 "IPAB refers opposition to anti-cancer drug to patent office")
Natco has developed a generic version of the drug under the brand name Albupax. Emails sent to Celgene, which acquired Abraxis BioScience in 2010, and Natco Pharma for comment on the order didn’t elicit a response till the time of going to press.
IPAB set aside an order of the Assistant Controller of Patents & Designs, saying it was passed in “flagrant violation of principles of natural justice”. An order issued by IPAB Chairman K N Basha and technical member (patents) DPS Parmar said it remanded the matter to the Assistant Controller of Patents & Designs for fresh consideration. It also directed the procedure be completed within three months from the date of the IPAB order.
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On July 24, 2009, the assistant controller of patents & designs had refused to grant a patent to US-based Abraxis BioScience’s albumin-bound paclitaxel for an injectable suspension that had the brand name Abraxane and was used in the treatment of breast, lung and pancreatic cancers.
It has a net sales of $649 million and is expected to reach $1.5-2 billion by 2017, said the company's counsel. Abraxis Bioscience was acquired by New Jersey-based Celgene Corporation during 2010 and the upfront payment value of Abraxis BioSciences was at around $2.9 billion.
Natco Pharma complained that they were not offered a copy of an affidavit from Anindy Sircar who was a representative from Biocon, which was filed by Abraxis to establish enhanced efficacy. The bench ordered that the Assistant Controller should provide a copy of a particular affidavit to the generic manufacturer and they shall be given opportunity to give reply.
Justice Basha said that the bench is not going into the merits of the claim and contention of both the sides on merit and the order is only on the contention that there is a violation regarding principles of natural justice.
The first priority application for patent on the drug was filed by Abraxis on December 9, 2002 and the application was published under section 11 (A) on April 1, 2007, after which Natco Pharma has filed a pre-grant opposition against giving approval of patent to the drug. Natco has developed the generic version of the drug, under the brand name Albupax.
The originator firm argued in IPAB that the decision of Assistant Controller of Patents was wrong, and the order in dispute is liable to be set aside for gross violation of principles of natural justice. It contested that the Assistant Controller has heard and put in order on the grounds of insufficiency (which means the claims are not supported by the examples and description), which was not pleaded by Natco.
It also argued that the controller did not provide opportunity to the company to argue the dispute as per provision under Section 14 of the Patent Act, 1970, which is appealable. Instead, the petition was argued under section 25(1), which was not appealable during 2009. The counsel appeared for Abraxis informed that it was only after a Delhi High Court order observing that the pre-grant opposition is appealable, that the company could file an appeal with the IPAB.
The company also argued that during the procedure in the patent office, on March 10, 2009 Natco Pharma filed additional document and Abraxis objected taking this into consideration through an interlocutory petition. Without even looking into the said petition the controller proceeded to hear the matter, it alleged.
The counsel appeared for Natco argued that the impugned order does not cause any violation of principles of natural justice and said that the patent official was right in refusing patent for the drug.
The IPAB bench said that the finding and consideration on the ground of insufficiency, especially when it was not pleaded, “is illegal”.