The District Court for the Southern District of Florida today ruled that Apotex’s proposed filgrastim and pegfilgrastim products will not infringe the asserted claims of Amgen’s ’138 patent (U.S. Patent. No. 8,952,138).  The court, having found in favor of Apotex on the infringement issue, did not reach Apotex’s counterclaim that the claims of the ’138 patent were invalid due to lack of enablement.  As we previously reported, the court ruled in July that Apotex had failed to prove that the ’138 patent was invalid on grounds of anticipation, obviousness, lack of written description and indefiniteness.

Despite Apotex’s win on the patent issue, the court permanently enjoined Apotex from launching its product until following its 180 days’ notice of intent to market its product, which may not be given until after Apotex gains approval from the FDA to market its product.

Although not discussed by the court in today’s decision, the Federal Circuit, in its decision upholding the preliminary injunction in this case, explained how Apotex could win on the issue of infringement of the patents asserted by Amgen and still be enjoined: the 180 days’ notice of intent to market, which gives the patent owner “time to make a decision about seeking relief based on yet-to-be litigated patent,” must be given regardless of the outcome of any first phase “patent dance.”  (Amgen v. Apotex, No. 2016-1308, slip op. at 12-13 (Fed. Cir. 2016)).