BDR Pharmaceuticals' application for Compulsory License for Bristol-Myers
cancer drug rejected by the Indian Patent Office
In its latest decision (dated October 29, 2013), the Controller General of Patents in India has rejected Mumbai based BDR Pharmaceuticals International Pvt. Ltd's application for compulsory license for Bristol-Myers cancer drug SPRYCEL (active pharmaceutical ingredient DASATINIB - Patent number 203937) stating that BDR Pharmaceutical failed to make out a prima facie case for the making of an order under section 87 of the Act.
BDR Pharmaceuticals had requested for compulsory license earlier this year (on March 4, 2013) claiming that DASATINIB is a suitable chemotherapeutic option for the treatment of CML and is prescribed when a patient is resistant or develops resistance to the drug IMATINIB, in view of the improved tolerance and efficacy of the drug. It was further claimed that DASATINIB is administered as 50 mg tablets with a dosage of 100 mg per day and thus, two tablets are to be consumed per day until disease progression or until the patient can no longer tolerate the medicine. Based on this premise BDR Pharmaceutical stated that the price of each tablet sold by the patentee is INR 2761 /- which works out to INR l,65,680/- for 60 tablets per month per patient and about INR19,88,160/- per year per patient. BDR claimed in its application that it would make the drug available at INR 8100 per month for the treatment of a CML patient and that it would be offering the drug free of cost to a certain percentage of patients suffering from CML as determined by the cancer specialists.
In the instant case BDR had sent a letter dated February 2, 2012, to Bristol Mayer (the patentee) requesting for a voluntary license for manufacturing DASATINIB. By letter dated 13th March 2012, the patentee raised certain queries such as "facts which demonstrate an ability to consistently supply high volume of the API, DASATINIB, to the market ", "facts showing BDR's litigation history or any other factors which may jeopardize Bristol-Myers Squibb's market position ", "quality related facts and in particular compliance with local regulatory standards and basic GMP requirements", "quality assurance systems due diligence", "commercial supply teams", "safety and environmental profile ", "risk of local corruption".
BDR took this reply of the patentee as "clearly indicative of the rejection of the application for voluntary license and did not pursue the matter." Thereafter on March 4, 2013 BDR filed an application with the Patent Office for grant of compulsory license.
The Controller in his decision, while rejecting the application, stated that the decision to grant a voluntary license, particularly on a subject matter covered by a patent, is an important decision for a patentee. While, it is possible that some of the queries raised by the patentee may not be strictly reasonable, it is natural that the patentee may seek additional information from the requesting party to satisfy himself about the credentials and capability of the said party.
It is pertinent to mention that on BDR's assumption of queries raised by the Patentee as indicative of rejection of the application for voluntary licensee the Controller stated that
"On the face of the record, I am of the view that the applicant's contention that the said letter is 'clearly indicative of the rejection of the application for voluntary license does not hold good, as the aforementioned queries raised by the patentee appear largely to be reasonable" and that the Applicant ought to have appreciated that the provisions relating to compulsory license are to be invoked as the last resort, i.e. if the mutual deliberations do not lead to a result within six months, in accordance with the scheme of the law.
The Controller held the applicant did not make efforts to obtain a license from the patentee on reasonable terms and conditions and therefore rejected the said application.
The decision would sure cause some ripples in the ongoing tussle between the Indian Intellectual Property regime and the multinational drug makers. This decision would lift the spirits of the pharmaceutical patent holders in India who have been time and again raising concerns over Indian practices especially after grant of Indiaís first compulsory license (against Bayer's Nexavar) and Supreme Courtís decision against Gleevec. It is however yet to be seen if this decision is challenged by BDR, which in all probability seems quite probable.
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The Controllerís order can also be accessed from the Patent Officeís website at