What was BDR asking for in this case?

A compulsory licence to make and sell dasatinib, a cancer drug patented by Bristol Myers Squibb.

Which legal test was central to the decision?

Section 84(6)(iv) of the Patents Act: the applicant must try for a voluntary licence on reasonable terms and fail within a reasonable period.

Why did the Controller reject the application?

BDR’s efforts and follow-up were found insufficient under Section 84 and the procedure under Section 87 was not properly followed.

Did competition law stop civil court interference?

Section 61 of the Competition Act bars civil court jurisdiction over matters the Act empowers the competition authorities to decide.

What is the quick exam takeaway?

No licence unless you show real, timely attempts for negotiation and proper compliance with Section 87 procedure.

BDR Pharmaceuticals v. Bristol Myers Squibb (2013)

Zero-AI, zero-plagiarism classroom explainer for quick study and exam use.

Authority: Controller of Patents Year: 2013 Citation Compulsory Licence Patents Act 1970 Read: ~6 min

Author: Gulzar Hashmi · India · Published: 2025-11-01

CASE_TITLE

BDR Pharmaceuticals International Pvt Ltd v. Bristol Myers Squibb Co. (2013)

Slug: bdr-pharmaceuticals-international-v-bristol-myers-squibb-2013

Keywords

PRIMARY_KEYWORDS: compulsory licence; Section 84(6)(iv); Section 87; dasatinib

SECONDARY_KEYWORDS: BDR Pharma; Bristol Myers Squibb; Controller of Patents; Competition Act Section 61

Quick Summary

BDR asked for a compulsory licence to make and sell dasatinib. The Controller said: show that you tried for a voluntary licence on fair terms and failed within a reasonable time, and follow the Section 87 procedure. BDR’s outreach and follow-up were not enough. The application was rejected.

PUBLISH_DATE: 2025-11-01 AUTHOR_NAME: Gulzar Hashmi LOCATION: India

Issues

Do delayed or missing communications count as a procedural irregularity when applying for a compulsory licence?
Did BDR meet Section 84(6)(iv): real efforts, reasonable terms, and reasonable time?

Rules

Section 84(6)(iv): Applicant must try to obtain a licence on reasonable terms; efforts must fail within a reasonable period fixed by the Controller.
Section 87: Follow the prescribed procedure for hearing and evidence during compulsory licence applications.
Competition Act, Section 61: Civil courts cannot entertain matters reserved to competition authorities; no injunctions against actions under the Act.

Facts (Timeline)

02 Feb 2012: BDR writes to BMS seeking a licence for dasatinib.

13 Mar 2012: BMS replies with questions: capacity, supply plans, and market impact details.

04 Mar 2013: BDR files a compulsory licence application before the Controller (Mumbai).

04 May 2013: Controller informs BDR: no prima facie case made out.

Hearing: Controller reviews communications and compliance with Sections 84 and 87.

Order: Application rejected for not meeting the legal and procedural thresholds.

Timeline graphic of letters, application, and order in BDR Pharma v. BMS

Arguments

Applicant (BDR)

Asked for a licence and faced delays; considered that refusal.
India needs affordable access to dasatinib.
Licence should be granted to meet public interest and pricing concerns.

Patentee (BMS)

BDR did not answer key queries (capacity, quality, supply).
Negotiation attempts were thin and not timely.
Section 84(6)(iv) and Section 87 requirements were not met.

Judgment

The Controller held that BDR’s communications and follow-up did not show real, continuous efforts on reasonable terms. The year-long gap before filing, and lack of full replies to BMS’s queries, weighed against BDR. The application failed the procedural path under Section 87 and was rejected.

Gavel and medicine icons illustrating the decision in BDR Pharma v. BMS

Ratio Decidendi

Show genuine, timely negotiation efforts on fair terms (Section 84(6)(iv)).
Follow the Section 87 procedure strictly.
Breaks in dialogue and incomplete responses hurt the prima facie case.

Why It Matters

Compulsory licences in India demand paperwork and proof. You must negotiate seriously, respond fully, and file with clean procedure. Public interest matters, but it cannot replace the statutory steps.

Key Takeaways

Reasonable-terms negotiation + reasonable time are mandatory showings.
Answer patentee’s queries; keep the trail active and documented.
Section 87 procedure can decide the fate of the application.
Competition Act Section 61 limits civil court roles in competition matters.

Mnemonic + 3-Step Hook

Mnemonic: “Ask-Answer-Apply”

Ask: Request on reasonable terms and keep talking.
Answer: Reply to every query with proof.
Apply: File under Section 87 with full compliance.

IRAC Outline

Issue	Rule	Application	Conclusion
Did BDR meet the Section 84(6)(iv) requirement?	Must try for a licence on reasonable terms; fail within a reasonable time.	BDR’s communication gaps and limited replies weakened its showing.	No; threshold not met.
Was Section 87 procedure followed?	Statutory steps for hearing and evidence are mandatory.	Controller found non-compliance.	Application rejected.

Glossary

Compulsory Licence: Government-authorised licence without patentee consent, if legal tests are met.
Reasonable Terms: Fair price and conditions expected in good-faith negotiations.
Prima Facie Case: Minimum proof needed to move forward to a full hearing.