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Implications of SCOTUS inter partes review ruling on biologics

One recent decision by the U.S. Supreme Court might have escaped the notice of many in the country. We doubt that entrepreneurs in New Jersey and elsewhere missed the news, however, considering the potential scope of the ruling across all areas of industry, including life sciences.

The case was Oil States Energy Services, LC, v Greene’s Energy Group, LLC. The issue was whether inter partes review (IPR), an administrative process instituted by the U.S. Patent and Trademark Office to deal with challenges to patents, violates the Constitutional guarantees due process in the courts against a taking by the government.

In a 7-2 ruling, the court said the IPR system is OK and went further by explaining that patents, rather than being property owned by holders, are public rights granted by the government. In that context, the justices said, the USPTO’s use of IPR is a legitimate exercise of its rights-granting authority.

While the decision specifically addressed questions related to patents covering devices and methods used in hydraulic fracturing for petroleum extraction, legal observers say the implications are far broader than that. Nearly all industries stand to be affected, including the fields of biologic and biosimilar pharmaceuticals. Analysts note that developers of biosimilar drugs regularly rely on IPR as a means to challenge the validity of patents granted for biologic drugs.

With the decision, biosimilar drug makers are assured of being able to continue using the IPR process, which offers the potential for faster and less costly adjudication of patent challenges than going through the courts.

The legal matters associated with any new or existing business endeavor create unique challenges. To anticipate and avoid issues, or deal with disputes when they arise, it’s important to work with an attorney who understands nuances of monetizing science and technology.



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