AstraZeneca v. Apotex

November 10, 2010 – Blog Post

The Federal Circuit issued an opinion in AstraZeneca v. Apotex on Monday, November 01, 2010. In the opinion, the court affirmed a district court’s holdings regarding preliminary injunction for method claims and anticipation of product claims having to do with Apotex’s ANDA to market a generic version of AstraZeneca’s budesonide suspension, an anti-inflammatory drug administered through a nebulizer.

The Federal Circuit first upheld the district court’s finding of no anticipation of AstraZeneca’s asserted method claims. Apotex contended that another patent claiming the administration of budesonide within liposomes anticipated AstraZeneca’s method claims. However, the district court construed the term “budesonide composition” in AstraZeneca’s asserted method claims as involving solutions or suspensions, but not liposomes, and that therefore the reference involving liposomes did not anticipate the asserted method claims. Finding that the district court properly used the claims, specification, and expert testimony to construe “budesonide composition,” the Federal Circuit affirmed the district court’s claim construction, and, accordingly, the resulting conclusion of no anticipation for the method claims.

Likewise, an AstraZeneca advertisement allegedly anticipating its product did not do so, according to both the district court and the Federal Circuit. AstraZeneca’s asserted method claims limit the claimed treatment to dosages “at a frequency of not more than once per day.” The advertisement in question stated that the initial recommended dosage frequency was twice per day and that the maintenance dosage “should be the lowest dose which keeps the patient symptom-free.” While this might seem to indicate the possibility of decreasing administration of the drug to a once-daily frequency, an AstraZeneca expert testified that, at the time, they had not thought that such a low dosage frequency was adequate. The district court thus concluded, and the Federal Circuit agreed, that the advertisement was not referring to a once daily dosage as a person having ordinary skill in the art would have understood it when it ran.

In a dissenting opinion, Judge Bryson argued that AstraZeneca’s asserted method claims were anticipated by both the previous patent and by the advertisement. Judge Bryson argued that the specifications of the asserted patents supported another construction of “budesonide composition,” contrary to the expert testimony, and that the advertisement’s support for reducing dosages to minimum effective levels would anticipate the once-daily administration of the asserted method claims.

Relevant to AstraZeneca’s request for a preliminary injunction, the district court found that AstraZeneca would likely succeed in showing active inducement, and the Federal Circuit affirmed. While AstraZeneca’s asserted method claims claimed dosages “at a frequency of not more than once per day,” Apotex’s product label instructed the user to start with more frequent administration and “titrate down” to a minimum necessary dosage. To demonstrate a likelihood of proving induced infringement, AstraZeneca would have to assert that Apotex actively engaged in the inducement. Apotex’s Director of Regional Affairs testified that the FDA decided not to allow the Apotex to remove the “titrate down” language at the ANDA stage, but that Apotex did not appeal that FDA decision. The district court also mentioned that Apotex could have sought approval for smaller dosages of budesonide that patients could administer more often than once daily, but that Apotex did not do so. Because the district court found that Apotex apparently knew of the potential to induce infringement and because Apotex had other options that it did not pursue to avoid infringement, the district court found active inducement. The district court used this finding to support its grant of a preliminary injunction, and the Federal Circuit affirmed.

The district court, citing Federal Circuit precedent, found merit to Apotex’s contention that AstraZeneca’s asserted kit claims were anticipated because the budesonide composition was known in the prior art. AstraZeneca failed in its attempt to create novel subject matter of the budesonide composition by labeling it with directions for an allegedly novel administration regimen because the Federal Circuit had previously ruled that printed matter not functionally related to a substrate will not distinguish an invention from prior art. See In re Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983). The Federal Circuit affirmed the district court ruling, stating that the “instructions in no way function with the drug to create a new, unobvious product.”

The examination of the advertisement as potential prior art in AstraZeneca v. Apotex suggests that references to be used as prior art should be interpreted from the perspective of a person having ordinary skill in the art at the time of the reference’s release and not at the time of a later validity determination. Because the advertisement ran at a time when budesonide would not have been administered so infrequently, the Federal Circuit ruled that instructions to decrease the dosage as needed were not anticipatory.

Additionally, where a generic manufacturer realizes the possibility for inducing infringement, the manufacturer should take precautions to avoid infringement. Though Apotex’s employee testified that she did not think their generic product would infringe, she exhibited behavior indicating that she realized a risk and did not pursue options to mitigate that risk. Generic manufacturers should tread more carefully when they realize that they may have some risk of inducing infringement