European Court of Justice Limits SPC’s To Active Ingredients

In a recent judgment (C-431/04), the European Court of Justice (ECJ)
has gone against the Opinion of the Advocate General and ruled that
the German courts were correct in rejecting an application for a
Supplementary Protection Certificate (SPC) for the chemotherapeutic
Gliadel™.

SPCs are provided under Regulation 1768/92/EEC and extend the lifetime
of patents covering medicines up to five years to compensate for the
effectively reduced lifetime of such patents due to the lengthy
marketing approval procedures that have to be followed before
launching a new medicine on the market. Article 1(b) of the Regulation
defines the “product” to be protected by an SPC as “the active
ingredient or combination of active ingredients of a medicinal
product”.

The product in question, Gliadel™, comprises the cytotoxic drug
carmustine embedded in a matrix made of the polymer polifeprosan. The
Federal Patent Court had rejected the SPC, arguing that Gliadel™ was
no true combination of active ingredients but rather a new formulation
of the long known carmustine.

On appeal, the German Supreme Court (BGH) had addressed a referral to
the ECJ, asking whether the concept of a “combination of active
ingredients” within the meaning of Article 1(b) of the Regulation must
be interpreted as including a combination of two substances, only one
of which has pharmacological properties of its own for a specific
therapeutic indication and the other is necessary for the therapeutic
efficacy of the first substance.

In his opinion on the case, the Advocate General concluded that the
ECJ should respond in the affirmative.

The decision issued by the ECJ reaches entirely the opposite
conclusion to that of the Advocate General, holding that “a substance
which does not have any therapeutic effect of its own and which is
used to obtain a certain pharmaceutical form of the medicinal product
is not covered by the concept of active ingredient”.

In coming to its decision, the ECJ sought to define the term “active
ingredient”. Therefore, the Court referred to the Explanatory
Memorandum to the Regulation specifying that “the proposal for a
Regulation therefore concerns only new medicinal products. It does not
involve granting a SPC for all medicinal products that are authorised
to be placed on the market. Only one SPC may be granted for any one
product, a product being understood to mean an active substance in the
strict sense. Minor changes to the 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 ECJ found that the same reasoning also applied to the
interpretation of Article 3 of Regulation 1768/92/EEC. Accordingly,
the combination of a substance not having a therapeutic effect with an
active ingredient could not give rise to a “combination of active
ingredients” within the meaning of Article 1(b) of Regulation
1768/92/EEC.

Thus, this judgement of the ECJ does not enable for obtaining SPCs for
novel formulation of known drugs which will be a disappointment to the
research-based drug industry.

For more information on this topic, please contact Dr. Stefan Danner at danner@maiwald.de. Dr. Stefan Danner is a patent attorney at the Munich office of Maiwald Patentanwalts GmbH. His main areas of practice include patent prosecution, opposition, and litigation as well as preparing freedom-to-operate and validity opinions in the fields of molecular biology, biochemistry, microbiology, and pharmacology.

The information contained in this alert is provided for informational purposes only and does not represent legal advice. Neither the APLF nor the author intends to create an attorney client relationship by providing this information to you through this message.

 

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