76

[No. 3)

Merrel Dow Pharmaceuticals Inc. and Anr.

v. H.N. Norton & Co. Ltd.

[1996) R.P.C.

IN THE HOUSE OF LORDS

10

Before: LORD JAUNCEY OF TULLICHETTLE

LORD BROWNE-WILKINSON
LORD MUSTILL
LORD LLOYD OF BERWICK
LORD HOFFMANN

15

19-22,26-28 June and 26 October 1995

MERRELL Dow PHARMACEUTICALS INC. AND ANOTHER
V. H.N. NORTON & CO. LTD. AND OTHERS

20

Patent - Anti-histamine - Terfenadine metabolite - Metabolite inevitably

formed from terfenadine in human body - Fact of metabolite's existence not
published until after priority date of patent in suit - Anticipation - Prior useWhether alleged infringing act invalidated patent if done before priority date - 25
Whether invention made available to public by prior disclosure of terfenadine
used as anti-histamine - Communication of information essential - Patent
anticipated by prior disclosure but not by uninformative prior use.
Infringement - Difficulty of applying doctrine of absolute liability under 30
patent for old product used in old way for new purpose.
European Patent Convention - Construction - Highly undesirable for
provisions to be construed differently in European Patent Office from
interpretation in national courts.
35
Patents Act 1977, sections 2(1), (2), 60(1)(a), (2), 64, 130(7).
European Patent Convention, Article 54.

40
The patent in suit related to certain anti-histamine products. One of the
substances was inevitably formed as a metabolite of the known anti-histamine
drug terfenadine in the human body but the fact that the metabolite existed had
not been published at the priority date. The appellants alleged that sale of
terfenadine by the respondents for use as an anti-histamine was an infringement 45
of the patent under section 60(2) of the Patents Act 1977.
Before the priority date, terfenadine had been taken by participants in
clinical trials. Also, the specification of the appellants' earlier patent ("the
terfenadine patent") had published information on the chemical composition of 50
terfenadine and that it should be taken for its anti-histamine effect.

77
[No. 3]

House of Lords

The Patents Court had found the patent invalid and ordered it to be revoked.
An appeal to the Court of Appeal was dismissed. On a further appeal to the
House of Lords, the sole issue was whether, so far as the claim to the metabolite
5 included its manufacture by the action of terfenadine in the human body, the
patent in suit was invalid because the invention was not new.
The appellants argued that the Patents Act 1977 had overturned previous
principles of United Kingdom patent law, namely that the Crown could not
10 grant a patent which would enable the patentee to stop another trader from
doing what he had done before, and that the test for anticipation before the
priority date was co-extensive with the test for infringement afterwards. Except
as provided by section 64, it was not enough that something should have been
done before; under the definition of the state of the art in section 2(2)
15 information about what was being done must have been made available to the
public. No information about the metabolite had been made available to the
public before the priority date of the patent in suit: no one could know about
something which he did not know existed.
20

The respondents said that although the metabolite had not previously been
identified chemically, its manufacture in the body was nevertheless part of the
state of the art.

Held, dismissing the appeal:25

(1) In construing a section of the Patents Act 1977 said by section 130(7)
to be so framed as to have, as nearly as practicable, the same effects as the
corresponding provision of the European Patent Convention ("EPC"), the
United Kingdom courts must have regard to the decisions of the European
30 Patent Office on the construction of the EPC. It would be highly undesirable
for the provisions of the EPC to be construed differently in the European Patent
Office from the way they were interpreted in the national courts of a
Contracting State (p. 82).
(2) Article 54 of the EPC made it clear that to be part of the state of the
art, the "invention" must have been made available to the public. An invention
was a piece of information. Making matter available to the public within the
meaning of section 2(2) therefore required the communication of information.
The use of a product made the invention part of the state of the art only so far
40 as that use made available the necessary information. Under the 1977 Act a
patent could be used, subject to section 64, to stop someone doing what he had
done before if the previous use was secret or uninformative. Acts done secretly
or without knowledge of the relevant facts, which would amount to
infringements after the grant of the patent, would not count as anticipations
45 before (pp. 86-87).
35

PLG Research Ltd. v. Ardon International Ltd., [1993] RS.R. 197 at 225
(Aldous J.), and MobillFriction-reducing additive (Decision G02I88), [1990]
E.P. O.R. 73 at 88, approved.
50

78
Merrel Dow Pharmaceuticals Inc. and Anr.
v. H.N. Norton & Co. Ltd.

[1996] R.P.C.

(3) The same thing might be known under one description and not known
under another. Section 2(2) did not purport to confine the state of the art about
products to knowledge of their chemical composition. It was part of the state of
the art if the information which had been disclosed enabled the public to know 5
the product under a description sufficient to work the invention. For some
purposes, at least, products need not be known under their chemical description
in order to be part of the state of the art. If a recipe which inevitably produced
a substance was part of the state of the art, so was that substance as made by
that recipe. Whether or not a person was working a product invention was an 10
objective fact independent of what he knew or thought about what he was doing
(pp. 88, 89, 90).

BayerlDiastereoisomers (Decision T12/81), [1979-85J E.P.O.R. volume B 308

at 312, CPClFlavour concentrates (Decision T303/86), [1989J 2 E.P.O.R. 95 at 15
98, and Availability to the Public (Decision GO 1192), [1993J E.P.O.R. 241,
considered.
(4) In this case anticipation by use was similar to anticipation by
disclosure in that no one was aware that the product was being made. The 20
distinction here was that as regards the anticipation by use the acts relied upon
conveyed no information which would have enabled anyone to work the
invention but relied solely on the fact that the product had been made, while the
anticipation by disclosure relied upon the communication to the public of
information which enabled it to do an act having the inevitable consequence of 25
making the product (p. 90).
(5) In this case the "invention" was the making of the metabolite within the
human body by the ingestion ofterfenadine (p. 83).

30
Knowledge of the metabolite had been made available to the public by
the terfenadine specification. For many purposes the description was not
sufficient to make the product part of the state of the art. It would not enable
anyone to work the invention in the form of isolating or synthesising the
metabolite. But it enabled the public to work the invention by making the 35
metabolite in their livers. The fact that they would not have been able to
describe the chemical reaction in these terms did not mean that they were not
working the invention. For the purposes of the particular invention in issue, the
terfenadine specification contained sufficient information about the metabolite
40
to make it part of the state of the art (p. 90, 93).
(6)

(7) If anticipation by use was to be treated separately from anticipation by

disclosure, it must be assumed that the participants in the clinical trials took
terfenadine without being at liberty to discover its composition and produced
within themselves a substance which had not then been readily capable of being 45
identified but was now known to have been the metabolite. Under the Patents
Act 1949 such uninformative use would undoubtedly have invalidated the
patent, but under the 1977 Act the claim for the metabolite could not be
dismissed simply on the ground that making it was something that had been
50
done before (p. 85, 87).

Bristol-Myers Co. (Johnson's) Application, [1975J R.P.C. 127 (H.L.), referred

to.

79
[No. 3]

House of Lords

Lord Jauncey of Tullichettle

Lord Browne-Wilkinson

Observed:-

Liability for infringement was absolute. It depended upon whether the act in
5 question fell within the claims and not the alleged infringer s state of mind.
This doctrine was difficult to apply to a patent for the use of a known substance
in a known way for a new purpose. How did one tell whether the person
putting the additive into his engine was legitimately using it to inhibit rust or
infringing by using it to reduce friction (p. 92)?
10

MobilfFriction-reducing additive (Decision G02/88), [l990J E.P.O.R. 73,

referred to.
The following cases were referred to in the speech of Lord Hoffmann.
15

Availability to the Public (Decision GOlI92), [1993] E.P.O.R. 241, [1993]

O.J. E.P.O. 277.

BayerlDiastereoisomers (Decision T12l81), [1979-85] E.P.O.R. volume B

20 308, [1982] O.J. E.P.O. 296.
Bristol-Myers Co. (lohnson s) Application, [1975] RP.C. 127 (H.L.).
CPC/Flavour concentrates (Decision T303/86), [1989] 2 E.P.O.R. 95.
25
MobillFriction-reducing additive (Decision G02/88), [1990] E.P.O.R 73,
[1990] O.J. E.P.O. 93 and 469.
PLG Research Ltd. v. Ardon International Ltd., [1993] F.S.R. 197 (Aldous
30 J.).
This was an appeal to the House of Lords by Merrell Dow Pharmaceuticals
Inc. and Marion Merrell Dow Ltd. from the judgment dated 16 February 1994 of
the Court of Appeal ([1995] RP.C. 233) dismissing an appeal from the judgment
35 dated 23 June 1993 of Aldous J. in the Patents Court ([1994] R.P.C. 1) when in
actions for infringement of patent No. 2048258 against H.N. Norton & Co. Ltd.
and against Penn Pharmaceuticals Ltd. and Generics (UK) Ltd. he found the
patent invalid and ordered it to be revoked.
40

Simon Thorley Q. C. and Andrew Waugh, instructed by Bird & Bird, appeared
for the appellants. Christopher Floyd Q.c. and Henry Whittle, instructed by
Roiter Zucker, appeared for the respondent H.N. Norton & Co. Ltd. Alastair
Wilson Q.c. and Colin Birss, instructed by S.J. Berwin & Co., appeared for the
respondents Penn Pharmaceuticals Ltd. and Generics (UK) Ltd.

45
Lord Jauncey of Tullichettle:- 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.

50

Lord Browne-Wilkinson:- 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.

80
Lord Mustill
Merrell Dow Pharmaceuticals Inc. and Anr.
Lord Lloyd of Berwick v. H.N. Norton & Co. Ltd.
Lord Hoffmann

[1996] R.P.C.

Lord Mustill:- 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
~~

Lord Lloyd of Berwick:- 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.
10

Lord Hoffmann:-

1. The Patent in Suit

Merrell Dow Pharmaceuticals Inc. is a U.S. company with a United Kingdom 15
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. 20
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 25
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 30
composition of the acid metabolite formed in the liver. Its chemical name is 4-[4(4-hydroxydiphenylmethyl-I-piperidinyl)-I-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
35
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(l)(a) of the Act of 1977. Merrell 40
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(l)(a). It is not however alleged to be an infringement,
because section 60(5)(a) exempts any act "done privately and for purposes which 45
are not commercial." Nevertheless, say Merrell Dow, another pharmaceutical
company cannot supply terfenadine to the public without infringing under section
60(2):
50

81
[No. 3]

10

House of Lords

Lord Hoffman

"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 the 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,
15 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 1977 because it is not subject to licences
of right.
20
3. The Proceedings
Merrell Dow has commenced two actions for infringement against other
pharmaceutical companies. This appeal comes before your Lordships' House in
25 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
30 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. 1 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
35 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

40

45

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 defmes 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.
[1994] R.P.C. 1

50

2 [1995] R.P.C. 233

82
Lord Hoffmann MerreU Dow Pharmaceuticals Inc. and Anr.
v. H.N. Norton & Co. Ltd.

[1996] R.P.C.

(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 10
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.
15
(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 flling of the European patent application."
20
It is therefore the duty of the United Kingdom 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 United Kingdom but they are of great persuasive authority; first, because they 25
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.
30

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 35
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 40
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 45
patented product. Liability is absolute.
The corollary of this principle is that the novelty of the invention must be coextensive 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 50

83
[No. 3]

House of Lords

Lord Hoffinann

not new.
As the Enlarged Board of Appeal of the EPO said in its
MOBIUFriction reducing additive Decision G02/88 [1990] E.P.O.R. 73, 83:
5

10

"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
15 human body. It may be possible for Merrell Dow to amend the specification to
exclude manufacture in this manner and form. In ordering the patent to be
revoked, Aldous J. granted a stay pending an application to amend. Your
Lordships need not therefore be concerned with the fact that a good deal of
ground covered by the patent is admittedly new. The argument may proceed as if
20 the invention were confmed to making the acid metabolite in the manner and form
which the respondents challenge. In the rest of this judgment, when I speak of
"the invention," I shall therefore mean the making of the acid metabolite within
the human body by the ingestion of terfenadine.

25 6. The Intuitive Response

Mr. Thorley Q.C., who appeared for Merrell Dow, realistically acknowledged
that a United Kingdom patent lawyer's intuitive response to this claim was likely
to be one of incredulity. A patent is granted for a new invention. But in 1980
30 there was nothing new about terfenadine. Full information about its chemical
composition and method of use had been published in its patent specification in
1972. Participants in clinical trials had actually been taking the drug. Making
and using terfenadine was therefore part of the state of the art. What did the acid
metabolite patent teach the person who was using terfenadine? It gave him some
35 information about how the product worked in terms of chemical reactions within
the body. But it did not enable him to do anything which he had not been doing
before.
Why, therefore, should the later patent confer a right to stop people from doing
40 what they had done before? Ever since the power of the Crown to grant
monopolies was curbed by parliament and the courts at the beginning of the
seventeenth century, it has been a fundamental principle of United Kingdom
patent law that the Crown could not grant a patent which would enable the
patentee to stop another trader from doing what he had done before. In this case
45 it so happens that Merrell Dow held both the terfenadine patent and the acid
metabolite patent. So the problem did not emerge until the first patent had
expired. But the argument would have been exactly the same if someone else had
discovered and patented the acid metabolite. If Mr. Thorley is right, he would
have been entitled to stop MerreIl Dow selling terfenadine.
50

84

Lord Hoffmann Merrell Dow Pharmaceuticals Inc. and Anr. [1996] R.P.C.
v. H.N. Norton & Co. Ltd.
Other extraordinary consequences were discussed in argument. Someone
discovers an interesting looking chemical and patents it. It is later discovered that
this chemical is made in a temporary and unstable form during the cooking of a
well-known dish according to a recipe in Elizabeth David. Can the patentee bring
infringement proceedings against anyone who uses the recipe on a commercial
scale? Examples to reinforce one's initial incredulity could be multiplied.
Mr. Thorley meets these arguments head-on. He says that the 1977 Act
overturned the previous principles of United Kingdom patent law. It was passed,
as its long title said, to introduce a new law of patents. Under the EPC, it is no
longer the case that a patent cannot enable the patentee to stop someone doing
what he has done before. Under the defmition of the state of the art in section
2(2), it is not enough that something should have been done before. It requires
that information about what was being done should have been made available to
the public. In this case, Mr. Thorley says that no information about the acid
metabolite had been made available to the public before the priority date of the
later patent. Parliament, says Mr. Thorley, was aware that this change of
principle might produce hardships and anomalies. It provided to some extent for
such cases in section 64 of the 1977 Act. This gives a person who, before the
priority date, was doing or making effective and serious preparations to do an act
which would have been an infringement if the patent was in force, a personal
right to continue doing that act. But the section is narrowly drawn. It has no
application in this case because none of the defendants were marketing
terfenadine before the priority date of the acid metabolite patent. Nevertheless,
Mr. Thorley says that the very existence of section 64 shows that Parliament
recognised that the effect of the new law was that people might find themselves
unable to go on doing what they or someone else had done before.

10

15

20

25

These are serious arguments which cannot be dismissed simply on the grounds 30
that they produce results which seem contrary to common sense. I must therefore
invite your Lordships to look more closely at the grounds upon which the
respondents say that, although the acid metabolite as a chemical compound had
not previously been identified, its manufacture in the body by the ingestion of
terfenadine was nevertheless part of the state of the art.
35

7. Two Kinds of Anticipation?

An anticipation is the traditional English term for that part of the state of the
art which is inconsistent with the invention being new. The word is not used in 40
the 1977 Act but is nevertheless convenient. In this case, Mr. FIoyd Q.C., who
appeared for H.N. Norton & Co. Ltd., the respondents in the first appeal, said
that the invention had been anticipated in two ways. First, he said it had been
used before the priority date. According to the paragraph 5 of the joint Statement
of Facts and Issues put before your Lordships, "Terfenadine was made available 45
to and used by volunteers in clinical trials in 1977/1978." They had made the
acid metabolite in their livers and experienced its anti-histamine effects.
Secondly, Mr. FIoyd said before the priority date the invention had been disclosed
in the specification of the terfenadine patent. That was a publicly available
document which told one how to make terfenadine and that it should be taken for 50
its anti-histamine effect. The inevitable result of following those instructions was
to make the acid metabolite. I shall call these two arguments anticipation by use
and anticipation by disclosure.

85
[No. 3]

House of Lords

Lord Hotfmann

8. Anticipation by Use

Mr. Floyd Q.C. did not put antIcIpation by use in the forefront of his
5 argument. His main submission was based on disclosure in the terfenadine
specification.
Mr. Alastair Wilson Q.C., who appeared for Penn
Pharmaceuticals Ltd. and Generics (UK) Ltd., the respondents in the second
appeal, did not argue anticipation by use at all. I nevertheless propose to deal
with it first, because I think that the discussion may illuminate the issues which
10 arise on the alternative argument.
It is important to notice that anticipation by use relies solely upon the fact that
the volunteers in the clinical trials took terfenadine and therefore made the acid
metabolite. There is no suggestion in the Agreed Statement of Facts and Issues
15 that the volunteers were also at liberty to analyse the terfenadine to discover its
composition. If it was open to them to have done so, they would have been in the
same position as if they had read the terfenadine specification and the arguments
for anticipation by use would have been the same as for anticipation by
disclosure. If anticipation by use is to be treated as a separate argument, it must
20 be assumed that the volunteers were given terfenadine capsules by employees of
Merrell Dow for the sole purpose of swallowing them. They took them without
knowing their composition and produced within themselves a substance which
was not then readily capable of being identified but is now known to have been
the acid metabolite.
25
(a) The Old Law

30

35

40

45

50

I think that there can be no doubt that under the Patents Act 1949,
uninformative use of the kind I have described would have invalidated the patent.
One of the grounds for revocation in section 32(1) was (e): ''the invention ... is
not new having regard to what was known or used, before the priority date of the
claim, in the United Kingdom." (Emphasis added) Ground 32(1)(i) was that
before the priority date the invention was "secretly used" in the United Kingdom.
In Bristol-Myers Co. (Johnson's) Application [1975] R.P.C. 127 this House
decided that use included secret or otherwise uninformative use. (I distinguish
between secret and uninformative use because the House decided by a majority
that "secret" meant that information about the invention had been deliberately
concealed. It did not include a case in which the manufacturer was also unaware
of the relevant facts.) Bristol-Myers had applied for a patent with a product
claim for an ampicillin compound which was found to be more stable than
alternative forms. Beechams were able to show, from samples providentially
retained, that before the priority date they had made some quantities of that
particular compound, although at the time they did not know or care which
ampicillin compound it was and were unaware of the advantages discovered by
Bristol-Myers. Furthermore, they had marketed the ampicillin in a form which
made it impossible to discover what the original compound had been. Thus the
anticipation upon which Beechams relied conveyed no relevant information about
the product to the general public. The compound in the hands of the reasonably
skilled member of the public told him nothing about its distinctive chemical form
or how he could make it or what the advantages of that form would be.
Nevertheless, the compound was anticipated by use.

86
Lord Hoffinann Merrell Dow Pharmaceuticals Inc. and Anr. [1996] R.P.C.
v. H.N. Norton & Co. Ltd.
The reasoning of the House was founded upon two principles of the old United
Kingdom patent law. The first, to which I have already referred, was that the
Crown could not grant a patent. which would enable the patentee to stop another
trader from doing what he had done before. It did not matter that he had been 5
doing it secretly or otherwise uninformatively. The second was that the test for
anticipation before the priority date was in this respect co-extensive with the test
for infringement afterwards. If the use would have been an infringement
afterwards, it must have been an anticipation before. For the purpose of
infringement, it was not necessary that the defendant should have realised that he 10
was doing an infringing act. Such knowledge was therefore equally unnecessary
for anticipation.
(b) The New Law

15
Mr. Floyd submitted that Bristol-Myers Co. (Johnsons) Application was still
good law. In section 2(2), the state of the art comprised "all matter," which could
be "a product, a process, information about either, or anything else" which had
been "made available to the public" in any way, including by "use." Mr. Floyd
said that "all matter" must include products or processes which conveyed no 20
information about themselves. Otherwise, why make separate mention of
"information about either"? The product itself therefore counted as part of the
state of the art and could be made available to the public by use. Thus the acid
metabolite had been made available to the public by use, even though such use
conveyed no information to the public about the nature of the product or how to 25
make it.
I think that this argument, which in any event depends upon a rather refined
inclusio unius construction of the parenthetical expansion of the words "all
matter," dissolves completely when one looks, as one must, at Article 54. This 30
provision makes it clear that to be part of the state of the art, the invention must
have been made available to the public. An invention is a piece of information.
Making matter available to the public within the meaning of section 2(2)
therefore requires the communication of information. The use of a product makes
the invention part of the state of the art only so far as that use makes available the 35
necessary information.
The 1977 Act therefore introduced a substantial qualification into the old
principle that a patent cannot be used to stop someone doing what he has done
before. If the previous use was secret or uninformative, then subject to section 40
64, it can. Likewise, a gap has opened between the tests for infringement and
anticipation. Acts done secretly or without knowledge of the relevant facts,
which would amount to infringements after the grant of the patent, will not count
as anticipations before.
45
This construction of section 2(2) is supported by a number of authorities both
in the courts of this country and the EPO. I shall refer to only two. In PLG
Research Ltd. v. Ardon International Ltd. [1993] ES.R. 197, 225, Aldous J.
said:
50
"Mr. Thorley submitted that if a product had been made available to the
public, it was not possible thereafter to patent the product whether claimed as

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15

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Lord Hoffinann

a product claim or a product-by-process claim. That submission is too broad.

Under the 1977 Act, patents may be granted for an invention covering a
product that has been put on the market provided the product does not provide
an enabling disclosure of the invention claimed. In most cases, prior sale of
the product will make available infonnation as to its contents and its method
of manufacture, but it is possible to imagine circumstances where that will not
happen. In such cases a subsequent patent may be obtained and the only
safeguard given to the public is section 64 of the Act."
And in MOBIUFriction reducing additive Decision G02/88 [1990] E.P.O.R.
73 the Enlarged Board of Appeal of the EPO said (at page 88):
"[T]he Enlarged Board would emphasise that under Article 54(2) EPC the
question to be decided is what has been 'made available' to the public: the
question is not what may have been 'inherent' in what was made available (by
a prior written description, or in what has previously been used (prior use), for
example). Under the EPC, a hidden or secret use, because it has not been
made available to the public, is not a ground of objection to [the] validity of a
European patent. In this respect, the. provisions of the EPC may differ from
the previous national laws of some Contracting States, and even from the
current national laws of some non-Contracting States. Thus, the question of
'inherency' does not arise as such under Article 54. Any vested right derived
from prior use of an invention is a matter for national law ..."
Mr. Thorley is therefore right in saying that his claim cannot be dismissed simply
on the ground that making the acid metabolite is something which has been done
before. To that extent, the intuitive response is wrong.

30 9. Anticipation by disclosure
I turn therefore to the ground upon which the respondents succeeded before
Aldous J. and the Court of Appeal, namely that the disclosure in the terfenadine
specification had made the invention part of the state of the art. This is different
35 from the argument on anticipation by use because it relies not upon the mere use
of the product by members of the public but upon the communication of
information. The question is whether the specification conveyed sufficient
information to enable the skilled reader to work the invention.
40

Mr. Thorley says that no one can know about something which he does not
know exists. It follows that if he does not know that the product exists, he
cannot know how to work an invention for making that product in any form. The
prior art contained in the terfenadine specification gave no indication that it
would have the effect of creating the acid metabolite in the human body.
45 Therefore it did not contain sufficient information to enable the skilled reader to
make the substance in that or any other form. It did not make the acid metabolite
available to the public.
What does Mr. Thorley mean when he says that no one knew that the acid
50 metabolite existed? What MerreIl Dow's research revealed was that something
was created in the liver which could be given a chemical description. But the
same thing may be known under one description and not known under another.

88
Lord Hotlinann Merrell Dow Phannaceuticals Inc. and Anr. [1996] R.P.C.
v. H.N. Norton & Co. Ltd.

For example, the inhabitants of a village may know the elderly gentleman of
military bearing as a prize-winning rose grower without knowing that he had won
the VC in the war. In answer to the question: "Do you know the holder of the VC
in your village?" they would truthfully answer "I did not know that such a person
existed".

There is an infinite variety of descriptions under which the same thing may be
known. Things may be described according to what they look like, how they are
made, what they do and in many other ways. Under what description must it be 10
known in order to justify the statement that one knows that it exists? This
depends entirely upon the purpose for which the question is being asked. Let me
elaborate upon an example which was mentioned in argument. The Amazonian
Indians have known for centuries that cinchona bark can be used to treat malarial
and other fevers. They used it in the form of powdered bark. In 1820, French 15
scientists discovered that the active ingredient, an alkaloid called quinine, could
be extracted and used more effectively in the form of sulphate of quinine. In
1944, the structure of the alkaloid molecule (C:zoH~202) was discovered. This
meant that the substance could be synthesised.
20
Imagine a scientist telling an Amazonian Indian about the discoveries of 1820
and 1944. He says: "We have found that the reason why the bark is good for
fevers is that it contains an alkaloid with a rather complicated chemical structure
which reacts with the red corpuscles in the bloodstream. It is called quinine."
The Indian replies: "That is very interesting. In my tribe, we call it the magic 25
spirit of the bark." Does the Indian know about quinine? My Lords, under the
description of a quality of the bark which makes it useful for treating fevers, he
obviously does. I do not think it matters that he chooses to label it in animistic
rather than chemical terms. He knows that the bark has a quality which makes it
30
good for fever and that is one description of quinine.
On the other hand, in a different context, the Amazonian Indian would not
know about quinine. If shown pills of quinine sulphate, he would not associate
them with the cinchona bark. He does not know quinine under the description of
a substance in the form of pills. And he certainly would not know about the 35
artificially synthesised alkaloid.
I recognise that there is a distinction between cinchona bark and terfenadine.
The former is a substance occurring in nature and the latter is an artificial
product. This might have been relevant if the medicinal qualities of the bark had 40
been unknown and a person who discovered them had tried to patent the bark or
the natural alkaloid. But the distinction is not material to the present question,
which is essentially an epistemological one: what does it mean to know
something, so that it can be part of the state of the art? The quinine example
shows that there are descriptions under which something may in a relevant sense 45
be known without anyone being aware of its chemical composition or even that it
has an identifiable molecular structure. This proposition is unaffected by whether
the substance is natural or artificial.
So far I have been considering what it means to know about something in 50
ordinary everyday life. Do the same principles apply in the law of patents? Or
does patent law have a specialised epistemology of its own? Mr. Thorley argues

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Lord Hoffmann

that it does. He says that for a substance to be known so as to be part of the

state of the art within the meaning of section 2, it must be known (or be readily
capable of being known) by its chemical composition. No other description will
5 do. He says that by 1977 the science of chemistry had advanced so far that the
chemical composition of virtually everything was either known or readily
ascertainable by analysis. Therefore the legislature assumed that knowledge that
something existed could safely be equated with knowledge of its chemical
composition. Section 64 would provide a safety net for people like Amazonian
10 Indians who were doing things with substances which did not readily yield to
analysis.
My Lords, I think that on this point the Patents Act 1977 is perfectly clear.
Section 2(2) does not purport to confine the state of the art about products to
15 knowledge of their chemical composition. It is the invention which must be new
and which must therefore not be part of the state of the art. It is therefore part of
the state of the art if the information which has been disclosed enables the public
to know the product under a description sufficient to work the invention.
20

For most of the purposes of a product claim, knowledge of its chemical

composition will be necessary to enable the public to work the invention. It is
something they will need to know in order to be able to make it. So in
Availability to the Public Decision GOJ/92 [1993] E.P.O.R. 241 the President of
the EPO referred to the Enlarged Board of Appeal the question of the
25 circumstances in which making a product available to the public would count as
making available its chemical composition. The Board answered that the
composition or internal structure of a product becomes part of the state of the art
if it is possible for a skilled person to discover it and reproduce it without undue
burden. Mr. Thorley took this case to mean that in no context can a product be
30 part of the state of the art unless its chemical composition is readily discoverable.
But that is not what the case says. The Board was asked about the
circumstances in which the chemical composition of a product becomes part of
the state of the art. It was not asked about the circumstances in which knowing
its chemical composition was necessary for the purpose of treating the product as
35 part of the state of the art.
Other decisions of the EPO seem to me to make it clear that, at least for some
purposes, products need not be known under their chemical description in order
to be part of the state of the art. In BAYERlDiastereomers Decision T12/8J
40 [1979-85] E.P.O.R. Vo!. B. 308, 312, the Technical Board of Appeal said:

45

50

". . . [T]he concept of novelty must not be given such a narrow interpretation
that only what has already been described in the same terms is prejudicial to it.
The purpose of Art. 54( 1) EPC is to prevent the state of the art being patented
again. Art. 54(2) EPC defines the state of the art as comprising everything
made available to the public before the date of filing in any way, including by
written description. There are many ways of describing a substance in
chemistry and this is usually done by giving its precise scientific designation.
But the latter is not always available on the date of filing . . . [It] is the
practice of a number of patent offices to accept the process parameter, in the
form of a product-by-process claim, for closer characterisation of inventions
relating to chemical substances. To the Board's knowledge this is also the

90
Lord Hoffmann MerreII Dow Phannaceuticals Inc. and Anr. [1996] R.P.C.
v. H.N. Norton & Co. Ltd.
practice at the European Patent Office. If inventions relating to chemical
substances defined by claims of this kind are patented, it necessarily follows
that the resulting patent documents, once they enter the state of the art, will be
prejudicial to the novelty of applications claiming the same substance although
in a different and perhaps more closely defined form."

In other words, if the recipe which inevitably produces the substance is part of
the state of the art, so is the substance as made by that recipe. CPCIFlavour
Concentrates Decision T303186 [1989] 2 E.P.O.R. 95 was a case about actual 10
recipes for cooking. The application was to patent a process for making flavour
concentrates from vegetable or animal substances by extraction with fat solvents
under pressure in the presence of water. The claim specified certain parameters
for the ratio between the vapour pressure of the water in the meat or vegetables
and the vapour pressure of the free water. Opposition was based upon two cook- 15
book recipes for pressure-frying chickens and making stews which in nontechnical terms disclosed processes having the same effect. The. Technical Board
of Appeal said (at page 98):
..It is sufficient to destroy the novelty of the claimed process that this process 20
and the known process are identical with respect to starting material and
reaction conditions since processes identical in these features must inevitably
yield identical products."

Furthermore, it did not matter that the cook did not realise that he was not only 25
frying a chicken, but also making a "flavour concentrate" in the surplus oil. It
was enough, as the Board said, that "some flavour of the fried chicken is
extracted into the oil during the frying process even if this is not the desired result
of that process."
30
Mr. Thorley said that CPCIFlavour Concentrates can be explained on the
ground that the flavour concentrates as made according to the cooking recipes
could have been analysed and chemically identified. Perhaps they could. But this
was not the ground for the Board's decision. It proceeded on the basis that for
the purpose of being part of the state of the art, a process for making flavour 35
concentrates was sufficiently described by a recipe for cooking food which did
not expressly refer to the flavour concentrates but would inevitably have the
effect of making them.
In this case, knowledge of the acid metabolite was in my view made available 40
to the public by the terfenadine specification under the description "a part of the
chemical reaction in the human body produced by the ingestion of terfenadine and
having an anti-histamine effect". Was this description sufficient to make the
product part of the state of the art? For many purposes, obviously not. It would
not enable anyone to work the invention in the form of isolating or synthesising 45
the acid metabolite. But for the purpose of working the invention by making the
acid metabolite in the body by ingesting terfenadine, I think it plainly was. It
enabled the public to work the invention by making the acid metabolite in their
livers. The fact that they would not have been able to describe the chemical
reaction in these terms does mean that they were not working the invention. 50
Whether or not a person is working a product invention is an objective fact
independent of what he knows or thinks about what he is doing. (The position

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Lord Hoftinann

may be different when the invention is a use for a product; in such a case, a
person may only be working the invention when he is using it for the patented
purpose: see the discussion of the MOBIUFriction reducing additive case in the
5 next section). The Amazonian Indian who treats himself with powdered bark for
fever is using quinine, even if he thinks that the reason why the treatment is
effective is that the tree is favoured by the Gods. The teachings of his traditional
medicine contain enough information to enable him to do exactly what a scientist
in the forest would have done if he wanted to treat a fever but had no supplies of
10 quinine sulphate. The volunteers in the clinical trials who took terfenadine were
doing exactly what they would have done if they had attended Merrell Dow's
Strasbourg symposium and decided to try making the acid metabolite in their
livers by ingesting terfenadine.
15

It may be helpful at this point to highlight the similarities and the distinctions
between the case for anticipation by use, which I have rejected, and the case for
anticipation by disclosure, which I have accepted. In both cases no one was
aware that the acid metabolite was being made. In the case of anticipation by
use, however, the acts relied upon conveyed no information which would have
20 enabled anyone to work the invention, i.e. to make the acid metabolite. The
anticipation in this form relies solely upon the fact that the acid metabolite was
made, as the anticipation in Bristol-Myers Co. (Johnson's) Application relied
solely upon the fact that ampicillin trihydrate had been made and sold to the
public. It disavows any reliance upon extraneous information, such as the
25 formula for making terfenadine and the instructions to take it for its antihistamine effect. Anticipation by disclosure, on the other hand, relies upon the
communication to the public of information which enables it to do an act having
the inevitable consequence of making the acid metabolite. The terfenadine
specification teaches that the ingestion of terfenadine will produce a chemical
30 reaction in the body and for the purposes of working the invention in this form,
this is a sufficient description of the making of the acid metabolite. Under the
description the acid metabolite was part of the state of the art.

10. The MOBIUFriction reducing additive case

35
Mr. Thorley claimed support from the decision of the Enlarged Board of
Appeal, to which I have already referred, in MOBIUFriction reducing additive
Decision G02/88 [1990] E.P.O.R. 73. Mobil had attempted to patent a
40 substance for use as a friction reducing additive in lubricating oil. This was
opposed by Chevron, who were able to show that the substance was already
known and in use for inhibiting rust-formation in ferrous metal. There was no
dispute that this put an end to the product claim, which would have entitled
Mobil to a monopoly of the product for every possible use. But Mobil then
45 applied to amend the application to restrict it to the use of the substance for
reducing friction, saying that its usefulness for this purpose had not been
previously appreciated. The Technical Board of Appeal, hearing an appeal by
Mobil from a successful opposition by Chevron, referred three questions to the
Enlarged Board of Appeal, of which the third was:
50

92
Lord Hoffmann

Merrell Dow Pharmaceuticals Inc. and Anr. [1996] R.P.C.

v. H.N. Norton & Co. Ltd.

"Is a claim to the use of a compound for a particular non-medical purpose

novel for the purpose of Art 54 EPC, having regard to a prior publication
which discloses the use of that compound for a different non-medical purpose,
so that the only novel feature in the claim is the purpose for which the
compound is used?"

(The reference to "non-medical" purpose is because patents for a second use of

medical products give rise to certain special problems under the EPC. It can for
present purposes be ignored.)
10
The Enlarged Board accepted Chevron's submission that while using an old
substance in a new way to achieve a new purpose might be novel, the use of an
old substance in an old way to achieve a new purpose would not. In the latter
case, the only difference would lie in the mind of the user: he would be doing the 15
same thing with the same substance but with a different purpose in mind. One
might expect this to lead to the conclusion that if the additive was the same and it
was being used in the same way (e.g. by pouring it into the engine) then an
attempt to patent its use as a friction reducer when it was previously thought only
20
to inhibit rust should fail.
The Enlarged Board went on to say, however, that a claim for the use of an old
compound in an old way for a new purpose (B) could be interpreted to include
"the function of achieving purpose B (because this is the technical result)." In
such case, the fact that the substance achieved that purpose would be an objective 25
"functional technical feature" of the invention, not residing only in the mind of the
user. Thus the fact that the substance did reduce friction was a new technical
feature which, if novel, could constitute a patentable invention.
I think it is fair to say that, in the United Kingdom at least, this aspect of the 30
Enlarged Board's decision has been criticised on the ground that a patent for an
old product used in an old way for a new purpose makes it difficult to apply the
traditional United Kingdom doctrine of infringement. Liability for infringement
is, as I have said, absolute. It depends upon whether the act in question falls
within the claims and pays no attention to the alleged infringer's state of mind. 35
But this doctrine may be difficult to apply to a patent for the use of a known
substance in a known way for a new purpose. How does one tell whether the
person putting the additive into his engine is legitimately using it to inhibit rust or
infringing by using it to reduce friction? In this appeal, however, we are not
concerned with this aspect of the case. The part upon which Mr. Thorley relies is 40
the decision that the claimed technical feature, i.e. the friction reducing quality,
was novel even though it was 'inherent' in the substance. The Enlarged Board
said, in a passage which I have already quoted:
". . . under Article 54(2) EPC the question to be decided is what has been 45
'made available' to the public: the question is not what may have been
'inherent' in what waS made available (by a prior written description, or in
what has previously been used (prior use), for example). Under the EPC, a
hidden or secret use, because it has not been made available to the public, is
not a ground of objection to [the] validity of a European patent."
50

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Lord Hoffmann

My Lords, I do not think that this principle is in issue in this appeal. I have
accepted it fully in the discussion of anticipation by use, in which the above
passage has already been quoted. It was applied by the Technical Board of
5 Appeal to the facts of MOBIL IFriction reducing additive when that case went
back to the Technical Board of Appeal after the decision in principle by the
Enlarged Board: see [1990] E.P.O.R. 514. The Technical Board decided that so
far as friction reduction had been an inevitable concomitant of the use of the
additive for other purposes, it was a case of uninfonnative use like Bristol-Myers
10 Co. (Johnson's) Application. Or to put the same thing in another way, a
description of the product by its chemical composition or as "something in the
lubricating oil which inhibits rust formation" or any other of the descriptions
under which it was previously known would not enable anyone to use if for the
purpose of reducing friction, even though this would be the inevitable
15 consequence of doing so. It did not therefore prevent the invention in the form
sanctioned by the Enlarged Board from being novel.
But the argument in this appeal for anticipation by disclosure involves no
"doctrine of inherency". It does not claim that the acid metabolite must be
20 deemed to have been made available by the teachings of the terfenadine patent
even though all information about it remained hidden. It claims instead that the
acid metabolite was sufficiently disclosed under the description "an antihistamine chemical reaction in the human body which occurs after taking
terfenadine". The respondents say that for the purposes of the particular
25 invention in issue, the specification contained sufficient information about the
acid metabolite to make it part of the state of the art. For the reasons I have
given, I think it did. I would therefore dismiss the appeal.
30

35

40

45

50