The Chennai patent office has rejected an application by US-based Abraxis BioScience related to a new composition for Paclitaxel, an anti-cancer drug marketed under the trade name Abraxane, citing lack of novelty and inventive step.
The patent office rejected the application, disposing of a pre-grant opposition filed by the local Natco Pharmaceuticals. Natco had argued that the claimed composition was merely a new form of a known substance and, hence, under Section 3 (d) of the Indian Patent Act was not patentable unless it exhibits enhanced efficacy.
The current composition as claimed in the patent application was a combination of known substances, namely Paclitaxel, an anti-Sparc antibody, and Abraxis had not produced any document to prove its enhanced efficacy, Natco argued.
Paclitaxel is used to treat a number of types of cancer, including ovarian, breast, lung and pancreatic, among others.
Abraxis filed a national phase application for the patent in India 2006, having conventional priority of US application in 2004. The request for examination was filed in April, 2008 and a pre-grant opposition was filed by Natco in September 2008.
Refusing to proceed with the application, Sharana Gouda, assistant controller of patents & design, Chennai , said: “ In view of my findings the claims of the instant application do not involve inventive step as required under Section 2(1) (ja) of the Patents Act 1970, and are not patentable under Section 3 (d) of the Act.”
The assistant controller concluded that Abraxis’ argument of surprising demonstration of technical effect cannot be considered as enhanced efficacy to meet the requirements of the patentability. “ There is no submission by the applicant (Abraxis) of comparative efficacy between the free Paclitaxel and Paclitaxel coupled to an anti-Sparc antibody. Therefore, I agree with opponent’s (Natco) argument that the invention is a Paclitaxel coupled with an anti-Sparc antibody, and hence cannot be patentable,” patent office said.
Abraxis’ patent agent submitted that the proposed invention was contrived in the ingenuity of conjugating the right molecule with an accurate targeting vehicle and to the precise target entity that will yield maximum effect, namely, the targeted concentration of the therapeutic agent at the tumour site.
Abraxis Bioscience develops, manufactures and markets therapeutics and technologies for treatment of cancer and other critical illnesses. Its products include the protein-based nanoparticle chemotherapeutic compound Abraxane.
It offers drugs for treatment of cancer, multiple sclerosis, Alzheimer’s and some cardiovascular diseases. The company was formerly known as New Abraxis, Inc and its name was changed to Abraxis BioScience, Inc, in November, 2007.
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