SSJR Wins Appeal Establishing Clear Precedent That Kit Claims Covering FDA Drugs Are Invalid Because Drug Labels Do Not Constitute Patentable Subject Matter

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In early 2009, Astra Zeneca filed for a preliminary injunction in New Jersey District Court to prevent SSJR client Apotex from launching its generic version of AZ’s Pulmicort Respules (budesonide). AZ asserted among other things that Apotex’s launch would infringe the kit claims in U.S. Patent No. 6,598,603 and No. 6,899,099. The kit claims recite two elements (1) a budesonide composition and (2) a label indicating administration by nebulization in a continuing regimen at a frequency of not more than once per day. The New Jersey Court agreed with SSJR’s argument that the kit claims were invalid because the budesonide composition and suspension were known in the prior art and that the instructions in the claimed label are non-statutory subject matter and therefore not entitled to patentable weight. The Court of Appeals for the Federal Circuit agreed with SSJR’s arguments, affirmed the District Court ruling, and rejected AZ’s argument that a kit claim directed to a drug product with a FDAapproved label is patentable. SSJR’s victory establishes clear precedent that kit claims based on drug labeling are invalid.