Drug: Lumigran RC
Two PM(NOC) decisions relating to the same patent were recently released by the Federal Court. In both cases, the applications were allowed, prohibiting the Minister from issuing an NOC to both Cobalt and Apotex for their generic versions of Allergan’s drug. The Court’s reasons are substantially similar between the two decisions.
The Court described the ‘691 Patent in issue as relating to eye drops used in the treatment of glaucoma and ocular hypertension. There was an older version of the drug that had already been marketed to patients. This new version of the drug performed as well as the old but with fewer side effects, even though the amount of active drug was decreased.
The Court found that a person of skill in the art would have expected that reducing the active drug would also reduce efficacy. It was found that the increased penetration of active drug resulting from the new combination of substances was not suggested in the prior art. Instead, the Court held that the discovery of a new combination having the efficacy of the old was only found through experimentation and inventive steps, such as the experimental trials that used various combinations of ingredients. The result was found to not be self-evident, and not obvious to try.
The patent was further found to be soundly predicted as the data in the patent set out the factual basis, and the sound line of reading was implicit in the data itself. Lastly, it was found that the later patent was not anticipated by the patent for the earlier version of the drug, even though it fell within the scope of the earlier patent. This was because nothing in the earlier patent would enable a skilled person to arrive at the new invention.