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Footnotes

1.1 So far as known compounds having no previous "medical history" were concerned, it fairly quickly became the practice to take the express wording of the convention as to what was patentable and draft claims in the form,

"Compound X for use in treating Y."

or even following the decision in Pyrrolidone Derivatives/Hoffman-LaRoche T 128/82 [1984] OJ EPO 164.,

"Compound X for therapeutic use."

This did not solve the problem of second medical uses. However, in Esai's Application [1985] OJ EPO 64., the Enlarged Board of Appeals adopted a formulation that had previously been suggested by the Swiss Patent Office:

The use of compound X for the manufacture of a medicament for treatment of disease Y.
The "Swiss formulation" has since been followed by at least the British courts (John Wyeth & Brother Ltd's Application [1985] RPC 545) and Swedish courts.Hydropyridine/SE reported in English [1988] OJ EPO 198 The Dutch Patent Office initially refused to allow claims in this form unless there is something novel about the form of the medicament in question itself not merely in its manner of use (Decision of Dutch Patent Office Appeal Board dated 30 September 1987 (No. 16673) reported at [1988] OJ EPO 405) This position was, however, overruled by statute when the Dutch Patent Law was amended in 1995.

Some question has been raised as to whether such claims are effective in France in view of the decision of the Paris Court of Appeals in ..... . It seems, however, that other factors were involved in that decision.

2. Elan Transdermal Limited v. Ciba Geigy noted at [1995] EIPR D-76.

3. T 227/91 [1994] OJ EPO 491. The prohibitions on medical treatment claims have been narrowly construed in other cases. In the earlier case of Flow measurement/Summers [1989] OJ EPO 171, the Appeal Board allowed a claim for a process whereby an electrically conductive liquid containing a medicament is introduced into a patient by means of a pump attached to an implanted dosing apparatus. The Board reasoned that the purpose of Article 52 (4) is to ensure that a physician or veterinarian can practice his profession freely without being restricted by fears of patent infringement. This being the case, since the claim in question did not restrict the physician in selecting appropriate administration of medicaments it did not fall within the patentability bar. In this case, the claim was to a method of measuring liquid flow that was particularly applicable to determining whether drugs such as insulin were flowing freely from an implanted reservoir. The Board concluded that "the steps [claimed] even in an implanted device-- represent no more than a method of measuring the efficiency of [a] pump fitted in the device". Hence, the method was patentable.

4. All methods of treatment of humans or animals are, however, not necessarily unpatentable if they are carried out for reasons other than therapy or diagnosis. For example, claims directed to cosmetic treatments have been allowed even if the treatment has some therapeutic value, as was the case in Appetite suppressant/DuPont, where the allowed claim was:

A method of improving the bodily appearance of...a mammal which comprises orally administering to said mammal [a material] in a dosage effective to reduce appetite and repeating said dosage until a cosmetically beneficial loss of body weight has occurred.

4. Claim 2 defined "said mammal" as a human. The Board reasoned that although there were medical reasons to lose weight, most people wished to do this for cosmetic rather than medical reasons and in this case the claim was specifically limited to obtaining cosmetic results.

5. Cornea/Thompson T24/91 [1995] OJ EPO 512.

6. Decision T82/93 [1996] OJ EPO 274.

7. T182/09 [1994] OJ EPO 641.

8. T 143/94 [1996] OJ EPO 430.

9. T0051/93 decided 8 June 1994.

10. The decision is also of interest in pointing out that it is only when a claim is written in the special form permitted for second medical uses that consideration of the stated use of the product is relevant to assessing novelty. The applicants had included conventional product by process claims for those countries where there were reservations against the grant of patents for pharmaceutical products (Austria, Greece and Spain) and had argued that a statement of use meant that such claims should also be allowed. They were rejected as lacking novelty.

11. ICI/Cleaning Plaque T 290/86 [1991] EPOR 157.

12. Bayer/Immunostimulant [1993] OJ EPO 440.

13. Contraceptive method/The General Hospital T820/92 [1995] OJ EPO 113. In this case claims to a method of contraception were refused where the treatment involved the administration of two different hormones at different times in the menstrual cycle, one of the hormones being included so as to have a prophylactic effect to counter adverse effects that had been associated with the use of the other. The fact that the use of one of the required elements was clearly unpatentable rendered the whole method of use claim unpatentable (a Swiss-style second medical use claim was allowed). It is not clear, however, that this proposition is accepted in other areas of subject matter where other considerations may apply.

14. T74/93 [1995] OJ EPO 712.

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© Copyright 1997 John Richards - Posted 11/29/97 v3
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