In general, patent systems seek to reward inventors by granting them the exclusive right to exploit their patented innovation. However, when it comes to inventions that confer a medical benefit, that right is not as clear cut. Instead, patent systems, such as the European one, seek to prevent patent rights from hindering the legitimate activities of medical practitioners by excluding from patentability methods of treatment of the human or animal body by therapy or surgery. Medical use claims enable innovators to seek patent protection for medical inventions without falling foul of this exclusion.
For many years, ‘Swiss-style’ medical use claims have been used to seek protection for the second or further medical use of a substance. The claims take the following format: ‘Use of product X in the manufacture of a medicament for the treatment of disease Y’. The implementation of the European Patent Convention (EPC 2000) initiated a shift away from this type of claim by providing statutory basis for a simpler format of medical use claim, ie ‘Product X for use in treating disease Y’. Article 54(5) EPC 2000 provides that a substance for ‘any specific use’ in a method of treatment by surgery or therapy may be patented, if the medical use is not known.
Clarifying the need for novelty
The first key decision of 2010, G2/08 (brought by Kos Life Sciences, now Abbot Respiratory LLC), concerns the issue of patentability of dosage regimes, but is more broadly applicable. The case at issue concerned a drug already known to treat a certain disease, with the only distinction from the prior art being a new dosage regime for the drug. Prior to G2/08, there had been conflicting European Patent Office (EPO) case law concerning this situation, with decisions ruling both that a new dosage regime can be capable of imparting novelty to a medical use claim, but also that a dosage regime should be thought of as a method of medical treatment unable to impart novelty.
In a ruling that is likely to provide opportunities for extending patent protection in respect of pharmaceuticals, G2/08 clarified that the ‘any specific use’ of Article 54(5) EPC 2000 should be construed broadly – and that a new specific use is not limited to a new disease. Accordingly, a dosage regime can be a specific use capable of giving rise to a patentable medical use invention.
The logic of G2/08 applies not only to dosage regimes, but also to other medical uses such as treatment of patient sub-populations and drug administration routes, which could also give rise to patentable medical use inventions. Thus, G2/08 leaves open many interesting avenues for extending patent protection in respect of pharmaceuticals.
Of course, it should be remembered that all other patentability requirements of EPC 2000 must be met and the EPO has emphasised that new medical uses must give rise to a genuinely new technical teaching. To benefit from the potential extension to patent protection provided by G2/08, applicants will need to be sure to fully describe a new medical use and be prepared to evidence a genuinely new technical effect provided thereby.
The end of Swiss-style claims
G2/08 also looked at medical use claims more generally, ruling that Swiss-style claims will no longer be allowable under EPC 2000. The decision has no retroactive effect, but applications with a filing or earliest priority date of 29 January 2011 or later will not be granted if they contain Swiss-style claims. It is entirely possible that the simpler EPC 2000 medical use claim format provides a different level of protection than Swiss-style claims. Thus, for applications in which Swiss-style claims are permitted, there could still be value in including both types of claim where possible. In addition, Swiss-style claims are a recognised and accepted claim format in many other countries, so their inclusion in new applications intended for multiple jurisdictions is still advisable.
The second key decision of 2010, G1/07 (brought by Medi-Physics), addresses the exclusion from patentability of methods of treatment by surgery and considers the extent to which methods which involve an invasive intervention on the body are excluded from patentability. Rather than providing clear cut boundaries, G1/07 sets out guidance on how the surgical methods exclusion is to be applied on a case-by-case basis by the EPO.
G1/07 involved a magnetic resonance imaging (MRI) method, including a step of injecting a contrast agent directly into the heart. The question posed, in essence, was whether an intervention step on the body caused a method to be excluded even if the step itself was not aimed at maintaining life and health. Previous EPO case law conflicted on whether it is the nature or the purpose of the intervention step that is key in determining if a method is excluded.
G1/07 rules that it is the nature of a physical intervention that determines if a method is excluded from patentability. Thus, if an intervention step is ‘surgical’, the method comprising the step will be excluded from patentability, irrespective of the purpose of the intervention step. G1/07 does, however, recognise that methods involving only a minor intervention with no substantial health risks may not be excluded. Room has been left open for interpretation on a case-by-case basis as to what constitutes a ‘surgical’ intervention and more case law on this issue is likely to arise.
Overall, G2/08 and G1/07 represent important clarification on exclusions from patentability for medical inventions and G2/08, in particular, is welcome news for applicants seeking to maximise patent protection for pharmaceutical products.
Jennifer Harris is an associate in the London offices of Kilburn & Strode LLP
For previous NewLegal Review coverage of the Kos Life Sciences case, click here
For details on how Swiss-style claims are treated in other territories, click here and here