Prescription & OTC Drugs

Sterne Kessler’s pharmaceuticals team helps small molecule drug companies across the full range of IP – patents, litigation, opinions and strategy.

Sterne Kessler helps ethical drug companies to develop robust, defensible patent portfolios that create substantial shareholder value over the entire lifecycle of a drug. That work includes patents defending fundamental, breakthrough inventions as well as follow-on patents supporting product manufacturing, methods of use and FDA approved labeling. In today's competitive landscape, strong patent protection is critical in bringing pharmaceuticals to market. We understand the challenges and risks clients face, so we focus on providing high-value counseling. Ultimately, a strategy is only as good as its execution. Our attorneys and agents have drafted and prosecuted hundreds of patent applications for small molecule pharmaceuticals. We've also developed expertise in identifying additional patentable inventions as a new chemical entity works its way through the development process. We represent institutions involved in the development of:

• New chemical entities
• New methods of chemical synthesis
• Drug design platforms
• Drug screening and assays
• Formulations
• New therapeutic methods
• In vivo diagnostics
• Medical imaging and contrast agents

In many instances, technology commercialization in the pharmaceutical industry requires multiple technical disciplines. Our deeply experienced ethical drug team extends to related technical areas, including:

• Medical devices
• Computer-aided drug discovery
• Bioinformatics
• Biodefense

For those collaborating, licensing or commercializing innovations, we provide counseling regarding agreements and freedom to operate in the marketplace. Additionally, we conduct intellectual property due diligence to support those who are licensing or investing in promising new technologies. Finally, we have a leading ANDA litigation practice and support branded drug companies in high-stakes Hatch-Waxman litigation.