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MONA GUPTA COUNSEL TELEPHONE: 215-567-2010. EXTENSION 160 FAX: 215-751-1142
mgupta@crbcp.com
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Ms. Gupta has extensive experience with complex and high-stakes patent litigation, especially pharmaceutical patent litigation involving the Hatch-Waxman Act, both at the district court and appellate court levels. Ms. Gupta's litigation practice is mainly focused on representing generic drug companies in patent infringement cases involving Abbreviated New Drug Applications (ANDAs) that include a Paragraph IV certification to the Orange Book listed patents for brand-name drugs. She has been involved in all phases of ANDA patent litigation, from the preparation of notice letters, pleadings to discovery, trial and appeal. She has extensive experience with "Markman" claim construction hearings, summary judgment hearings, preliminary injunction hearings and the corresponding briefing process, as well as substantial appellate experience. Ms. Gupta has managed and coordinated the litigation team during several ANDA trials. She also has experience with FDA issues relating to ANDA litigation. She is a member of the firm's ANDA Litigation Team.
Tibotec and G.D. Searle, LLC v. Hetero Drugs et al. (D.N.J. 2011). Represent defendants in a patent infringement suit relating to ANDA filing for an antiretroviral pharmaceutical drug sold under the name Prezista® (darunavir).
United States of America and Board of Trustees of Univ. of Ill. v. Hetero Drugs et al. (D.N.J. 2011). Represent defendants in a patent infringement suit relating to ANDA filing for an antiretroviral pharmaceutical drug sold under the name Prezista® (darunavir).
Orexo AB v. Edict Pharmaceuticals (D.N.J. 2010). Represent defendant in a patent infringement suit relating to ANDA filing for a sleep-aid pharmaceutical drug sold under the name Edluar® (zolpidem).
In re '318 Patent Litigation (D. Del. 2005 and Fed. Cir. 2008). Represented one of seven defendants in a patent infringement suit related to ANDA filing for an Alzheimer's pharmaceutical drug sold under the name Razadyne®/Reminyl® (galanthamine). Patent was found invalid and was affirmed by the Federal Circuit.
Genzyme and Bone Care v. Pentech and Cobrek (N.D. Ill 2008 and 2010). Represent defendants in a patent infringement suit relating to ANDA filing for a secondary hyperparathyroidism pharmaceutical drug sold under the name Hectorol® (doxercalciferol), where one of the patents is also subject to an inter partes reexamination proceeding at the U.S. Patent and Trademark Office.
Connetics and Stiefel v. Pentech, Cobrek and Cipla (N.D. Ill 2007 and 2008). Represented defendants in a patent infringement suit related to ANDA filings for dermatological pharmaceutical drugs sold under the names Luxiq® (betamethasone valerate) and Olux® (clobetasol propionate).
Eli Lilly and Co. v. InvaGen Pharmaceuticals, Inc (S.D. Ind. 2009). Represented defendant in a patent infringement suit related to ANDA filing for osteoporosis pharmaceutical drug sold under the name Evista® (raloxifene).
Sanofi-Aventis/BMS et al. v. Apotex et al. (S.D.N.Y. 2003 and Fed. Cir. 2006). Represented defendants in a patent infringement suit related to ANDA filing for a blockbuster anti-platelet pharmaceutical drug sold under the name Plavix® (clopidogrel bisulfate).
In re Omeprazole Litigation (2nd wave) (S.D.N.Y. 2001 and Fed. Cir. 2007). Represented Apotex defendants in a patent infringement suit related to ANDA filing for a blockbuster acid reflux pharmaceutical drug sold under the name Prilosec® (omeprazole).
Syntex, Allergan and Roche Palo Alto v. Apotex et al. (N.D. Cal. 2001/2005, Fed. Cir. 2004/2007 and Supreme Court 2007). Represented defendants in a patent infringement suit related to ANDA filings for ophthalmic pharmaceutical drugs sold under the names Acular® and Acular LS® (ketorolac tromethamine).
Supreme Court of Pennsylvania
U. S. Supreme Court
U. S. Court of Appeals for the Federal Circuit
U. S. Court of Appeals for the Third Circuit
U. S. District Court for the Eastern District of Pennsylvania
Member, American Intellectual Property Law Association
Member, Philadelphia Bar Association - Intellectual Property Committee, Women in the IP Subcommittee, Women in the Profession Committee
Member, The Philadelphia Intellectual Property Law Association
Member, The Historical Society of the U.S. District Court for the Eastern District of Pennsylvania
Member, South Asian Bar Association
High-Stakes ANDA Pharmaceutical Litigation and Paragraph IV Challenges, The Legal Intelligencer IP Supplement, April 2008
Examining Phillips: Is it a Step Towards Predictable Construction Claims? The Patent Lawyer, Winter 2005
Named Pennsylvania SuperLawyer by Philadelphia Magazine, 2006-2011
Named Pennsylvania Rising Star by Philadelphia Magazine, 2005
Named Top 50 Women Lawyers in Pennsylvania by Philadelphia Magazine, 2007
Drexel University: B. S. Engineering magna cum laude 1991
Rutgers University: J.D. 1994
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MONA GUPTA COUNSEL
INDUSTRIES SERVED
Computer Systems
Medical Devices
Pharmaceuticals
Telecommunications
Mechanical
ADMITTED TO PRACTICE
Supreme Court of Pennsylvania
U. S. Supreme Court
U. S. Court of Appeals for the Federal Circuit
U. S. Court of Appeals for the Third Circuit
U. S. District Court for the Eastern District of Pennsylvania
AWARDS & RECOGNITION
Named Pennsylvania SuperLawyer by Philadelphia Magazine, 2006 - 2011
Named Pennsylvania Rising Star by Philadelphia Magazine, 2005
Named Top 50 Women Lawyers in Pennsylvania by Philadelphia Magazine, 2007
EDUCATIONAL BACKGROUND
Drexel University: B.S Engineering magna cum laude 1991
Rutgers University: J.D. 1994
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