UPDATE Amgen v. Apotex: Amgen argues they have met their burden to prove infringement

Amgen v. Apotex (pegfilgrastim)

As we previously reported, on July 20, the Southern District of Florida granted Amgen’s motion for judgment on partial findings that the ’138 patent was not proven invalid on grounds of anticipation, lack of written description, indefiniteness and obviousness. The Court did not address lack of enablement, however, nor did the Court address Apotex’s motion for judgment on partial findings that Amgen did not meet its burden to prove infringement.

On August 4th, Amgen filed an opposition to Apotex’s motion for judgment arguing that Amgen had met its burden of showing that Apotex’s refold mixture has the requisite protein concentration at or above about 1 g/L of protein, which they stated was “more than sufficient to prove infringement.” Amgen further argues that Apotex’s claims that they do not infringe because of their “paste” theory lacks “credible evidentiary foundation.” Apotex had asserted that they do not infringe because their inclusion bodies are “approximately two-thirds water.” Amgen, however, argues that the water content in Apotex’s inclusion bodes was never reported in their FDA submissions or batch records, and regardless does not save Apotex from infringement because “Apotex is []seeking approval for a refolding process that is covered by the ’138 patent. This is an infringement.”

Stay tuned for further developments at Big Molecule Watch.

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