A claimed feature associated with mere regulatory compliance cannot be used to establish the secondary consideration of commercial success for the purposes of rebutting an otherwise prima facie case of obviousness. Here, for example, the claimed “sterility” of a pharmaceutical product was found to be an insufficient nexus between the novel features of the patented product and the commercial success because sterility is simply an FDA requirement. “Whether or not there is a nexus between the novel features of the patented product and the commercial success must be evaluated in terms of what is driving sales, not what is allowing the product to reach the shelf in the first place.” It may therefore be best to avoid citing compliance with regulatory minimums as objective evidence of non-obviousness even if being first to comply and therefore first to market is what is driving sales.
Background / Facts: The patent being asserted here is directed to a sterile, pharmaceutically effective budesonide product, which is used to treat asthma in children. Although a prima facie case of obviousness was established for the claimed sterile budesonide compositions in light of non-sterile budesonide compositions, sterile compositions of corticosteroids other than budesonide, and five well-known sterilization techniques, the patentee presented various secondary indicia of non-obviousness. In particular, the patentee noted that it was the first to meet the FDA’s sterility requirement, thus satisfying a long-felt need and meeting the nexus requirement of commercial success.
Issue(s): Whether the claimed “sterility” meeting the FDA’s requirement regarding the same is sufficient to establish a nexus with commercial success.
Holding(s): No. “We … reject [the patentee’s] attempt to equate regulatory compliance with evidence of nonobviousness. … Under [this] theory, there would likely always be commercial success when a pharmaceutical product experiences substantial sales because the product must comply with FDA requirements in order to be sold in the United States. Sterility is an FDA requirement; it is not driving demand for [the commercial product]. [The patentee] conflates the two. Whether or not there is a nexus between the novel features of the patented product and the commercial success must be evaluated in terms of what is driving sales, not what is allowing the product to reach the shelf in the first place.”