Eli Lilly and Company (Respondent/Claimant) v Human Genome Sciences, Inc. (Appellant/ Defendant)
| Jurisdiction | England & Wales |
| Judge | Sir Robin Jacob,Lord Justice Hooper,And |
| Judgment Date | 05 September 2012 |
| Neutral Citation | [2012] EWCA Civ 1185 |
| Docket Number | Case No: A3/2008/2673 |
| Court | Court of Appeal (Civil Division) |
| Date | 05 September 2012 |
[2012] EWCA Civ 1185
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE CHANCERY DIVISION, PATENTS COURT
Mr Justice Kitchin
HC06 C02687
Royal Courts of Justice
Strand, London, WC2A 2LL
Lord Justice Hooper
Lord Justice Lewison
and
Sir Robin Jacob
Case No: A3/2008/2673
MR ANDREW WAUGH QC & MR MILES COPELAND (instructed by Field Fisher Waterhouse LLP) for the Respondent
MR SIMON THORLEY QC & MR MICHAEL TAPPIN QC (instructed by Powell Gilbert LLP) for the Appellant
Hearing dates : 3 – 4 July 2012
Sir Robin Jacob (giving the first judgment at the invitation of Lord Justice Hooper):
The Story so Far: the points we have to decide
Kitchin J held HGS's EP (UK) 0,939,804 invalid, [2008] EWHC 1903 (Pat). His principal grounds were that none of the claims were "susceptible," (Art. 57 EPC)—"capable" (s.1(1)(a) of the Patents Act 1977)—of industrial application and were obvious because the patent constituted mere speculation. The latter is the so-called AgrEvo ( T-0939/92) ground. He also held some of the claims were insufficient, others not. He rejected other attacks on the patent.
HGS appealed all the findings adverse to it and Lilly cross-appealed some of those adverse to it. This Court unanimously upheld Kitchin J on the question of industrial applicability and did not go on to consider other points, [2010] EWCA Civ 33.
The Supreme Court reversed that decision and held certain claims sufficient and valid, [2011] UKSC 51. The combined effect of its decision and those below, i.e. the position to date, is that:
a) All the claims are susceptible of industrial application;
b) All the claims are novel and inventive;
c) Claims 1 and 10 and their dependent claims are sufficient.
During the course of argument I wondered whether there was an AgrEvo point still open to Lilly. But Mr Thorley pointed out that in the Supreme Court it was conceded as standing or falling with the susceptibility of industrial application point. So an AgrEvo obviousness case was not a point that could now be taken and it was not.
The Supreme Court decision left over for determination three issues. They concern claims 13, 18 and 19. I here use the current numbering which arose as a result of the decision of the TBA. Kitchin J used the original numbering.
HGS appeals Kitchin J's finding that claims 18 and 19 (pharmaceutical and diagnostic compositions) are insufficient. Lilly appeals his finding that claim 13 is sufficient and that its amendment does not extend the protection it provides.
Commercially the really important claim is 13. At the time of the patent, neither the patentees nor anyone else, knew whether neutrokine-a or any of its antibodies or both would actually be valuable products. Claim 1 was to the isolated polynucleotide sequence for neutrokine-a (and variants of it). Claim 10 was to the polypeptide neutrokine-a and variants of it. None of these have proved valuable commercially.
But further research work by HGS and others, all of which was doubtless time-consuming, expensive and risky, has led to identification of specific antibodies to neutrokine-a which are promising. HGS in association with GSK have an antibody product for the treatment of lupus, Lilly an antibody product for the treatment of rheumatoid arthritis and multiple myeloma. We were told that Biogen and Genentech have potential antibody products too. These products, we were told, each have their own patents, as does HGS for its lupus product. Some may think that the evidence of this further substantial research work even in the face of HGS's patent belies the notion that failure to grant patent protection far upstream from a practical product would have a "chilling effect" on research. That is not for us to say.
Commercially therefore what is at stake is whether the inventors and developers of these "downstream" products have to pay tribute to HGS because it has the master claim to all neutrokine-a antibodies. We are not of course concerned with the amount of such tribute which may be payable. I say no more than that if it were to be determined pursuant to an application for a compulsory licence pursuant to s. 47 of the Patents Act 1977 the question would be what is a "reasonable term" fixing the amount payable and that the assessment of that might well include the degree of risk, expense and work incurred by the respective parties.
The sufficiency of claim 13
As now amended this reads:
An isolated antibody or portion thereof that binds specifically to:
(a) the full length Neutrokine-a polypeptide (amino acid sequence of residues 1 to 285 of SEQ ID NO: 2); or
(b) the extracellular domain of the Neutrokine-a polypeptide (amino acid sequence of residues 73 to 285 of SEQ ID NO: 2)
Effectively this means any antibody that binds specifically to neutrokine-a. The sufficiency point was argued before us on that basis. Kitchin J held the claim sufficient.
The statutory language of the sufficiency objection is taken from Art. 83 of the EPC, which provides:
The European patent application shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.
The Patents Act 1977 repeats these words as revocation ground s72(1)(c).
Kitchin J summarised at [239] the effect of this language as interpreted by case-law as follows:
The key elements of this requirement which bear on the present case are these:
i) the first step is to identify the invention and that is to be done by reading and construing the claims;
ii) in the case of a product claim that means making or otherwise obtaining the product;
iii) in the case of a process claim, it means working the process;
iv) sufficiency of the disclosure must be assessed on the basis of the specification as a whole including the description and the claims;
v) the disclosure is aimed at the skilled person who may use his common general knowledge to supplement the information contained in the specification;
vi) the specification must be sufficient to allow the invention to be performed over the whole scope of the claim;
vii) the specification must be sufficient to allow the invention to be so performed without undue burden.
Mr Waugh did not challenge any of this. Nor did he challenge a crucial finding of fact Kitchin J summarised at [250]:
In the light of all this evidence I am satisfied that it did not require undue effort to make and identify specific antibodies to Neutrokine-a at the priority date.
The full implications of this need spelling out a little more. There will be many, probably millions, of antibodies to neutrokine-a. Some will bind well, others less so. But they can all be made and isolated.
Given that, Mr Waugh needed to and did advance a more sophisticated attack than simply saying the products of the claim cannot be made. I summarise the main lines of the argument as follows:
(1) Even though you can make and isolate individual antibodies, you have no idea from the patent which, if any, actually has any practical use. Nearly all will, if investigated, prove to have none.
(2) It would take undue effort to find out which of the millions have any use. Mr Waugh likened the problem to identifying which of a large pool of tadpoles was a tadpole which would develop into a frog which when kissed would turn into a prince.
(3) The patent is aimed at products which have a valuable use, particularly as a pharmaceutical or diagnostic.
(4) So claim 13 should be read as confined to such products. Because it requires undue effort to find them, the claim is insufficient.
He reinforced his submissions in three ways:
(5) By reference to claims 18 and 19.
(6) By reliance on the decision of this court in Pharmacia v Merck [2001] EWCA Civ 1610, [2002] RPC 41.
(7) By reliance on the principle that the extent of a patent monopoly should correspond to the technical contribution to the art.
I would reject all these submissions. I start with the main one. There are I think two, related, answers to it. Firstly, at the level of generality of this patent, all the antibodies have a "use." Mr Thorley pointed out that "useful" could encompass uses other than pharmaceutical or diagnostic, for instance as a purifying agent if the binding is strong. He submitted that each member of the very large class of antibodies has, in a general sense, potential utility. Each member is susceptible of industrial application because the Supreme Court has said so. And that is enough. All the claim calls for is an antibody which specifically binds to neutrokine-a: that in itself is its potential utility. True it is that discerning any particular specific utility would or might involve a research project — undue effort — but that does not matter. Nor does it matter that one product may well be useless or much less so than other members of the class.
The second answer is one of construction. Mr Waugh's argument involves reading in the further limitation that the antibody should be "useful" (assuming that this has a sufficiently precise meaning). Such a construction would divide antibodies to neutrokine-a into two classes, those which are "useful" and those which are not. And it would involve undue effort to find out whether a particular antibody was useful or not; to separate the wheat from the chaff.
The trouble with that submission is that the claim does not contain any limitation to "useful." One does not read words into patent claims (or other documents for that matter) unless the context...
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