USV Private Limited
Vice President – IPM
Macleods Pharamceuticals Limited
Director & Head-Business Development, Portfolio & Strategy
Kashiv Biosciences Pvt. Ltd.
Dr. Paras Vasanani is presently associated with Kashiv BioSciences LLC (US based innovator pharma company) as Director & Head Business development, Portfolio & Strategy. Dr. Paras has pursued M.Pharm and Ph.D. with specialization in the field of Pharmaceutical Sciences from M.S.University, Vadodara. He did his MBA from IIM-Ahmedabad. He is registered Indian Patent Agent and Trademark Agent. Hehas more than 10 patents on his name as inventor. Dr. Vasananiremained as spoke person at various National & International Conferences, Symposiums and Universities.
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.
General Counsel and Vice President (Legal)
USV Private Limited
Mr. Sandeep K. Rathod is a senior legal & IP professional from India and a keen observer of
Health and IP Policy in the developing world for the last
2 decades. He has a LL.M. from India and a LL.M. from USA. His professional role encompasses providing
legal and strategic advice to senior management on the entire gamut of issues affecting the pharmaceutical industry ranging from
pricing to IP to commercial disputes.
Sandeep Rathod teaches Patent Litigation and writes on patent issues.
Member and Registered Patent AttorneyCozen O’Connor
Director-Global Regulatory AffairsAdvanz Pharma
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
Group Head & Vice President Regulatory AffairsReliance Life Sciences
PartnerMaynard Cooper and Gale
PartnerSterne, Kessler, Goldstein & Fox P.L.L.C.
PartnerGreen, Griffith & Borg-Breen LLP
ShareholderMaynard Cooper & Gale
PartnerPergament & Cepeda LLP
General Manager - Intellectual Property CellSun Pharmaceutical Industries Ltd
Head LegalMacleods Pharmaceuticals Ltd.
Vice President | Shareholder | Pharmaceutical Practice Co-ChairXact Data Discovery
PartnerArent Fox LLP
United States District Court
PrinicipalLambert Hornby Limited
Associate DirectorKashiv Biosciences Pvt. Limited
Japanese Patent Attorney - HeadKuzuwa & Partners
Sr. General Manager, IPR – LegalMylan Laboratories Limited
Director & Head, Business Development, Portfolio and StrategyKashiv Biosciences
Ph.D., PartnerGreenblum & Bernstein, P.L.C., USA
Director – Regulatory Affairs (Head – Medical Devices; India Regulatory; Regulatory Assurance & Data Systems)Cipla
Sr.Vice President & Head Global Regulatory AffairsMankind Pharma Ltd
PartnerRemfry & Sagar
PartnerTaft, Stettinius and Hollister
Partner and Co-chair, Intellectual Property PracticeGoldberg Segalla
Ph.D. - Patent AttorneyTaft, Stettinius and Hollister
Partner Executive Committee Member Practice Group Co-Leader, Hatch-Waxman and Biosimilars - Diversity Committee Co-ChairSchiff Hardin
Vice President & Shareholder - Pharmaceutical Practice SMEXact Data Discovery
PartnerUpadhye Cwik LLP.
Partner and Litigation Department Co-ChairCantor Colburn LLP
Senior In-House Patent AttorneyIndoco Remedies Limited
Vice President of Intellectual Property and Global Product Portfolio ManagementGlenmark Pharmaceuticals Ltd.
Vice President & Shareholder - Pharmaceutical Practice Co-ChairXact Data Discovery
Partner Lerner David
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.
Director-Global Regulatory Affairs
Abhishek Sinha is an experienced Regulatory Affairs Professional in Generics / Off-Patent space with 17+ years of global experience in industry across product life cycle ranging from product development, life cycle Management, in licensing and Mergers and acquisitions.Postgraduate in Pharmaceutics from BIT Mesra( Goldmedalist), PG Diploma in Patents Law from NALSAR and Executive certification in Growth Strategy from IIM Joka Kolkata with around 14 years experience in people management and 5 years (and continuing) in leadership roles. He has worked with Dabur Research Foundation, Ranbaxy Laboratories and now currently working as Director Global Regulatory Affairs ADVANZ PHARMA.
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.
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.
Group Head & Vice President Regulatory Affairs
Reliance Life Sciences
Dr. Bobby George is serving as the Group Head, Vice President Regulatory Affairs at Reliance Life Sciences, Navi Mumbai. He is responsible for regulatory services across the company’s business verticals (plasma proteins, biosimilars, pharmaceuticals etc.), for both domestic and export markets. He has been part of the leadership team at Reliance in getting all the 18 biosimilar products approved and commercialized. He holds a Ph.D in Pharmacology and has around 22 years of industry experience. Dr. George is also an avid speaker and writer. He has to his credit 38 publications in peer reviewed journals and has written 3 book chapters. Dr. Bobby George has also authored and published an interesting book on Pharma healthcare titled The Act that Wasn't®
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.
Maynard Cooper & Gale
Christopher Harnett “Chris” a Shareholder in Maynard Cooper’s office in New York City, focuses his practice on the litigation of intellectual property matters. He has nearly 30 years of experience, successfully trying patent infringement and trade secret cases involving a wide range of technologies, including pharmaceuticals, biotechnology, medical devices, computer systems, and consumer products.
Chris works closely with clients to develop integrated legal and business-focused strategies that best serve their needs, relying on his strong background in science, legal experience, and expertise to achieve his clients’ objectives. Chris Harnett earned his J.D. at Georgetown University Law Center after the American University awarded him an M.A. in Cellular Biology and Molecular Biology.
Pergament & Cepeda LLP
Edward Pergament litigates patent infringement actions and drafts patent opinions for a variety of clients. He has a broad patent and technical experience in a variety of fields, including pharmaceuticals, cosmetics, food, medical devices, vapor deposition processes, photography, and optics. At present, his practice is focused mainly on pharmaceutical patent litigation and establishing generic positions, counseling clients in pharmaceutical and chemical industries with respect to life cycle management and other strategic issues. Mr. Pergament is 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.
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.
Macleods Pharmaceuticals Ltd.
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 Courtand 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.
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.
Lambert Hornby Limited
Kashiv Biosciences Pvt. Limited
Mr. Kaushal Joshi is an experienced patent professional with biologics background & has extensively worked on
first and second wave biosimilars & new biologics. He has participated in
litigation, opposition proceeding in India, Europe and USA including
BPCIA litigation. He has drafted more than
65 patent applications & prosecuted several applications pertaining
to biologics & small molecules in several jurisdictions.
At present, he is associated with Kashiv Biosciences Pvt. Ltd. as associate director and looking after IP department. He started career with
Zydus healthcare and further worked with Glenmark & Lupin pharmaceutical.
He holds Master Degree in Biotechnology and completed research work in IIT Delhi & Intas Pharmaceutical on Biosimlar development. Mr. Kaushal Joshi also holds a law degree and license to practice before Indian patent office.
Kevin Nelson is an intellectual property attorney with a focus on large-scale complex patent infringement litigation. For more than 15 years, he has guided clients through the
legal and regulatory challenges and changes associated with obtaining approval to commercially market a product under the
Hatch-Waxman amendments to the
Federal Food, Drug, and Cosmetic Act. In addition to helping clients develop a strategy for
filing an abbreviated new drug application (ANDA), Kevin has represented clients in every phase of
patent litigation and has successfully argued before the United States Court of Appeals for the Federal Circuit. His matters have involved patents purportedly covering well-known pharmaceutical products and methods for using those products. He also has successfully represented clients in inter partes review (IPR) proceedings.
In the face of an evolving and uncertain biosimilar industry in the United States, Kevin has counseled clients on navigating the biosimilar legal and regulatory pathways. He has also advised clients on regulatory matters before the U.S. Food and Drug Administration, such as opposing citizen petitions. Rounding out his experience, Kevin has handled cases involving trademark and copyright infringement, false or unfair advertising, and unfair competition claims. Kevin Nelson has completed his B.A. in Political Science from Indiana University (1998) and Juris Doctor Degree from DePaul Unviersity College (2201).
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.
Sr. General Manager, IPR – Legal
Mylan Laboratories Limited
Dr. Mahendra Thakre is an in-house patent counsel working asSr. General Manager, IPR-Legal atMylan Laboratories Limited, based at Hyderabad (India). He has earned his Doctoral Degree (PhD), Mastersin Business Management, Masters in Pharmaceutical Sciences,PG Diploma in Patents Law and a degree in Law (LLB). During overaround 18 years of industrial and academic experience in organizations like Dr. Reddy’s Laboratories, and National Institute of Pharmaceutical Education and Research (NIPER), he has established an expertisein strategy for para IV & generic opportunity in US in-line with Hatch-Waxman Act, opposition, invalidity opinion preparation for blocking patents, IP strategy, and patent litigation across geographies. He has strong experience in pharmaceutical/ regulatory legislation, patents, in-bound patent / technology licensing, policy analysis. He has deep interest in IP Policy in developing countries and advise senior leadership team on critical issues and policy developments. He is also an eminent speaker in various conferences and symposiums and is a visiting professor in number of premier institutions in India.
Myoka “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. MikiGoodin 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.
Director & Head, Business Development, Portfolio and Strategy
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 – Regulatory Affairs (Head – Medical Devices; India Regulatory; Regulatory Assurance & Data Systems)
Dr. Praveen Kumar is currently working as Directory of Regulatory Affairs at Cipla, heading Medical Devices, India Regulatory, Regulatory Assurance and Data Systems functions. He has around 20+ years of Healthcare Regulatory and Quality experience in Combination Products, Medical Devices, Pharma, BioPharma including research experience. Dr. Praveen Kumar is IRCA certified ISO 13485:2003 & ISO 9001:2015 Lead Auditor and has accomplished various certifications and accreditations.
Sr.Vice President & Head Global Regulatory Affairs
Mankind Pharma Ltd
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.
Ph.D. - Patent Attorney
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.
Mr. Sandeep K. Rathod is a senior legal & IP professional from India and a keen observer of Health and IP Policy in the developing world for the last 2 decades. He has a LL.M. from India and a LL.M. from USA. His professional role encompasses providing legal and strategic advice to senior management on the entire gamut of issues affecting the pharmaceutical industry ranging from pricing to IP to commercial disputes.
Sandeep Rathod teaches Patent Litigation and writes on patent issues.
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
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
Steve Coyle is a Partner and co-chairs the firm's Litigation Department. He is a trial lawyer with more than 20 years' experience in litigating and trying complex disputed matters, and he has specialized in patent and all varieties of intellectual property litigation for the past 15 years. 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. He is also the Chair of Cantor Colburn’s Pharmaceutical Litigation Practice. Steve represents clients as both plaintiffs and defendants in a variety of other patent matters, involving such diverse technologies as software, cybersecurity, fiber optics, induction lighting, microwave circuit boards, robotic measurement equipment, media packaging, flexible gas piping, and telecommunications. Steve has substantial experience litigating trademark, copyright, and trade secret matters as well. He has tried and litigated patent and
other intellectual property cases 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 In-House Patent Attorney
Indoco Remedies Limited
Swati Veera is an accomplished Patent Attorneyhaving 25 years’ experience in IP Field.
Currently, she works as Senior In-House Patent Counsel at Indoco Remedies Ltd, and prior to joining Indoco, she worked at IP Dept. of Piramal Enterprises Ltd, Sun Pharma. and Lupin. In her career in the IP field, she has been involved in strategic patent portfolio management; drafting and prosecuting over 500 Indian and world-wide patentapplications; providing legal opinions on patentability, patent infringement, freedom-to-operate analysis and validity issues. She also engages in IP licensing activities, and devising strategies for patent litigations.
Swati has mentored several budding IP Professionals and Law students. She is a frequent speaker on emerging areas of patent lawat various events. She is recognized amongst “Top 100 Powerful Women in Law” by WIPF in 2017. Also, Swati Veera received recognition as “IP Star Woman of the Year” from Legal Era Magazine in January 2019.
Vice President of Intellectual Property and Global Product Portfolio Management
Glenmark Pharmaceuticals Ltd.
Dr. Taranpreet Singh Lamba is presently working as Vice President of Intellectual Property and Product Portfolio Management in Glenmark Pharmaceuticals Limited, Mumbai. He has more than 19years of rich experience in the patent matters with specific focus in managing patent portfolios, infringement analysis and litigations for various geographies like US, EP, India and Emerging Markets. He is also a Head of Product Portfolio in Glenmark for making future pipeline for key regulated markets including US, Europe.
Dr. Taranpreet Singh Lamba is a pharmacy graduate and has done M. Tech in Pharmaceutical Technology from NIPER and has further also done specialization in patent law.
Vice President & Shareholder - Pharmaceutical Practice Co-Chair
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.
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.