Use Claims, & Where They Cannot be Used
A recent Technical Board of Appeal (TBA) decision (T1635/09) of the European Patent Office (EPO) has highlighted the difficulties associated with claiming a non-therapeutic use where an inevitable therapeutic effect also results.
Bayer Schering Pharma was the proprietor of EP0735883, which was granted in November 2006 with claims directed to the use of an oral dosage form for contraception. Although the treatment of humans (or animals) by surgery or therapy is explicitly excluded from patentability under Article 53(c) EPC, European case law has established that, as pregnancy is not an illness, its prevention by contraception is not a therapeutic treatment within the context of Article 53(c) EPC (T820/92 and T74/93). The claims of the granted patent were therefore drafted in second non-medical use form, i.e. as “use” claims. Four notices of opposition were filed against the patent, including on the grounds of lack of novelty and inventive step, insufficiency, and exclusion from patentability. The patent was maintained in amended form by the opposition division, a decision which was subsequently appealed by the patentee and three of the opponents. During the course of the appeal hearing, 24 requests and 136 cited prior art documents were considered by the TBA, highlighting the complexity of the issues raised in this case. Of the requests filed, the Main Request and Auxiliary Requests 1, 2, 23 and 24 were discussed in relation to Article 53(c)EPC.
Claim 1 of the Main Request was drawn to the use of an oral dosage form comprising a number of hormones for contraception in a female. The opponents argued that the low dosages of the hormones aimed to reduce side effects associated with oestrogen uptake, such as cardiovascular and thrombolytic complications, and as such the claims covered therapeutic uses specifically excluded from patentability.
In response, the patentee argued that whether or not a claimed method was therapeutic depended primarily on the intended purpose set out in the claim, and on this basis “a use….for contraception”, did not fall within the Article 53(c) EPC exclusion. This notion was rejected by the TBA, however, who found that the intended use is not the sole factor for deciding whether or not the exclusion applies, but that it must be examined “whether the subject-matter of the claim as a whole encompasses one or more therapeutic steps and/or therapeutic effects”. In the case in hand, they found that the therapeutic use, namely the prevention or reduction of pathological side effects, was inseparably associated with the per se non-therapeutic contraceptive process, such that the claims as a whole encompassed a therapeutic method. Claim 1 of the Main Request was thus found to contravene Article 53(c) EPC.
The Patentee sought, in a series of auxiliary requests, to circumvent the Article 53(c) EPC exclusion by separating out the therapeutic and non-therapeutic aspects of the invention. Firstly, in Auxiliary Request 1 submitted by the Patentee, claim 1 was identical to that of the Main Request, save for an amendment to recite “non-therapeutic” use. The TBA held that such a disclaimer could not be introduced in circumstances where the use necessarily includes one or more therapeutic steps, since “the question whether or not a claimed use is therapeutic can be decided only in the light of the activities carried out and/or the effects achieved, in the course of that use”. They further noted that the introduction of the disclaimer would contravene the clarity provisions set out in Article 84 EPC, since the disclaimer “non-therapeutic” was inconsistent with the subsequently defined use, which was deemed to be therapeutic in substance. Claim 1 of Auxiliary Request 1 was ultimately held to be excluded from patentability under Article 53(c) EPC despite the introduction of the disclaimer.
In another attempt to overcome the Article 53(c) EPC exclusion, claim 1 of Auxiliary Request 2 (and the sole claim included in Auxiliary Request 23) had been redrafted into a Swiss-type claim, i.e. a claim in the form “use of substance or composition X for the production of a medicament or therapeutic application Y”. The TBA therefore considered whether the rewording of a “use” claim into a Swiss-type claim met the requirements of the EPC, or whether the reformulation of the claim constituted an unallowable extension of the protection conferred by the granted patent under Article 123(3) EPC.
In order to make this assessment, the TBA first looked at whether a Swiss-type claim should be construed as a claim to (a) the use of a substance or composition for a specific purpose or (b) the manufacture of a medicament. Taking guidance from Enlarged Board of Appeal (EBA) decision G1/83, the TBA found the Swiss-type claim to be “a process of manufacture, the novelty of which exceptionally arises from the intended use of the product”. The TBA therefore concluded that the amendment of claim 1 into Swiss-type ormat, constituted a change of claim category from a “use” claim to a “process claim”. The consequences of this finding arise primarily from the application of Article 64(2) EPC, which stipulates that the protection conferred by a process claim extends to the products directly obtained by that process. This issue had been dealt with previously by the EBA in G2/88, a decision now referenced by the TBA, where it was reasoned that “Article 64(2) EPC is not directed to a patent whose claimed subject-matter is the use of a [product] to achieve an effect (this being the normal subject of a use claim): it is directed to a European patent whose claimed technical subject-matter is a process of manufacture of a product; the Article provides that for such a patent, protection is conferred not only upon the claimed process of manufacture, but also upon the product resulting directly from the manufacture. Thus, provided that a use claim in reality defines the use of a particular physical entity to achieve an “effect”, and does not define such a use to produce a “product”, the use claim is not a process claim within the meaning of Article 64(2) EPC”.
As a result, the TBA found that the Swiss form of claim 1 included in Auxiliary Requests 2 and 23 extended protection to the direct product of the method, which was not covered by the use claim as granted. Auxiliary Requests 2 and 23 were therefore found to contravene Article 123(3) EPC.
A final attempt in Auxiliary Request 24 to reformulate claim 1 into a corresponding purpose-related product claim also failed, with the TBA finding Article 54(5) EPC (which allows for the new further medical use form of claim, "substance X for use in the treatment of disease Y"), to be inapplicable to the patent at issue, which was granted before the requisite provisions entered into force under EPC 2000. Irrespective of this finding, the TBA noted that the conversion of a use claim into a purpose-related product claim would in any event constitute an impermissible extension of the scope of protection, insofar as the purpose-related product claim, which is directed to the product per se, would cover within its scope manufacture of the product, where the corresponding use claim would not.
The patent at issue in this case was consequently revoked. This decision emphasises the need for careful claim drafting in Europe where the invention relates to a method of treatment of the human or animal body having both therapeutic and non-therapeutic effects.
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