Case: Eli Lilly Canada Inc v Teva Canada Limited and the Minister of Health

Drug: ALTIMA® (injectable pemetrexed disodium compound)

Nature of case: PM(NOC) Regulations

Successful party: Teva Canada Limited

Date of decision: January 14, 2013

Summary

Eli Lilly Canada Inc. (“Lilly”) brought an application under the Patented Medicines (Notice of Compliance) Regulations (the “NOC Regulations”) for an Order prohibiting the Minister of Health from issuing a Notice of Compliance (“NOC”) to Teva Canada Limited (“Teva”) with respect to a generic version of Lilly’s injectable pemetrexed disodium compound (Altima®) until the expiry of Canadian Patent Nos. 1,340,794 (the “’794 Patent”) and 2,400,155 (the “’155 Patent”).

The parties came to an agreement regarding infringement of the ‘155 Patent. Allegations of invalidity with respect to the ‘794 Patent were still in dispute. However, Teva failed to file any evidence to support its allegations and subsequently withdrew its Notice of Allegation (“NOA”). Lilly took the position that it was still entitled to a prohibition Order while Teva maintained that the application should be dismissed for mootness.

Lilly argued that Teva’s withdrawal of its NOA raised an abuse of process issue if Teva were to subsequently file a second NOA and raised concerns about potential exposure to section 8 damages. There was also a concern about the possibility of the Minister issuing a NOC to Teva despite the withdrawal of its NOA.

The Court held that the application was moot for the following reasons: (1) Lilly’s concerns regarding abuse of process were speculative at this time because there was no clear evidence as to what motivated Teva’s decision to withdraw its NOA or that Teva would attempt to file a second NOA in the future; (2) Lilly’s concern about its potential exposure to section 8 damages was based on the assumption that Teva would improperly file a second NOA that could withstand an abuse of process challenge; and (3) there was no concern that the Minister would issue a NOC to Teva despite the withdrawal of Teva’s NOA since that was not an outcome permitted by section 7 of the NOC Regulations. The Court noted that these concerns had been previously considered and rejected by the Federal Court.

Conclusion

The Court commented that in circumstances similar to the case at bar, it had no doubt that the Court could issue an Order of prohibition. However, the Court stated that it would be undesirable to do so and followed the authorities before it. Since there were no live issues between the parties after Teva’s withdrawal of its NOA, Lilly’s application was dimissed as moot.

Link to decision:

Eli Lilly Canada Inc v Teva Canada, 2013 FC 28