Hatch-Waxman ANDA Litigation and Counseling

Goldberg Segalla’s Pharmaceutical ANDA Litigation team brings together highly accomplished attorneys with broad and interdisciplinary technical and scientific training as well as decades of high-stakes patent litigation experience. Our lawyers serve as trusted advisors to generic pharmaceutical companies and their executives at every stage of pharmaceutical product selection, patent due diligence, litigation, and monetization involving the federal Drug Price Competition and Patent Term Restoration Act (or Hatch-Waxman Act). Our Hatch-Waxman litigation and lead trial experience covers scores of patents and products in jurisdictions across the U.S.

But we also understand that patent litigation is a means and not an end. We do not chase every potential defense. We do not believe in old-school “scorched-earth” litigation tactics. The practice of law has changed and we understand that. The days of wasteful and duplicative billable hours are gone. We believe in delivering value and peace-of-mind to our clients. We stick to our budgets and can also offer alternative billing arrangements. We make it our standard practice to learn everything we can about each client’s business practices, immediate needs, and long-term goals, so we can better tailor our services and strategies to provide the most comprehensive and cost-efficient representation.

With a keen understanding of not only the legal issues related to the Abbreviated New Drug Application (ANDA) process, but also of the pharmaceutical regulatory environment and the business, legislative, and political pressures our clients face, we have developed an approach that covers the whole lifecycle of individual products and groups of products — through selection, litigation and agency review, and commercialization and marketing — that promises the advice and lawyering our clients deserve and are entitled to.

Our Experience 

Collectively, our team has handled pharmaceutical product selection and Hatch-Waxman litigation for various products including:

  • Abiraterone
  • Alosetron
  • Amphetamine
  • Aripiprazole
  • Atorvastatin
  • Bendamustine
  • Bivalirudin
  • Calcium acetate
  • Canagliflozin
  • Capecitabine
  • Cilastatin/Imipenem
  • Clozapine
  • Dextroamphetamine
  • Esmolol
  • Esomeprazole
  • Famotidine
  • Fentanyl
  • Gabapentin
  • Guaifenesin
  • Hyoscyamine
  • Levofloxacin
  • Linagliptin
  • Macitentan
  • Metformin
  • Omeprazole
  • Pemetrexed
  • Polyethylene glycol
  • Prasugrel
  • Sodium picosulfate
  • Terfenadine
  • Zolpidem
Selection and Counseling

Drawing on the resources of both the Intellectual Property and Life Sciences Practice Groups, this team brings together highly experienced trial attorneys possessing academic degrees in a range of scientific disciplines, practical experience in the technology and life science industries, decades of experience in patent litigation, and invaluable fluency with corporations’ internal business and litigation strategies — meaning we bring to each client, product, and matter a global understanding of the pharmaceutical patent landscape. We take a strategic and comprehensive approach to ANDAs based on up-front discussions with our clients and decisions on overall objectives, risk tolerance, and financial standing. We help our clients anticipate risk and position themselves for success — long before litigation and other product development concerns commence.

Pharmaceutical product selection We assist companies in searching for, evaluating, and choosing the right products to pursue, offering an informed and comprehensive assessment accounting for financial projections, the anticipated number of companies pursuing the same product, and potential litigation issues and costs. We also advise on formulation design (including development of design-around strategies), licensing and marketing, and other technical, scientific, and logistical concerns.

Pre-litigation support — We frequently provide pre-litigation patent evaluations, offer counsel on non-infringement and validity, conduct necessary prior art searches, and prepare freedom to operate (FTO) opinions for pharmaceutical patents and products.

Paragraph IV certification letters and detailed statements/FLBs — In analyzing the potential non-infringement of virtually any product and the invalidity of any patent, we  advise on Paragraph IV certification letter strategies and regularly prepare accompanying detailed statements/FLBs to ensure compliance with the Food, Drug, and Cosmetic Act.

ANDA Litigation

Our lawyers have a long history of success litigating patent cases, including complex multi-district litigation (MDL), in U.S. District Courts all over the country, frequently in hotbeds of patent litigation in Delaware, New Jersey, Texas, and California; as well as before the U.S. Patent and Trademark Office, the U.S. Court of Appeals for the Federal Circuit, and the International Trade Commission.

Clients rely on our strong relationships with leading experts in pharmacology, drug formulation, therapeutic uses of drugs, synthetic and medicinal chemistry, polymorphism, and all forms of analytical testing. We win cases by combining their clout and technical expertise with our litigators’ abilities to translate hard science into compelling narratives that make it easy for courts to side with our clients — sometimes beginning long before anticipated litigation has commenced, continuing through claim construction and the discovery process, and culminating in favorable summary judgments or victories at trial.

Our vast range of scientific and legal experience allows us to handle Hatch-Waxman litigation, no matter the product or venue, with a holistic approach to ensure that we meet all of our clients’ needs — with one eye on immediate concerns and the other on future risks and liabilities. We also work with all parties constructively to find a business solution outside the courtroom when that offers the best path to achieving the client’s objectives.

A Different Approach  

Choosing the right pharmaceutical product to genericize and bring to market is an art rooted in science and patent law. Generic pharmaceutical companies, operating in a uniquely challenging business environment, have to take into account their long-term financial investment, technological requirements, and the burdens of litigation. In addition, U.S. federal laws set strict and complicated timetables for ANDA filings, related litigation, exclusivity, and marketing. Pharmaceutical patent trials and appeals are an expensive endeavor. And the cases that settle have to pass antitrust review, which can jeopardize significant investment and years of effort.

Goldberg Segalla’s collaborative culture and value system are shifting the paradigm of pharmaceutical patent litigation. Our attorneys work together across diverse practice areas to provide the most comprehensive and efficient defense or counsel possible. For example, our litigators, backed by the firm’s pioneering E-Discovery Practice Group, can cut down and manage discovery and e-discovery demands — which can be extraordinarily taxing in pharmaceutical and ANDA litigation — to minimize litigation’s impact on day-to-day business operations and the bottom line. Fluid collaboration among our Antitrust and Competition, Mergers and Acquisitions, and Cybersecurity and Data Privacy teams helps us to guide our clients more effectively through the lifecycle of the drug, from product selection to filing an ANDA, potential litigation, packaging and promotion, and management in the marketplace.