Lilly, Regeneron and a puzzling point: can you help?

Yesterday saw a parade of blogposts from all three of the current batch of guest Kats. Today the IPKat is delighted to host this post from a former, and highly distinguished guest Kat, Professor Norman Siebrasse. This Kat will be even more delighted if his talented crop of patent-wise readers can assist Norman in resolve a utility-related puzzle that is currently exercising him. Writes Norman:
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 herehave 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 JAI the 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

Lilly, Regeneron and a puzzling point: can you help? Lilly, Regeneron and a puzzling point: can you help? Reviewed by Jeremy on Thursday, July 04, 2013 Rating: 5


Anonymous said...

The best patent attorneys I know do not take EPO and UK case law too seriously, and certainly they do not look for consistency. In HGS v Lilly the Supreme Court summarised 15 'general principles' (para 107) that could be derived from the EPO case law on how much data needs to be in the patent specification. It does not make sense to have so many general principles. Really the EPO was deciding each case on its own merit and then justifying the decision based on some principle they came up with at the time. So T1329/04 should not be taken too seriously. It simply matched the facts of that case.

Anonymous said...

The law only appears inconsistent if you consider Conor to be good law. To all with a plurality of brain cells the decision is utterly ridiculous. Still, ours is not to reason why.

MaxDrei said...

It is my impression, from the Conor and HGS decisions of the supreme court, that it is too quick to bend before the weight of the EPO jurisprudence, out of a misguided idea of what is needed, to foster "harmony" under the EPC.

In both cases, I think the SC missed a chance, and in both decisions got it wrong, in disagreeing with their learned and specialist patents judges below.

The UK supreme court has a duty to pilot the EPO through the shoals of obviousness and utility. Many at the EPO look to the UK SC to do exactly that. For the EPO, the infringer is deemed not to exist. When was the last time that the EPO had to balance the interests of opposed litigants, one the patent owner and the other the party accused of infringement of the claim in suit?

The UK SC judges are the only ones who can reconcile domestic UK law with that of the EBA. They have the eloquence to explain the true legal line, for use by those members of DG3 who are striving to bring the EBA around to the best line. The EBA needs robust decisions from the SC, as a means of testing the rigour of its own caselaw.

Anonymous said...

In response to MaxDrei: I attended Oral Proceedings at the EPO shortly after the UK Conor decision came out. None of the members of the Examining Division had heard about it (let alone read it), and they did not seem to think that they needed to know about patent decisions from national courts. I therefore think that the UK Supreme Court has little influence at the EPO.

MaxDrei said...

Anonymous, I do not doubt what you write but do not find it conclusive.

Civil law does not work like common law. There is no Binding Precedent. Instead there is Darwinian competition between legal lines of thought, debated between commentators of influence, with only the fittest line of logic surviving. It is what the commentators write, what the published learned papers argue, what the textbooks include, that carries weight.

Take claim construction, for example. How to understand Art 69, EPC. Note how Germany's Supreme Court digested the three Improver questions, fell in line, and was left feeling let down by England, when SCOTUK later backed away from its own three hitherto essential questions.

I can assure you, that the line of legal logic coming out of SCOTUK is noted with interest by those patent jurists on The Continent who like arguing, and has a power to persuade them which is in proportion to the power of its legal logic.

This process of influence does take quite a long time though.

But what I am writing is no more than my personal experience, based in Munich. Readers, if you have a different impression, do comment further, please.

Norman said...

Max Drei,

I was hoping that you would comment on this post. Perhaps I can ask a follow-up question. I agree that Conor was wrongly decided by the UKHL. As I understand the patent and the decisions below, the patentees believed they had discovered the use of an anti-angiogenics eluting stents for preventing restenosis. They had not; the Wolff prior art in particular disclosed the same concept. The patentees ultimately narrowed the claim to taxol on stents. The patentees had specifically mentioned taxol, while Wolff had not. However, so far as I can tell, at the time of the application the patentees had no reason to believe that taxol was particularly effective. That being so, the claim to taxol was an arbitrary selection from the general class of anti-angiogenics, and so should be invalid for obviousness. As Jacob LJ put t: “Just to name one "other" anti-replicate which, on the information given in the patent, is no more and no less likely to be found to work in practice is not to make an invention. Things would be different, of course, if the patentee had _disclosed_ that in some way "taxol" was different, or better, or one of only a few anti-proliferatives that would work. . . . He would have made and disclosed a valuable selection from the range of possible anti-mitotics.” My question is this: in EPO practice, would it be sufficient to have disclosed that taxol is particularly effective, or it is necessary that the to have the experimental data supporting that conclusion in the patent itself. Suppose the application had said, “Anti-angiogenic drug-eluting stents are known, but we have discovered that taxol is 100 times more effective than any previously known anti-angiogenic,” but the application did not provide any data to support this statement. Then, during prosecution, the applicant have provided ample pre-filing evidence to support that statement, that might have been included in the original application, but was not. Would that application be refused for the reason that the data had not been provided in the patent itself? It seems to me that upholding the validity of such a patent be consistent with Jacob LJ’s decision in Conor, since he said only that the application must disclose “in some way” that taxol was different. He did not say that the data itself must be disclosed.

MaxDrei said...

Norman, I'm flattered by your note to me, because I'm most definitely not an expert. Like you, I am using these columns only to tease interesting answers out of others, and learn from them. I post under a pseudonym because I do not want my clients to see how weak is my grasp of the law.

But to your question, I think Conor prevailed over Wolff because he had in his appln, right from the outset, a claim to taxol and an example using taxol. For EWHL and DG3, this was enough to i) express a preference for taxol and ii) render it "plausible" that taxol solves the relevant objective problem. The later-filed evidence merely confirmed what the appln as filed had already promised.

My uneasiness is because nowhere in the appln as filed does the Applicant hint or suggest that taxol will work better than anything else within the ambit of the claims as filed. On the contrary, the burden of the A publication is that "They all work" or that "Taxol is no better than any of the others". Nevertheless, Conor gets a patent for giving to the public a non-obvious contribution to the art, a "selection" of taxol out from everything else, the proposition that "taxol works, but nothing else does". I think this is an invention that Conor had still not made at the filing date. I think the prosecution amendment enabled the Applicant unfairly to improve its position over what it had at the filing date. There is an Art 123(2) issue here, I think, but for the EPO taxol is there in the appln as filed, the Example and the claim, so no chance of prevailing on Art 123(2).

As I say, I think EWHC and EWCA got it right, and EWHL took the politically correct route. It still grieves me that the specialist patent judges were dumped on.

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