Non-Patentable Subject Matter Revocation Cases.
1. Legal Framework
The Indian Patents Act, 1970, under Section 3, specifies categories of inventions that are not patentable. These include:
Section 3(a) – Inventions contrary to law, morality, or public order.
Section 3(b) – Inventions harmful to the environment or health.
Section 3(c) & (d) – Discovery of new forms of known substances without enhanced efficacy.
Section 3(e)-(k) – Traditional knowledge, mathematical methods, methods of agriculture, diagnostic methods, business methods, computer programs, etc.
Revocation occurs when a granted patent is challenged for falling into one of these non-patentable categories, usually under Section 64 (Revocation by court or controller).
2. Landmark Indian Case Laws on Non-Patentable Subject Matter
Case 1: Novartis AG v. Union of India (Gleevec Case, 2013)
Court: Supreme Court of India
Facts: Novartis applied for a patent for the beta-crystalline form of Imatinib Mesylate. Indian Patent Office rejected it under Section 3(d) because it was a new form of a known substance without increased efficacy.
Decision:
Supreme Court upheld the rejection.
Key observation: Mere modification of known compounds does not qualify as an invention unless it demonstrates enhanced therapeutic efficacy.
Significance:
Landmark in pharma patents.
Reinforced Section 3(d) as a barrier to evergreening.
Set precedent for revocation of patents that are incremental modifications of known substances.
Case 2: Bayer Corporation v. Union of India (Sorafenib Tosylate Case, 2014)
Court: Intellectual Property Appellate Board (IPAB) / Delhi High Court
Facts: Bayer challenged generic manufacturers for producing Sorafenib (anticancer drug). Generic companies challenged Bayer’s patent under Section 3(d).
Decision:
Court emphasized that the patent was granted only if the invention showed enhanced efficacy, which Bayer could not conclusively prove.
Significance:
Example of revocation based on non-patentable subject matter.
Section 3(d) prevents evergreening, even for life-saving drugs, unless substantial therapeutic advantage exists.
Case 3: Monsanto Technology LLC v. Nuziveedu Seeds Ltd. (2017)
Court: Delhi High Court
Facts: Monsanto’s patent on genetically modified Bt cotton was challenged by Nuziveedu under Section 3(j) – plants and seeds are non-patentable.
Decision:
Court upheld that plants and seeds in India are excluded from patent protection, even if genetically modified.
Significance:
Reinforced the principle that biological materials like seeds cannot be patented, aligning with public policy and food security concerns.
Set precedent for revocation of patents that fall within non-patentable biological matter.
Case 4: Ericsson Inc. v. Lava International Ltd. (2015)
Court: Delhi High Court
Facts: Ericsson claimed patent infringement for software-based communication technology. Lava challenged the patent under Section 3(k) – computer programs per se are not patentable.
Decision:
Court analyzed whether the invention was a technical contribution beyond a computer program.
Patent was partially revoked because the claimed invention was primarily software without technical effect.
Significance:
Clarifies that software patents in India must involve a technical solution, otherwise they are revocable.
Example of revocation due to non-patentable subject matter under Section 3(k).
Case 5: Indian Immunologicals Ltd. v. Controller of Patents (2010)
Court: IPAB
Facts: Indian Immunologicals applied for a patent on a vaccine preparation method. Controller revoked the patent citing Section 3(b) – hazardous to health / environment.
Decision:
Court confirmed revocation because the claimed method did not demonstrate safe application and posed public health risk.
Significance:
Example of revocation on public safety grounds.
Section 3(b) serves as a check against inventions harmful to humans, animals, or the environment.
Case 6: Novartis v. Glenmark Pharmaceuticals (2006)
Court: Delhi High Court
Facts: Glenmark challenged Novartis’ patent claims on a cancer drug, arguing it was a new form of known substance without efficacy improvement (Section 3(d)).
Decision:
Court ruled in favor of Glenmark.
Patent was revoked as incremental modifications do not qualify as patentable inventions in India.
Significance:
Reinforced strict interpretation of Section 3(d).
Prevented evergreening practices in pharma.
3. Common Themes Across Cases
Pharmaceutical patents are most scrutinized for non-patentability.
Evergreening (minor modifications of existing drugs) is often rejected under Section 3(d).
Plants, seeds, and software per se are non-patentable (Sections 3(j), 3(k)).
Public interest, health, and environment are primary considerations in revocation.
Courts increasingly rely on technical contribution to differentiate patentable and non-patentable inventions.
4. Key Observations
Revocation of patents in India often hinges on Sections 3(d), 3(j), 3(k), 3(b).
Courts emphasize substantial improvement, technical effect, and public interest.
India’s stringent approach to non-patentable subject matter prevents evergreening, unlike some Western jurisdictions.
Patentees must demonstrate real efficacy, technical innovation, and public safety compliance to avoid revocation.
5. Summary Table of Cases
| Case | Year | Court | Section Invoked | Key Reason for Revocation | Significance |
|---|---|---|---|---|---|
| Novartis AG v. Union of India | 2013 | SC | 3(d) | New form of known drug without enhanced efficacy | Landmark anti-evergreening case |
| Bayer Corp v. Union of India | 2014 | HC/IPAB | 3(d) | Lack of enhanced therapeutic efficacy | Pharma patent revocation precedent |
| Monsanto v. Nuziveedu Seeds | 2017 | HC | 3(j) | Plants and seeds non-patentable | Biological patents not allowed |
| Ericsson Inc. v. Lava | 2015 | HC | 3(k) | Computer program per se | Software patents need technical contribution |
| Indian Immunologicals Ltd. | 2010 | IPAB | 3(b) | Unsafe vaccine preparation | Public health grounds |
| Novartis v. Glenmark | 2006 | HC | 3(d) | Incremental modification | Pharma evergreening prevention |
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