Canada’s Intellectual Property Firm

Mixed Results for Ramipril Use Patents

Two recent decisions of the Federal Court have considered the test of infringement of a new use patent under the Patented Medicines (Notice of Compliance) Regulations (“Regulations”), with mixed results.

On October 11, 2005, a Judge granted Aventis’ application to prohibit the Minister from issuing a notice of compliance (NOC) to Apotex for its ramipril product until after the expiry of Patent No. 1,246,457 (Aventis v. Apotex, 2005 FC 1381). The ’457 patent covers the use of ramipril in the treatment of heart failure. Aventis sells ramipril under the brand name ALTACE which is widely prescribed in the treatment of heart failure.

Referring to two Court of Appeal decisions that considered the test for infringement of a new use patent under the Regulations (Procter & Gamble v. Canada (Minister of Health), 2002 FCA 290 and AB Hassle v. Canada (Minister of Health), 2002 FCA 421), the Judge found that proof on a balance of probabilities that third parties will infringe would satisfy the test of infringement. The Judge accepted Aventis’ evidence that Apotex’s ramipril product will inevitably be dispensed for heart failure, and found that Aventis has demonstrated that infringement will occur.

The Judge also determined that Apotex’s product monograph enclosed with the notice of allegation (NOA) is the relevant product monograph. The Court rejected Apotex’s argument that the product monograph revised to address Aventis' concerns about certain passages should be considered. In rejecting this argument, the Judge found that a party filing an NOA is obliged to put its full and best case forward, and an NOA is not an offer to open negotiations. The Judge agreed that the relevant product monograph indicates that Apo-Ramipril can be used to treat heart failure, and found that Apotex’s non-infringement allegations are not credible. Apotex has appealed.

On October 27, 2005, another Judge dismissed Aventis’ application to prohibit the Minister from issuing an NOC to Apotex for its ramipril product until the expiry of Patent No. 2,023,089 (Aventis v. Apotex, 2005 FC 1461). The ’089 patent covers the use of ramipril for the treatment of cardiac and vascular hypertrophy and hyperplasia (“Hypertrophy”).

ALTACE is prescribed for the treatment of Hypertrophy, although it is not formally approved for such use. Apotex conceded that “off-label” prescribing of its ramipril product will occur once the NOC is issued, with the result that patients will consume it to treat Hypertrophy. However, the Judge found that infringement by patients is not enough; there must be “something more”, be it inducement, procurement, marketing or some other nexus. The Court found that Aventis did not establish the required nexus, and so dismissed the application.

It remains for the Court of Appeal to clarify whether a second person’s allegation of non-infringement of a new use patent is justified where it is established that patients will infringe the new use patent once an NOC is issued to the second person.