Amin Talati Upadhye’s Litigation practice group steps in when our clients face adversarial challenges from government entities, competitor corporations, and from consumers in class actions alleging labeling, advertising and safety violations. Our firm has deep experience in FDA, USDA, and FTC disputes, patent and trademark infringement, Proposition 65, commercial breach of contract claims and Paragraph IV challenges to brand patents by generics. By thoroughly understanding the complexities of all facets of the food and drug industries, we are highly qualified to vigorously defend our clients’ interests in a range of forums from state and federal courts to regulatory agencies to alternative dispute resolution. Our team is prized for innovative litigation strategies which are increasingly emulated by others in this field and which provide streamlined and effective results.
Amin Talati Upadhye is most noted for its ability to handle a variety of regulatory matters and enforcement proceedings before all types of federal and state agencies. Our services include:
- Defending against FDA, USDA. FTC, State AG and Department of Health Regulatory Actions
- Defending against product seizures, recalls, injunctions and criminal proceedings
- Pursuing Customs Rulings, advisory opinions, duty drawback requests and liquidation protests
- Representing clients in DEA and EPA enforcement proceedings.
Consumer False Advertising Class Actions
With the rise of GMOs, organic foods and nutritional supplements, companies in these industries are increasingly subject to claims of deceptive advertising centering on definitions like natural or organic, or otherwise challenging stated health benefits. As class actions in the FDA-regulated industries have increased, our team’s multidisciplinary approach – combining regulatory and scientific savvy with deep expertise in intellectual property and commercial disputes – has proven to be of great value to the manufacturers of food, beverage, dietary supplement and cosmetic products.
Our litigators work seamlessly with our FDA compliance attorneys to guide clients through this minefield, anticipating challenges and helping companies stay compliant. When it is necessary to defend against a class action, we develop and execute creative and aggressive strategies to defeat class actions and allow our clients to achieve their business objectives.
Our intellectual property litigation experience includes prosecution and defense of patent and trademark infringement actions and competitor false advertising litigation under 43(a) Lanham Act. Our services in this area include:
- Paragraph IV, Hatch-Waxman, patent and FDA litigation
- Representing clients in enforcing their patents and trademarks, and defending against claims of infringement and disputes concerning inventorship and ownership
- Developing strategic litigation strategies including counterclaiming and alternative business objectives such as cross-licensing
- Participating in administrative proceedings before the Patent Office Board of Patent Appeals and Interferences and the Trademark Trial and Appeal Board
- Advising on all aspects of patent litigation including infringement and validity analysis
- Prosecution history issues relating to priority of invention and inequitable conduct; patent misuse and damages; antitrust issues and preliminary and permanent injunctions
- Counseling on all aspects of trademark litigation including trademark and trade dress infringement, likelihood of confusion analysis, protection of good will and brand value of client products, oppositions to pending trademark applications and petitions to cancel existing registrations
- Litigating claims of unfair competition, tortious interference, antitrust and related state law claims.
Our business litigation practice encompasses all facets of commercial relations particular to the food and drug industries. Much of our work focuses on breach of contract cases involving IP licensing and manufacturer/supplier disputes. Examples of our work include:
- Assisting with breach of contract matters related to defective manufacturing, misuse or theft of IP confidentiality and non-compete
- Litigating corporate matters such as partnership and shareholder disputes
- Counseling on all aspects of trade regulation and competitive disputes
- Prosecuting and defending professional and product liability claims
- Defending state and federal business claims involving the False Claims Act, breach of contract, fraud, replevin, anti-kickback statutes and tortious interference.
Proposition 65 Litigation
California’s Safe Drinking Water and Toxic Enforcement Act of 1986, known as Proposition 65, requires businesses offering consumer products for sale in California to give warning of possible exposure to specified chemicals. Actions arising over extremely low, safe levels of certain ingredients in foods can be brought by the California Attorney General, state or municipal prosecutors or by individuals or groups acting in the public interest. We provide counseling to companies subject to such litigation by:
- Providing guidance on how to comply with safety standards and consumer warning label requirements
- Assessing risk and exposure levels and developing appropriate remedial programs
- Defending against bounty hunters
- Petitioning the State to remove chemicals from the Proposition 65 list of substances
- Assisting in Proposition 65 audits
- Working with experts to demonstrate that listed chemicals in our clients’ products present no significant risk of cancer