In December 2007 Life Sciences Update we reported on the reference to the ECJ in Case 452/07 Health Research Inc. under Council Regulation (EEC) No 1798/92 concerning the creation of a supplementary protection certificate for medicinal products, which establishes the scheme by which Supplementary Protection Certificates (SPCs) enable de facto patent term extensions in European jurisdictions of up to 5 years to be secured for pharmaceuticals. The reference in Case 452/07 Health Research Inc. concerns the time limit for filing an application for an SPC. A yet further reference to the ECJ under this Regulation, and also under the corresponding Regulation (EC) No 1610/96 concerning the creation of a supplementary protection certificate for plant protection products, has now been made in Case C-482/07 AHP Manufacturing BV. This new reference concerns whether the grant of an SPC to one applicant precludes the grant of a subsequent SPC to another applicant in respect of a different basic patent.

In Case C-482/07 AHP Manufacturing BV The Hague District Court has referred the following questions to the ECJ for a preliminary ruling:

  1. Does Council Regulation (EEC) No 1768/92 …, and more specifically Article 3(1)(c) thereof, preclude the grant of a certificate to the holder of a basic patent for a product for which, at the time of the submission of the application for a certificate, one or more certificates have already been granted to one or more holders of one or more other basic patents?
  2. Does Regulation (EC) No 1610/96 …, and more specifically recital 17 and the second sentence of Article 3(2) thereof, give rise to a different answer to Question 1?
  3. When answering the previous questions, is it relevant whether the last application submitted, like the previous application or applications, is submitted within the period prescribed by Article 7(1) of Regulation (EEC) No 1768/92 or that prescribed by Article 7(2) of Regulation (EEC) No1768/92?
  4. When answering the previous questions, is it relevant whether the period of protection afforded by the grant of a certificate pursuant to Article 13 of Regulation (EEC) No 1768/92 expires at the same time as, or at a later time than, under one or more certificates already granted for the product concerned?
  5. When answering the previous questions, is it relevant that Regulation (EEC) No 1768/92 does not specify the period within which the competent authority, as referred to in Article 9(1) of that Regulation, must process the application for a certificate and ultimately grant a certificate, as a result of which a difference in the speed with which the authorities concerned in the Member States process applications may lead to differences between them as to the possibility of a certificate being granted?

The point at issue first arose in Case 181/95 Biogen Inc v SmithKline Beecham Biologicals. The ECJ held that different proprietors of different basic patents could each secure separate SPCs over the same medicinal product. Although such SPCs might have different expiry dates as a result of the different basic patents expiring at different dates, they are all subject to the same constraint that they must also expire not more than 15 years after first marketing authorisation for the product. However the issue of whether multiple SPCs can exist for the one product must now be assessed in the light of Article 3(2) of the Plant Protection Products SPC Regulation, a provision which is expressed also to apply to the Medicinal Products SPC Regulation:

3(2)The holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for this product may be issued to each of these holders.

Although the second sentence of Article 3(2) allows two or more applications for SPCs concerning the same product and emanating from two or more holders of different patents to proceed where the applications are each “pending”, it does not address the situation where the applications are not “pending” together. Such a situation can arise where one SPC having been granted on one basic patent held by one party, another SPC is only later sought by the different holder of a patent which has taken much longer to proceed to grant. On the face of Article 3(c) of the Medicinal Products SPC Regulation, which prevents the grant of an SPC where the product has already been the subject of an SPC in the same Member State, the second patentee would be prevented from seeking an SPC purely as a result of the delays of patent offices for which it was not responsible.

In the UK the Patent Office in In the matter of Chiron Corporation's and Novo Nordisk A/S' SPC Application [2005] RPC 24 has rejected such an unfair and arbitrary approach and held that the grant of an SPC for a product to the holder of a basic patent before an application was lodged in relation to the same product by a different holder of a different basic patent on the basis of a common marketing authorisation did not provide a ground for rejecting the later application under Article 3(c). The only constraint was that where there were a number of patents in different hands, but protecting the same product, all holders of basic patents could be granted an SPC but only one SPC could be granted for that product to each. This new reference in Case 482/07 Health Research Inc. will determine whether or not the sensible approach of the UK Patent Office will prevail throughout Europe.