AstraZeneca has filed a patent infringement case against Aurobindo Pharma and Aurobindo Pharma USA. The action relates to an abbreviated new drug application (ANDA) filed by Aurobindo Pharma with the US Food and Drug Administration (FDA) for approval to market 2.5 mg and 5 mg saxagliptin hydrochloride tablets — generic versions of AstraZeneca’s Onglyza drug product — prior to the expiration of the US patent.
AstraZeneca is the holder of the new drug application through which the FDA granted approval for the marketing and sale of saxagliptin hydrochloride tablets. AstraZeneca markets the tablets in the US through its Delaware arm — AstraZeneca Pharmaceuticals — under the trade name Onglyza.
On December 2, 2014, Aurobindo notified through a notice letter to AstraZeneca AB and AstraZeneca Pharmaceuticals that Aurobindo Pharma had submitted an ANDA to the FDA under Section 505(j) of the Federal Food, Drug, and Cosmetic Act. AstraZeneca received the notice letter on or around December 3, 2014. The notice letter states that Aurobindo seeks approval from the FDA to engage in the commercial manufacture, use, and sale of generic saxagliptin hydrochloride tablets before the expiration of the patent.
“Aurobindo’s submission of ANDA to obtain approval to engage in the commercial manufacture, use, offer to sell, or sale of generic saxagliptin hydrochloride tablets prior to the expiration of the patent constituted a technical act of infringement. Upon information and belief, the product described in ANDA would infringe one or more of the claims of the patent,” a court order said. “If Aurobindo’s marketing and sale of generic saxagliptin hydrochloride tablets prior to expiration of the patent and all other relevant exclusivities is not enjoined, AstraZeneca will suffer substantial and irreparable harm for which there is no remedy at law,” the order added.