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Wednesday, 1 April 2009

Q: When is medical use no use? A: When it's in a patent claim

The IPKat's friend, patent attorney Kevin Cordina, takes this opportunity to raise a patentability issue that troubles him, involving an inconsistency between the way the law treats use-of-medical-product patent claims. Kevin writes:

"Article 53(c) of the European Patent Convention (EPC), and its equivalent in many national patent systems, excludes from patentability any method of medical treatment by surgery or therapy practised on the human or animal body. Any claim which is characterised as a method of medical treatment is thereby automatically prevented from consideration for the grant of a patent, regardless of its inventive merit. Article 53(c) adds: "this provision shall not apply to products, in particular substances or compositions, for use in any of these methods", thus allowing protection to be obtained (subject to the usual criteria of patentability) for medical products, including substances and compositions.

It is generally accepted that a new non-medical use of a known product can be protected by a claim in the form "Use X of known product Y", but such a claim formulation is not possible for medical uses. Articles 54(4) and (5) EPC provide compensation to the inventor of a new medical use of a known substance or composition. They allow a composition or substance itself to be patented for a new use even though that composition or substance is already known for use in a non-medical field, or for a different medical use. Such claims may be in the form 'X for medical treatment' (first medical use) or 'X for the treatment of Y' (second medical use). In non-medical fields claims of this form would lack novelty over prior disclosure of X for a different purpose because 'for' is read as 'suitable for'.

Articles 54(4) and (5), in contrast with Article 53(c), are restricted to 'compositions and substances'. Accordingly medical use claims cannot be used for new medical uses of known apparatuses. This potentially leaves a whole class of invention without the ability to be protected, simply on the basis that the invention is implemented using an apparatus rather than a composition.

Given that the drafters of the EPC included the term 'product' in Article 53(c), and provided substances and compositions as examples, it seems surprising that Articles 54(4) and (5) are restricted to only substances and compositions. Section 4A(2) of the UK Patents Act 1977 uses a different form of words and does not make any reference to products, but solely refers to substances and compositions. Yet another form exists in the previous Section 4(3) of the UK Patents Act which reads "... a product consisting of a substance or composition ...". In effect this is probably equivalent to the new wording, but it is interesting to see the potentially broader word 'product' slip out.

Are inventions that are based on substances and those based on apparatuses deliberately treated differently? Or is it simply the case that, when these sections were drafted, medical devices had not matured sufficiently for new medical uses of known devices to have been considered? Given the rapid advances in the use of devices for the treatment of new conditions, this category of invention seems likely to assume greater significance. The inability to secure patent protection could inflict injustice to inventors in respect of inventions that have no less potential to 'do good' than a new use of a known substance which could be protected".

The IPKat would also like some answers to the questions in the final paragraph and hopes that readers can help (please post your comments below if possible). Merpel says, regardless of what the law actually means, it would be great if some serious debate were to be kick-started as to the policy issues which underlie the law: do they serve the public interest and, if not, how might they be better able to do so?

7 comments:

Anonymous said...

The approach of the EPO to this type of claim is clear, "Compound/composition X, for use in treating disease Y" is not excluded by Art.53(c) and is novel over the use of the compound/composition X for the treatment of disease Z according to Art.54(5).

"Apparatus/device A, for use in the treatment of disease Y", is not excluded by Art.53(c) but it is not novel over Apparatus A regardless of its use in the state of the art, unless the apparatus/device A had to be adapted in some way to the new medical use, which means that it is somehow physically different from the known apparatus/device (in which case it would in reality be apparatus/device A').

Consequently, the protection of new medical treatments involving known apparatus and devices (as opposed to compounds and compositions) is excluded from protection by the EPC, either by the novelty requirement ("device for use" claims) or by the exclusion under Art.53(c) ("use of device A for treating disease X" claims).

The wording of Art.54(4)(5) was deliberate (referring only to compounds and compositions). Apparatus and devices are deliberately excluded from Art.54(4)(5. Art.54(5) in particular was introduced with the EPC-2000 revision in order to avoid the need for the "Swiss-type claim" for second medical uses (although this is still accepted by the EPO).

Indeed the legal basis of the medical exclusion was broadened under the EPC-2000 because claims directed to medical treatment are excluded from patentability as a whole under Art.53(c), whereas under EPC-1973, they were only excluded from industrial application under Art.52(4) EPC-1973 (although in practice it means that they remain excluded).

ARA said...

I assume that “whole class of inventions” mentioned in the post broadly fall under the following categories:

i. wherein known devices have found completely new uses that were not thought of before, for example, a known device causes a different “technical effect” when used in a certain procedure in a certain way.

Is the “new use” a discovery? How and where to place limitations such that discoveries do not become inventions?

ii. wherein known devices were specifically adapted for a new use(s) and the adaptations led to transforming the devices into new devices that cause a , for example, the device is transformed beyond a certain threshold such that a known device becomes a new device.

Would a technical transformation suffice? How about functional and structural transformations?

Besides, medical devices being tools may be used in practically limitless (and creative) ways, and therefore will pose challenges in protecting and enforcing them against infringers, rules of exhaustion (for patented devices) too would erect hurdles.

The area appears full of challenges and provides quite a marginal ground in which to play.

Anonymous said...

The exclusion for methods of medical treatment excludes therapeutic methods and surgical methods for treatment of the human or animal body from patent protection, and extends to diagnostic methods practised on the human or animal body. Where the subject matter is a second use claim for a device, the incentives of the patent system would not necessarily be applicable, for it is accepted that much research and development goes into finding new and further medical uses of known substances or compositions.

The use of the term ‘product’ in Article 53(c) EPC was inserted to appease the pharmaceutical industry and other relevant players that while the exclusion for methods of medical treatment remains, it would not affect the patentability (on a standalone basis) of products, including substances and compositions.

Yes, it seems that they are – somewhat. They are both patentable and are not affected by the exclusion of methods of medical treatment from patent protection (see Article 53(c) EPC, second sentence). The difference, it seems to me, to lie in the different approach to patentability of second (or further) medical uses of substances and compositions which are patentable (Article 54(4) and 54(5) EPC) and second (further) medical uses of products (excluding substances or compositions) which are not patentable (EXPANDABLE GRAFTS/Surgical device [2002] EPOR 24). There have been a handful of decisions of the Technical Boards of Appeal of the European Patent Office that have addressed the question of whether patent protection for second (and further) medical uses of devices are available.

The overwhelming response of the TBAs was that such claims were not allowable. This was because such products were essentially different from the medicaments that such second use claims relate to. The rationale which underpinned patent protection for second (further) medical uses based on EISAI/Second medical indication (giving a purposive interpretation to Article 54(5) EPC 1973); and Article 54(4) and 54(5) EPC 2000 seems apposite in the case of products (devices or instruments). Moreover, it is likely that the numbers of such inventions would not be great and perhaps the research incentive in finding second or even further medical uses of such products might be non-existent.

Anonymous said...

...medicaments are consumables whereas medical devices are not, and one of the primary objective of patent system is to provide incentives for research, second or further use of medical devices may not make a case here - except for highly exceptional cases

Anonymous said...

Anon @3:18,
Since when are medical devices all "non-consumable"? I for one would not like to have a stent inserted if it had previously been used. Surgical devices are also often use onece only due to the problems of suitable sterilisation.

Anonymous said...

Great question!

I have a relevant case at the moment where I am confused as to what the best course of action is.

I have an implantable device which is implanted in the body for novel Purpose A. The device is however known where it is implanted in the body for purpose B. Purpose A and Purpose B have different therapeutic effects. But the known product could be used for Purpose A even though this has not been disclosed.

If the product were used in a non-medical procedure, then I could get protection via "Use of product X for YZ". If the product were a composition or substance then I could get protection for "Composition X for use in Treatment YZ". However, in my case, I have a product for a novel medical use and a claim to "Product X for use in treatment YZ" does not seem to be allowed.

This seems to me to be a form of discrimination of medical products. What is the difference between a composition/substance and an implantable device? The regulatory requirements and the research/development for getting the device on the market will most likely be just as large as a substance/composition.

What is the best course of action? Should I drop the application or should I instead try a claim to "Product X for use in treatment YZ" which does not seem to be "allowable"? Does anybody have any relevant case law?

/Marc

Kevin Cordina said...

Hi Marc, I'm glad you've posted, I was beginning to think I was the only one to have this problem.

Drop me an email and perhaps we can share some thoughts - I would certainly be intereted in hearing about your case.

Kevin

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