Lilly Icos LLC applied for Israel Patent Number 147642, a national phase of WO/2001/008688) BETA-CARBOLINE DRUG PRODUCTS. The patent application concerns Tadalafil, a treatment for male impotence due to erectile dysfunction which is marketed as Cialis.
After allowance, the patent application published for opposition purposes and Teva filed an opposition claiming that the invention was essentially using smaller particles as a technique for improving the rate of solubility of the drug and was therefore obvious.
Eventually the sides overcame their differences and the opposition was withdrawn. However, using his authority under Section 34 of the Israel Patent Law, Deputy Commissioner Noach Shalev Shlomovits defended the public interest and refused the patent, ruling that the technique of reducing particle size as a means of increasing rate of solubility lacked any inventive step.
As he was terminating his contract, and in accordance with Ordinance 74 and Section 159, the Deputy Commissioner gave the parties 30 days to file any appeals so he would be able to close the file himself rather than having his replacement learn the material.
Solubility is a surface effect. Since the amount of surface area for a given weight of material increases as particle size decreases, it is clear that shrinking particle size will increase rate of solution. It seems, therefore, that the Deputy Commissioner is correct.