Saturday, 4 August 2012

T 1170/07 – Let’s Be Reasonable

In this case the opponent filed an appeal against the decision of the Opposition Division to maintain the patent on the basis of the claims as granted and a description amended during the appeal proceedings (which, if I may add, appears to be a very rare outcome).

Claim 1 of the main request read:
1. The use of tetrahydrolipstatin for the manufacture of an oral pharmaceutical preparation for treating type II diabetes mellitus per se, the amount of tetrahydrolipstatin to be employed in unit dosage form, which consists essentially of tetrahydrolipstatin formulated as an oral composition, the amount of tetrahydrolipstatin being effective to alleviate or cure type II diabetes mellitus per se and in the range of from 60 to 720 mg of tetrahydrolipstatin per day, wherein the pharmaceutical preparation is to be administered from two to three times per day. (my emphasis)
One of the question before the Board was whether the expression “consists essentially of” complied with the requirements of A 123(2):

[3.1] Claim 1 of the main request includes a unit dosage form, which consists essentially of tetrahydrolipstatin formulated as an oral composition. Before evaluating whether the original application in its entirety specifically discloses such a unit dosage form, it first has to be established what the term “consisting essentially of”, which cannot be found in the original application, means in this context.

The [opponent], making reference to decision T 468/99, argued that “consisting essentially of” meant that the claimed composition must not contain any additional components that might influence the properties of the composition, which even excluded excipients such as PVP or microcrystalline cellulose. The consequence of such an interpretation would be that the unit dosage form formulated as an oral composition would be restricted to tetrahydrolipstatin per se, as any additional compound would have some effect on the properties of the composition.

However, claims should be read in a technically reasonable way. Unit dosage forms formulated as oral compositions necessarily comprise a vehicle or carrier for the active agent, otherwise a safe administration of the active agent is not possible. This requires the presence of further compounds or excipients, which, as was mentioned above, have an influence on the properties of the composition in terms of release rate, stability etc. As a consequence, “consisting essentially of” cannot have this restrictive meaning in the present case. The board concludes that under the specific circumstances of the present case “consisting essentially of” excludes further active agents useful in the treatment of NIDDM but allows the presence of additional compounds forming the carrier of tetrahydrolipstatin.

The passage on page 1, lines 23-27, of the original application discloses that tetrahydrolipstatin, when administered orally, is useful in the treatment and prevention of NIDDM. This disclosure does not specifically mention that tetrahydrolipstatin is used in the absence of further active agents. However, the passage on page 2, lines 22-23, indicates that the pharmaceutical preparations “can also contain still other therapeutically valuable substances” [emphasis by the board], which means that the absence of such therapeutically valuable substances is clearly envisaged. Furthermore, all three formulation examples (examples 1 to 3) concern compositions with tetrahydrolipstatin as the only active agent.

The board concludes therefrom that treatment of NIDDM with oral compositions comprising tetrahydrolipstatin as the sole active agent constitutes the most preferred embodiment of the original application. As a consequence, the substitution of “consisting essentially of” for “comprising” is allowable under A 123(2).

Should you wish to download the whole decision, just click here.

The file wrapper can be found here.