Biosimilars

Sterne Kessler’s industry team helps companies navigate the substantial opportunities and challenges associated with the launch of biosimilar drugs.

The global market for biosimilars is poised for rapid expansion as patents for landmark biological drugs expire. As a pioneer in the protection, leveraging, and enforcement of biotechnology innovations, Sterne Kessler is uniquely positioned to address the IP needs of companies seeking to capitalize—both biotech innovators and biosimilar developers. We have one of the most experienced biotechnology practices in the United States. Sterne Kessler has been at the forefront of the rapidly evolving biotechnology industry for more than 30 years. In addition, we have a proven track record in high-stakes Hatch-Waxman/ANDA counseling and litigation. The Biologics Price Competition and Innovation Act (BPCIA) has created a unique pathway for biosimilar drugs and our experience makes us uniquely qualified to help.

Unique Pathway Requires Unique Attorneys

The abbreviated approval pathway for biosimilars in the United States 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.

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 60 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.
• We have assembled a deep bench of experienced litigators, technical experts, patent attorneys, and patent agents with extensive experience representing both branded and generic pharmaceutical companies in blockbuster ANDA matters.
  • Our body of ANDA work comprises more than 50 Paragraph IV filings and over 500 opinions.
  • We have translated that extensive ANDA experience to navigating the BPCIA, and particularly the litigation options available under that regime.
• We are the clear leaders in life sciences and biotechnology litigation before the Patent Trial and Appeal Board (PTAB).
• Our professionals are trained to evaluate complex intellectual property issues in the context of the business environment to ensure alignment with your strategic goals.