The Netherlands: Inclusion in the G-Standard of a generic medicine held not to be infringing


In Glaxo Group Ltd v. Pharmachemie B.V., the District Court of The Hague was asked to consider the question whether the inclusion of the generic medicine Ondansetron in the so-called ‘G-Standard’ prior to the expiry of the patent protection (of a second medical use of) this medicine constituted patent infringement. In its judgment of 4 July 2007, the court answered that it did not.

The G-Standard is a database published by the company Z-Index B.V., a subsidiary of the Royal Dutch Pharmaceutical Society (KNMP). The database was set up in 1985. It served to meet the need amongst pharmacists to have an effective tool for reimbursement from health insurers. Over the years, the G-Standard has become a multi-function central information source for all relevant parties in the public health environment. It is no longer used by pharmacists alone, but also by manufacturers, wholesalers, general practitioners and insurance companies.

Pursuant to Section 53(1) the Dutch Patent Act 1995, the patentee has the exclusive right to make, use, put on the market or resell, hire out or deliver the patented product or the product directly obtained by a patented process, or otherwise deal in it in or for his business, or to offer, import or stock it for any of these purposes. Glaxo argued that the inclusion in the G-Standard of generic Ondansetron had to be considered an ‘offer’ for any of the given purposes, or at least an offer in the sense of Section 53(1). The District Court did not agree.

The District Court held that the mere publication of a generic medicine in the G-standard could not automatically be understood to be an offer to perform acts reserved for the patentee in relation to that medicine. The District Court considered that the G-standard was primarily a tool for acts including ordering and supplying medicines, rather than a platform for offering medicines. The publication of a medicine in the G-standard could therefore be regarded as a preparatory act for the supply of the medicine, rather than as an offer in its own right.

The District Court also ruled that Pharmachemie had not used the G-standard as a tool to offer generic Ondansetron. Pharmachemie included generic Ondansetron in the G-standard of June 2006 (published mid-May 2006) in order to facilitate the trade in the medicine upon the expiry of the patent on 24 June 2006. The District Court considered that including Ondansetron in the G-standard was necessary for this because if the medicine were not published in the G-standard, (i) it could not be included in patient and medication control systems; (ii) it could not be paid for by health insurers; and (iii) logistical problems would arise. In addition, the District Court held that the publisher of the G-standard, Z-index, used a strict monthly production schedule. Furthermore, Pharmachemie explicitly informed the customers of the G-standard via a so-called ‘Taxebrief’ (of 29 May 2006) that it would not supply generic Ondansetron before 25 June 2006.

The District Court held that in this light, a reasonable interpretation of the law entails that the mere fact that the information from the G-standard of June 2006 was available a few weeks before the expiry date of EP 266 should not be regarded as an offering of generic Ondansetron.