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Thursday, 15 May 2014

Swiss-type claims and double patenting: of opportunities and anomalies

A recently published European Patent Office Board of Appeal decision caught this Kat's eye, since it deals with Swiss-style patent claims.  One of the first things that ever puzzled him was Swiss-style claims and their place in an otherwise well-run world.  Anyway, this decision subsequently caught the attention of Katfriend and occasional blog contributor Suleman Ali (Holly IP), who kindly prepared the following guest post:

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 herethrows 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. 
Another type of Swiss claim here
Swiss roll here

16 comments:

Anonymous said...

Alas, as the scope of the Swiss claim has never being truly tested in court anywhere in the world, as far as I am aware, but I would appreciate it if someone could post any decisions they are aware of. The AZ v Ranbaxy case did not get to the heart of the Swiss claim, but merely rejected an attempt by AZ to stretch the scope beyond that that could even considered realistic.

Use of Swiss claims should ever have been banned by the Enlarged Board simply because there was a new claim format allowed. If the Swiss claim is not allowable today, it should never have been made allowable. Are the Enlarged Board admitting a serious mistake was made in 1984, even under the watchful eye of Big Brother?

As regards the broadening or not of claims scope, the EPO have always allowed the conversion of Method of Treatment claims into Swiss claims. Why? Was it 'let's be kind to US attorneys' day?

Presumably, the Swiss claim is of identical scope to the MOT claim. Can't be broader or narrower by one iota as that would infringe 123(2), unless the skilled person would unambiguously derive the Swiss-claim from the application. This makes the skilled person cleverer than previously thought, surely?

If the scope of Swiss and MOT are identical, therefore, we need not concern ouirselves with understanding the scope of the Swiss claim when determining the difference with the new 'compound for use' claim. We simply compare the scope of the 'compound for use' claim with the MOT claim.

The MOT claim is a method claim, and therefore is narrower than the compound for use claim. I conclude this because manufacturing compound X with the intent of sale for use in a medical method, would not infringe the MOT claim. If the manufacturer simply stockpiled the material and through away the key to the warehouse, they would not have infringed the patent. The 'compound for use' claim, on the other hand, would be infringed by such manufacture.

The EPC 200 claim is therfore broader than the MOT claim, and must therfore be broader than the Swiss claim. The Enlarged Board are correct.

Does anyone think this makes sense?

Darren Smyth said...

Dear Anon at 09:53

Thank you for your detailed and thought provoking comments. I do quibble with two things that you say.

Firstly, I don't think it legally or logically correct that the scope of Swiss and MOT claims must be the same, otherwise conversion would offend Article 123(2). The technical information imparted by the two claim forms must be the same, and I think it is. Therefore no new matter is taught by the Swiss form that is not already taught by the method claim. It does not follow that they have to have the same scope. I think this view is consistent with G1/03 regarding undisclosed disclaimers, which although not the identical point, states that a disclaimer can be added without offending Article 123(2) to "disclaim subject-matter which, under Articles 52 to 57 EPC, is excluded from patentability for non-technical reasons."

Secondly, I also don't think it is correct that "If the Swiss claim is not allowable today, it should never have been made allowable." When the Swiss form claim was the only allowable form in a particular case, of course it had to be allowable. When there is another very similar form available, as there now is, then having both forms is, arguably, and according to the EBA in G2/08, not "concise", because the number of claims is increased without sufficient justification. Therefore Article 84 EPC is not complied with.

I do agree with your conclusion that Swiss and EPC 2000 claims have different scope, so that the Board of Appeal is correct in the main case under discussion, T1780/12.

At the hearing in G2/08, and in some of the prior written submissions, there was some discussion of what the different forms of claim might cover (ie be infringed by), but the Chairman apparently accepted the point (actually put forward by me) that this was none of his, or the EPO's, business.

I think that it is hard to define exactly what is the scope of either form of claim, but up until now it rarely suits either party in litigation to really challenge this, so we are left with an accepted status quo with rather little legal underpinning or explanatory jurisprudence.

Best wishes

Darren

Anonymous said...

AHP v Novartis at the Court of Appeal in 2000 concerned a Swiss Form Claim.

Claim 1 was: "1. Use of rapamycin for the preparation of a medicament for inhibiting organ or tissue transplant rejection in a mammal in need thereof".

See: http://www.bailii.org/ew/cases/EWCA/Civ/2000/231.html

Alas, the argued case only dealt with infringement and insufficiency. Obviously nobody wanted to poke the bear...

Darren Smyth said...

Dear Anon at 11:29 thank you for your comment. Your "nobody wanted to poke the bear" is much more evocative than my "it rarely suits either party in litigation to really challenge this" but I think we have drawn the same conclusion...

Darren

Anonymous said...

IF: It is the Enlarged Board's position that the Swiss claim is no longer alowable, as opposed to being no longer allowable together with the new claim format, then it is not a question of conciseness.

My position is still open on added matter, but I'm not sure the disclaimer case assists the argument.

Anonymous said...

Darren

I would be interested to hear why you believe that Swiss and EPC 2000 claims have different scope.

The Board in this decision simply stated in paragraph 22 that:

"It is generally accepted as a principle underlying the EPC that a claim to a particular physical activity (e.g. method, process, use) confers less protection than a claim to the physical entity per se, see decision G 2/88 (supra, reasons, point 5)."

However, this is a very superficial analysis that doesn't really analyse the scope of protection offered by Swiss-type and EPC2000 claims.

When one reads G 2/88, paragraph 5, it can be seen that the Enlarged Board was describing a very specific situation, namely the comparison between a product claims and a use claim (i.e. not a Swiss-type claim):

"It is generally accepted as a principle underlying the EPC that a patent which claims a physical entity per se, confers absolute protection upon such physical entity; that is, wherever it exists and whatever its context (and therefore for all uses of such physical entity, whether known or unknown). It follows that if it can be shown that such physical entity (e.g. a compound) is already in the state of the art (for example in the context of a particular activity), then a claim to the physical entity per se lacks novelty. It also follows that a claim to a particular use of a compound is in effect a claim to the physical entity (the compound) only when it is being used in the course of the particular physical activity (the use), this being an additional technical feature of the claim. Such a claim therefore confers less protection than a claim to the physical entity per se."

It seems to me that this argument does not apply to a Swiss-type claim. As I understand it, a Swiss-type claim would provide absolute protection for the product (under Article 64(2) EPC). It also protects all methods of manufacture (see paragraph 6.3 of T 795/06 [translation available on K's Law]).

All that being the case, where does the difference in scope lie?

Darren Smyth said...

Dear Anon at 12:00

I am responding because you ask the question, but I fear I am not going to be very helpful. I believe that Swiss and EPC 2000 claims have different scope basically because I accept the EPO jurisprudence to that effect. I agree with you that this analysis is very superficial: this is because the EPO rapidly runs into the problem that it has no competence to pronounce on matters of infringement.

I agree with you that to really answer the question a detailed analysis of the scope of each claim would be needed. But we don't have any detailed guidance even on Swiss claims (which have been around for years) let alone on the newer EPC 2000 claims, I don't think it is possible to be definitive. Since Swiss claims are being phased out, it is possible that we will never know.

Best wishes

Darren

Anonymous said...

From the US, the use of MOT is confusing to me, and seems disjoint from what that term means here.

It appears that 35 USC 100(b) seems closer to the mark:

(b) The term “process” means process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.

Anonymous said...

Sorry, but.. what is a MoT claim ? I thought MoT designated the famous test, not a type of claim.

Darren Smyth said...

To the last two Anons - MOT stands for Method of Treatment (specifically referring to method of medical treatment), ie the form of claim excluded from patentability according Article 53(c) EPC. Sorry for thoughtlessly continuing to use the abbreviation - it is not standard. This claim form is allowed in the USA, as earlier commentators have referred to. So an example of such a claim might be:

A method of treating disease X by administration of a pharmaceutically effective amount of compound Y to a mammal in need thereof.

Does that help?

Darren

Anonymous said...

Darren - what jurisprudence to that effect?

As far as I am aware, G 2/88 simply states:

"It follows that when deciding upon the admissibility of any amendment to the claims of a patent which is proposed in opposition proceedings (whether or not such amendment involves a change of category of claim), what has to be considered and decided is whether the subject-matter which is protected by the claims, as defined by their categories in combination with their technical features, is extended.

It is not necessary to consider the national laws of the Contracting States in relation to infringement when making such a decision, however."

So that means it is necessary to determine the subject matter that is protected by EPC2000 claims, but that is not protected by Swiss-type claims (noting that any test for infringement is irrelevant).

From my reading of the decision, the Board completely fails to do this. It side-steps the issue by claiming that process claims are narrower than product claims. However, this can only be stated once the claims have been analysed.

Anonymous said...

PS It's worth considering paragraphs 14 of T 1635/09 (translation on K's law) and paragraph 6.3 of T 795/06 when determining the scope of the different second medical use claims.

Both indicate that a Swiss-type claim protects a purpose-limited product, and all means of manufacturing it.

What then does an EPC2000 claim protect that a Swiss-type doesn't?

Anonymous said...

Darren,
I'm afraid that Y is inefficient for treating X. W would probably work but only if combined with Z. Or perhaps you were talking about X' which indeed can be treated with Y if administrated to the subgroup of patients ABC but only twice a day during a week. But I wonder if a week means one week.

Anonymous said...

Mind your P's and Q's!!!

Norman said...

It seems to me that on its face at least, an MoT claim, as per Darren’s example, is broader than a Swiss-type claim because an MoT claim would, and a Swiss-type claim would not, be infringed by a physician who administers a pharmaceutical to a patent in order to treat the disease in question. In this US this does not present a problem for MoT claims because of 35 USC § 287(c)(1), which, as I understand it, would provide the physician with a defence in such circumstances. (Though I should say that the provision is convoluted, and I would like confirmation of that point from a US lawyer.)

Norman S

Anonymous said...

In T1570/09 the Board did not allow the applicant to have both Swiss-style and EPC2000 medical use claims in the same case.

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