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.