Pharmacapsules @ Gowlings: April 3, 2012 - Volume 11, Number 4

Edited by Jennifer L. Wilkie and Isabel Raasch

Mylan Pharmaceuticals ULC v. Pfizer Canada Inc., 2012 FCA 103 - Aricept (donepezil), appeal of NOC case

The Court of Appeal upheld on Order prohibiting the Minister of Health from issuing a NOC to Mylan for donepezil, a drug for the treatment of Alzheimer's type dementia, until expiry of Pfizer's '808 Patent. Mylan had alleged that the patent was invalid due to an unsound prediction of the promised utility, but the trial judge found that this allegation was not justified. 

On appeal, Mylan argued that the trial judge erred in failing to find that the '808 Patent promised that donepezil would have acceptable toxicity and be safer and longer acting than prior compounds. The Court of Appeal reviewed the judge's findings on construction and the promise of the patent. The promise of the '808 Patent was found to be a "a new class of compounds has been discovered (donepezil being one) which, having regard to the