|Judgments - Conor Medsystems Incorporated (Respondents) v Angiotech Pharmaceuticals Incorporated and others (Appellants)
HOUSE OF LORDS
 UKHL 49
on appeal from:  EWCA Civ 5
OF THE LORDS OF APPEAL
FOR JUDGMENT IN THE CAUSE
Conor Medsystems Incorporated (Respondents) v Angiotech Pharmaceuticals Incorporated and others (Appellants)
Lord Scott of Foscote
Lord Walker of Gestingthorpe
Baroness Hale of Richmond
Lord Neuberger of Abbotsbury
Antony Watson QC
Andrew Waugh QC
Colin Birss QC
(Instructed by Howrey LLP )
Comptroller General of Patents Solicitors (acting in place of Respondents):
(Instructed by Treasury Solicitors)
6 and 7 MAY 2008
WEDNESDAY 9 JULY 2008
HOUSE OF LORDS
OPINIONS OF THE LORDS OF APPEAL FOR JUDGMENT
IN THE CAUSE
Conor Medsystems Incorporated (Respondents) v Angiotech Pharmaceuticals Incorporated and others (Appellants)
 UKHL 49
"[D]espite 15 years of clinical experience and research in the field of restenosis prevention, this has not yet resulted in the revelation of unequivocal beneficial effects of any particular drug. Other newer approaches likely to receive more attention in the future include anti-bodies to growth factors, gene transfer therapy and antisense oligonucleotides. Whether there is a feasible monotherapy, whether we have to focus on a drug combination, or whether we are only searching for the 'Holy Grail' remain to be answered."
"The present invention relates generally to compositions and methods for treating cancer and other angiogenic-dependent diseases, and more specifically, to compositions comprising anti-angiogenic factors and polymeric carriers, stents which have been coated with such compositions, as well as methods for utilizing these stents and compositions."
"purportedly resides in the idea of seeking to treat or prevent restenosis by coating a stent with a taxol/polymer composition. The disclosure is of no more than this. The idea is not shown to work (either in humans or in animals), nor to work to any particular extent, nor to work with any particular polymer nor with any particular amount of drug. The invention thus lies in the idea of trying some, one or more, taxol/polymer combinations to determine whether restenosis can thereby be treated. It is at this level of generality that inventiveness must be assessed."
" 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]."
"Q. The teaching on page 12, lines 33-38 [of the patent in suit] , is that an anti-angiogenic composition can be used to treat restenosis. Correct, professor?
A. Either prevent or treat.
Q. Prevent or treat."
"In summary, this study demonstrated that 48 hours after taxol application to the CAM, angiogenesis was inhibited. The blood vessel inhibition formed an avascular zone which was represented by three transitional phases of taxol's effect. The central, most affected area of the avascular zone contained disrupted capillaries with extravasated red blood cells; this indicated that intercellular junctions between endothelial cells were absent. The cells of the endoderm and ectoderm maintained their intercellular junctions and therefore these germ layers remained intact; however, they were slightly thickened. As the normal vascular area was approached, the blood vessels retained their junctional complexes and therefore also remained intact. At the periphery of the taxol-treated zone, further blood vessel growth was inhibited which was evident by the typical redirecting or 'elbowing' effect of the blood vessels Taxol-treated avascular zones also revealed an abundance of cells arrested in mitosis in all three germ layers of the CAM; this was unique to taxol since no previous study has illustrated such an event. By being arrested in mitosis, endothelial cells could not undergo their normal metabolic functions involved in angiogenesis. In comparison, the avascular zone formed by suramin and cortisone acetate do not produce mitotically arrested cells in the CAM; they only prevented further blood vessel growth into the treated area. Therefore, even though agents are anti-angiogenic, there are many points in which the angiogenesis process may be targeted.
We also observed the effects of taxol over the 48 hour duration and noticed that inhibition of angiogenesis occurs as early as 9 hours after application. Also, we observed the revascularization process into the avascular zone previously observed. It has been found that the avascular zone formed by heparin and angiostatic steroids became revascularized 60 hours after application. In our study, taxol-treated avascular zones did not revascularize for at least 7 days after application implying a more potent long-term effect."
"Q. The disclosure that a compound is anti-angiogenic would be of no assistance to you in concluding whether that compound would actually work to inhibit the proliferation of smooth muscle cells?
A. That is correct, at that time, yes."
"Q. There is no data in this patent which demonstrates that any of those compounds actually worked to treat restenosis?
A. That is correct.
Q. The patent does not address the question of whether any of the compounds will inhibit the proliferation of smooth muscle cells?
A. That is correct.
Q. It does not address the question of whether local administration of any of the compounds will cause unmanageable side-effects?
A. I think that is correct, yes.
Q. The patent does not address the question of the dose of drug that will be needed to prevent or cure restenosis?
A. That is true.
Q. lt does not address the question of the period of time for which the drug should rest at the location in question?
A. True. That is correct."
"61. In summary, therefore, the Claimant's case is that it is sufficient for the purposes of invalidating the claims of the patent in suit that the interventional cardiologist, in consultation with someone of skill and experience in the field of anti-mitotic drugs of one sort or another, would see paclitaxel (taxol) as worth experimentation. The Patentees' case is that the properties of taxol are such that the skilled person would not think that it was suitable for local administration in a drug-eluting stent. The Patentees' contentions centre on the toxic character of taxol. It is therefore necessary at this point to deal with a particular question which has vexed this case. Is it sufficient for Conor to show that taxol is an obvious candidate for testing on a drug-eluting stent in addition to the material specifically identified in Wolff, or is it necessary to show that taxol is an obvious, or the obvious, material to use in a drug-eluting stent for administration to human beings? Put another way, is the patent vulnerable only if it can be shown that the skilled person would have an expectation of success sufficient to induce him to incorporate taxol in a drug-eluting stent, or is it sufficient that without any expectation of success he would test or screen taxol?
62. In my judgment, this question is to be answered by assessing the contribution to the art disclosed by the specification. For the reasons that I have given above, I am satisfied that the disclosure of the specification is that taxol may be incorporated in a stent. It does not suggest that such a stent would be safe or that such a stent would work to prevent restenosis. I think it is fair to say that the sum of the disclosure of the specification is that taxol should be incorporated in a drug-eluting coating on a stent with a view to seeing whether it works to prevent restenosis and whether it is safe. If it is obvious to the skilled person that taxol should be incorporated in a drug-eluting coating on a stent with a view to seeing whether it prevents restenosis and is safe, then the claim is invalid, the specification having made no contribution to the art. It is obviously preferable to identify the correct question before assessing the evidence. In this case, the profound difference between the parties as to the nature of the inventive step has led them to identify as relevant very different factors.
64. The claim is to a physical device, that is, to a stent upon which is a drug-eluting coating loaded with taxol and optionally with other active ingredients as well. If, as I consider is the case here, the specification provides directions to make such a stent, but provides no data or other material suggesting that such a stent is in fact suitable for the treatment of restenosis, then success in preventing restenosis is not, in my view, a relevant consideration when assessing the obviousness of constructing such a stent. I accept immediately that there must be some motive [for] making such a stent: but a sufficient motive is the testing of such a stent to see if it has potential in the treatment of restenosis. In the present case, therefore, I reject Mr Waugh's contention that the definite object in view is the treatment or prevention of restenosis. The object in view is the testing of a taxol-loaded stent to see if it is of any use in the treatment or prevention of restenosis: that is all the specification provides."
" [T]he patentee sufficiently clearly indicates in the patent that it is advantageous to use taxol (inter alia but also specifically for restenosis) and states as reason for this that taxol scores well in the CAM assay to demonstrate its anti-angiogenic effect, bearing in mind that the patentee saw the solution for restenosis in the use of an anti-angiogenic factor."
"battle fatigue, combat stress reaction, post-traumatic stress disorder in civilian and military emergency situations, neurological symptoms associated with chemical warfare and nausea associated with chemical or biological warfare."
" [A] technical effect which justifies the selection of the claimed compounds must be one which can be fairly assumed to be produced by substantially all the selected compounds..."
"[T]he issue here is how much weight can be given to speculations in the application in the framework of assessing inventive step, which assessment requires that facts be established before starting the relevant reasoning. In the board's judgment, enumerating any and all putative functions of a given compound is not the same as providing technical evidence as regard a specific one [T]here is not enough evidence in the application to make at least plausible that a solution was found to the problem which was purportedly solved."
"12. The appellant filed post-published evidence establishing that GDF-9 was indeed a growth differentiation factor. This cannot be regarded as supportive of an evidence which would have been given in the application as filed since there was not any. The said post-published documents are indeed the first disclosures going beyond speculation. For this reason, the post-published evidence may not be considered at all. Indeed, to do otherwise would imply that the recognition of a claimed subject-matter as a solution to a particular problem could vary as time went by. Here, for example, had the issue been examined before the publication date of the earliest relevant post-published document, GDF-9 would not have been seen as a plausible solution to the problem and inventive step would have had to be denied whereas, when examined thereafter, GDF-9 would have to be acknowledged as one such member. This approach would be in contradiction with the principle that inventive step, as all other criteria for patentability, must be ascertained as from the effective date of the patent. The definition of an invention as being a contribution to the art, i.e. as solving a technical problem and not merely putting forward one, requires that it is at least made plausible by the disclosure in the application that its teaching solves indeed the problem it purports to solve. Therefore, even if supplementary post-published evidence may in the proper circumstances also be taken into consideration, it may not serve as the sole basis to establish that the application solves indeed the problem it purports to solve."
"But this is miles away from indicating that taxol is a particularly suitable anti-angiogenic for a drug eluting vascular stent or that the CAM assay is a test for a drug which will actually work to prevent restenosis in a drug eluting vascular stent."
"is the patent vulnerable only if it can be shown that the skilled person would have an expectation of success sufficient to induce him to incorporate taxol in a drug-eluting stent, or is it sufficient that without any expectation of success he would test or screen taxol?"
"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."
LORD SCOTT OF FOSCOTE
LORD WALKER OF GESTINGTHORPE
"It is enough that the person versed in the art would assess the likelihood of success as sufficient to warrant actual trial. . . . The Superintending Examiner and the Patents Appeal Tribunal were both of opinion that, filtration processes being common to many industries, these documents, although addressed primarily to the mining and paper industries respectively, were likely to be read by those concerned with the asbestos cement industry, and that such readers would have realised that here was a newly-introduced flocculating agent which it was well worth trying out in their own filtration process. I can see no grounds which would justify this court in reversing this concurrent finding by two expert tribunals."
Diplock LJ was not here expounding a technical doctrine. On the contrary, he was at pains to stress the need to avoid generalisation. A little earlier in his judgment he had said (at pp 494-495):
"I have endeavoured to refrain from coining a definition of 'obviousness' which counsel may be tempted to cite in subsequent cases relating to different types of claims. Patent law can too easily be bedevilled by linguistics, and the citation of a plethora of cases about other inventions of different kinds. The correctness of a decision upon an issue of obviousness does not depend upon whether or not the decider has paraphrased the words of the Act in some particular verbal formula. I doubt whether there is any verbal formula which is appropriate to all classes of claims."
"When patents and patent applications succumb to invalidity attacks, obviousness is the most common cause. This inevitably generates friction between the community of patentees and applicants on the one hand and patent offices and national courts on the other. A company which has spent millions of dollars on research and has produced a valuable new drug will be understandably irritated when, say, a court declares the patent invalid for obviousness, thereby opening up the market to competitors who are free to copy. That irritation is likely to be particularly acute when the raison d'être of the patent system is said to be the economic encouragement of research and development.
The problems can be approached by considering first the concept of 'obvious to try'. The classic statement of this principle is set out in the judgment of the Court of Appeal in Johns-Manville Corporation's Patent. It was said that a development should be treated as obvious if 'the person versed in the art would assess the likelihood of success as sufficient to warrant actual trial'. Statements to similar effect have been made by the EPO.
On its face, this produces an unworkable or irrational test. If the reward for finding a solution to a problem and securing a monopoly for that solution is very high, then it may well be worthwhile for large players to examine all potential avenues to see if one gives the right result, even though the prospects of any one of them succeeding are much less than 50/50. What makes something worth trying is the outcome of a simple risk to reward calculation. Yet, if the reward is very large, the avenues worth trying will be expanded accordingly. So, the more commercially attractive the solution and the more pressing the public clamour for it, the harder it will be to avoid an obviousness attack. In those circumstances a solution which is quite low down a list of alternatives, all of which are more or less worth trying, will fail for obviousness; a consequence which is consistent with the decision in Brugger v Medic-Aid."
Sir Hugh goes on to suggest that as technology advances rapidly, this is a serious and growing problem.
"The patent is a very long document, containing some 37 pages of description and 34 pages of figures. Very little of it is about restenosis and stents."
That is putting it quite mildly. The inventors were carrying on research work with various substances which held out the prospect of exciting medical advances, not only in preventing restenosis but also in the treatment of cancer. They understandably wished to cover as much ground as possible in the specification. But in doing so they risked making it so unfocused as to end up with nothing capable of resisting a challenge to its validity.
BARONESS HALE OF RICHMOND
LORD NEUBERGER OF ABBOTSBURY