Infliximab – USA

Infliximab – USA

U.S. District Court for the District of Massachusetts granted Celltrion’s “Gilead Motion” for summary judgment of invalidity of U.S. Patent 6,284,471. Celltrion got FDA approval for biosimilar version (Inflectra) of Janssen’s Remicade® (infliximab) product–in April 2016.

The Gilead Motion
As summarized in the court’s September 28, 2016 Memorandum and Order, Celltrion filed a motion for summary judgment of invalidity of the ‘471 patent based on obviousness-type double patenting in view of U.S. Patent 6,790,444. Since the ‘471 patent was granted before the ‘444 patent, the theory of obviousness-type double patenting was based on the Federal Circuit decision n Gilead. In that case, the court held that a patent that issues after but expires before another patent can qualify as a double patenting reference for that other patent.

But the issue was slightly different from Gilead case where both the patents were post-GATT. In this case ‘471 is pre-GATT (17 or 20 rule) and ‘444 is post GATT (20 year rule). The court then emphasized the policy concerns behind the doctrine, and found that they would be violated if the ‘471 patent was permitted to extend beyond the term of the ‘444 patent:

Thus, the court determined that the ‘444 patent is citable as an obviousness-type double patenting reference against the ‘471 patent. In view of Celltrion’s concession that the claims were not patentably distinct, the court held that the challenged claims of the ‘471 patent are invalid for obviousness-type double patenting.

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