Friday, January 28, 2011

Fossilized Footprints of Section 39

Merck & Co Inc. v. Apotex Inc. / lovastatin 2010 FC 1265, Snider J

The invention at issue in the lovastatin decision related to a process for making lovastatin with the micro-organism A. terreus, and the patent (1,161,380), had both process and a product-by-process claims. A traditional fermented rice, Red Yeast Rice, was said by Apotex (and Wikipedia!) to contain lovastatin produced by a mold of the genus Monascus. The process claims are clearly unaffected, but Apotex argued that the product-by-process claims were therefore invalid as being anticipated by Red Yeast Rice. The obvious rebuttal to this that the product-by-process claims only encompass the product when made by the particular process, in this case by A. terreus; but as Apotex pointing out, Hoffmann-LaRoche Ltd. v. Canada (Commissioner of Patents), [1955] S.C.R. 414, 23 C.P.R. 1 clearly established that a product-by-process claim is to be treated as a product claim, in the sense that it will be anticipated if the product is known, even though made by different process. Snider J accepted this point as being established by the authorities, but with great reluctance, saying she had “considerable difficulty in understanding how the conclusion in Hoffmann-LaRoche 1955 can fit with the protection offered by the Patent Act,” and calling the result “illogical” [578] and even unprincipled [579].

In the end, Snider J held that the claims were valid as she was not satisfied that lovastatin was actually present in the Red Yeast Rice prior to the priority date [598], or, if it was, that it was adequately disclosed [608]. This raises some interesting questions as to the precise requirements for enabling disclosure.

However, I have a simpler question. What does it matter whether the process-by-product claims are valid? As Dr. Fox explained in his annotation to the Exchequer Court decision in Hoffmann-LaRoche, product-by-process claims, in principle at least, offer no advantage to the patentee as compared with simple process claims, because under the Saccharin doctrine, importation, use and sale in Canada of a product manufactured abroad using the patented process, is itself an infringement of the process patent (for recent affirmation see Eli Lilly Canada Inc. v. Apotex Inc. / cefaclor 2010 FCA 240 [17]-[20]). The evident difference between a product-by-process claim, and a process claim together with the Saccharin doctrine, relates to the burden of proof. Under the old s 39(1) the patentee was restricted to product-by-process claims in respect of the substances intended for food or medicine, but at the same time it was presumed by s 39(2) that any product of the specified composition was presumed to by produced by that process. While the SCC decision in Hoffmann-LaRoche is brief and somewhat cryptic, it appears to me, particularly from the decision of Rand J, that this presumption is what drove the result. It is a fair presumption if there is only a single method known for producing what is a novel compound, but if the compound is not new, it would be wrong to allow a patentee to take advantage of it when in fact the product might very well have been made by some other process. In that case, the patentee should be left to the protection of the Saccharin doctrine, where it would carry the burden of proof.  If that is the real issue, then it was rendered largely moot in the lovastatin case, as Snider J interpreted s 39(2) as imposing only a very weak evidentiary burden which had been met by Apotex. And of course it is entirely moot under the current Act, with that entire section having been repealed.

So, it seems to me that the rule from Hoffmann-LaRoche, that a product-by-process claim amounts to a product claim for purposes of anticipation, is really just a vestige of the old s 39. With the repeal of s 39(2) that rule is no longer necessary; but on the other hand, with the repeal of s 39(1), product-by-process claims are themselves no longer necessary.

No comments:

Post a Comment