Merrell Dow Pharmaceuticals Inc. and Others v H.N. Norton & Company Ltd ; Merrell Dow Pharmaceuticals Inc. and Others v Penn Pharmaceuticals Ltd and Others
| Jurisdiction | England & Wales |
| Judge | Lord Jauncey of Tullichettle,Lord Browne-Wilkinson,Lord Mustill,Lord Lloyd of Berwick,Lord Hoffmann |
| Judgment Date | 26 October 1995 |
| Judgment citation (vLex) | [1995] UKHL J1026-1 |
| Date | 26 October 1995 |
| Court | House of Lords |
[1995] UKHL J1026-1
Lord Jauncey of Tullichettle
Lord Browne-Wilkinson
Lord Mustill
Lord Lloyd of Berwick
Lord Hoffmann
House of Lords
OPINIONS OF THE LORDS OF APPEAL FOR JUDGMENT IN THE CAUSE
My Lords,
I have read in draft the speech of my noble and learned friend Lord Hoffmann. For the reasons which he gives, I too would dismiss the appeal.
My Lords,
I have had the advantage of reading in draft the speech of my noble and learned friend Lord Hoffmann. For the reasons he gives, I too would dismiss the appeal.
My Lords,
I have read in draft the speech of my noble and learned friend Lord Hoffmann and for the reasons which he gives, I too would dismiss the appeal.
My Lords,
I have had the advantage of reading in draft the speech of my noble and learned friend Lord Hoffmann and for the reasons which he gives, I too would dismiss the appeal.
My Lords,
1. The Patent in Suit
Merrell Dow Pharmaceuticals Inc is a U.S. company with a U.K. subsidiary. I shall call them both "Merrell Dow". About 25 years ago Merrell Dow discovered an anti-histamine drug called terfenadine. It is used by people who suffer from hay fever and similar allergies and has the advantage that, unlike some other anti-histamines, it does not have the side-effect of making one drowsy. In 1972 Merrell Dow obtained a patent for terfenadine in the United Kingdom. After a period of extension under the Patents Act 1977, it finally expired in December 1992. Other pharmaceutical companies then started to make and market terfenadine.
In these proceedings Merrell Dow claim that their monopoly in terfenadine continues by virtue of a later patent which still has another 5 years to run. It was obtained in the following circumstances. After they had patented terfenadine, they did some research into the way it worked. They found that it passed through the stomach to be absorbed in the small intestine and was then 99.5% metabolised in the liver. This was why it had no side-effects. They analysed the chemical composition of the acid metabolite formed in the liver. Its chemical name is 4-[4-(4-hydroxydiphenylmethyl-1-piperidinyl)-1-hydroxybutyl]-a,a-dimethylbenzeneacetic acid, but I shall call it the acid metabolite. No one had identified it before. So they patented the acid metabolite as claim 24 of a patent granted in 1980 for a number of related anti-histamine products. This is the patent in suit.
2. The Claim for Infringement
A patent for a product is infringed by anyone who makes the product without the consent of the proprietor: see section 60(1)( a) of the Act of 1977. Merrell Dow's research, which they made public at a symposium in Strasbourg in January 1982, showed that one cannot swallow terfenadine without shortly afterwards making the acid metabolite in one's liver. This is claimed to be an act falling within section 60(1)( a). It is not however alleged to be an infringement, because section 60(5)( a) exempts any act "done privately and for purposes which are not commercial." Nevertheless, say Merrell Dow, another pharmaceutical company cannot supply terfenadine to the public without infringing under section 60(2):
"Subject to the following provisions of this section, a person (other than the proprietor of the patent) also infringes a patent for an invention if, while the patent is in force and without the consent of the proprietor, he supplies or offers to supply in the United Kingdom a person other than a licensee or other person entitled to work the invention with any of means, relating to an essential element of the invention, for putting the invention into effect when he knows, or it is obvious to a reasonable person in the circumstances, that those means are suitable for putting, and are intended to put, the invention into effect in the United Kingdom."
Merrell Dow say that supplying terfenadine commercially is an infringement under this subsection because it involves knowingly supplying consumers with the means, relating to an essential element for the making of the acid metabolite, for putting the invention into effect. So they retain their monopoly in marketing terfenadine until the metabolite patent expires in the year 2000. Indeed, the monopoly is stronger than it was under the terfenadine patent during its last four years of extension under the Patents Act 1988 because it is not subject to licences of right.
3. The Proceedings
Merrell Dow has commenced two actions for infringement against other pharmaceutical companies. This appeal come before your Lordships' House in consequence of motions to strike them out as disclosing no cause of action. The motions were heard by Aldous J., who was invited to decide as a matter of law (under RSC Ord 14A) that on the undisputed facts which I have stated, the patent was invalid. Several grounds were put forward but I need trouble your Lordships with only one, namely, that so far as the claim to the acid metabolite includes its manufacture by the action of terfenadine in the human body, the patent was invalid because the invention was not new. It was on this ground that Aldous J. dismissed the actions and his decision was affirmed by the Court of Appeal. Your Lordships decided in the first instance to hear argument on this point alone. The hearing was then adjourned. Since I understand your Lordships to be of the opinion that the Court of Appeal and Aldous J. were right and the other points have not been argued, I shall say nothing about them.
4. Novelty
By section 1(1)( a) of the Act of 1977, it is one of the conditions for the grant of a patent that the invention should be new. Section 2 defines what is meant by new.
2. (1). An invention shall be taken to be new if it does not form part of the state of the art.
(2) 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.
The 1977 Act was passed to give effect to the European Patent Convention ("EPC"). Section 130(7) says that various sections, including section 2, were "so framed as to have, as nearly as practicable, the same effects in the United Kingdom as the corresponding provisions of the [EPC]." The provision which corresponds to section 2 is Article 54:
"(1) An invention shall be considered to be new if it does not form part of the state of the art.
(2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application."
It is therefore the duty of the U.K. courts to construe section 2 so that, so far as possible, it has the same effect as Article 54. For this purpose, it must have regard to the decisions of the European Patent Office ("EPO") on the construction of the EPC. These decisions are not strictly binding upon courts in the U.K. but they are of great persuasive authority; first, because they are decisions of expert courts (the Boards of Appeal and Enlarged Board of Appeal of the EPO) involved daily in the administration of the EPC and secondly, because it would be highly undesirable for the provisions of the EPC to be construed differently in the EPO from the way they are interpreted in the national courts of a Contracting State.
5. The Invention
Before coming to the question of whether the invention was new, one must first be clear about what it was. Claim 24 of the patent in suit was to the acid metabolite as a product. The scope of the monopoly conferred by a product claim is defined by section 60(1)( a), which provides that where the invention is a product, a person infringes the patent if, without the consent of the proprietor, he "makes, disposes of, offers to dispose of, uses or imports the product or keeps it whether for disposal or otherwise." For this purpose it does not matter how the product is made or what form it takes. The monopoly covers every method of manufacture and every form which comes within the description in the claim. So claim 24 includes the making of the acid metabolite in one's liver just as much as making it by synthetic process; in the body as well as in isolation. Nor does it matter whether or not the infringer knows that he is making, using etc. the patented product. Liability is absolute.
The corollary of this principle is that the novelty of the invention must be co-extensive with the monopoly. If there is any method of manufacture or form of the product which is part of the state of the art, then to that extent the invention is not new. As the Enlarged Board of Appeal of the EPO said in its Decision G02/88 MOBIL/Friction reducing additive [1990] EPOR 73, 83:
"It is generally accepted as a principle underlying the EPC that a patent which claims a physical entity per se, confers absolute protection upon such physical entity; that is, wherever it exists and whatever its context� . It follows that if it can be shown that such physical entity (that is, a compound) is already in the state of the art (for example in the context of a particular activity), then a claim to the physical entity per se lacks novelty."
In this case, the respondents would have no objection to a claim to the synthesisation of the acid metabolite or to the product in isolation. The only respect in which they say it is not new is when made by terfenadine as part of the human body. It may be possible for...
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