Hatch-Waxman Litigation

Why Cooley

Cooley’s patent litigators bring decades of experience with Hatch-Waxman matters and have protected billions of dollars in sales for branded pharmaceutical companies. Cooley’s deep experience in litigation, patent prosecution, and FDA and regulatory counseling regarding pharmaceutical products enables us to provide sophisticated analysis and advice in this area. We partner with clients to protect their commercial interests in breakthrough technologies that are changing the world. At the outset, we develop comprehensive technical analyses to map out a winning litigation strategy and focus on breaking down complex scientific concepts to achieve our clients’ goals.

Our team includes litigators with PhDs, master’s degrees and undergraduate degrees in fields such as biology, biochemistry, biophysics, chemistry, chemical engineering, molecular biology, molecular genetics and physiology. Many of our litigators are also members of the patent bar, and our litigation teams regularly draw from our 90+ person life sciences patent counseling and prosecution practice, which is the largest of its kind among any law firm in the US. Having such resources in-house enables us to perform in-depth internal analyses and reduces the need for costly outside experts for many litigation tasks.

The Cooley platform

  • Robust, full-service life sciences platform allows for seamless collaboration with lawyers across related areas, including licensing, litigation, FDA/regulatory, strategic transactions and collaboration deals, and venture financing
  • Partnership with our life sciences patent team – the largest of any law firm in the US – to leverage prosecution and counseling and litigation capabilities
  • Full paralegal support facilities (20+ paralegals with IP experience)
  • Close relationship with Europe and US patent office personnel, including the US Patent Trial and Appeal Board