Pharmaceutical / Biotechnology / Medical Devices

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Pharma/Biotech/Med Devices
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ANDA Hatch-Waxman Litigation
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King & Spalding has one of the broadest and deepest benches of lawyers, scientists and consultants in the United States specializing in the representation of pharmaceutical, biotechnology and medical technology companies. More than 125 lawyers and professionals devote all or a substantial portion of their practices to clients in these industries, with specialized experience at every stage of the product life cycle -- from emerging growth company counseling on intellectual property and clinical trials, through licensing and finance, to FDA approval, manufacturing, and marketing, and post-approval regulatory, transactional, and litigation matters.

King & Spalding currently represents more than 200 pharmaceutical, biotechnology, and medical device manufacturers on litigation, intellectual property, regulatory and corporate matters. We represent 8 of the Top 10, 15 of the Top 20, and 18 of the Top 25 pharmaceutical/biotechnology manufacturers as well as 8 of the Top 10 and 12 of the Top 20 medical device manufacturers. We also have extensive early-stage experience. Approximately 50 of our current pharmaceutical/device clients are early-stage R&D companies.

Over the past several years, King & Spalding has aligned its internal and external structures to better serve our pharmaceutical, biotechnology, and medical technology clients. These steps include:

  • Developing bench strength (through internal development and lateral recruitment) in every key area of legal need, including intellectual property, business and product liability litigation, government investigations, FDA regulation, and government advocacy & public policy.

  • Leveraging the expertise of non-lawyer professionals (including more than 20 MDs, PhDs, and others with advanced medical, scientific and technical degrees) to provide counsel and support that integrates legal, regulatory, scientific and technical issues.

  • Deploying internal knowledge management systems focused on FDA-regulated manufacturers, ensuring that King & Spalding lawyers and professionals stay informed about key industry and business developments.

  • Aggressive internal training programs focused on legal, regulatory, and business developments of interest to pharmaceutical, biotechnology, and medical technology companies.

From start-up through product launch to patent expiry, our clients rely on King & Spalding’s substantive expertise, bench strength and collaborative approach to client service.

Andrew T Bayman (Andy) 
T: +1 404 572 3583 ATLANTA