Merck & Company Inc. v Generics (UK) Ltd
| Jurisdiction | England & Wales |
| Judge | LORD JUSTICE JACOB,LORD JUSTICE PILL |
| Judgment Date | 03 February 2004 |
| Neutral Citation | [2004] EWCA Civ 151 |
| Docket Number | A3/103/2642 |
| Court | Court of Appeal (Civil Division) |
| Date | 03 February 2004 |
[2004] EWCA Civ 151
IN THE SUPREME COURT OF JUDICATURE
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT
CHANCERY DIVISION
(MR JUSTICE LADDIE)
Royal Courts of Justice
Strand
London, WC2
Lord Justice Pill
Lord Justice Jacob
A3/103/2642
MR DAVID KITCHIN QC AND MR THOMAS HINCHLIFFE (instructed by Lovells) appeared on behalf of the Appellant
THE RESPONDENT DID NOT APPEAR AND WAS NOT REPRESENTED
This is a renewed application for permission to appeal, the original application having been initially refused by me on paper.
The case is one of alleged infringement of Patent No: 0,402,152. It concerns a product whose simple generic name is Alendronate. Alendronate is a pharmaceutical used for the treatment of osteoporosis. It is not, as such, patented. The patent for a pharmaceutical composition containing alendronate was held invalid by this court in November last year.
This patent is for a process for making alendronate. Before Laddie J there was only one issue: infringement. That turned entirely on whether claim 1 of the patent covered the process used to make the defendant's product. Only claim 1 was in issue.
Claim 1 reads:
"A process for the preparation of crystalline [alendronate] which comprises:
(a) reacting 4-aminobutyric acid with a mixture of phosphorous acid and PCL 3 in the presence of methanesulfonic acid;
(b) treating with water;
(c) bringing the pH to 4.3 with sodium hydroxide solution at a temperature of 20–25°C;
(d) cooling to 0–5°C; and
(e) collecting the desired compound by filtration, washing with water and 95% ethanol and air drying."
The process used to make the product proposed to be sold by the defendant is called the "Cipla process". It differs from that described in the claim in a variety of respects. In the judgment of Laddie J (at paragraph 22) he sets out a table which shows the differences. So far as step (a) is concerned, instead of using methane sulphonic acid, the defendants use a different sulphonic acid. They use a different temperature range and, I believe, a different pH. They use a different temperature range for step (d), and they use a different step for step (e) for collecting the desired compound.
It is said that each of these variants from the claim are obvious and self-evident, and that would have been to any reader of the specification. It is further said that the true virtue of this invention is that, for the first time, it was possible to make alendronate without the risk of solidification during the course of carrying out the process. So, it is said, that the Cipla process takes the heart of what was inventive about claim 1.
The law as to the extent of protection of a European patent is contained in Article 69 of the European Patent Convention. This provides:
"The extent of the protection conferred by a European patent, or a European Patent application, shall be determined by the terms of the claim, nevertheless the description and drawings shall be used to interpret the claims."
it is the terms of the claims which count.
The Protocol on the interpretation of Article 69 gives guidance on how those terms are to be understood. It provides:
"Article 69 should not be interpreted in the sense that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Neither should it be interpreted...
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