Tuesday, November 8, 2011

Post-Published Evidence in Europe

Human Genome Sciences Inc v Eli Lilly & Co [2011] UKSC 51 rev’g [2010] EWCA Civ 33 aff’g [2008] EWHC 1903 (Pat)

In HGS v Eli Lilly the UKSC, relying on case law of the EPO Technical Board of Appeal, held that post-filing evidence may be used to confirm the utility of a claimed invention, though such evidence cannot be the sole basis for establishing utility: [107(ix)]. The point is made most clearly in the TBA decision in T 0898/05 Hematopoietic receptor/ZymoGenetics:

Admittedly, no experimental evidence for the suggested role of the receptor and/or its ligands is made available in the application. Later evidence, however, confirmed this sort of "educated guess", which the examining division considered to be - in its own words - "reasonably credible".

(Note that the UKSC and the TBA in T 0898/05 refer to this as “later evidence,” but the TBA normally uses the term “post-published” evidence, as did Jacob LJ in the EWCA.)

The TBA case law is quite consistent on this point. Of the cases reviewed by the UKSC and EWCA in HGS v Lilly, T 0898/05 ZymoGenetics, T 1165/06 IL-17 related polypeptide/Schering, and T 0018/09 Neutrokine/Human Genome Sciences all rely on post-published evidence to establish that the claimed invention did indeed have the utility asserted in the patent. In some cases that evidence was published years after the filing date. Two more cases, T 0870/04 and T 1452/06 consider post-published evidence, though conclude it was not helpful on the facts. The case most hostile to post-published evidence was T 1329/04 Factor- 9/John Hopkins [sic] but even there the TBA did not dismiss such evidence outright, but said only at [12] that “even if supplementary post-published evidence may in the proper circumstances also be taken into consideration, it may not serve as the sole basis to establish that the application solves indeed the problem it purports to solve.”

This is contrary to Canadian law. As the Binnie J said for the Court in Wellcome / AZT 2002 SCC 77, at [46]:

Nor, in my view, is it enough for a patent owner to be able to buttress speculation with post-patent proof, and thereby to turn dross into gold. Utility is an essential part of the definition of an "invention" (Patent Act, s. 2). A policy of patent first and litigate later unfairly puts the onus of proof on the attackers to prove invalidity, without the patent owner's ever being put in a position to establish validity. Unless the inventor is in a position to establish utility as of the time the patent is applied for, on the basis of either demonstration or sound prediction, the Commissioner "by law" is required to refuse the patent (Patent Act, s. 40).

It should be noted that the TBA expressed similar views in T 1329/04 John Hopkins at [12], as did Jacob LJ in the EWCA at [92]. However, in light of the EPO case law, neither the Board nor Jacob LJ felt it possible to reject the use of such evidence entirely, and both instead stated that its use must be confined to confirming a use already stated in the specification. This point was also confirmed by the UKSC. Even with this caveat, the use of post-published evidence in Europe clearly goes far beyond what is permitted in Canada.

We should also note that in Genetics Institute, LLC v Novartis Vaccines & Diagnostics, Inc 655 F.3d 1291 (Fed Cir) the US Federal Circuit Court of Appeals has recently allowed the use of confirmatory post-filing evidence in the context of an obviousness determination: “the district court did not err in its nonobviousness analysis by considering, as evidence of unexpected results, the ability of the claimed proteins to bind vWF, even if, as Genetics contends, the role of the a3 region was not appreciated as of the ´620 patent's priority date.” Note that T 1329/04 was also a decision on inventive step, so appears that in the EPO the use of post-published evidence is not confined to the question of industrial application.

Given the SCC’s clear holding in Wellcome / AZT, the expanded use of post-published evidence in the UK, the EPO and the Federal Circuit is unlikely to have an immediate or direct impact in Canadian law. And I must say that the policy reasons for permitting the use of post-published evidence are not clear to me; they were not discussed at all in any of the EPO decisions, or in the Federal Circuit decision in Genetics v Novartis. I would speculate that this trend may be linked to the substantive view that a new molecule of undoubted medical interest should satisfy the utility requirement per se, regardless of how much is known of its particular use; alternatively, it may reflect an unease with allowing a challenge based on lack of utility against a drug that, at the time of litigation, is known to be very useful and valuable.

Whatever its explanation, the trend in other jurisdictions in favour of post-published evidence may have an indirect effect in Canadian law. Even though the European position is unlikely to be adopted in Canada, it may have a moderating effect on the law as recently developed in the Federal Courts, which is that the factual basis for sound prediction must be disclosed in the patent itself. A middle ground between these two extremes is that the evidence must exist at the relevant date, even though it is not all disclosed in the specification. And after all, that was the law applied by Wetston J at trial in the decision that was ultimately upheld by the SCC in Wellcome / AZT.

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