Mind + Muscle

technical minds + legal muscle

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Biosimilars

The global market for biosimilars is poised for rapid expansion as patents for key biological drugs expire.

Sterne Kessler is uniquely positioned to address the intellectual property needs of those seeking to capitalize on this new market whether they be biotech innovators or biosimilar developers.  We have one of the most experienced biotechnology practices in the United States.  As a pioneer in the protection, leveraging and enforcement of biotechnology innovations, Sterne Kessler has been at the forefront of the rapidly evolving biotechnology industry for more than thirty years.  In addition, we have a proven track record in high-stakes Hatch-Waxman/ANDA counseling and litigation.

What Sets Sterne Kessler Apart?

 
  • Our team of professionals is both legally adept and technically astute.  Most have earned an advanced technical degree (more than 50 have a Ph.D.) and significant industry or academic experience.
  • We are experienced biotech advisors, having represented companies through the years that have been positioned at the cutting edge of technologies like genomics, bioinformatics, vaccines, nanomedicine, and pharmacogenomics.
  • We are recognized leaders in IP issues relating to therapeutic antibodies, which now make up the fastest growing segment of the pharmaceutical industry.
  • In Hatch-Waxman and ANDA matters, we have assembled a deep bench of experienced litigators, technical experts, and attorneys and agents with extensive experience representing both brand and generic pharmaceutical companies in blockbuster ANDA matters.  Our body of ANDA work comprises more than 50 Paragraph IV filings and over 500 opinions.
  • Our professionals are trained to evaluate complex intellectual property issues in the context of the business environment to ensure alignment with your strategic goals.

Unique Pathway Requires Unique Attorneys


The abbreviated approval pathway for biosimilars in the U.S. is fundamentally distinct from the Hatch-Waxman pathway for generic small molecule drugs.  Companies anticipating biosimilar competition for their key products or contemplating bringing a biosimilar challenge require an IP legal team that understands the nuances and the issues that can arise with each.  Our knowledge of biotech patent law and years of experience dealing with the patent issues involved in Hatch-Waxman/ANDA matters combine to create a team of professionals that can tackle the most sophisticated IP issues faced by those in this emerging industry, whether they are innovators or biosimilar challengers.

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