Amin Talati & Upadhye (ATU) attorneys advise on U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) and related state regulations. The firm handles FDA and USDA filings, product labeling, packaging and website compliance reviews as well as counseling on cGMPs (current good manufacturing practices), inspections, 483s, warning letters, detentions, seizures, injunctions, import alerts and Prop 65.

Companies must advertise carefully to avoid FTC, State AG and class action lawsuits. ATU attorneys review websites, print, radio and television advertising for compliance. The firm works closely with clients to develop and verify adequate substantiation for product claims. ATU further represents companies in various advertising challenges such as class actions and inquiries from the National Advertising Division and the Electronic Retailing Self-Regulation Program.

ATU helps identify, protect, defend and monetize a company’s intellectual property assets. ATU assists its clients with patent and trademark searches, USPTO and international filings, IP licensing, and patent and trademark infringement actions. ATU further counsels its clients on how to avoid intellectual property infringement lawsuits by providing freedom-to-operate opinions. ATU also has a Brand-Generic FDA/Patent drug practice where it specializes in Abbreviated New Drug Applications (NDI), patent opinion work on infringement and freedom to operate, and patent litigation in the drug space.

ATU drafts and negotiates intellectual property and commercial agreements. ATU provides counseling on IP licensing and joint venture agreements, as well as on manufacturing and supplier quality assurance agreements. The firm also assists with broker/distributor agreements and breach of contract disputes.