Innovator with Drug on Register Has Standing in Review of Minister’s Decision as to Whether Data Protection Is Triggered by an NDS

Hospira Healthcare Corp v Canada (Health) 2014 FC 179 Tabib Pr
            oxaliplatin / ELOXATIN

Hospira filed an NDS for “Chemical Entity A,” which, for the purposes of this decision, was assumed to be oxaliplatin [4]. This NDS was rejected for reasons having nothing to do with data protection. Sanofi then listed its drug Eloxatin, with oxaliplatin as the API, on the Register of Innovative Drugs. The Minister then resumed consideration of Hospira’s NDS. In one of its answers to the Mininster’s inquiries, Hospira made reference to the product monograph for Eloxatin. The Minister considered that Hospira had thereby made “direct or indirect comparison” between its drug and Eloxatin, and therefore placed Hospira's application on what might be called “data protection hold” pursuant to section C.08.004.1 of the Food and Drug Regulations (the data protection provision) [5]. Hospira sought judicial review of this decision, and Sanofi sought to be named as a party on the basis that it was a person “directly affected by the order sought” under Rule 303(1)(a).

Prothonotary Tabib noted that the data protection regime is intended to protect the interests of innovative drug makers by preventing others from relying on their data during the exclusivity period, and “[i]t is beyond question that the order sought will directly prejudice Sanofi, as it will remove the protection and its right to the exclusion of Hospira’s product from the market, both of which were intended for Sanofi’s direct benefit” [19]. She therefore held that Sanofi did have a right to be added on the third branch of the test for interpreting Rule 303 set out in Forest Ethics Advocacy Assn 2013 FCA 236 [20].

In coming to this conclusion, Tabib Pr usefully pointed out that there are two lines clear lines of authority:

[13] On the one hand, it has been held that an innovator drug manufacturer does not have standing to bring or respond to an application to judicially review a decision of the Minister of Health under the Food and Drugs Act or the Food and Drugs Regulations in respect of the issuance or proposed issuance of an NOC to another drug manufacturer

[14] On the other end of the spectrum, there is equally constant jurisprudence that an innovator whose patents are listed against a drug on the register maintained under the [PM(NOC)Regulations] does have standing where the issue in a judicial review is whether or not the rights and protections afforded to it under the PM(NOC)Regulations are engaged by another manufacturer’s application for an NOC

She noted that neither of these lines of authority controlled the present case; the distinction cannot be based on whether it is the NOCRegulations or the Food and Drugs Regulations that are involved, as there is no principled reason for saying that a person’s interest is necessarily “directly affected” by one regulation but not the other [15].

Obviousness is Objective

E Mishan & Sons, Inc v Supertek Canada Inc 2014 FC 326 Hughes J
            2,779,882

Mishan v Supertek is a straightforward case which illustrates the objective nature of the obviousness inquiry [128]. The inventor believed he had invented an ingenious new type of garden hose, but he was not aware of a key prior art patent which rendered the invention obvious.

The problem addressed by the 882 patent was that of unwieldy garden hoses, which are difficult to store and unravel because of their length. The solution provided was a hose consisting of a elastic inner tube contained within an outer fabric tube, with the tubes coupled to each other at each end. Under pressure, the inner tube would elongate until constrained by the outer tube. When turned off, the inner elastic tube would contract, causing the hose to shrink. The inventor had developed the hose primarily for use as a residential garden hose, but the specification stated that it could be used to convey “fluid” including water, gases and even flowable solids [138]. The prior art was US patent 6,523,539, the McDonald patent, which was titled “Self-elongating oxygen hose for stowable aviation crew oxygen mask.” It operated in essentially the same way as the plaintiff’s hose. The main difference between the McDonald invention and the 882 patent was that the former was intended for air supply in aircraft and for conducting oxygen or air. Given the minor difference, and the fact that the 882 patent stated that it could be used for fluids generally, it was relatively straightforward for Hughes J to conclude that the 882 patent was obvious over McDonald.

 McDonald patent

882 patent

Consequently, there was an important question as to whether the McDonald patent was part of relevant state of the art. On the facts, the answer was straightforward: “McDonald was not only findable but found by those interested in expandable hoses. There is no evidence to the contrary” [91].

Commercial success and motivation were argued as showing invention:

[144] There are a number of secondary factors that have been raised. There was motivation to create a simple, inexpensive garden hose that could be promoted in the direct retail market by television advertising and the like. It was a commercial success. But motivation and success alone do not mean that there was, in the objective sense, an invention. Khubani testified to that when he referred to items such as amber sunglasses and dust mops that had been available for years but were great successes in the direct retail environment.

The inventor of the 882 patent did not begin his research by doing a search of the patent prior art, and apparently the same is true of garden hose designers in general. If they had, the patentee’s solution would have been arrived at sooner. The notional skilled person is probably not as clever as real-world inventors, but she may sometimes be better informed about the prior art.

Note that the costs awarded to the defendant were reduced because it had raised too many issues on which they were unsuccessful. This is a message from Hughes J that the case should be restricted to the real issues [162].