Novartis’ Gilenya Patent Invalidated as Obvious

On April 12, 2017, the Federal Circuit affirmed the determination by the US Patent and Trademark Office (USPTO), Patent Trial and Appeal Board (Board) that the claims of  U.S. Patent No. 8,324,283 (“the ’283 patent”) were invalid as obvious.

US Patent No. 8,324,283

According to public databases, Novartis AG is the assignee of the ’283 patent, directed to pharmaceutical compositions for the treatment of multiple sclerosis. The ’283 patent, according to its abstract, relates to sphingosine-1 phosphate (S1P) receptor agonists and a sugar alcohol suitable for oral administration. According to its label, Gilenya acts by internalizing S1P receptors, which sequesters lymphocytes in the lymph node, to prevent relapse of multiple sclerosis. According to the Food and Drug Administration (FDA), Gilenya, approved in 2010, became the first oral disease-modifying drug approved by the Food and Drug Administration (FDA) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis. A Novartis website states that Gilenya had over $3 billion in sales in 2016.

Board Decision

According to the Federal Circuit Decision, Torrent Pharmaceuticals Limited filed inter partes review (IPR) proceedings of the ’283 patent in 2014. The Board determined that the claims of the ’283 patent were invalid as obvious in its Final Written Decision of September 24, 2015. Novartis appealed the decision to the Federal Circuit, and the Federal Circuit affirmed the Board’s decision.

Federal Circuit Decision

According to the Federal Circuit’s decision, Novartis argued on appeal that the Board “erred in its motivation to combine analysis because it failed to read the prior art as a whole and overlooked critical evidence of . . . known disadvantages” of a claimed active ingredient. However, the Federal Circuit affirmed the Board’s finding, concluding that “substantial evidence supports the Board’s finding that . . . a person of skill in the art would have been motivated to combine” the features of the cited art.

 

Robert Hilton
Dr. Robert J. Hilton is an associate in our San Diego office. Dr. Hilton's practice focuses primarily on patent prosecution in the chemistry and life sciences fields. Dr. Hilton earned his J.D. at the J. Reuben Clark Law School at Brigham Young University. While in law school, Dr. Hilton was the president of the Student Intellectual Property Law Association. Dr. Hilton worked at the University Technology Transfer Office during law school, where he gained experience with patent protection and technology licensing. Prior to attending law school, Dr. Hilton earned his Ph.D. in biochemistry. Dr. Hilton's research involved the studies of metals in biological systems. This work required an in depth understanding and training in a variety of chemistry biochemisty techniques such as electron microscopy, ICP-MS, PCR, cell culture, protein purification, and gel electrophoresis. Dr. Hilton was a summer associate for the firm in 2013, and joined the firm in 2014.
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