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1st – 3rd March 2023 Mumbai
IP managementGlenmark Pharmaceuticals Ltd.
Director IPRDr. Reddy's Laboratories
PrincipalR. K. Dewan & Co.
Head & Associate Vice President-Business Development, Portfolio & StrategyKashiv BioSciences LLC
Associate Partner LexOrbis
Global General Counsel Dr. Reddy's Laboratories
Leader Hatch-Waxman and Biosimilar Litigation PracticeMcAndrews Held & Malloy
Head IPREncube Ethicals Private Limited
PartnerMcAndrews, Held & Malloy Ltd
General Manager - Global IP Zydus Cadila
Sr Regional Manager and Head (IPFC & TISC)National Research Development Corporation (DSIR Enterprise, Ministry of S&T, Govt. of India)
Former Chairman In-Charge & Technical Member-Patents Intellectual Property Appellate Board (IPAB) Department for Promotion of Industry and Internal TrMinistry of Commerce and Industry, Government of India.
Group General CounselWockhardt Ltd
Patent Attorney L.S.Davar & Co
Managing PartnerPergament & Cepeda LLP
Head & Patent Counsel Intellectual Property ManagementUnichem labs
Head of Intellectual PropertyNovozymes
United States Intellectual Property Counselor for South AsiaUnited States Department of Commerce
Senior IP DirectorQuestel
Partner and Head IP of Patent – Design - Copyright DepartmentUnited Trademark & Patent Services
Partner in the Intellectual Property Khaitan & Co.
Director, Head - IPR departmentNeuland Laboratories Limited
PartnerGreenblum & Bernstein, P.L.C., USA
Sr. Director (Head) - IP Fresenius Kabi
Sr.Manager-TrademarksBrand Protection, Sun Pharmaceutical Industries Limited.
Patent Director HGF
PartnerRemfry & Sagar
Ph.D., PartnerTaft Stettinius & Hollister LLP
PartnerS. MAJUMDAR & CO
Asst. Principal Attorney - Chemical DepartmentL. S. Davar & Co.
HOD - Intellectual Property Management Glenmark Life Sciences
Glenmark Pharmaceuticals Ltd.
Dr. Reddy's Laboratories
R. K. Dewan & Co.
Head & Associate Vice President-Business Development, Portfolio & Strategy
Kashiv BioSciences LLC
Global General Counsel
Leader Hatch-Waxman and Biosimilar Litigation Practice
McAndrews Held & Malloy
Aaron Barkoff leads the Hatch-Waxman and Biosimilar litigation practice at McAndrews. He has extensive first-chair trial experience in ANDA litigation. Over his 20-year career, he has represented clients ranging from the world’s largest pharmaceutical companies to start-ups, now focusing on generic and biosimilar companies. He has also represented both petitioners and patent owners in more than a dozen IPRs at the Patent Trial and Appeal Board.
Aaron is recognized in the IAM Patent 1000. IAM said he litigates “high-stakes patent infringement cases with poise.” It also noted that, “Innovative and thorough, Aaron has excellent writing and presentation skills, which go a long way towards the favorable outcomes he achieves; his style is systematic, convincing, and calm. He responds with incredible speed and communicates with you as if he’s across the table, not across the country.”
His strong technical background in biochemistry and biotechnology, combined with his deep understanding of FDA regulatory issues, enables him to provide life science companies with keen insights on patent litigation strategy. He also 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.
Amgen Inc. v. Amneal Pharms. LLC, et al., Nos. 16-853, 17-713 (D. Del.)
Lead trial counsel for Piramal Healthcare in ANDA litigation concerning Sensipar® (cinacalcet hydrochloride). Won trial verdict of non-infringement in 2018. Advised Piramal through at-risk launch in 2019. Won Federal Circuit affirmance of non-infringement in 2020. Won recovery of $33 million in lost-profit damages from Amgen in 2021.
Bial – Portela & CA, SA et al. v. Alkem Laboratories Ltd., Nos. 18-304, 20-786, 21-186 (D. Del.)
Lead trial counsel for Alkem Laboratories in ANDA litigation concerning Aptiom® (eslicarbazepine acetate). Trial scheduled for June 2022.
Tolmar Therapeutics, Inc. et al. v. Foresee Pharmaceuticals Co., Ltd., No. 21-15782 (D.N.J.)
Lead trial counsel for Foresee Pharmaceuticals in patent litigation concerning Foresee’s product CAMCEVI, a treatment for advanced prostate cancer. Case pending.
Astellas US LLC et al. v. Apotex Inc. et al., No. 18-1675 (D. Del.)
Lead trial counsel for Accord Healthcare in ANDA litigation regarding Lexiscan® (regadenoson). Case settled on terms favorable to Accord.
Sumitomo Dainippon Pharma Co., Ltd. et al. v. Piramal Healthcare UK Ltd., No. 18-13478 (D.N.J.)
Lead trial counsel for Piramal Healthcare in ANDA litigation concerning Latuda® (lurasidone hydrochloride). Case settled on terms favorable to Piramal.
Amgen Inc. et al. v. Accord BioPharma, No. 18-61828 (S.D. Fla.)
Lead trial counsel for Accord BioPharma in biosimilar litigation concerning Neupogen® (filgrastim) and Neulasta® (pegfilgrastim). Case settled on terms favorable to Accord.
EnviroLogix Inc. v. Ionian Technologies, LLC et al., Nos. IPR2018-00405 and -00406 (PTAB)
Lead IPR counsel for Ionian Technologies (Abbott Laboratories) concerning isothermal DNA amplification. Won decisions denying institution of IPR on all grounds.
Encube Ethicals Private Limited
McAndrews, Held & Malloy Ltd
General Manager - Global IP
Sr Regional Manager and Head (IPFC & TISC)
National Research Development Corporation (DSIR Enterprise, Ministry of S&T, Govt. of India)
Former Chairman In-Charge & Technical Member-Patents Intellectual Property Appellate Board (IPAB) Department for Promotion of Industry and Internal Tr
Ministry of Commerce and Industry, Government of India.
Group General Counsel
L.S.Davar & Co
Pergament & Cepeda LLP
Head & Patent Counsel Intellectual Property Management
Head of Intellectual Property
United States Intellectual Property Counselor for South Asia
United States Department of Commerce
Senior IP Director
Partner and Head IP of Patent – Design - Copyright Department
United Trademark & Patent Services
Partner in the Intellectual Property
Khaitan & Co.
Director, Head - IPR department
Neuland Laboratories Limited
Greenblum & Bernstein, P.L.C., USA
Paul A. Braier, Ph.D., Esq. (email@example.com)
Greenblum & Bernstein, P.L.C., USA
Paul 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. Paul 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. Paul travels throughout the world to meet with current and prospective clients, including regular visits to India.
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. Paul is an editor for 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, 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. Paul is a member of the American Intellectual Property Law Association, the American Bar Association, and the American Chemical Society.
Sr. Director (Head) - IP
Brand Protection, Sun Pharmaceutical Industries Limited.
Remfry & Sagar
Taft Stettinius & Hollister LLP
S. MAJUMDAR & CO
Asst. Principal Attorney - Chemical Department
L. S. Davar & Co.
HOD - Intellectual Property Management
Glenmark Life Sciences