Patent Office refuses divisional patent for GSK Biologicals' vaccine

The application was related to a novel formulation comprising a combination of a cancer antigen or a derivative

The Patent Office has rejected a divisional application of GlaxoSmithKline (GSK) Biologicals, filed seeking patent for vaccines against cancer, for various reasons including lack of inventive step. The parent application, filed at the Kolkata office of Patent authority in May 2007, was withdrawn by the company earlier.

The company filed the divisional patent application titled ‘Vaccines’ on May 2007 claiming priority to an international application and UK patent application. The first examination report was issued on February, 2010. The application was divided out of the patent allocation, which was directed to an immunogenic composition, method of treatment using the same, use of the composition and a method of manufacturing the composition.

 

The Patent Office raised the objection that the composition, manufacturing method, its use and method of treatment falls within the definition of single inventive concept, and the authority did not raise any objection regarding the plurality of invention in the examination report of the morhther application.

"Further it is observed that, claims of the alleged divisional application are identical to that of mother application. In view of this, filing of the present application as a divisional one has no merit and cannot be allowed a divisional status," under the sections of the Patents Act, it said. It added that the first claim is very broad and non-definitive, with a large number of possible antigens to be covered in it.

The company did not attend a hearing scheduled this month, said the order.

“Now since the instant application does not comply with the requirements of the Act as per the objections raised as above, I hereby refuse the instant application,” S Kundu, deputy controller of patents & designs, Patent Office, Kolkata, said in the order.

The company, in its patent specification, claimed that the invention is related to a novel formulation comprising a combination of a cancer antigen or derivative thereof and a combined adjuvant composition comprising an immunostimulatory oligonucleotide and a saponin.

According to Section 16(1) of the Patents Act, 1970, a patent applicant, before the time of grant of patent can file a further application (divisional patent) if he so desires or in order to address the objection of the Controller of Patent that the claim in the first patent application relate to more than one invention. In such instance, the patent applicant can file a further application, but has to ensure that the main application and the divisional applications may be amended to ensure that neither of the complete specifications includes a claim for any matter claimed in the other.