Unipharm Successfully Opposes and Voids three out of four allowed Smithkline Beecham Patent Applications for Thiazolidinedione Hydroenation

Under Israel Law, once allowed by an Examiner, a patent application publishes and oppositions may be filed within three months of publication. Grounds for opposition including, inter alia, lack of novelty, obviousness, that the opposer and not the applicant is the true inventor.

In the cases in question are IL 131392 and it’s divisionals: IL166189 and IL 166550, and IL 135898, all relating to addition of hydrogen about the C=C double bond of  thiazolidinedione TZD in the production of Rosiglitazone, with IL 131392 and IL166189 and IL 166550 relating to use of the relatively gentle borohydride reducing agent on the thiazolidinedione and IL 135898 relating to achieving the same product by reacting the with hydrogen in the presence of a palladium on carbon catalyst under pressure.

Unipharm was represented by Adv. Adi Levit, and Smithkline Beecham by Richard Luthi and Luzzatto et Luzzatto.

The Commissioner of  Patents, Dr. Meir Noam determined the issue in question was inventive step and ruled that the correct standard was obvious to try, not obvious to succeed. Noam found the first group – IL 131392, IL166189 and IL 166550 as lacking inventive step, but allowed the IL 135898 case.

The decision was, in my opinion, well argued and reflects the fact that unlike his predecessors who were lawyers, Dr. Noam is also a patent attorney with a Ph.D. in chemistry, which is certainly a great background as most oppositions, and the vast majority of most commercially significant ones having ramifications locally and abroad, relate to the pharmaceutical industry.

One thing I am not happy with, but assume I am missing something: The IL 135898 case relates to reacting TZD with hydrogen in the presence of a surface catalyst under pressure. Now le Chatalier’s principle (If a chemical system at equilibrium experiences a change in concentration, temperature, volume or partial pressure, then the equilibrium shifts to counter-act the imposed change.), thermodynamics and the general behavior of surface catalysts and chemical kinetics all suggest to me that to increase likelihood of adding a pair of hydrogens about a C=C bond, increasing pressure should help. Thus I cannot understand why the IL 135898 case was considered not obvious to try and thus allowed. Am I missing something?



Categories: drugs, Intellectual Property, Israel Patent Office, Israel Patent Office Rulings, Israel Related, News, obviousness, Patents, pharmaceuticals, pharmaceuticals and Biotechnology, Uncategorized

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