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Apotex's Grastofil™ (Filgrastim) and Lapelga™ (Pegfilgrastim) Biosimilar Products Determined Not to Infringe an Amgen Patent, Clearing Way for Launch Following Regulatory Approval

On September 6, Judge Cohn of the Southern District of Florida ruled, following a bench trial, that Apotex's filgrastim and pegfilgrastim biosimilar products do not infringe a method of manufacturing patent enforced by Amgen. Judge Cohn ruled that Apotex's manufacturing process for both products did not infringe, either literally or by equivalents, Amgen's US Patent No. 8,952,138, for two independent reasons. This decision represents the first occasion in which a biosimilar applicant proceeding under the BPCIA has achieved a district court victory.

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