T 636/09 – Lack Of Reference

Who said this was a cannabis-free blog?

Claims 1 and 7 of the main request before the Board read (in English translation):

1. A process for producing an extract containing tetrahydrocannabinol, cannabidiol and optionally the carboxylic acids thereof from Cannabis plant material, wherein the dried plant material is comminuted and wherein Cannabis sativa L., of the fibre type is employed as cannabis plant material; wherein said plant material is extracted by means of CO₂ under supercritical pressure and temperature conditions at a temperature in a range from 31 °C to 80°C and at a pressure in a range from 75 bar to 500 bar, or is extracted in the subcricital range at a temperature of 20°C to 30°C and a supercritical pressure of 100 bar to 350 bar; and the obtained primary extract is separated out under subcricital conditions or under conditions subcricital in terms of pressure and supercritical in terms of temperature.

7. A primary extract from cannabis plant material, containing tetrahydrocannabinol and cannabidiol and optionally the carboxylic acids thereof, characterized in that it may be obtained through a process in accordance with any one of claims 1 to 6; and in that it contains at least reduced proportions of monoterpene and sesquiterpene hydrocarbons, alkaloids, flavonoids, and chlorophylls.

The Board found claim 7 to lack novelty:

*** Translation of the German original ***

[3] The primary extract defined in present claim 7 is characterised both by the production process and by the feature that it contains at least reduced proportions of monoterpene and sesquiterpene hydrocarbons, alkaloids, flavonoids, and chlorophylls. Document D3 […] discloses a supercritical extraction of marihuana that is carried out with CO₂ that has a density of 0.9 g/ml at the chosen temperature of 40°C. It has to be noted that under these circumstances the pressure of supercritical CO₂ lies within the presently claimed pressure range of between 75 and 500 bar, which means that this feature is implicitly disclosed. Moreover, [the Board] has to agree with the Opposition Division that in the process disclosed in document D3 the individual fractions are quenched (abgefangen) at a subcritical temperature of 25°C. The expression “trapped” used un document D3 implies that the CO₂ extract is kept at normal conditions, i.e. room temperature and atmospheric pressure, which means that the CO₂ evaporates and only the extraction residue, i.e. the primary extract, is left. It follows that all process steps mentioned in claim 1 of the present main request are disclosed in document D3. In this context it has to be noted that the industry-scale (großtechnisch) character of the process defining the claimed product, to which the [patent proprietor] has repeatedly referred, cannot serve as a distinguishing feature, be it only because said process defined in claim 1 does not contain any feature allowing to derive an industry-scale dimension. The absence of the industry-scale character cannot be interpreted into the claim by reference to the description, as the [patent proprietor] has requested by referring to A 69. In view of this conclusion the question of whether an industry-scale process would result in structural features of the product obtained therein allowing to distinguish [this product from a product] obtained in an analytical process comprising the same process steps, may remain unanswered.

As far as the starting material is concerned, the Board comes to the conclusion that the starting material “Cannabis sativa L., of the fibre type” defined in the main request is not different from the marihuana used in document D3. As stated in the impugned decision […] marihuana, in contrast to hashish, also designates dried plant material. The [patent proprietor] bases the difference between the plant material used in the impugned patent and the marihuana used in document D3 on the expression “fibre type”, which, in contrast to marihuana, was characterised by a reduced Δ⁹-THC content. However, as can be seen in the original application […], the expression “hemp of the fibre type” and its synonym “industrial hemp” are defined differently in different countries. In Germany, the upper limit of industrial hemp is fixed at 0.3% Δ⁹-THC, whereas in Switzerland the upper limit is 0.5%. Consequently, the Board comes to the conclusion that the expressions “hemp of the fibre type” or “industrial hemp” are not clearly defined expressions for the skilled person and cannot constitute distinguishing features for the starting material but only represent its intended use.

Thus document D3 discloses a starting material that is identical to [the starting material of] the claimed subject-matter and an identical extraction process.

It remains to be discussed whether the feature “and in that it contains at least reduced proportions of monoterpene and sesquiterpene hydrocarbons, alkaloids, flavonoids, and chlorophylls” of claim 7 can establish novelty over document D3, which, as was correctly stated in the impugned decision, does not make any statements on the exact composition of the extracts. However, as the Board has already suggested in the annex to the summons to oral proceedings […] this feature is not suitable for establishing novelty over document D3 because there is no reference value and, therefore, because it is completely unclear with respect to which reference product these contents are reduced. In the absence of a reference value this feature can also mean that the parts of said substances are relatively small in comparison to the amount of the extracted main component, Δ⁹-THC, which certainly is the case for the extraction product disclosed in document D3, too.

Thus the Board arrives at the conclusion that the subject-matter of claim 7 of the present main request is not novel over document D3. Thus the requirements of A 54 are not fulfilled.

Should you wish to download the whole decision (in German), just click here.

The file wrapper can be found here.