Nathan Fan is a JD candidate at Osgoode Hall Law School.

The EPO’s Enlarged Board of Appeal recently ruled that Swiss-type claims are no longer patentable in the EU, resolving the long-standing question while putting Abbott Respiratory’s patent application case to rest. However, the Enlarged Board’s decision also held that new dosage regimes for an old product were in fact patentable, upholding prior Enlarged Board decisions.

Kos Life Sciences, Inc. (now Abbott Respiratory LLC) originally filed for a European patent application on 19 September 1994 for a Swiss-type claim for the “use of nicotinic acid for the manufacture of a sustained released medicament for use in the treatment of hyperlipidemia”, but was rejected by the EPO on the grounds that it lacked novelty under Article 54(1) and (2) of the European Patent Convention (EPC) 1973 (i.e. the dosage regime was the only distinguishing feature between the secondary use and the previously claimed use) and that it did not meet the requirements of Article 52(4) EPC 1973  (i.e. it was a method of treatment of the human body).

Abbott Respiratory LLC appealed the decision to the Board of Appeal, but as the application was still pending as of 13 December 2007 – the day on which the newly amended EPC 2000 was to come into force – the Board of Appeal deferred the case to first seek clarification of the law regarding Swiss-type claims, stating that “the question of whether medicaments for use in methods for treatment by therapy, where the only feature likely to confer novelty on the claim is a dosage regime, are patentable under Article 53(c) and 54(5) EPC 2000 was an important point of law”.

The Board of Appeal then, in their 22 April 2008 decision, referred three questions to the EPO Enlarged Board of Appeal:

Question 1:

Where it is already known to use a particular medicament to treat a particular illness, can this known medicament be patented under the provisions of Articles 53(c) and 54(5) EPC 2000 for use in a different, new and inventive treatment by therapy of the same illness?

Question 2:

If the answer to question 1 is yes, is such patenting also possible where the only novel feature of the treatment is a new and inventive dosage regime?

Question 3:

Are any special considerations applicable when interpreting and applying Articles 53(c) and 54(5) EPC 2000?

With regards to Question 1, the Enlarged Board considered the G 5/83 decision as authority for allowing patentability for a second therapeutic indication of a known product, although the Board noted that it was not specified whether that second use could be something other than the treatment of another disease. However, Article 54(5) under the EPC 2000 attempted to clarify this by allowing patentability of a known substance or composition for “any specific use” of the product in a method of therapy, provided that this use is novel. In defining “any specific use”, the Board adopted a broad construction, and thus the new use within Article 54(5) could in fact be the treatment of the same disease as the first therapeutic indication.

In answering Question 2, the Board held that since “any specific use” ought to be given a broader construction, there would be no reason to treat a new dosage regime of a known medicament any differently than any other specific use that is acknowledged in case law. However, the Board did address the concerns of “evergreening”, and stressed that the requirements of novelty and inventiveness developed in the whole body of jurisprudence must be firmly applied to a new dosage regime claim. In particular, the Board stated that the claim must be verbally different from the previous claim and must reflect a different technical reading.

The Board also noted the concern that the category of claims under Article 54(5) could receive a broad interpretation so as to result in the restriction of medical practitioners to prescribe or administer generics. However, the Board declined to advance any restrictions as it noted that the Board had no power to broaden or reduce the scope of the provisions enacted by the legislator. The Board provided consolation in that, if the situation were to reach the point that medical practitioners were restricted in their professional practice, their freedom could be protected by other means on the national level.

In addressing Question 3, the board noted that the patentability of Swiss-type claims have always been due to a loophole in the EPC 1973 provisions. Under the provisions, only the first medical indication of a known composition was entitled to be drafted in the form of a purpose-related product claim under Article 54(4) EPC 1973. However, because it was not the intention of the legislator to exclude secondary therapeutic indications of a known medicament from patentability, Swiss-type claims were granted adequate, although exceptional, novelty and allowed patentability. In such Swiss-type claims, the medicament was not novel and the subject-matter of such a claim was only rendered novel because of its new therapeutic application.

The revised Article 54(5) EPC 2000 explicitly permitted the form of purpose-related product claims for any further specific use of a known medicament in a method of therapy and in effect closed the loophole for Swiss-type claims in EPC 1973. As the Board put it: “when the reason of the law ceases, the law itself ceases”. Thus, the Board held that Swiss-type claims do not meet the requirements of patentability due to the “absence of any functional relationship of the features (belonging to therapy) conferring novelty and inventiveness…and the claimed manufacturing process”.

In summary, the EPO Enlarged Board of Appeal answered the three referred questions in the following manner:

Answer 1:

Where it is already known to use a medicament to treat an illness, Article 54 (5) EPC does not exclude that this medicament be patented for use in a different treatment by therapy of the same illness.

Answer 2:

Such patenting is also not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art.

Answer 3:

Where the subject matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer have the format of a so called Swiss-type claim as instituted by decision G5/83.

As a result, new dosage regimes for a medicament that treat the same illness are patentable under the claim formulation of “substance or composition X for use in the treatment of disease or condition Y”. However, the claims will not receive patentability in the Swiss-type form of “use of a substance or composition X for the manufacture of a medicament for treatment of disease or condition Y”.

Due to the fact that there have been many Swiss-type patents that have been granted or that are currently pending approval, the abolition of Swiss-type claim patentability will not be imposed retroactively and will not come into effect until three months following the publication of the decision in the Official Journal of the EPO.

Posted in Innovation, Patentability, Patents, Pharmaceutical Drugs