Merrell Dow Pharmaceuticals Inc. and Another v H N Norton & Company Ltd
| Jurisdiction | England & Wales |
| Judge | THE VICE-CHANCELLOR,LORD JUSTICE LEGGATT,LORD JUSTICE HENRY |
| Judgment Date | 16 February 1994 |
| Judgment citation (vLex) | [1994] EWCA Civ J0216-6 |
| Court | Court of Appeal (Civil Division) |
| Date | 16 February 1994 |
[1994] EWCA Civ J0216-6
(Mr. Justice Aldous)
Before: The Vice-Chancellor (Sir Donald Nicholls) Lord Justice Leggatt Lord Justice Henry
IN THE SUPREME COURT OF JUDICATURE
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION (PATENTS COURT)
MR. SIMON THORLEY QC and MR. ANDREW WAUGH (instructed by Messrs. Bird & Bird, Solicitors, EC4 1JP) appeared on behalf of the (Plaintiffs) Appellants.
MR. CHRISTOPHER FLOYD QC and MR. HENRY WHITTLE (instructed by Messrs. Rioter Zucker) appeared on behalf of the (Defendants) Respondents (H.N. Norton & Co. Ltd.)
MR. ALASTAIR WILSON QC and MR. COLIN BIRSS (instructed by Messrs. S.J. Berwin & Co., Solicitors, WC1X 8HB) appeared on behalf of the (Defendants) Respondents (Penn Pharmaceuticals & anr.)
Terfenadine is a drug which has proved to
be of great use as an anti-histamine. In December 1972 the first plaintiff applied for a United Kingdom patent for terfenadine and in due course this was granted, under No. 1,413,138. The patent, which I shall call the terfenadine patent, expired in December 1992. The defendants in these two actions then commenced selling terfenadine to pharmacists and others. The terfenadine patent having expired, this was an unexceptional happening. One would have expected that the plaintiffs could have no grounds for complaint. However, the plaintiffs did object. They relied on a new patent obtained by the first plaintiff and of which the second plaintiff is the exclusive licensee.
The background to the new patent was that in the 1970s the plaintiff group carried out medical research. They discovered more about the way terfenadine works within the human body. Terfenadine is absorbed in the small intestine, and 99.5% is metabolised in the liver. The plaintiffs discovered that this acid metabolite is almost exclusively responsible for the anti-histamine activity of terfenadine. The acid metabolite was then made the subject of a claim in a new United Kingdom patent, numbered 2,042,258, granted to the first plaintiff in March 1983. Claim 24, which is the only claim relevant to these proceedings, is to a product comprising the acid metabolite. I shall refer to this patent as the 'acid metabolite patent'. It is the patent in suit in these actions.
The proceedings
Founding themselves on the acid metabolite patent, the plaintiffs issued writs against the defendants. They claimed injunctions to restrain the defendants from infringing the acid metabolite patent, and other relief. The defendants are not themselves making the acid metabolite; they are selling terfenadine. The acid metabolite is made by the patients themselves within their own bodies. But, it is said, the defendants are supplying a means for putting the acid metabolite invention into effect. The defendants are supplying the terfenadine to pharmacists and others, with a view to it being used by individuals who are in need of anti-histamine treatment. They take doses of it, as tablets or in some other way, to relieve their symptoms of hay-fever or other allergies. The inevitable consequence is that the terfenadine will be metabolised within their bodies in the form of the acid metabolite which is the subject of the acid metabolite patent. So although the defendants are not themselves making or selling or using the acid metabolite, they are guilty of contributory infringement of the plaintiffs' acid metabolite patent under section 60(2) of the Patents Act 1977.
The plaintiffs sought interlocutory injunctions. The defendants responded with applications seeking, in substance, the revocation of the acid metabolite patent on the ground that the invention claimed therein, namely the acid metabolite compound, is not new. I need not go into the procedural details. On 23rd June 1993 Aldous J. found in favour of the defendants and made an order revoking the acid metabolite patent. From that order the plaintiffs appealed.
Introductory observations
The first point which strikes one about this case is that the defendants are doing no more than selling terfenadine for use in the way specifically taught in the plaintiffs' terfenadine patent, namely, for ingestion by individuals as a form of anti-histamine treatment. The terfenadine patent described how terfenadine can be manufactured and disclosed its medical uses. That patent has run its course and has now expired. As a matter of first impression it would be startling if the plaintiffs could stop the public from manufacturing or selling terfenadine.
The second point to note is that this is not to belittle the contribution the plaintiffs may have made to medical knowledge by identifying the way terfenadine works within the body. Identifying acid metabolite may have beneficial consequences. For instance, if acid metabolite is prepared outside a human body, and then introduced into a patient's body, this may avoid undesirable side-effects which in rare circumstances can arise from the use of terfenadine. The defendants do not seek to challenge that a patent, limited to acid metabolite produced otherwise than in the body by the use of terfenadine, might be valid. The acid metabolite patent is not so limited. The defendants assert that the patent is therefore bad for lack of novelty. The patent includes within its embrace acid metabolite produced in the ordinary course inside the body when a patient takes terfenadine.
The third point to note is that in this case the discovery of acid metabolite was made by the same persons as those entitled to the terfenadine patent. This makes the assertion of the acid metabolite patent seem the less attractive, for they have already enjoyed the monopoly conferred by the terfenadine patent. In principle, however, the case can stand no differently from how it would if a third party had made this discovery and had obtained the acid metabolite patent. The question is whether, given the prior publication of the terfenadine patent, and the prior use of terfenadine, a claim to acid metabolite (not limited to acid metabolite produced by other means) is valid, regardless of who was the patentee of terfenadine.
The statutory provisions
I turn to the Patents Act 1977. One of the conditions which must be satisfied before a patent may be granted for an invention is that the invention is new (section 1). Section 2 defines novelty for this purpose. Section 2 (1) provides that an invention shall be taken as new if it does not form part of 'the state of the art'. Section 2 (2) defines this expression. This definition is central to this case, because the case turns on the proper interpretation of this definition and its application to the facts of this case. Section 2(2) reads:
"The state of the art in the case of an invention shall be taken to comprise all matter (whether a product, a process, information about either, or anything else) which has at any time before the priority date of that invention been made available to the public (whether in the United Kingdom or elsewhere) by written or oral description, by use or in any other way".
In short, the plaintiffs' case is that before 10th April 1979, the priority date of the acid metabolite invention, neither the product nor any information about it had been made available to the public in any way. That was so, because until then the very existence of acid metabolite was unknown to the public. Nobody had appreciated that within the human body this compound was produced in response to terfenadine.
" Made available to the public"
I am unable to accept the plaintiffs' submissions. The key issue is to identify what is made available to the public by the disclosure of a process. Here the terfenadine patent taught and made known, by which I mean made available to the public, a method of anti-histamine treatment comprising a particular process: the administering of terfenadine into the human body. The terfenadine patent...
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