Case No: HC 2001 CO1034
Neutral Citation Number: [2002] EWHC 1172 (Pat)
 
IN THE HIGH COURT OF JUSTICE
PATENTS COURT

Royal Courts of Justice
Strand, London, WC2A 2LL

Date: 19 June 2002

Before :

THE HONOURABLE MR JUSTICE JACOB
- - - - - - - - - - - - - - - - - - - - -
Between :

	Synthon BV	Claimant	
	- and -		
	Smithkline Beecham plc	Defendant	

- - - - - - - - - - - - - - - - - - - - -
- - - - - - - - - - - - - - - - - - - - -

Michael Silverleaf QC and Piers Acland (instructed by Bird & Bird) for the Claimant
Justin Turner (instructed by Simmons & Simmons) for the Defendant

Hearing date : 11 June 2002
- - - - - - - - - - - - - - - - - - - - -
Approved Judgment

I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.

.............................
THE HON MR JUSTICE JACOB

Mr Justice  Jacob: 

1.	Synthon seek revocation of SKB's UK Patent No. 2,336,364. Its earliest possible priority date is 2.7.1998.  The principal basis of the attack is Synthon's prior patent application, filed on 10th June 1997.   The Synthon application had not been published by SKB's priority date.  Nonetheless Synthon say that by reason s.2(3) of the 1997 Act (corresponding to Art 54(3) of the EPC) their application "shall be taken to comprise" part of the state of the art.   On that basis they say that the SKB invention is not "new" and hence is not patentable, see s.1(1) and s.2(1).  SKB accept the position on dates.  However they say it is not shown that the inventions of the two applications are the same.   Hence, although the Synthon application forms part of the state of the art, it is not novelty destroying.

2.	SKB's claim 1 reads as follows:

"Paroxetine methanesulfonate in crystalline form having inter alia the following characteristic IR peaks: 1603, 1513, 1194, 1045, 946, 830, 776, 601, 554, and 539  4cm-1.; and/or the following characteristic XRD peaks: 8.3, 10.5, 15.6, 16.3, 17.7, 18.2, 19.8, 20.4, 21.5, 22.0, 22.4, 23.8, 24.4, 25.0, 25.3, 25.8, 26.6, 30.0, 30.2, and 31.6  0.2 degrees 2 theta."

3.	It is thus to paroxetine methane sulphonate in crystalline form having certain IR peaks (the XRD's do not matter for present purposes).   SKB also disclose a process for  making this product.    The Synthon application discloses a method of preparation of a number of paroxetine salts.  The first of these is paroxetine methane sulphonate.   So there is a recipe for making this compound. The application says the compound so made has been characterised, that is to say certain measurements have been made on it.  They set out the results of the measurements in Table 1.   An IR spectrum is given.  To the uneducated reader, at least, this is a different spectrum from that in the SKB patent.   SKB say that Synthon have disclosed a different crystalline form from that in their claim.   So their claim is novel.

4.	Synthon say that is too simplistic.  First they say that the significance suggested to be attached to the different IR spectra is not correct - that viewed with the eyes of the skilled man what matters is not just peaks but the whole spectrum.  They say that a skilled man would not or would not necessarily take it that the rival inventors were talking about different polymorphs of the same chemical.   They say that an understanding of the disclosures therefore depends on the court being properly educated at trial.   With that I am not concerned today.   Nor, so far as the current point is concerned, do I have to consider Synthon's related assertion that this compound does not have polymorphs - in football supporter speak "there is only one paroxetine methane sulphonate."

5.	What I am concerned with now is a more straightforward matter.   Synthon say that if you follow the recipe in their application and conduct proper IR tests, you do indeed get the peaks identified in the SKB patent and not those identified in the Synthon patent itself.   So, they say, this is a simple case of lack of novelty.    They have conducted experiments to prove that the recipe makes the product having the SKB peaks and, having regard to certain criticisms, wish to do some more.

6.	SKB say that all such experiments are irrelevant; that it does not matter if the inevitable result of following the Synthon recipe is a product within SKB's claim.   They say the well-established "inevitable result" test for anticipation laid down in General Tire v Firestone [1972] RPC 457 at 485 is not enough where s.2(3) (Art. 54(3)) is invoked.   Thus, they say, the court should now preclude the giving of any evidence about what is made when the recipe is followed.

7.	If they were right on the law, then they would be right on the irrelevance of any experiments.  But are they?    I think not and turn to examine the position in more detail

8.	I begin with the general rule about the state of the art.  It is contained in s.2(2):

"The state of the art in the case of an invention shall be taken to compromise 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 be made available to the public (whether in the United Kingdom or elsewhere) by written or oral description, by use or in any other way."

9.	It corresponds to Art 54(2) of the EPC which reads:

"The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use or in any other way, before the date of filing of the European patent application."

10.	Both sides accept the UK provision does not differ in meaning from the more elegant provision from which it is derived

11.	It is now well-settled that the governing words are "made available to the public."   And that they mean information enabling the skilled man to put the invention into practice must be made available.  Unlike our earlier law, mere prior use (e.g. by commercialising the invention) is not novelty destroying  - see Merrell Dow [1996] RPC 76. The product of the invention can be in all the shops, but the invention is not "made available to the public" unless the skilled man can work out, without undue effort, how it is made.   When the prior art consists of a recipe for making a product, if the inevitable result of following the recipe is a particular product, then that product (when made by that recipe at least) is not new: the skilled man has already been given the necessary information to work the invention.

12.	Take this case for instance.   Suppose it were under s.2(2), i.e. that the Synthon application had actually been published before the priority date.  And suppose it were proved that by carrying out the process described one inevitably got the product of the SKB claim.   Then the SKB claim so far as covering the product made by the process would lack novelty.   The fact that the Synthon application mischaracterised the IR spectrum (if that is indeed so) would be irrelevant.   As Lord Hoffmann said in Merrell Dow at p.90:

"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." 

13.	Whether the substance per se can also be regarded as disclosed in the circumstances of this case remains for debate.   I have not heard argument on the point.

14.	Mr Turner, for SKB, did not concede that if the case were under s.2(2) there would be any lack of novelty.  He said his position "would be harder to maintain."   But, given the authority of Merrell Dow I see no answer to the point, at least so far as the SKB claim covers the compound when made by the Synthon process.

15.	Does it make any difference that the case is under s.2(3)?   This provides:

"Additionally the content of European patent applications as filed, of which the dates of filing are prior to the date referred to in paragraph 2 and which were published under Article 93, shall be considered as comprised in the state of the art."

16.	It corresponds to Art.54(2):

"The state of the art in the case of an invention to which an application for a patent or a patent relates shall be taken also to comprise matter contained in an application for another patent which was published on or after the priority date of that invention, if the following conditions are satisfied, that is to say -

(a)	that matter was contained in the application for the other patent both as filed and as published; and

(b)	the priority date of that matter is earlier than that of the invention."

Again no-one suggests that the pointless UK re-write differs in meaning from the EPC.

17.	At first sight the position seems to be simple.   The state of the art is deemed to include the unpublished earlier application.   But only for the purposes of attacks on the basis of lack of novelty.  This is  because s.3, corresponding to Art. 56,  makes it clear that s.2(3) does not apply to the objection of lack of inventive step (obviousness).    Apart from that, an application deemed to be part of the state of the art is to have the same effect as if it were actually part of the state of the art.

18.	Mr Turner says no, the position is more complex than that.   He says that one must focus simply on the content of the prior application.   It will only be novelty destroying if you can tell from the face of the document that what is in the later claim is old.   You do not, in particular, ask whether, if a process or recipe is set out in the earlier application, that process produces a particular result.  You just take the result as stated by the patentee.   Thus he says, there is no point in any of the experiments.   

19.	He bases his argument on the history of the provisions, to which I now turn.   Once upon a time UK law had an objection to validity called prior claiming.  It was in the Patents Act 1949 s.32(1)(a).   The general idea was that there should not be two monopolies for the same invention.   Although the objection was broadly as old as our patent law itself, in the 1960's the concept ran into trouble.  It involved a comparison of claims in the earlier and later applications or patents.   The difficulties were well-known for those of us old enough to remember, see particularly Kromschröder's Patent [1960] RPC 75 and Daikin Kogyo's Patent [1974] RPC 559.   The problems are discussed in the Report of the Committee to Examine the Patent System and Patent Law ("the Banks report") Cmnd. 4407 (1970), paragraphs 325-327.   Alternative approaches to deal with co-pending applications where the earlier had not been published by the priority date of the latter had also been under consideration by this time.  In particular the 1963 Convention on the Unification of Certain Points of Substantive Law on Patents for Inventions ("the Strasbourg Convention") proposed  a "whole contents" approach.   Art. 4 provided as follows:

"Subject to the provisions of paragraph 4 of this Article, 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 the date of the patent application or of a foreign application, the priority of which is validly claimed.

Any Contracting State may consider the contents of applications for patents made, or of patents granted, in that State, which have been officially published on or after the date referred to in paragraph 2 of this Article, as comprised in the state of the art, to the extent to which such contents have an earlier priority date."

20.	Art 5 excluded the whole contents for the objection of lack of inventive step:

"An invention shall be considered as involving an inventive step if it is not obvious having regard to the state of the art.  However, for the purposes of considering whether or not an invention involves an inventive step, the law of any Contracting State may, either generally or in relation to particular classes of patents or patent applications, for example patents of addition, provide that the state of the art shall not include all or any of the patents or patent applications mentioned in paragraph 3 of Article 4."

21.	Art 6 provided that if the whole contents approach was not adopted, then there had to be a prior claiming approach:

"Any Contracting State which does not apply the provisions of paragraph 3 of Article 4 shall nevertheless provide that no invention shall be validly protected in so far as it includes matter which is or has been validly protected by a patent in that State which, though not comprised in the state of the art, has, in respect of that matter, an earlier priority date."

22.	Banks actually recommended an extended "whole contents" approach - such that the contents of the prior application could be available not only for novelty but also lack of inventive step attacks.   However when it came to the EPC, the solution adopted was indeed that of the Strasbourg Convention. The text of the EPC in this area is based on that of Strasbourg.

23.	What Mr Turner seeks to get out of all this is that the point of Art 54(3) (hence s.2(3)) is that it is essentially aimed at preventing double patenting.    That is reinforced he says by the fact that Art 54(3) only applies at all in EPC member states which are designated by both applications, see Art 54(4).   And, he submitted, the recent decision of Laddie J in Woolard's Appn 12th April 2002 also showed that Art 54(2) was concerned with that problem

24.	Mr Turner further submits that one should focus on the word "content."  It is the content of the prior document which must be novelty destroying.  If you have to do experiments then you are going beyond the content.

25.	Mr Turner also focussed on the question of priority.  He relied on what was said by Lord Oliver in Asahi [1991] RPC 485.   The case actually decided that under s.2(3) a prior application had to be enabling to invalidate on the basis of lack of novelty. Lord Oliver said at p. 541:

"Secondly, the "matter" deemed to be part of the state of the art by reason of being contained in a pending application unpublished at the priority date of the application in suit must itself have an earlier priority date by reason of having been disclosed for the purposes of section 5.  It is difficult to see any reason why there should be deemed to be included in the state of the art anything more than what was disclosed in the application which gave it is priority under section 5.  If that disclosure would not, if published, have made the invention available to the public it is not easy to see why it should do so simply because fortuitously it was not published at the priority date".

And at p.  542 he said:

"The equivalent or approximate equivalent of the subsection is paragraph 3 of article 54 of the Convention which refers to the "content" of prior European Convention applications, a word not apt to refer to anything more than is actually contained in the applications.  I do not think that "matter contained" can have wider meaning or refer to anything other than that which can be gleaned from the face of the application (see particularly article 88(3) and (4))."

26.	Mr Turner specifically pointed to the underlined sentence.   You cannot, he said, "glean" merely from the recipe what product it makes.    Anyway the Synthon application says you make a different product from that claimed by SKB.   Experiments to find out what the recipe actually makes go well beyond "gleaning" from the document.

27.	Finally Mr Turner relied upon a decision of the Technical Board of Appeal of the EPO, Rhône-Poulenc/Taxoids T77/97 [1998] EPOR 257, approved in effect by the Enlarged Board in G2/98, 31st May 2001.

28.	I am impressed by none of these points.   I begin with the observation that it would be bizarre for the EPC (or Strasbourg) to have had in mind two sorts of novelty, one for actually prior published cases and one for deemed prior published cases.  Nothing in the language spells that out as one would expect for such a significant difference. The best that Mr. Turner can do is to suggest that the use of the word "content" in Art 54(3) implies the difference.   That is making a little word do more work than it can reasonably manage.   "Content" means what is taught by the document.  Synthon's application teaches the recipe and hence, if it is clear and unambiguous, the product made by it. 

29.	As to the "double patenting" point, I think Mr Turner's difficulty is that it is beside the point.   The whole contents approach means you do not look at what the earlier application actually claimed, but what information is in the document.   Synthon's document teaches a process.   Provided that teaching is unambiguous it inexorably also teaches the product of that process.  Whether one should regard the teaching as extending to the product however made or simply to the product as made by the process does not matter for present purposes. I merely observe that it is conventional for a patent to be allowed for a per se chemical claim if the chemical is new and non-obvious, one way of making it is described (or no instructions are needed by a skilled man) and the patentee has identified a sufficient use for the chemical.   Then the chemical itself is treated as the invention.

30.	So if there is an inevitable result flowing from using the recipe the SKB claim may be wholly or partially invalid.  Either way, if Synthon's experiments prove what they say they do, they are relevant and admissible.

31.	Woolard is likewise beside the point.  Laddie J merely held that a withdrawn prior application did not count for the purposes of s.2(3).  His reasoning (about the avoidance of double patenting) is not relevant here.  He was not concerned with how the whole contents rule of Art 54(3) actually works at all.   Indeed his reasoning would apply if instead of that rule the rule had been the old prior claiming rule or something like it.

32.	As to Asahi I think Mr Turner is taking what Lord Oliver said out of context.  At that stage of the development of patent law the "enabling" rule had not been fully established.  Merrell Dow has now made it plain that any piece of prior art must be enabling to invalidate on the grounds of lack of novelty.  So the rule as established in Asahi is of general application.  It is the same for Art. 54(2) and (3) and not different as Mr Turner suggests.   When Asahi was decided that was not entirely clear, indeed there is a passage (which I have underlined) in Lord Oliver's speech which suggested otherwise:

"True it is that [Art.54(2)] designates ways in which matter may be made available to the public without an enabling disclosure (for instance by use of the invention) but nonetheless if what is relied on is simply a document or documents describing the invention it seems to me inescapable that an enabling disclosure is necessary before the invention can said to have been made available to the public."

34.	As to the priority point, Mr Turner's difficulty is this:  there is no reason why Synthon's disclosure would not entitle it to priority for a claim to the recipe described and for a claim at least to the product of that recipe when made by it.  It might (I do not decide now) also give priority to a claim to the product itself. 

35.	Nor do I read G2/98 as having anything to do with any potential question of priority here.  The questions posed of the Enlarged Board, which it answered, were of a different nature.  They were concerned with what is meant by "same invention" in Art. 87 for the purposes of claiming priority.  It involved the familiar old problem of differing degrees of generality between an earlier and later document.

36.	Accordingly I think that the effect of carrying out the process of the Synthon application is a relevant matter.  Evidence as to that effect is admissible.