Medical Methods in Europe: Further Guidance from the EPO

This article was included in our Summer 2010 edition of Inside IP magazine.

In February of this year the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) issued two decisions, G 1/07 and G 2/08, commenting on the patentability of methods of treatment, surgery and diagnosis. Together these decisions represent the first major guidance on the subject to emerge from the EBA since the revision of the law introduced by the EPC 2000 in December 2007. The content of these decisions and the implications in respect of European patents and patent applications is discussed below.

The Law

As with many jurisdictions around the world, the EPO seeks to allow medical and veterinary practitioners the freedom to operate without fear of patent infringement, whilst at the same time acknowledging the effort required to discover new and inventive methods of treatment, surgery and diagnosis. It attempts to do this via two complementary provisions. The first, Article 53(c) EPC 2000, specifies that:

European patents shall not be granted in respect of … methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body…’

Meanwhile Article 54 specifies in paragraphs (4) and (5) that this:

‘shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in [such methods], provided that its use for any such method is not comprised in the state of the art’ (the so-called first medical use),and further that it:

‘shall also not exclude the patentability of any substance or composition [comprised in the state of the art] for any specific use in [such methods], provided that such [specific] use is not comprised in the state of the art’ (the so-called second medical use).

These provisions have been subtly re-worded from the equivalent provisions in the preceding version of the EPC, in a manner which was generally thought to be a tidying up exercise. How these provisions are to be interpreted however is left to case law to decide. The two new EBA decisions provide the following crucial guidance in this respect.

G 1/07 – Methods of treatment by surgery

G 1/07 concerned the patentability of an imaging method that requires the injection of a contrasting agent into the heart. In discussing this point, the EBA reached a number of conclusions relevant to the patentability of methods of treatment by surgery in general.

Firstly, confirming the applicability of decision G 1/04 to the EPC 2000, the EBA held that the presence of at least one surgical step in a multi-step method excludes that method from patentability, and that accordingly:

‘a claim which comprises a step encompassing an embodiment which is a “method for treatment of the human or animal body by surgery … cannot be left to encompass that embodiment.’

Thus, the law appears unchanged in this regard. However, the EBA then went on to discuss at greater length the extent of the exclusion. In particular it clarified that:

‘the meaning of the term “treatment by surgery” is not to be interpreted as being confined to surgical methods pursuing a therapeutic purpose’.

Thus, it seems that in most cases methods of surgery for non-curative purposes such as cosmetic surgery, the termination of pregnancy, artificial insemination, embryo transplants, sterilisation, castration, surgery for experimental and research purposes and the removal of organs, skin or bone marrow from a living donor may well be excluded from patentability.

Despite then discussing the issue at great length the EBA perhaps understandably refused to give a clear all-embracing definition of what is and is not a method of treatment by surgery. Accordingly, what is and is not surgery will not always be clear. Nonetheless, the EBA indicated that factors to consider include:

• the importance of maintaining the life and health of the subject;
• how invasive the method is; and
• the degree of risk to the health of the subject.

The only clear decision the EBA gave however was in relation to the imaging method in question, where it was held that whilst:

'A claimed imaging method is not to be considered as being a treatment of the human or animal body by surgery… merely because during a surgical intervention the data obtained by the use of the method immediately allow a surgeon to decide on the course of action to be taken during a surgical intervention’,

'A claimed imaging method, in which, when carried out, maintaining the life and health of the subject is important and which comprises or encompasses an invasive step representing a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise, is excluded from patentability as a method for treatment of the human or animal body by surgery’.

Accordingly, whilst useful guidance has been provided, ultimately there is still a large ‘grey’ area that will have to be decided/argued on a case-by-case basis.

G 2/08 – Dosage regimens

G 2/08 concerned the patentability of so-called second medical use claims and in particular second medical use claims in which the use has been characterised by a specific dosage regimen, which distinguishes it from the prior art.

Whilst the prosecution of such claims before the EPO is commonplace, it is not without controversy. In particular up until now the EPO’s attitude to such claims has been hard to predict with different Technical Boards of Appeal coming to different conclusions as to whether a specific dosage regimen can ever be considered a technical feature capable of rendering a second medical use claim novel and inventive. Clarification in this regard was therefore long overdue.

Fortunately G 2/08 has provided the necessary clarification, the EBA stating that:

'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’ and that consequently:

'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.’

Whilst this is undoubtedly good news for the applicant/patentee, it must be remembered that the dosage regimen in question must still meet the remaining criteria of the EPC; in particular of course it must be both novel and inventive.

G 2/08 – Second medical uses of products

Whilst not forming part of the decision as such, an interesting further remark was made by the EBA within its reasoning which might have a profound impact on the patentability of medical devices and the like. The EBA stated that:

'the respective provisions of Articles 53 (c), 54 (4) and (5) EPC… constitute provisions of the law… aiming at allowing as a matter of principle patent protection for products, substances or compositions for use in therapeutic methods.’

It appears to signal for the first time that first and second medical use claims to all products (not just medicaments) might be allowed. This appears to run contrary to earlier lower Board of Appeal decisions, e.g. T 227/91 in which it was held that second medical use claims to surgical instruments were not allowed on the grounds that ‘a surgical use of an instrument is not analogous to a therapeutic use… since the former is not consumed in the application and could be repeatedly used for the same or even for other purposes as well’.

In future therefore it will certainly be worth arguing strongly for medical use claims to be allowed in relation to medical devices, even if it is far from certain as to whether they will ultimately be accepted.

Avoiding the exclusion

Whilst in practice it has generally proven possible to obtain protection for a novel and inventive method, either via a claim drawn to a non-medical method per se, or via a claim drawn to a first or second medical use, both of the above two decisions have provided further guidance which may help in this regard.

In particular, in G 2/08 the EBA supported an earlier lower Board of Appeal decision (T 1020/03), stating:

‘there is a seamless fit, either a method of using a composition is not a treatment by therapy and… so is patentable subject to compliance with the other provisions of the EPC, or else a method is a treatment by therapy… and so not itself patentable, but… a composition… for use in such treatment by therapy is patentable for unspecified therapy as a first medical indication or for a specified therapy as a further medical indication, again subject to compliance with the other provisions of the EPC, in particular novelty and inventive step.’

This is important. It emphasises that there should be no ‘gap’ down which the applicant can fall. In other words, subject to the method of using a substance being novel and inventive, in theory at least you should always to be able to get a claim either drawn to the method per se, or else drawn to the substance for use in the method.

Of course in practice the issue may not be so straightforward, particularly where the method can be seen as both therapeutic and non-therapeutic. It may be then necessary to divide the subject matter of the claim accordingly.

In relation to claiming the non-therapeutic portion of the method, this should not usually be a problem. In G 1/07 it was emphasised that you should simply be able to disclaim the therapeutic embodiment. So long as the disclaimer only serves to avoid the legal exclusion, basis for the disclaimer in the application as filed should not be required.

However in relation to claiming the therapeutic portion of the method as for example a composition for use in said method, difficulties may arise. In particular, it may be necessary to argue that there is either explicit or implicit basis in the application as filed for restricting the method to one for treatment of the human or animal body by surgery or therapy. In the vast majority of cases this should be possible, however as a matter of good practice it may be advisable to ensure that there is basis for such a restriction when drafting any new application.

Swiss-type claims

A final important point to raise is the impact of the EPC 2000 on so-called Swiss-type claims, i.e. second medical use claims in the form:

‘Use of X for the manufacture of a medicament for the treatment of Y’.

The format of such claims is essentially a legal creation in view of the ambiguity in the preceding version of the EPC. Supposedly equivalent or possibly slightly broader protection is now explicitly afforded under the EPC 2000 by using the much simpler wording:

‘X for use in the treatment of Y’

In a tidying up exercise therefore, the EBA held in G 2/08 that second medical use claims in the Swiss-type format are no longer allowable before the EPO.

Importantly, the EBA emphasised that this decision has no retroactive effect, i.e. it does not apply to applications currently pending or granted. It only applies to future applications. At the time of going to press the precise date for this decision to enter into force had not yet been set.

Summary / Key points

• The presence of at least one surgical step in a multi-step method excludes that method from patentability
• The surgery does not have to be for a therapeutic purpose to be excluded
• What is and is not surgery will not always be clear, but factors to consider include:

1. the importance of maintaining the life and health of the subject;
2. how invasive the method is; and
3. the degree of risk to the health of the subject

• Where it is already known to use a medicament to treat an illness, it is allowable to patent the same medicament for use in a different treatment (e.g. a dosage regimen) by therapy of the same illness (provided of course said treatment is novel and inventive)
• For a novel and inventive method of using a given substance, in theory you should always be able to get a claim either drawn to the (non-medical) method per se, or else drawn to the substance for use in the (medical) method
• You may be able to avoid the exclusion of a method by disclaiming any embodiments that include the surgical or therapeutic step
• In future Swiss-type claims will no longer be allowed; second medical use claims must be drafted in the form ‘X for use in the treatment of Y’

Stephen Johnson 14 Jun 2010

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