The Enlarged Board declares ‘Swiss-type’ claims redundant under EPC 2000

On 19 February 2010, the EPO Enlarged Board of Appeal (EBoA) announced their decision in G2/08, thereby providing important answers to the questions addressing the fate of ‘second medical use’ claims under EPC 2000. Key aspects of the decision are summarised below.

Background to the decision
Under the EPC, methods for treatment of the human or animal body by surgery or therapy are excluded from patentability¹. This exclusion is founded in the interests of public health as discussed by the EBoA in their recent decision, G1/07. In view of this exclusion, the EPC makes clear that substances or compositions for use in medical methods may still be patented¹. Furthermore, Article 54(5) of the EPC 1973 as enacted expressly provided for the patenting of substances or compositions for use in excluded medical methods even though the substance or composition was already known in the state of the art.

The admissibility of purpose-related product claims in the medical field led to a situation whereby patentees additionally sought to patent known substances or compositions for use in further therapeutic applications despite the fact that their use in medicine was comprised in the state of the art. The EBoA dealt with this key issue in their seminal decision, G5/83. The EBoA confirmed that claims directed towards a “specified new and inventive therapeutic application” were admissible under the EPC provided that they were drafted in the ‘Swiss-type’ format i.e. use of substance X in the manufacture of a medicament for the treatment of disease Y.

Although in G5/83, the EBoA did not define what amounted to a “specified new and inventive therapeutic application”, subsequent decisions of the Technical Board of Appeal indicated that so-called second medical use claims could encompass situations wherein the substance was used in a different way to treat the same illness, for example, use in a new dosage regime.

Under EPC 2000, the provisions under Article 54 were revised and Article 54(5) EPC 1973 was re-drafted as Article 54(4) EPC 2000. In addition, the new Article 54(5) under EPC 2000 expressly acknowledges the patentability of any substance or composition for any specific use in a medical method provided that such use is not comprised in the state of the art.

Despite this express acceptance of second medical use claims under EPC 2000, it has not been clear up to this point whether the body of case law developed in relation to second medical use claims under EPC 1973 is still applicable. The current decision provides important guidance in this area.

The Enlarged Board’s decision

Second medical use claims under EPC 2000
The first question referred to the EBoA focussed on whether a medicament already known for use in the treatment of a particular illness could be patented for use in a different, new and inventive treatment for therapy, albeit of the same illness.

In response, the EBoA, following the comments submitted by the president of the EPO, noted that the intention of the authors of the revised Convention was to maintain the status quo as regards the availability of patent protection for further therapeutic uses. The purpose of new Article 54(5) EPC 2000 was to enshrine the case law evolved by the EPO EBoA in the EPC. The EBoA thus confirmed that under the new law the ‘lacuna’ in the former provisions, which had been filled with decision G5/83, no longer exists.

In considering the potential breadth of second medical use claims, the EBoA referred to the fact that Article 54(5) EPC 2000 stipulates that any specific use not comprised in the state of the art may be eligible for patent protection. As such, it would not be appropriate for the EBoA to impose a distinction whereby the specific use must necessarily relate to treatment of a different disease.

Thus, the EBoA concluded that the new use within the meaning of Article 54(5) EPC 2000 need not be the treatment of another disease.  

Dosage regimes
The second question referred to the EBoA specifically related to whether new and inventive dosage regimes could constitute second medical uses under EPC 2000.

Consistent with their response to the first question, the EBoA concluded that patenting is possible where a dosage regime is the only feature not comprised in the state of the art. However, the EBoA did acknowledge concerns relating to the effect that this provision may have on patentees seeking extended terms of patent protection for the use of drugs to treat the same illness. In this regard, the EBoA stressed that:

“for the assessment of novelty and inventive step of a claim in which the only novel feature would be the dosage regime, the whole body of jurisprudence relating to the assessment of novelty and inventive step generally also applies.” (paragraph 6.3)

In particular, the EBoA noted that where a dosage regime was selected from the teaching of a prior disclosure, the jurisprudence with respect to selection inventions would apply.

The fate of Swiss-type claims under EPC 2000
The EBoA’s conclusions in relation to questions 1 and 2 indicate that the amendment to Article 54(5) under EPC 2000 has not led to significant substantive changes in the law in relation to second medical use claims. However, the amendment does now permit second medical uses to be claimed more directly as ‘novelty-of-purpose’ product claims, similar to those accepted for first medical uses under the old law. For example, “Substance X for use in the treatment of disease Y”.

So what does this mean for the fate of Swiss-type claims? Some practitioners have continued to include Swiss-type claims in their applications alongside the purpose-limited product claims. However, as noted by the EBoA in this decision, some feel that Swiss-type claims do not fulfill the requirements of patentability. In particular, the features conferring novelty and inventiveness i.e. the new therapeutic application, are not reflected in a claim directed towards the manufacturing process.

In light of the above, the EBoA have now expressly stated that:

“When 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.” (paragraph 7.1.3 , emphasis added)

The EBoA note that many applications containing this type of claim are still pending and confirm that this new law shall have no retroactive effect i.e. it would appear that Swiss-type claims do not have to be removed from pending applications. However, there is to be a three-month time limit after publication of this decision for future applications to comply with this new decision. As such, new applications filed three months from publication of this decision should not claim second medical uses in the Swiss-type format.

Summary
Many will welcome this decision for the increased certainty that it brings for claims directed to second medical uses. In particular, the decision provides important clarification that dosage regimes may be protected in accordance with Article 54(5) EPC 2000, provided that they meet the requirements for patentability. However, some may feel reluctant to abandon Swiss-type claims, given that the scope of protection is arguably not the same as the purpose-related product claims. On a national level, this may be particularly relevant given that there is little evidence to date on how ‘novelty-of-purpose’ patents will fare in litigation proceedings.

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Boult Wade Tennant

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¹ Article 53(c) EPC

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