Hatch-Waxman Litigation

Patent challenges in pursuit of early market entry are a fact of life for branded pharmaceutical products. Latham’s pharmaceutical patent litigators have extensive experience preparing for and defending against these challenges.

Latham lawyers, many of whom have technical backgrounds in chemistry and biological sciences, understand the strategic and tactical implications that are particular to Hatch-Waxman cases. Latham lawyers provide invaluable input into protecting each client’s market opportunities, including pre-suit investigations, FDA strategy and related litigation, Patent Office proceedings, District Court litigations, and appeals. The firm has handled a wide array of innovative drug products for some of the largest drug companies and specialty pharmaceutical companies.

Preparing for Hatch-Waxman Litigation

Victory requires a simple and clear explanation of the patents surrounding a product and why they are deserved. Early consideration of patent strategy is also important to coordinating the trial message with regulatory and marketing messages describing how the product helps patients and meets important health needs. Latham recommends early evaluation of the patent portfolio while there is time to amend pending claims and correct issued patents. Latham’s pharmaceutical patent litigators work with clients to tailor a comprehensive action plan before the first challenge arrives that will carry all the way through trial.

Latham’s successful representations of innovator companies begins with the ability to analyze the client’s patents and master the underlying science. Latham’s Hatch-Waxman team includes 25 attorneys with life sciences technical degrees, including 9 doctoral degrees and 4 intellectual property analysts with doctorate degrees in life sciences disciplines including organic chemistry, chemical engineering, biochemistry, and molecular biology.

Litigating the Hatch-Waxman Case

Latham’s litigation approach is tailored to clients' business and strategic objectives. For the most successful branded drug products, companies must plan for the possibility of serial litigation against multiple defendants. The best trial and settlement results come from being ready to go to trial. Latham’s pharmaceutical patent litigators use the firm's extensive experience with Hatch-Waxman litigations to develop a case that accounts for multiple challengers presenting multiple theories.

Navigating Parallel Proceedings

Innovator companies increasingly face IPR challenges to their patents at the PTAB at the same time they are litigating in the district court. Victory at the PTAB is crucial to protect the patent portfolio and to set the stage for further successes at the district court. With approximately 30 lawyers registered with the USPTO, Latham has experience handling more than 170 IPR proceedings, and has been exceptionally successful in representing patent owners at the PTAB.

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