An international biopharmaceutical company sought to enter the market for a series of biosimilars of commercially available biologics. These biologics included five of the best-selling drugs in the world, each having billions of dollars in worldwide sales.
The company conducted an exhaustive search and interviewed numerous U.S. law firms, seeking one that could handle the identification and navigation of potential patent issues and any litigation from manufacturers of brand-name biologics. The company chose Leydig because of the firm's considerable experience with "small molecule" generic drug litigation (so-called "ANDA litigation") and the firm's deep bench of biotech attorneys and patent agents.
Leydig worked with the client for several years to identify the potential patent issues, a particularly challenging task since there is no central listing of potentially relevant patents for biosimilars. The firm then assessed the effect of the potential patent issues and worked with the client’s business and technical personnel to chart a course forward through the thicket of identified patents for each of the commercially available biologics.
After the U.S. Food and Drug Administration (FDA) accepted the client’s first biosimilar application, Leydig represented the client in the fully anticipated suit filed by the brand company under the then relatively new Biologics Price Competition and Innovation Act (BPCIA). The brand company terminated the litigation voluntarily after only a few months when Leydig provided evidence that the client did not infringe the asserted U.S. patents.
For the client’s second biosimilar, Leydig provided an arsenal of information on the brand company’s many U.S. patents to facilitate the negotiation of a license/settlement agreement with the brand company. Leydig’s strategy and thorough preparation spared the client from costly and protracted litigation that could have delayed the biosimilar’s release. The head of the Intellectual Property Group at the client noted that the license/settlement agreement would not have been possible without the support of Leydig over the preceding years.