Methods of medical treatment

Claims to both therapeutic and non-therapeutic methods

8.42 In some cases a claim can be construed to include both therapeutic and nontherapeutic methods, as exemplified by the following claim:

“A method for inhibiting the coagulation of blood by contacting the blood with a carrier containing compounds X and Y.”

This claim could be construed as including a method of treating the blood in a patient as part of a therapeutic method, and a method of treating stored blood in a tube, which is not a method of medical treatment. In such cases, the claim should be carefully construed to determine its scope.

8.43 Therapeutic and non-therapeutic effects of a claimed method must be clearly distinguishable. If the non-therapeutic effect is inseparable from the therapeutic effect, or if it is merely a secondary consequence of the therapy, then regardless of any disclaimer or a purely formal rewording of the claim, the invention is not capable of industrial application under Section 16(2). Both the UK Courts and the EPO have held that if a claim encompasses a use comprising a non-therapeutic element that is associated with a therapeutic element and that latter element is an essential part of the claimed method, the claim is non-patentable. For example, in T 290/86 ICI/Cleaning Plaque OJEPO 1992, 414 a claim directed to a cosmetic method for the removal of plaque from teeth, was considered to also have a therapeutic benefit in preventing tooth decay and gum disease:

“… the claimed use of a lanthanum-containing composition for cleaning plaque and/or stains from human teeth … will always inevitably have a therapeutic effect (at least in the prophylactic sense) as well as a cosmetic effect. Thus the invention as here claimed is not directed solely to a cosmetic effect, but is also necessarily defining ‘a treatment of the human body by therapy’ as well.”

If the effects are separable, then the existence of a possible therapeutic use should not prevent cosmetic or other non-therapeutic methods from being industrially applicable under Section 16(2) provided the therapeutic use is not part of the claim.

8.44 Generally, disclaimers to exclude methods of treatment by therapy are allowable. However, where a disclaimer is employed there must be support in the specification for such non-therapeutic methods or else the amendment will constitute added matter (G 01/03 PPG/Disclaimer OJEPO 2004, 413; G 02/10 SCRIPPS/Disclaimer OJEPO 2012, 376). In ICI (Richardson’s) Application [1981] FSR 609, a claim to a method of producing an anti-oestrogenic effect in a human and, which excluded any method of treatment by therapy was rejected since the specification did not describe any application of the method other than in the treatment of breast cancer or infertility. Any disclaimer needs to exclude all possible therapeutic methods, not merely those disclosed in the specification, and the scope of the remaining monopoly should be clear. For example, the term “cosmetic” in a claim to a method of treatment is generally acceptable as a sufficient limitation, as long as there is support in the specification for such non-therapeutic method in the application as filed (T 144/83 DU PONT/Appetite suppressant OJEPO 1986, 30). If there is no such support from the application as filed, then the amended claim will constitute added matter. However, if it is unambiguously clear from the specification that the claims relate only to nontherapeutic methods, then no amendment is required.

8.45 The Examiner should take care, where the claim has been limited to exclude therapeutic methods, to require amendment of the description, so that all references to a therapeutic effect are removed. It should be clear from both the claims and the description that therapeutic methods do not fall within the scope of the invention.