Patent evergreening is a strategy used by companies to extend the life of their patents and maintain commercial exclusivity. It involves obtaining additional patents for minor modifications or variations to an existing product or process. The goal is to prevent competition and keep the patent owner’s revenues flowing.
Patent
“Patents is a statutory right granted by the respective governments. It gives one exclusive rights and bars others from making, using, selling and importing a product or process, based on the patented invention without one’s prior permission.”
Patents encourage investment in drug development by offering 20 years of exclusive market access to its holder to recover their R&D investment.
Evergreening is where a company extends its patent on a drug by re-patenting slightly modified versions of the drug.
For example, they might release the original drug in its salt form, even if this does not bring a therapeutic improvement.
3India along with Brazil, Thailand, and South Africa one of the few countries with laws against evergreening.
The Indian Patent Act, as amended by the Patents (Amendment) Act 2005 under Section 3(d), states that drugs cannot be patented if they result from the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance.
Section 3(e) of the Act restricts patenting mixtures of known compounds unless a synergistic effect is proven, and Section 3(i) prevents patents on treatment methods.
Novartis AG v. Union of India (2013): Novartis’ patent application for the cancer drug Glivec (imatinib), used to treat leukemia, was rejected as it did not show significant technical advancement.
The decision, upheld by both the Madras High Court in 2005 and the Supreme Court in 2013, set a strong precedent against evergreening practices.
Roche v. Cipla (2012): The Delhi High Court ruled in favour of Cipla in a patent infringement case over Roche’s anti-cancer drug Tarceva. Roche’s patent for the polymorph B version of Tarceva was rejected on the basis of Section 3(d).
Johnson & Johnson’s TB drug Bedaquiline: Last year, the patent office in India rejected the secondary patent of Johnson and Johnson’s TB medication bedaquiline, used for the treatment of those with drug-resistant infections
Mains PYQ
1. Bring out the circumstances in 2005 which forced amendment to section 3(d) in the Indian Patent Law, 1970. Discuss how it has been utilized by Supreme court in its judgment rejecting Novartis patent application for “Glivec”. Discuss briefly the pros and cons of the decision.
Challenge of Evergreening of patents for India
1. Despite these legal safeguards, evergreening remains a challenge in launching affordable biosimilars as seen in the ongoing controversy surrounding pertuzumab, used to treat certain types of breast cancer.
In India, due to its heavy disease burden, population density, and lack of access to affordable medical care for a majority of the citizens, patent evergreening is a challenge.
2. Patent evergreening poses a significant threat to public health by impacting the accessibility and affordability of essential medicines.
While India’s legal framework aims to curb such practices, recent studies reveal that around 72 per cent of granted pharmaceutical patents are minor or secondary. The need for stronger scrutiny and opposition is obvious.
3. With India being one of the biggest manufacturers of generics, the country’s patent law has a specific section that disallows the ever-greening of patents.
It says that a drug cannot be termed an invention if a new form of the same substance is developed without any significant improvement in efficacy.
4. To safeguard public health and promote genuine innovation, India needs to strengthen its patent opposition mechanisms, ensuring that the patent system serves its intended purpose rather than extending monopolies through minor modificatio