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England and Wales Court of Appeal (Civil Division) Decisions
You are here: BAILII >> Databases >> England and Wales Court of Appeal (Civil Division) Decisions >> Hospira UK Ltd v Genentech Inc  EWCA Civ 780 (27 July 2016)
Cite as:  RPC 13,  EWCA Civ 780
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ON APPEAL FROM THE HIGH COURT OF JUSTICE
The Hon Mr Justice Birss
Strand, London, WC2A 2LL
B e f o r e :
LORD JUSTICE FLOYD
LORD JUSTICE DAVID RICHARDS
| HOSPIRA UK LIMITED
|- and -
Richard Meade QC, Tom Mitcheson QC and Jeremy Heald (instructed by Taylor Wessing) for the Respondent
Hearing dates: 12 and 13 July 2016
Crown Copyright ©
Lord Justice Floyd
"A formulation consisting of a lyophilized mixture of a lyoprotectant, a buffer, a surfactant and an antibody, wherein the lyoprotectant is trehalose, wherein the buffer is histidine, wherein the surfactant is polysorbate 20 and wherein the antibody is [trastuzumab], such that an amount of said lyophilized mixture containing 450mg of said antibody can be reconstituted with 20ml of BWFI (0.9 or 1.1% benzyl alcohol) to yield a concentrated protein solution containing 22 mg/ml of said antibody, 52 mM trehalose, 4 mM histidine pH 6.0, 0.009% polysorbate 20."
"The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success."
"Whether a route has a reasonable or fair prospect of success will depend upon all the circumstances including an ability rationally to predict a successful outcome, how long the project may take, the extent to which the field is unexplored, the complexity or otherwise of any necessary experiments, whether such experiments can be performed by routine means and whether the skilled person will have to make a series of correct decisions along the way."
"What is a reasonable or fair expectation of success will again depend upon all the circumstances and will vary from case to case. Sometimes, as in Saint Gobain, it may be appropriate to consider whether it is more or less self-evident that what is being tested ought to work. So, as this court explained in that case, simply including something in a research project in the hope that something might turn up is unlikely to be enough. But I reject the submission that the court can only make a finding of obviousness where it is manifest that the test ought to work. That would be to impose a straitjacket on the assessment of obviousness which is not warranted by the statutory test and would, for example, preclude a finding of obviousness in the case where the results of an entirely routine test are unpredictable."
"… whether there is any teaching in the prior art as a whole that would (not simply could, but would) have prompted the skilled person … to modify or adapt the closest prior art … thereby arriving at something falling within the terms of the claims, and thus achieving what the invention achieves".
"We accept that the "could" test is a minimum condition that must be satisfied on the facts before obviousness can be established in any given case. With this qualification, we agree with the judge's comment … that the proper question depends on the facts of each case, though always bearing in mind that, under section 3 of the 1977 Act, the onus ultimately falls on the defendants to show that the alleged invention was obvious to a person skilled in the art, having regard to any matter which formed part of the state-of-the-art at the priority date."
The judgment of Birss J
"225. The person skilled in the art is not a real person. The skilled person never sees what is inventive and never misses what is obvious. They represent part of the application of a legal standard to patents. It may be that some real skilled teams would find a working formulation which did not involve testing any of these ingredients. That does not alter the fact that all three ingredients are obvious agents to test.
226. In my judgment all of the differences between the claim and Carter are the result of nothing more than the application of routine screening techniques to common general knowledge excipients by a skilled team motivated in the way I have described already. There is no suggestion that any invention could be found to exist in the ratios or concentrations in the claim if the skilled team employed the relevant excipients. Accordingly there is a strong case that the claimed subject matter involves no inventive step over Carter."
"It is not true to say that a real team would arrive at a formulation consisting of polysorbate 20, histidine and trehalose. It would be idle to pretend otherwise and Hospira do not do so. But what Hospira's submission is getting at is that the claimed result can be reached by the application of nothing other than routine approaches applied to excipients which were part of their common general knowledge. In my judgment on the facts of this case that is correct."
"One engineered molecule – our humanised anti-p185HER2 antibody31 – is currently being evaluated in a phase II clinical trial for the treatment of p185HER2 – overexpressing breast cancer."
"In my judgment in this case the skilled team who arrived at the Table 5 Solution would be pleased they produced a stable lyophilised formulation, and no doubt proud of their work, but not surprised. It is not a surprise is that a stable lyophilised formulation of trastuzumab can be made. Nor would the identity of the ingredients be a surprise. Although none of the excipients are the most commonly used, they are all part of the common general knowledge."
"… it was far from established that any non-aqueous non-toxic solvent would produce a stable ointment. The judge found that "there is no proper evidence either way as to whether they [i.e. other such solvents] would work or not." Nor was it established that the skilled team would expect that any non-aqueous solvent would do. Keeping water wholly out was a known real problem." (paragraph 19).
"it was not even proved that there was a good expectation that if you did try 20 [non-aqueous solvents] one of them would work."
"Cases, so far as regards the law, are most useful, but when they are applied to particular facts, they, as a rule, are of little service. Each case depends on its own particular facts and the facts of almost every case differ."
Lord Justice David Richards
Lord Justice Kitchin