Innovation Europe > News > Innovation EU Vol2-1 > Seligsohn Gabrieli & Co.

In the case examined in this article, the Israeli Commissioner of Patents implemented the test of "Obvious to Try" in the field of chemistry, accepting an Opposition of Teva to the Celebrex of GD Searle & Co.

Teva Pharmaceutical Industries and another Israeli company, Trima, opposed a patent application filed by GD Searle & Co (a subsidiary of Pfizer Inc), claiming the formulation of an orally administered drug, which includes the active ingredient celecoxib. The drug formulation, the subject of the invention, has been marketed under the name Celebrex and is used for the relief of pain and inflammations. The drug formulation process included the milling of the active ingredient celecoxib, using the method of "impact milling", prior to mixing the celecoxib with excipients. The milling process produced celecoxib in a particulate form, which is claimed to provide an improved bioavailability of the drug, namely a higher level of absorption of the active ingredient in the blood.

Our firm successfully represented Teva and Trima in this opposition, arguing mainly that the subject invention was obvious. The Commissioner of Patents ("the Commissioner") accepted the Opposition, ruling that the invention is obvious and not patentable, based on the test of "Obvious to Try". Although this test was briefly discussed by the District Court in 1999, it is, to the best of our knowledge at Seligsohn Gabrieli & Co., the first time this test is established and used by the Commissioner to find that an invention is obvious. This is an important decision in the relatively uncharted waters of this test.

The Commissioner indicated that in US and English case law the test of "Obvious to Try" has been adopted, however it was criticised. In his opinion it seems proper to use this test at least in the field of pharmaceutical chemistry and there is no reason to dismiss it in Israeli law, but rather it has to be implemented on the specific facts of the tried case.

The Commissioner describes the two different approaches found in US and English case law. Said approaches included, on the one hand, a limiting approach (towards the inventor), according to which, in order to acknowledge that it was indeed obvious to try the solution offered by the alleged invention, it is required that only a "reasonable expectation of success" will arise from the prior art, or that a person versed in the art could simply assess the "likelihood of success as sufficient to warrant actual trial".

On the other hand, the lenient approach requires a higher level of assurance that the claimed solution will be effective, or in other words that it should be "more or less self evident that what is being tested ought to work".

The preceding District Court decision that dealt with this test did not state which of the above approaches is correct, but only determined that an invention would be considered "Obvious to Try", if the person versed in the art knows, based on prior art, that there existed a problem which required a solution, and is familiar with the components of the experiment which brings the desired solution.

Based on the above, in implementing the facts of the matter at hand, the Commissioner accepted the Opponents’ contentions and determined that although not devoid of disadvantages, the method of milling an active ingredient, in order to obtain an improved bioavailability, was a known method, and is one of the first methods to be tried by a skilled person as was sufficiently proved by the opponent.

The Commissioner relied on a publication submitted by the Opponents that described an experiment performed on the active ingredient celecoxib. In this experiment, the celecoxib was given to patients in two different formulations, a capsule and fine suspension. The Commissioner accepted the Opponents’ argument that the term "fine suspension" represents particles of a small size and that the experiment revealed improved bioavailability which was demonstrated in a good absorption of the celecoxib in the blood.

Therefore, the Commissioner determined that there was an incentive to a person versed in the art to reduce the size of the specific active ingredient of celecoxib in order to obtain the desired improved bioavailability and thus it was "Obvious to Try" what is claimed in the application. Consequently, the Commissioner decided that the invention claimed in the application lacks an inventive step being obvious and accepted the opposition.

It would be interesting to see how this test is further developed in Israel’s patent case law, whether in general or particularly regarding inventions in the field of chemistry.

For more information, contact:

Seligsohn Gabrieli & Co.
Intellectual Property Litigation
Tel: +972 3 5661446
Website: www.sgl.co.il