Patent Office refuses patent to Italian research firm Indena to treat mucositis

Also rejects a pre-grant opposition filed by a scientist while considering application

The Indian Patent Office has refused patent protection for a medicine of Italian research firm Indena SPA to treat Mucositis, a painful inflammation that occurs after chemo or radiotherapy treatment for cancer, in India. The office also refused a pre-grant opposition filed by a scientist in the Council of Scientific and Industrial Research (CSIR), Delhi against the application.

The patent application, submitted in January 2009 for approval, is for an invention related to the therapeutically effective amount of plant extracts that can be administered alone or in combination with a therapeutically effective amount of one or more anti-inflammatory agent and other pain removing agents and antifungal agent.

The invention is on methods for treating and preventing mucositis, in particular mucositis following the administration of chemotherapy drugs or a combination of said drugs with radiotherapy. Indena sells a Mucositis drug under the trade mark Samital.

The pre-grant opposition was filed by V K Gupta, CSIR, on December 2012 arguing that the use of various extracts for the treatment of various disease are known and claimed that the invention is not novel, not inventive and not patentable. He also submitted ancient Indian texts to substantiate his argument.

In its response, the company argued none of the exibits cited by the opponent disclose a composition containing all the active ingredients, as claimed in the instant invention for the treatment of mucositis.

One of the side effects of radiotherapy, and above all chemotherapy, is mucositis, which normally affects the astroenteric tracts especially the mouth, esophagus, stomach, intestine and vagina in women. It is a serious symptom and affects the quality life of the patient. None of the traditional knowledge speaks about mucositis, it said.

The opponent did not attend the hearing and not submitted any written note of arguments in respect to the pre-grant opposition. The Patent Officer observed that the opponent failed to establish all the grounds of opposition under anticipation, obviousness and non-patentability and rejected the pre-grant opposition.

After considering various revised claims and arguments the official observed that, in view of the prior art documents the person skilled in the art can easily arrive at the instantly claimed combination without involving any inventive skill. Also instant application fails to provide any improved synergistic effect for the claimed combination.

The Patent Office refused to proceed with the application as it observed that the patent cannot be allowed based on various sections in the Patents Act.