Patent Office refuses divisional application for Wyeth's antibiotic combination

Order issued is liable to be changed based on direction of Calcutta HC, says official

The Patent Office has refused a divisional application of Wyeth's drug piperacillin and tazobactam injection, an antibiotic the company markets in US under the brand name Zosyn, used for treatment of serious infections.

The Patent Office observed that the application contains same set of claims as that of the parent application and thus it is not patentable.

The decision comes on Wyeth Holdings Corporation's divisional application titled Compositions containing piperacillin and tazobactam useflu for injection, on May, 2008, to a parent application filed on September 7, 2005.

The invention is related to a combination which the company is marketing in US under the trademark Zosyn in US and some other countries like India and and under the registered trademark Tazocin in other countries. The composition is useful for intravenous administration as antibiotics for hospitalised patients with serious infections, say documents.

In an order issued on August 25, Soumen Ghosh, assistant controller of patents and designs refused the application stating that the claimed composition failed to exhibit sufficient data for better efficacy or any unexpected result and therefore, does not involve any inventive step.

"The present application has been filed with the same set of claims 1 to 37 as that of the mother or parent application. Although called a 'divisional' application but no division has actually been made from the parent application as per section 16(1) of the 'Act and exactly the same parent application has been filed," said said the order.

"There is no plurality of 'inventions' found in the mother application. Therefore, in the absence of more than one invention, applicant's suo moto action of filing the 'divisional' application is not understood except for the continuation of the withdrawn or lapsed parent application in the disguise of 'divisional' application," it added.

However, a matter related to the divisional patents is pending before the High Court of Calcutta and even though there is no bar or restriction imposed to the office from issuing order or decision in respect of other pending divisional applications, the order issued is liable to be changed in respect of objection on divisional issue in accordance with the direction that may be received from the High Court of Calcutta, it said.

Earlier, the Patent Office has sent a hearing letter to the company raising the main objection regarding non allowability of the application as a divisional application under section 16 of the Patent Act. Also, the objections on the grounds of lack of novelty, inventive step and section 3(e) of the Act, were imposed.

During a hearing conducted on January, 2014, I S Bhattacharya, attorney of the company, argued that the composition is novel and inventive because it has greater stability. The attorney also argued that a Writ Petition has been filed before the High Court at Calcutta challenging the IPAB order dated August 10, 2011, which refuses this type of divisional applications on the ground of lack of plurality of inventions.

According to earlier reports, the Delhi Network of Positive People, a support group for people living with HIV/AIDS has earlier approached the Delhi High Court, seeking the Delhi High Court's direction to the Ministry of Industry and Commerce to prevent abuse of the process in filing of divisional patent applications, including by amending of the Patents Act.

The Court directed the Union Government officials to take a decision on whether any amendment needed in the Patent Rules to address the issue of abuse of the process of filing of divisional patent.