Brand to Generic Drug Leaders
Our generic drug company clients come to us because we help them grow their business. Patents and other FDA regulatory obstacles exist, but we help our clients overcome these legal obstacles. By employing keen business and legal sense, we help our clients win the race to the market. We do this by exercising great business judgment on legal strategy and when necessary, in Paragraph IV- Hatch Waxman litigation. Amin Talati Upadhye’s Brand to Generic Drug Practice provides strategic advice both to generic companies seeking to challenge patents and overcome FDA hurdles to bring drugs to market, and to Fortune 500 pharmaceutical companies seeking to strategically create patent and FDA barriers to protect their brand name products for the long term.
Amin Talati Upadhye has developed a special renown in the representation of generic drug companies in Paragraph IV litigation: the process whereby generic companies challenge patents held by brand name companies in order to bring these important, often life-saving, medications to the market in generic forms. We know this space very well because we live it each day. We know what strategies will work and which won’t. We partner with our clients to provide excellent value-added legal advice that drives their business forward. We are never afraid to litigate, but we also know the value of a strategic settlement. Our client’s business needs come first. This is why clients call upon us.
Shashank Upadhye, Practice Group Leader, is globally recognized as a thought-leader in the area of Brand to Generic Drugs: he is the author of the key legal treatise on the topic, “Generic Pharmaceutical Patent & FDA Law,” (now in its 10th Edition). With years of chief in-house counsel experience at three different international pharmaceutical companies, he is regularly sought out for his interpretation of patent law in the Brand to Generic process and is a frequent keynote speaker at conferences on pharmaceuticals, FDA, antitrust and health care law.
In addition to the firm’s extensive knowledge of the Paragraph IV litigation process, the team at Amin Talati Upadhye represents drug companies at every stage of the lifecycle of their products including:
- Strategic advice at the beginning of the development pipeline
- Prototype development and clinical trials with an eye toward gaining regulatory approval, and
- Eventual patent applications and possible challenges in court
The firm also provides counsel on matters such as product launch management, pre-market approval, labeling, advertising, cGMP (Form 483 observations and Warning Letter responses), and litigation. Our members have deep experience in abbreviated new drug applications, patent opinions and ANDA/Hatch-Waxman patent litigation. Our clients in this space include Ezra Pharmaceuticals, Alkem, Gnosis, Fera Pharmaceuticals, InnoPharma , Torrent Pharmaceuticals, and Macleods Pharmaceuticals.
Our lawyers help clients understand and navigate the complex intersection of IP, patent, and antitrust laws, specifically on NDA’s, paper NDA/505(b)(2) applications, ANDA’s, suitability petitions for different forms, trademark issues in drug dosage forms (the issues related to size, shape, and color), the 180-Day Exclusivity, Orphan Drug Exclusivity (ODE), REMS protections, and other FDA related non-IP exclusivity.