Case Brief: F. Hoffman-La Roche Ltd v Cipla Ltd (2012) Delhi High Court
🧾 Case Brief:
F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd. (2012)
Court: Delhi High Court
Citation: 2012 (50) PTC 71 (Del)
Type of Case: Patent Infringement
Judge: Justice Manmohan Singh
📌 Background:
Parties:
Plaintiff: F. Hoffmann-La Roche Ltd. (a Swiss pharmaceutical company) and its Indian subsidiary.
Defendant: Cipla Ltd. (an Indian pharmaceutical company).
Subject Matter:
Dispute over alleged patent infringement of the cancer drug Erlotinib Hydrochloride, sold by Roche under the brand name "Tarceva".
🧪 Facts of the Case:
Roche held a patent for Erlotinib Hydrochloride, a drug used for the treatment of non-small-cell lung cancer.
Cipla launched a generic version of the drug under the brand name "Erlocip", claiming it was in the public interest due to high cost of Roche's drug.
Roche filed a patent infringement suit seeking:
Injunction against Cipla.
Damages for unauthorized production and sale of the patented drug.
⚖️ Issues Before the Court:
Was Roche’s patent valid and enforceable in India?
Did Cipla’s product infringe Roche’s patent?
Should the court grant an injunction against Cipla?
Was public interest a relevant consideration in patent enforcement?
🧠 Arguments:
Plaintiff (Roche):
They held a valid patent in India.
Cipla’s generic drug was chemically identical to the patented invention.
Infringement was clear as the same molecule was being used.
Defendant (Cipla):
Denied infringement.
Claimed that Roche’s patent was not novel and lacked inventive step.
Argued that the drug was life-saving, and public interest required access at affordable prices.
Claimed the price difference: Tarceva (₹4800/tablet) vs Erlocip (₹1600/tablet).
🏛️ Judgment (Delhi High Court, 2012):
1. On Validity of the Patent:
The court did not conclusively decide on the validity of Roche's patent.
However, it acknowledged the prima facie validity since the patent was granted and not revoked.
2. On Infringement:
The court held that Cipla’s product fell within the scope of Roche’s patented compound.
However, the court found that no clear evidence of infringement was established at the interim stage due to complexity of chemical comparison.
3. On Public Interest:
The court considered the public interest in accessing affordable life-saving medication.
It refused to grant an injunction because it would harm public access to a cheaper alternative.
4. Injunction Denied:
The court denied the interim injunction.
Cipla was allowed to continue selling Erlocip during the pendency of the suit.
However, Cipla was required to maintain accounts of sales in case damages were later awarded.
⚖️ Legal Principles Laid Down:
Public Interest as a Factor:
Courts can consider public interest in refusing injunctive relief even if prima facie infringement exists.
Balance of Convenience:
The court weighs the balance of convenience between enforcing a patent and ensuring access to essential medicines.
No Blanket Injunctions in Patent Cases:
Particularly in life-saving drugs, injunctions are not automatic and must be evaluated case-by-case.
📚 Subsequent Developments:
The case went on appeal to the Division Bench of the Delhi High Court and later to the Supreme Court.
In 2015, the Delhi High Court Division Bench upheld Roche’s patent, confirming infringement by Cipla.
However, it acknowledged that no damages would be granted since Roche failed to prove actual loss.
📌 Summary of Case Brief:
| Element | Details |
|---|---|
| Parties | F. Hoffmann-La Roche Ltd. vs Cipla Ltd. |
| Court | Delhi High Court |
| Year | 2012 |
| Issue | Patent infringement, public interest, injunction |
| Held | No interim injunction; public interest prioritized |
| Significance | Balanced patent rights with access to affordable drugs |
🧾 Conclusion:
The Roche v. Cipla (2012) case was a landmark judgment in Indian patent law, especially in the pharmaceutical sector. It highlighted:
The tension between intellectual property rights and public health.
That patent rights are not absolute.
Courts may refuse injunctions where public health and affordability are at stake, even in the presence of valid patents.
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