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Hatch-Waxman

Throughout our history we have maintained a simple but deeply rooted objective: protecting our clients' intellectual property to allow them to maximize their market share, maximize the value of their intellectual property capital, and obtain a fair return on their hard work, investment, and innovation. When representing innovator drug companies, we pursue multiple strategies to maximize returns on our clients' investments during market exclusivity periods.

 

We do this by taking an interdisciplinary approach— ensuring that all scientific issues are understood fully throughout the product development and protection process—by extending our intricate, thorough, and expert knowledge of the pharmaceutical industry and accompanying experience in all aspects complementary to Hatch-Waxman. Our patent litigators work closely with our Patent prosecutors and trademark and regulatory attorneys to provide solutions that maximize the return on our clients' significant investments in research and development.

 

In the Hatch-Waxman context, this means that from the earliest stages we bring together the best team within the ranks of our firm to strategize the best course of action that will achieve our clients' objectives. This fully integrated approach—everything from pre-suit investigations to PTO actions, Orange Book tactics, Title I strategies of the Hatch-Waxman Act, ANDA filings (especially certification requirements pursuant to Paragraph IV), and FDA affairs—has proven invaluable to our clients in pharmaceutical litigation. Hatch-Waxman is the door into the courthouse, but once in front of a judge or jury, you must still litigate the underlying science; it is there that the differences— in patent litigation experience, in technical mastery— become evident.