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Shashank Upadhye, Esq., managing partner at Amin Talati Upadhye, will discuss intellectual property/patent issues for active pharmaceutical ingredients and abbreviated new drug applications at CPhI North America in Philadelphia, PA, on Tuesday, April 24, 2018.
On Tuesday, April 24, 2018, Shashank Upadhye, Esq., managing partner at Amin Talati Upadhye, will discuss examples of intellectual property/patent issues that can occur during active pharmaceutical ingredients (API) and abbreviated new drug applications (ANDA) development at CPhI North America in Philadelphia, PA.
Topics covered in the presentation include polymorph and impurity issues, patents on monograph, formulations, how to develop defensible evidence, contracting issues with partners, when to retain counsel, and reducing legal costs.
Upadhye has focused his legal career on pharmaceutical law with an emphasis on IP and FDA issues, assisting API and ANDA applicants with overcoming legal issues for more than 20 years. He also spent several years as the chief of legal/IP/FDA counsel at Apotex, Sandoz, and Eon Labs. He has also authored legal text on pharmaceutical and FDA law.
Currently, Upadhye counsels brand companies seeking to patent and launch brand-name products in the long term, as well as generic-drug companies seeking to challenge patents and maximize 180-day exclusivity with FDA compliance. He also provides legal input at every stage of the product lifecycleÂ-from product selection, R&D, regulatory affairs, product launch, and ongoing marketing/sales.