On July 13, 2011, Justice O’Reilly of the Federal Court granted an application commenced by Hoffmann-La Roche under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a NOC to Apotex Inc. for its generic version of the brand drug, Cellcept® (mycophenolate mofetil (“MMF”)), until the expiry of Hoffmann-La Roche’s Canadian Patent 1,333, 285.

The ‘285 Patent includes claims to the compound MMF (a pro-drug of the previously known compound MPA), which is an immunosuppressive drug used primarily in organ transplants, and describes certain advantages of the invention.  In its NOA, Apotex alleged that the ‘285 Patent was invalid mainly on the grounds of: (1) lack of utility – that MMF’s utility was neither demonstrated nor soundly predicted, and (2) obviousness – that MMF was an obvious variant on the prior art.

The Court construed the promise of the ‘285 Patent to include some of the advantages stated in the patent because it is those advantages (advantageous pharmacokinetic properties) that lead to enhanced bioavailability and enhancing bioavailability was the problem that the inventors were trying to solve.  The Court also construed that the invention related to use in mammals, including humans, in view of the use to which MPA had historically been put.  

On the issue of demonstrated utility, the Court equated the promise of the patent with the utility of the invention.  The Court then found that data disclosed in the patent was sufficient to demonstrate the stated invention as of the filing date.  The Court also found that even though the patent did not disclose any human tests on MMF, the study done in monkeys demonstrated the utility of MMF as an effective prodrug of MPA.  Indeed, MMF's sole mission was to deliver MPA and MPA was well-known to be useful in the treatment of conditions in humans. Thus, the utility in humans had been demonstrated at the relevant date. The Court added that even if the stated utility had not been demonstrated it was soundly predicted based on the data in the patent.

In respect of obviousness, the Court determined that MMF was not obvious to try, nor was it more or less self-evident that it would work.  The Court also noted that Apotex provided no evidence about how it found the prior art it was relying on.  Prior art should be discoverable on a reasonably diligent search.  As such, the Court was skeptical of the value of some of the prior art references relied on by Apotex’s experts.

For a copy of the decision, please see: http://www.gowlings.com/knowledgeCentre/enewsletters/pharmacapsules/pdfs/T-1165-09.pdf