On 12 October 2012 the District court of The Hague referred questions relating to Article 3(c) of the SPC Regulation to the CJEU in proceedings between the Dutch patent office and Georgetown University.
Georgetown was the proprietor of a basic patent which protected four active substances, which are indicated as HPV6, HPV11, HPV16 and HPV18 and had been granted a marketing authorisation for the combination of these substances. Based on the above mentioned marketing authorisation and patent, Georgetown had applied -in 2007- for an SPC for each of HPV6, HPV11, HPV16 and HPV18 individually. The application for HPV 16 had been refused by the Dutch Patent Office; the other applications were still pending. Georgetown subsequently appealed to the District Court.
The Patent Office stated that the application (for a certificate for HPV16) should be refused based on article 3 under c, because two certificates had already been granted based on the same basic patent, namely one for the combination of HPV16 and 18, and one for the combination of HPV6, 11, 16 and 18.
One certificate per patent?
The court considered that in paragraphs 40 and 41 of the Medeva case (C-322/10), the Court of Justice, of its own accord, had explicitly stated in the context of article 3 under c:
"in a situation such as in the main proceedings (…) where the patent protects a product, in accordance with article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent (see Biogen, paragraph 28)."Strictly speaking, this could be read as a "one certificate per patent" rule. However, the court does not consider this an 'acte clair'. It remarks that, if the rule should be interpreted as prescribing only one certificate per basic patent, a patentee could simply circumvent this by applying simultaneously for several patents each protecting one single product, instead of protecting several products in one patent. The patent holder would thus still be able to receive SPCs for each product.
In addition, the Court wonders, if only one SPC per patent could be granted, how to deal with the situation that several applications are pending simultaneously, and one application is decided on before the other applications.
Surrender of the earlier certificate
Another issue in this case related to the surrender of SPCs. Georgetown stated that it was willing to surrender its SPCs for the combination of HPV16 and 18, and for the combination of HPV6, 11, 16 and 18, if that would mean that it would be able to obtain an SPC for HPV 16. Georgetown argued that surrendering a certificate has retrospective effect and that, therefore, after the surrender, the SPCs should be deemed to never have been granted, and the SPC for HPV 16 applied for would be the first certificate for the product.
The Court considers that article 14 of the Regulation provides the right to surrender but does not mention retrospective effect. In addition, the Court states that it appears that the definition of the term 'surrenders' must be considered to be a matter of Community law.
Furthermore, the text of article 3 (c) of the Regulation does not clearly imply that a surrendered certificate would or would preclude a new certificate for the product being granted.
The court then refers five questions to the Court of Justice, the informal translation of which is as follows:
In the situation that a basic patent in force protects several products, does regulation 469/2009 […], more specifically article 3, preamble and under c thereof, preclude the grant of a certificate for each of the protected products to the holder of the basic patent?
If the first question is to be answered in the affirmative, how should article 3, preamble and under c of the Regulation be interpreted in the situation wherein a basic patent in force protects several products and on the date of the application for a certificate for one of the products protected by the basic patent (A), other products protected by the basic patent (B,C) have not already been the subject of a certificate, however, certificates on the applications for those products (B,C) have been granted before the application for a certificate for the first product (A) has been decided on? (emphasis added)
Is it important, when answering the previous question, whether the application for one of the products protected by the basic patent (A) has been submitted on the same date as the applications for other products (B,C) protected by the same basic patent?
If the first question is to be answered in the affirmative, can a certificate be granted for a product protected by the basic patent in force, if another product protected by the basic patent has already been the subject of a certificate, but the holder of the certificate surrenders this last-named certificate with the intention to be granted a new certificate based on the same basic patent?
Is it important, when answering the previous question, whether the surrender has retrospective effect, and is the question whether the surrender has retrospective effect determined by article 14, preamble and under b of the Regulation, or is it determined by national law? In the event that the question whether surrender has retrospective effect is determined by article 14, preamble and under b of the Regulation, should that provision be taken to mean that surrender has retrospective effect?"
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