BRI vs. Phillips Standard: “Treating” Definitions with Care

Posted by John Nguyen on Jul 30, 2018

Typically, the PTAB and district courts apply different claim construction standards, which can cause the two forums to construe the same term from the same patent differently. Such divergent treatment occurred in a recent PTAB decision, Mylan Pharmaceuticals Inc. v. Janssen Oncology, Inc. (IPR2016-01332). In Mylan, the PTAB’s claim interpretation of the term “treatment” differed from the district court’s interpretation of the same term in co-pending litigation. The Mylan decision illustrates the divide between the two forums’ claim construction standards and the consequences that those different standards can have on an IPR.

The PTAB typically determines the scope of claims based on the “broadest reasonable interpretation” (BRI) claim construction standard. District courts, on the other hand, apply the “Phillips” standard, named after the Federal Circuit case that explained it. Under Phillips, claim terms are given “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.”

Janssen’s challenged patent (U.S. Patent No. 8,822,438 B2) concerns methods of “treatment” that comprise administering a protein inhibitor in combination with a therapeutic agent. Although the district court, applying Phillips, interpreted “treatment” to require use of the method to stop or eliminate cancer, the PTAB determined that “treatment” could address the consequences of cancer in other ways (e.g., palliative effects). The PTAB explained that it is “not bound by the district court’s reasoning and claim constructions in related proceedings.”

The outcome of the IPR, which rendered all claims of the ’438 patent unpatentable, was decidedly influenced by the PTAB’s differing interpretation. One of Janssen’s arguments in defense of its patent was that the prior art that Mylan cited did not disclose anti-cancer effects. The PTAB explained, however, that this would not distinguish the prior art because the claims encompassed “treatment” beyond anti-cancer effects.

Takeaways

Since the PTAB and district courts typically apply differing claim constructions, it is important to evaluate constructions under both standards early in parallel proceedings. The differing standards can lead to differing constructions, which may affect the invalidity and infringement theories of the case.

Also, parties to IPRs should be aware that the PTO is currently considering regulations that would require the PTAB to apply the Phillips standard in IPRs. Parties should, therefore, also consider the potential consequences of the PTAB and district court applying the same standard. These regulations would require even closer coordination between litigation and IPR strategies.

Topics: Patent Owners, BioPharma

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