Pages 66-73

WORKING SESSION

Exclusions from patentability with special focus on the medical field

Sylvie MANDEL - Court of Cassation judge, France - Exceptions to patentability in the medical field

My talk will focus essentially on French case law. As chairwoman of the Legal Board of Appeal, Ms Günzel is undoubtedly far more qualified than I to present the position of the European Patent Office (EPO).

Why are methods of treatment by therapy or surgery and diagnostic methods excluded from patentability?

Such methods were originally excluded because they were not industrially applicable. Under Article 6(4) of the 1978 French Law, methods for treatment of the human or animal body by surgery or therapy could not be regarded as industrial inventions. The reference to industrial applicability was abolished both in the French Law and in the EPC as revised on 29 November 2002. The wording used in the relevant provisions of the two laws is identical:

Article 53(c) EPC: European patents shall not be granted 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; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

The same wording appears in Article L 611-16 Intellectual Property Code.

Why this exception?

In reality, these methods are non-patentable for ethical and "ordre public" reasons. It is considered to be incompatible with human dignity for a human being's health to be subject to a third party's consent. In addition, doctors and vets should be able to exercise their profession freely and choose how to treat their patients without having to depend on a third party or seek authorisation. In the medical world, the collective interest outweighs that of inventors.

How have the French courts reacted?

It is a fundamental principle of law that all exceptions must be interpreted narrowly. The problem, however, is that the law does not define what constitutes a method of treatment or diagnostic method. The courts have therefore tried to delimit the scope of these terms.

I. Early decisions: narrow approach to defining therapeutic or diagnostic methods

This is an inventor-friendly approach.

Four judgments can be cited.

1) Judgment of Paris Court of Appeal of 26 May 19831

This judgment set aside a decision by the director of the French Patent Office, the Institut national de la propriété industrielle (INPI), to refuse a patent application claiming a process and an implantable device for obtaining information on the rhythm of cardiac activity. In the court's view, the device's purpose was not a surgical or diagnostic method directly practised on the human body, but merely a means of obtaining haemodynamic data which was pre-processed using a clock and then used by the doctor to make a diagnosis. It found that it was therefore a specific, patentable process.

Reading this judgment, one cannot help but be reminded of the decision recently given by the EPO's Enlarged Board of Appeal on 16 February 2010,2 in which it found that a medical imaging method in which maintaining the subject's life and health is important, and the performance of which comprises or encompasses an invasive step amounting to a substantial physical intervention on the body requiring medical expertise and entailing a substantial health risk, is excluded from patentability. It therefore seems that, in the Enlarged Board's view, any method comprising or encompassing a step of treating the human or animal body by surgery or therapy is non-patentable under Article 53(c) EPC.

2) Judgments of the Paris Court of Appeal of 24 September 19843

In a first judgment, the Court of Appeal set aside the INPI director's decision to refuse a patent application concerning a method of regulating the menstrual cycle and of birth control whereby post-ovulation administration of a hormone either brought forward the start of menstruation or prevented pregnancy. The court's reasoning was that the invention did not concern the abstract discovery of a means of curing or preventing diseases, but rather pharmaceutical compositions and the conditions for their use. This suggests that, in the court's view, there is no treatment if the person is in good health. Pregnancy is not an illness.

In a second judgment of the same date, the Paris Court of Appeal similarly held that the INPI director had wrongly refused a patent application for a device and a process facilitating the extracorporeal blood circulation of a living being. The process entailed taking a sample of plasma from a healthy being, whilst continuously reinjecting the blood cells and remaining plasma throughout the extracorporeal circulation session, and was characterised by the feature that the blood was taken from, and at least part of it reinjected into, the same vein at approximately the same point.

The INPI director had found that the invention constituted not only a method of treatment by surgery, because blood was taken and then reinjected into a vein, but also a method of treatment by therapy, because the patient or healthy donor received treatment under medical supervision reinjection was essential on health grounds. Reasoning once again that methods of treatment were aimed at preventing or curing diseases, the Court of Appeal ruled that there was no such method in this case; that the method merely comprised taking a plasma sample and not the potential use of that plasma in treating another patient; that it was irrelevant that the sample was taken by or under the supervision of a doctor; and that the donor could not be regarded as receiving treatment during this procedure. It therefore held that it was not a method of treatment by surgery or therapy.

Finally, in a third judgment of the same date, the Paris Court of Appeal held that a method of controlling parasites in warm-blooded animals was not a method of treatment by therapy, but an industrially applicable process, because it was a hygienic measure that served to improve the animals' breeding conditions and development by killing their parasites.

II. Twenty years later: broader - and thus stricter - approach to defining "therapeutic or diagnostic method"

Apart from a decision given by the Paris Court of Appeal on 28 June 2006, it can be seen that, on the whole, the courts now take a stricter approach to defining therapeutic or diagnostic methods.

In the judgment of 28 June 2006,4 the idea resurfaced that a process with a hygienic purpose is not a therapeutic method. The invention in question related to a device for automatically milking animals, such as cows, and a method of after-care of the udder whereby it was automatically cleaned by spraying a liquid containing a disinfectant agent. The Court of Appeal found that, although the disinfectant agent was sprayed for prophylactic purposes, this was not a method of treating the animal by therapy, but an industrially applicable process allowing it to be milked in accordance with hygienic standards. It thus concluded that the post-milking method did not fall under the non-patentable exceptions in Article L 611-16 Intellectual Property Code.

However, four judgments can be found in the case law of the Paris Court of First Instance, the Paris Court of Appeal and the Court of Cassation over the period from 1994 to 2003 in which the term "method" was interpreted more broadly still, thus making it more difficult to establish patentability.

In a judgment of 16 November 1994,5 the Court of First Instance held that the invention of a substance (CuDIPS) to protect human skin against the sun's rays amounted to a method for treatment of the human body by therapy, and was therefore non-patentable, on the ground that the claimed properties were no more than the result of the anti-inflammatory effect of a topical application of CuDIPS.

In a judgment of 13 September 2000,6 the same court held that the claims in a European patent relating to the application as such of an adhesive for joining human or animal tissue were directed to a non-patentable therapeutic application to the human or animal body, and not to the process of manufacturing the adhesive. Compared with the previously cited Paris Court of Appeal's 1983 judgment, in which an implantable device for obtaining cardiac information was considered patentable, this judgment takes a stricter line and illustrates the broader interpretation of the term "therapeutic method".

On 29 October 1997, the Paris Court of Appeal rendered a judgment in the same vein,7 in which, for the first time, it gave a definition of a method of treatment by surgery or therapy as "a method comprising a coherent series of reasoned and successive steps taken by the skilled person with a view to identifying means of preventing, treating, relieving, eliminating or alleviating the symptoms of a disorder resulting from an illness or dysfunction of the human or animal body, or of curing that disorder". On that basis, the court ruled that a patent application directed to a method of cleaning and dilating the dental canals by vapour cavitation in a pre-introduced liquid using a laser beam steered or focused by a fibre optic concerned a method of treatment of the human body by surgery essentially aimed at devitalising a diseased tooth. It found that the method could not be isolated from its intended purpose of treatment and refused to take into account that it could be performed "in vitro" on a tooth removed from the jaw.

Finally, there is also a judgment of the Court of Cassation of 17 June 20038 which qualified the Paris Court of Appeal's judgments of 24 September 1984 and 28 June 2006.

In this case, which again concerned a method of dental hygiene, the Court of Cassation ruled that methods having a therapeutic effect which could not be isolated from the claimed aesthetic effect were non-patentable and, accordingly, annulled the Paris Court of Appeal's judgment, in which it had found that the applicant had merely sought protection for an aesthetic treatment. Cleaning teeth not only served to improve their appearance, but also prevented dental diseases.

The most recent decision on the matter of methods of treatment by therapy is again a judgment of the Paris Court of Appeal, dated 13 June 2008.9 In this case, the European patent concerned an electronic device for adrenergic stimulation of the lymphatic system in the venous media, specifically that of the smooth muscles in vascular tissue, which provided a flexible but reliable means of monitoring the effectiveness of the treatment when applied. The claimed device comprised at least two electrodes attached to the patient's body, means of measuring the impedance between the electrodes and means of regulating the tension of the impulses applied between the electrodes so as to keep the impulse intensity at a constant value throughout the adrenergic stimulation session. The tissue was thus stimulated by electric impulses. Is this a method of treatment? The Court of Appeal ruled that it was not, holding that the patent merely concerned "a device which, although designed to improve a treatment, used defined means of achieving that aim by application of technical means and was industrially applicable".

What approach should be taken?

What should take priority: the doctor's free choice of treatment or technical innovation?

Do we continue to follow the approach set by the EPO's Enlarged Board of Appeal on 15 February 2010 in G 1/07, in which it refused to restrict surgical methods solely to those with a therapeutic purpose and found that a medical imaging method entailing an invasive step could be regarded as a surgical method?

Or should we opt instead for the approach adopted by the United States, where therapeutic, surgical and diagnostic methods are patentable, but doctors can nevertheless do their jobs without having to seek authorisation to apply those methods and without exposing themselves to infringement litigation? Time will tell, but perhaps this matter will be settled by the future case law on European and EU patents. Let us hope so at least.