Court Upholds Validity of AstraZenec's Prilosec Patents

In a lengthy decision released last Thursday, Judge Barbara S. Jones upheld the validity of AstraZeneca's (AZN) two formulation patents on Prilosec (U.S. Patent Nos. 4,786,505 and 4,853,230) and found that Apotex and Impax (IPXL.PK) infringe the patents, while Mylan (MYL) and Lek, a division of Sandoza (a Novartis Pharmaceuticals (NVS) subsidiary), do not. The defendants had challenged the validity of the patents on grounds of lack of best mode, enablement and written description under § 112; public use and disclosure under § 102(b); and obviousness under § 103(a).

The decision marks another milestone in patent litigation that began seven years ago, when AstraZeneca filed suit against at least eight companies that filed ANDAs for generic versions of Prilosec. In a 2002 decision that was later affirmed by the Federal Circuit, Judge Jones found that Andrx, Cheminor and Genpharm infringe the same two patents and that Schwarz Pharma does not.

Separately, Judge Jones also recently denied Impax's motion to dismiss the suit against it for lack of subject matter jurisdiction. Impax argued in its motion that the suit should have been dismissed because the '505 and 230 patents expired on April 20, 2007 and AstraZeneca had dismissed its claim for damages against Impax. The court, however, found that AstraZeneca has pediatric exclusivity on Prilosec until October 20, 2007, and therefore the court still has jurisdiction.

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