PATENT EVERGREENING: A CASE STUDY ON NOVARTIS AND ITS IMPLICATIONS

Introduction 

Patent evergreening is a controversial practice employed by pharmaceutical companies to  extend the exclusivity period of their patents on drugs. This practice has far-reaching  implications for access to affordable medications, competition within the pharmaceutical  industry, and public health. This article examines the case of Novartis, a prominent  pharmaceutical company, and its patent evergreening practices with a specific focus on the  drug Glivec (imatinib).  

Patent evergreening refers to the strategy of obtaining secondary patents for minor  modifications or improvements to an existing drug. By securing additional patents,  pharmaceutical companies can extend their market exclusivity and delay generic competition,  thus maintaining high prices and impeding access to affordable medications. The practice  typically involves securing patents for alternative forms, salts, polymorphs, formulations, and  methods of treatment or dosage regimens. 

Section 3(d) of the Indian Patents Act, 1970: 

In the Indian context, Section 3(d) of the Patents Act of 1970, plays a crucial role in addressing  patent evergreening and promoting access to affordable medicines. Section 3(d) states that  mere new forms of known substances or substances resulting from the mere use of a known  process cannot be granted patents unless they demonstrate enhanced efficacy. 

The key objective of Section 3(d) is to prevent the granting of patents for trivial or insignificant  modifications that do not bring about a substantial therapeutic advantage over existing  products. It aims to strike a balance between providing incentives for genuine innovation and  ensuring that patents are not granted for minor or obvious variations of known substances. 

Under Section 3(d), to overcome the prohibition on patenting new forms of known substances,  an applicant must demonstrate enhanced efficacy or significantly improved therapeutic benefits  compared to the known substance. This provision sets a higher threshold for patentability and  requires applicants to provide evidence of substantial enhancement in the efficacy of the  invention

The case of Novartis and its patent evergreening practices has sparked widespread discussion  and debate in the pharmaceutical industry and beyond. Novartis’ attempts to secure secondary  patents for minor modifications or improvements to Glivec have raised concerns about access  to affordable medications, competition, and the balance between intellectual property rights  and public health. The Supreme Court of India issued a landmark decision on April 1, 2013, in  the case of Novartis AG v. Union of India & Others.¹

Novartis and Glivec: A Case Study 

Glivec, also known as Gleevec or imatinib mesylate, is a breakthrough drug developed by  Novartis for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors  (GIST). Approved by the U.S. Food and Drug Administration (FDA) in 2001, Glivec  demonstrated remarkable efficacy in improving patient outcomes. 

Primary Patent: Novartis obtained the primary patent for Glivec in 1993, providing exclusivity  for manufacturing and selling the drug. The original patent was set to expire in 2013. 

Secondary Patents: To extend its market exclusivity, Novartis pursued secondary patents for  Glivec by making minor modifications and obtaining additional intellectual property  protection. These secondary patents covered different forms, salts, polymorphs, formulations,  and methods of treatment or dosage regimens related to imatinib. 

Legal Challenge and Controversy: 

Patent Denial in India: Novartis applied for a patent on the beta-crystalline form of imatinib  mesylate in India in 2006. However, the Indian Patent Office rejected the application on  grounds of lacking novelty and inventive steps. This decision aligned with India’s stricter  interpretation of patentability criteria following the World Trade Organization’s Agreement on  Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Indian Supreme Court Ruling: 

In its judgment, the Indian Supreme Court upheld the decision of the Intellectual Property  Appellate Board (IPAB) and rejected Novartis’ patent application. The court ruled that the beta crystalline form of imatinib mesylate did not meet the criteria for patentability under the Indian  Patents Act. The court’s decision was based on several key factors. First, it determined that the  beta-crystalline form of imatinib mesylate did not satisfy the requirement of novelty, as it was  not a new substance or a new product with enhanced therapeutic efficacy. The court held that  a new form of a known substance must exhibit significantly enhanced therapeutic efficacy  compared to the known substance to meet the novelty requirement. 

Second, the court considered the inventive step requirement and concluded that the beta crystalline form of imatinib mesylate did not involve any inventive step. It held that the  modification from the known substance was merely a new form that did not bring about a  substantial therapeutic advantage over the existing form. 

Additionally, the court analyzed the Section 3(d) provision of the Indian Patents Act, which  prevents the grant of patents for mere new forms of known substances, unless they demonstrate  enhanced efficacy. The court interpreted this provision to mean that for a new form to be  patentable, it must show a significant increase in therapeutic efficacy. 

The judgment of the Indian Supreme Court in the Novartis case had significant implications. It  reaffirmed the importance of balancing patent protection with public health interests, ensuring  access to affordable medicines, and preventing unjustified patent evergreening. The decision  was seen as a victory for generic drug manufacturers and public health advocates, as it allowed  for the continued availability of affordable generic versions of imatinib in India. 

Implications and Significance: 

Access to Affordable Medications: The Indian Supreme Court’s ruling safeguarded access to  affordable generic versions of Imatinib for patients in India. This decision had implications  beyond India, as it allowed for the production and export of low-cost generic versions,  benefiting patients in other countries that relied on India’s generic pharmaceutical industry.

Public Health Impact: The Novartis case raised concerns about the impact of patent  evergreening on public health. By extending market exclusivity and delaying generic  competition, pharmaceutical companies can maintain high prices, limiting access to life-saving  medications. The ruling highlighted the importance of ensuring access to affordable medicines  as a fundamental aspect of public health. 

Policy Considerations: The Novartis case prompted discussions on the need for patent reform  and the balance between intellectual property rights and public health. Stricter examination  standards and safeguards against patent evergreening were recognized as essential to prevent  the grant of patents for trivial modifications lacking substantial therapeutic benefits. 

Industry Transparency and Accountability: The case brought attention to the wider issue of  patent evergreening within the pharmaceutical industry. It emphasized the importance of  transparency and accountability in patenting practices to ensure that patents are granted only  for genuine innovations that provide significant clinical advancements. 

Other Important Judicial Interpretations: 

➢ F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd²:  

This case involved a patent dispute between Roche and Cipla over the drug Erlotinib, used for  treating lung cancer. Roche alleged patent infringement by Cipla’s generic version. The Delhi  High Court ruled in favor of Cipla, holding that Roche’s patent was not valid as it lacked  inventive steps and did not satisfy the requirements of Section 3(d) of the Indian Patents Act.  The judgment affirmed the strict interpretation of patentability criteria, including the enhanced  efficacy requirement under Section 3(d). 

➢ Bayer Corporation v. Union of India & Others³:  

This case dealt with the patentability of the anti-cancer drug Sorafenib Tosylate, marketed as  Nexavar. Bayer held a patent for the drug and challenged the grant of a compulsory license to  Natco Pharma, allowing it to manufacture and sell a generic version. The decision by the  Intellectual Property Appellate Board (IPAB) upheld the grant of the compulsory license,  recognizing the importance of ensuring affordable access to life-saving medicines.

Conclusion: 

The case of Novartis and Glivec serves as a significant example of patent evergreening and its  implications for access to affordable medications. The legal challenges faced by Novartis  underscored the need for stringent examination standards and safeguards against the granting  of patents for trivial modifications. These judgments have played a significant role in shaping  the interpretation and application of patent law in India, particularly concerning the issue of  patent evergreening. They have emphasized the need for strict adherence to patentability  criteria, including novelty, inventive step, and enhanced efficacy under Section 3(d) of the  Indian Patents Act. These judgments have contributed to ensuring access to affordable  medicines and balancing the interests of patent holders with public health concerns in India Balancing intellectual property rights with public health interests is crucial to ensure  innovation, competition, and access to essential medicines. By addressing patent evergreening  effectively, policymakers can foster a competitive pharmaceutical market that prioritizes  affordable and life-saving treatments for all.

1. Novartis AG v. Union of India & Ors., (2007) 4 MLJ 1153 ↩︎
2. F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd, (2009) 40 PTC 125 (Del) ↩︎
3. Bayer Corporation v. Union of India & Others 2014 (60) PTC 277 (Bom) ↩︎