Summary
The Court restored interim conditions governing Reliance’s marketing of TrastuRel after the Division Bench relaxed them without considering both sides’ applications as previously directed. The established arrangement and balance of convenience should not have been disturbed before trial. Reliance could nevertheless participate without impediment in government tenders specifying the generic name Trastuzumab, and final disposal of the suit was expedited.
Issues
- Whether the Division Bench complied with the direction to consider both sides’ applications together.
- Whether expiry of the patent or regulatory approval warranted changing the established interim arrangement.
- What protection and further proceedings were appropriate.
Held
- Considering the plaintiffs’ contentions only in deciding Reliance’s application did not satisfy the express direction for analogous consideration of the competing applications. The orders showed deliberate segregation, not an inadvertent omission. (¶¶ 18, 19, 20, 21, 26, 27)
- The Single Judge’s marketing arrangement had operated for years and Reliance had participated in government procurement. It should not have been disturbed without proper consideration of balance of convenience and the unresolved evidentiary issues. (¶¶ 22, 23, 25, 26, 27)
- The suit concerned extended passing off, use of the plaintiffs’ data and references to their product, rather than enforcement of an expired patent. Patent expiry therefore did not directly resolve the asserted claim. Final approval and related issues remained for the suit. (¶¶ 24, 25)
- The Single Judge’s interim directions were restored, but Reliance must be permitted to participate without impediment in government procurement specifying the generic drug name. The High Court was requested to decide the suit preferably within twelve months of receipt. (¶ 28)
Result
Appeal allowed without costs and the Division Bench order set aside. The Single Judge’s directions of 25 April 2016 became operational, subject to protection for Reliance’s participation in generic-name government procurement. Expedited trial requested; observations were confined to this appeal and did not bind the pending suit.