SmithKline Beecham Plc's (Paroxetine Anhydrate) Patent
| Jurisdiction | England & Wales |
| Judge | Lord Justice Aldous,Lord Justice Sedley,Mr Justice Lindsay |
| Judgment Date | 25 June 2003 |
| Neutral Citation | [2003] EWCA Civ 872 |
| Court | Court of Appeal (Civil Division) |
| Docket Number | Case No: A3/2002/1646;/1646A |
| Date | 25 June 2003 |
[2003] EWCA Civ 872
IN THE SUPREME COURT OF JUDICATURE
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM CHANCERY DIVISION
MR JUSTICE PUMFREY
Royal Courts of Justice
Strand,
London, WC2A 2LL
Before:
Lord Justice Aldous
Lord Justice Sedley and
Mr Justice Lindsay
Case No: A3/2002/1646;/1646A
Mr A. Waugh QC and Mr J. Turner (instructed by Simmons & Simmons) for the Appellant
Mr R. Wyand QC and Mr M. Tappin (instructed Addleshaw Goddard) for the Respondent
In his judgment of 12th July 2002 ( [2002] EWCH 1373 (CH)), Pumfrey J held that claims 1, 2, 3, 7, 10(ii), 12 and 13 of UK Patent GB 2, 297, 550 (the patent) invalid and claims 10(i) and 11 valid. Against the judge's order SmithKline Beecham Plc (SB), the patentees, appeal. BASF AG cross-appeal contending that the judge should also have held claims 10(i) and 11 valid.
SB have not attempted to overturn the judge's conclusion that claims 1, 2, and 6 and the second alternative in claim 10 (claim 10(ii)) were invalid. Their appeal essentially turns upon a question of construction, in particular the meaning of the phrase "substantially free of bound propan-2-ol" which appears in claim 3. If that phrase has the meaning for which SB contend then, upon the findings of the judge, claim 3 and its dependent claims would be valid.
BASF support the judge's conclusion on construction. They also contend that claims 10(i) and 11 should have been held to be anticipated by the disclosure in UK patent application no. 8526407, referred to for convenience as 407, or was obvious in the light of that disclosure.
Construction – It is convenient at the outset to set out the issue. The relevant claims showing, underlined or deleted, the amendments allowed on 17th April 2001 are in this form:
"1. Paroxetine hydrochloride anhydrate substantially free of bound propan-2-ol.
1. 2. Paroxetine hydrochloride anhydrate substantially free of bound organic solvent.
2. 3. Paroxetine hydrochloride anhydrate substantially free of bound propan-2-ol with the proviso that it is other than Form Z.
…
3. 8. Paroxetine hydrochloride anhydrate substantially free of bound propan-2-ol as defined in claim 1 in Form A; which is characterised in that …
4. 9. Paroxetine hydrochloride anhydrate substantially free of bound propan-2-ol as defined in claim 1 in Form B; which is characterised in that …
5. 10. Paroxetine hydrochloride anhydrate substantially free of bound propan-2-ol as defined in claim 1 in Form C; which is characterised in that …
6. 11. Paroxetine hydrochloride anhydrate substantially free of bound propan-2-ol as defined in claim 1 in Form D which is characterised in that …
7. 12. Paroxetine hydrochloride anhydrate as defined in claim 3 8, which is in the form of needles.
8. 13. Paroxetine hydrochloride anhydrate as defined in claim 4 9, which is in the form of needles.
9. 14. Paroxetine hydrochloride anhydrate as defined in claim 5 10, which is in the form of needles or prisms.
…
10. 16. A process for the preparation of paroxetine hydrochloride anhydrate substantially free of bound propan-2-ol which comprises crystallising paroxetine hydrochloride in either:
(i) an organic solvent or mixture of organic solvents which form a solvate with the paroxetine hydrochloride and which are not removable by conventional vacuum oven drying techniques; or
(ii) an organic solvent or mixture or organic solvents which do or do not form a solvate with the paroxetine hydrochloride but which are removable by conventional vacuum oven drying;
thereafter in the case of (i) displacing the solvated solvent or solvents using a displacing agent and in the case of (ii) by removing the solvent.
11. 18. A process for the preparation of paroxetine hydrochloride anhydrate substantially free of bound organic solvent which comprises displacing the solvated solvent or solvents from a paroxetine hydrochloride solvate using a displacing agent.
12. 19. A pharmaceutical composition comprising a compound as claimed in any one of claims 1–9 3 or 7–15 and a pharmaceutically acceptable carrier.
20. The use of a compound as claimed in any one of claims 1–9 3 or 7–15 in the manufacture of a medicament for the treatment and/or prevention of the Disorders as defined herein."
The reasons for the amendment are clear. SB decided that it was appropriate to delete claim 1. As old claims 8, 9, 10 and 11 were either directly or indirectly dependent on claim 1, it was necessary to add into those claims the limitation in claim 1 "substantially free of bound propan-2-ol". Thus the ambits of those claims were the same after amendment as before.
The importance of the phrase "substantially free of bound propan-2-ol" arises out of an allegation that claim 3 and its dependent claims lacked novelty. BASF relied upon an experiment in 407 in which the anhydrate was produced using acetone as the solvent. Propan-2-ol was never used. The result was Form A. As that experiment did not use propan-2-ol, it was contended that the phrase was not limiting and therefore claim 3 was anticipated.
The judge, supported by BASF, held that the phrase "substantially free of bound propan-2-ol" as used in claim 3 meant what it said. It followed that claim 3 was anticipated by paroxetine hydrochloride anhydrate (PHA) even though it was not substantially free of the solvent used in preparation, provided it was free of bound propan-2-ol which was not and could not have been present.
SB contend that in context "propan-2-ol" is a synecdoche. It is an example standing for whichever member of the class of solvents that was used in the process of production. Any other construction rendered the specification inconsistent.
Section 125 of the Patents Act 1977 makes it clear that the invention of a patent is to be taken to be that specified in the claims. The claims have to be interpreted with the aid of the description. However the Protocol on the Interpretation of Article 69 of the European Patent Convention applies. That Protocol has been considered in a number of judgments. It is sufficient for the purposes of this case to record that the proper approach is to seek the middle ground between literal construction and treating the claims as guidelines. That quest has to achieve reasonable certainty for the public and fair protection for the patentee.
I did not discern any difference of substance between the parties as to the general principles to be adopted. The difference lay in the application and the result. However Mr Waugh QC, who appeared for SB, submitted that any difficulty of construction should be resolved in favour of the patentee. He relied upon the speech of Lord Davey in Parkinson v Simon [1895] 12 RPC 404 at 411. That submission has been dealt with in full in the judgment of Sedley LJ, with which I agree. I therefore turn to the specification which I will consider taking into account the submissions of the parties.
The issue of construction depends in the main upon the way the opening paragraphs are to be understood against the background of the claims. The specification is headed "Paroxetine Hydrochloride Anhydrate Substantially Free of Bound Organic Solvent". It then states that the invention relates to novel compounds, to processes for preparing them and to their use in treating medical disorders. It acknowledges that Example 8 of EP-B-223403 (403) was prior art. That example describes the preparation of PHA as platelets melting at 118 ºC and with certain IR bands by crystallisation from a water-containing solvent. It continues:
"Subsequent repetition of the preparation described in Example 8 has failed to yield any type of paroxetine hydrochloride anhydrate, and there is no clear teaching elsewhere in the document of any alternative route or modification to the process which would generate the anhydrate.
Paroxetine hydrochloride is also purported to be disclosed in the International Journal of Pharmaceutics 42, (1988) 135 to 143, published by Elsevier. The anhydrate is said to be produced by crystallising paroxetine hydrochloride from anhydrous propan-2-ol. Subsequent repetition of this process has resulted in a propan-2-ol solvate of paroxetine hydrochloride. That is to say that there is bound propan-2-ol in the product. This bound propan-2-ol cannot be removed by conventional drying techniques such as vacuum oven drying.
Paroxetine hydrochloride anhydrate substantially free of bound propan-2-ol has not been described in the literature, nor has any method been disclosed which would yield such a product as an inevitable result. A method for preparing paroxetine hydrochloride anhydrate substantially free of bound propan-2-ol has now been found. Furthermore, surprisingly, four new forms of paroxetine hydrochloride anhydrate have been found as have processes for their preparation. These forms are hereinafter referred to as A, B, C and D respectively. The characterising data for Forms A, B, C and D do not correspond to the characterising data provided in Example 8 of EP-A-223403.
Accordingly, the present invention provides paroxetine hydrochloride anhydrate substantially free of bound organic solvent.
The present invention also provides paroxetine hydrochloride anhydrate substantially free of bound propan-2-ol with the proviso that it is other than Form Z.
Substantially free of bound organic solvent is to be interpreted to be less than the amount of propan-2-ol which would remain solvated, i.e. bound, within the crystal lattice of the product under conventional vacuum oven drying conditions."
Mr Waugh submitted that when the specification was read through the eyes of the skilled...
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