The Court of Justice of the European Union (CJEU) gave its opinion on the Medeva and Georgetown cases today, 24 November 2011. The decisions have implications not only for the parties involved, but also for the pharmaceutical industry at large.
The CJEU decision is helpful for pharma companies involved in products that contain multiple active ingredients, such as vaccines. It allows a company to get SPC protection as long as the medicine that has marketing authorisation includes the active ingredient "specified" in the patent claims. The court concluded, contrary to the English court's view, that there was no need for a precise match between the patent claims and the list of active ingredients in the medicine.
In addressing the issue of infringement of SPCs the decision gives a broad scope in relation to third party combination products. What remains unclear is what the CJEU means by the requirement that active ingredients be "specified" in the patent claims. It is not uncommon to have patents that claim chemical entities by reference to a class of molecules. It remains to be seen whether a claim to a class which does not call out the authorised active ingredient by name is sufficient.
Background – the Supplementary Protection Certificate ("SPC") system
The aim of the SPC system is to compensate for loss of patent protection due to regulatory delays in obtaining marketing authorisation. The 20 year patent monopoly starts to expire on the day the patent is filed. Pharma companies cannot, however, exploit that monopoly until they get marketing authorisation. Getting marketing authorisation (from the European Medicines Agency (EU-wide) or national agencies) takes years: sometimes 10 or 15 years.
The SPC system is based on an EU regulation, (No. 469/2009 – the "SPC Regulation") and provides for an additional period of patent-like protection once a patent has expired to compensate innovators for this "lost" patent term. SPCs can last for up to five years (five and a half years if a paediatric extension is obtained). The SPC system requires a link between the protection given in the "basic" patent to the medicines that are authorised by the relevant healthcare agencies (such as EMA). The nature and requirements of this linkage are the source of the dispute in the current cases.
Background – the Medeva case
Public health policy often requires that vaccines contain a combination of active ingredients directed to a number of different diseases or different strains of a virus so that multiple immunisations can be carried out via one injection.
For an SPC to be granted there must be a patent and a marketing authorisation that relate to the active ingredient(s). Where there is a mismatch between the patent (which, for example, might claim only one active ingredient) and the marketing authorisation (which, for example, might cover a number of active ingredients in a multi-disease vaccine), the UK Courts had taken the view that no SPC should be granted, because the patent and marketing authorisation must relate to the same active ingredients.
Medeva's patent was for a vaccine against the whooping cough virus. However, Medeva was required to market the vaccine as a combination product with a number of active ingredients designed to vaccinate against other diseases. This meant that Medeva could not obtain a marketing authorisation solely for a vaccine covering the whooping cough virus. Medeva applied for five SPCs for different vaccine combinations, each including its patented active ingredient(s) (Pertactin and FHA) against the whooping cough virus. The applications were rejected, both by the Patent Office, and on appeal, by the Patents Court, on the grounds that the active ingredients covered by SPC applications included vaccines against diseases other than whooping cough, which were not protected by the original patent.
Medeva appealed to the Court of Appeal, arguing that the hearing officer had misconstrued the meaning of the words "product protected by a basic patent", and should be interpreted to cover any product containing the patented vaccine, regardless of whether it was sold as a single vaccine or in combination with other vaccines. The Court of Appeal referred the issue to the CJEU for consideration.
The CJEU's Decision
The CJEU disagreed with the English courts. It ruled that the relevant test was whether the medicine that is the subject of the marketing authorisation contains the active ingredients "specified" in the patent claims. So, for example, if the patent claims 2 active ingredients, API-A and API-B, and the authorised product contains 3 active ingredients (API-A, API-B and API-C) then, according to the CJEU, an SPC can be obtained (article 3(a) of the SPC Regulation). The SPC granted in that case would be an SPC for API-A and API-B as they are specified in the patent claim.
Although it was not asked the question, the CJEU gave its opinion that infringement of the SPC is essentially determined in the way it is for a patent. So, an SPC for a product comprising API-A and API-B would be infringed by any medicine containing API-A and API-B regardless of what other API the medicine contained.
Whilst the decision is helpful for those who are forced to market products as combinations not foreseen in their patents, there is a note of caution. Article 3(d) of the SPC Regulation requires that the marketing authorisation relied upon to apply for the SPC is the first in the EU for that "product" (defined in the SPC Regulations as the active ingredient or combination of active ingredients). The CJEU's opinion is that any medicine containing API-A and API-B is the first MA for API-A and API-B even if the medicine was in fact authorised with additional APIs. In cases where the monotherapy is the first product to market with any combination being later authorised this should not be a problem but it does mean that careful checking is required to ensure the correct MA is relied upon.
The part of the decision that raises a serious question is what is meant when the CJEU says that the "product" (active ingredient) in the authorised medicine must be "specified in the wording of the claims of the basic patent". The Advocate General's opinion had put forward a test that the requirement in the SPC Regulation that the "product is protected by the basic patent" meant that the product should be the "subject matter" of the patent. That test was particularly vague. The test stipulated by the CJEU that the active ingredient(s) must be "specified" in the claim is an improvement to some extent in directing the enquiry to the claims. Where it raises questions is in relation to claims that contain a class of active ingredients. For example, where a patent claims API-A combined with a suitable antibiotic without naming the antibiotic is that sufficient for the grant of an SPC on API-A plus penicillin (or does the claim need to name penicillin)?
There is also an oddity in the Court's opinion that no more than one SPC may be obtained per patent. The decision cites the Biogen decision in support of this proposition. Biogen itself refers to article 3(c) of the SPC Regulation to support the same view. However, article 3(c) deals with a different issue altogether, requiring that the product has not already been the subject of an SPC. There appears to be no basis for this particular point in the SPC Regulation. The effect of this aspect of the decision will be felt most by those who undertook, for example, early stage research and have patents they consider are infringed by a number of products made by others. Following today's decision multiple SPCs held by such parties are in danger.