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Sunday, 22 January 2012

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 para41 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.


Anonymous said...

I agree with this analysis. Otherwise, the Court would have answered that one SPC has already been granted for A, so no need to assess the possibility for A+B. Since it considers A+B, even though an SPC for A was already granted on the basis of the same patent, nothing (exc.art.3a) was precluding in principle the grant of a second SPC for A+B...

Anonymous said...

Hmm, I am not so sure. It's a bit of a stretch to take Daiichi that far. You have to read Daiichi in the light of the questions that were put before the CJEU. If you look at the questions referred, (eg. Daiichi para 20) there is no mention of Art 3(c) in there whatsover, nor any mention of the point encapsulated by Art 3(c). Thus, to say that "...if the CJEU was going to kill the A + B SPC in Daiichi on the basis of Art 3(c) they would have said so", is an extrapolation too far...

Manos Markakis said...

I concur with the above analysis of Mr. Herwig von Morze.

Further arguments speaking against the restrictive interpretation of article 3c that “only one SPC per patent should be granted” may be derived from the Explanatory Memorandum to the proposal for the SPC Regulation (COM(90) 101 final) [SPC Blog link here], which was explicitly relied upon by the CJEU in the recent Medeva & co. rulings. In particular:

Para 29 of the Memorandum (explaining article 1) states that: “the purpose of the expression “product protected by a patent” is to specify what types of invention may serve as a basis for a certificate. The proposal does not provide for any exclusions. In other words, all pharmaceutical research, provided that it leads to a new invention that can be patented, whether it concerns a new product, a new process for obtaining a new or known product, a new application of a new or known product or a new combination of substances containing a new or known product, must be encouraged, without any discrimination, and must be able to be given a supplementary certificate of protection provided that all of the conditions governing the application of the proposal for a Regulation are fulfilled”.

Furthermore, para 36 of the Memorandum (explaining article 3) states that “it would not be acceptable, in view of the balance required between the interests concerned, for this total duration of protection for one and the same medicinal product to be exceeded. This might nevertheless be the case if one and the same product were able to be the subject of several successive certificates. This calls for a strict definition of the product within the meaning of Article [1]. If a certificate has already been granted for the active ingredient itself, a new certificate may not be granted for one and the same active ingredient whatever minor changes may have been made regarding other features of the medicinal product (use of a different salt, different excipients, different pharmaceutical presentation, etc.).”.

The above explanations clarify that article 3c aims to prevent successive SPCs being granted for “one and the same product”, within the meaning of article 1b. Article 3c is ‘product’ oriented, not ‘basic patent’ oriented. When the basic patent discloses more than one ‘products’, such as multiple active ingredients and/or combinations of active ingredients, each one of those ‘products’ is eligible for its own SPC. In such case, there can be no mention of “minor changes regarding other features of the medicinal product”, but essentially of “other products”.

In fact, nothing prevents the basic patent from disclosing more than one inventions-’products’, save for article 82 EPC. The question whether the inventions-’products’ encompassed in a single basic patent all meet the requirements of patentability (such as whether the combination of active ingredients A+B is novel with respect to A alone) is to be determined in accordance with substantive/national patent law, not under article 3c of the SPC Regulation.

Therefore, granting multiple SPCs for different ‘products’, on the basis of a single basic patent, does not fall foul of article 3c, since each one of those ‘products’ “has not already been the subject of a certificate”.

Finally, it should be also born in mind that the potential restriction “one SPC per patent” is rather formalistic and can be easily circumvented by filing divisional applications.

In light of the above considerations, para 41 of Medeva (Case C-322/10) may also be interpreted and read as follows:
“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; where a patent protects multiple products, multiple certificates may be granted for that basic patent” (a contrario).

Manos Markakis

Manos Markakis said...
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