CASE: Sanofi-Aventis Canada Inc., et al. v. Apotex Inc. and Novopharm Limited (Federal Court)

DRUG: ALTACE® (ramipril)

NATURE OF CASE: Patent Infringement Action

SUCCESSFUL PARTY: Apotex Inc. and Novopharm Limited

DATE OF DECISION: June 29, 2009 (public reasons released July 6, 2009)

SUMMARY:

On June 29, 2009 Justice Snider of the Federal Court of Canada found that claims 1, 2, 3, 6 and 12 of Canadian Patent No. 1,341,206 (“the ‘206 Patent”) in relation to the drug ALTACE® (ramipril) were infringed by Apotex Inc. and Novopharm Ltd. but were invalid. Claim 12 of the ‘206 Patent was the narrowest of the claims at issue and was construed by Justice Snider as claiming eight individual stereoisomers, one of which was ramipril. The ‘206 Patent is owned by Schering Corporation. Each of Sanofi-Aventis Canada Inc. and Sanofi-Aventis Deutschland GmbH are licensees under the ‘206 Patent.

Justice Snider held that the evidence was clear that the sale of Apo-Ramipril and Novo-Ramipril constituted an infringement of the claims at issue in this proceeding. Snider J. held that a Gillette Defence was unavailable to the Defendants as they had not argued that the ‘206 Patent was anticipated. After finding infringement, Justice Snider determined the claims at issue to be invalid.

In assessing the validity of the ‘206 Patent, the Federal Court stated that its “key determination” was the finding that, as of the Canadian filing date, the inventors of the ‘206 Patent could not soundly predict that all eight stereoisomers of claim 12 of the ‘206 Patent would have the utility promised by the patent. Since the other claims in dispute included the same compounds as are covered by claim 12, the Court ruled that these claims were also invalid. The Court ruled, in the alternative, that these same claims were invalid for obviousness. Given its findings on validity, the Court did not assess the evidence presented during the damages phase of the trial.

Promise of the Patent

In construing the promise of the patent, Justice Snider ruled that the ‘206 Patent promises that all of the compounds will have utility as both ACE inhibitors and antihypertensives.

Sound Prediction of Utility

The Court concluded that no factual basis for a sound prediction could be established based on the work of the Schering scientists alone. Therefore, the Court turned to the knowledge that was available to Schering as of the relevant date. Snider J. found that Schering’s testing, along with other public information, provided a factual basis and sound line of reasoning for the prediction that ramipril itself would meet the promise of the ‘206 Patent. However, Justice Snider then held that there was not a factual basis for the prediction that certain other stereoisomers of claim 12 would have the promised utility. Justice Snider found that there was no evidence that certain public knowledge was, in fact, used or relied upon by the Schering scientists at the time of the filing of the patent and therefore Schering could not now rely on such knowledge to support their prediction of utility. Snider J. also found that the disclosure of the ‘206 Patent was insufficient to satisfy the disclosure requirement of the test for sound prediction.

Sound Prediction of Making

Justice Snider rejected Apotex’s contention that the doctrine of sound prediction requires that, at the time of the Canadian filing, Schering was required to soundly predict and disclose in its specification methods of making and isolating each of the stereoisomers of claim 12.

Obviousness

In applying the test for obviousness, which was recently clarified by the Supreme Court of Canada, Justice Snider decided that, in the alternative to her ruling on sound prediction, the claims in dispute were invalid as being obvious. Justice Snider held that making the substitutions necessary to ACE inhibitors known as of the relevant date to come to ramipril was obvious to try and was “more or less self evident”. Snider J. also observed that obviousness is not merely the reverse of sound prediction and outlined the differences between these two legal principles. Snider J. stated that a finding that an invention is based on a sound prediction does not necessarily mean that the invention was obvious.

Double Patenting

The Defendants argued that the disputed claims of the ‘206 Patent are invalid on the basis of double patenting over certain claims of Hoechst Aktiengesellschaft’s Canadian Patent No. 1,187,087 (“the ‘087 Patent”). Snider J. rejected the Defendants’ allegation of double patenting on the basis that double patenting could only arise where the patents are held by the same party. Justice Snider found that the owners of the respective patents were different, and further found that it was irrelevant to double patenting that Sanofi Deutschland, the successor of Hoechst, was a licensee under the ‘206 Patent. After assessing the dates relevant to these two patents and the complicated fact scenario that gave rise to the patents, the Court also ruled that the ‘206 Patent could not be considered a “later patent” as compared to the ‘087 Patent. Thus, the Court found that obviousness double patenting was inapplicable.

First Inventorship

Apotex argued that the Schering scientists were not the first to invent ramipril, because Schering did not isolate and test ramipril before Hoechst. Justice Snider rejected Apotex’s argument that a compound cannot be invented unless it is actually made, because this would run counter to the doctrine of sound prediction. Based on the facts before it, the Court was not persuaded that Hoechst was an earlier inventor.

LINK TO DECISION:

The reasons have not yet been posted on the Federal Court website - the citation will be 2009 FC 676.