Lilly, Regeneron and a puzzling point: can you help?
Some dicta in the recent decisions in Lilly v JAI [2013] EWHC 1737 (Pat) [noted by the IPKat here] and Regeneron v Genentech [2013] EWCA Civ 93 [noted by the IPKat here] have me puzzling over a point of European law that is relevant to a current controversy in Canada.
In the Canadian law of pharmaceutical patents, there is a controversial requirement that, in certain circumstances, data supporting utility must be disclosed in the patent itself (see here). I had understood that this was generally not required in Europe. In Conor v Angiotech [2008] UKHL 49 [noted by the IPKat here] the question was whether it was obvious to use a taxol-coated stent for preventing restenosis. This indirectly raised disclosure of utility, as counsel for the defendant sought to argue that the disclosure was inadequate on the basis that the specification “did not contain information about human or animal tests which showed that it would work or provide enough information about doses and so forth to enable the skilled person to work it” [18]. The House of Lords dismissed this argument [19]:
There is no requirement in the EPC or the statute that the specification must demonstrate by experiment that the invention will work or explain why it will work. As the [ District Court of The Hague] said (at paragraph 4.17):"... it is not required in the view of the court that experimental data concerning such use of taxol stents in humans and the actual prevention of restenosis be included in the patent to further substantiate [the claim]."
In Regeneron at [103] the EWCA remarked, that in the case of a claim to a therapeutical use, the patentee “must show, for example by appropriate experiments, that the product has an effect on a disease process so as to make the claimed therapeutic effect plausible.” That in itself is not at all inconsistent with Conor v Angiotech, but the Court went on to quote Salk T609/02, which made it very clear that the information regarding therapeutic efficacy must be provided in the patent itself – “It is required that the patent provides some information in the form of, for example, experimental tests, to the avail that the claimed compound has a direct effect [on the disease]” – because “Sufficiency of disclosure must be satisfied at the effective date of the patent, ie on the basis of the information in the patent application together with the common general knowledge then available to the skilled person” [8].
That statement is true, but the real question is whether the disclosure of data supporting therapeutic utility is a question of sufficiency. The applicant in Salk argued that the disclosure was sufficient if the patent disclosed the use (it did) and disclosed how to make the compounds (it did), and that the compounds did in fact work (they did, though this was proven by post-filing experiments), so that a person following the directions in the patent would in fact treat the disease.
While the precise legal issue was different, I find this reasoning in Salk very difficult to reconcile with the statement in Conor that “There is no requirement in the EPC or the statute that the specification must demonstrate by experiment that the invention will work.” My own view is that the applicant in Salk was right and the issue is not really one of sufficiency. In Salk there was no pre-filing evidence at all of the utility of the invention, and I think that it could have been decided on the basis that post-published evidence “may not serve as the sole basis to establish that the application solves indeed the problem it purports to solve” (T 1329/04, quoted in HGS v Lilly [2011] UKSC 51 [50] [noted by the IPKat here]. The Board’s assertion that the data had to be in the application itself was a direct response to the applicant’s attempt to rely on post-published evidence to establish therapeutic effect, and not a response to reliance on evidence from outside the application. In Regeneron the data in the patent did provide the necessary basis, and in Lilly v JAIthe claimed invention simply did not work at all across the full scope of the claim, so both of these cases would have been decided the same way even if we take the statement in Conor at face value.
So, my question is this: can any readers point me to any European decisions in which there was good pre-filing evidence that the invention worked, and yet the patent was held to be invalid on the basis that that evidence was not disclosed in the patent itself?Puzzles here, here and here
Monkey puzzle here
Puzzles and Dragons here
