2018 Year In Review: Life Sciences

2018 was another significant year for intellectual property in Canada with numerous court decisions and legislative changes. This article briefly summarizes some of the highlights in the life sciences realm, and provides outlooks on what is expected in 2019.

Utility and The Aftermath of AstraZeneca

Following the landmark decision in AstraZeneca v Apotex, 2017 SCC 36 ("AstraZeneca"), the lower courts have faithfully followed the Supreme Court decision in ending the often criticized Promise Doctrine, despite attempts by parties at disguising the Doctrine under other causes of action. Both the Federal Court and the Ontario Superior Court firmly stated in Hospira Healthcare Corp v Kennedy Trust for Rheumatology Research, 2018 FC 259 ("Hospira"), and Apotex Inc v Abbott Laboratories Ltd, 2018 ONSC 5199, that the Promise Doctrine allegations cannot be repackaged under the guise of insufficiency, overbreadth or misrepresentation. In Hospira, the Court noted that "it would be inconsistent to discard [the Promise] doctrine only to have it resurface under another principle without clear language to do so". A "scintilla" of utility as explained in AstraZeneca continues to be the Canadian standard. With such clear language, we are unlikely to see Promise Doctrine arguments play a significant role in future litigation.

CIPO Practice

Use claims can still be methods of medical treatment

Commissioner's Decision No. 1442, Re Application No 2,416,408: Methods for therapy of neurodegenerative disease of the brain, demonstrates a strict application of CIPO's 2015 practice notice on medical uses (PN 2015-01). The Commissioner refused application 2,416,408 on the basis of obviousness and being directed to a method of medical treatment. Interestingly, the claims rejected for encompassing a method of medical treatment were not method claims per se, but were written as use claims. Claim 12 reproduced below is a representative example:

12. Use of an adeno-associated virus (AAV) expression vector comprising a neurotrophin encoding transgene to ameliorate defective, diseased or damaged dopaminergic neurons in the brain of a mammal, wherein said AAV expression vector is for in vivo direct delivery into one or more delivery sites within a region of the brain containing targeted dopaminergic neurons, wherein each of said one or more delivery sites is within 500µm from a targeted neuron and no more than 10mm from another delivery site.

The Commissioner's decision noted that when determining whether a claim is directed to a medical use, the relevant inquiry is whether any one of the essential elements prevents, interferes with or requires the professional skill of a physician and not whether the claim is worded as a "use" claim. With this in mind, the Commissioner determined that the claims encompassed intracranially delivering the contemplated AAV expression, and that this entails a surgical step and the professional skills of a physician.

While it is common practice in Canada to circumvent the medical use prohibition using use claims, prudence must be taken to ensure the claims do not inadvertently encompass a medical method.

Late requests...