FCA allows appeal on lack of sound prediction (Latanoprost)

In a decision released yesterday, the Federal Court of Appeal has allowed Apotex’s appeal and held that Pfizer’s 132 Patent relating to latanoprost “fails to meet the requirements for sound prediction.”

The decision is Apotex Inc. v. Pfizer Canada Inc. and Pharmacia Atkiebolag 2011 FCA 236 (PDF). Writing for the Court, Justice Trudel wrote:

[24] For the Applications Judge, Apotex’s position that the promise of the patent is chronic use of the compound amounted to a “mistaken premise” upon which Apotex wrongly relied for its case. At paragraph 192 of her reasons, she held that Apotex “was unable to show that its basic premise was sound” and dismissed the argument. I agree with Apotex that, in so doing, the Applications Judge overlooked Pfizer’s own evidence that glaucoma, at the time of filing, would have been known by the POSITA to be a chronic condition that required chronic treatment.

[27] … I see it as an error to construe the promise of the ‘132 patent without consideration as to the nature of the disease it purports to treat effectively.

Once the Court accepted Apotex’s construction of the claims, it reviewed the utility of the patent de novo along with the principles of sound prediction:

[30] … In our case, utility would be demonstrated if the patent disclosed studies showing that latanoprost, when administered on a chronic basis, reduced intraocular pressure without causing substantial side effects.

[31] However, at the time of filing, the uncontested evidence was to the effect that the inventors had only conducted “single dose” studies on animals and healthy humans; latanoprost had not been tested on patients with glaucoma or on a chronic basis. The evidence from experts on both sides also reveals that the ‘132 patent was based on a prediction of utility, i.e., that which was observed in the single dose study could soundly be predicted to apply to chronic use …

[40] However, the factual basis supporting the promise of the patent is clearly not a chronic use
study. None of the studies used multiple doses, …

[42] The inventor’s line of reasoning is nowhere to be found in the disclosure of the ‘132 patent.
When asked where, in the patent, was disclosed the line of reasoning, Dr. Wolff could not point to
any excerpt …

The decision is an appeal from a decision of Justice Heneghan in Pfizer Canada Inc. v. Canada (Health), 2010 FC 447.

The Federal Court of Appeal had previously considered the 132 patent in PharmaScience v. Pfizer, 2011 FCA 102 and came to a different result in that case, finding the allegations not justified and granted the prohibition order.

[Update: the decision is now available from the FCA website at 2011 FCA 236.]