What was the background?
These proceedings concern the interpretation of Article 3 of the SPC Regulation, which provides that an SPC will be granted for a product (where product means an active ingredient or combination of active ingredients) which is protected by a ‘basic patent,’ has a valid MA and has not already been subject to an SPC. Article 3(d) of the SPC Regulation states that the MA must be ‘the first authorisation to place the product on the market as a medicinal product.’
These proceedings came about following the Comptroller General of Patents, Designs and Trademarks’ decision to reject Abraxis’ application for an SPC for the active ingredient paclitaxel in the form of nanoparticles bound to albumin (nab-paclitaxel) on the ground that it did not comply with Article 3(d) of the SPC Regulation. Paclitaxel has an earlier MA but nab-paclitaxel represents a new formulation of that active ingredient and is protected by the basic patent relied upon by Abraxis in support of its SPC application (that patent does not protect paclitaxel as such). The Comptroller General held that, although the SPC Regulation permits the grant of an SPC for a new and inventive therapeutic use of an old active ingredient (following Neurim Pharmaceuticals (1991)), its scope does not extend to a new and inventive formulation of an old active ingredient.
Abraxis appealed to the Patents Court arguing that it had met the condition laid down in Article 3(d) of the SPC Regulation in the light of the solution arrived at by the Court of Justice in Neurim Pharmaceuticals (1991). However, the Patents Court decided that the scope of the Neurim Pharmaceuticals (1991) judgment was not clear and that, therefore, the interpretation of Article 3(d) was not obvious in the case of a new or inventive formulation of an old active ingredient. The Patents Court stayed the proceedings and requested a ruling on the interpretation of Article 3(d) of the SPC Regulation.
The Patents Court considered that nab-paclitaxel does not constitute either an active ingredient distinct from paclitaxel or a combination of active ingredients comprising paclitaxel and albumin because albumin does not have any therapeutic effect. The question referred to the Court of Justice is therefore based on the premiss that paclitaxel is the only active ingredient in nab-paclitaxel.
What did the court decide?
First, the court of Justice examined and agreed with the Patent Court’s conclusion that nab-paclitaxel does not constitute an active ingredient distinct from paclitaxel and it is not a combination of active ingredients comprising paclitaxel and albumin.
In reaching this decision the court noted that, although the definition of active ingredient is not provided in the SPC Regulation, it is settled case-law that its meaning must be determined by considering the usual meaning in everyday language, and that it is generally accepted in pharmacology that the term ‘active ingredient’ does not include substances forming part of a medicinal product which do not have an effect of their own on the human or animal body.
Consequently, as albumin acts as a carrier in nab-paclitaxel, and such carriers do not have any therapeutic effects of their own, albumin cannot be regarded as being an active ingredient within the meaning of the SPC Regulation, even if it allows paclitaxel (the active ingredient with which it is associated) to exercise its therapeutic effect more effectively.
Secondly, the court turned to the referred question and held that the MA relied on in support of an application for an SPC concerning a new formulation of an old active ingredient, cannot be regarded as being the first MA for the product concerned.
The court stated that its finding, which supports a narrow interpretation of Article 3(d) of the SPC Regulation, is confirmed by the Explanatory Memorandum to the proposal for the original SPC Regulation. This Explanatory Memorandum confirms that the legislature establishing the SPC regime was intended to protect not all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product. It also suggests that minor changes to a medicinal product, such as a new dose, the use of a different salt or ester, or a different pharmaceutical form, will not lead to the issue of a new SPC.
The court also referred to recitals 3, 4, 5 and 9 of the SPC Regulation which confirm that the SPC regime is intended to encourage investment into research by compensating pharmaceutical companies for the considerable length of time it can take between filing a patent application and obtaining an MA for a medicinal product. However, recital 10 confirms in achieving that objective, all the interests at stake, including those of public health should be taken into account.
The court noted that such an objective would be jeopardised if, in order to fulfil the condition set out in Article 3(d) of the SPC Regulation, it were possible to take into account, in respect of a new formulation of an old active ingredient, solely the first MA to be covered by the scope of the basic patent protecting that new formulation and to disregard an MA which had been granted previously in respect of the same active ingredient in another formulation.
Furthermore, the court held that such an interpretation of Article 3(d) of the SPC Regulation would risk leading to legal uncertainty and inconsistencies as to the circumstances in which an SPC may be obtained, as it would be difficult to determine in which specific circumstances an MA granted in respect of a new formulation of an old active ingredient may be covered by that provision.
The court also confirmed that the judgment in Neurim Pharmaceuticals (1991) does not call into question its interpretation of Article 3(d) of the SPC Regulation. In Neurim Pharmaceuticals (1991), which concerned a new therapeutic use (rather than a new formulation) and the veterinary medicinal product SPC Regulation (rather than the medicinal products SPC Regulation), the Court of Justice held that Articles 3 and 4 of the that SPC Regulation must be interpreted as meaning that the mere existence of an earlier MA obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product for which an MA has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the SPC application.
However, that exception to the narrow interpretation of Article 3(d) of that SPC Regulation does not refer to cases of a new formulation. This means that exception cannot be relied on in the case of an MA granted for a new formulation of an active ingredient which has already been the subject of an MA, even if the MA for that new formulation was the first to come within the scope of the basic patent relied on in support of the SCP application for that new formulation.
Although this reasoning explains why the Court of Justice felt able to interpret Article 3(d) of the SPC Regulation in the way it did in the present case, it does not (as mentioned above) clarify whether an SPC can be granted for any new therapeutic application or whether an SPC can be granted only where the earlier MA was for veterinary medicinal products.