Pages 252-257

INFORMATION FROM THE CONTRACTING / EXTENSION STATES

FR France

Judgment of the Cour de cassation (court of cassation), commercial division, dated 26 October 1993^*

Headword: Alfuzosine

Article: 6 and 8 of the amended Law of 2 January 1968 (= Section L.611-10, 11 and 16 of the 1992 Code on Intellectual Property)

(Article: 52(4) and 54(5) EPC)

Keyword: "Proceedings for payment of remuneration" - "Medicines" - "Two patents relating to the same active ingredient for different medical uses" - "Patentability of the second medical use (no)"

Headnote

A second medical use of a known medicine is not patentable.

Summary of facts and submissions

1. In the present dispute the opponents are Mr Najer and the company Synthélabo. Mr Najer accuses Synthélabo of not having paid the remuneration due to him from exploitation of the pharmaceutical product Xatral. He refers to the contract dated 3 February 1972 governing the duties of technical director, a post held by him with Synthélabo until 1979, which stipulated that "the variable part of Mr Najer's remuneration shall consist of a percentage of the turnover realised ... from the sale to third parties of pharmaceutical products created in the chemistry laboratories attached to the department under Mr Najer's authority, and protected by patents for which an application has been filed by Synthélabo ..." and that "the patents which shall confer entitlement to proportional remuneration shall be those for which an application is filed between 31 May 1972 and the day Mr Najer leaves the Group".

2. In 1977 the chemical research department, run at the time by Mr Najer, isolated the chemical molecule of alfuzosine. In 1978 Synthélabo filed patent application No. 78 03175, covering in particular this active ingredient for the treatment of cardiovascular diseases. In 1985 a second patent, No. 85 07950, then claimed a "composition containing alfuzosine in combination with any appropriate excipient and intended for the treatment of urinary diseases". In November 1988 Synthélabo marketed the product Xatral, based on alfuzosine, for the treatment of urinary diseases.

3. On 7 April 1989 Mr Najer then brought an action against Synthélabo for payment of the remuneration due under the contract, pleading that patent No. 78 03175 covered the product Xatral. Synthélabo responded that the product was covered only by the second patent. In its judgment dated 29 March 1990, the Paris Tribunal de Grande Instance (Court of First Instance) found in Mr Najer's favour, ruling that his claim for remuneration based on patent No. 78 03175 was well founded.

4. In its judgment dated 11 June 19911 the Paris Court of Appeal reversed this judgment on the grounds in particular that:

"It should in fact be noted that it is the marketing of the pharmaceutical product and not of the active ingredient in its composition that gives rise to entitlement to remuneration." (...)

The pharmaceutical product is a specific product as defined in Section L.511 of the Public Health Code:

"A medicinal product shall be understood to be any substance or combination of substances presented for treating or preventing disease in human beings or animals and any product which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying their physiological functions."

The same definition appears in Council Directive No. 65/65/EEC.

The medicine is characterised essentially by the therapeutic use to which the product represented by it is intended to be put.

Case law has always made a distinction between the active ingredient and the pharmaceutical product since only the latter has this specific purpose. To be patented as such the product must indicate, in addition to the disease it is intended to cure or prevent, details of its use, ie its dosage and how it is to be administered. (...)

It is not (...) disputed that the chemical product alfuzosine was created before 10 August 1979.

In order to determine whether the pharmaceutical product was created before that date the scope of the patent applied for in 1978 needs to be examined. (...)

The patent thus covers a chemical product and a pharmaceutical product.

However, as Synthélabo points out, the only therapeutic use indicated is cardiovascular treatment, in particular use as an antihypertensive.

It is an established fact that the pharmaceutical product Xatral is specifically intended for the treatment of urinary diseases. (...)

In conclusion, it cannot be justifiably claimed that the 1978 patent covers the medicine Xatral. (...)

Synthélabo has good grounds for claiming that the specific character by which a medicine is defined means that an identical product disclosed as having a different medical use is a new medicine. (...)

In a series of judgments dated 5 December 19842, the Enlarged Board of Appeal of the European Patent Office acknowledged the patentability of a second medical use that is new and involves an inventive step; such use has also been considered patentable in several decisions by other countries. (...)

It is clear from the above-cited provisions in Article 8 of the Law of 1978 that a second medical use per se is patentable. (...)

In the present case the use of alfuzosine as a medicine for the treatment of urinary diseases is not comprised as such in the state of the art and in particular in the 1978 patent (or in the 1979 patent of addition rectifying an incorrect formula in the patent).

Consequently Synthélabo legitimately obtained, in addition to a first patent relating to the use of alfuzosine in cardiovascular diseases, a second patent for a totally different new and inventive use. (...)

Finally, it is irrelevant that Mr Najer submits that since patent No. 78 01375 "confers on its proprietor the right to prevent the use of alfuzosine for the manufacture of medicines, whatever the intended therapeutic indication", it follows "that it can prevent the manufacture of Xatral" and that "Xatral is thus protected by the claims of the 1978 patent".

This amounts to confusion between the scope of the right and the extent of the protection.

The patent cannot protect uses which it has not described and claimed.

Whereas the proprietor of a product patent can stop exploitation of a new use which is the subject-matter of another patent, he himself is unable to exploit it without the consent of the other patent's proprietor; admittedly a new use of a known patented product is a dependent invention, but the right to this invention belongs to the proprietor of the second patent which is dependent on the first one.

In conclusion, on 10 August 1979 the pharmaceutical product Xatral was not protected by a patent for which an application had been filed by Synthélabo.

5. Concerning the appeal lodged by Mr Najer, the Court rules as follows:

Reasons for the judgment (extracts)

Concerning the third part of the sole ground:

Considering Articles 6 and 8 of the Law of 2 January 1968.

Whereas, according to the judgment contested, Mr Henri Najer, technical director of Synthélabo until 1979, brought an action against the latter for payment of remuneration due from the exploitation of the pharmaceutical product Xatral for which a patent, registered as No. 85 07950 and relating to "pharmaceutical compositions containing alfuzosine", was granted in respect of an application filed on 28 May 1985, basing his claim on the patent registered as No. 78 03715 and relating to "amides of alkylene diamines and their medical use", granted in respect of an application filed on 6 February 1978, and on the clauses of a contract dated 3 February 1972 governing the duties of technical director and providing in particular that "the variable part of Mr Najer's remuneration shall consist of a percentage of the turnover realised by the companies in the Group from the sale to third parties of pharmaceutical products created in the chemistry laboratories attached to the department under Mr Najer's authority, and protected by patents for which an application has been filed by Synthélabo".

Whereas in order to dismiss the claim, the judgment notes that patent No. 78 03175 claimed medical use only as an antihypertensive in the treatment of cardiovascular diseases for the active ingredient described and subsequently referred to as "alfuzosine" whereas the product called "Xatral", defined by patent No. 85 07950 as containing alfuzosine in combination with any appropriate excipient, is specifically intended for the treatment of urinary diseases, and accepts that the use of alfuzosine as a medicine for treating urinary diseases was not comprised in the state of the art and that this second medical application of the active ingredient was new and involved an inventive step.

Whereas, in thus ruling, the Court of Appeal has violated the texts referred to above.

On these grounds (...) declares null and void in all its provisions the judgment delivered on 11 June 1991 (...); consequently restores the case and the parties involved to their original state prior to the judgment and refers the case to the court of appeal in Lyon.

FR 1/95