Intellectual Property

This Article appears in the October 2005 issue of Generics Web

SPCs - When Can They Be Granted?

Chiron's Application to The Patent Office.

Chiron's application : ReFacto

Earlier this month, the Hearing Officer of the UK Patent Office gave his decision in relation to an application by Chiron and Novo Nordisk ("the Applicants") for an SPC for their product ReFacto. Two other products containing the same active ingredient already had SPC's, and there was a question as to whether the Applicants were entitled to an SPC given that Council Regulation (EEC) No. 1768/92 concerning SPCs for medicinal products (the Medicinal Products Regulations) does not appear to allow the grant of a certificate for a product which is already the subject of a granted certificate. The Applicants had applied for an SPC on 17th March 2003 in relation to a patent granted on the 18th September 2002. The first authorisation for ReFacto was stated to be an EMEA authorisation. Two other SPCs based on the same EMEA authorisation for other products containing the same active ingredient had already been granted to Genetics Institute and Karbivitrum and the Examiner rejected the Applicants' application on the basis that there were previous SPCs, granted before the basic patent had been granted to the Applicants, and before they had lodged their application for an SPC. The Hearing Officer considered the appeal

Article 3 of the Medicinal Products Regulations

On the face of it, the wording of Article 3 of the Medicinal Products Regulations which states that an SPC may be granted "If, amongst other criteria, the product has not already been the subject of a certificate", would seem to preclude the grant of an SPC to the Applicants, however, all European legislation must be construed purposively, or, as the Applicants argued, "teleologically". In other words, the Tribunal or Court must look to its underlying general principles when seeking to find the meaning of a provision.

This kind of construction differs from the traditional literal approach of English Law, and the US approach.

Teleological construction

Because the provision should be interpreted teleologically, the Hearing Officer considered the recitals to the Medicinal Products Regulations, Travaux Preparatoires, and jurisprudence of the European Court of Justice.

The Recitals state, amongst other things that:

"Medicinal products, especially those that are the result of costly research, will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide sufficient protection to encourage such research…The period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research…."

The Hearing Officer also took account of the case of Biogen -v- Smith Kline Beecham (C-181/95) ('Biogen'). Biogen wanted an SPC based on patents which it had licensed to SKB. Institut Pasteur, which had also licensed patents on the same product to SKB already had an SPC, and SKB argued that the Medicinal Products Regulation permitted only one certificate to be granted for each product - that is to say, each identical active ingredient, even when the product in question was based on several patents. The matter was referred to the ECJ, which allowed Biogen's application and stated that "under Article 3(c) of the Regulation…only one certificate may be granted for each basic patent", Advocate General Fennelly, considering the same case, went further, concluding that the fact that the same product was covered by several basic patents belonging to different holders did not preclude the grant of an SPC to each holder of a basic patent. He stated that "the text of the Regulation applies simply to a simple situation, in which basic research, product development, production marketing are vertically integrated: where the holder of the patent or patents relating to a medicinal product, the marketing which has been authorised in the Member State is also the holder of relevant marketing authorisation. The regulation was obviously drafted on the basis of this classic model. Article 1(c) may be thought to assume that in a case where there are numerous patents, possibly of different kinds, these will be held by a single holder who is in a position to choose between them and to designate one as the "basic patent" for the purpose of the procedure for the grant of a certificate…The assumption becomes more important in Article 3 ( c), which requires that…."the product has not already been the subject of a certificate"….

The Applicants also referred to the Dutch Sigma-Tau Decision. That was a decision of the Dutch Patent Office nullifying a rejection under Article 3(c) of an application for an SPC by Sigma-Tau on the basis that the Wellcome Foundation already had an SPC on the product. The UK Patent Office is not bound by the decisions of other patent offices, and these are taken into account. In the Sigma-Tau case, in contrast to the application being considered by the Hearing Officer, applications for SPCs were co-pending.

Finally, the Hearing Officer affected by the Advocate General's comment that a restriction of supplementary protection to just one patent in each Member State would almost certainly result in the fragmentation of the market.

Hearing Officer's conclusions

Taking all of these factors into account (recitals, Advocate-General's comments on the meaning of 3(c), and fragmentation of the market, Sigma-Tau decision) and despite the ECJ's comment in Biogen that "under Article 3(c) of the Regulation…only one certificate may be granted for each basic patent", the Hearing Officer concluded that "It makes no sense to impose an arbitrary rule that certificates could only be granted to more than one applicant if the corresponding applications were co-pending….such an arbitrary rule sits ill with the general principle of legal equity mentioned by Advocate General Fennelly.. [there is] no justification for rejecting the application on the grounds of a Supplementary Protection Certificate having already been granted to the same product, but to a different patent holder when the application was lodged. On the contrary, it seems to me that to reject the application in these circumstances will run contrary to the purpose of the Medicinal Products Regulation, when viewed in the light of Biogen…It is necessary to consider how [Article 3(c)] impinges on application such as the present one, filed after an earlier application for the same product had been granted".

The Hearing Officer stated "I take the view that the ECJ intended that it is not permissible for one and the same patent holder to multiply extend the protection for a medicinal product over time by obtaining successive certificates… All holders of basic patents may be granted a Supplementary Protection Certificate, but only one certificate may be granted for that product to each…..The duration of a Supplementary Protection Certificate should be such as to provide adequate effective protection….it would be unacceptable…for this duration for one and the same medicinal product to be exceeded. Therefore, it should be possible for all patent holders to benefit from supplementary protection of the same product, but the balance between the interests concerned should not be taken too far towards patent holders by allowing them to muliply extend their protection for the product over time by obtaining successive certificates".

Generic Companies take note

The Hearing Officer's decision makes rather heavy reading. Clearly, it extends the monopoly afforded to ReFacto. Generic versions of ReFacto will not be able to be marketed until the Applicants' SPC expires, notwithstanding the expiry of the SPCs granted in respect of basic patents granted to Genetics Institute and Kabivitrum. Generic versions of the products sold by Genetics Institute and Kabivitrum should be abGle to be marketed. I have no idea of the differences between the products or the basic patents protecting them, and whether, in practise, the distinction is clear. I think that the decision of the Hearing Officer in this case is probably correct. It does re-enforce the fact that generic companies must be extremely careful in deciding whether or not they are free to market a product. They must check basic patents and SPCs granted to all of those selling products containing a particular active ingredient. It is not enough to assume that they are free to market if the SPC of one party selling the product has already expired.

If you have any questions concerning this decision, I would be happy to consider them.

Anna McKay, August 2005

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