Richter Gedeon Vegyeszeti Gyar RT v Generics (UK) Ltd (t/a Mylan) [2016] EWCA Civ 410

Case No A3/2014/2161

[2016] EWCA Civ 410

IN THE COURT OF APPEAL (CIVIL DIVISION)

[2014] EWHC 1666 (Pat)

ON APPEAL FROM The High Court of Justice

Chancery Division

Patents Court

The Hon Mr Justice Sales

Venue Royal Courts of Justice, Strand, London, WC2A 2LL

Date 26/04/2016

Before

LORD JUSTICE FLOYD

MR JUSTICE ARNOLD

SIR ROBIN JACOB

Between

RICHTER GEDEON VEGYESZETI GYAR RTAppellant

GENERICS (UK) LIMITED (t/a Mylan)Respondent

Michael Silverleaf QC and Lindsay Lane (instructed by Bristows LLP) for Appellant

Piers Acland QC (instructed by Innovate Legal) for Respondent

Hearing Hearing date: 23 rd February 2016

Judgment

SIR ROBIN JACOB (giving the first judgment at the invitation of Floyd LJ):

[1]For the last time, with some sadness, I have pressed the “Start New Civil Appeals Judgment” button of the judgment template.

[2]The patentee, Gedeon, appeal from the judgment of Sales J of 22nd May 2014 (

[2014] EWHC 1666 (Pat)

) whereby he held that its EP Patent 1 448 207 (UK) was invalid for obviousness.

Jurisdiction to hear the appeal

[3]The Judge initially, and then Kitchin LJ on the papers, refused permission to appeal. But Vos LJ, on a renewed oral application, granted limited permission confined to a single point set out in his order (the “permanent form point”). When we came to read the papers it seemed to us possible that the point actually argued in Gedeon’s skeleton argument (“the illegitimate to ask point”) was outwith that limited permission. At the outset we raised this with Mr Silverleaf (for Gedeon) because it was a matter potentially going to our jurisdiction, see James v Baily Gibson

[2002] EWCA Civ 1690

[4]Mr Silverleaf showed us a letter from the Court stating that Vos LJ had “approved the Appellant’s redrafted Grounds of Appeal and skeleton argument”. In those circumstances it seemed to us that either Vos LJ’s order had been drawn up too narrowly and was open to amendment or should be read more widely than seemed at first sight. Either way we would have jurisdiction to entertain the point to be argued. We accordingly proceeded to do so. Mr Acland (for Generics) did not challenge that course of action.

The facts

[5]Claim 1 of the patent reads: Pharmaceutical composition as single application dose, characterized by containing 1.5 + 0.2 mg of levonorgestrel as active ingredient in admixture with known excipients, diluents, flavoring or aromatising agents, stabilizers, as well as formulation-promoting or formulation-providing additives, commonly used in the pharmaceutical practice.

[6]Levonorgestrel was already known as an emergency post-coital contraceptive. But it was administered in two doses of 0.75mg taken 12 hours apart after intercourse. The contribution of the patent was for a single double dose. Clearly that has significant compliance advantages.

[7]If it was inventive to appreciate that a single double dose would do as well as two doses separated by twelve hours then the patent would be good. But the Judge held it was not. He held it was obvious from a prior publication of a paper by Professor Stephen Killick (“Killick”) published in Gynaecology Forum, Congress Issue, dated 27 November 2000. The Judge described the document as “a leading journal in the field” but it is more in the nature of a newsletter and would not naturally have been peer reviewed. It was published a year before the priority date of the patent, 27th November 2001.

[8]Killick is a report of a presentation at a conference in which the work of the World Health Organisation on emergency contraception was described by some researchers. Killick reports that they had disclosed the partial result of an ongoing trial.

[9]That trial consisted of three regimens, a two dose levonorgestrel regimen, a single dose levonorgestrel regimen and a mifepristone regimen. The results showed, albeit provisionally, that they did not significantly differ one from another.

[10]Killick reports, three times, that the dose of levonorgestrel used in the single dose regimen was 1.5g. The patent claim, however, specifies 1.5mg – a thousandth of the dose stated in Killick double the individual dose used in the known two-dose regimen. The evidence established that a person skilled in the art would clearly realise that there was a mistake in Killick – a 1.5g dose was too massive to be credible. But the evidence did not go so far as to establish that the skilled person would appreciate what the dose used in the trial of the single dose regimen of levonorgestrel actually was. The document cannot be read as actually disclosing a 1.5mg dose.

[11]So the skilled person would see that there was a dose which could be used for a once only regimen and was apparently as good as the known two-dose regimen but he/she would not know what that dose was.

[12]The Judge held (there is no challenge on the facts) that to the notional person skilled in the art, having appreciated the mistake: 32 …..It would have been obvious that the dose amount was suspect, and a clinician wishing to understand what was being reported in the Killick article would have thought that the obviously sensible course would be to get in touch with him (or with those identified as having made the presentation in September 2000) to check on the true amount. Had anyone done this, there is little doubt that he (or they) would have checked with Dr von Hertzen and would have reverted with a correction and the information that the true dose amount for the single dose regimen which was the subject of the research was 1.5 mg of levonorgestrel.

[13]Thus, held the judge, the true dose was obvious because the skilled person would, without invention, be able to ascertain it and would have an incentive to do so. The “permanent form” point.

[14]This was not pursued in oral argument before us but was advanced before Vos LJ. He described it thus:

“if material that is an important part of prior art is not anywhere written down, then it can be said that it is not sufficient for the purpose of the application of an obviousness test.”

[15]I am not surprised that the point was not pursued in the oral argument. It has been established English law since at least Humpherson v Syer

(1887) 4 RPC 407

. The Court of Appeal, reversing Kekewich J (again – it was a regular thing in those days!), held that an oral prior disclosure could be relied upon as prior art: “Was Widmer a person free in law and equity to use the information as he pleased?” asked Bowen LJ at p.413. That nothing was written down and that the information was potentially ephemeral (suppose Widmer died?) was irrelevant.

[16]That rule is clearly also part of modern EPC law. Article 54(2) provides: The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application. An “oral description,” the evidence of which is inherently potentially ephemeral, is enough as a basis for an attack of lack of novelty or obviousness. The Widmer question matters as much now and for the same reason and purpose as it did in the nineteenth century.

The illegitimate to ask point

[17]Mr Silverleaf contended that the Judge had erred in law, that he had “permitted the notional skilled person to ‘don the mantle’ [I prefer anorak] of a real person”. This would mean substituting the private knowledge of a third party to that of the skilled person.

[18]The proper approach, submitted Mr Silverleaf, is to decide what the common general knowledge of the person skilled in the art was, to read the cited document with that knowledge and to ask whether the invention was obvious. The exercise is limited to that which is entirely cerebral.

[19]If one goes further, and considers whether, having read the documents, the skilled person would ask someone else, Mr Silverleaf submitted one is really extending the common general knowledge to include the knowledge of a third person. The invention is not obvious in the light of the actual common general knowledge of the skilled person alone.

[20]Mr Silverleaf accepted, as he had to, that not everything to be taken into account when assessing obviousness had to be notionally in the head of the notional person. In particular it is well established that the notional person may, where it is obvious to do so, consult a reference work. For instance if, for some reason he needed to know the co-efficient of expansion of brass, he could look it up and would know where to do so.

[21]Arnold J summed it up in KCI v Smith & Nephew

[2010] EWHC 1487 (Pat)

[2010] FSR 31

at [112] in a passage which was approved by this Court on appeal

[2010] EWCA Civ 1260

[2011] FSR 8

at [6]:

“… even if information is neither disclosed by a specific item of prior art nor common general knowledge, it may nevertheless be taken into account as part of a case of obviousness if it is proved that the skilled person faced with the problem to which the patent is addressed would acquire that information as a matter of routine. For example, if the problem is how to formulate a particular pharmaceutical substance for administration to patients, then it may be shown that the skilled formulator would as a matter of routine start by ascertaining certain physical and chemical properties of that substance (e.g. its aqueous solubility) from the literature or by routine testing. If so, it is legitimate to take that information into account when assessing the obviousness of a particular formulation. But that is because it is obvious for the skilled person to obtain the information, not because it is common general knowledge.”

[22]Mr Silverleaf sought to characterise the sort of information which a person skilled in the art would know he could look up as a “species of or extension of … common general knowledge.” But that is not correct– as Arnold J made clear. It will be taken into account for an obviousness assessment not because it is in the notional head of the notional person but because it would be obvious to such a person to look it up.

[23]I cannot see any logical distinction between a case where it obvious to look something up and one where it is obvious to ask and clear that the answer would be given and would be clear. The notional asking is exactly equivalent to the notional looking up. In both cases the prior art spurs the action of finding out in a non-inventive way.

[24]Nor am I impressed with Mr Silverleaf’s suggestion that the Judge was wrong to attribute the likely action of a real person with that of a notional person. On the contrary the notional person, hampered by lack of any spark of inventive capacity, will act in the same way as real people provided that action involves no imagination. Ringing up a man who you know knows is clearly not inventive.

[25]Accordingly I think Mr Silverleaf’s attack on the judgment fails and I would dismiss this appeal.

[26]I only add a word of caution. The facts here are unusual – a clearly obvious error, a clear source to ask what the correct figure was and a clear finding not only that an answer would be given but that it would be unambiguous. It does not follow that the “skilled man would ask” route to obviousness would follow for cases where the facts are not so precise or sure. Mr

Justice Arnold:

[27]I agree.

Lord Justice Floyd:

[28]Mr Silverleaf QC argues that the Judge took an illegitimate approach, because he accepted the respondent’s argument that one could supplement the disclosure of Killick with the result of an enquiry which the skilled person would make. Although the Judge found that the correct dosage used in the trial had been made available to the public at the conference itself, the respondent was not relying on that oral disclosure, but on what was disclosed in the written report in Gynaecology Forum, supplemented by the response to a notional enquiry made of the author or the presenter. That was impermissible.

[29]Mr Silverleaf would be right in the context of an attack based only on lack of novelty. The absence of the correct dosage in Killick means that the invention is novel over Killick, and one cannot make Killick disclose something which it does not. Obviousness is, however, concerned with what the skilled person would do in the light of disclosure comprised in the state of the art. For that reason it is not concerned only with what is in the state of the art. What the skilled person would do in the light of the state of the art is a pure question of fact, which is not constrained by any special rule of law, other than that the skilled person is incapable of invention. The skilled person would plainly not be able to obtain information which was confidential, or which required insight or undue effort to uncover, or which he or she would not know where to find. But where it is established that the skilled person would have been prompted by the state of the art to ask for a specific piece of information from a source which would be obvious, and that the information requested would have been freely given, a finding of lack of inventive step is, as it was here, properly open. The case is no different from one where the skilled person would have to perform routine tests with a drug in order to arrive at a claimed pharmaceutical formulation or dosage range. There is no requirement that the results of those tests should have been prior published, far less that they be common general knowledge.

[30]For those reasons, which accord entirely with those given by Sir Robin Jacob and with which I agree, I too would dismiss the appeal. I hope I will be permitted to add, given what he says in the first paragraph of his judgment, that all those who have practised in this field of law are very greatly indebted to him for sharing with us, in the vast number of so clearly expressed judgments which he has drafted on that template, his great depth of learning in this subject.