M/s. BDR Pharmaceuticals International Pvt. Ltd. v. M/s. Bristol Myers Squibb Co.

M/s. BDR Pharmaceuticals International Pvt. Ltd.

v.

M/s. Bristol Myers Squibb Co.

CLA No. 1 of 2013 before the Controller of Patents, Mumbai

Decided on: 29.10.2013

The applicant (M/s. BDR Pharmaceuticals International Pvt. Ltd.) requested the patentee (M/s. Bristol Myers Squibb Co.) for a voluntary license to manufacture and market active pharmaceutical ingredient DASATINIB covered by the Patent granted to the Patentee vide their letter dated 2^nd February, 2012. The Patentee vide their reply dated 13^th March, 2012 raised certain queries on the applicant, inter alia, the details that demonstrate the ability of the applicant to consistently supply high volumes of the DASATINIB in the market, any factors that may jeopardize Patentee’s market position, quality related facts,  etc.

On 4^th March, 2013 the applicant filed an application for compulsory licensing under Section 84 of the Patents Act, 1970 before the Controller of Patents, Mumbai. On 4^th May, 2013 it was informed to the applicant that no prima facie case has been made out for making of an order. In the meanwhile, on 10^th May, 2013 the applicant replied to the patentee and on 1^st July, 2013 the patentee replied to the applicant. On 9^th July, 2013 the applicant again replied to the Patentee. On 15^th July, 2013 the Patentee filed a petition under Rule 137 to bring on record the communications that were held between the parties after filing of the compulsory licensing application.

On 16^th September, 2013 the Compulsory License Application was heard and the applicant submitted:

• That all the grounds under sub-section 84(1)(a), (b) and (c) have been made out in the present case.
• The reply dated 13^th March, 2013 of the Patentee asking so many queries is clearly indicative of the rejection of the application for voluntary license.
• By not specifically replying to the terms, the patentee can continue to ask for more information and keep the request for voluntary license in abeyance. This leads to exploitation of Section 84(6)(iv).
• Further, such information can be used by the Patentee in suits filed by it against the applicant.
• Moreover, the applicant submitted that the attorney of the patentee had publicly declared that the strategy on behalf of the patentee was to keep the potential compulsory license applicants engaged without a clear outright rejection.

The Hon’ble Controller negativated the contentions of the applicant and said:

• That the stage for making ruling on applicability of 84(1)(a), (b) and (c)  on merits has not yet arrived.
• The patentee cannot indefinitely delay an applicant for making an application for compulsory license. At best, patentee can prevent an applicant for a period of six months from making an application for compulsory license.
• That the queries raised by the patentee in it’s reply are reasonable
• The applicant was unable to justify that as to what query raised by the patentee could jeopardize his position either before this forum or before the Courts.

Hon’ble Controller held that the statement of the attorney of the patentee did not give the applicant freedom to bypass the procedure namely sincere mutual deliberations for a reasonable period as mandated by the law. The Hon’ble Controller also observed that  the applicant waited for 1 year to file the present application, which demonstrated that the applicant did not intend to engage in any kind of dialogue after making the initial offer to the patentee. Applicant ought to have appreciated that the provisions of compulsory license are to be invoked as 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. In Controller’s opinion the applicant did not make efforts to obtain a license from the patentee on reasonable terms and conditions.

On the application for taking on record the subsequent communications, the applicant contended that the requirement of Section 84(6) which requires the controller not to take into account matters subsequent to the making of the application, the applicant submitted that the same applies to any measures taken by the patentee but not to the applicant.

This contention was also negativated, inter alia, on the grounds:

• That the law has to apply with equal vigour, same intent and same manner to all situations within the purview of a section.
• Considering such communication would be granting an undue advantage to an applicant.
• Further, the mutual deliberations between the patentee and the applicant cannot succeed if they happen under a constant shadow of pending application for compulsory license.

It was submitted by the applicant that the acts of the patentee, i.e. filing of court cases and delay tactics are ‘anti-competitive practice’. In response, the Hon’ble Controller relied on Section 3(5) and Section 61 of the Competition Act, 2002 to hold that that the act of filing of infringement suits cannot be held as anti-competitive and even if they are, the controller is not entitled to adjudicate upon the same.

It was finally held that there was deliberate intent on part of the applicant to enter into any dialogue with the patentee and the exercise of a deliberate choice to only invoke the provisions relating to compulsory licenses without taking the requisite steps laid down by the law, cannot be classified as an ‘irregularity in procedure/timeline’, which can be waived or condoned or declared to be not applicable. The applicant did not follow the scheme of the law and failed to make out prima facie case for making of an order under Section 87 of the Act. The application for compulsory license was rejected.

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