Photocure Asa v Canada (Health), 2015 FC 959
This Federal Court (“FC”) decision reflects the Minister of Health’s (“Minister”) continued trend in applying a restrictive interpretation in defining “innovative drug” under the Food and Drug Regulations, CRC, c 870 (“Regulations”) and the Minister’s restrictive approach to data protection.
Photocure ASA (“Photocure”) applied for judicial review of the Minister’s decision denying data protection for Cysview (previously known as HEXVIX), a new medicinal ingredient. The Minister denied data protection for Cysview after finding it was not an “innovative drug” and it consequently would not be added to the Register of Innovative Drugs. Deferring to the Minister, in its closing comments the FC indicated the scope of “innovative drug” does not extend to combinations of the enumerated variations of previously approved medicinal ingredients in the Regulations (salt, ester, enantiomer, solvate or polymorph).
Click here to view the image.
Photocure markets hexaminolevulinate hydrochloride (“HAL HCl”) under the name Cysview for use as an optical imaging agent in the detection and management of non-muscle invasive bladder cancer.  Photocure submitted Cysview for approval as an “innovative dug” to obtain data protection under the Regulations. Section C.08.004.1 of the Regulations states that new drugs qualify as “innovative drugs” and are eligible to receive data protection if they contain a medicinal ingredient not previously approved in a drug by the Minister, or that is not a variation of a previously approved medicinal ingredient, such as a salt, ester, enantiomer, solvate or polymorph. The Minister denied Cysview data protection, finding that it was ineligible because HAL HCl was an ester variation of a previously approved medicinal ingredient, aminolevulinic acid hydrochloride (“ALA HCL”).  Photocure applied for judicial review of the Minister’s decision, alleging that the Minister erred in finding that HAL HCl was an ester variation of a previously approved medicinal ingredient and that it should have been considered an “arguable variation” of a previously approved medicinal ingredient. [4-5]
The FC applied a reasonableness standard to find that the Minister’s decision not to grant Cysview “innovative drug” status was reasonable. The FC refused to consider new evidence that was not before the Minister. Photocure’s application was dismissed.
Photocure and the Minister both filed additional affidavit evidence. On judicial review, a court will not admit evidence that was not before the decision-maker, subject to recognized exceptions. The FC ruled the additional affidavit evidence inadmissible, as it did not fit into any of the recognized exceptions. 
Reasonableness Standard of Review
Photocure argued that at issue was a question of law, the Minister’s interpretation of the meaning of “innovative drug,” and that the standard of review was thus correctness.  The Minister argued that at issue was a question of fact or mixed fact and law, determining whether Cysview was an ester of ALA HCl, and that the standard of review was reasonableness.  The FC agreed with the Minister and held that reasonableness was the proper standard of review.  At issue was a question of fact or mixed fact and law, whether one drug was a variation of another. Furthermore, since the FC had no expertise in making such determinations, deference was owed to the decision-maker. 
To determine if the Minister’s decision was reasonable, the FC had to consider the existence of justification, transparency and intelligibility within the decision-making process, and determine whether the Minister’s decision fell within a range of possible, acceptable outcomes.  The FC reviewed the Minister’s decision, which clearly conveyed that the Minister considered the whole structure of the ALA HCl, and all of the evidence that was before the Minister in making the decision. 
Photocure had argued that 1) HAL HCl was a salt of HAL, which has not been previously approved; 2) that HAL was an ester of ALA, which has not been previously approved; and 3) that HAL HCl was therefore not an “ester” of ALA HCl within the meaning of “innovative drug” in the Regulations. The Minister’s decision acknowledged and agreed with Photocare’s first two arguments, and that both HAL HCl and ALA HCl were salts. However, the Minister’s decision concluded that because the structure of HAL HCl was identical to ALA HCl, both of which were salts, but with the addition of an ester group, HAL HCl was an ester of ALA HCl.  The FC thus held that it was reasonable for the Minister to deny Cysview data protection because ALA HCl was an ester of a previously approved medicinal ingredient, even though it was also a salt. 
Photocare attempted to argue that HAL HCl was an ”arguable variation” of ALA HCl, however, Photocare did not argue that the interpretation of “variation” could not include a variation that was both a salt and an ester before the Minister.  The FC was thus not required to specifically address that argument since it was outside of the scope of the judicial review. The FC did however note that the enumerated variations (salt, ester, enantiomer, solvate or polymorph) in the Regulations did not foreclose drugs that were a combination of the examples (such as a drug that is both a salt and an ester or other combination).  Canada’s approach and restrictive interpretation to “innovative drug” is stricter than other countries, such as the US and EU, which have more liberal approaches that allow variations of previously approved medicinal ingredients in some circumstances.