Evergreening of Patents in India refers to the practice of extending the life of a patent by making minor modifications to an existing patent, thereby preventing generic versions of the patented product from entering the market. This practice is often used by pharmaceutical companies to maintain their market share and profits.
Overview
Evergreening of patents is a contentious issue in India, as it can limit access to affordable medicines and hinder innovation. In India, the patent law is governed by the Patents Act, 1970, which was amended in 1999 to comply with the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. The amended Act introduced product patents for pharmaceuticals and agrochemicals, allowing companies to patent new products and processes. However, the Act also introduced provisions to prevent evergreening, such as Section 3(d), which prohibits the patenting of new forms of known substances unless the new form has enhanced efficacy.
Legal Framework
The Patents Act, 1970, as amended in 1999, is the primary legislation governing patents in India. Section 3(d) is a key provision that prevents evergreening by prohibiting the patenting of new forms of known substances unless the new form has enhanced efficacy [1]. The Section states that a new form of a known substance shall not be considered as involving an inventive step, unless the new form has a significant effect on the efficacy of the known substance.
Procedure
The process of evergreening involves making minor modifications to an existing patent, such as changing the salt form of a drug or making minor changes to the manufacturing process. The patent applicant then files a new patent application for the modified product, which is often granted as a new patent. In India, the patent office is responsible for examining patent applications and determining whether they meet the requirements of the Patents Act.
Key Cases
- Natco Pharma Ltd. v. Bayer Corporation[2] (2011): The Delhi High Court held that the patent for the cancer drug Sorafenib was invalid due to evergreening, as the new form of the drug did not have enhanced efficacy.
- Novartis AG v. Union of India[3] (2007): The Supreme Court of India held that the patent for the cancer drug Imatinib Mesylate was invalid due to evergreening, as the new form of the drug did not have enhanced efficacy.
- Roche v. Cipla[4] (2004): The Delhi High Court held that the patent for the anti-HIV drug Efavirenz was invalid due to evergreening, as the new form of the drug did not have enhanced efficacy.
See Also
- Patentability criteria in India
- Section 3(d) of the Patents Act, 1970
- Evergreening of patents in other countries
- Pharmaceutical patents in India
- Patent office in India
- Intellectual property law in India
- TRIPS agreement