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Expert Corner

Intellectual Property expert

SPC protection for combination products: future scenarios

The European Court of Justice has recently handed down two judgments Medeva (C-322/10) and Georgetown (C-422/10) clarifying how EU countries should apply SPCs to combination products.

Combination drug therapy has proven to be highly beneficial in the treatment of several diseases such as cancer, HIV (AIDS), tuberculosis, diabetes, cardiovascular diseases and central nervous system disorders. Vaccines very often involve a combination of antigens. Combination therapy has become more and more important in recent years.

The development of a combination therapy very often occurs after the development and/or commercialisation of the corresponding immunotherapy, when normally the NCE patents for the single compounds are already filed or granted.

The main issues faced by these decisions are as follows:

(1)      The first issue (under Article 3(a) of the SPC regulations) concerns whether a patent claiming only one active ingredient from a combination of active ingredients in an authorised drug can be used to obtain an SPC for that drug.

The court decided that an SPC could be granted for a combination of active ingredients only if those active ingredients were “specified in the wording of the claims”. This implies that:

– An SPC cannot be granted for an authorised medicinal product which is a combination of two active ingredients (A + B) if the literal wording of the basic patent claims A in isolation. This applies even if the claims use “comprising” or similar language which does not exclude the presence of another active ingredient.

– An SPC cannot be granted for an authorised medicinal product which is a combination of A + B if the literal wording of the basic patent claims a combination of A with another unspecified active ingredient.

– An SPC may be granted for an authorised medicinal product which is a combination of A + B if the literal wording of the basic patent claims A in combination with the specified active ingredient B. 

Issue still open to debate: How specific do the claims need to be: does a Markush claims suffice?

Presumably, National Courts will invalidate SPCs to combination products that have been granted on the basis of the “infringement test’ but where the active ingredient(s) are not specified in the wording of the claims of the basic patent. As a matter of fact, the Court of Rome on 25 November 2011, applying ECJ ordered the provisional suspension of the preliminary injunction previously granted to Novartis under its SPC covering the medicinal combo product “Cotareg” (valsartan + HCTZ). 

 (2) The second issue (under Article 3(b)) was whether the authorisation of a drug that contains a combination of active ingredients can be used to obtain an SPC for only one active ingredient from that combination.

This issue was decided allowing SPCs to be granted for single active ingredients that are authorised for use with other active ingredients.

So there does not need to be an exact match between the authorised product and the SPC application: the authorised product can be wider.

(3)      The meaning of first marketing authorisation

As you may know , a further requirement for obtaining an SPC is dependent on the marketing authorisation relied on being the first in the EU for that “product” (Article 3(c), SPC Regulation).

Before the ECJ’s decisions, it had been understood that the first marketing authorisation for a combination product namely A+B would be the first marketing authorisation for the exact combination product A+B. However, the ECJ has decided that the first marketing authorisation would be any marketing authorisation that includes A+B, even if the drug was authorised with additional active ingredients.

(4)     The scope of SPCs

ECJ gave some helpful guidance as to the scope of an SPC stating that “an SPC thus granted in connection with such a product confers, upon the expiry of the patent, the same rights as were conferred by the basic patent in relation to the product, within the limits of the protection conferred by the basic patent, as provided for in Article 4 of the regulation”. An SPC for active ingredient A would be infringed by use/sale of a medicinal product containing active ingredients A and B.

National courts will enforce SPCs to single active ingredients against the generic versions of combination products containing a protected active ingredient

Consequently Generic manufacturers will delay the launch of combination products until SPCs to the individual active ingredients have expired (or have been invalidated).

(5)     Number of SPCs

ECJ states that only one SPC can be granted per patent. However in the light of Biogen, where a patent claims more than one product, more than one SPC can be granted provided that each SPC relates to a different product.

These decisions may require a change in drafting practice for patent applications directed to pharmaceutical and plant protection products, as well as a review of existing patent applications and even granted patents, so that they claim specific combination products if SPC protection is desired for such combinations in the future.

 

February 2012

 

 

 

For further information please contact Anna Pezzoli

 

 

 

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