For clients in the food, drug, and consumer product industries, Amin Talati Upadhye offers unparalleled depth in intellectual property and FDA regulatory matters. Our team’s expertise in both of these areas, coupled with the added value of being seasoned IP litigators, allows us to become strategic partners with our clients, guiding their products through the pipeline with a vigilant eye on the protection of their intellectual property.
The IP team at Amin Talati Upadhye advises companies at every stage of the product lifecycle. We counsel our clients from the beginning of product development through prototype development and clinical trials, with the goal of enhancing product value and gaining FDA approval. We then continue to provide support through eventual patent applications and potential challenges in court or the Patent Office.
Although many of our attorneys are trained scientists, we also leverage our extensive business law experience to help clients realize the full value of their intellectual property rights through licensing agreements, joint ventures, and other distribution programs. We provide comprehensive assistance on issues associated with the acquisition, enforcement and exploitation of intellectual property. When it is necessary to defend challenges before regulatory agencies or in court, our IP litigators are known for their innovative strategies which are increasingly emulated by others in the field. For example, Amin Talati Upadhye lawyers acted as lead trial counsel in the groundbreaking case Merck & CIE, et al. v. Gnosis S.p.A., et al. where they achieved the first successful invalidation of several pharmaceutical patents through the new IPR process. This matter was also significant as it was the first time the Federal Circuit affirmed the Patent Trial and Appeal Board’s invalidation of a pharmaceutical patent in the new IPR process.
Led by Shashank Upadhye, the firm’s IP team has developed a special renown in the representation of generic drug companies in Paragraph IV litigation; when companies challenge patents held by brand name companies in order to bring these important, often life-saving, medications to the market in generic forms. Shashank is regularly sought out for his interpretation of patent law in the Brand to Generic process, in addition to patent and trademark opinion work on infringement and freedom to operate, expert testimony and litigation in the drug and medical device spaces.
Our team is focused on the food, beverage, nutritional supplement, cosmetic and drug industries, but also has extensive experience with medical devices, biotechnology, and human and animal life sciences.
More on Patent Protection, Licensing and Freedom to Operate here.
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