Case: Eli Lilly Canada Inc. v. Attorney General of Canada and Minister of Health  

Drug: TRIFEXIS® (spinosad and milbemycin oxime)

Nature of case: Judicial Review of Minister of Health’s Decision  

Successful party: Minister of Health

Date of decision: February 17, 2014

Summary

This was an application for judicial review of a decision of the Minister of Health (“Minister”) which denied the listing of Eli Lilly Canada Inc.’s (“Eli Lilly”) patent, Canadian Patent No. 2,379,329 (the “’329 Patent”), on the Patent Register for failure to meet the product specificity requirements set out in section 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations (the “Regulations”). The Minister’s conclusion that the ‘329 Patent did not contain claims for the formulation comprising both medicinal ingredients of the drug TRIFEXIS®  was held to be reasonable.

The application for judicial review was dismissed.

This case adds to a developing line of case law that requires a high degree of matching between patents sought to be added to the Patent Register and the product that is approved to be sold.

Background

TRIFEXIS® contains two medicinal ingredients, spinosad and milbemycin oxime, and is a veterinary drug indicated for the prevention of heartworm, hookworm, roundworm, whipworm and flea infestations in dogs and cats. Eli Lilly sought to list the ‘329 Patent on the Patent Register against their drug TRIFEXIS® on the basis that the patent claimed a formulation containing both medicinal ingredients.

The ‘329 Patent contains, inter alia, claims for:

A single-dose oral formulation for controlling an ectoparasite infestation in a dog or cat comprising an ectoparasitic amount of spinosad, or a physiological acceptable N-demethyl derivative or salt thereof, and a physiological acceptable carrier in a dosage form including a tablet, caplet, liquid, or chewable treat.

Each claim of the patent specifically references the medicinal ingredient spinosad. The other medicinal ingredient, milbemycin oxime, is not directly claimed.  Rather, milbemycin oxime is indirectly claimed through the term “oral formulation”, referred to in the disclosure of the patent. The term “oral formulation” is defined in the patent as:

“The formulations of this invention may further include, in combination with the spinosyn component, one or more other compounds that have activity against the specific ectoparasite or endoparasite to be controlled, such as, for example ... milbemycins …” [Emphasis added]

Minister erred in construing the ‘329 Patent

Eli Lilly argued that the ‘329 Patent is directed to a formulation that contains both spinosad and milbemycin oxime by directly claiming spinosad and referencing milbemycin indirectly through the definition of the term “oral formulation” present in each claim. The Court agreed and held that the Minister had erred in applying an overly restrictive construction of the ‘329 Patent. Properly construed, “the ‘329 Patent is directed not only to a formulation including spinosad as the only active ingredient, but also to formulations that include other active ingredients such as, but not restricted to, milbemycin oxime.”1  

Although the Minister erred in the construction of the patent claims, this finding is not conclusive of the patent listing issue and as such, the court went on to consider the patent claims and the approved drug submission to determine eligibility for listing.

Strict product specificity requirement  

Despite the Court’s less restrictive construction of the ‘329 Patent, the court found in essence that the claims did not match the formulation in the approved drug submission, commenting that “The jurisprudence has been consistent that the current version of subsection 4(2) of the Regulations, as amended in 2006, has introduced a product specificity requirement and that there must be a perfect match between what is claimed and what has been authorized.”  The Court found itself bound by the reasoning in the Federal Court’s decision in Gilead Sciences Canada, Inc. v. Canada (Ministry of Health)2 (“Gilead”), (upheld on appeal) where the Justice Mosley found, “…that it was insufficient for a patent to meet the product specificity requirement by referring to a class of compound rather than to a specific medicinal ingredient.”3 The Court held that the reasoning in Gilead should equally apply to the determination for listing of the ‘329 Patent.

It is interesting to note that while Eli Lilly had also raised the argument that in Gilead, the Court had not considered the Regulations in light of a member country’s obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the North American Free Trade Agreement (NAFTA), the Court did not specifically address this issue in its conclusion that the ‘329 Patent was ineligible for listing on the Patent Register.

Conclusion

In the result, the Court concluded that the Minister’s decision to refuse listing of the ’329 Patent for failing to meet the product specificity requirement was reasonable.  Eli Lilly’s application for judicial review was dismissed.

Link to decision:

Eli Lilly Canada Inc. v. Attorney General of Canada and Minister of Health, 2014 FC 152