Georgetown Opinion: now in English too

Yesterday The SPC Blog posted this item on the Opinion of the Advocate General in Case C-484/12 Georgetown University v Octrooicentrum Nederland, acting under the name NL Octrooicentrum.

Unfortunately the Opinion was available on the Curia in a wonderful selection of languages -- but not English.  Now, thanks to Mary Smillie (Rouse), we have an unofficial English translation prepared by her colleagues. You can read it here.

Georgetown: Advocate General Jääskinen advises the CJEU

The Opinion of Advocate General Niilo Jääskinen (right) in the Dutch reference for a preliminary ruling from the Court of Justice of the European Union in Case C-484/12 Georgetown University v Octrooicentrum Nederland, acting under the name NL Octrooicentrum  was posted on the Curia website this morning, but at the time of this blogpost was not yet available in English.

The referring court asked the following five questions:

"Question 1

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?

Question 2

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?

Question 3

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?

Question 4

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?

Question 5

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?""

As for the first question

"7. Given the jurisprudence of the Court and the Advocate General Trstenjak in the cases which gave rise to the judgments in Medeva and Georgetown University and Others, the Court is already sufficient information to respond to said first question. Thus, in this case, it is appropriate to conclude only the second to fifth questions, which are unpublished. In addition, it should be noted that these four questions were asked by the court only if the answer to the first question is yes, which is the premise presented in 1 of these conclusions".

The Advocate General has advised the Court to rule as follows (thanks to Google Translate):

"I propose that the Court reply as follows to the second to fifth questions referred by the Court in 's-Gravenhage (Netherlands)

(1) A waiver of the supplementary protection certificate is governed by Article 14 b) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for drugs, not by national law. In addition, when such waiver is effective only for the future, it may not subsequently be admitted that, as a result of such waiver, the product in question had never been to a certificate within the meaning of Article 3 c) of that Regulation.

(2) In the event that an applicant has filed several supplementary protection certificate for separate products but covered by the same patent, it is up to him to decide which of these applications is a priority. In the absence of choice, it is up to national authorities to draw the consequences under national law".

Watch this space for comment and analysis, which is bound to be forthcoming.

Hague Court's Georgetown questions

The SPC Blog posted this piece towards the end of October on the five questions which the District Court in The Hague was referring to the Court of Justice of the European Union for a preliminary ruling in a case which has now been designated by Curia as Case C-484/12 Georgetown University. The official English version of the questions, as cut-and-pasted from the UK IPO and mildly edited, appears below:

"1. Does Article 3(c) of the Regulation preclude, in a situation where there is a basic patent in force which protects several products, the holder of the basic patent from being granted a certificate for each of the protected products?

2. If so, how should Article 3(C) be interpreted in the situation where there is one basic patent in force which protects several products, and where, at the date of the application for a certificate in respect of one of the products (A) protected by the basic patent, no certificates had in fact yet been granted in respect of other products (B, C) protected by the same basic patent, but where certificates were nevertheless granted in respect of those applications in respect of the products (B, C) before a decision was made with regard to the application for a certificate in respect of the first-mentioned product (A)?

3. Is it significant for the answer to the second question whether the application in respect of one of the products (A) protected by the basic patent was submitted on the same date as the applications in respect of other products (B, C) protected by the same basic patent?

4. If the answer to question one is in the affirmative, may a certificate be granted for a product protected by a basic patent which is in force if a certificate had already been granted earlier for another product protected by the same basic patent, but where the applicant surrenders the latter certificate with a view to obtaining a new certificate on the basis of the same basic patent?

5. If the issue of whether the surrender has retroactive effect is relevant for the purpose of answering question four, is the question of whether surrender has retroactive effect governed by Article 14(b) of the Regulation or by national law? If it is governed by Article 14(b), should that provision be interpreted to mean that surrender does have retroactive effect?".

If you would like to comment on this case and advise the UK government whether it should make any representations, please email policy@ipo.gsi.gov.uk by the agreeably generous deadline of 10 January 2013 -- a welcome change from the three or four days within which one usually needs to respond.

Georgetown University: Hague Court refers five more questions to CJEU

From our friend Annemieke W. Kooy (attorney at law, BarentsKrans N.V., The Hague) comes news of a further reference to the Court of Justice of the European Union (CJEU) on the subject of SPCs. The CJEU must by now be seriously wondering whether there is a pan-European conspiracy to deluge it with SPC-related references. Anyway, concerning the case in question, Annemieke explains as follows:

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.

Background

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:

Question 1

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?

Question 2

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)

Question 3

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?

Question 4

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?

Question 5

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?"