Life Sciences Patent Litigation & Counseling

Intellectual property is the pulse of the life sciences industry. For innovators in this dynamic sector, protection of breakthrough therapeutics is paramount.

Loeb & Loeb’s patent lawyers help branded drug companies, biotechnology firms and medical device manufacturers obtain, protect and monetize IP assets in order to achieve the companies’ business objectives and strengthen their foothold in a competitive market.

Our life sciences team has successfully litigated high-stakes patent disputes in federal courts throughout the country, before the U.S. Court of Appeals for the Federal Circuit and within the U.S. Patent and Trademark Office.

Our representation of global pharmaceutical leaders spans the full range of Hatch-Waxman Act matters. We handle all phases of Paragraph IV disputes under Hatch-Waxman, including litigating the infringement, validity and enforceability of patents. Our extensive trial experience includes helping life sciences innovators take advantage of inter partes review (IPR) and other postgrant proceedings to protect their IP rights.

Several members of our team bring extensive prior experience defending generic drug manufacturers in Hatch-Waxman claims, enabling us to offer a unique perspective to our branded clients pursuing enforcement actions in this complex area. We also leverage this insight to provide clients with strategic analyses concerning patent and exclusivity protection, as well as patent opinion and due diligence services in connection with corporate and commercial transactions.

Our counseling and litigation experience extends to compound, formulation, diagnostic, method-of-treatment and medical device patents. Well-versed in the approval pathway for biologics and biosimilars, we also develop strategies to protect biotech products under the Biologics Price Competition and Innovation Act.

Loeb’s skilled patent lawyers and trial-ready litigators include Ph.D.s with advanced training in virology, biochemistry, and neurobiology. This potent blend of scientific and legal acumen allows us to partner with our clients’ technical and business teams to provide comprehensive IP strategies that deliver results.

Our full range of patent services in the life sciences arena includes:

• Prosecuting patent actions in federal courts, including complex Hatch-Waxman litigation
• Representing clients in postgrant proceedings, including IPR
• Developing and executing strategies for patent prosecution, exploitation and exclusivity
• Rendering patent validity, clearance and infringement opinions
• Preparing and negotiating licensing agreements
• Conducting due diligence investigations
• Counseling on FDA regulatory issues and exclusivity policies and FTC oversight of settlements and orphan drug rules