The trial judge granted prohibition in respect of one patent claiming a novel crystalline form of atorvastatin (the "crystalline form patent") and denied prohibition in respect of another patent claiming a novel process for making atorvastatin (the "process patent"). The net effect is that the generic company is prohibited from entering the market until the expiry of the patent upon which prohibition was granted.
The generic manufacturer admitted that it would infringe the crystalline form patent in India, as the claimed crystalline form was an intermediate. However, the final product imported into Canada would not contain any of the infringing crystalline form. The generic manufacturer produced data relating to its intermediates, which allowed expert witnesses to conclude that the intermediates infringed the crystalline form patent.
The Court applied the Saccharin doctrine to find that, despite the fact that the intermediate was made in India, it was nonetheless an infringement of the patent. Specifically, without the intermediates, the generic company would not have been able to produce the amorphous form of atorvastatin in its final product. Thus, a strong link was established between the use of the patented product and the product sold in Canada.
With respect to the process patent, it was found invalid for insufficiency. The Court found that the disclosure of the process patent required that a seed be present in order to allow for crystallization of the end product. The Court further found that, as of the date of publication of the patent, the prior art did not teach how to make the seed crystal. Thus, the disclosure was insufficient and the patent was invalid.
Of note, it seems that the application for the crystalline form patent, which taught how to make the seed crystal, was published on the same day as the process patent. However, the Court found that it was unlikely that a skilled addressee would discover a patent application published on the same day as the relevant date for determining sufficiency in this case. Thus, the crystalline form patent was not allowed as prior art to provide instruction for the process patent.
In addition, the Court found that the generic company had failed to provide a legal and factual basis for its allegation of non-infringement. The fact that the innovator sought leave to file reply evidence is strong evidence that it did not have an understanding of the case it had to meet from the Notice of Allegation. The generic company argued that there was no prejudice since reply evidence had been filed. However, the Court did not accept this argument. As the generic company fully understood the argument that it was planning to make, the innovator had been handicapped by the failure to disclose that argument. Thus, the allegation of non-infringement was found to be not justified.
The full text of the decision can be found at: http://decisions.fct-cf.gc.ca/en/2007/2007fc898/2007fc898.html