Recent Federal Circuit Decision Illustrates Challenges in Proving Obviousness
This non-precedential decision is of interest not for any new exposition of patent law but merely as a convenient marker to demonstrate how far the pendulum has swung away from the recent loose standards allowing disparate references to be combined to support an obvious rejection of a patent claim. In the district court below, a bench trial on a Hatch-Waxman infringement suit brought against defendants Dr. Reddy’s and Teva by Genzyme and Sanofi resulted in a decision for the plaintiffs. The court held that the defendants had failed to prove that the sole claim in issue (claim 19) was invalid for obviousness and as infringement was not disputed the verdict of infringement was entered. The technology in the case related to a method for mobilizing and harvesting stem cells in a subject by first treating the subject with G-CSF and then with plerixafor thereby increasing the number of stem cells available for harvesting from the blood for use in treating leukemia by transplantation. The defendants had relied on a combination of references to effectuate an obviousness defense. In a first combination, a paper by Hendrix et al. was cited to show that plerixafor produced increased white blood cells (WBCs) in the circulation. The authors suggested that the action of this agent may cause “release of...