2,261,630 / infliximab / INFLECTRA
Locke JA, for the Court of Appeal, held that Phelan J had erred in his novelty analysis [71], and remanded the issue to him for reconsideration [75]. The issue is very interesting and raises a fundamental question regarding the nature of novelty: is an invention anticipated if the prior art suggests that the invention be made, but it has not actually been made as of the claim date?
Kennedy Trust’s 630 patent relates to the treatment of rheumatoid arthritis [RA]. RA is an autoimmune disorder that leads to painful and sometimes debilitating inflammation of the joints. The use of methotrexate [MTX] was well known in the prior art as a treatment for RA, but many patients with RA do not respond completely to treatment with MTX alone and there was therefore a pressing need for an improved treatment. Cytokines are proteins that serve as chemical messengers in the body, and researchers had discovered a number of pro-inflammatory cytokines in tissue samples from rheumatoid joints. It was hypothesized that RA might be treated by blocking the action of the relevant cytokines, thereby suppressing the inflammatory response. The inventors of the 630 patent discovered that TNF-α was a key cytokine that “sat at the apex of an inflammatory cascade.” Centocor (a predecessor to Janssen) had developed infliximab, an anti-TNF-α monoclonal antibody. The inventors of the 630 patent collaborated with Centocor to explore the use of infliximab as a treament for RA. While patients initially responded, the duration of the effect was limited and the patients all relapsed. The inventors then decided to try infliximab in combination with MTX. Trials established that the combination of MTX and infliximab has enhanced efficacy over either drug alone as well as a sustained duration of effect [7]-[8], [FC 9-15].
The successful trials led to the 630 patent. Claim 1 is to the adjunctive use of an anti-TNF-α antibody and MTX for the treatment of rheumatoid arthritis in patients who do not respond fully to MTX alone [FC Appendix B]. Claim 3 of the patent is to the adjunctive use of infliximab in particular, in combination with MTX for the same purpose [FC Appendix B].
Hospira argued that the 630 patent was anticipated by a number of prior art documents and Phelan J had rejected all these attacks [FC 196]. Only two prior art documents were at issue on appeal. One was the “1994 Kennedy Report,” which stated as follows [68]:
The aim is to further investigate the tolerability and efficacy of repeated use of
[infliximab] in a randomised, blinded fashion, both in comparison with standard therapy
[MTX] and in combination with this drug. It is expected that the results will be available
by autumn 1995 and should provide an indication of the likely utility of [infliximab] as a
long-term disease suppressing agent in clinical practice.
At the claim date, as the clinical trial was not complete and there were no results [FC 169]. In effect, the 1994 Kennedy Report identified the essential elements of the Claim 3 and says “We are trying this.”
The second item of prior art was Higgins, which “discloses the possibility of combining an anti-TNF-α antibody with MTX” [69]. In effect, Higgins disclosed the essential elements of Claim 1 and suggested “Someone should try this.” The Kennedy Report and Higgins were slightly different, but neither Phelan J nor Locke JA suggested that anything turned on the fact that the trial referred to in the Kennedy Report was actually in progress, and that it was being undertaken by the authors of the report, rather than being a suggestion to others, as in Higgins.
So, the question boils down to this: is an invention anticipated by a prior art document saying “Someone should try X,” where X is the invention?
Phelan J dismissed these prior art references as being speculative [167], [191]. In my post on his decision, I agreed with that conclusion. I must say that I am still inclined to think that Phelan J was right, but the point is not an easy one.
In holding that the Kennedy Report and Higgins did not anticipate, Phelan J emphasized that these documents did not disclose the “special advantage” of the combination: [FC 169], [FC 172] re Kennedy Report, [FC 179] re Higgins. Locke JA noted that for anticipation “there is no requirement for any particular results, including the kind of results described by the Judge as the special advantage” [72]. The special advantages themselves were not an element of the claims, which were simply to the adjunctive use of infliximab and MTX [71]. So, it is clear that if infliximab and MTX had actually been used in combination to treat RA in patients who did not respond to MTX alone, then Claim 3 would be anticipated even if the treating physician did not realize that the combination was much more effective than the sum of the individual effects. To the extent that Phelan J’s holding was dependent on this point, he erred.
On another point, Higgins refers not to infliximab, but to a different anti-TNF-α antibody (“CDP1571”). Phelan J stated that “[Higgins] does not disclose the possibility of combining infliximab with MTX and therefore fails at the first stage of the Sanofi analysis” [FC 196(b)]. But as Locke JA pointed out, “[e]ach claim should be considered separately” [71]. Higgins did not anticipate Claim 3 because it does not refer to infliximab, but Claim 1 is a different issue.
More generally, Phelan J remarked that Higgins did not disclose “a multitude of other elements of the 630 Patent” [FC 196(b)]. Locke JA noted that this was all beside the point unless these other elements were essential [71], [72]. This failure to consider the specific essential elements of the claim was the main thrust of Locke JA’s criticism of Phelan J’s reasons [71], [72].
Locke JA’s points are all well-taken and they reflect weaknesses in Phelan J’s analysis. But they do not directly address what seems to me to have been driving Phelan J’s conclusions, namely the fact that the prior art documents were all just suggestions [167]. I suspect that’s why Phelan J wasn’t as precise as he might have been as to which claim he was addressing and what the essential elements were of each claim; it is all irrelevant if the prior art does not anticipate because it is speculative.
This brings us back the main question: is X anticipated by the suggestion “Someone should try X”? If I walk outside my house right now and shout to the world “Someone should try the combination of CBD and oregano oil as a treatment of Alzheimer’s” and it turns out to actually work, have I thereby anticipated that invention? Surely the answer must be no. I think that would be so even if the combination is actually easy to make and administer effectively. The point therefore strikes me as being one of the disclosure requirement, rather than enablement.
What is the basis for distinguishing my wild statement from the statements in the Kennedy Report and Higgins? No doubt those suggestions had a better foundation than my suggestion about CBD and oregano oil (though my mother would swear that oregano oil is a cure for everything). But the fact that they had some kind of reasonable basis for the suggestion does strike me as an adequate basis for distinguishing them in terms of novelty. That their suggestions might have been taken seriously by a skilled person is certainly relevant to obviousness, but novelty goes to what has actually been done, not that which might be done.
Locke JA remarked that the quoted paragraph from the 1994 Kennedy Report “appears to point the reader to precisely the kind of improvement that would occur from the claimed adjunctive therapy” [72]. But in a famous phrase from General Tire [1972] RPC 457, 485-86, “A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.” This remains good law in Canada in respect of anticipation: Free World 2000 SCC 66 [26]; Sanofi 2008 SCC 61, [20].
More generally, in Hill v Evans, (1862) 45 ER 1195 (Ch) at 1200, another decision of “unquestionable authority” (Sanofi [24]), Lord Westbury stated that “the information as to the alleged invention given by the prior publication must, for the purposes of practical utility, be equal to that given by the subsequent patent,” and “the prior knowledge of an invention to avoid a patent must be knowledge equal to that required to be given by a specification.” This point has since been repeated in almost every leading case on anticipation: see eg Halocarbon [1979] 2 SCR 929 at 947; Consolboard [1981] 1 SCR 504 at 534; Free World 2000 SCC 66 at [25]; Sanofi at [20]. A suggestion to try MTX and infliximab does not seem to me to be the practical equivalent of disclosing that the combination had been successfully tried. In Pope Appliance Corp v Spanish River Pulp and Paper (1929), 46 RPC 23 at 52, the Privy Council expressed the same test this way: “Would a man who was grappling with the problem solved by the Patent attacked, and having no knowledge of that Patent, if he had had the alleged anticipation in his hand, have said, ‘That gives me what I wish’?” In the case of the Kennedy Report, or Higgins, the answer must be “no.” Many suggestions had been made by many people. What was wanted by those grappling with the problem of MTX incomplete responders was not suggestions of routes the might be explored.
These are general statements of the principle underpinning anticipation. The test that is usually applied to implement the principle is, as Locke JA noted, that “[t]he disclosure requirement is satisfied if performing what is described in the prior art reference would necessarily result in infringement” [73]. The point was put slightly differently in Baker Petrolite 2002 FCA 158 [42.8]: “the novelty of a claimed invention is destroyed by the prior disclosure (by whatever means) of an embodiment which falls within the claim.” It seems to me that a suggestion that someone should try carrying out the invention is not an embodiment of the invention.
Now, another classic articulation of the rule is that “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], quoted with approval in Sanofi [25]. It is true that if the suggestion made by the Kennedy Report had been performed, it would have anticipated. But as used in Synthon, “if performed” does not mean that every suggestion in the prior art must be assumed to have been actually carried out. The conditional signals the hypothetical nature of the test, which asks whether the subject matter disclosed in the prior art would infringe if that which was actually carried out before the patent was granted, were to be carried out after the patent was granted. Suggesting that someone combine infliximab and MTX to treat RA would not infringe the 630 patent, even if the suggestion were made after the patent was granted. At most, it might be an element in inducing infringement, but the suggestion itself would not constitute direct infringement.
The patentee has the exclusive right to make, sell or use the invention, so it will be anticipated if the invention is made, sold or used before the claim date. Clearly neither the Kennedy Report nor Higgins used or sold the invention, so the question is whether they made it. An invention does not need to be physically made to anticipate; paper anticipation is enough. The question of what it means to make an invention “in the true sense of the word,” was at issue in the cases as to who was the first to invent under the old Act: see The Permutit Company v Borrowman, (1926) 43 RPC 356 (JCPC) at 359; Ernest Scragg & Sons (1964), [1964] ExCR 649, 675-77. It was clear law that “the date of the conception of the idea of an invention does not determine its date”; Scragg & Sons at 674. The classic test was set out by Viscount Cave LC in the leading case of The Permutit Company v Borrowman, at 359:
It is not enough for a man to say that an idea floated through his brain; he must at least
have reduced it to a definite and practical shape before he can be said to have invented a
process.
On the facts of Permutit, the date the Respondant had made the invention, which was for the use of greensand for the purpose of softening water, was unquestioned: “It is undisputed that in the month of November, 1913, he conceived the idea, that he then made some experiments for the purpose of testing it, that he actually made a few filters in which greensand was used
for the purpose of softening water and sold one of those filters to a friend.” The putative prior inventor, on the other hand, had the same idea, but he “did not test his idea; he made no experiments for that purpose; he did no work for that purpose.” While he “took a portion of greensand and carried it to his agent's office for the purpose of having it forwarded to parties in New York with the idea that they would do the necessary work and report to him,” that was not enough: “those parties. were unknown to him, that he heard nothing from them, and they made no report to him” (359). This is closely analogous to the Kennedy Report, and further along than Higgins. It is seems clear that neither the Kennedy Report nor Higgins would be considered to have made “in the true sense of the word,” the invention set out in any claim of the 630 patent. Of course, that was in the context of the first-to-make determination, not in the context of anticipation, but I see no reason why the same test should not apply. At the very least, given that the courts have given careful consideration to the question of what it means to “make” an invention, that case law should be followed absent some clear reason why the different context requires a different analysis.
In summary, there were some problems with Phelan J’s analysis, as pointed out by Locke JA. These issues featured prominently in Phelan J’s analysis, and it was not unfair of Locke JA to focus on them. Nonetheless, my sense is that Phelan J’s underlying concern, particularly as expressed at [167], was simply the speculative nature of the suggestions made in the prior art. I read Phelan J’s emphasis that the special advantages of the invention had not been disclosed as an indirect way of making the point that the invention had not been made. Similarly, if the prior art had not made anything at all which could be capable of anticipating, it did not really matter whether what was (not) made comprised any or all of the essential elements of the invention. And in any event, regardless of what Phelan J intended, it seems to me that his conclusion that the Kennedy Report and Higgins were not anticipatory can be supported on the basis that they did not establish that the invention had been made prior to the claim date, and not having been made, it could not have been “made known.”
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