Hospira UK Ltd v Genentech, Inc.
| Jurisdiction | England & Wales |
| Judge | Lord Justice Floyd,Lord Justice David Richards,Lord Justice Kitchin |
| Judgment Date | 27 July 2016 |
| Neutral Citation | [2016] EWCA Civ 780 |
| Docket Number | Case No: A3/2014/4302 |
| Court | Court of Appeal (Civil Division) |
| Date | 27 July 2016 |
[2016] EWCA Civ 780
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
The Hon Mr Justice Birss
Royal Courts of Justice
Strand, London, WC2A 2LL
Lord Justice Kitchin
Lord Justice Floyd
and
Lord Justice David Richards
Case No: A3/2014/4302
Michael Tappin QC and Mark Chacksfield (instructed by Marks & Clerk Solicitors) for the Appellant
Richard Meade QC, Tom MitchesonQC and Jeremy Heald (instructed by Taylor Wessing) for the Respondent
Hearing dates: 12 and 13 July 2016
This is an appeal from the decision of Birss J dated 21 November 2014 in an action by Hospira UK Limited ("Hospira") for revocation of two patents, European patents (UK) Nos. 1 516 628 and 2 275 119. The judge held both patents invalid on the ground of lack of inventive step and added matter. Genentech Inc. ("Genentech"), whose patents these are, appeals to this court with permission granted by the judge himself.
Both patents are concerned with pharmaceutical formulations of the important breast cancer drug Herceptin, the active ingredient in which is the monoclonal antibody trastuzumab. There were two general approaches to formulating such proteins at the priority date. One was to produce a liquid formulation. The other was to produce a dry lyophilised (i.e. freeze-dried) formulation. Both approaches were common general knowledge. The liquid formulation would be directly injected. The dry, lyophilised formulation would be made up into a sterile solution for injection. Lyophilised material was likely to be stable for longer than a liquid since chemical reactions are faster in solution. On the other hand, steps needed to be taken to ensure that the lyophilisation process itself did not degrade the protein.
A lyoprotectant is a substance used to protect the protein in the lyophilisation process. Substances such as dextrose, glucose, lactose, and sucrose as well as some alcohols and glycols were in common use as lyoprotectants at the priority date.
There were other classes of excipients which would also be considered for inclusion in a lyophilised formulation. These included but were not limited to buffers and surfactants. Buffers were used to keep the pH at a level required for stability of the protein. Surfactants were used to minimise aggregation of proteins. Other excipients having defined roles, such as anti-oxidants and bulking agents, were also known and were used when required.
Although there are two patents, the disclosure of the two specifications is in all material respects identical. It is common ground that, at least for the objections of obviousness and added subject matter, it is sufficient to consider claim 2 of 1 516 628 which, in the proposed amended form considered by the judge, reads as follows:
"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."
So the patent is about making a lyophilised formulation where you have chosen the excipients trehalose, histidine and polysorbate 20 as lyoprotectant, buffer and surfactant respectively. The third and fourth words of the claim " consisting of" are the draftsman's way of saying that the ingredients are those specified and no others. The words of the claim following "such that" are a way of specifying the relative proportions of the excipients and the antibody. It is not suggested that there would be any invention in arriving at suitable proportions once the excipients had been identified.
Trastuzumab is a large protein molecule. The formulation of large protein molecules was a more difficult and complex task than the formulation of small molecules. The judge said that the task was a challenge and that finding a stable formulation was an essentially empirical exercise. At the priority date of the patent the biotechnology industry, although not yet involving the largest pharmaceutical companies, was a significant specialist industry. A number of protein products had been formulated for human use, including some in dry, lyophilised form.
The judge rejected allegations that the invention was obvious over the common general knowledge alone and over a document known as Draber. There is no appeal against those findings. He held, instead, that the invention was obvious over Carter, a pair of documents which disclose that trastuzumab, an anti-HER2 antibody, was in phase II clinical trials for breast cancer. That was because a skilled team consisting of a clinician and a formulator would, by the priority date, be motivated to produce a lyophilised version of the antibody, and the claimed combination was simply an example of the work product of the necessary screening programme to find a satisfactory combination of excipients. To arrive at such a combination would not have involved any inventive effort.
The law
I start with the well-known passage from the judgment of Kitchin J (as he then was) in Generics (UK) Ltd v H. Lundbeck A/S [2007] EW HC 1040 (Pat), at [72], which has been approved at the highest level:
"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."
It follows that the court is required to embark on a multi-factorial assessment. The approach of the appellate court to such questions is well-known: the decision is not open to independent evaluation in this court unless the judge has made an error of principle: see Biogen Inc v Medeva Plc [1997] RPC 1 at [45] per Lord Hoffmann.
It is also well-settled that "obvious to try" is not a substitute test for obviousness: see e.g. per Lewison LJ in Medimmune Ltd v Novartis Pharmaceuticals UK Ltd [2012] EWCA Civ 1234, [2013] RPC 27 at [181]. There is only one statutory question, namely whether the invention was obvious at the priority date. In the same case at [90] to [95] Kitchin LJ explained that whether the invention was obvious to try was merely one of many considerations which it may be appropriate for the court to take into account in addressing the statutory question. It must in any case be coupled with a reasonable or fair prospect of success. At [91] Kitchin LJ emphasised:
"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."
Thus a judge's assessment whether an approach has a reasonable or fair prospect of success is itself another multi-factorial assessment, where this court should again pay proper respect to the evaluation of a trial judge.
There is also no single standard of what amounts to a fair expectation of success. Thus Jacob LJ's statement in Saint Gobain PAM SA v Fusion-Provida Ltd [2005] EWCA Civ 177 at [35] that it must be "more-or-less self-evident that what is being tested ought to work" is far from being a test of universal application. In Novartis AG v Generics (UK) Ltd (trading as Mylan) [2012] EWCA Civ 1623 Kitchin LJ (with whom Lewison and Munby LJJ agreed) warned against imposing a straitjacket on the law by adopting any form of words as a standard. He said at 55:
"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."
Indeed, so much was confirmed by Lord Hoffmann in Conor Medsystems v Angiotech Pharmaceuticals [2008] UKHL 49, [2008] RPC 28 at [42], approving Jacob LJ's comprehensive review of the authorities in this area in the Court of Appeal in that case, including his view that "how much of an expectation depended upon the particular facts of the case."
It is also often debated whether the correct question is whether the skilled person would, or whether he or she could, arrive at the claimed invention without inventive effort. A "would" test can be misleading, as it is liable to bring in irrelevant considerations, such as whether it would be worthwhile commercialising an otherwise technically obvious product, see per Oliver LJ in Windsurfing...
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