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.

"One SPC per patent" again -- this time in the Netherlands

From our friend Martijn de Lange comes news of a fascinating Dutch development. Explains Martijn:

"The Court of Appeal has decided in a case concerning the product irbesartan + HCTZ that the CJEU rulings in Medeva and Georgetown should be read as "one SPC per patent", not "one SPC per product per patent" (see (i) this summary on the IE-Forum blog, and (ii) the full judgment which is reasonably readable with Google Translate). 

The Court notes that, even if this restriction set by the CJEU would not be in agreement with the SPC Regulation, this does not automatically imply that the restriction does not apply. 

The Court points out that the CJEU has on other occasions imposed restrictions on IP rights which cannot (directly) be found in the applicable guidelines or regulations. 

The Court then explains that this restriction may be in agreement with the Regulation if the term 'product' is interpreted narrowly as the ' invented basic substance'.

This all came in on the eve of the oral hearing last week in Luxembourg in the Georgetown, Eli Lilly and Actavis cases.

Most of the parties involved (like most if not all national patent offices in the past) have have rejected the "one SPC per patent" interpretation, but I do agree with the Court of Appeal that this is what the CJEU meant in Medeva and Georgetown and, in my opinion, the Court of Appeal does a most admirable job under the circumstances in explaining how this could be in agreement with the Regulation since the CJEU does not provide any argumentation in their own judgements, hence the mess we're in".

Note that this was a case for injunctive relief, adds Martijn, not a decision on the merits.

Thanks so much, Martijn, for keeping us up to date!

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?"

Post-Medeva CJEU references on the horizon, this time from the Netherlands

From The SPC Blog's friend Margot Kokke (De Brauw Blackstone Westbroek N.V., Amsterdam) comes news that a Dutch District Court is proposing to refer some questions to the Court of Justice of the European Union in Dutch Georgetown and Queensland cases regarding the continuing saga of "one SPC per patent" (it seems that not all national intellectual property offices are continuing the practice of granting "one SPC per product per patent" as they used to do in the days before before Medeva.

The Dutch court in question here is the District Court of The Hague, which wants to obtain preliminary rulings that clarify the "one SPC per patent" rule mentioned in paragraphs 41 of Medeva (C-322/10) and 34 of Georgetown (C-422/10) in two parallel decisions: (Dutch) Georgetown and (Dutch) Queensland.

Initially the Dutch IPO refused the requested SPCs, basing its decision on Article 3(b) of the SPC Regulation but, once it was clarified in Medeva that an SPC for a single product can be granted based on a marketing authorisation containing that product together with other active ingredients, this was no longer an issue. The IPO subsequently refused to grant the SPCs based on Article 3(c) of the Regulation: in both cases another SPC (Queensland) or SPCs (Georgetown) was/were granted based on the same patent. The Court doubts whether the fact that Queensland renounced its right to the other SPC makes a difference as it is not sure whether the renunciation of an SPC has retroactive effect. The most important questions are:

* Does Article 3(c), in the situation where (the claims of) a basic patent claims several products, preclude the grant to the owner of the patent of an SPC for every product that is claimed?

* If the answer to this questions if affirmative, where an SPC is granted for one product but was renounced, does this preclude the grant of an SPC for another product claimed by the same basic patent?

* If it should be relevant that the renunciation has retroactive effect, is this governed by Article 14 of the SPC Regulation or by national law? In the latter case, does renunciation of an SPC have retroactive effect?

The parties have six weeks to give their opinion on the proposed questions, before the Court will formulate its final referral.

"One SPC per patent"? Not in Sweden!

Regular readers of The SPC Blog will recall how much interest has been generated by the question whether, following the recent round of Court of Justice rulings, there is a rule of "one SPC per patent" (see for example earlier posts here and here).

Now we have a fresh contribution on this topic from Camilla Lidén (Valea AB, Stockholm), who has written in to tell us how the Swedish Patent and Registration Office (PRV) is dealing with the situation:

"With reference to your earlier posting regarding MedImmune and Queensland and the issue with the “one SPC per patent” I just wanted to add that the PRV has actually published a notice on its homepage regarding this issue last week, after receiving several questions from the public.

PRV announced that at this stage it sees no reason for changing its practice regarding the number of supplementary protection certificates (SPCs) that can be obtained from one basic patent. One of the reasons is that this issue does not form part of the Medeva referral and, further, as far as it can tell, neither Biogen nor Medeva contain any judgment providing the basis for the conclusion that the Court should consider that the patent term for a basic patent only can be extended by one single SPC no matter how many products that are protected by the basic patent and that several of these products have been authorized for marketing as a pharmaceutical. Accordingly we conclude that, for now in Sweden, there should be no direct obstacle to obtaining several SPCs from one basic patent.

More information can be found here (currently only in Swedish)".

Many thanks, Camilla. It will be good to hear from correspondents in other countries as to whether their authorities issue similar or contradictory statements.

Jut one SPC per patent? What the Court of Justice really said

Following Martijn de Lange's recent post, "'Just one SPC per patent': time for some number-crunching" (here), our friend and colleague Herwig von Morze has written this defence of the view that a single basic patent can support more than one SPC. He first quotes para.41 of the Court of Justice (ECJ) ruling in Medeva which states:

“Second, where a 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)" 

and then explains that this statement

"may create the impression that each basic patent can only give rise to one certificate, regardless of how many different products this patent covers. However, this impression of the statement is misguided as it ignores Medeva’s (Biogen’s) reference to Art. 3(c) of Reg. 469/2009.  Art. 3(c) does not limit the number of certificates per basic patent to one in general terms but limits this number to one for a specific product. Art. 3 as a whole does not, and cannot, address a situation concerning an assortment of products covered by a basic patent, but defines the granting requirements for a single product. It is noteworthy that Art. 3(a) to (d) uses the definite article “the” product and not “a” product. If a certificate for a product covered by a basic patent would rule out a certificate for another product, then the indefinite article would have been used in Art. 3(c). Therefore para. 28 of Biogen and similarly para. 41 of Medeva must be read and supplemented in conformity with Art. 3 (c) as follows:

“Under Article 3(c) of the Regulation, however, only one certificate may be granted for a product for each basic patent.”

The statement in Medeva para. 41 does not create new law: it just repeats Biogen para. 28 which has been in place since 1997. To my knowledge there are no court decisions denying a certificate for a product covered by a basic patent where that basic patent already gave rise to an earlier certificate covering another product based on Biogen para. 28. However, if other SPC readers have different information, will they please come forward.

Daiichi (Case C-6/11) may be of relevance for the interpretation of Biogen para. 28/Medeva para. 41. It deals with a situation where the claims of a basic patent are limited to a single active ingredient A and the subject of the marketing authorization is directed to A+B. According to the decision, no SPC is possible for the combination A+B, because this combination is not identified (specified) in the claims of the basic patent, as required by Art. 3(a). However, Daiichi raised no objection pursuant to Art. 3(c), although previously a SPC had issued for A supported by the same basic patent, a fact before the British court and the ECJ. The ECJ’s ruling would at least imply that a SPC would have been possible for A+B, had the patent claims identified (specified) this combination. This further supports the opinion expressed here that, contrary to one impression created by  Biogen para. 28/Medeva para. 41, a single basic patent would be capable of supporting more than one SPC (one for the product A and another one for the product A+B)".

The SPC Blog thanks Herwig for his close analysis of the ipsissima verba of the ECJ and hopes to hear from any readers who have information concerning court decisions denying a certificate for a product covered by a basic patent where that basic patent previously gave rise to an earlier certificate covering another product based on Biogen para. 28.