The generic and specialty pharmaceutical industry continues to experience a period of significant growth as generic pharmaceutical companies work to provide affordable access to modern medicines that improve the lives of millions of people. Successful competition in this environment requires a multifaceted business approach that analyzes ever-changing domestic and foreign markets to determine the best path for increasing a company’s product portfolio. Further, while seeking to avoid FDA Orange Book-listed patents, generic companies frequently invest in the research and development of improved processes for making pharmaceutical products, different formulations of products, or new uses of products, all of which can result in increased intellectual property for a company. Coordinating these business, scientific and legal efforts is necessary for success.
Sutherland’s Generic and Specialty Pharmaceutical Team works closely with our clients to evaluate their business goals and conduct an aggressive legal analysis of Hatch-Waxman Abbreviated New Drug Application (ANDA) and Section 505(b)(2) filing strategies to meet those goals. Sutherland began providing legal support to the pharmaceutical industry more than 30 years ago. Today we are a leading U.S. law firm serving many of the world’s largest pharmaceutical companies as they produce next-generation drugs through genetics, biologics, biochemicals, proteomics and more.
Sutherland provides a broad range of intellectual property services to clients in the generic and specialty pharmaceutical industry. We have experience with a vast array of technologies, including small molecule and follow-on biologic products; synthesis and polymorph purification; oral dosage and injectable formulations; packaging; alternative indications; and transdermal and other drug delivery devices.
Our services for generic and specialty pharmaceutical clients include:
- Litigating Hatch-Waxman and other pharmaceutical patent matters, including litigation arising from Paragraph IV certifications, section viii statements, and International Trade Commission (ITC) complaints
- Prosecuting patent applications for our generic pharmaceutical clients
- Preparing product clearance and freedom-to-operate opinions that address patent infringement, validity and enforceability issues
- Drafting ANDA Paragraph IV Notices, Detailed Statements, and Offers of Confidential Access
- Conducting intellectual property due diligence in connection with mergers and acquisitions
- Planning for the expansion of pharmaceutical and biosimilars product pipelines
- Counseling clients on FDA regulatory matters
- Analyzing FDA Orange Book exclusivity issues
- Landscaping third-party patent portfolios
- Developing strategies for product design-arounds
- Engaging experts for testifying and counseling
Sutherland’s Generic and Specialty Pharmaceutical Team collectively has decades of experience dealing with issues faced by our clients. In addition to that experience, many of our intellectual property attorneys hold Ph.D.s or other advanced technical degrees in fields such as organic and inorganic chemistry, pharmacology, molecular biology, and medicine, which allow for a keen understanding of the legal issues affecting generic and specialty pharmaceutical companies.
© 2013 Sutherland Asbill & Brennan LLP