Friday, April 24, 2020

Argentum's arguments for standing rejected by the CAFC in Gilenya case

Gilenya (generic name fingolimod) is a sphingosine-1-phosphate receptor modulator, used mainly in the treatment of multiple sclerosis.
On April 23, 2020, the CAFC decided a case related to Gilenya, which related to the issue of standing of the company Argentum to challenge US 9,187,405 in IPR proceedings.

On February 3, 2017, Apotex Inc. and Apotex Corp.
(collectively, Apotex) filed a petition for inter partes review
of Novartis Pharmaceuticals Corporation’s U.S. Patent No.
9,187,405. The Board instituted proceedings on July 18,
2017, and granted Sun Pharmaceutical Industries, Ltd.,
Sun Pharmaceutical Industries, Inc., and Sun Pharma
Global FZE’s (collectively, Sun); Teva Pharmaceuticals
USA, Inc. and Actavis Elizabeth LLC’s; and Argentum
Pharmaceuticals LLC’s requests for joinder under 35
U.S.C. § 315(c). After institution, Patent Owner, Novartis,
filed a contingent motion to amend. On July 11, 2018, the
Board concluded that Apotex, Sun, Teva, Actavis, and Argentum (collectively,
Petitioners) had not demonstrated
unpatentability of the claims and denied the motion to
amend as moot. Petitioners appealed the Board’s findings.
During the appeal process, all Petitioners other than Argentum settled their respective appeal with Novartis

In a rather lengthy analysis of three arguments for standing, the CAFC concluded
that Argentum did not have standing, and this particular challenge to the
Gilenya patent has gone away.


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