Patent Office refuses Wockhardt's application related to osteoarthritis drug

The company claimed that its invention shows at least 25% reduction in soft stool effect as compared to other drugs

The Patent Office has refused to proceed with the patent application of Wockhardt for an oral salt form of Diacerein, used to treat osteoarthritis, stating that the application lacks inventive step.

The company's claims for the invention titled oral compositions of Diacerein or salts thereof with reduced soft stool, include an oral pharmaceutical composition comprising 20-45 mg of rhein or diacerein, or salts, characterised in the composition showing at least 25 per cent reduction in soft stool effect as compared to a 50 mg diacerein formulation marketd under the trade name Art 50.

The First Examination Report, on the application, while examining the claims, raised objections that the first three claims do not meet the requirements of clarity and the application does not meet the criteria of inventive step.

The company filed a reply to the objections that the Patent raised.

The applicants have amended claims with addition of additional matter,  which is beyond the scope of earlier claimed claims, such an amendments is out of scope of Section 59 read with section 57 of the Patent Act and therefore not allowable, stated the order.

"The pills are useful against osteoarthritis. The problem solved by the present invention may be regarded as the provision of an alternative galenical form providing increased bioavailability of the specified drugs. However, the company's claim on 25 per cent reduction in soft stool effect of the drug, is merely a statement of problem while it should set out how the desireable properties are obtained," the Patent Office noted.

While the Patent Office scheduled a hearing seeking further clarification on the reply to the FER objectioins, the company representatives did not attend the scheduled hearing, leaving the objections raised at various stages as outstanding.

"On consideration of all the documents available on record and in view of above outstanding objections raised /communicated at various stages during the prosecution of application are still remain outstanding as on the date , accordingly, I refuse to proceed further on this Patent Application," the order stated.