Drug: ARIMIDEX® anastrozole
Mylan alleged that the patent is invalid for lack of utility and obviousness. The Court first considered a number of preliminary issues. With respect to the admissibility of an affidavit of an expert, the Court held that the witness’s credentials as an expert impact the weight and not the admissibility of the affidavit. Further, the Court declined to hear a motion by AstraZeneca at the outset of the hearing seeking to strike portions of Mylan’s Memorandum of Fact and Law that allegedly made an argument that was not contained in the Notice of Allegation (NOA). The Court held that the memorandum is not a pleading that can be struck and that interlocutory motions in applications are exceptional. The Court dismissed the motion but directed that arguments with respect to the adequacy of the NOA be made during the course of the hearing. The Court ultimately found that the NOA was adequate to provide notice to AstraZeneca.
The Court construed the promise of the patent, considering the language of the patent itself as well as the evidence of the experts. The Court found that the patent does not promise therapeutic utility, and that a statement as to the “object” of the invention did not amount to a promise. The Court considered the testing referred to in the patent and found that utility had been demonstrated. In the event the Court was incorrect with respect to the promise of the patent and that the promise was broader than the Court’s finding, the Court found that the patent would be invalid for lack of demonstrated or soundly predicted utility.
With respect to obviousness, the Court noted that there was no obvious starting point for the development of the claimed compound and therefore the inventive promise would not have been obvious to a skilled person.