About

We are focused on the industries of food and beverages, nutritional supplements, cosmetics and pharmaceuticals. We provide full legal services for the lifecycle of products aimed at improving the population’s health and wellness.

Amin Talati Upadhye has gained a strong reputation for its work at the cutting edge of food, drug (FDA), advertising (FTC) and intellectual property (IP) laws, responding nimbly to rapid changes in the regulatory climate and market place. We work with some of the most innovative products in this sphere, such as raw juices, allergy-free foods, botanical drugs, cosmeceuticals and hemp products. We counsel on regulatory compliance and risk-analysis, product development, as well as on trademark and patent protection.

In addition to guiding our clients through the strategic development of new products through regulatory approvals to the marketplace, we advise on all post-launch processes as well to ensure labeling, advertising, safety and manufacturing compliance requirements. We counsel on recalls, consumer false advertising class actions, trademark and patent infringement disputes, FDA, FTC and State AG government investigations, commercial (breach of contract) litigation, unfair competition, Proposition 65, National Advertising Division and Consumer Product Safety Commission matters. We also provide IP and compliance due diligence assessments in mergers/acquisitions and guide companies on IP freedom-to-operate opinions.

Our attorneys also work closely with pharmaceutical companies through the entire development pipeline, from prototype development and clinical trials with an eye towards gaining FDA approval, through eventual patent applications and possible infringement challenges in court. We have developed a special renown in the representation of generic drug companies in Paragraph IV litigation: the process whereby companies challenge patents held by brand name companies in order to bring these important, often life-saving, medications to the market in generic forms.

What Our Clients Say

"Their strength is their knowledge of the regulatory and legal hurdles and for finding the best regulatory fit for a product concept. They know the health care industry leaders and the agencies that regulate them. 

This firm excels at facilitating interactions with government regulatory and industry's self regulating bodies."

– CEO of Major Pharmaceutical Company

ATU Client Victory Named One of the Top USPTO American Invents Act Decisions of 2016 by Law360–Led by Joe Cwik Invalidating Merck’s Reduced Folate 5-MTHF Patent Claims

Law360, “A Look Back At The Top AIA-Related Decisions Of 2016” by Matthew Bultman. Bloomberg BNA’s Pharmaceutical Law & Industry Report: Joe Cwik Discusses Changing Landscape of Patent Infringement Litigation Due to New Inter Partes Review Process. To read the full article, please click HERE.

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