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Biologics & Biosimilars

Harness IP has the skills and experience to help bring your biologic or biosimilar product to market — and navigate the competitive patent landscape — as a part of your launch strategy.

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Harness IP offers a deep understanding of biologics from both legal and scientific perspectives. As a firm focused exclusively on intellectual property, we hire attorneys with diverse scientific, engineering and business backgrounds who understand the unique challenges of biologics innovation and the associated branding needs.

We assembled our biologics team with these considerations in mind, including a comprehensive understanding of the Biologics Price Competition and Innovation Act (BPCIA) and the Public Health Service Act (PHSA), as well as the scientific training necessary for understanding the unique qualities of these innovations and presenting them.

We work with clients from research companies, universities and hospitals around the globe, and we have represented sophisticated companies in more than 300 cases involving large molecules.

Our experience includes:

  • Patent prosecution
  • Patent landscape analysis
  • Patent portfolio management
  • Working with FDA counsel as a part of comprehensive launch strategies
  • Freedom to Operate opinions
  • Section 271(g) infringement analyses
  • Due diligence
  • Post-grant proceedings (Inter Partes Review, Ex Parte Review, Derivation, and Post Grant Review)

For analysis and further information on emerging Issues in biologics and biosimilars law, please visit the following areas of the Harness IP blog: