Doctrine Of Equivalents Application India
1. Meaning and Concept
The Doctrine of Equivalents (DoE) is a principle in patent law that prevents an infringer from evading infringement liability by making only minor or insubstantial changes to a patented invention. Essentially, even if an invention does not fall literally within the claims of a patent, it can still infringe if it performs substantially the same function in substantially the same way to achieve substantially the same result.
This doctrine aims to protect the patentee’s rights from unfair circumvention while balancing the public interest.
Origin: The concept was first developed in U.S. law (Graver Tank & Mfg. Co. v. Linde Air Products Co., 1950), and later adapted in various jurisdictions including India.
2. Legal Position in India
India’s Patents Act, 1970 does not explicitly mention the doctrine of equivalents. However, Indian courts have recognized the principle through judicial interpretation, especially under Section 48(1) and Section 104 of the Patents Act, which define infringement and allow courts to look beyond literal wording to the substance of the invention.
The key tests applied are similar to the function-way-result test, which asks:
Does the alleged infringing product/method perform substantially the same function?
Does it operate in substantially the same way?
Does it achieve substantially the same result?
3. Landmark Indian Case Laws on Doctrine of Equivalents
Case 1: Roche Products (India) Pvt. Ltd. v. Cipla Ltd. (2010)
Court: Delhi High Court
Facts: Cipla produced a generic version of Roche’s patented anti-cancer drug Erlotinib. Roche claimed infringement.
Decision & Principle:
The Court rejected literal infringement because Cipla’s process differed technically from Roche’s patent claims.
However, the Court acknowledged that if the differences were insubstantial and the result/function was the same, DoE could apply.
Significance: This case highlighted the potential applicability of DoE in India, though courts were cautious about applying it in favor of patentees without clear evidence.
Case 2: Novartis AG v. Union of India (Gleevec Case, 2013)
Court: Supreme Court of India
Facts: Novartis’ patent application for the beta-crystalline form of imatinib mesylate was denied under Section 3(d) for lack of enhanced efficacy.
Decision & Principle:
Though primarily about patentability, the Court discussed infringement implications.
The decision reinforced that mere minor modifications to evade patent claims do not escape infringement, aligning with the doctrine of equivalents.
Significance: The judgment indirectly recognized that functionality over literal wording is key in infringement analysis.
Case 3: Bayer Corporation v. Natco Pharma Ltd. (2012)
Court: Delhi High Court
Facts: Bayer’s patented drug, Sorafenib Tosylate, was allegedly infringed by Natco.
Decision & Principle:
Court examined whether Natco’s process achieved the same therapeutic effect through substantially similar methods.
It confirmed that minor changes to the process do not avoid infringement if the essence of the invention is copied.
Significance: This case is a direct application of DoE in pharmaceutical patents in India.
Case 4: F. Hoffmann-La Roche Ltd. v. Cipla Ltd. (2010)
Court: Delhi High Court
Facts: Roche alleged that Cipla infringed its patent on a cancer drug.
Decision & Principle:
The Court analyzed the claim structure and whether the Cipla version fell within the purview of equivalence.
While literal infringement was not proven, the judgment discussed that DoE could be applied if claims are interpreted in light of purpose and substance.
Significance: Reinforced judicial willingness to apply DoE, especially in life-saving drugs.
Case 5: Merck Sharp & Dohme Corp. v. Glenmark Pharmaceuticals Ltd. (2015)
Court: Delhi High Court
Facts: Merck alleged Glenmark’s generic version infringed its patent.
Decision & Principle:
Court considered function, way, and result in analyzing infringement.
Glenmark’s modification did not materially alter function, method, or result, hence it could be infringing under DoE.
Significance: Set precedent for generic pharma products: minor chemical tweaks cannot evade patent protection if they perform the same therapeutic function.
4. Tests Applied for Doctrine of Equivalents
Indian courts use multiple tests, usually derived from US and European jurisprudence:
Function-Way-Result Test: Does the alleged infringing product work in substantially the same way to achieve the same result?
Insubstantial Differences Test: Are the differences between the invention and the alleged infringement minor or trivial?
Triple Identity Test (from UK jurisprudence, sometimes applied in India):
Identity of function
Identity of way/method
Identity of result
5. Key Observations
Indian courts are cautious in applying DoE because it can affect public access to medicines.
Most applications are in pharmaceutical and biotech patents, where minor modifications are common.
Courts tend to balance patent protection and public interest, particularly under Section 3(d).
While not codified, the principle is emerging steadily in India, following global trends.
6. Summary
Doctrine of Equivalents protects patentees against minor alterations that evade literal infringement.
Indian courts require a careful factual and technical analysis using the function-way-result test.
Major Indian cases applying DoE:
Roche Products (India) Pvt. Ltd. v. Cipla Ltd.
Novartis AG v. Union of India
Bayer Corporation v. Natco Pharma Ltd.
F. Hoffmann-La Roche Ltd. v. Cipla Ltd.
Merck Sharp & Dohme Corp. v. Glenmark Pharmaceuticals Ltd.
The trend shows increasing acceptance of DoE, especially in pharmaceuticals, but courts maintain a strict evidentiary standard before ruling in favor of patentees.
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