Practices

Hatch-Waxman Litigation

Why Cooley

Breakthroughs happen with Cooley. At Cooley, we don’t just advise – we accelerate your achievements. Our collaborative approach draws upon unparalleled experience and our extensive industry network to drive strategic solutions and resolve challenges. With Cooley as your catalyst, you’re not just part of the life sciences industry – you’re shaping it.

Cooley’s patent litigators bring decades of experience with Hatch-Waxman matters and have protected billions of dollars in revenue for branded pharmaceutical companies. Cooley’s in-depth experience in litigation, patent prosecution, and FDA and regulatory counseling regarding pharmaceutical products enables us to provide sophisticated analysis and advice in this area. 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 doctorate, master’s and undergraduate degrees in fields such as biology, biochemistry, biophysics, chemistry, chemical engineering, molecular biology, molecular genetics and physiology. Many of our litigators also are members of the patent bar, and our litigation teams regularly draw from our 100-person+ life sciences patent counseling and prosecution practice, which is one of the largest of its kind among any law firm in the US. Having such resources in house allows us to perform in-depth internal analyses and reduces the need for costly outside experts for many litigation tasks.

The Cooley platform

  • Our 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
  • Our collaborative and seamless partnership with our life sciences patent team allows us to leverage prosecution and counseling, as well as litigation, capabilities
  • Our team benefits from full paralegal support facilities (20+ paralegals with IP experience)
  • We maintain a close relationship with Europe and US patent office personnel, including the US Patent Trial and Appeal Board (PTAB)