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13 January 2014Big Pharma

SPCs at the CJEU

Georgetown University v Octroocentrum Nederland (Netherlands Patent Office)

Background

In 2007, Georgetown University filed eight SPC applications with the Netherlands Patent Office (OCN) based on European patent number 0647140 entitled ‘Papillomavirus vaccine’. The patent was awarded on December 12, 2007 (the day of the SPC application) and expired on June 23, 2013. Two of the SPC applications covered combinations of the active ingredients of the vaccine, four were for the individual active ingredients, and two others related to two of the individual ingredients.

Two applications were granted in 2008, but in 2010 one was rejected by the OCN (the other five are pending), initially on the grounds that the marketing authorisation (MA) for Sanofi Pasteur’s drug Gardasil relied on in support of the SPC application related to a medicinal product containing other active ingredients beyond that covered by the application. Following CJEU decisions in two cases referred from the UK (Medeva and Georgetown University and Others), however, it decided that this ground could no longer prevent the award of an SPC.

The OCN then said that the decision not to award the SPC could be based on Article 3(c) of Regulation 469/2009 which, it said, provides that only one SPC can be awarded for each basic patent; Georgetown had already obtained two SPCs based on the same patent.

The case ended up at the Rechtbank’s-Gravenhage, which referred six questions to the CJEU, observing that if the OCN was right, the rule could easily be circumvented by holders separating their patents to ensure each protected only one product.

Key questions

The Dutch Court referred five questions, of which the CJEU answered the first: “Does Regulation 469/2009 …, more particularly Article 3(c) thereof, 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?”

Conclusion

The CJEU answered the first question in the negative, meaning it was not required to answer the remaining four questions. It said:

“The CJEU’s decision should allow companies wider scope to obtain SPCs covering multiple products based on the same patent.”

“The answer to Question 1 is that, in circumstances such as those in the main proceedings where, on the basis of a basic patent and an MA for a medicinal product consisting of a combination of several active ingredients, the patent holder has already obtained an SPC for that combination of active ingredients, protected by that patent within the meaning of Article 3(a) of Regulation 469/2009, Article 3(c) of that regulation must be interpreted as not precluding the proprietor from also obtaining an SPC for one of those active ingredients which, individually, is also protected as such by that patent.”

Implications

The CJEU’s decision should allow companies wider scope to obtain SPCs covering multiple products based on the same patent, subject to the limitations laid out by the Actavis Group v Sanofi ruling.

Actavis Group v Sanofi

Background

Sanofi owns a patent covering a family of compounds including the antihypertensive active ingredient irbesartan, and pharmaceutical compositions including the active ingredient in combination. Sanofi obtained an SPC on the basis of an MA for Aprovel, which contains irbesartan as its sole active ingredient, in 1999. In the same year, Sanofi also obtained an SPC based on the MA for CoAprovel, relating to airbesartan–hydrochlorothiazide combination, based on the same patent.

Actavis challenged the second SPC, claiming that the combination is not protected by the basic patent, and further, that the ‘product’ in question had already been the subject of an SPC.

Key questions

The High Court of Justice (England and Wales) referred two questions:

(1) What are the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of … Regulation 469/2009?

(2) In a situation in which multiple products are protected by a basic patent in force, does Regulation 469/2009, and in particular Article 3(c), preclude the proprietor of the patent being issued a certificate for each of the products protected?

Conclusion

The court answered the second question, and given its answer, found no need to answer the first: “The answer to the second question referred is that, in circumstances such as those in the main proceedings where, on the basis of a patent protecting an innovative active ingredient and an MA for a medicinal product containing that ingredient as the single active ingredient, the holder of that patent has already obtained an SPC for that active ingredient entitling him to oppose the use of that active ingredient, either alone or in combination with other active ingredients, Article 3(c) of Regulation 469/2009 must be interpreted as precluding that patent holder from obtaining—on the basis of that same patent but a subsequent MA for a different medicinal product containing that active ingredient in conjunction with another active ingredient which is not protected as such by the patent—a second SPC relating to that combination of active ingredients.”

Implications

Companies may not obtain a second SPC on the basis of an MA for an active ingredient in combination with another which is not protected as such by the patent, if it already has an SPC for the initial active ingredient.

Eli Lilly and Company v Human Genome Sciences (HGS)

Background HGS has a European patent covering the discovery of a new protein, neutrokine alpha (α). The patent discloses and claims that protein and also relates to antibodies that bind specifically to the protein. Eli Lilly wants to market a composition used in the treatment of autoimmune diseases, containing an antibody as active ingredient (known as LY2127399) that it accepts is covered by HGS’s patent.

It sought a declaration that any HGS application for an SPC based on its patent and an MA covering LY2127399 would be invalid, because the antibody is not covered by the “basic patent”, since the claim in the patent is too broadly drafted to be seen to specify LY2127399.

Key questions

The High Court of Justice (England and Wales) referred three questions:

(1) What are the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of Regulation 469/2009?

(2) Are the criteria different where the product is not a combination product, and if so, what are the criteria?

(3) In the case of a claim to an antibody or a class of antibodies, is it sufficient that the antibody or antibodies are defined in terms of their binding characteristics to a target protein, or is it necessary to provide a structural definition for the antibody or antibodies, and if so, how much?

Conclusion

The CJEU found that, “in order for an active ingredient to be regarded as ‘protected by a basic patent in force’ ... it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula.

Where the active ingredient is covered by a functional formula in the claims of a patent issued by the EPO, Article 3(a) of Regulation 469/2009 does not, in principle, preclude the grant of an SPC for that active ingredient, on condition that it is possible to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 of the EPC and the Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question, which is a matter to be determined by the referring court.”

Implications

National courts are tasked with interpreting whether patent claims relate “implicitly but necessarily and specifically” to the active ingredient in question. This may lead to different interpretations in different national courts.