Amgen Canada Inc. v. Apotex Inc, 2015 FC 1261 

Drug: filgrastim

The Federal Court has dismissed an application for prohibition for obviousness. The invention was described as “to take the ‘naturally occurring' protein reported by Dr. Karl Welte at Sloan-Kettering Institute and to create, by recombinant means, a protein having some or all of the amino acid sequence and some or all of the biological properties of that protein so as to have available, in sufficient quantities, a recombinant protein which showed promise for further research.”

Apotex alleged the patent was invalid for novelty, obviousness and inutility at the hearing.

The Court was satisfied on the evidence that the product of Claim 43 was not anticipated because it is not identical to the “natural” product of Welte because of the inclusion of the “Met” at the beginning of the amino acid sequence, and because the amino acid sequence of claim 43 following the “Met” is quite possibly but not certainly the sequence of the natural product.

In finding the invention obvious, the Court held that the difference between the inventive concept of Claim 43 and what Welte disclosed is that Claim 43 identifies the amino sequence of a polypeptide beginning with a Met that has some or all of the sequences of Welte's factor and some or all of its biological properties. This was found to require “skilled work” and not the “creative work” necessary to deserve patent protection. While the Court noted that perhaps Amgen would be entitled to a patent claiming an inventive process or processes, the end product, which is simply the protein made by whatever process, was not itself inventive. 

For utility, the Court found the promise of the patent was to create a manufactured protein having some or all of the amino acid structure, and some or all of the biological properties of the natural protein. Claim 43 was found to do this and it was demonstrated at the time the patent was filed. The Court further held that whether or not the inventor had a sound basis for predicting that the manufactured protein would be useful in certain therapy is relevant only with respect to claim 33, and not claim 43. Claim 43 is directed only to the recombinant protein and not to its uses. Therefore, claim 43 had utility.

Costs were not awarded to any party. The Court stated that Apotex pursued many issues as to invalidity and non-infringement in its NOA, and all were dropped but the three mentioned above. Furthermore, Amgen was found to have initially asserted many claims, before reducing it to only one claim. The Court found this constant change meant the parties did not make matters clear and efficient for each other or the Court.