Sometimes it is very difficult to predict how the courts will decide whether claimed combinations are invalid for obviousness. In Hoffman v. Apotex (Fed. Cir. 2014), the Federal Circuit invalidated a number of claims directed to a method of administering a drug described with ranges as being obvious.
The patent at issue was directed to a drug for treating osteoporosis. The drug treatment consisted of a monthly dosing of a 150 mg of ibandronate. The primary dispute in the appeal revolved around whether monthly dosing regimen of the drug at the 150 mg level is obvious.
During litigation, numerous research studies showed the desirability of moving from a daily regimen to a weekly and even a monthly regimen due to patient compliance issues. However, the patent owner attempted to show that the prior literature taught that the efficacy of the monthly dosing regimen would not be effective. Hence, a monthly regimen would not have been obvious according to the patentee. In support thereof, the patent owner put forth various studies which according to their interpretation of the data showed that monthly dosing regimen would be ineffective. Nonetheless, other studies showed the opposite results.
In light of the opposing studies, the Federal Circuit stated conclusive proof of efficacy is not necessary to show obviousness. All that is required is a reasonable expectation of success and that, it believed, was demonstrated by the references.
As for the 150mg dosing level, the court assumed that amount was the result of using a daily dose of 5 mg each day for 30 days, resulting in a total dose of 150 mg. But no reference used that calculation and no reference suggested that total amount would be correct, or that a little more or a little less might needed. A 1996 article studied a daily dosing regimen of 0.25 mg to 5 mg. Positive results were received with dosages between 2.5 mg and 5.0 mg. The results were “virtually equal” between the 2.5 mg and 5 mg doses. The 2.5 mg dose was thereby deemed the most effective dose. As such, utilizing simple math, a 2.5 mg to 5.0 mg daily dose would scale up to 75 mg to 150 mg on a monthly basis. Roche attempted to show that a simple upward scale was not obvious due to an unexpected increase in absorption when 150mg doses were used. Roche put forth evidence that the increased dose for a daily regimen did not significantly increase the absorption or efficacy of the drug, but that efficacy did increase significantly when the 150 mg dose was used monthly. The Federal Circuit dismissed the “somewhat greater” than expected results for the 150 mg dose since there was a reasonable expectation that the 150 mg dosing would be successful in achieving the desired result of treating osteoporosis. The unexpected results did not negate the finding that it was obvious to try using 150 mg doses.
One judge dissented, arguing that none of the references supported multiplying a daily dose of 5 mg by 30 days and giving a single, monthly, 150mg dose, and that there was expert testimony supporting Roch’s position. Since the decision was based on a summary judgment where conflicting facts are to be resolved by a jury, and it only takes more than a scintilla of evidence to get to the jury and avoid summary judgment, the dissent thought the case should go to trial. The majority disagreed. The divided court and the conviction of their respective arguments shows that sometimes parties can view the same references and draw very different conclusions.
This case also illustrates the difficulty in maintaining validity of a patent when the invention is embodied in the ranges expressed in the claim language.
I invite you to contact me with your patent questions at (949) 433-0900 or [email protected] Please feel free to forward this article to your friends. As an Orange County Patent Attorney, I serve Orange County, Irvine, Los Angeles, San Diego and surrounding cities.