Methods of medical treatment

Some specific examples of therapeutic/surgical and non-therapeutic/ surgical methods

Cosmetic treatments

8.60 Purely cosmetic treatments of the skin and hair are considered patentable inventions. For example a cosmetic treatment for strengthening hair was considered patentable (Joos v Commissioner of Patents [1972] 126 CLR 611, 619). Similarly, a method of reducing normal hair loss by administration of a composition defined by its active ingredients was considered a patentable non-therapeutic method once the claims were restricted to it being carried out as a cosmetic treatment (T 453/95 REDKEN).

8.61 Similarly, in Virulite’s Application BL O/058/10:

“A method of cosmetically treating a superficial area of mammalian skin around, above or below an eye by reducing or alleviating or removing or diminishing wrinkles that occur as a result of natural aging, the method comprising irradiating the skin…”

was considered to be a cosmetic method for removing wrinkles by phototherapy, and was allowed as the removal of wrinkles caused by ageing had no apparent therapeutic benefits.

8.62 In T 383/03 GENERAL HOSPITAL/Hair removal method OJEPO 2005, 159 it was also held that a method to remove body hair was non-therapeutic as the excess of body hair is not considered to be a condition that causes pain or discomfort and is directed to an aesthetic purpose, which is clearly distinguishable from a therapeutic purpose. Thus, an application containing claims directed to a purely cosmetic treatment by administration of a chemical product may be considered industrially applicable (see also T 144/83).

8.63 In contrast, a cosmetic treatment that has a therapeutic effect is considered a method of therapy. For example, the use of a composition for the local treatment of comedones (blackheads) was generally regarded as a cosmetic method of non medical body hygiene. However, when applied for the treatment of acne this might be regarded as a method of therapy (T 36/83 ROUSSEL-UCLAF/Thenoyl peroxide OJEPO 1986, 295). In T 36/83, the Technical Board of Appeal considered that the cosmetic and therapeutic compositions were similar and consequently a cosmetic use may result in an incidental therapeutic effect. Nonetheless, they considered that the following claim was allowable as it was sufficiently limited to the cosmetic use of the compound:

“Use as a cosmetic product of thenoyl peroxide.”

The description expressly disclosed two very different properties of a compound used in the treatment of comedones, i.e. its anti-bacterial and its hygienic action. The application showed that pharmaceutical and cosmetic preparations could have very similar, if not identical, forms. The distinction was clearly set out in the description as filed. The Board decided that the cosmetic application of a product, which also had a therapeutic use, was patentable, since the Applicants had only claimed in respect of “use as a cosmetic product”. The use of the term “cosmetic” was held to be sufficiently precise, although the cosmetic treatment according to the application might also incidentally involve a medical treatment.

8.64 Therefore, methods of a purely cosmetic nature, which are not invasive to the human body and that do not have a therapeutic purpose are usually allowable, such as, for example, methods for: deodorization, decoration, or beautification. Nevertheless, a cosmetic method comprising one or more surgical steps may be considerd to be a method of surgery.

Protection of the skin

8.65 Methods of protecting the skin by simply blocking UV radiation are not considered to be therapeutic, but where a method produces physiological effects then it is considered to be a non-patentable therapeutic method. For example, in T 1077/93, the EPO Technical Board considered that claims directed to the use of the cupric complex of 3,5-Diisopropyl salicylic acid (CuDIPS) as a cosmetic product for the protection of human epidermis against ultraviolet radiation, had also to take into consideration the mechanism by which CuDIPS acted. The Board then concluded that at least part of the protective effects did not derive from a simple filtering at the level of the skin surface, but rather from an interaction with the cellular mechanisms in the epidermis, with the purpose of preventing a pathological state (erythema); therefore the process is considered to be a method of therapy.

Methods of hygiene, including treatment of parasites

8.66 Methods of hygiene will generally be capable of industrial application even though they may ultimately prevent the occurrence of diseases. However, methods of treating or preventing infestation of parasites, including the treatment of head lice, will generally be regarded as methods of therapy. For example, treatment of parasites residing on the skin of a human or animal is considered to be therapy (see T 116/85):

“A method for the control of ectoparasitic infestations of pigs comprising the application to a localised area of the pig’s body surface of a pesticidal composition.”

The Technical Board of Appeal considered that the invention was directed to the treatment of permanent ectoparasites based on the experimental evidence of the description of the patent application, and held that since permanent ectoparasites cause direct harm to the infested host, the control or eradication of permanent ectoparasites is a therapeutic treatment of the animal body. Consequently, the treatment of, for example, head lice, is considered therapeutic.

8.67 This is further supported in Ciba-Geigy’s Application BL O/35/85, a method of controlling parasitic helminths by the use of an anthelmintic composition was considered a disease requiring medical treatment of the animal and that such treatment, whether curative or preventative, constituted therapy even if the host animal is unaffected and that it is only the parasites that are being killed. Accordingly, the Hearing Officer held that the claims in question were not allowable. Nevertheless, the Examiner should always assess if there is a direct link between the treatment and the condition to be treated or prevented.

8.68 For example, in Commonwealth Scientific & Industrial Research Organization’s Application BL O/248/04 it was held that a method for reducing parasitic infestations by destroying the hair follicles in the skin of sheep was allowable since it was not directly linked to a disease state.

8.69 To fall within the exclusion of being a method of therapy, there should be a direct link between the treatment and the condition to be treated or prevented.

Treatment of stock animals

8.70 The treatment of stock animals in order to improve the quality of meat or increase the production of milk, eggs or the like would not be regarded as therapy, even if the substances concerned may have therapeutic benefits. However, in such cases the claims should clearly be limited to the non-therapeutic aspects. For example, in T 774/89 BAYER, the EPO Technical Board allowed claims directed at medication to increase milk production in cows since the benefits of administering the medication were not linked to the health of the cow. To establish its decision, the Board assessed if a non-therapeutic method would be expected to show an improvement on the normal condition of the subject, rather than just return an animal to a normal, healthy condition.

8.71 However, if the industrial benefit (e.g. an increase in meat yield) is a result from improved health through a therapeutic treatment, then it may not be allowable. For example, in T 780/89 BAYER/Immunostimulant OJEPO 1994, 797 claims directed to the use of compounds for immunostimulation or stimulating the animal body’s own defences were considered to constitute therapy even with the Applicant arguing that immunostimulation merely increased meat production.

8.72 This was further confirmed in T 438/91 MEIJI/Feeds [1999] EPOR 333, wherein the step of feeding said animals had the effects of (a) remedying scours (via treatment with bifidobacteria included in the feed) and of (b) weight increase of the animals being bred. However, since (a) and (b) cannot be separated, the Technical Board of Appeal considered the claimed method to relate to a method of therapy or prophylactic treatment of domestic animals and thus not allowable.

Oral care

8.73 Methods for the removal of dental plaque, or preventing the formation of plaque are considered to be therapeutic and thus not allowed as all such methods have the effect of treating or preventing dental caries (Oral Health Products (Halsteads) Application [1977] RPC 612; Lee Pharmaceuticals’ Applications [1975] RPC 51). The inherent therapeutic effect of removing plaque cannot be separated from the purely cosmetic effect of improved appearance of the teeth, and so restriction of such a claim to a cosmetic method is not possible (see T 290/86).

8.74 Non-patentable oral care method claims are those that may include, for example, references to antiseptic action, treatment of abscess, gumboil, gingivitis, inflammation of gums, mouth ulcers, periodontitis, pyorrhoea, periodontal disease, sensitivity, stomatitis and thrush.

8.75 However, in T 675/11 COLGATE-PALMOLIVE the Technical Board of Appeal considered that the “for use in the treatment of halitosis” of the claimed dentrifice composition was not a method of treatment by therapy as only in extreme cases it can be considered a disease, such as, for example, chronic halitoses.

Pain, addiction and fatigue

8.76 The relief of pain is considered to be therapeutic, even where the pain has no pathological cause. In the case of T 81/84 RORER/Dysmenorrhoea OJEPO 1988, 202, the claim:

“A method for relieving the discomfort of a human female attendant to menstruation, which method comprises administering thereto an effective amount of an amidino-urea of the general formula: X.”

was considered a therapeutic method; it was stated that irrespective of the origin of pain, discomfort or incapacity, its relief, by the administration of an appropriate agent, is to be construed as “therapy” or “therapeutic use”.

8.77 However, a method to reduce discomfort by cooling (T 385/09 LELY ENTERPRISES), and a method to reduce the perception of fatigue in healthy individuals (T 469/94 MIT) have been considered non-therapeutic since it is not comparable with the relief of pain, discomfort or incapacity.

8.78 Methods of treatment of addiction or withdrawal symptoms are considered to be therapeutic.

Obesity, appetite suppresion and weight reduction

8.79 Treatment of obesity is generally considered to be therapeutic. However, methods of weight reduction for purely cosmetic reasons are not considered therapeutic and hence are industrially applicable under Section 16(2). Claims to such methods must be drafted to clearly relate to cosmetic weight loss only – for example the following would be allowable:

– A claim limited to a purely cosmetic purpose, such as “A method of improving the body appearance …” (see T 144/83 DU PONT/ Appetite suppressant OJEPO 1986, 30).
– A claim limited to healthy subjects, such as “A method of improving the skeletal muscle performance of healthy subjects …” (T 1230/05 BIOENERGY).

Contraception, abortion and fertility treatment

8.80 In general, methods of contraception are allowed since pregnancy is not an illness or disorder (Schering A.G.’s Application; T 74/93 BRITISH TECHNOLOGY GROUP/Contraceptive method OJEPO 1995, 712) but may be excluded under Section 16(2) if the method contains a therapeutic element.

8.81 For example, a contraceptive method using one active ingredient with concomitant treatment to reduce its ill effects by using a second agent would not be allowable (T 820/92 GENERAL HOSPITAL/Contraceptive method OJEPO 1995, 113). In this case, even though the use of an oral contraceptive constituted a non therapeutic method, the Technical Board of Appeal considered that the claimed concentrations of the hormone content in the oral contraceptive were specifically selected at low levels in order to prevent or reduce the likely pathological side effects of the contraceptive. Consequently, the Board held that the claim is intrinsically indistinguishable from the non-therapeutic contraceptive method since the prevention of side effects is considered to be a therapeutic method.

8.82 Claims to methods of abortion, termination of pregnancy or induction of labour are not allowable regardless of the reasons for treatment (UpJohn (Kirton’s) Application [1976] RPC 324). Moreover, methods to prevent or cure any diseases that may occur during pregnancy, but which are not inherently linked to the pregnancy itself, may still be considered therapeutic.

8.83 Methods of infertility treatment, including methods of in vitro fertilisation, are considered to be therapeutic. Implantation of an in vitro fertilised embryo would generally involve a surgical process (see Occidental Petroleum’s Application) and therefore would not be industrially applicable under Section 16(2).

Methods relating to implanted devices

8.84 Methods relating to implants and the like may be patentable provided the claimed method does not relate to any therapeutic effect. For example, if the invention were to a method of monitoring the performance of the implanted device without any changes being made to the output signal then the method would be considered non therapeutic (T 789/96 ELA MEDICAL/Therapeutic method OJEPO 2002, 364). Similarly, a method for measuring the flow of a drug from an implant, and which did not control the flow of the drug, was also held to be non-therapeutic (see T 245/87 SIEMENS/ Flow measurement OJEPO 1989, 171).

8.85 On the other hand, a method of optimising an artificial respiration system while the system is in use was considered by the EPO Technical Board in T 1680/08 BÖHM to be indistinguishably linked to the therapeutic use of the respiration system in keeping the patient alive and consequently the claim was not allowable.

8.86 In addition, a method of operating a pacemaker in which its output to the heart was adjusted was deemed a method of treatment by therapy (T 82/93 TELECTRONICS/Cardiac pacing OJEPO 1996, 274). In this case, the Applicant’s argument that this was a “technical operation performed on a technical object” was considered irrelevant.

Treatments performed outside the body

8.87 In general, a therapeutic treatment of the human or animal body is not capable of industrial application under Section 16(2) even if the actual treatment takes place outside the body.

8.88 Examples of such treatments include blood dialysis where the blood is returned to the same body after treatment (Calmic Engineering’s Application [1973] RPC 684 and Shultz’s application BL O/174/86); it is necessary that the blood is returned to the same body for this to be considered to be a method of therapy. Therefore, treatment of blood for storage in a blood bank is not regarded as therapeutic treatment.

8.89 Similarly, methods for treating samples that have been extracted from the human body (e.g. blood, urine, skin, hair, cells or tissue) and methods for gathering data by analysing such samples are generally not considered to be therapeutic, unless the process is performed on the presumption that the samples are to be returned to the same body (see T 1075/06 FENWAL). For example, in T 794/06 GAMBRO LUNDIA it was argued that a method of preparing a dialysis solution carried out while the patient was connected to the dialysis system was not therapeutic since the dialysis solution was never in contact with the patient’s blood.