India’s Patent Revocations: Strengthening Access and Challenging Evergreening

The Indian Patent Office’s recent decision to revoke Novartis’ patent on the cardiac drug Vymada marks another chapter in the country’s robust stand for patient access against the tide of patent evergreening. At the heart of this and previous landmark cases lies Section 3(d) of the Indian Patent Act—a provision designed to ensure genuine innovation while preventing minor, incremental changes from being used to unjustly extend patent monopolies.

Landmark Cases: A Timeline

• Novartis v. Union of India (Glivec/Imatinib Mesylate): In 2013, the Supreme Court of India rejected Novartis’ application to patent a beta-crystalline form of the anti-cancer drug Glivec. The court ruled that the new version did not meet the higher bar of “enhanced efficacy” required by Section 3(d), and thus could not be patented. This decision was hailed by patient groups and humanitarian organizations for preserving affordable generic access, with the cost of generics being a fraction of branded Glivec’s price.[1][2][3][4][5]

• Pfizer’s Sutent (Sunitinib Malate): Pfizer’s patent for its kidney cancer drug Sutent was revoked on grounds that it lacked an inventive step and was structurally obvious from prior art. Indian companies, notably Cipla and Natco, challenged the patent, allowing lower-cost generics to enter the market.[9][10][11][12][13]

• Bayer—Nexavar (Sorafenib): Bayer failed to overturn a compulsory license for Nexavar, a liver and kidney cancer drug. Natco Pharma was granted permission to market a generic at a significantly lower price, further illustrating India’s commitment to public health.[10][9]

• Roche—Tarceva (Erlotinib): Roche lost its patent infringement case over the cancer drug Tarceva when the Delhi High Court allowed Cipla’s generic version after years of litigation. The case established strong precedent for generic competition when innovation cannot be substantiated.[9][10]

The Implications

• Patient Access Prevails: These judgments have led to dramatic price reductions for life-saving medicines, supporting millions of patients not only in India but globally.
• Section 3(d)—A Legal Bulwark: Courts have consistently upheld this provision, requiring real therapeutic benefits—not just physical modifications or minor tweaks—to grant patent protection.
• Global Precedent: India’s line of decisions is watched closely by developing countries seeking to balance intellectual property rights with affordable healthcare.

The recent revocation of Novartis’ Vymada patent continues this trend, reinforcing India’s resolve to champion genuine pharmaceutical innovation while resisting attempts to prolong monopolies through patent evergreening.

Appendix: Sources and Further Reading

These cases illustrate India’s proactive stance in promoting access to affordable medicines for all, rejecting weak patent claims, and setting robust global standards for pharmaceutical patent scrutiny. [17][2][3][4][5]

Sources
[1] Novartis v. Union of India & Others https://en.wikipedia.org/wiki/Novartis_v.Union_of_India&_Others
[2] Indian court rejects Novartis patent https://www.nature.com/articles/nature.2013.12717
[3] Novartis loses Indian Glivec patent case https://pharmatimes.com/news/novartis_loses_indian_glivec_patent_case_1004741/
[4] Novartis Loses Historic India Patent Case On Cancer Drug … https://cancer.org.in/advocacys/novartis-loses-historic-india-patent/
[5] Section 3(d) of Indian Patent Act: Interpretation and … https://thelegalschool.in/blog/section-3d-of-indian-patent-act
[6] India rejects Novartis patent appeal | Business https://www.chemistryworld.com/news/india-rejects-novartis-patent-appeal/6048.article
[7] Imatinib challenge dismissed in India https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(07)70261-9/fulltext
[8] Section 3(d) and Pharmaceutical Patents in India https://nopr.niscpr.res.in/bitstream/123456789/55114/1/JIPR%2025(3-4)%2065-73.pdf
[9] India revokes Pfizer’s patent on Sutent https://pmlive.com/pharma_news/india_revokes_pfizers_patent_on_sutent_434858/
[10] India revokes patent on Sutent, Pfizer to appeal https://pharmatimes.com/news/india_revokes_patent_on_sutent_pfizer_to_appeal_976504/
[11] INdIA: THE SUNITINIB CASE https://www.remfry.com/wp-content/uploads/2017/11/india-the-sunitinib-case.pdf
[12] Pfizer to appeal India decision to revoke cancer drug patent https://www.reuters.com/article/business/healthcare-pharmaceuticals/pfizer-to-appeal-india-decision-to-revoke-cancer-drug-patent-idUSBRE89408E/
[13] India Pfizer local patent for cancer drug revoked https://www.marketwatch.com/story/india-pfizer-local-patent-for-cancer-drug-revoked-2012-10-05
[14] Relooking at the reach of Section 3(d) of the Indian Patents … https://www.asialaw.com/NewsAndAnalysis/relooking-at-the-reach-of-section-3d-of-the-indian-patents-act-1970-after-nov/Index/1854
[15] Section 3(d) – Landmark Cases https://www.candcip.com/section-3-d-landmark-cases
[16] Court interprets “known substance” in respect of Section 3(d … https://corporate.cyrilamarchandblogs.com/2024/02/court-interprets-known-substance-in-respect-of-section-3d-of-the-patents-act/
[17] India revokes patent of Novartis’ cardiac drug https://timesofindia.indiatimes.com/business/india-business/india-revokes-patent-of-novartis-cardiac-drug/articleshow/123908557.cms