Drug Regulation Patent

Natco vs Abraxis: Patent Win, but Regulatory Struggle

downloadOn June 18th, 2014, the Indian Patent Office, for the second time, denied a patent to the anti cancer drug Abraxane manufactured by US- Based Abraxis BioSciences.

The first rejection by the IPO was earlier in 2009, based on a pre-grant opposition filed by generic drug manufacturer Natco Pharmaceuticals.  Earlier this year, SpicyIP had reported that Abraxis had appealed this rejection to the IPAB on the ground of a violation of procedural law (they were not afforded an opportunity to be heard under S.14 of the Patents Act). The IPAB had upheld Abraxis’ contention and had remanded the case back to the IPO. The IPO has now rejected the patent application for the second time.

While I could not get access to the actual order, Times of India Reports that the patent was rejected on the grounds that it lacked inventive step, and under the (in?)famous S.3(d) of the Patents Act, i.e. the drug did not demonstrate enhanced efficacy over a known substance.

Abraxis is expected to either appeal the order in front of the IPAB again, or file a Writ Petition. If the order of the IPO is upheld, it is a win for generic drug manufacturers such as Natco and Cipla (which has launched the drug  Paclitax Nab).

However, although the patent win means that Natco is free to launch its version of the drug, the regulatory issue will continue to haunt them considering Natco’s history with Abraxane.  Around 4 years ago, the media was rife with the news that Abraxis had complained to the DCGI about serious safety and efficacy issues in Natco’s version of the drug, Albupax. The DCGI, upon investigation, had concluded that Albupax contained excessively high amounts of endotoxins and chloroform, and had revoked Natco’s license to manufacture the drug. DCGI had also gave a ‘no objection’ to authorities in Andhra Pradesh to prosecute Natco under the Drugs and Cosmetics Act. Where things got murky was that Natco, upon appeal to the Health Minister, got the DCGI’s decision overturned with little cogent reasoning to support the decision. SpicyIP, with the tool of RTI, had brought out a special investigative report which unearthed the entire controversy, and the report can be accessed here.

Despite Natco’s alleged clean chit, the company has still not launched Albupax. In the Investigative Report, we had asked- “Is this indicative of the fact that NATCO is wary of not being able to comply with safety standards? Is this fear of releasing new batches an alleged admission that the earlier batches of Albupax were not “safe”? Or does this have to do with other business considerations?” These questions continue to remain relevant as Natco has once again tasted success in its legal battle with respect to Abraxane.

Spadika Jayaraj

Spadika Jayaraj

Spadika is a student of the National Law School of India University, Bangalore. Apart from Intellectual Property Law, she is also interested in Law and Technology issues.

One comment.

  1. Avatarr k jain

    In the legal fight between Natco and Abraxane which seem to be bordering on “not allowing the other to do what I will not do”, I wish to draw upon a more fundamental question, which does not get covered by the questions posed by the investigating team to NATCO.
    If the product is the same as that of NATCO which means it is still not in congruence with the applicable safety standards. If the product is an improvement which does not seem to be the case because the verdict of IPAB could have come only in case of same product, then in such a case how right is IPAB to give judgment confining only to the patentibility issues only. Under section 3 of the patent act , any drug which is injurious to public health cannot be patented. When the safety issue has been highlighted in a fairly credible manner (rejection by DGCI), it is what should be decided first. And the IPAB is no agency to be adjudicator on this.
    IPAB by confining to see the patent aspect with respect to section 3(d) – (increased efficay) has not been judicially prudent apart from becoming part of the game plan of two antagonistic corporates. IPAB could have been more judicious in defining the framing of issues on which it adjudicated upon.
    Patent Agent


Leave a Reply

Your email address will not be published.