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Case No: A2/1999/1278
IN THE SUPREME COURT OF JUDICATURE
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM CHANCERY DIVISION
MR JUSTICE LADDIE
Royal Courts of Justice
Strand, London, WC2A 2LL
Date: 27th July 2000
B e f o r e :
LORD JUSTICE SIMON BROWN
LORD JUSTICE ALDOUS
and
LORD JUSTICE SEDLEY
(1) American Home Products Corporation
(2) Professor Roy Calne
(Claimants/Respondents)
AND
(1) Novartis Pharmaceuticals UK Limited
(2) Novartis Pharma AG
(Defendants/Appellants)
- - - - - - - - - - - - - - - - - - - - -
(Transcript of the Handed Down Judgment of
Smith Bernal Reporting Limited, 190 Fleet Street
London EC4A 2AG
Tel No: 020 7421 4040, Fax No: 020 7831 8838
Official Shorthand Writers to the Court)
- - - - - - - - - - - - - - - - - - - - -
Henry Carr QC and Piers Acland (instructed by Bristows for the
Defendant/Appellants)
John Baldwin QC and Michael Tappin (instructed by Linklaters for the
Claimants/Respondents)
- - - - - - - - - - - - - - - - - - - - -
Judgment
As Approved by the Court
Crown Copyright ©
ALDOUS LJ:
1. The appellants, Novartis Pharmaceuticals UK Limited and Novartis Pharma AG,
are defendants in a patent action. There is no need to differentiate between
them and I will refer to them as Novartis. They are also claimants in an
action for a declaration of non-infringement.
2. The respondents are Professor Sir Roy Calne and American Home Products
Corporation. Professor Sir Roy Calne is the patentee of European Patent (UK)
0401747, the patent in issue, and American Home Products Corporation are the
exclusive licensees which work the invention the subject of that patent. Again
there is no need to differentiate between them and I will refer to them as the
patentees.
3. The parties to the action agreed that the issues of infringement and
insufficiency should be tried first and the remaining attacks upon validity and
the issue of whether both the Novartis companies infringed should be stood over
to be heard at a later date. That course was acceptable to the Court and
therefore those issues came on for trial before Laddie J. In his judgment
([2000] RPC 547) he held the patent infringed and that the allegation of
insufficiency failed. He therefore refused to make the declaration of
non-infringement that was sought.
4. The patent is based upon the discovery by Professor Sir Roy Calne that a
product, produced by the bacterium streptomyces hygroscopicus, called
rapamycin, was useful to suppress transplant rejection. Rapamycin was at the
priority date of the patent, 6th June 1989, known to have antifungal and
antitumour properties.
5. Because rapamycin was a known product at the priority date, it could not be
patented: neither could its use as a treatment, because that would offend
section 4(2) of the Patents Act 1977. For those reasons the main claims of the
patent followed the form known as "Swiss type" which is used to claim an
invention for a second medical use. Claim 1 therefore claims as inventive:
"1. Use of rapamycin for the preparation of a medicament for inhibiting organ
or tissue transplant rejection in a mammal in need thereof."
6. The basic issue raised in this appeal revolves around the alleged
infringement. Novartis have produced an immunosuppressant which is referred to
as SDZ RAD. It is a derivative of rapamycin. The judge upheld the patentees
contention that it fell within the ambit of claim 1. Novartis contend that he
was wrong and that the claims of the patent do not cover a derivative such as
SDZ RAD. If they do, then the patent is invalid as "the specification of the
patent does not disclose the invention clearly enough and completely enough for
it to be performed by a person skilled in the art" (section 72(1)(c)). In
essence they contend that if the claims were to be construed as the patentees
contend, the specification would be insufficient as there is no disclosure in
the specification of how to make or select derivatives of rapamycin to prepare
a medicament "suitable for inhibiting organ or tissue transplant rejection in a
mammal" as required by claim 1.
7. The technical background to the invention and the technical information
needed to understand the dispute were set out by the judge with clarity. I
gratefully adopt them in full.
"Technical background
(a) Transplant rejection
2. The patent and this case are concerned with medicaments which are or may be
of use in the treatment of patients who have undergone surgical transplants.
Save for the case of identical twins, each of us has a genetic make up which is
different from everyone else. If living tissue, such as a heart or kidney, is
taken from one person and is transplanted into another, the recipient's immune
system is likely to recognise the transplant as foreign. It will automatically
try to attack and exclude or kill the intruder. If this happens the transplant
is said to be rejected. This problem can be reduced to some extent by selecting
a donor whose genetic makeup is very similar to that of the recipient. For
example close relatives may have very similar tissues. If this is done the
transplant will look only a little bit foreign to the recipient's immune system
and the rejection may not be so severe. However, even if this is done, the
immune system in the recipient is still likely to try to reject the graft. For
this reason it is currently necessary to use drugs which weaken the immune
response of the recipient. Such drugs are called immunosuppressants.
3. Although a number of immunosuppressants are known and used they vary in
efficacy and, to a greater or lesser degree, cause undesirable side-effects in
the recipient. It is common to use a cocktail of such immunosuppressants. At
the date of the patent in suit three types of immunosuppressant in particular
were used, frequently together. They are azathioprine, a group of chemicals
known as corticosteroids and cyclosporin. Cyclosporin is the most powerful of
these but it is nephrotoxic, that is to say it is capable of poisoning kidney
tissue. It is not in dispute that scientists have been searching for additional
and preferably better drugs to use as transplant rejection inhibitors.
(b) Biological activity
4. Living organisms contain numerous complicated molecules. A molecule is made
up of number of different atoms, such as carbon, hydrogen and oxygen connected
together in a particular arrangement. It is convenient and conventional to draw
a molecule's structure by showing a flat plan of the atoms connected together.
For example, benzene, which is made up of a ring of 6 interconnected carbon
atoms (C) each of which is connected to one hydrogen atom (H) can be depicted
as follows:
Illustration 1:
Click here for Picture
5. This is highly stylised and merely indicates which atoms are connected to
which, rather like the map of the London Underground system. In fact, just like
the stations in the London Underground, the atoms are usually not all in one
plane. Most large organic molecules take up a complicated three-dimensional
form. This is referred to as the molecule's tertiary structure or conformation.
It is the nature of the atoms in the molecule and the forces which exist
between them which twists the molecules into their sometimes complicated
three-dimensional shapes. There are numerous molecules which have very specific
biological activities. Examples are antibiotics, enzymes and antibodies. It has
become recognised over time that in many cases the biological activity of these
molecules is largely dependent upon the molecule's shape. It is the ability of
a molecule to fit onto another molecule - for example on the surface of a
living cell - which allows it to perform or causes its biological function. For
example enzymes are large molecules, only particular parts of which, because of
their spatial relationship to one another, help to promote particular chemical
reactions. If the molecule is modified so as to alter significantly the shape
of that part of the molecule which is responsible for its biological action, it
may lose all or most of that activity. Although all analogies break down at
some point, the importance of the shape of a biologically active molecule can
be explained as follows. The molecule can be likened to a key. The complicated
shape of part of it (equivalent to the wards on the key) enables it to fit into
a complementary location (equivalent to the wards in the lock) on another
molecule: for example, on the surface of a cell. The interaction allows the
molecule to perform its biological function, just as the interfit between the
key and lock allows the former to operate the latter. If the part of the
molecule which has the important shape is modified, it may lose its ability to
interact with the other molecule. In much the same way, modification of the
shape of the `business end' of a key may make it incapable of fitting into or
operating the lock. On the other hand, altering a part of the molecule which
has little effect on the shape of the interfitting parts has little effect on
biological activity. In much the same way, modification of the shape of the
shank or handle of a key is much less likely to stop it opening the lock.
6. Unlike the key and lock analogy, the interfit between a biologically active
molecule and its target is `soft'. Whereas a key either does or does not
operate a lock, in the case of biologically active molecules, the better the
fit the more active the molecule is.
7. A molecule may have more than one biological activity. Part may render it
poisonous, another part may make it an effective enzyme, a third may give it
hormonal properties and so on. Furthermore a molecule which through evolution
has developed to perform one particular biological function may happen to have
a shape which enables it to perform another, and unintended, function. For
example a molecule taken from one living system may have an entirely different
and unexpected effect on another living system, the shape of the molecule
bestowing on it activity which it either did not need or did not have in the
system from which it is derived. Once again, using the analogy of keys and
locks, it is as if a piece of shaped metal designed, say, as a paper-clip is
found by chance to have the necessary shape to fit and operate a lock.
8. A chemical discipline has grown up, called medicinal chemistry. The
expertise of a medicinal chemist was discussed by Professor Bycroft, himself a
medicinal chemist and Head of the Pharmacy School and of the School of
Pharmaceutical Sciences at the University of Nottingham, who gave evidence on
behalf of the claimants. He said that a medicinal chemist is typically an
organic chemist who has experience of synthesising organic molecules and is
involved in the study of structure-activity relationships of pharmacologically
active compounds i.e. the use of organic compounds (synthetic or natural) as
drug agents. The medicinal chemist has to have not only a knowledge of the
molecular chemistry of the compounds with which he is concerned but also a
`feel' for the biological effects, including the possible effects of
modifications. The medicinal chemist, by his experience and training, will
accordingly have and need to have a working knowledge of the various
disciplines which surround the strict organic chemistry concerned. A medicinal
chemist will also develop expertise in looking at the shape of molecules. As
the evidence in this trial showed, he would be expected to know in many cases
how the atoms within a molecule interact with each other spatially. For
example, he will know that some types of atom-to-atom bonds will twist or
modify the shape of the molecule in which they are located. Thus he may know
that a particular atom-to-atom bond in a particular location will make it
difficult for those atoms, and therefore the parts of the molecule immediately
adjacent to them, to twist or rotate in relation to each other as compared to a
different pairing of atoms at the same position in an otherwise identical
molecule.
...
10. In fact the molecule known as rapamycin was not discovered by Professor
Calne. It is produced naturally in a particular strain of bacterium called
Streptomyces hygroscopicus. It is a large molecule the structure of
which is depicted in two dimensions and schematically as follows:
Illustration 2:
Click here for Picture
11. The numbers 1 to 40, with the exception of 7, all represent carbon atoms
while 7 represents a nitrogen atom. Hydrogen atoms (H) bonded directly to
carbon atoms are not shown but it is readily apparent where they are, since it
is known that carbon has a valency of 4. Thus the carbon at position 12 has two
of its bonds occupied (by single bond connections to the carbon atoms at 11 and
13). It therefore has two free bonds. Each bond is capable of connecting to a
single hydrogen atom so there are two hydrogen atoms at this location. On the
other hand the carbon at 18 has three of its bonds shown as occupied. Therefore
there is a single remaining bond connected to a single hydrogen atom. If one
starts with the carbon atom indicated by 1, it will be seen that there is a
string of interconnected atoms all the way round to carbon 34. This is then
connected to carbon at 1 by an oxygen (O) atom. This therefore is a loop of
interconnected atoms. It is referred to as the macrolide ring. To it is
attached a side chain consisting of the part of the molecule containing carbons
35 to 40. The macrolide ring is therefore:
Illustration 3:
Click here for Picture
.....
The defendants' product
13. The defendants have also produced an immunosuppressant containing a
macrolide ring. It is referred to as SDZ RAD. It has the following
structure:
Illustration 4:
Click here for Picture
14. It is made by a two-step process in which the hydroxyl (OH) unit connected
to the carbon atom at position 40 on the side ring of rapamycin is O-alkylated
with a 2-hydroxyethyl group. Save in this respect, it has a chemical
composition which is identical to rapamycin. The proper chemical name for SDZ
RAD is 40-O-(2-hydroxyethyl)-rapamycin."
The judge also made these findings of fact:
"37. I do not think that there was much dispute between the parties and I find
as a fact that on reading the patent a skilled addressee would have understood
the following as a result of the content of the patent and common knowledge in
the art in the late 1980's:
(a) At that time it was very likely that the immunosuppressive effect
discovered by Professor Calne, like the biological activity in other known
large molecules, was dependent on the shape of the rapamycin molecule or a part
of it.
(b) The immune response is a multi-stage process, details of which were not
then (and even now are not) known. It was likely that rapamycin acted in the
second half of the process but where precisely and how was not known and would
be likely to take a long time to find out.
(c) The mechanism by which rapamycin worked was not known. That is to say, it
was not known what part or parts of the molecule gave it its efficacy nor was
the shape or location of the receptor sites in the molecules to which it
attached itself known.
(d) There was a strong probability that other molecules derived from rapamycin
would exhibit similar conformation in those areas which made rapamycin
efficacious and would also exhibit similar immunosuppressant activity. Put the
other way round, it was most unlikely that rapamycin was the only molecule of
similar shape which exhibited such efficacy although it was not possible to be
certain that this was so. As a corollary it was unlikely that Professor Calne
had happened to hit upon the only molecule within the large number of molecules
with similar composition and shape which happened to work.
(e) Similarly, it was unlikely that Professor Calne had struck upon the most
efficacious molecule.
(f) Whether any particular molecule derived from rapamycin would work at all
was impossible to predict with certainty.
(g) The number of possible derivatives of rapamycin is vast. It is almost
certain that many of them would not exhibit immunosuppresant activity: just as
it would not be possible to predict with certainty which derivatives have
immunosuppressant activity, it would not be possible to predict how many would
have such activity.
(h) It was likely, but not known, that the important part or parts of the shape
of the rapamycin molecule was or were to be found on the macrolide ring.
(i) It was at the time possible to make changes to rapamycin which would be
expected to produce little or no change to the shape of the macrolide ring and
others which would be expected to produce large changes to the shape of that
ring.
(j) Those derivatives of rapamycin which were most likely to work were those
which involved small changes to the side chain rather than changes to the
macrolide ring.
(k) A skilled addressee team would be able to make up a list of possible
derivatives with those most likely to exhibit immunosuppressive activity at the
top and those least likely to work at the bottom. Finding derivatives which
work would involve a systematic and progressive iterative process in which
different derivatives were made by modifying different parts of the rapamycin
molecule. That process would not be rapid or guaranteed of success.
(l) Even if a rapamycin derivative were produced which had immunosuppressant
activities, it would be impossible to be certain that it did not exhibit
unpredictable defects, such as toxicity, low rates of absorption and so on
which would render it unsuitable for clinical use. Discovering whether such
defects exist would involve testing, some of it in vivo, and
would take a long time."
8. The judge also held that "no-one in 1989 was able to set down on a piece of
paper with certainty what other derivatives work": even among the experts,
predicting which derivatives were most likely to work would produce different
lists of candidate molecules. Also, testing rapamycin, which included in vitro
and in vivo tests, was a lengthy and, no doubt, costly process. Doing the same
for a number of derivatives would be commensurably longer and more costly.
The Patent
9. The patent is entitled "Use of rapamycin and derivatives and prodrugs
thereof in the manufacture of a medicament for inhibiting transplant rejection
in mammals". At the outset the specification states that the invention relates
to the use of rapamycin for the preparation of a medicament for inhibiting
organ or tissue transplant rejection in mammals. It goes on to explain what
the judge set out in paragraph 3 of his judgment (see above). It then states,
page 3 lines 19 to 21, that:
"It would be extremely useful to discover a compound having immunosuppressive
activity which could be employed to increase transplant acceptance in a
recipient but without causing serious toxic side effects typically associated
with conventional immunosuppressant therapy, such as discussed above."
10. The patent continues with a review of what was known about rapamycin and
then comes to the object of the inventor which was to discover a compound
having increased immunosuppressant activity with low toxicity. There follows
on page 3 lines 43 to 47 this description of what the inventor discovered.
"The present inventor has discovered that rapamycin can be used for the
preparation of a medicament for inhibiting organ or tissue transplant rejection
in a mammal in need thereof.
The present inventor has also discovered a pharmaceutical composition
comprising (a) rapamycin in combination with (b) one or more other
chemotherapeutic agents for inhibiting transplant rejection selected from the
group consisting of azathioprine, corticosteroids, cyclosporin and FK-506."
11. The specification continues with two paragraphs relied on by the patentees
to support their submission that the word "rapamycin", when used in claim 1,
includes derivatives of rapamycin.
"Rapamycin is an antifungal antibiotic which is extractable from a
streptomycete, e.g. Streptomyces hygroscopicus. Methods for the
preparation of rapamycin are disclosed in Sehgal et al., US Patent Nos
3,929,992 and 3,993,749. In addition monoacyl and diacyl derivatives of
rapamycin and methods for their preparation are disclosed by Rakhit US Patent
No. 4,316,885. Furthermore, Stella et al., US Patent No. 4,650,803 disclose
water soluble prodrugs of rapamycin i.e. rapamycin derivatives including the
following rapamycin prodrugs: glycinate prodrugs, propionate prodrugs and the
pyrrolidino butyrate prodrugs.
The present invention includes the use of natural and synthetic rapamycin,
genetically engineered rapamycin and all derivatives and prodrugs of rapamycin,
such as described in the aforementioned US patents, US Patent Nos 3,929,992:
3,993,749: 4,316,885: and 4,650.803."
12. The specification goes on to explain that the inventor had noted the
efficacy of rapamycin in inhibiting transplant rejection e.g. by depressing the
immune system in mammals without the attendant toxic side-effects associated
with other conventional immunosuppressive agents. It also explains how
rapamycin can be used in combination with other drugs. To illustrate the
invention the specification sets out the results of studies that were conducted
using rapamycin on rats and pigs.
13. The specification ends with this conclusion:
"In conclusion, rapamycin is a very effective immunosuppressive agent which can
be employed to inhibit allograft transplantation rejection in mammalian
subjects."
14. There follows 11 claims of which only claim 1, 5 and 11 are relevant.
"1. Use of rapamycin for the preparation of a medicament for inhibiting organ
or tissue transplant rejection in a mammal in need thereof."
...
5. Use of rapamycin according to any one of claims 1 to 4, wherein said
medicament is formulated for administration of rapamycin to said mammal in an
amount of from 1 to 5 mg/kg/day.
...
11. A pharmaceutical composition for use as a medicament comprising a
combination of (a) rapamycin and (b) one or more chemotherapeutic agents from
the group consisting of azathioprine, corticosteroids, cyclosporin and
FK-506."
Infringement - the appeal
15. The main issues on the appeal depend upon the construction of claim 1.
The primary issue concerns the meaning of the word "rapamycin" in claim 1. In
particular, whether SDZ RAD, being a derivative of rapamycin, falls within the
claim.
16. Mr Baldwin QC, counsel for the patentees, submitted that claim 1 should be
read as meaning "rapamycin itself and derivatives thereof which exhibit the
same type of inhibition to organ rejection as rapamycin and which are suitable
for the preparation of a medicament for inhibiting organ or tissue transplant
rejection in a mammal." The judge, I think, construed claim 1 differently. He
construed the word "rapamycin" as including derivatives with the result that
the functional words in the claim limited it to rapamycin and its derivatives
which were suitable for preparation of a medicament which was suitable for
treating organ transplant rejection. He said in paragraph 46 of his
judgment:
"46. .... Notwithstanding the wording used in the claims, I have come to the
conclusion that the scope of protection afforded by the patent includes
derivatives of rapamycin. It does not, however, cover all derivatives. The
claims refer to the use of rapamycin in the preparation of "a medicament for
inhibiting organ or tissue transplant rejection". All the derivatives covered
by the claims must have similar utility. It follows that the scope of the
patent includes such derivatives of rapamycin as exhibit the same type of
inhibition to organ rejection as rapamycin itself does."
17. Novartis submitted that the claim when properly construed was limited to
use of rapamycin. They went on to submit that if its ambit was widened to
include derivatives, or rapamycin-like derivatives, the patent was invalid
because there was no sufficient disclosure to enable performance. I will come
to the submissions on insufficiency, but first I will construe claim 1.
18. This Court has explained in a number of cases the correct approach to
construction. The most recent is the explanation in paragraphs 18 to 26 of my
judgment in Wheatley v Drillsafe Limited C.A. 5th July 2000. I shall
adopt that approach.
19. In the present case, both parties put forward distinguished experts in the
field of chemistry, transplant medicine and toxicology. Some of them expressed
their views as to how the word "rapamycin" would be understood by them in the
context of claim 1. Not surprisingly there was a difference of opinion. There
is no need to resolve which opinion was right as they are irrelevant. The task
of the Court, once educated as to technical words, is to interpret the claim as
a claim, in the context of the specification, according to the principles laid
down in the Protocol. None of the witnesses were qualified to do that and did
not purport to do so.
20. The judge considered how the word "rapamycin" had been used in the
specification. He held that "all the description in the specification is
directed at a single known chemical." I agree. Throughout the specification
the word "rapamycin" is used to denote the molecule rapamycin. In a passage, I
have quoted the specification states that "the present inventor has discovered
that rapamycin can be used for preparation of a medicament ...." for treating
transplant rejection. That must be read as meaning rapamycin itself. The
specification four lines later states that "the present invention provides the
use of rapamycin for the preparation of a medicament for inhibiting organ or
tissue transplant rejection ...". A similar statement is made in the
concluding paragraph of the specification. That amounts to a clear statement
that the invention was the use of rapamycin itself, not a derivative. That is
not surprising as no derivative had at that time been produced and tried and as
the judge found "finding other similar molecules (to rapamycin) with similar
activities would have been a long and laborious job." The only references to
derivatives are in the title and in the passage on page 3 line 54 to page 4
line 3. That passage draws the distinction between rapamycin and derivatives,
but the specification does not itself identify a single derivative which had
been shown to work.
21. Against that background I turn to consider the question of infringement
with the aid of the questions, called in Wheatley "the Protocol
questions".
22. Question 1 - Does the variant have a material effect upon the way that
the invention worked?
It is important to have in mind that the invention is the discovery of a second
medical use for rapamycin. The variation is the class of compounds called
derivatives of rapamycin. The actual variant in issue is SDZ RAD.
23. Mr Baldwin relied upon the functional parts of the claim. He submitted
that as the claim only covered variants which were suitable for producing a
medicament which had to be suitable for inhibiting rejection, the variants
could not have a material effect upon the way that the invention worked.
Further the functional limitation meant that the second question would be
answered in the affirmative as it would be obvious that the variant would work
in the same way.
24. That submission, as Mr Carr QC, who appeared for Novartis pointed out,
meant that the first two Protocol questions had to be answered in a patentee's
favour if a claim was limited to variants which would work and obviously work.
The fallacy involved in that approach can be demonstrated by taking SDZ RAD,
the derivative in question, as the variant. The invention is the second
medical use of rapamycin. Thus the first question can be stated as - Does the
variant, the derivative of rapamycin called SDZ RAD, have a material effect
upon the way that the invention worked, namely the way rapamycin worked as a
medicament for inhibiting rejection? So stated it is clear that the variant is
the derivative and the invention to be considered is the second medical use
contained in the functional requirements of the claim.
25. I think Mr Baldwin realised that there could be difficulty in relying upon
the functional part of the claim to answer the first two questions. It was for
that reason that he submitted that the variants, the derivatives, should be
limited to those that had rapamycin-like activity. If that was the definition,
then the first two questions would be answered in the affirmative. The
conclusion is logically right, but it is a hopeless submission. As the judge
held, the specification used the word "rapamycin" as denoting the molecule
rapamycin. Derivatives are referred to in the passage bridging pages 3 and 4
and in the heading. The word "derivative" is never qualified: to the contrary
the passage at the top of page 4 states in terms "The present invention
includes use of natural and synthetic rapamycin, genetically engineered
rapamycin and all [my emphasis] derivatives and prodrugs of rapamycin
...". There is no basis in the specification to enable the skilled person to
decide whether a particular derivative had rapamycin-like effect other than the
requirement of the functional part of the claim. Some test or standard would
be needed before such a limitation could be read into the claim, particularly
as the mechanism by which rapamycin worked was not known nor was it described
in the specification (see above in paragraph 37(c) of the judge's judgment).
Thus such a claim would never have been allowed by the European Patent Office
and would be invalid for insufficiency.
26. It is sufficient, for the purpose of answering the first question, to take
SDZ RAD as the variant. Although the judge did not make any explicit finding
as to the equivalence of SDZ RAD to rapamycin, there was evidence that use of
SDZ RAD would not materially affect the way the invention worked. I will
therefore assume that question 1 should be answered in favour of the patentee,
namely in the affirmative.
27. Question 2 - Would it have been obvious to a skilled person that the
variant would not have a material effect upon the way the invention
worked?
I have already rejected the primary submission of the patentees that the answer
should be in the affirmative because the variant was a derivative which had
rapamycin-like effect or was a derivative which complied with the functional
limitation in the claim. The variant is either all derivatives of rapamycin or
the particular derivative SDZ RAD.
28. Upon the findings of fact by the judge, this question has to be answered
"No". As the judge held, there was, at the date of the patent, a strong
probability that other derivatives would work, but it was impossible to predict
with certainty whether any particular one would. It may be that SDZ RAD was a
good candidate to try, but it was not obvious that it would work as an
immunosuppressant. To find out, the product would have to be made and tested.
A similar conclusion would be reached for other derivatives. At most it was
likely that one or more derivatives would work, but which would require
research.
29. Mr Baldwin, relying upon a sentence in my judgment in Wheatley,
submitted that this question should be modified so that an affirmative
answer would be obtained if the skilled person would have expected that the
variant would not produce a material effect. That submission fails for two
reasons. First the judge did not find that the skilled person would have had
that expectation. Second, the modification of the question is inconsistent
with the settled law and I believe with the aim of the Protocol. As I pointed
out in Wheatley, it is fair to the patentee to include within the
claim immaterial variants and to exclude material variants: thus question 1.
However third parties have to be taken into account. Question 2 is designed
for that purpose in that it excludes variants unless third parties should have
realised they were immaterial. For there to be reasonable certainty, those are
the variants which are obviously or clearly immaterial.
30. Mr Baldwin reminded us that the patentees had disclosed that rapamycin was
a good immunosuppressant. He submitted that that disclosure had given to the
world, not only the second medical use of rapamycin, but also the knowledge
that derivatives of rapamycin would work as immunosuppressants. It followed
that the technical contribution of the patent extended beyond the second
medical use of rapamycin and included derivatives which had the same effect.
That submission fails upon the facts found by the judge. The skilled person,
who read the specification, would not be able to predict how many derivatives
would have the appropriate effect nor be able to predict with any certainty
whether any would or which would. The inventor, as stated in the
specification, had only discovered and described the second medical use of
rapamycin. It was left to others to find out which derivatives, if any,
worked. Also, concentration on what was the technical contribution does not
reflect the true task of the court which is construction of the claim according
to the Protocol. As pointed out in Wheatley, it is unfair to a patentee
to construe his claim in a way not intended. To ignore a limitation could
render a patent invalid contrary to the wishes of the patentee. In any case it
would be unfair to third parties to construe a claim in a way that the patentee
had indicated by language that it should not be construed. That of course is
the purpose of the third question which does not arise in this case as I have
answered question 2 in the negative. However I will go on to consider question
3 upon the assumption that question 2 was answered in the affirmative.
31. Question 3 - Would the skilled person have understood from the language
of the claim that the patentee intended that strict compliance with the primary
meaning was an essential requirement of the invention?
In my view the answer must be "Yes". As I have explained the specification
throughout uses the word "rapamycin" as denoting the molecule rapamycin.
Derivatives are referred to as such. It would therefore be surprising if a
different nomenclature was used in the claims. Second the specification sets
out on page 3 line 43 to 47 what the inventor discovered, namely that rapamycin
was a useful immunosuppressant either by itself or in combination with other
drugs. It would therefore be surprising to find in the claim that the word
"rapamycin" was used in a different sense as meaning compounds extending
outside the discovery. The suggestion that all derivatives were included could
not be right as the skilled person would not believe that they would all work.
Third, claim 1 is not a claim which contains words which are difficult to
construe. The word "rapamycin" prima facie has the same meaning in the claim
as it does in the specification. If the patentee had intended to cover
derivatives, he could easily have done so. Fourth, a claim to rapamycin and
rapamycin derivatives or rapamycin-like derivatives would not have been allowed
by the European Patent Office as it would have lacked support and would have
been speculative. This forms the basis of the insufficiency dispute to which I
turn. To do that I shall assume that claim 1 should be construed as suggested
by the patentees despite the conclusion reached that Novartis are right on
construction.
Insufficiency
32. Section 72(1)(c) of the Patents Act 1977 provides that a patent may be
revoked on the ground that "the specification of the patent does not disclose
the invention clearly enough and completely enough for it to be performed by a
person skilled in the art."
33. Having regard to the findings of fact made by the judge, there is no
dispute as to what is the disclosure in the specification. But there are two
differences of substance between the parties. The first requires a decision as
to whether the disclosure has to be sufficient for the full ambit of the claim
to be performed and the second, what particularity of disclosure is necessary.
34. The first was settled in principle by the House of Lords in Biogen Inc
v Medeva Plc [1997] RPC 1. The reasons for the conclusion reached were
given by Lord Hoffmann. In the relevant passages of his speech he also
indicated, in general terms, the answer to the second. At page 53 he pointed
out that his reasons for deciding that the Biogen patent was not
entitled to the earliest priority date applied to consideration of whether the
claims were sufficient. That reasoning appears at pages 47 to 49. The parts
relevant to section 72 are as follows:
" The concept of an enabling disclosure is central to the law of patents. For
present purposes, it touches the matters in issue at three different points.
First, as we have seen, it forms part of the requirement of "support" in
section 5(2)(a). Secondly, it is one of the requirements of a valid application
in section 14. And thirdly, it is essential to one of the grounds for the
revocation of a patent in section 72. I shall start with section 14. Subsection
(3) says:
"The specification of an application shall disclose the invention in a manner
which is clear enough and complete enough for the invention to be performed by
a person skilled in the art."
This is plainly a requirement of an "enabling disclosure". In addition,
subsection (5)(c) says that the claim or claims shall be "supported by the
description". It was by reference to subsection (3) that Lord Oliver of
Aylmerton, who gave the leading speech in Asahi, reasoned at page 536
that a description would not "support" the claims for the purpose of subsection
(5)(c) unless it contained sufficient material to enable the specification to
constitute the enabling disclosure which subsection (3) required: "the Act can
hardly have contemplated a complete application for a patent lacking some of
the material necessary to sustain the claims made". By parity of reasoning, he
said that "support" must have the same meaning in section 5(2)(a).
The absence of an enabling disclosure is likewise one of the grounds for the
revocation of a patent specified in section 72(1). Paragraph (c) says that one
such ground is that -
"the specification of the patent does not disclose the invention clearly enough
and completely enough for it to be performed by a person skilled in the
art."
This is entirely in accordance with what one would expect. The requirement of
an enabling disclosure in a patent application is a matter of substance and not
form. Its absence should therefore be a ground not only for refusal of the
application but also for revocation of the patent after grant. Similarly, the
same concept is involved in the question of whether the patent is entitled to
priority from an earlier application. This is not to say that the question in
each case is the same. The purposes for which the question is being asked are
different. But the underlying concept is the same.
.....
The need for an enabling disclosure to satisfy the requirements of support
under section 5(2)(a), valid application under section 14 and sufficiency under
section 72(1)(c) has, I think, been plain and undisputed since the decision in
Asahi. What has been less clear is what the concept of an enabling
disclosure means. Part of the difficulty has been caused by a misinterpretation
of what the Technical Board of Appeal of the E.P.O. said in Genentech
I/Polypeptide expression (T 292/85) [1989] O.J. E.P.O. 275. This was a
patent for a plasmid suitable for transforming a bacterial host which included
an expression control sequence or "regulon" which could enable the expression
of foreign DNA as a recoverable polypeptide. The Examining Division was willing
to grant a patent only in respect of the plasmids, bacteria and polypeptides
known at the date of application. The Technical Board of Appeal allowed the
appeal, saying that the Examining Division had taken too narrow a view of the
requirement of enabling disclosure:
"What is also important in the present case is the irrelevancy of the
particular choice of a variant within the functional terms ´bacteria',
´regulon' or ´plasmid'. It is not just that some result within
the range of polypeptides is obtained in each case but it is the same
polypeptide which is expressed, independent of the choice of these means. ...
Unless variants of components are also embraced in the claims, which are, now
or later on, equally suitable to achieve the same effect in a manner which
could not have been envisaged without the invention, the protection provided by
the patent would be ineffectual ... The character of the invention this time
is one of general methodology which is fully applicable with any starting
material, and is, as it was already stated, also independent from the known,
trivial, or inventive character of the end-products." [paras. 3.1.3, 3.1.5,
3.3.2]
In other words, the applicants had invented a general principle for enabling
plasmids to control the expression of polypeptides in bacteria and there was no
reason to believe that it would not work equally well with any plasmid,
bacterium or polypeptide. The patent was therefore granted in general terms.
In Mölnlycke AB v. Procter & Gamble Ltd [1992] F.S.R. 549,
however, Morritt J. interpreted this decision to mean that it was a general
rule of European patent law that an invention was sufficiently disclosed if the
skilled man could make a single embodiment. This interpretation was followed by
Aldous J. in Chiron Corporation v. Organon Teknika Ltd [1994] F.S.R.
202, although I think I detect in his judgment some surprise that the E.P.O.
should have adopted such a mechanistic and impoverished approach to the concept
of enabling disclosure. As we shall see, he applied the same rule in the
present case.
In fact the Board in Genentech I/Polypeptide expression was doing no
more than apply a principle of patent law which has long been established in
the United Kingdom, namely, that the specification must enable the invention to
be performed to the full extent of the monopoly claimed. If the invention
discloses a principle capable of general application, the claims may be in
correspondingly general terms. The patentee need not show that he has proved
its application in every individual instance. On the other hand, if the claims
include a number of discrete methods or products, the patentee must enable the
invention to be performed in respect of each of them.
Thus if the patentee has hit upon a new product which has a beneficial effect
but cannot demonstrate that there is a common principle by which that effect
will be shared by other products of the same class, he will be entitled to a
patent for that product but not for the class, even though some may
subsequently turn out to have the same beneficial effect: see May &
Baker Ltd. v. Boots Pure Drug Co. Ltd. (1950) 67 R.P.C. 23, 50. On the
other hand, if he has disclosed a beneficial property which is common to the
class, he will be entitled to a patent for all products of that class (assuming
them to be new) even though he has not himself made more than one or two of
them.
...
I think that in concentrating upon the question of whether Professor Murray's
invention could, so to speak, deliver the goods across the full width of the
patent or priority document, the courts and the E.P.O. allowed their attention
to be diverted from what seems to me in this particular case the critical
issue. It is not whether the claimed invention could deliver the goods, but
whether the claims cover other ways in which they might be delivered: ways
which owe nothing to the teaching of the patent or any principle which it
disclosed.
It will be remembered that in Genentech I/Polypeptide expression
the Technical Board spoke of the need for the patent to give protection against
other ways of achieving the same effect "in a manner which could not have been
envisaged without the invention". This shows that there is more than one way in
which the breadth of a claim may exceed the technical contribution to the art
embodied in the invention. The patent may claim results which it does not
enable, such as making a wide class of products when it enables only one of
those products and discloses no principle which would enable others to be made.
Or it may claim every way of achieving a result when it enables only one way
and it is possible to envisage other ways of achieving that result which make
no use of the invention."
35. Mr Baldwin submitted that the inventor had disclosed in the specification
a beneficial property of a class of products, namely that rapamcyin and
derivatives with rapamycin-effect had immunosuppressant qualities. I disagree.
36. As the judge held, Professor Calne hit upon a new use for rapamycin. The
specification contains an enabling disclosure of that product. Whether any
particular molecule derived from rapamycin would work at all was impossible to
predict with certainty nor how many would have immunosuppressant activity.
Even if a rapamycin derivative were produced which had immunosuppressant
activity, it would be impossible to be certain that it did not exhibit
unpredictable defects. Discovering those defects would need in vivo tests
which would take a long time. As the judge described the claim, it covered all
the molecules which would work, but left it uncertain as to which ones do and
how many of them there are. Such a claim does not reflect a class with a
unifying characteristic. It is a claim to a number of compounds with the
number and identity being left to the skilled person to find out.
37. Professor Calne had not discovered nor had he disclosed in his patent a
class or a beneficial property of a class of compounds. Rapamycin had before
the priority date been reported as inhibiting two experimental immunopathies
(see page 3 line 25 of the specification). But the reports did not, according
to the specification, teach its use for transplant rejection in mammals nor did
they disclose the discovered beneficial effect on toxicity. The invention as
described was the discovery that rapamycin had those advantages. Some
derivatives would be expected to have similar advantages, but the skilled
person would not be able to predict which ones would have that actuality and,
even if the right one was selected, it would take prolonged tests to find out
whether it had the appropriate qualities. It follows that, as Lord Hoffmann
pointed out in Biogen, the patent, to be sufficient, must provide
an enabling disclosure across the breadth of the claim.
38. General guidance was given by this Court in Mentor Corporation v
Hollister Inc [1993] RPC 7 on what was required to establish an enabling
disclosure, or to put it another way, what standard of disclosure was needed
for a patent to be sufficient as required by section 72(1)(c). At page 10
Lloyd LJ said:
"But if a working definition is required then one cannot do better than that
proposed by Buckley LJ in giving the judgment of the Court of Appeal in
Valensi v. British Radio Corporation [1973] R.P.C. 337. After referring
to a number of earlier authorities, including Edison & Swan v.
Holland, he said:
"We think that the effect of these cases as a whole is to show that the
hypothetical addressee is not a person of exceptional skill and knowledge, that
he is not to be expected to exercise any invention nor any prolonged research,
inquiry or experiment. He must, however, be prepared to display a reasonable
degree of skill and common knowledge of the art in making trials and to correct
obvious errors in the specification if a means of correcting them can readily
be found."
Then a little later:
"Further, we are of the opinion that it is not only inventive steps that cannot
be required of the addressee. While the addressee must be taken as a person
with a will to make the instructions work, he is not to be called upon to make
a prolonged study of matters which present some initial difficulty: and, in
particular, if there are actual errors in the specification - if the
apparatus really will not work without departing from what is described -
then, unless both the existence of the error and the way to correct it can
quickly be discovered by an addressee of the degree of skill and knowledge
which we envisage, the description is insufficient."
In that case there was a mistake in the specification. But Buckley LJ's
language is equally apt to cover an omission. Aldous J held that the Valensi
test is as apposite under the 1977 Act as it was under the 1949 Act. I
agree."
39. It is also right to bear in mind what I said in that case, cited by Lloyd
LJ at page 11. He said:
"It is dangerous to generalise. Aldous J made the point well in his judgment in
the present case (at page 19B to D):
"Even where patents relate to articles, the inventions disclosed in different
specifications can be different in kind. For example, the invention disclosed
may relate to an article which will perform a particular function or an article
which is cheaper to make than similar articles. In the latter case, it is the
very essence of the invention disclosed in the specification that the article
can be made more cheaply and therefore to perform the invention, the person
skilled in the art must be able to make the article cheaply as described in the
specification. In the former case, the person skilled in the art must be able
to produce the article which will perform the function, as that is the
invention disclosed".
Then a little later he said:
"In each case, it is a question of fact, depending on the nature of the
invention, as to whether the steps needed to perform the invention are ordinary
steps of trial and error which a skilled man would realise would be necessary
and normal to produce a practical result."
40. There is a difference between on the one hand a specification which
requires the skilled person to use his skill and application to perform the
invention and, on the other, a specification which requires the skilled person
to go to the expense and labour of trying to ascertain whether some product has
the required properties. When carrying out the former the skilled person is
trying to perform the invention, whereas the latter requires him to go further
and to carry out research to ascertain how the invention is to be performed.
If the latter is required the specification would appear to be insufficient.
41. The patentees wish to construe claim 1 to include derivatives of rapamycin
which exhibit inhibition to organ rejection like rapamycin itself. Thus upon
the patentees' construction, the specification must teach how to perform the
invention with such derivatives of rapamycin. Upon the judge's findings of
fact, the specification does not contain that teaching and therefore the patent
would be insufficient, if that were the correct construction of claim 1.
42. The judge held that the number of possible derivatives was vast and
whether any particular molecule derived from rapamycin would work at all was
impossible to predict with certainty. Many derivatives would not exhibit
immunosuppressant activity. Those which involved small changes to the side
chain would be the most likely to work. Thus the skilled person could make up
a list of possibles, with those believed to be the most likely at the top of
the list. Even so, finding appropriate derivatives, if they existed, would
involve a systematic and iterative process. Further, when a derivative which
had appropriate activity had been identified, it would be impossible to be
certain that it did not exhibit unpredictable defects. To discover whether it
did would require further tests which would take a long time.
43. The very uncertainty and unpredictability found by the judge meant that
the skilled person was being required to carry out research. The duty upon the
patentee is to provide a description which enables the skilled person to
perform the invention, in this case across the breadth of the claim; not to
supply a starting point for a research programme. If the claim includes
derivatives of rapamycin, an enabling description of such derivatives is needed
so that the products of the claim can be ascertained.
44. The judge concluded in paragraph 65 of his judgment that the "amount of
work involved in finding useful derivatives of rapamycin does not impose an
undue burden on those working in the field and this argument of insufficiency
fails." However the specification has to be sufficient to enable the invention
to be performed. There is a difference between research to find out which
derivatives work and the application of the teaching in the specification with
appropriate skill and tenacity. In this case the specification tells the
skilled man where to start but, upon the construction of claim 1 sought by the
patentees, it leaves him to ascertain by research what will work. Once it is
appreciated that a claim which encompasses derivatives has to be sufficient
across its breadth, the extent of the research task becomes apparent. The
number of derivatives is vast and the task of ascertaining which will satisfy
the functional part of the claim will also be vast and correspondingly
burdensome.
45. The judge appears to have been influenced by his view as to the needs of a
patentee, such as Professor Sir Roy Calne, who has discovered a second medical
use of one molecule, to obtain a monopoly covering more than the particular
molecule in a case where the skilled person would realise that some derivatives
were likely to work. This can be illustrated from these paragraphs in his
judgment:
"44. I do not believe that any reasonable and objective person skilled in the
art would read this patent as indicating that the inventive contribution was
limited to rapamycin alone or that Professor Calne intended to restrict his
monopoly simply to the use of that single chemical. ... To do that would have
rendered the patent virtually valueless. It would have left out of its scope,
for example, those closely similar molecules which could be derived by standard
chemistry from rapamycin and which probably would have included many which
those in the art would have expected to have equivalent or even better
immunosuppressant properties. It would have disclosed to the art the novel seam
of interrelated molecules but have claimed only one of them. In practice it was
inevitable that the discovery of the activity of rapamycin would lead workers
in the art to look for similar molecules derived from rapamycin which would
have a better profile of properties. That is inherent in the evidence of
Professor Acheson, another of the defendants' expert witnesses. He said:
"I have been informed by Novartis that the aim of the SDZ RAD program within
Novartis was to develop new and improved rapamycin derivatives. Such a project
was clearly justifiable. There is no reason why a natural product, such as
rapamycin, should be the best drug for treating a particular medical condition.
There are known examples of synthetic derivatives, developed from a natural
product, which show improved or advantageous functions and properties over the
natural product itself. The production and screening of potentially useful
derivatives is a huge task but vital. Because there is no sure way of
predicting which derivatives of complex biological molecules, if any, will
possess new and improved properties, it is, however, a high risk venture."
....
64. ... Furthermore, even if Professor Calne had been lucky and sufficiently
funded enough to have a large team of technicians working with him so that he
had been able to put into his patent application not only the good news about
rapamycin but also the same good news about one or two derivatives, Mr. Carr's
argument would have applied with exactly the same force to all the other
derivatives which had not been tried by the Professor and his team. In addition
Mr. Carr's argument would apply with equal force whether the scope of the
patent is as I have held it to be here, namely applying to rapamycin and
working derivatives, or had been limited to an arbitrary list of identified
derivatives. In each case the same process of synthesis and testing would be
needed. It would follow that the only safe course in this field would be to
limit one's patents to those molecules you have tried and tested. Again, that
would make patents in relation to pharmaceuticals more or less valueless. As a
practical matter it is likely that full testing even of one molecule
such as rapamycin itself is not possible before a patent is applied for."
46. For my part I do not agree that a patent limited to the second use of
rapamycin is virtually valueless. The patent protects the second medical use
and the long and expensive work that has been carried out to obtain regulatory
approval. Thus a person who wishes to market a derivative has to make the
derivative and then carry out the long and expensive work needed to get it on
the market. Without the patent, other manufacturers could use the work of the
patentees. In any case, I do not believe that the patent system should be used
to enable a person to monopolise more than that which he has described in
sufficient detail to amount to an enabling disclosure. If it was, it would in
this case stifle research to find a derivative of rapamycin which was a
substantially better immunosuppressant than rapamycin itself. This statement
by Lord Hoffmann in respect of the work done by Professor Murray, the inventor
of the Biogen patent is, I believe, apt:
"It is said that what Professor Murray showed by his invention was that it
could be done. HBV antigens could be produced by expressing Dane particle DNA
in a host cell. Those who followed, even by different routes, could have
greater confidence by reason of his success. I do not think that this is
enough to justify a monopoly of the whole field. I suppose it could be said
that Samuel Morse had shown that electric telegraphy could be done. The Wright
Brothers showed that heavier-than-air flight was possible, but that did not
entitle them to a monopoly of heavier-than-air flying machines. It is
inevitable in a young science, like electricity in the early nineteenth century
or flying at the turn of the last century or recombinant DNA technology in the
1970s, that dramatically new things will be done for the first time. The
technical contribution made in such cases deserved to be recognised. But care
is needed not to stifle further research and healthy competition by allowing
the first person who has found a way of achieving an obviously desirable goal
to monopolise every other way of doing so. (See Merges and Nelson, On the
Complex Economics of Patent Scope (1990) 90 Columbia Law Review 839.)"
47. I conclude that if claim 1 were to be construed in the way suggested by
the patentees, it would be invalid.
Respondents' Notice
48. The patentees contended in this Court that infringement had been
established even if claim 1 was restricted to the use of rapamycin itself. The
judge did not have to deal with those contentions and did not do so.
49. First the patentees submitted that Novartis had infringed because they had
done an act falling within section 60(1)(c) of the 1977 Act. That provides
that a person infringes if:
"Where the invention is a process, he disposes of, offers to dispose of, uses
or imports any product obtained directly by means of that process, or keeps any
such product whether for disposal or otherwise."
50. The patentees submitted that claim 1 was a process claim. Novartis had
manufactured SDZ using rapamycin as the starting material. The first step was
to alkylate the C40 hydroxyl. The second step was to hydrolyse off the silyl
group to give SDZ RAD. Thus Novartis had imported a product (SDZ RAD) obtained
by means of the process of claim 1 in that they had used rapamycin for the
preparation of a medicament (SDZ RAD) which was suitable for inhibiting
transplant rejection.
51. The simplicity of the patentees' submission hides the difficulties. As Mr
Carr pointed out, the submission involves reading the word "medicament" as
covering any medicament which will inhibit transplant rejection. If so, the
only connection that the medicament would have with rapamycin would be that it
was the starting material or a starting material used in what might be a
complex manufacturing process. Such a construction would result in the claim
being hopelessly invalid on the ground of insufficiency because there is no
enabling disclosure of any medicament other than rapamycin.
52. The claim has to be construed in context. It is a Swiss-type claim to an
invention for a the second medical use of rapamycin. As the specification
makes clear, the medicament that provides the inhibition is rapamycin. There
is no disclosure of any other medicament. It would be unfair to the patentee
to construe the word "medicament" as meaning any product whether or not it
contained rapamycin as that would render the patent invalid. SDZ RAD is not a
medicament within the meaning of that word in claim 1. As I have pointed out
the claim is not a claim to a class or principle and therefore it has to be
sufficient across its width. It follows that the claim, to be construed as
suggested would be invalid unless there was an enabling disclosure of
medicaments which might not have any rapamycin present and their method of
manufacture. There are none. I did not understand that Mr Baldwin wished the
claim to be construed in a way that would make it invalid. It follows that the
word "medicament" must be construed as referring to the product rapamycin which
is the product described in the specification as having been discovered by the
inventor to have the beneficial immunosuppressant properties.
53. The second submission was that Novartis had imported a product made by the
process of claim 1 which had the essential characteristics of rapamycin. In
effect the relevant identity of rapamycin was present in SDZ RAD. That
submission cannot be accepted for the same reasons. It is in essence a
reformulation of previous submissions made by the patentees.
54. SDZ RAD is a derivative of rapamycin. Chemically it retains a substantial
part of the molecule rapamycin. For it to come within the ambit of claim 1,
the word "rapamycin" must be construed as covering derivatives of rapamycin
which retain the essential characteristics of rapamycin. For the reasons I
have given that is not a possible construction. If it was, the patent would
have been invalid for insufficiency.
55. The third submission relies upon the fact that up to 0.8% of SDZ RAD is
rapamycin. It is there as an impurity due to the fact that it is the starting
material for the manufacturing process of SDZ RAD. I am prepared to accept
that the therapeutic effect of the rapamycin will be in proportion to its
amount. Even so, the claim is not infringed. To construe claim 1 as covering
a medicament which only contains 0.8% rapamycin would be contrary to all rules
of construction. The technical contribution of the inventor was the discovery
of the second medical use of rapamycin. He did not discover that medicaments
which only contained 0.8% rapamycin had any therapeutic effect and there is no
enabling disclosure of how to make such a medicament. As Lord Hoffmann pointed
out in Biogen, the concept of an enabling disclosure is central to the
law of patents. It is only necessary to contemplate answering the Protocol
questions in respect to a variant where the medicament included only 0.8%
rapamycin to see that the claim must be construed as meaning that the
medicament has to be essentially rapamycin.
56. The patentees also relied upon claim 11. This claim must also be
construed in context. For the reasons already given this claim is not
infringed.
57. Finally I draw attention to the decision of the District Court of the
Hague Case No.99/1435 March 2000 which dealt with the corresponding Dutch
patent. I note that that court came to the same conclusion as I have. However
I have not relied upon the reasons given as we were told it was to be appealed
and was decided upon different evidence.
Conclusion
58. For the reasons given, I have come to the conclusion that SDZ RAD does not
infringe any claim of the patent. If so, the patent is sufficient. I would
therefore allow the appeal and make an order to that effect.
SEDLEY LJ:
59. I agree.
SIMON BROWN LJ:
60. I also agree.
Order:
1. The Appeal is allowed.
2. The Respondent's notice is dismissed.
3. The Order of Laddie J made on 6th December 1999 is set
aside.
4. The Respondent's claim of infringement of European Patent UK No 401747
("the Patent") is dismissed.
5. (i) Novartis' costs of this Appeal and Respondents Notice, and (save as
specified below) Novartis' costs at first instance be paid by the Respondents
and each on them on the standard basis and subject to detailed assessment if
not agreed.
(ii) Novartis' costs relating to the Counterclaim in Claim HC 1999 No. 03633
in respect of lack of novelty and lack of inventive stop be reserved to the
judge at first instance at the trial of those issues.
(iii) Novartis have permission to apply for a payment on account of their
costs pursuant to CPR Part 44.3(8)
6. And it is declared that the making, disposing of, offering to dispose of,
using, importing, or keeping SDZ RAD in the United Kingdom does not infringe
any claim of the Patent.
7. Permission to appeal to the House of Lords refused.
(Order does not form part of the approved judgment.)
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