Past Speakers 2016

Director
Sterne Kessler Goldstein & Fox

Mr. Varughese is a director in the firm's Litigation Group and focuses his practice on patent litigation with a special emphasis on pharmaceutical patent litigation under the U.S. Hatch-Waxman Act. He has handled cases involving a broad range of technologies in the pharmaceutical and biotechnological arts, including controlled-release polymers, hypoglycemic treatments, antilipidemic treatments, antimalarials, nutritional supplements, microfluidics, and in vivo imaging. Mr. Varughese's experience includes pre-filing investigations, discovery, expert witness preparation, Markman proceedings, dispositive motions, and trial. He also has experience in reexamination proceedings co-pending with district court actions.

Additionally, Mr. Varughese has extensive experience in counseling clients on FDA regulatory matters, early commercialization strategies, patent settlement and licensing, supply and distribution agreements, drug products liability, and antitrust issues bearing on pharmaceutical patent settlements.

Shareholder
Mcandrews
Aaron Barkoff focuses on pharmaceutical and biotechnology patent litigation. He has impressive trial experience in ANDA litigation, representing clients ranging from the world's largest pharmaceutical companies to specialty and generic drug companies. He also represents both patent owners and petitioners inInter PartesReview proceedings at the Patent Trial and Appeal Board. Aaron's strong technical background, combined with his deep understanding of FDA regulatory issues, enables him to provide life science companies with keen insights on patent litigation strategy, including biosimilar litigation strategy under the BPCIA. Further, he advises clients on Orange Book patent listings, patent term extensions, and FDA exclusivity. Aaron is the founder and editor of Orange Book Blog, a widely-read blog reporting on developments at the intersection of patent and FDA law.
Partner
HGF
Jonathan has a doctorate in chemistry from Oxford University and is a Fellow of the Royal Society of Chemistry. Jonathan is a member of the Board of HGF and is the head of the Oppositions & Appeals, and Asia Teams at HGF. Jonathan’s practice involves providing commercially-focused advice on patent strategy, portfolio management, and litigation. This includes obtaining and defending patent rights, providing opinions and challenging third party rights, challenging third party rights by opposition or litigation, and due diligence to support corporate acquisition and licensing deals. He has also been responsible for filing all of the foundation patents for graphene on behalf of the two Nobel Prize winners.
Partner
Greenblum & Bernstein, P.L.C., USA
Paul is a supervisor in 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. Paul is involved extensively in the firm's pharmaceutical practice, and advises generic and branded drug companies on strategic planning and new product introduction. He works extensively with Hatch-Waxman issues and the interface of patent and FDA law.
 
Paul is a regular panelist in seminars given in association with the annual conferences of the International Generic Pharmaceutical Association and the European Generics Association and other conferences. Paul works closely with the Journal of Generic Medicines and regularly contributes articles on patent law and generic drugs.
 
Paul 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, Paul was a staff member of the Journal of Legal Ethics.
 
Paul is admitted to the Virginia State Bar and the Court of Appeals for the Federal Circuit, and is registered to practice before the United States Patent and Trademark Office. Paul is a member of the American Intellectual Property Law Association and the American Chemical Society.
MD, JD
Merchant & Gould
Edward Pardon, MD, JD, is a partner in the Madison, Wisconsin offices of Merchant & Gould, focusing his practice on Hatch-Waxman litigation, patent opinions, citizen petitions, and counseling related to FDA regulatory issues associated with the Hatch-Waxman Act. Dr. Pardon has substantial experience including cases involving zoledronic acid, linagliptin, acetaminophen, diclofenac, dexmedetomidine, rosuvastatin, fexofenadine, and niacin/simvastain. He has been adjunct faculty at the University of Wisconsin Law School and is a member of the American College of Legal Medicine. Prior to entering law, Dr. Pardon practiced medicine for ten years, and he has been a speaker at this conference for the past four years.
Global IP Head
Intas Pharmaceuticals Ltd

Dr. Alpesh Pathak is currently Global IP Head at Intas Pharmaceuticals Ltd.

Dr. Alpesh has also written a book Entitled “Protecting Patent Fundamentals” which is well appreciated in patent professionals and major universities wherein patent is one of the value added subject in the respective technical discipline.

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 for ANDA, Handling litigation across the globe and related activities, drafting and prosecution of patent applications, drafting and negotiation of intellectual property agreements with third parties, and due diligence analyses in supporting in-licensing and out-licensing activities.

Prior to joining Intas, Dr. Alpesh has worked with some of the leading pharmaceutical companies like Alembic Ltd, Lupin Ltd., Zydus Cadila and Cadila Pharmaceuticals. Alpesh holds a PhD degree from The Sardar Patel University. Dr. Alpesh Pathak is a registered Patent agent. Besides having PG diploma in Patent Law degree from Nalsar Uni, Hyderabad, he has undergone various specialized courses on US litigations and European patent practices. He has completed Masters from the Sardar Patel University, and a B.Sc. from the Same University with specialization in organic chemistry. Dr. Alpesh is also active in certain knowledge development programs for creating IP awareness by conducting lectures in various universities and conferences in India and abroad. He also currently a visiting faculty at Sardar Patel University and Gujarat Technical University (GTU).

Partner
Osbrone Clark

Andrea has longstanding experience in advising and representing national and international clients on technology transfer, in particular as regards the in- and out-licensing of IP Rights as well as research and development collaborations and antitrust issues. Among her further areas of expertise are trademark and unfair competition law.

A special focus of her activity is the field of employee invention law. She has extensive experience with the IP-aspects of M&A transactions.

Andrea studied law in Goettingen, the Hong Kong and Bonn. She obtained a doctorate from the University of Jena in 2001.

Prior to joining Osborne Clarke in 2014, she was a partner at Baker & McKenzie.

Partner
Locke Lord LLP
Miki Goodin is a partner in Locke Lord's intellectual property and litigation departments. 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. She has extensive experience in all areas of litigation, from fact discovery (written and deposition), expert discovery (expert reports and depositions), dispositive and preliminary injunction motion practice, through trial and appeals. Miki also represents clients in antitrust and patent litigation actions, provides patent counseling related to the Hatch-Waxman provisions, and represents both domestic and international clients in a variety of disputes involving the entertainment and media industry.
Shareholder
Winthrop & Weinstine
Sri K. Sankaran is an experienced trial lawyer who helps clients in a wide range of cases involving intellectual property. Sri has handled patent infringement cases in a variety of fields, including software, communication networks, pharmaceuticals and nutritional supplements. He has also litigated copyright, trademark, trade secret and unfair competition matters. Sri also works with organizations in the examination and certification industries to develop strategies to maintain the security of their examination content and to combat examination subversion.
Patent Attorney & Partner
Krishna and Saurastri Associates
Ms. Richa Pandey is a Patent Attorney and a Partner with Krishna and Saurastri Associates, Delhi (Gurgaon) office. She is an advocate and a registered patent agent. Her core work areas include patent filing, patent prosecution, patent opposition, patent litigation, patentability opinions, searches, invalidity opinions and portfolio management. Ms. Pandey holds a Degree in Law and a Bachelor’s Degree in Science from the University of Lucknow. Ms. Pandey has also been a guest speaker at various national & International conferences on Intellectual Property.
JD
Merchant & Gould
Jeffrey Ward, JD, is the managing partner of the Madison, Wisconsin offices of Merchant & Gould. Mr. Ward has been active in litigating Hatch-Waxman cases for almost 30 years, and has led trial teams in numerous litigation matters, many times to verdict. He also focuses his practice on patent opinions, citizens petitions, and client counseling on FDA regulatory issues, labeling issues, and patent certification strategies associated with the Hatch-Waxman Act. Mr. Ward has been named to the IAM Patent 1000—The World’s Leading Patent Practitioners from 2013-2015, and has also be named an IP Star by Managing IP for the past three years. Mr. Ward has a Bachelor of Science degree in Chemical Engineering, and has previously been a speaker at this conference.
Associate
Sterne Kessler Goldstein & Fox

Ms. Vira is an associate in the firm's Litigation and Biotechnology groups. Her practice focuses on patent litigation in U.S. district courts and U.S. Patent and Trademark Office (USPTO) litigation. In particular, Ms. Vira has extensive experience representing clients in the pharmaceutical industry in U.S. District Court litigation arising under the U.S. Hatch-Waxman Act and before the U.S. Federal Circuit on appeal. Ms. Vira also represents clients before the USPTO Patent Trial and Appeals Board (PTAB) in inter partes review proceedings.

Ms. Vira has litigated cases involving a broad range of technologies in the pharmaceutical and biotechnological arts and has experience with all phases of litigation from pre-filing investigations, fact and expert depositions, trials, and appeals.

Partner
Saikrishna and Associates

Mr. J. Sai Deepak is an engineer-turned-litigator with a bachelors degree in mechanical engineering from Anna University (2002-06) and a bachelors degree in law from IIT Kharagpur (2006-09). Sai has been a litigator with Saikrishna & Associates since July 2009 and is an Associate Partner in the Litigation Team of the Firm. Sai has carved a niche for himself in Civil Commercial and Corporate litigation, especially in the areas of Intellectual Property, Competition law, Drug regulatory laws, Indirect Taxation and Economic Offenses. He has handled multiple patent matters across technology segments including pharmaceutical and telecom patents. Since March 2013, Sai has led the Firm’s team which represents Indian mobile brands against Ericsson in Standard Essential Patent litigations.

Sai has played a critical role in landmark decisions such as Tata Sons v. Greenpeace where the law relating to the interplay between constitutional freedoms and IP rights was laid down. In December 2013, Sai successfully argued on behalf of private players from the State of Madhya Pradesh in the Basmati Geographical Indication dispute seeking inclusion of the State in the Basmati GI application. Sai also led the Firm’s team which represented online intermediaries before the Supreme Court in the successful constitutional challenge to the intermediary liability regime under the Information Technology Act. Apart from IP practice, Sai also extensively handles matters relating to Competition law and economic offenses.

Sai is an avid writer and has articles to his credit in reputed international journals such as Max Planck Institute’s International Review of Intellectual Property Law and Competition law, and national journals. He has won a few international and national legal writing competitions such as the 2008 Legal Writing Competition of the International Association for the Advancement of Teaching and Research in Intellectual Property (ATRIP). Sai has been invited in the past to present his views on important IP developments by fora in India. Sai is a prolific legal blogger as well. As a student of law, his blogpost on the Bajaj-TVS patent dispute was cited extensively and relied upon by a Division Bench of the Madras High Court to reverse the findings of the Single Judge. His blog “The Demanding Mistress” is widely read by IP practitioners, law makers and policy analysts in India and abroad.

Shareholder
Polsinelli

Ron Daignault thrives on developing strategies to address clients’ legal concerns, and then implementing those strategies in and outside the courtroom in a focused, cost-effective and nimble way. As an intellectual property litigator and trial attorney he has represented clients in patent, trademark, false advertising, trade secret and copyright cases across a broad spectrum of industries and technologies, and has developed particular expertise in pharmaceutical Hatch-Waxman litigation for generic and branded companies. With more than 20 years of experience, Ron has been involved in 15 bench and jury trials and evidentiary hearings and has been lead counsel or second chair in most of them. He has also argued before United States courts of appeals and the New York appellate division.

 

Ron further understands that many cases never go to trial, nor do they necessarily need to. He is committed to working with clients to develop cost effective strategies for results that make sound business sense. This commitment has led to enduring attorney-client relationships based on trust. To achieve positive outcomes, Ron believes in meticulous preparation, creative thinking and efficient case management - from pre-suit counseling and due diligence, fact and expert discovery, patent claim construction and summary judgment, to settlement or trial.

 

Partner
Eversheds

Adrian has extensive experience of all aspects of intellectual property, in particular complex patent litigation in a number of industry sectors.

He has recently advised on disputes involving pharmaceuticals, somatic cell therapy, semiconductor chip design, inkjet printing technology, digital compression algorithms, LCD flat-panel technology, telecoms and pharmaceuticals. He also frequently helps clients with disputes involving confidential information, database rights, trade marks, copyright and designs.

Away from the court room, he is regularly involved in the negotiation and drafting of technology licence agreements and other contracts relating to IP such as R&D collaborations, joint ventures, co-promotions and other commercial arrangements. He also advises on the EC and UK competition law aspects of these agreements, and issues relating to technical standardisation, essential IPR and patent pooling.

He has a wealth of experience in handling the IP aspects of many major corporate transactions, including for FTSE 100 and Fortune 500 corporations.

Member
Amin Talati & Upadhye, LLC

Shashank Upadhye is a Member at Amin Talati & Upadhye. Mr. Upadhye has extensive experience dealing with legal and regulatory matters in the pharmaceutical and medical device industries. He joined the firm from an international AmLaw 100 firm where he headed the Life Sciences/FDA department. Prior to that, Mr. Upadhye worked at Apotex, Inc.,in Toronto, Ontario, where he was the Global Head of Intellectual Property. Before joining Apotex, Inc., he was the U.S. Head of Intellectual Property at Sandoz, Inc. in Princeton, NJ.

As the former Head of Intellectual Property at two leading pharmaceutical companies he interacted with all levels of technical and business management and counseled in matters such as product selection, Research & Development support, FDA regulatory affairs, litigation management, and product launch management. As a senior member of the executive team he routinely advised and coordinated legal efforts regarding global litigation in patent, trademark, and copyrights. More specifically, he counseled on early market opportunities for generic drug clients, particularly in the field of “Paragraph IV” brand-generic pharmaceutical matters. His specialties include development of strategy and tactics in Abbreviated New Drug Application matters; patent opinion work on infringement and freedom to operate; patent litigation in the drug and medical device spaces.

Vice President- Intellectual Property Cell
Panacea Biotec Ltd.

Dr. Mahalaxmi Andheria brings with her an experience of more than 15 years in the Pharma & Biotech Industry. She has been actively involved in Formulation R&D for 5 years before she decided to switch to IPR and thereafter IPR has been her primary area of focus. Dr. Andheria is a PhD in Pharmaceutics from ICT (former UDCT, Mumbai) and a post-doctorate from University of Cincinnati, USA.

In her present association with Panacea Biotec since the last 10 years, she has been instrumental in managing the IPR Department consisting of specialists in diverse fields including biological (vaccines and biosimilars), pharmaceutical & synthetic chemistry area. She has established a seamless collaboration with Business Development and R&D expanding the horizon of her department beyond traditional IPR, broadening the outlook into portfolio planning, strategizing innovation and through creative participation in collaborations.

In addition Dr. Andheria actively engages in dialogue with policy makers in an effort to contribute towards the development of a robust and balanced National IP Policy in India.

 
Griffith Hack
Wayne has particular experience and expertise in the pharmaceutical, biotechnology and agricultural chemicals sector. He led the team in the Australian patent proceedings that clarified the law relating to the patentability of methods of medical treatment and he has represented clients in many of the leading pharmaceutical patent cases conducted in Australia in the last 20 years. Wayne has often conducted patent litigation in Australia as part of a multi-jurisdictional team and, as a consequence, he is particularly well experienced in dealing with the issues which can arise in that context. Wayne also provides freedom-to-operate, regulatory and competition law advice to companies in the pharmaceutical, biotechnology and other industry sectors.
 
Wayne is also a prominent speaker on intellectual property matters and a proven author having written extensively for a number of professional journals such as The European Intellectual Property Review and the Journal of Intellectual Property Law and Practice. He is also the author of two chapters in “Butterworths Patent Litigation, Enforcing a Global Patent Portfolio” published in 1995. and a co-author of the Australian chapter of the Oxford University Press publication entitled “Pharmaceutical, Biotechnology and Chemical Inventions: World Protection and Exploitation” published in 2012. Most recently he contributed the Australian overview chapter on the regulation of therapeutic goods forming part of “Commercialisation of Health Care” published in 2013 by Sweet & Maxwell.
 
M.B., B.S., M.D., Esq.
Cohen & Gresser LLP

Dr. Walia practices commercial and intellectual property litigation in a variety of disciplines, including pharmaceutical patent litigation, Hatch-Waxman litigation (including ANDA litigation), and products liability. He also practices healthcare, regulatory, and compliance law. Prior to law school, he completed his premedical education from Delhi University and earned a medical doctorate degree from Armed Forces Medical College, the second highest ranked medical school in India. He practiced as an attending anesthesiologist physician in several American hospitals. He was named byManaging IP as a 2015 “IP Star” in the areas of reexamination, Hatch Waxman, Orange Book, and PTAB. Dr. Walia is fluent in Urdu, Hindi, and Punjabi.

He earned his J.D. from St. John’s University School of Law where he served as Editor-in-Chief of the New York Real Property Law Journal, the Articles & Notes Editor of the American Bankruptcy Institute Law Review, president of the Patent Law Society, and as a member of the Moot Court Honor Society. Prior to joining the firm, Dr. Walia practiced at Kaye Scholer, LLP. Dr. Walia is a member of the firm’s Diversity Committee.

Executive Director, Hong Kong - Commonwealth – Asean
Darts-ip

His role is to develop the Commonwealth database to answer in an efficient way the needs of the corporates (including Indian pharma companies), lawyers, IP agents, Courts, IP offices, basically anybody dealing with IP.

From his offices in Hong Kong and Kolkata (India), he is in charge of the management of all the Commonwealth countries as well as Hong Kong. He is also working on the "ASEAN" database (Singapore, Malaysia, Thailand, Indonesia, Vietnam and Philippines mainly). He is responsible for business development and setting up sales teams across the area to promote and offer the database to new clients.

Having a legal background, he is also in charge of setting up legal teams to analyse the decisions and he is actively developing the search engine to provide the clients with the best tools on the market.

Finally, he offer regular trainings to clients to ensure that they are having the best experience with Darts-ip.

Partner
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. He has significant experience in all fields of intellectual property, including litigation, patent and trademark prosecution, licensing and counseling.

For the past 15 years, Alan Clement has been intimately involved in a number of multi-patent complex Hatch-Waxman pharmaceutical patent infringement litigations, including acting as lead trial counsel on numerous matters. From written discovery to fact depositions, to expert reports and depositions, to motion practice and to lead counsel at trial (including cross examination of key expert witnesses of brand companies), he has been involved in all aspects of these actions.

Partner
YUASA and HARA

Mr. Yamamoto is a patent attorney, and a partner of YUASA and HARA, and is the acting Chief of the Chemical Section.

He has extensive experience in pharmaceutical and biotechnology research and worked in the field as a researcher and developer at a chemical company for ten years before specializing in intellectual property. He has represented a variety of companies in the fields of pharmaceuticals, biotechnology, diagnostics, and food and beverages. He is experienced in patent prosecution, invalidation trials, and infringement lawsuits. He was chosen by Lawyer Monthly Legal Awards 2014 and 2015 as “Biotechnology Lawyer of the Year,” and chosen by Corporate LiveWire Global Awards 2015 as “Biotechnology Lawyer of the Year”.

Partner
JACKSON, ETTI & EDU

Chinyere is a partner in the firm and has over 24 years’ experience in all aspects of Intellectual Property law. Her practice primarily focuses on the prosecution of Trademarks, Patents & Designs; Commercial IP advisory, IP Enforcement & Brand Protection, Anti-Counterfeiting, and Copyright, Media & Entertainment law. She heads the IP Asia Unit of the firm and represents a number of local and international blue chip companies.

Chinyere is internationally recognized as an expert in her field and her various appointments and accolades attest to this. She is the immediate past Chairperson of the IP Committee of the Section on Business Law of the Nigerian Bar Association, a position she held for 7 years; a Patron of The Law Society, University of Lagos, Nigeria;and a member of the Stakeholders Committee of the IP Law Association of Nigeria (IPLAN).In 2012, she was appointed as a member of the Dispute Resolution Panel of the Nigerian Copyright Commission (NCC). She is also a columnist for the IP Section of ESQ Legal Magazine.

Chinyere is an active member of several international IP organizations, including the Asian Patent Attorneys Association (APAA), based in Japan, where she is an Observer member; the International Federation of Intellectual Property Attorneys (FICPI), based in Switzerland, where she is one of only three Nigerians who have been admitted into the Individual Membership; Pharmaceutical Trademark Group (PTMG), where she is her Firm’s nominee; and The Institute of Trademarks Agents (ITMA).

On the home front, she has successfully organized/ facilitated a number of seminars and workshops, on IP. She has also written a number of articles for publication in the journals of various organizations, both local and international, on IP related issues.

Regional Head - South Asia
MSF – Access Campaign

Leena Menghaney is the South-Asia Head for MSF’s Access Campaign. Area of work and expertise is Public Health, Innovation and Intellectual Property. A graduate from the Dept of International Relations & Economic Studies, Jadavpur University, Calcutta she also has a LL.B degree from the University of Delhi.

In the last decade generic production in India has emerged as crucial for the supply of quality affordable medicines to the developing world, especially for newer drugs such as antiretrovirals (ARVs) for the treatment of HIV. She worked extensively on the people’s campaign for the inclusion of public health safeguards in the Patent (Amendment) Bill 2005, as its provisions seriously affected the production of affordable generic drugs.

She is working with government, civil society and other stakeholders to implement public health safeguards in the Indian patent law. Since March 2005, her work involves providing technical legal support for ‘oppositions’ filed by people living with HIV/AIDS against pending patent applications on antiretrovirals and other essential drugs. She has also been involved in providing legal analysis on various free trade agreements and bilateral investment treaties being negotiated by India with many developed countries. When multinational pharmaceutical company Novartis tried to challenge the public health safeguards in India’s patent law in 2006, MSF joined public interest groups in successfully opposing the pharmaceutical company’s legal action in order to safeguard India’s position as the ‘pharmacy of the developing world’. She has been coordinating this work for MSF.

More recently she has started working on alternative models on research and development for drugs and diagnostic tools for neglected diseases such as Tuberculosis.

She is also providing technical support to Fix the Patent Law Campaign in South Africa on their national patent regime and how this is having a significant adverse impact on the affordability and accessibility of medicines for South Africans. She has drafted a technical briefing paper that lays out the problems with South Africa's current patent regime, which registers but does not examine patents, and also proposes a solution, the establishment of a patent examination system.

Senior Associate
Montaury Pimenta Machado & Vieira De Mello
Bruna Rego Lins is a Senior Associate at Montaury Pimenta Machado & Vieira de Mello. She has done Masters in Intellectual Property and Innovation from the Brazilian PTO Academy and has 18 years of experience. She has also done LL.M. in Intellectual Property Law from The George Washington University Law School.
Partner
Luthra & Luthra Law Offices
Senior In-House Patent Attorney (Counsel)
Indoco Remedies Limited (India)

Swati Veera has over 21 Years of experience in the field of IP, particularly Patents. Ms. Veera’s experience includes patent drafting, prosecution, litigation (including Hatch-Waxman litigation strategy and related issues), patent portfolio management, patentability evaluation, conducting invalidity and non-infringement studies and rendering opinions; and devising overall pharmaceutical patent strategies and implementing the same.

Currently, Ms. Veera is working as Senior In-House Patent Attorney (Counsel) at Indoco Remedies Limited. In her current role, she provides strategic expertise on a broad range of IP issues, advises senior management on IP issues that have legal implications, prepares opinions relating to patent infringement, patent validity and freedom to operate issues; and deals with IP related contracts and related legal disputes. Prior to joining Indoco, Ms. Veera worked as In-House Patent Counsel and Head of Patents Dept. at Piramal Healthcare Ltd., where she headed a team of 15, including 13 Patent professionals, and worked towards expanding Piramal’s Patent Portfolio continuously for the Life-sciences unit, and handled patent infringement, freedom to operate and invalidity issues for the generic business. She has also worked as patent professional for leading Indian Pharmaceuticals including Sun Pharma. and Lupin Labs.

She has also been actively involved in spreading patent awareness among different functions of the Company (Business development, R&D etc) through the designing and lecturing of In-house Patent training courses.

Solutions Consultant
Thomson Reuters
Partner
Locke Lord LLP