Wednesday 15 July 2015

Indian Patent Office refuses to grant Abraxis’ patent on anti-cancer drug ‘Abraxane’ after pre-grant opposition by Natco
                                                


Date of decision- June 01, 2015
Applicant- M/s Abraxis Bioscience, LLC, USA
Opponent- Natco Pharma Limited, Hyderabad

IN THIS ISSUE

The Assistant Controller of Patents & Designs, on June 01, 2015, refused to grant patent application pertaining to a new composition for Paclitaxel, an anti-cancer drug marketed under the trade name Abraxane by Abraxis, citing lack of novelty and inventive step, in response to a Pre-grant opposition filed by Natco.

The application for Abraxane formulation was refused since it lacks inventive step, and violates Section 3 (d) of the Indian Patents Act -- a provision under which Novartis lost the patent on its blockbuster cancer drug, Glivec in 2013. Section 3(d) - an important safeguard in the patent law specifically applicable for pharma and chemical industries, prohibits grant of patents to new forms of known substances, unless the new form results in enhanced efficacy over the known substance. 

FACTS

The Applicant had filed Indian Application No.4572/CHENP/2006 on December 14, 2006 entitled ‘Treatment methods utilizing albumin-binding proteins as targets’. The patent application pertains to Abraxane, a composition of paclitaxel coupled to an anti-SPARC antibody with a pharmaceutically acceptable carrier.

The Opponent filed a Pre-grant opposition on September 8, 2008 under section 25(1) of the Indian Patents Act and presented the following arguments: 

OPPONENT’S CONTENTIONS

Obviousness/Lack of Inventive Step (section 25 (1) (e))

     The Opponent submitted that the following features of the present invention are already known in the art and hence the invention lacks inventive step, based on the cited documents:

    1. Composition free of cremophor
    2. Use of paclitaxel- antibody therapy for targeted, selective delivery and better cytotoxicity;
    3. SPARC is a potential marker for such targeted delivery;
    4. Affinity of SPARC to bind with albumin;
Section 3(d) and Section 3(e)

The Opponent contented that the present composition is a combination of known substances, namely paclitaxel and anti-SPARC antibody. There is no demonstration of efficacy and thus it fails to qualify as a patentable invention under Section 3(d). Such composition claimed in the impugned application is a mere admixture and not patentable under Section 3(e) of the Act.

APPLICANT’S CONTENTIONS

The Applicant contended that an anti-SPARC antibody is not taught in the prior art. The Applicant argued that Section 3(d) objection is irrelevant for the claims of the instant invention.

CONTROLLER’S DECISION

In light of the above findings, the Assistant Controller, agreeing with the Opponent’s contentions, concluded that the claimed composition is obvious to a person skilled in the art in view of the disclosures cited by the Opponent. The present composition is a combination of known substances, namely paclitaxel and anti-SPARC antibody. The Applicant failed to demonstrate efficacy and thus it fails to qualify as a patentable invention under Section 3(d), hence the application for grant of a patent was refused under section 15 of the Patents Act, 1970.

The Controller’s decision can be accessed on the below link: 

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