On August 22, 2023, the Federal Circuit issued a nonprecedential decision, a hallmark case between Sun Pharmaceuticals Industries, Inc. and Incyte Corp., that has stirred conversation amongst legal professionals in the pharmaceutical industry. The court held that claims directed to deuterated analogs of ruxolitinib, a powerful treatment option for diseases like myelofibrosis, were unpatentable as obvious. The Federal Circuit delivered this verdict in affirmation to a Patent and Trial Appeal Board (”Board”) decision from IPR2017-01256 that held unpatentable all claims of U.S. Patent No. 9,249,149 (“the ’149 patent”).
According to JD Supra, the legal battle began when Sun Pharmaceuticals filed an intra-partes review petition revoking the 149 patent claims held by Incyte Corp. The 149 patent in question covered deuterated analogs of ruxolitinib. The Federal Circuit rendered the 149 patent invalid on the basis of obviousness.
According to the court, the decision was rooted in a stringent application of the principles of obviousness. Essentially, if a person of ordinary skill in the art could predict with reasonable expectation that the patent’s specifications would have the claimed benefits, then the subject matter would be termed “obvious”.
Incyte’s reliance on evidence of unexpected results and commercial success did not weigh favorably in the court’s eyes given the information available at the time the application was made. Therefore, this case serves as an example for corporations and law firms alike of the depth of evidence necessary to successfully assert non-obviousness in litigation.
Furthermore, the ruling has prompted increased dialogue regarding the patentability of deuterium-substituted drugs. This precedent underscores the court’s approach to apparent ‘incremental’ changes to existing pharmaceutical compounds, where such changes could be perceived as a patentable improvement, or viewed alternatively as deemed ‘obvious’ and therefore failing to meet necessary patentability criteria. This could potentially alter approaches to future patent filings and disputes within the pharmaceutical industry.