Collectively, we have substantial experience with rendering patentability, validity and infringement opinions, drafting patent applications and related patent prosecution, and handling all aspects of reexamination, reissue, and interference cases. Our FDA Practice Group is one of the largest in the country and has the experience to counsel pharmaceutical clients on all regulatory issues related to the research, development, testing, approval and marketing of pharmaceuticals, including drugs, biologics and biotechnology products. Morgan Lewis' FDA practice is premised on the understanding and use of science to support and advance appropriate legal and regulatory positions. To enhance our ability in this area, the FDA practice group has created a regulatory science division, headed by Dr. Sharon Segal, and staffed by specialists in a variety of scientific disciplines. Finally, the FDA practice group also is able to address its clients' European regulatory and product strategy issues through our two FDA lawyers in London.
Disputes affecting the industry take many forms and are resolved in many forums.
In some instances, the disputes arise between competitors over issues such as patent infringement, or between partners over failed joint venture projects. In other instances, companies face suits from consumers for product liability, or from dissident shareholders claiming violations of securities laws. Additionally, because the industry is highly regulated, companies may find themselves the targets of governmental investigations or enforcement actions. All of these situations can threaten a company's financial viability or undermine the public's confidence in its products or services. We do so with the intensity and creativity necessary to protect our clients' interests, and with a sensitivity to the unique character of an industry that must operate with the highest level of integrity and accountability while under public scrutiny.