Opposition to Patent Applications 153109 In The Name Of The Merck & Co. Inc. (August 2010)


The Patents Registrar accepted Unipharm’s opposition to the patent applications for lack of novelty and lack of inventive step. The application related to the once weekly regimen for the known drug Fosalan, claiming for minimization of side effects in the upper GI track if taken once a week at a dose of 70 mg instead of 10 mg each day.  It was held that the claimed regimen was already known and published in the “Lunar” magazine and that according to known rules in toxicology (such as the Haber Law stating that toxicity is the product of frequency and concentration) the “invention” and the alleged benefit of minimizing side effects were obvious to the skilled man in the art.