Earlier this year  European Patent Office (EPO) Board of Appeal decided in T1780/12 (Cancer treatment/BOARD OF REGENTS, THE UNIVERSITY OF TEXAS SYSTEM, 30 January 2014) that, for the purposes of double patenting, a Swiss-style medical use claim ("Use of X in the manufacture of a medicament for treating Y") was not directed to the same subject matter as the equivalent EPC 2000 medical use claim ("X for use in a method of treating Y").  An applicant can therefore have two European patents covering the same invention -- as long as one uses Swiss-style claims and the other uses EPC 2000-style medical use claims. The issue is not as straightforward as it sounds because we’ve never exactly known what subject matter Swiss-style claims cover, though they provide effective protection for medical inventions. 

By way of background, Swiss-style medical use claims were given approval in 1984 by G5/83 as a way of providing protection for new medical uses of known drugs.  Though the Swiss-style claim refers to ‘manufacture of a medicament’, in truth the claim is a legal fiction.  In time the Swiss-style claim became the scaffold to which all manner of features could be attached in order to protect a wide range of medical inventions.  Swiss-style claims were used not only to protect the use of a drug to treat new conditions, but also new methods of delivery, new patient groups, new mechanisms of action and, most controversially, new dosage regimens.  The dosage regimen controversy was tackled by T1020/03 in 2004, which decided that a Swiss-style medical use claim could be limited by a dosage regimen, and that this could be the feature that gave patentability, despite previous decisions to the contrary. The issue was ultimately settled by G2/08 in 2010 [on which see Katpost here]. 

Forcing inventions to fit into Swiss-style claims has led to interesting variations of the basic structure. A personal favourite of mine is the following claim allowed in T2003/08, which stretches a Swiss-style claim to cover use of particular column to treat a patient’s plasma outside the body. 

‘1. Use of a specific ligand for human immunoglobulin in the manufacture of a column having said ligand coupled thereto for the treatment of a patient suffering from dilated cardiomyopathy, said treatment comprising passing plasma of the patient over the column under conditions which effect the binding of said specific ligand to immunoglobulin in the patient's plasma, thereby removing a significant portion of the immunoglobulin from the patient's plasma, and reinfusing the plasma to the patient.’ 

However through all these variations EPO Examiners have not allowed features that contribute to patentability to be part of the ‘manufacturing a medicament’ step of the claim, supporting the position that a Swiss style claim was not a true method claim.  The UK decision in Ranbaxy v AstraZeneca [2011]EWHC 1831 [on which see Katpost here] throws a little more light on this issue.  In those proceedings Ranbaxy sought a declaration of non-infringement for importing an intermediate product that was used in the manufacture of the relevant medicament, but which was not present in the final medical product defined in a Swiss-style claim. AstraZeneca, the patentee, argued that the Swiss-style claim covers a method which could be used to make the imported intermediate product and that, therefore, the intermediate product infringes by virtue of being the direct product of the process.  The Court was not sympathetic to interpreting the Swiss-style claim to be a broad method claim, concluding that Ranbaxy did not infringe for the simple reason that the relevant product was not present in the medicament defined in the claim. 

Norbert seeks the meaning of Y.  Y not?

In 2007 EPC 2000 came into force, giving us a new medical use claim of the form ‘X for use in a method of treating Y’ that could be limited in all the ways that a Swiss-style claim could be.  The two claim types coexisted peacefully for a little while, but in 2010 G2/08 sounded the death knell for the Swiss-style claim in Europe, establishing that, in view of the new EPC 2000 medical use claims, the Swiss-style claim was no longer needed, and would not be allowable for cases with a priority date of 29 January 2011 or later.  Clearly the two claims must be very similar if one could replace the other. 

However in 2008 T250/05 found that converting Swiss-style claims to EPC 2000 medical use claims would extend the scope of protection, and thus was not allowed post-grant.  In G2/08 too the Enlarged Board tentatively said that the rights conferred by an EPC 2000 medical use claim are ‘likely broader’ than those conferred by a Swiss style claims. 

It’s difficult to see in practice though how EPC 2000 medical use claims are broader.  EPO Examiners certainly don’t differentiate between the two claim types when assessing novelty, so they would seem to have the same scope for validity.  I don’t know of any situations where they would be different for findings of direct infringement. 

Returning to T1780/12, this decision concerns the situation in which the applicant already had a patent where the invention was claimed using Swiss-style claims, and now via a divisional wanted a patent claiming the invention using EPC 2000 medical use claims.  The only issue to be decided was whether claiming the same invention using the two different claim formats represented double patenting. The actual subject matter of the invention is not relevant to the double patenting issue, but if you are curious to know the Swiss-type claim 1 of the granted case was as follows: 

‘1.  Use of a composition comprising a biologically effective amount an anti-aminophospholipid antibody, or an antigen-binding region thereof, in the manufacture of a medicament for the treatment of cancer by killing tumor vascular endothelial cells of a vascularised tumor.’ 

The Board essentially decided on the issue by simply taking the view that the Swiss-style claim is a ‘purpose-limited process claim’ and so must be different from the EPC 2000 medical use claim which is a ‘purpose-limited product claim’.  G5/83 does not refer to Swiss-style claims being ‘purpose-limited process claims’ and I don’t think everyone would agree on this definition of Swiss-style claims.  However, once the two types of claims have been defined as being of different categories, it then follows that they do not cover the same subject matter for the purposes of double-patenting. 

The Board went on to justify its view based on Preparatory Document MR/18/00 from the EPC 2000 legislators, which mentions the intention for the new medical use claim “to match as closely as possible the scope of protection to the scope provided by a ‘Swiss-style claim’” which seems to imply some difference between the two claim types.  The Board also referred to T250/05 which, as mentioned above, judged EPC 2000 medical use claims to have a broader scope.

I’m not sure I agree with the Board’s reasoning that a Swiss-style claim is simply a purpose-limited process claim.  I think it is something more complex.  However I also see that, once a legal fiction has been set up, it should be accepted that anomalies can arise.  At the moment it seems that Swiss-style claims and EPC 2000 medical use claims are the same, or very similar, for validity and infringement purposes, but do differ in scope from each other when considering post-grant amendment or double patenting.  The EPO also views converting between the two claim types as not adding matter, and I’m guessing the claims would also be the same for the purposes of claiming priority from the other claim type.