India Shuns Onglyza Compulsory License But Lee To Fight On?
This article was originally published in Scrip
India's Controller General of Patents is said to have viewed unfavourably the compulsory license (CL) application for AstraZeneca's Onglyza (saxagliptin) by the Hyderabad-based Lee Pharma, although Lee appears keen to hang on to the challenge.
Lee's attorney, Afzal Hasan, managing partner at Hasan and Singh, told Scrip that the firm had received a notice from the Patent Controller with his views and reasons on the CL application and that the Controller seemed "convinced" with certain points put forth such as Lee's capabilities and that the firm had followed procedural aspects as required in such cases.
"On contentious issues like reasonable requirements [of the public with respect to the product have not been satisfied], affordable price and working in India, the Controller has said that he is not convinced with our arguments. So he has given us an opportunity for a hearing," Hasan told Scrip.
Lee would need to reply to the Controller's notice and file a request for an opportunity to be heard.
"After the hearing is completed only then will the Controller decide whether to accept or refuse our application. At this stage it is only procedural issues and it has not been refused," Hasan maintained.
He expects Lee to pursue the CL application and believes that its grounds for the challenge are "very strong."
Some industry experts, though, claimed that given the Patent Controller's current stance, Lee's CL application appeared to have a rather slim chance of success, if any at all.
A comment from the Patent Controller's office could not immediately be got.
AstraZeneca did not specifically comment on the Patent Controller's notice but said that it had always maintained "affordable access" to its medicines in India and elsewhere.
"AstraZeneca has complete confidence in its intellectual property that protects our inventions and does not believe that such intellectual property is a barrier to access to medicines in developing countries," it said.
Earlier a report in the local media said that India's Patent Controller, Rajiv Aggarwal, had turned down Lee Pharma's CL application for saxagliptin on the grounds that substitutes to the product were readily available on the market and that the challenger's claim that requirements of the public were not being met had not be proven.
The report quoted the Controller as also saying that the applicant had failed to prima facie show that the patented invention is not worked in the territory of India and hence a case had not been made out for an order under Section 84 of India's patent regulations.
Under Section 84, any person can, after three years from sealing of a patent, make an application for a compulsory license if:
? the "reasonable" requirements of the public with respect to the product have not been satisfied or
? if the patented invention is not available at a "reasonably affordable" price or;
? the patented invention is not "worked" in India. [This is generally construed to imply manufacturing in India].
India approved its first ever CL in the area of medicines for Nexavar (sorafenib) in March 2012 allowing Natco to self-manufacture and sell a version of the product for just over 3% of the price that Bayer sells the drug for in India. A court judgement in the Nexavar CL case had, however, earlier implied that manufacture [by the patent holder] in all cases may not be necessary to establish working in India. Experts have also in the past referred to the Telemecanique and Controls versus Schneider Electric Industries case that reportedly establishes that importation may be considered as working.
Earlier, Lee had in its CL application – the third in the Indian pharmaceutical segment after BDR's CL attempt for Sprycel (dasatinib) failed – claimed that saxagliptin met all the three grounds laid down to qualify for a CL under Section 84. Some experts, though, at that time referred to a rather low probability of success for the CL application.
Significantly, AstraZeneca recently moved the Delhi High Court seeking permanent injunction against Lee, restraining it against infringement of the saxagliptin patent.
AstraZeneca's actions came in the backdrop of Lee applying for a manufacturing licence for saxagliptin in May this year. The license has apparently yet to be granted, details in the Delhi High Court order dated July.29, said.
Lee's counsel had then stated that the firm had applied for a CL in July and till the petition is "finally decided", the defendants will not infringe the AstraZeneca patent and have "no intention" to launch the impugned products in the market "directly or indirectly" and also not export the same. The case is set for listing on Oct. 8, though the court clarified that the CL petition will be decided by the Patent Controller in accordance with law.