The Indian Patent Office (IPO) has revoked Novartis’ patent in India for its cardiac drug Vymada on the grounds of lack of novelty and inventive step. This decision not only impacts the pharmaceutical industry but also reinforces India’s jurisprudence on the delicate balance between rewarding innovation and safeguarding public health.
Legal Basis for Revocation
The revocation was grounded in the requirements of the The Patents Act, 1970, particularly:
- Section 2(1)(j): Defines an “invention” as a new product or process involving an inventive step and capable of industrial application.
- Section 2(1)(ja): Defines “inventive step” as a feature of an invention involving a technical advance as compared to existing knowledge or having economic significance, which makes the invention not obvious to a person skilled in the art.
- Section 3(d): Excludes from patentability the mere discovery of a new form of a known substance unless it results in the enhancement of the known efficacy of that substance. Introduced through the 2005 amendment, Section 3(d) was a response to widespread concerns about “evergreening,” i.e., extending patent monopolies through minor modifications of known drugs.
After evaluating the claims, the IPO concluded that Vymada (sacubitril/valsartan) did not demonstrate a sufficient inventive step and lacked novelty when assessed against prior art. The decision underscores the Indian approach: mere incremental improvements or new formulations of existing molecules will not meet patentability standards without demonstrable enhanced efficacy.
This blog is a part of our The Ultimate Guide to Intellectual Property Law Blogpost.
Precedential Context
The revocation of Vymada sits comfortably within a long line of Indian judicial and administrative precedents.
Novartis AG v. Union of India (2013) 6 SCC 1 (the Glivec case)
- The Supreme Court rejected Novartis’ patent application for Glivec (Imatinib Mesylate beta crystalline form).
- The Court held that unless there is a demonstrable increase in therapeutic efficacy, new forms of known substances cannot qualify as inventions under Section 3(d).
- This case firmly established India’s global reputation as a jurisdiction unwilling to compromise public health interests.
F. Hoffmann-La Roche Ltd. v. Cipla Ltd. (2009) (Delhi High Court)
- In a dispute over Erlotinib, the court emphasized the tension between patent protection and access to life-saving drugs.
- It highlighted the necessity of balancing Intellectual Property (IP) rights with India’s constitutional commitment to affordable healthcare.
Enercon (India) Ltd. v. Aloys Wobben (2013) 5 SCC 306
- The Court clarified the scope of “inventive step,” noting that it must be a genuine technical advancement not obvious to a skilled person in the art.
Administrative Practice of IPO
- In line with Section 3(d), the IPO has regularly scrutinized applications involving polymorphs, dosage forms, and derivatives of known substances. Many such patents have been denied or revoked for failing to show enhanced efficacy.
Together, these cases provide the jurisprudential backdrop that informed the Vymada decision.
Implications of the Decision
For Patients and Public Health
The revocation clears the path for generic manufacturers to produce and market more affordable versions of Vymada, which is widely prescribed for chronic heart failure. Cardiovascular diseases are India’s leading cause of death; thus, the availability of cheaper alternatives could significantly reduce treatment costs, improve access, and ultimately save lives.
For Pharmaceutical Innovators
The ruling underscores India’s high threshold for patentability. Incremental innovations or “tweaks” that lack demonstrable therapeutic advancement will likely face rejection under Section 3(d). Innovator pharmaceutical companies must therefore:
- Provide robust clinical evidence of enhanced efficacy in their patent applications.
- Rethink strategies that rely on evergreening practices.
- Reassess pricing models to ensure commercial viability despite potential generic competition.
Policy and International Trade Dimensions
- TRIPS Compliance: India’s stringent patentability criteria, particularly Section 3(d), have often been criticized by multinational pharma lobbies as being “innovation unfriendly.” However, the WTO’s TRIPS Agreement allows member states to define patent standards provided they comply with minimum thresholds. India’s approach remains legally defensible under TRIPS flexibilities.
- International Perceptions: Decisions like this may fuel industry concerns over India’s “patent climate,” possibly impacting foreign investment. Conversely, they strengthen India’s global standing as a champion of access to affordable medicines in the Global South.
- Generic Exports: Indian generic companies stand to gain not only domestically but also in international markets where Vymada is not under patent protection. This could boost India’s pharmaceutical exports, aligning with its position as the “pharmacy of the world.”
Next Steps for Novartis
Novartis has potential remedies under Indian law:
Appeal under Section 117A of the Patents Act, 1970
- Appeals against decisions of the Controller of Patents now lie with the jurisdictional High Court following the abolition of the IPAB.
- Novartis may challenge the IPO’s findings on novelty and inventive step.
Judicial Review (Writ Petition):
- Novartis could argue that the IPO’s decision involved procedural irregularities or misapplication of law.
- However, judicial review is limited in scope and courts are generally reluctant to interfere with factual findings of technical authorities.
The course of action Novartis takes will determine how quickly generics can enter the market.
Broader Implications for Patent in India
The revocation of Vymada’s patent represents more than a single administrative decision. It is emblematic of India’s statutory and judicial philosophy: innovation will be rewarded, but only when it demonstrably benefits patients. Mere cosmetic changes or reformulations cannot enjoy monopoly protection at the expense of public health.
For patients, the decision offers hope of reduced costs and greater accessibility. For the generic industry, it opens lucrative opportunities. For multinational innovators, however, it raises urgent questions about how to navigate India’s patent regime.
Ultimately, the case reaffirms India’s resolve to align its intellectual property laws with its constitutional mandate to protect public health, even when that means challenging powerful global pharmaceutical giants.
