Comment
In three recent cases, the Court of Justice of the European Union ("CJEU") considered the meaning of "protected by the basic patent" under Article 3(a) of SPC Regulation 469/2009 (the "SPC Regulation") and whether it is possible to obtain more than one SPC per patent. The decisions make clear that the purpose of an SPC is to further both research and investment in research and not to extend patent protection by protecting new products containing the same active ingredient in combination with new unidentified active ingredients (see Actavis v Sanofi (C-443/12) below).
Introduction
Under Article 3 of the SPC Regulation, an SPC may only be granted if, at the date of the SPC application (a) the product in question is protected by a basic patent in force; (b) a valid marketing authorisation has been granted; (c) the product is not already the subject of an SPC certificate; and (d) the marketing authorisation is the first authorisation to place the product on the market as a medicinal product. In making a decision whether to grant an SPC, consideration should be given to the purpose of the SPC Regulation which is to encourage and reward research into pharmaceutical products, such that patent holders are not disadvantaged by the time taken to obtain marketing authorisation and place medicinal products on the market.
The three cases
In the case of Eli Lilly v Human Genome Sciences (C-493/12), Human Genome Sciences ("HGS") had applied for an SPC for its patent based on a marketing authorisation obtained by Eli Lilly.
(In a previous case, Eli Lilly tried to revoke HGS's patent which concerned antibodies which bind to a protein, neutrokine-α (an intercellular mediator in inflammation and immune response). Antibodies that bind specifically to neutrokine-α may inhibit its activity and thus be useful in the treatment of autoimmune diseases. The Supreme Court held that HGS's neutrokine-α patent was valid.)
Lilly argued in the present case that an SPC could not be sought for an active ingredient because the active ingredient was not specified in the patent (that is, in order for an SPC to be granted on the basis of HGS's patent, the patent would have to contain a structural definition of the active ingredients and the claims would have to be more specific).
The CJEU said that it was sufficient that the patent claims included only a functional formula in order for an active ingredient to be regarded as "protected by a basic patent in force" within the meaning of Article 3(a). It is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula .
Eli Lilly and Company Ltd v Human Genome Sciences Inc., Case 493/12, 12 December 2013 .
In Georgetown University v Octrooicentrum Nederland (C-484/12), a case which concerned one basic patent protecting a number of different products, the court considered whether it was possible to obtain an SPC for a single active ingredient protected by a basic patent when an SPC had already been granted for a product containing this active ingredient in combination with others.
Georgetown University's patent related to vaccines for strains of the human papilloma virus.
The question before the court was whether Article 3(c) of the SPC Regulation precluded the holder of a basic patent which protects several pharmaceutical products from being granted an SPC certificate for each of the products. The court said that, yes, it is possible to obtain several SPCs, one for each of those different products, provided that each product is protected as such by the basic patent within the meaning of Article 3(a).
Georgetown University C-484/12, 12 December 2013 .
However, in Actavis v Sanofi (C-443/12), the CJEU said it was not acceptable to extend patent protection of an active ingredient, for which an SPC had already been granted based on a basic patent, by granting a second SPC for a product containing the same active ingredient in combination with a second active ingredient.
Sanofi's patent related to the anti-hypertensive pharmaceutical product irbesartan. The court said that the first SPC covered the active ingredient irbesartan while the second SPC was for the active ingredient in combination with a diuretic not specifically identified in the claims of the patent. The court said both the first and second SPCs were connected with the same product and accordingly, patent protection could not be extended by a second SPC. The patent holder had, by virtue of the first SPC, already been compensated under the SPC Regulation for the delay to market its invention and was not entitled to a second round of compensation by virtue of the second SPC.
Pay for delay pharma settlements – no respite, more fines from the European Commission
The European Commission has recently handed out further fines to pharmaceutical companies for "Pay for delay" settlement agreements (by which the patent holder pays a generic company to remain out of the market for a period of time, which may include a period after the generic company could legally enter the market), which agreements have become very common in recent years. Pay for delay agreements allow the patent holder to continue earning monopoly profits by sharing part of them with the generic company. The Commission has now fined Johnson & Johnson and Novartis in relation to such agreements.
European Commission press release (IP/13/1233), 10 December 2013.
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