PTAB Decision Conflicts With District Court’s

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The PTAB and District Courts do not always see eye to eye when it comes to prior art.  On August 21, 2020, the Board issued a trio of final written decisions refusing to invalidate the claims of three patents, two of which have claims that were previously invalidated by a District Court.  Each forum’s decision was based on the same prior art reference.

Adapt Pharma Operations Limited and Opiant Pharmaceuticals, Inc. (collectively “Patent Owner”) own the challenged patents, U.S. Patent Nos. 9,629,965; 9,468,747; and 9,211,253.  All three patents are directed to intranasal naloxone, an opioid overdose medication sold under the brand name NARCAN.  Nalox-1 Pharmaceuticals, LLC (“Nalox-1”) petitioned for IPR of the patents, arguing that its primary prior art reference (“Wyse”) in combination with other references invalidated the challenged claims.

A central question in the IPR proceedings was whether Wyse encourages the use of benzalkonium chloride (BAC) as a preservative in intranasal naloxone formulations.  Nalox-1 argued that it does, but the Board disagreed because Wyse “teaches away” from using BAC in intranasal naloxone formulations.  A reference teaches away from a solution if it criticizes, discredits, or otherwise discourages that solution.  If is often difficult to show that a reference “teaches away” from a solution unless it directly discourages that solution.  The Board found that direct discouragement here, concluding that Wyse teaches away from using BAC because “[i]t not only presents results showing that BAC is not acceptable for use in intranasal naloxone formulations, but also provides data demonstrating that other preservatives, such as benzyl alcohol, are stable in such formulations.”

Notably, in a related case between Adapt and Teva Pharmaceuticals, Inc., a District Court reached the opposite conclusion about Wyse and held that claims from the ‘965 and ‘747 patents were obvious.

Takeaway:  The PTAB and District Courts occasionally reach opposing conclusions regarding obviousness of claims challenged by the same prior art in both forums.  Success in one forum does not guarantee the same result in the other.  Also, petitioners should steer clear of references that directly teach away from the claimed solution they are attempting to invalidate.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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