Pharma Evergreening Disputes India
Pharma Evergreening Disputes in India – Overview
Evergreening is a strategy used by pharmaceutical companies to extend the life of a patent beyond its original term. Companies may file patents for:
Slight modifications of known drugs (e.g., new formulations, salts, derivatives).
New dosages or delivery mechanisms.
Combination therapies.
Legal Framework in India:
Section 3(d) of the Indian Patents Act, 1970 (amended 2005) specifically targets evergreening. It states that:
"The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance is not patentable."
TRIPS Compliance: India must allow patents for genuine innovations but prevent abuse through evergreening.
Key Issues in Evergreening Disputes:
Whether the modification of a known drug constitutes a significant increase in efficacy.
Whether patent term extension is valid.
Whether generic manufacturers can legally produce alternative versions.
Landmark Evergreening Cases in India
1. Novartis AG v. Union of India & Others (2013) – Glivec Case
Court: Supreme Court of India
Drug: Glivec (imatinib mesylate) – cancer treatment
Facts: Novartis filed a patent for a new crystalline form of imatinib, claiming better solubility and bioavailability.
Issue: Whether the new form was patentable under Section 3(d).
Decision: Supreme Court rejected the patent.
Reasoning:
The new form did not demonstrate enhanced therapeutic efficacy.
Section 3(d) prevents evergreening of existing drugs.
Impact:
Landmark case against evergreening in India.
Allowed generic production, lowering drug costs.
2. Roche v. Cipla (2013)
Court: Delhi High Court
Drug: Tarceva (Erlotinib) – lung cancer treatment
Facts: Roche attempted to patent a new dosage formulation. Cipla argued it was an evergreening attempt.
Issue: Can a modified dosage schedule be patented under Section 3(d)?
Decision: Court partially upheld Roche’s claims but limited patent scope.
Reasoning:
Modifications must show significant therapeutic improvement.
Mere dosage changes do not satisfy inventive step.
Impact:
Clarified that dosage modifications are scrutinized under 3(d).
3. Bayer Corporation v. Union of India & Others (2010)
Drug: Beta-lactam antibiotic production process
Facts: Bayer filed patents for improved production processes. Competitors argued it was evergreening.
Issue: Are process improvements valid evergreening attempts?
Decision: Delhi High Court upheld Bayer’s process patents, rejecting claims of evergreening.
Reasoning:
Process patents are valid if they show novelty and industrial applicability.
Evergreening applies mainly to product patents.
Impact:
Differentiated between product modification (3d scrutiny) and process improvements.
4. Gilead Sciences v. Natco Pharma (2012)
Drug: Sofosbuvir – Hepatitis C treatment
Facts: Gilead attempted to patent improved formulations. Natco challenged as evergreening.
Issue: Whether minor chemical modifications extend patent term illegally.
Decision: Patent claims were narrowed, some rejected.
Reasoning:
Section 3(d) requires enhanced efficacy, not minor modifications.
Some modifications provided technical improvement but not therapeutic improvement.
Impact:
Reaffirmed Section 3(d) in restricting minor modifications.
5. Pfizer v. Cipla (2015)
Drug: Viagra (Sildenafil)
Facts: Pfizer filed a patent for a new dosage form. Cipla challenged as evergreening.
Issue: Can a new tablet formulation be patented?
Decision: Court rejected patent for new formulation, citing lack of inventive step and enhanced efficacy.
Impact:
Strengthened the position that patentable novelty must translate into therapeutic benefit.
6. Novartis v. Natco (2010) – India Glivec Generic Case
Drug: Glivec (generic challenge)
Facts: Natco applied for a compulsory license citing unaffordable pricing. Novartis argued patent protection.
Decision: IPO granted Natco compulsory license, but patent rejection under Section 3(d) made it moot.
Impact:
Linked evergreening with affordability and access to medicines.
7. Eisai Co. Ltd. v. Union of India (2011)
Drug: Aricept (Alzheimer’s treatment)
Facts: Eisai filed a patent for a new polymorph form. Indian Patent Office rejected it as evergreening.
Issue: Whether a new polymorphic form enhances efficacy.
Decision: IPO rejected patent under 3(d).
Reasoning:
Polymorphs must show significant therapeutic improvement.
Impact:
Reinforced strict scrutiny on chemical modifications without therapeutic benefit.
Key Legal Principles from Pharma Evergreening Cases
Section 3(d) is the cornerstone – minor chemical modifications without efficacy enhancement are rejected.
Generic entry is facilitated when evergreening is denied.
Process patents vs product patents: Process improvements are patentable, but product modifications face strict Section 3(d) scrutiny.
Dosage/formulation changes alone rarely qualify as inventive.
Public health considerations are a key factor in patent disputes.
RELATED Blog
comments