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More scope for European patents for methods of medical treatment

In its decision G1/07 (Medi-Physics), the Enlarged Board of Appeal of the European Patent Office (EPO) has ruled that current patent office practice on exclusion of methods of medical treatment from patentability has been too restrictive.

The European Patent Convention (EPC) excludes patents 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” (Article 53(c) EPC 2000). It is widely accepted that the purpose of the exclusion is to ensure that medical practitioners can choose the best possible treatment or diagnosis for their patients without fear of being liable for patent infringement. However, the legislator has chosen to address this by means of exceptions to patentability which do not simply define an immunity for medical practitioners. This has the effect that Article 53(c) EPC can be more far reaching than is necessary for its purpose.

Under current practice, the exclusion to patentability can reach claims that cover commercial body care and simple interventions on the body such as injections. The exclusion can also have the effect that protection is excluded for a device-related invention, when the invention can only be defined by the operation of the device in the context of the body. For example, in the case at bar in G1/07, a problem arose for a claimed MRI imaging technique because a reference to a contrast agent was needed to define the invention. The claim did so by means of a step of administering
the contrast agent to a patient.

One line of cases from the EPO Boards of Appeal has held that the exclusion of patents in respect of methods of treatment by surgery applies to any claim that includes a significant conservative intervention on the body. The issue of interpretation of the exclusion of methods of treatment by surgery reached the Enlarged Board of the EPO because some Boards of Appeal had mitigated this approach by limiting the effect of the exclusion to “curative treatment”, which would preserve patentability of claims that involve treatment for other purposes, such as MRI imaging.

Scope of the exclusion of treatment by surgery
The decision of the Enlarged Board in G1/07 rejects the limitation of the exclusion of treatment by surgery to curative treatment. However, the Enlarged Board spontaneously concluded that current patent office practice applied the exclusion too broadly. The exclusion should apply only to method claims with features that cover treatment with health risks that make it necessary to reserve the treatment for medical practitioners.

The Enlarged Board outlined the playing field, although it declined to give a final definition of what is excluded as treatment by surgery. The exclusion only applies to method claims and it depends on the features of the claim. If a treatment by surgery or diagnosis is not covered by any feature of the claim, the exclusion is not triggered merely because the claimed method could be used during a surgical operation (e.g. for imaging during the operation) or because it could be used for diagnostic purposes. On the other hand, the exclusion is triggered if a feature of the claim covers a treatment by surgery, even if the relevant feature is formulated at a level of abstraction that does not specifically identify a treatment by surgery, or if other features of the claim specify other non-surgical steps to achieve some non-surgical object.

Any definition of excluded treatment by surgery must cover the core of the medical profession”s activities, for which its members were specifically trained and for which they assume a particular responsibility. The Enlarged Board emphasized that, in view of the legislative text, it was the nature of the treatment encompassed by the claim that was decisive for the exclusion, not who performed the treatment. However, because the Enlarged Board defined this nature in terms of health risks that necessitate involvement of medical practitioners, this distinction may make little difference.

In the context of the case at bar, the claimed method should be excluded from patentability because the referring board found that the claimed method encompassed implementation by an invasive step (i.e. an injection into the heart) representing a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a health risk even when carried out with the required professional care and expertise.

The exclusion should not, however, be construed too expansively. The Enlarged Board explained that the definition of “treatment by surgery” should ensure that:

– In principle safe routine techniques are not excluded from patentability, even when of invasive nature. Uncritical methods involving only a minor intervention and no substantial health risk should not fall under the definition.

– A treatment that involves administration of a non-therapeutic agent is only excluded if it has a health risk associated with the mode of administration and not solely with the agent as such.

– The exclusion does not apply to methods which are merely directed to the operation of a device without themselves providing any functional interaction with the effects produced by the device on the body.

– Methods are not excluded in which health risks are disregarded (non-conservative methods), such as methods that involve killing animals.

Tattooing, piercing, hair removal by optical radiation and micro abrasion of the skin, and other techniques that are carried out in a non-medical, commercial environment like cosmetic salons and beauty parlors did not need to be excluded from patentability.

How to avoid exclusion
Although some inventions will not be able to escape exclusion from patentability, careful drafting of the claims and description will make it possible to avoid the exclusion for many inventions. The EPC emphasizes that product claims do not fall under the exclusion and the Enlarged Board has explicitly endorsed several ways to avoid that method claims fall under the exclusion of treatment by surgery.

One way is to disclaim embodiments that involve treatment by surgery. This can be applied, for example, to avoid a rejection of claims on cosmetic methods by disclaiming implementation by means of treatment by surgery. It might even be used to disclaim embodiments of certain medical methods. For example, in the case at bar, a disclaimer of the embodiment of administering the contrast agent by injection into the hearth might avoid the exclusion, leaving coverage for administration by inhalation. In order to prepare for such disclaimers, it may help to avoid describing only embodiments wherein the claim features involve treatment by surgery and to make clear that the invention is not limited to specifically described non-surgical embodiments,
f any.

Another way to avoid the exclusion could be to omit all features that cover treatment by surgery from the claim or, where possible, to use features such as “using pre-delivered…” or “using a pre-implanted …” instead. Whether the patent office will accept this depends on whether it can be argued that the “teaching of the invention is complete” without the treatment features. Obviously, this will not be possible when the teaching of the invention is how an agent should be administered or how a device should be implanted by treatment by surgery.

Applicants should be prepared to counter examiner”s arguments that the steps of delivery of agents, implanting a device etc. are essential for the definition of the invention when, in reality, the teaching of the invention pertains to how the agent or device is used. This may involv formulating the problem which is solved by the invention in technical, rather than medical terms, in a way that makes it possible to argue that the solution can be defined without including treatment by surgery. Arguments about the “contribution to the art” of the invention may also work. Under the related exclusion of diagnostic methods, the Enlarged Board explained that a claimed method of forming an image, even for medical purposes, can be said to be “complete” without a step of diagnosis using the image. Therefore, such a method was not an excluded diagnostic method.

It may be easier to avoid the exclusion with method claims directed at the operation of devices. The Enlarged Board pointed out that methods which are merely directed to the operating of a device without themselves providing any functional interaction with the effects produced by the device on the body, are teachings in which the performance of a physical activity or action that constitutes a method step for treatment of a human or animal body by surgery or therapy is not required in order for the teaching of the claimed invention to be complete. Even if, in such a case, the use of the device itself requires the application of a surgical step to the body or if the device is for therapeutic treatment, the same does not apply to the claimed method for operating the device.

The Enlarged Board”s decision emphasizes that the EPC does not have a vague general exclusion of “medical methods” from patentability. The exclusion of Article 53(c) EPC 2000 is specifically limited to methods of treatment by surgery, methods of treatment by therapy, and to diagnostic methods.

In its earlier decision G1/04, the Enlarged Board already made it clear that the exclusion of diagnostic methods does not apply if a method can be claimed without a feature of arriving at a diagnosis, for example if it merely claims measuring physical effects. The present decision G1/07 deals with treatment by surgery and shows that one should avoid including claim features that cover bodily interventions that involve health risks which necessitate execution by a medical practitioner. Only the exclusion of “treatment by therapy” has not been the subject of referral to the Enlarged Board. Boards of Appeal”s decisions suggest that this exclusion applies if a claim has a feature that covers a treatment that can have a therapeutic effect, even when claimed for a non-therapeutic purpose.

Although G1/07 may provide more scope for European patents, it also leaves uncertainty. Where possible, one should not rely only on method claims. It should be kept in mind that, although the Enlarged Board is the final authority on the law of the EPO, its decisions are not binding on the national European courts, which courts decide on validity after the grant of European patents. The national courts tend to follow Enlarged Board decisions, but there is no certainty that courts in some European countries will not exclude claims that are allowed under G1/07.