Now that the hot days are back, let us study a sunscreen decision. This decision shows once again how dangerous an unfortunately worded disclaimer can become.
Claim 1 as filed read:
1. A method of inhibiting the harmful effect of UVR exposure to the human skin comprising topically applying a therapeutically effective amount of genistein to the skin at a time sufficiently close to the time of UVR exposure to inhibit UVR-induced damage to the skin.
Following a negative search report, the claim was amended to a Swiss-type claim:
1. Use of genistein in the preparation of a chemopreventive agent, said chemopreventive agent not being merely a sunscreen, for treating human skin in order to inhibit the harmful exposure to ultraviolet radiation.
Claim 1 was finally granted as follows:
1. Use of genistein for the preparation of a topical chemopreventive medicament, said chemopreventive medicament not being merely a sunscreen, for the treatment of human skin in order to inhibit the harmful effect of exposure to ultraviolet radiation.
The opposition division (OD) maintained the patent in amended form.
At the oral proceedings before the Board the patent proprietor defended the maintenance of the patent on the basis of a new main request reading as follows:
1. Use of a therapeutically effective amount of genistein for the preparation of a topical chemopreventative medicament for the treatment of human skin in order to inhibit UVR-induced aging or UVR induced photocarcinogenesis by chemoprevention, said medicament applied at a time sufficiently close to the time of UVR exposure to inhibit said aging or photocarcinogenesis.
[3.1] Claim 1 as granted is subject to a proviso, namely “said medicament not being merely a sunscreen”. According to the [patent proprietor], this meant that sunscreens acting exclusively by blocking UV radiations were excluded. Hence this proviso in granted claim 1 excludes from the protection conferred the preparation of medicaments being only sunscreens. This finding was not contested by any Party.
[3.2] Claim 1 as amended differs from claim 1 as granted mainly in that the proviso had been deleted. With the deletion of the proviso, claim 1 no longer explicitly requires that the medicament is not a mere sunscreen.
[3.2.1] According to the [patent proprietor] the feature “in order to inhibit UVR-induced aging [or UVR induced photocarcinogenesis] by chemoprevention” indicated the mode of action of the medicament which action therefore comprised necessarily a physiological action, thereby excluding pure UVR blocking action, as a mere sunscreen would do.
[3.2.2] Claim 1 is formulated according to the Swiss-type claim format which is designed to protect a further new and inventive therapeutic application, in the present case, the preparation of a medicament for the inhibition of UVR-induced aging. Claim 1 further stipulates that the therapeutic application is achieved by chemoprevention. However, the mode of action of a medicament is not a technical feature in a Swiss-type claim, but is merely a technical insight into how the medicament may work. The indication of the mechanism of action of a medicament does not add any new technical feature to the Swiss-type claim, because the mechanism of action necessarily underlies the therapeutic use of that medicament. In the present case, the technical effect which is achieved by the topical application of the medicament comprising genistein, irrespective of any mechanism of action, is simply the prevention of UVR-induced aging, which is a technical feature already indicated in the claim. Accordingly, the [patent proprietor’s] attempt to promote a technical insight, here the mechanism of action, into a “technical effect" cannot succeed, the actual technical effect underlying the use of genistein for preparing the medicament being the prevention of aging.
[3.2.3] The [patent proprietor’s] further argument that the discovery of the mechanism of action opened new ways of treating UVR-induced aging cannot change the above findings, because the technical features reflecting these new modes of treatment, which would exclude the medicament from being merely a sunscreen, are not reflected in the claims.
As regards the mode of treatment, claim 1 requires merely that the medicament be applied “at a time sufficiently close to the time of UVR exposure to inhibit said aging”, which requirement does not exclude the medicament from being a sunscreen.
[3.2.4] Therefore, the Board concurs with the [opponent] that claim 1 as amended covers the possibility of the medicament being a mere sunscreen, all the more so because paragraph [0018] of the patent-in-suit foresees that the composition comprises UV blockers.
[3.3] Thus, claim 1 as amended according to either request encompasses the preparation of mere sunscreens, which embodiment was excluded from claim 1 as granted. Hence, the deletion of the feature “said medicament not being merely a sunscreen” in claim 1 has the effect of broadening the scope of the amended claim vis-à-vis claim 1 as granted with the consequence that claim 1 […] has been amended in such a way as to extend the protection conferred by the granted patent contrary to the requirement of A 123(3). […]
The patent is revoked.
To read the whole decision, click here.
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