INTRODUCTION:
The case of Novartis AG v Union of India revolves around a dispute over the denial of a patent for a drug called Glivec, which was manufactured by Novartis AG, a multinational pharmaceutical company. The case gained significant attention in India and internationally due to its implications for patent law and pharmaceutical innovation. Novartis AG, as the petitioner, sought a patent for a modified version of Glivec, a drug used in the treatment of certain types of cancer. Novartis AG argued that the modified drug fulfilled the requirements for patent protection under Indian law. On the other side, the respondent, the Union of India, represented the interests of the Indian government.
The case raised fundamental legal issues related to patentability criteria, the interpretation of Section 3(d), and the balance between encouraging innovation and ensuring access to affordable medicines. It brought into focus the concept of “ever greening” in the pharmaceutical industry, which refers to the practice of obtaining additional patents for minor modifications of existing drugs in order to extend market exclusivity. The Novartis case occurred against the backdrop of the broader historical context of patent law and the pharmaceutical industry in India. India, as a developing country with a large population and significant healthcare challenges, has been committed to striking a balance between incentivizing innovation and promoting affordable access to medicines. The case highlighted the importance of protecting intellectual property rights while considering the public interest and the need for affordable healthcare solutions. Given its implications for intellectual property rights, public health, and access to medicines, the case attracted attention from various stakeholders, including pharmaceutical companies, patient advocacy groups, legal experts, and the general public. The outcome of the case had the potential to shape the legal landscape surrounding patentability criteria and influence future patent disputes in India.
This case decision made a relief to millions of people around through world so that they can have access to medicines at lower cost and it also prevented the pharmaceutical industries from getting their patents ‘ever greening’.
This case is related to the Intellectual Property Rights (IPR) law. In this case the substantial questions of “invention” and “patentability” were discussed. Appellant in this case is Novartis AG, a pharmaceutical manufacturing company. Appellant appealed against the order of Assistant Controller of Patents in the Intellectual Property Appellate Board [Hereinafter also referred to as ‘IPAB’]. Further appellant appealed against the order of the IPAB in the Supreme Court of India. However, the IPAB was satisfied that product of appellant was an “invention” but The Supreme Court of Indian dissatisfied that product of the appellant was an “invention”. Appeal was dismissed in the Supreme Court of India with cost.
FACT OF THE CASE:
Dr. Jurg Zimmermann invented number of derivatives of N-phenyl-2-pyrimidine-amine, of which “Imatinib” was one of the derivatives. All the derivatives including “Imatinib” were patented in the United States vide United States Zimmermann Patent No. 5,521,184 on 28-05-1996. The Zimmermann compounds also got the European patents. Appellant invented a cancer inhibiting medicine “Gleevec/Glivec/β-crystalline Imatinib Mesylate [Hereinafter also refereed to as ‘β-IM’]”. Appellant applied for patent of β-IM on 17-07-1998. On 18-07-1997 appellant applied for patent in Switzerland so appellant claimed this date as priority date. At that time The Indian Office of Controller of Patent and Designs put the application on hold. The Patent Act, 1970 got amended in 2005. Assistant Controller of Patent vide order dated 25-01-2006, rejected the patent claim and held that the patent is disallowed by sec. 3 (d) of Patent Act, 1970 [Hereinafter also referred to as ‘PA’] . IPAB vide its order dated 26-06-2009 held that β-IM satisfy the test of “invention” under sec. 2 (1) (j) and (ja) of PA, it failed the test of enhanced efficacy given in sec. 3 (d) of PA. Therefore, denied the patent to the appellant. Appellant appealed to the Supreme Court of India under Article 136 of the Constitution. Novartis filed a patent application for the beta-crystalline form of Imatinib Mesylate, a[1] derivative of Glivec, claiming it to be a new invention. The patent application was rejected by the Indian Patent Office on the grounds that it did not satisfy the requirements of Section 3(d) of the Patents Act, as it merely involved a modification of a known substance. Novartis challenged this decision before the Intellectual Property Appellate Board (IPAB) and later the Supreme Court of India.
Glivec was already patented and available in the market, but Novartis AG claimed that the modified version had increased efficacy and improved therapeutic benefits. The modified drug was specifically designed to enhance bioavailability, stability, and efficacy compared to the original formulation. Novartis AG argued that these modifications qualified the drug for patent protection under Indian law. The provision aims to prevent the granting of frivolous patents for trivial modifications of known substances.
Novartis AG challenged the decision of the Indian Patent Office and took the case to the Intellectual Property Appellate Board (IPAB) and later to the Supreme Court of India. During the legal proceedings, Novartis AG contended that the modified version of Glivec fulfilled the requirements for patentability. The company argued that Section 3(d) should not impose an additional efficacy requirement beyond what is mandated by international patent standards.
On the other hand, the Union of India, representing the Indian government, defended the decision of the Indian Patent Office. The government argued that the modified drug did not qualify for a patent under Section 3(d) since it did not demonstrate significantly enhanced efficacy compared to the known substance.
The case centered on the interpretation and application of Section 3(d) of[2] the Indian Patents Act, which required the court to determine whether Novartis AG’s modified version of Glivec met the standard of enhanced efficacy for patentability. The facts of the case revolved around the scientific evidence and arguments presented by both parties regarding the therapeutic benefits and efficacy of the modified drug compared to the prior art. In summary, the facts of the case involved Novartis AG’s application for a patent for a modified version of Glivec, the rejection of the application by the Indian Patent Office based on Section 3(d) of the Indian Patents Act, and the subsequent legal dispute regarding the interpretation and application of[3] the patentability criteria.
Novartis filed a patent application for the beta form of Imatinib Mesylate B-IM, Imatinib Mesylate a drug used to treat chronic myeloid leukemia . The Indian patent office rejected the application on the grounds that the beta form was not a new invention and did not exihibit significant enhancement of efficacy. Novartis appealed the decision arguing that beta form was a novel invention and should be granted patent. They filed writ petition that the section 3 (d) of Indian patent act is unconstitutional.
LEGAL ISSUES :
The key legal issue in this case revolved around the interpretation and application of Section 3(d) of the Indian Patents Act. Section 3(d) states that a new form of a known substance is not patentable unless it demonstrates significantly enhanced efficacy compared to the known substance.
PETITIONER’S CONTENTION:
Novartis argued that the beta-crystalline form of Imatinib Mesylate exhibited enhanced efficacy and was a significantly more effective form of the drug. They contended that it should be considered a new invention and eligible for a patent.
RESPONDENT’S CONTENTION:
The Union of India and other respondents argued that the claimed invention did not meet the requirements of Section 3(d) as it was merely a new form of a known substance without any enhanced therapeutic efficacy. They contended that granting a patent for such inventions would impede access to affordable medicines and violate public health interests.
LEGAL PRINCIPLES ESTABLISHED:
The Supreme Court, in its judgment, clarified the interpretation of Section 3(d) of the Patents Act. The court held that for a new form of a known substance to be patentable, it must demonstrate significantly enhanced efficacy over the known substance. Mere incremental improvements or minor modifications would not meet the threshold of patentability.
IMPACT ON EXISTING LAW:
The judgment reinforced the requirement of enhanced efficacy for patentability, preventing the grant of patents for insignificant modifications of known substances. This decision had a significant impact on pharmaceutical patent applications in India and played a crucial role in safeguarding access to affordable medicines.
DISSENTING OPINIONS:
There were no dissenting opinions in this case. The judgment was delivered unanimously by the Supreme Court.
PUBLIC REACTION:
The case garnered significant attention both domestically and internationally. The judgment
was seen as a victory for public health advocates and access to affordable medicines.
ENFORCEMENT AND IMPLEMENTATION:
Following the judgment, the Intellectual Property Office and the courts have applied the principles laid down in the Novartis case to evaluate patent applications for new forms of known substances.
SUBSEQUENT DEVELOPMENTS:
The Novartis case set a precedent for subsequent cases involving patentability of pharmaceutical inventions in India. It influenced the understanding and interpretation of Section 3(d) in subsequent litigation and helped shape the Indian patent landscape.
COURT OBSERVATION:
The court recognized the delicate balance between promoting innovation and ensuring access to affordable medicines. It emphasized the need to prevent evergreening, a practice where pharmaceutical companies extend patent monopolies by making minor modifications to known substances without significant therapeutic benefits.
JUDGMENT:
The Supreme Court upheld the decision of the Intellectual Property Appellate Board, ruling that Novartis invention did not meet the requirements of patentability under Section 3(d) of the Patents Act. The beta-crystalline form of Imatinib Mesylate was deemed not eligible for a patent due to lack of significantly enhanced efficacy over the known substance.
RATIONALE:
The case also aims to balance the interests of innovation and public health, and to prevent evergreening of patents, which is the practice of extending the patent term by making minor modifications to an existing product.
The case revolves around the patentability of a drug called Glivec, which is used to treat chronic myeloid leukemia and some other types of cancer. Glivec is based on a chemical compound called imatinib, which was already known and patented by Novartis in the US. Novartis claimed that it had invented two new forms of imatinib: one was a salt form called imatinib mesylate, which made it soluble in water and suitable for oral administration; and the other was a specific polymorph (crystalline structure). The Court also clarified the meaning and purpose of section 3(d), stating that it was intended to prevent ever greening of patents and to ensure that only genuine inventions are granted patents in India.
The Court’s judgment was widely hailed as a victory for public health and access to medicines, as it ensured that generic versions of Glivec could continue to be produced and sold at affordable prices in India and other developing countries. Glivec is a life-saving drug for many patients suffering from CML and other cancers, but its price is prohibitive for most people. Novartis sells Glivec at about $2,600 per month per patient, whereas generic manufacturers sell it at about $175 per month per patient. The judgment was also seen as a reaffirmation of India’s sovereignty and policy space in determining its patent standards and protecting its public interest.
DEFECTS OF LAW:
The Supreme Court’s interpretation of section 3(d) of the Patents Act is too narrow and restrictive, and does not allow for incremental innovation in the pharmaceutical sector. The Court also did not take into account the international standards and practices of patentability, and the obligations of India under the TRIPS Agreement to grant patents for inventions that are new, involve an inventive step, and are capable of industrial application.
The Supreme Court’s judgment is based on a flawed understanding of the scientific and technical aspects of the case. The Supreme Court’s judgment is influenced by policy considerations and public interest arguments, rather than legal principles and objective criteria. The Court was swayed by the concerns of access to medicines, public health, and prevention of ever greening, which are not relevant for determining patentability. The Court also gave undue weight to the opposition by generic manufacturers, civil society groups, and patients’ associations, who had vested interests in challenging Novartis’ patent application. The Court failed to balance the rights and interests of patent holders and users, and to protect the incentives for innovation and research in the pharmaceutical industry
INFERENCE:
Indian Supreme Court has set a high standard for patentability of pharmaceutical products in India, and has upheld the principle of public health and access to medicines over the interests of multinational corporations. The case also shows that India has a strong and independent judiciary that can interpret and apply its own patent laws in accordance with its national priorities and policy objectives. The case also has implications for other developing countries that face similar challenges in balancing innovation and public health, and that may look up to India as a model for protecting their sovereignty and policy space in the field of intellectual property rights.
Etishri Dash
G.M Law college puri, Odisha
[1] https://www.lexology.com/search?q=
[2] https://www.pharmatimes.com/news
[3] https://www.pharmatimes.com/news