India Patent Office Rejects Dasatinib Compulsory Licence Bid
Espicom View : The rejection of BDR Pharmaceuticals' request for a compulsory licence for dasatinib will obviously come as a blow for the company and a relief for Bristol-Myers Squibb. However, the rejection marks an interesting development in the wider issue of intellectual property rights in India. The country has courted controversy amongst innovative manufacturers over the last year, including through decisions that separately denied Novartis a patent for its imatinib product, Gleevec/Glivec, and upheld a compulsory licence for Bayer's Nexavar (sorafenib). Such rulings led to accusations that India was weak on intellectual property rights, drawing criticism from companies and from the US Government. This latest rejection of a compulsory licence request should help India to assert that it takes protection of intellectual property seriously, whilst maintaining a balance with public health concerns.
On October 29, the Controller of Patents in the Patent Office in Mumbai, India, rejected an application for a compulsory licence for dasatinib. An application for a compulsory licence had been filed by BDR Pharmaceuticals under Section 84 of India's Patent Act on March 4. The application sought a compulsory licence for patent number 203,937, which was granted to Bristol-Myers Squibb on November 16 2006. Bristol-Myers Squibb and Otsuka market dasatinib under the brand name, Sprycel; it is used in the treatment of chronic myeloid leukaemia.
In its application, BDR noted that dasitinib is prescribed when a patient is resistant or develops resistance to imatinib, marketed by Novartis as Gleevec/Glivec. In April, the Indian Supreme Court denied Novartis' attempts to patent imatinib in a controversial ruling that has drawn criticism from the innovative industry. BDR submitted that Bristol-Myers Squibb markets dasatinib at a price of INR 2,761, which works out at INR 165,680 per patient per month, or INR 1,988,160 per patient per year. BDR proposed selling a compulsorily licensed version at INR 135 per tablet, working out to INR 8,100 per patient per month; this would have priced BDR's version at around 5% of the cost of the branded version. BDR would also pay royalties to Bristol-Myers Squibb at a rate fixed by the Controller of Patents, as is usual in compulsory licensing.
BDR informed the Patent Office that a patent infringement lawsuit had been filed against it by Bristol-Myers Squibb in the Honourable High Court of Delhi in 2009, after BDR had filed an application before the Drug Controller General of India to gain approval to market dasatinib in India. BDR alleged that the lawsuit was being adjourned over the last four years and that the patentee was indulging in delaying and blocking tactics. Bristol-Myers Squibb had additionally filed a second lawsuit against BDR in 2013.
BDR had previously requested a voluntary licence for the drug from Bristol-Myers Squibb on February 2 2012. Bristol-Myers Squibb responded with a letter dated March 13 2012, which raised a number of queries. According to the Controller of Patents, BDR took the reply to indicate that the voluntary licence request had been rejected, and did not pursue the matter further and made no effort to arrive at a settlement.
In a notice dated May 4 2013, BDR was informed that a prima facie case had not been made out for the making of an order under Section 84 of the Patent Act, as BDR had not acquired 'the ability to work the invention to a public advantage' in the absence of a requisite approval from the Drug Controller General of India. BDR had 'also not made efforts to obtain a licence from the patentee on reasonable terms and conditions.'
BDR had argued that by not specifically replying to its request for a voluntary licence, Bristol-Myers Squibb could continue to correspond and keep delaying the request. BDR's view was that if the patentee avoids specifically rejecting the voluntary licence request, the application for a compulsory licence could also be delayed indefinitely, unless the Controller of Patents intervenes. BDR submitted that this strategy is being adopted by all attorneys representing patentees in voluntary licence applications. However, the Controller of Patents argued that BDR's view that an application for a compulsory licence can be indefinitely delayed for want of specific denial from the patentee was misplaced. The Controller of Patents commented that Section 84(6) of the Patents Act clarifies that a patentee cannot indefinitely prevent an applicant for voluntary licence under Section 84. At most, the patentee can prevent a prospective applicant for six months. Additionally, the Controller of Patents queried BDR's claims that attorneys were adopting this strategy.
The Controller of Patents reached the opinion that BDR had not made efforts to obtain a licence from Bristol-Myers Squibb on reasonable terms and conditions. BDR had further argued that Bristol-Myers Squibb, in filing court cases and delay tactics, was acting in an anticompetitive manner. However, the Controller of Patents found that filing patent infringement lawsuits cannot be considered to be anticompetitive.
The Controller of Patents concluded that BDR had not followed the scheme of law, and thus had failed to make a prima facie case for the making of an order under Section 87 of the Patent Act. The application for a compulsory licence was thus rejected.