Chapter excerpt from the ebook MedTech IP: Lessons and Strategies for Success - view all chapters here.
The European Patent Convention (EPC) does not allow patents for methods for treatment of the human or animal body by surgery or therapy.
But when does a method amount to therapy? Some methods, such as taking an appetite reducing drug which causes weight loss, may have both cosmetic and therapeutic uses. In such cases, claims limited to the cosmetic use will generally be allowable. The fact that a chemical product has both a cosmetic and a therapeutic effect when used to treat the human or animal body does not render the cosmetic treatment unpatentable. Of course, cosmetic treatment by surgery would be excluded.
Therapy requires the curing or preventing of a disease or functional disorder of the body, and also requires there to be an effect on the body or part of the body.
Treatments and diagnostic methods are excluded from patentability only if they are carried out on the living human or animal body. Therefore, the diagnostic testing of blood outside of the body is not excluded, whereas a method of blood dialysis with the blood being returned to the same body would be excluded.
Let's take a look at some examples in more detail...
In 1877 Josef Rodenstock founded a company in Germany making ophthalmic lenses and frames. Rodenstock was an innovator who developed and patented numerous improvements to glasses, including sunglasses with UV protection and bifocal lenses with a close-up viewing area.
Rodenstock's company was to become a world-renowned major player in the optics industry, extending over 3 generations of the Rodenstock family. Today, Rodenstock GmbH is a major manufacturer of ophthalmic lenses and spectacle frames with over 5,000 employees, 14 production facilities in 13 countries, and sales in more than 85 countries.
What does Josef Rodenstock have to do with therapeutic methods? Well, wait and see! We shall return to Rodenstock later in this chapter.
In the last chapter we considered the meanings of surgery and diagnosis in the context of Article 53 of the European Patent Convention (EPC), which states that European patents shall not be granted in respect of:
(c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body...
In this chapter we shall consider the meaning of "therapy" in Article 53.
In the case law of the EPO the first definition of the term "therapy" was given in decision T 144/83. This decision related to an invention for a method of "improving bodily appearance" by taking an appetite reducing drug "until a cosmetically beneficial loss of body weight has occurred."
This invention presented a dilemma to the European Patent Office. The question was whether the invention amounted to a "therapy". On the one hand, a method of weight loss might be used to treat obesity, in which case it could be regarded as a therapy, in the sense that it is treating a disease or disability. On the other hand, a method of weight loss might also be used purely for cosmetic reasons, where there is no disease or disability to treat.
The EPO initially refused the application. The applicant appealed. How would the appeal board solve this conundrum? It is instructive to consider the reasoning of the appeal board, which is set out below.
The appeal board said:
Such exclusions from patentability must be construed narrowly and should not apply to treatments which are not therapeutic in character. As far as the language of the main claim is concerned, it clearly covers a method of cosmetic use and is unrelated to the therapy of human or animal body in the ordinary sense. This is because loss of weight, like gain of weight, is normally not dictated as a desirable effect by medical considerations at all. Cosmetic treatment is "designed to beautify hair, skin, complexion etc. ... or intended to improve appearance (cf. Concise Oxford Dictionary, Tenth Impression, 1980). Therapy, on the other hand, clearly relates to the treatment of a disease in general or to a curative treatment in the narrow sense as well as the alleviation of the symptoms of pain and suffering.
It must be admitted that the cosmetic treatment of the human or animal body, which alone is claimed in the present application, is adjoined to the therapeutic use without a sharp distinction in some cases. It may even be difficult to distinguish between the cosmetic and therapeutic effect, i.e. losing weight and curing obesity. This should not, however, be allowed to work to the disadvantage of an applicant who, according to the wording of his claims, seeks patent protection for cosmetic treatment but not for the therapeutic treatment as such. The fact that a chemical product has both a cosmetic and a therapeutic effect when used to treat the human or animal body does not render the cosmetic treatment unpatentable.
Remember that in this case the applicant had claimed taking the drug "until a cosmetically beneficial loss of body weight has occurred." It seems that this wording was instrumental in causing the appeal board to allow the patent, since the applicant was claiming a method which related only to cosmetic treatment, and not to therapeutic treatment.
The exclusion relating to "therapy" was therefore avoided, and the patent was granted.
Note that the appeal board stated that therapy relates essentially to the treatment of a disease or to a curative treatment. It is also established case law that both prophylactic and curative methods of treating disease are covered by the word "therapy" (see e.g., G 5/83, OJ 1985, 64). In other words, treatment which aims to maintain health amounts to a method for treatment by therapy as referred to in Art. 53(c) EPC, and therapy is not limited to treatments which restore health by curing diseases which have already arisen.
Now we will return to Josef Rodenstock, and his company Rodenstock GmbH!
On 25 April 2001 Rodenstock GmbH filed European Patent Application No. 08002475.5 for an improved type of varifocal lens. It is remarkable to think that over 140 years after Josef Rodenstock founded his spectacle company, Rodenstock are still making and patenting innovations relating to spectacles.
However, things were not to go smoothly for this particular patent application, as the EPO refused the application on the basis that the claims amounted to a therapeutic treatment and were therefore excluded from patentability under Article 53(c) EPC.
Of course, the exclusion under Article 53 applies only to methods, and not to products. The glasses themselves would therefore have been patentable, but the claims to which the EPO objected were effectively method claims, as they were directed to, "Use of a spectacle lens to correct a spectacle wearer's ametropia" wherein the spectacle lens had certain features.
Ametropia, by the way, is a general term covering any abnormal refractive condition of the eye, including short-sightedness, long-sightedness and astigmatism.
The patent application related to progressive lenses, which were defined in the application as follows:
Progressive spectacle lenses (also called varifocal lenses, multifocal lenses etc.) are usually understood to be spectacle lenses having a different (lower) power in the region through which a spectacles wearer views an object located at a great distance—hereunder referred to as a distance portion—than in the region (near portion) through which the spectacles wearer views a near object. Located between the distance portion and the near portion is the so-called progressive zone in which the power of the spectacle lens continuously increases from that of the distance portion to that of the near portion.
Such "progressive lenses" were already known at the time of the application, and the invention related to a new and clever way in which the power of the lens varied between the distance and near portions.
The appeal board first noted that the claimed use of a spectacle lens for correcting a spectacle wearer's ametropia was in effect a method, and would therefore be treated as such for the purposes of the decision.
The appeal board noted that, in refusing the application, the Examining Division had relied on decision T 24/91, according to which the term "therapeutic treatment" includes, "any treatment intended to relieve the symptoms of a functional disorder or to cure, alleviate, eliminate or attenuate functional weakness of the human or animal body, or which is capable of preventing or reducing the risk of its acquisition".
Eyesight problems, such as short-sightedness, could be regarded as a "functional disorder" or "functional weakness" of the human body, and therefore a method of treating this could be regarded as therapy.
The appeal board argued as follows (emphasis added):
However, it does not necessarily follow that during the claimed use the body of the person wearing the glasses is treated in any way and that the claimed invention therefore represents a therapeutic treatment of the human body within the meaning of Article 53(c) EPC.
In the board's opinion, therapeutic treatment of the body within the meaning of Article 53(c) EPC presupposes an effect on the body or part of the body to be treated which is the cause of a therapeutic effect. In the present case, the board cannot detect any influence on the body of the spectacle wearer that would lead to or contribute to a therapeutic effect or to the above-mentioned alleviation or attenuation of the symptoms of the spectacle wearer's ametropia. Such relief or attenuation of the symptoms of ametropia is achieved in the claimed invention, as already stated, only by a targeted change in the convergence or divergence of the light beam directed onto the eye of the glasses wearer, without the eyes of the glasses wearer being “treated” in some way.
Therefore, the board here agrees with the complainant's statements, according to which, in the claimed use, the spectacle lens is used as an external aid and thereby the ametropia of the spectacle wearer is at least partially compensated only by changing the light beam path, as long as the spectacle lens is worn by the spectacle wearer and without affecting the actual ametropia of the wearer's eyes in any way.
Since the claimed use cannot be attributed to any effect on the body, in particular on the eyes, of the wearer of glasses with a subsequent therapeutic effect, the board is of the opinion that there is no therapeutic treatment of the human body within the meaning of Article 53(c) EPC.
The board therefore considered that a "therapeutic treatment" required some intervention on the body or body part to be treated which caused a therapeutic effect.
Recall that Article 53 requires there to be treatment of the human or animal body by surgery or therapy. In the present invention, the glasses did not change the body of the wearer in any way. The eyes of the wearer remained unchanged. If the wearer was short-sighted before wearing the glasses, the wearer remained equally short-sighted after wearing the glasses.
We note that treatments and diagnostic methods are excluded from patentability only if they are carried out on the living human or animal body (G 1/04). Treatment or diagnosis of body tissues or fluids after they have been removed from the human or animal body are patentable, as long as the body tissues or fluids are not returned to the same body. Therefore the diagnostic testing of blood outside of the body is not excluded, whereas a method of blood dialysis with the blood being returned to the same body would be excluded.
Rodenstock have gone on to make many further innovations, including technology that determines and uses the biometrics of the whole eye for optimum lens calculation. Today Rodenstock holds more than 530 patents worldwide and has over 200 pending patent applications for innovations in lenses, frames and instruments. Josef Rodenstock would surely have been proud of these achievements.
