INFORMATION FROM THE CONTRACTING / EXTENSION STATES
Decision of the Hoge Raad (Supreme Court) dated 23 June 1995*
(Organon International BV et al v. Applied Research Systems ARS Holding BV)
Headword: Follicle stimulation hormone II
Article 30 (1), (3), (4) ROW (Patent Act 1977)
Keyword: "Period of grace - calculation - evident abuse" - "Right based on prior use" - "Right to conduct tests"
1. Evident abuse within the meaning of Article 55(1) EPC has occurred if it is clear and unquestionable that a third party was not authorised to communicate to other persons the information received.
2. Where a priority right exists, the calculation of the six-month time limit under Article 55(1) EPC during which an abusive disclosure is not novelty destroying is based on the date of priority and not that of filing.
3. The right based on prior use conferred by Article 30(4) ROW relates only to use within and for the company.
4. The exception for experimental purposes under Article 30(3) ROW does not extend to use of the patented subject-matter for research with the patented subject-matter.
From the reasons
ARS is the owner of European patent No. 211894 for a "follicle stimulating hormone" (FSH). (...) The priority date is 30 January 1985. The application which led to the patent being granted was published on 4 March 1987. (...)
Diosynth BV (appellant 2) (...) manufactured (...) FSH, the basis of the pharmaceutical preparation produced by Organon et al and known under the name Org 32489. (...) Organon International BV et al (appellant 1) carried out (...) clinical trials using this (...).
3.2 ARS applied for a temporary injunction (...) on the grounds that the production of Org 32489 and its use in clinical trials was an infringement of European patent No. 211894 (...).
Organon et al defended their action (...), arguing (...) that on the priority date the material described in the patent had been neither novel nor inventive and, subsidiarily, that their actions were justified under the exception for experimental use pursuant to Article 30(3) ROW and the right based on prior use pursuant to Article 30(4) ROW.
In his ruling the President (of the Arrondissementsrechtbank at The Hague) rejected the requested measures. (...) The Gerechtshof (The Hague) (...) in the main found for the appellants. The grounds cited by the Gerechtshof can (...) be summarised as follows:
(a) Organon et al unsuccessfully cite the publication of the Beck abstract, since this must be viewed as the result of an evident abuse (...) which furthermore occurred within the six-month time limit laid down in Article 55(1) EPC (...).
(b) Organon et al cannot lay claim to a right based on prior use, because the making of FSH available to hospitals and research centres for clinical trials cannot be regarded as use "to the benefit of the enterprise" within the meaning of Article 30(4), second sentence, ROW. (...)
(c) Similarly, Organon et al cannot plead that an exception was allowed for experimental use, since the extent of the research was considerable and aimed primarily at registering the medicament developed by Organon (...).
3.3.1 Ground of appeal 2 (...) contends that the Gerechtshof's view that the Beck abstract is the consequence of "an evident abuse" within the meaning of Article 55 (1)(a) EPC is incorrect (...).
The ground of appeal is unsuccessful. The Gerechtshof rightly agreed with the view (...) expressed by a board of appeal of the European Patent Office in a decision dated 1 July 19851 that an "evident abuse" had occurred "if it emerged clearly and unquestionably that a third party had not been authorised to communicate to other persons the information received". (...)
3.3.2 Ground of appeal 2.b contests as incorrect the view taken by the Gerechtshof that where a right of priority exists the time limit of six months mentioned in Article 55(1) EPC is not to be calculated from the date of filing, but from the date of priority.
This ground of appeal is unfounded. It follows from Article 89 EPC that the right of priority has the effect that, inter alia for Article 54(2) EPC - a provision which lays down the relevant state of the art in terms of time and hence is closely linked to Article 55(1) EPC - to be applied, the date of priority must be taken as being the date of filing of the European patent application. Article 55(1) EPC would not serve its purpose - to protect the applicant - if this provision were to be interpreted literally in cases of a pre-existing priority right. The system underlying the Convention thus justifies an interpretation according to which the date of priority also takes the place of the date of filing when calculating the time limit under Article 55(1) EPC.
3.4.1 Ground of appeal 3 contests the considerations underlying the Gerechtshof's decision to reject as unfounded the argument that Organon et al had a right based on prior use stemming from Article 30(4), second sentence, ROW. (...)
This ground of appeal cannot be endorsed. As the Gerechtshof correctly held, this provision contains an exception to Article 30(1) ROW governing the exclusive right of the patent proprietor and must therefore by its very nature be subjected to a restrictive interpretation. From the (...) explanatory memorandum to the draft Patent Act of 12 January 1977 (point 160) (...) it is clear that the exception only applies to use within or for the company (within the meaning of Article 30(1) ROW), and not to any of the other acts which are the exclusive preserve of the patent proprietor according to that paragraph. (...)
3.5.1 Ground of appeal 4 contests the view (...) that Organon et al are mistaken in pleading that they are covered by the exception for experimental purposes under Article 30(3) ROW. The ground of appeal includes an appeal on a point of law evidently aimed at persuading the Hoge Raad to abandon the view taken in its decision dated 18 December 1992 (NJ 1993, 735) that the scope of this exception is limited. Since the Hoge Raad sees no reason so to do, the appeal is dismissed.