Author: Jasmeet Makkar, Bharti Vidyapeeth Deemed University, Delhi
INTRODUCTION
Intellectual Property is a category of intangible property. Patent is a subset of it. Patent is an innovation of that grants an owner the legal right to prevent others from using, creating, commercialising it for a certain amount of time in publishing in an enabling disclosure of the invention is known as the patent.
A patent is a form of intellectual property that grants its owner the exclusive right to make, use, or sell an invention for a limited period. In exchange for this exclusive right, the inventor must publicly disclose detailed information about the invention, promoting technological advancement and innovation. Patents are granted by government authorities and vary in their specific terms and conditions across different jurisdictions.
A patent is a legal right granted by a government to an inventor for a limited period, typically 20 years. This right allows the inventor to exclusively make, use, or sell their invention. To obtain a patent, the invention must be novel, non-obvious, and have practical application.
The Novartis v. Union of India case is a significant landmark in Indian patent law. Novartis challenged the rejection of its patent application for a specific crystalline form of Imatinib mesylate. The Supreme Court upheld the rejection, reasoning that the new form did not offer significantly improved therapeutic efficacy compared to the existing form. This decision emphasized the importance of substantial innovation for patent eligibility and aimed to prevent ever-greening, a practice where minor modifications are used to extend patent protection on existing products.
DETAILS OF THE CASE
CASE NAME: NOVARTIS AG V. UNION OF INDIA
COURT: SUPREME COURT OF INDIA
BENCH: JUSTICE RANJANA PRAKASH DESAI & JUSTICE AFTAB ASLAM
APPELLANTS: NOVARTIS AG, NATCO PHARMA LTD. M/S CANCER PATIENTS AID ASSOCIATION
RESPONDENTS: UNION OF INDIA & OTHERS
JUDGEMENT DATE: 1ST APRIL 2013
BRIEF FACTS OF THE CASE
Key Points of the Novartis v. Union of India Case:
1. Patent Application by Novartis:
• In 1997, Novartis applied for a patent in India for Glivec, an anticancer drug used to treat gastrointestinal stromal tumors (GIST) and chronic myeloid leukemia (CML).
• The claim focused on the beta crystalline form of imatinib mesylate, an improved version of imatinib.
2. Features of Beta Crystalline Form:
• Superior flow properties.
• Enhanced thermodynamic stability.
• Reduced hydrophobicity compared to the alpha crystalline form.
• Claimed benefits in processing, storage, and manufacturing.
3. Patent Rejection by Indian Patent Office:
• Before 2005, Indian law did not allow product patents for pharmaceuticals.
• Post-2005, under the amended Patents Act, Section 3(d) required new forms of known substances to show “enhanced efficacy” for patent eligibility.
• The Patent Office rejected Novartis’ application, citing lack of demonstrated therapeutic efficacy.
4. Novartis’ Legal Challenge:
• Novartis filed two writ petitions in the Madras High Court:
a) Challenging the Patent Office’s rejection of its application.
b) Contesting the validity of Section 3(d), claiming it was vague, arbitrary, and violated Article 14 of the Constitution.
5. Madras High Court Decision:
• The court ruled it lacked jurisdiction to decide whether Section 3(d) complied with international treaties like TRIPS.
• Upheld Section 3(d) as clear and reasonable, aimed at preventing patent “evergreening” and ensuring access to life-saving medicines.
• Dismissed both writ petitions filed by Novartis.
THE CASE
Novartis AG, a multinational pharmaceutical company, sought a patent for a new crystalline form of Imatinib Mesylate, a drug used to treat chronic myeloid leukemia. The new form, known as beta-crystalline Imatinib Mesylate (β-IM), was claimed to have improved properties, such as enhanced bioavailability and stability, compared to the previously known forms.
The Legal Battle
Novartis filed a patent application for β-IM in India. However, the Indian Patent Office rejected the application, citing Section 3(d) of the Indian Patents Act, 1970. This section prevents the granting of patents for mere modifications of known substances unless they demonstrate a significant enhancement of efficacy. The patent office argued that β-IM did not meet this criterion.
Novartis challenged this decision, appealing to the Intellectual Property Appellate Board (IPAB). The IPAB, while acknowledging the novelty and non-obviousness of β-IM, upheld the patent office’s decision, citing Section 3(d).
Undeterred, Novartis further appealed to the Supreme Court of India. The company argued that β-IM was a novel invention with distinct properties and therapeutic advantages. They further contended that Section 3(d) was unconstitutional as it imposed stricter patentability requirements than international standards, particularly the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
PROVISIONS FROM THE INDIAN PATENTS ACT, 1970
[AMENDED 2005]
1. Section 3(d): INDIAN PATENTS ACT, 1970
• This section prevents the patenting of new forms of known substances unless they result in the enhancement of known efficacy.
• The objective is to prevent “evergreening” (the practice of extending the patent life of a drug through minor modifications) and ensure affordable access to medicines.
• Central to this case, as Novartis’ beta crystalline form of imatinib mesylate was rejected for lacking enhanced therapeutic efficacy.
2. Section 2(1)(j): INDIAN PATENTS ACT, 1970
• Defines “invention” as a new product or process involving an inventive step and capable of industrial application.
• The beta crystalline form was claimed to be an “inventive step,” which was scrutinized in the case.
3. Section 2(1)(ja): INDIAN PATENTS ACT, 1970
• Defines “inventive step” as a feature involving technical advancement or economic significance compared to existing knowledge.
4. Section 25: INDIAN PATENTS ACT, 1970
• Governs the procedure for opposition to the grant of patents.
• The rejection of Novartis’ patent application was influenced by pre-grant opposition and lack of enhanced efficacy under Section 3(d).
PROVISIONS FROM THE INDIAN CONSTITUTION
1. Article 14:
• Guarantees equality before the law and protection against arbitrary state actions.
• Novartis argued that Section 3(d) was vague, arbitrary, and violated this constitutional guarantee.
2. Article 226:
• Empowers High Courts to issue writs for enforcement of fundamental and legal rights.
• Novartis filed writ petitions in the Madras High Court under this article, challenging the Patent Office’s rejection and the validity of Section 3(d).
International Context
1. TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights):
• Sets global standards for intellectual property protection.
• Novartis argued that Section 3(d) was non-compliant with TRIPS, although the Madras High Court stated it could not adjudicate on international treaty compliance.
These provisions collectively shaped the outcome of the case, emphasizing India’s focus on balancing patent protection with public health needs.
ISSUES RAISED
Whether the invention is inconsistent u/s 3(d) of the act or not?
How should efficacy be interpreted u/s 3(d) of the patents act?
Does the invention qualify for the test of novelty and invention for the alleged products?
Whether the invention of the beta crystalline form of the imantinib mesylate claimed by the Novartis is more efficient than the substance from which it is derived i.e “imantinib mesylate”?
OBSERVATION BY THE SUPREME COURT
The Supreme Court of India made significant observations in the Novartis AG v. Union of India (2013) case while upholding the rejection of the patent application for the beta crystalline form of imatinib mesylate (Glivec). Here are the key observations:
On Section 3(d) of the Indian Patents Act
1.Purpose of Section 3(d):
• The court emphasized that Section 3(d) was introduced to prevent “evergreening” of patents and to ensure access to affordable medicines.
• The provision encourages genuine innovation while prohibiting minor, insubstantial changes to known substances from being patented.
2.Enhanced Efficacy Requirement:
• The Supreme Court clarified that “efficacy” in the context of pharmaceutical substances means therapeutic efficacy, i.e., the ability of the substance to treat or cure a disease.
• The court ruled that Novartis failed to provide sufficient evidence that the beta crystalline form of imatinib mesylate demonstrated enhanced therapeutic efficacy over the known form of imatinib.
3.Interpretation of “New Form”:
• The beta crystalline form was considered a new form of a known substance (imatinib mesylate). However, the court held that new forms of known substances must meet the enhanced efficacy requirement to be patentable under Section 3(d).
On Patent Law and Public Health
4.Balancing Patent Rights and Public Interest:
• The court noted that the Indian patent system aims to strike a balance between encouraging innovation and protecting public health by ensuring access to affordable medicines.
• The decision reaffirmed India’s commitment to the Doha Declaration on the TRIPS Agreement and Public Health.
5.Role of Patent Law in Preventing Evergreening:
• The court observed that Section 3(d) serves as a safeguard against evergreening, which could unjustifiably extend the monopoly of pharmaceutical companies, restricting the availability of cheaper generic drugs.
On the Role of Courts and Patent Authorities
6.Patent Authority’s Assessment:
• The court upheld the Patent Office’s finding that Novartis’ beta crystalline form did not meet the requirement crystalline form did not meet the requirements for patentability under Indian law.
7.Judicial Review:
• The Supreme Court clarified that its role was not to question the desirability of Section 3(d) but to interpret and apply the provision in line with legislative intent.
OUTCOME OF THE CASE
The Supreme Court dismissed Novartis’ appeal, reaffirming the rejection of the patent for the beta crystalline form of imatinib mesylate. The decision reinforced India’s stance on prioritizing public health and preventing evergreening while upholding the principles of the Indian Patents Act, 1970 (Amended 2005).
INDIAN PATENTS ACT, 1970
The Indian Patents Act, 1970 governs the framework for granting and regulating patents in India. It aims to balance the rights of inventors with the public interest, promoting technological advancements while ensuring accessibility to essential products, especially in healthcare.
1. Historical Context
•Enacted in 1970, the Act replaced the Indian Patents and Designs Act, 1911.
•Focused initially on process patents for pharmaceuticals and chemicals to prevent monopolies and ensure access to essential goods.
•Amended multiple times, notably in 1999, 2002, and 2005, to align with India’s commitments under the TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights).
2. Key Provisions
Types of Patents Granted:
•Product Patents: Introduced for pharmaceuticals and agrochemicals in the 2005 amendment.
•Process Patents: Granted for manufacturing processes.
Patentability Criteria:
•Novelty: The invention must be new and not disclosed to anywhere in the world.
•Inventive Step: The invention should involve a technical advancement or economic significance over existing knowledge.
•Industrial Applicability: The invention must be capable of being used in an industry.
Section 3 – Exclusions from Patentability:
•Section 3(d): Prohibits patents on new forms of known substances unless they show enhanced efficacy (e.g., Novartis AG v. UOI case).
•Section 3(k): Excludes mathematical methods, algorithms, and computer programs per se.
•Section 3(i): Excludes methods of treatment or surgery for humans or animals.
Patent Term:
•Patents are granted for 20 years in India from the filing date.
3. Rights of Patentees
•The patent holder has the exclusive right to prevent others from making, using, selling, or distributing the patented invention without consent.
•However, these rights are subject to limitations like compulsory licensing in public interest.
4. Important Amendments
•1999 Amendment: Allowed filing of “exclusive marketing rights” (EMR) applications as a transitional measure before full TRIPS compliance.
•2002 Amendment: Introduced provisions for patent applications, enhanced enforcement, and expanded patent office operations.
•2005 Amendment: Introduced product patents for pharmaceuticals and agrochemicals.
Incorporated Section 3(d) to prevent evergreening.
Enabled compulsory licensing for affordable access to essential products.
5. Objectives of the Act
•Promote innovation and technological advancement in India.
•Protect the rights of inventors while balancing public interest, especially in healthcare.
•Prevent monopolies and encourage competition through generic alternatives.
•Align India’s intellectual property regime with international standards under TRIPS.
6. Relevance
The Indian Patents Act, 1970, is particularly notable for its public health safeguards, including Section 3(d), which has become a global example of balancing patent rights with public health needs.
CONCLUSION
The Supreme Court of India’s landmark decision in Novartis AG v. Union of India (2013) upheld the rejection of Novartis’s patent application for the beta crystalline form of Imatinib Mesylate. The Court’s ruling cantered on Section 3(d) of the Indian Patents Act, 1970, which requires a new form of a known substance to exhibit significantly enhanced therapeutic efficacy. The Court determined that Novartis had failed to demonstrate such enhanced efficacy for the beta crystalline form compared to the existing forms of Imatinib Mesylate.
This decision has far-reaching implications for the pharmaceutical industry in India and globally. It reinforces India’s commitment to affordable healthcare by preventing pharmaceutical companies from obtaining patents on minor modifications of existing drugs, a practice often referred to as “evergreening.” By upholding the stringent standards for patent eligibility, the Court ensures that generic drug manufacturers can produce affordable versions of essential medicines, making them accessible to a larger population.
The Novartis case has also sparked debates about the balance between intellectual property rights and public health. While patents incentivize innovation, they can also hinder access to life-saving medications. This decision highlights the importance of striking a balance between protecting innovation and ensuring that essential medicines are affordable and accessible to all.
