Tuesday, January 21, 2020

A Scintilla of Utility for a Mechanical Invention

Seedlings Life Science Ventures, LLC v Pfizer Canada ULC 2020 FC 1 Grammond J
             2,486,935 / Auto-Injection of Medication

This post will discuss novelty, where, with respect, I feel Grammond J’s analysis went astray, as well as utility, where the decision provides a good illustration of what constitutes a “scintilla” of utility in the context of a mechanical invention. The facts are summarized here.

Novelty requires enabling disclosure of the claimed invention in the prior art: Sanofi 2008 SCC 61 [24]-[28]. This is a two-step test, and both steps must be satisfied for the claim to be anticipated. To satisfy the first step, disclosure, “the matter relied upon as prior art must disclose subject-matter which, if performed, would necessarily result in an infringement of the patent”: Synthon [2005] UKHL 59 [22]; Sanofi [25]. At this stage “[n]o trial and error is permitted”: Sanofi [32]. Without disclosure, there is no anticipation. If the disclosure requirement is satisfied, the second stage, enablement, requires that “the ordinary skilled person would have been able to perform the invention which satisfies the requirement of disclosure”: Synthon [26]. The enablement requirement is satisfied so long as the skilled person could perform the invention without undue burden”: Synthon [29] The stages are distinct. This is important because, as the SCC noted in Sanofi [27], “While trial and error experimentation is permitted at the enablement stage, it is not at the disclosure stage.” Lord Hoffmann explained in Synthon:

[30] [T]here is a serious risk of confusion if the two requirements are not kept distinct. For example, I have explained that for the purpose of disclosure, the prior art must disclose an invention which, if performed, would necessarily infringe the patent. It is not enough to say that, given the prior art, the person skilled in the art would without undue burden be able to come up with an invention which infringed the patent. But once the very subject-matter of the invention has been disclosed by the prior art and the question is whether it was enabled, the person skilled in the art is assumed to be willing to make trial and error experiments to get it to work. If, therefore, one asks whether some degree of experimentation is to be assumed, it is very important to know whether one is talking about disclosure or about enablement.

While Grammond J acknowledged the two-step nature of the test for enablement [106]-[109], he did not address the steps separately when it came to assessing novelty on the facts, and, with respect, he appears to have made the error that Lord Hoffmann cautioned against.

For example, with respect to claim 57, Grammond J held as follows:

[132] [The expert for Seedlings] argues that claim 57 is not anticipated, because its distinctive element is that “the needle shield extends beyond the forward end of the housing when the device is in its retracted storage configuration” and the needle shield of the ‘369 patent is flush with the housing. I agree with [the expert for Pfizer], however, that it would be within the common general knowledge of the skilled person to extend the needle beyond the housing without undue burden. Thus, I find that claim 57 is also anticipated.

The difficulty is that this analysis skips directly to considering undue burden, which arises only at the enablement stage, without first considering whether the claimed invention was disclosed. If the “distinctive element” of claim 57 is not present in the prior art, then it is not disclosed, because: “At this stage, there is no room for trial and error or experimentation by the skilled person. He is simply reading the prior patent for the purposes of understanding it”: Sanofi [25]. The disclosure requirement is therefore not satisfied, and consequently, the claim is not anticipated, regardless of how the enablement question is answered. Moreover, the enablement question is aimed at the same prior art that is the subject of the disclosure inquiry: the question is whether “the ordinary skilled person would have been able to perform the invention which satisfies the requirement of disclosure.” The question on enablement is whether the skilled person would have been able to perform the prior art without undue burden, not whether the skilled person would have been able to perform the claimed invention without undue burden. Grammond J appears to have run the two stages together by asking whether the claimed invention might have been derived from the prior art without undue effort, without first asking whether it was disclosed. The analysis of claims 44 and 47 [125], [127], and claims 45 and 46 [131], appears to take the same approach.

Utility is assessed at the Canadian filing date. By that time, a prototype of the invention falling within the claims had been fired four times, once with no needle or liquid, and three times with a needle and a syringe full of water. Two of these latter three tests were successful, but on the third attempt, the glass syringe broke:[156]-[160]. (More rigorous tests conducted soon after filing had a similarly uneven success rate: [161].) Grammond J held this was sufficient to establish demonstrated utility, given the low bar of a “scintilla of utility”: [151], [160]. Grammond J emphasized that a prototype that needs improvement and works imperfectly may nonetheless demonstrate utility: [162]. This was even though the prototype could not have been used to inject epinephrine in an emergency situation: [163]. Grammond J held that holding it to that standard, of the ultimate intended commercial application, would be to invoke the discredited promise doctrine. AstraZeneca 2017 SCC 36 has made it clear that the standard is much lower than that: “The use of the invention to inject medication other than epinephrine is not tantamount to using it ‘as a paperweight’”: [163].

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