Mains Paper 3: Science & Technology | Awareness in the fields of IT, Space, Computers, robotics, nano-technology, bio-technology and issues relating to intellectual property rights.
From UPSC perspective, the following things are important:
Prelims level: Evergreening, biologics, primary patents, secondary patents etc.
Mains level: Very important and comprehensive newscard on the IPR issue. It is very important to know how Indian Patent Law helps in thwarting evergreening practices.
Issues related to Patents
- Patents offer their owners market exclusivity for a limited period of time
- For medicines, this exclusivity should last as long as the primary patent is in effect, typically 20 years
- The end of patent exclusivity is referred to as a patent cliff, because drug prices fall steeply afterwards (by as much as 80%) owing to generic competition
- This fall in profits drives pharmaceutical companies to find new ways to postpone their exclusivity by filing secondary patents
- One of the most popular of these ways is ‘Evergreenning’
What are primary and secondary patents?
- Patents on active ingredients are referred to as primary patents
- In later phases of the drug development, patents are filed on other aspects of active ingredients such as different dosage forms, formulations, production methods etc
- These patents are referred to as secondary patents
How secondary patents affect the prices of medicines?[some examples]
- The rejection of a secondary patent for Novartis’ Glivec, a crucial leukaemia cure, was famously upheld by the Supreme Court of India in 2013
- While the same was granted in the U.S.
- Consequently, the cost of a monthly dose of the medicine in the U.S. was Rs. 1.6 lakh, while the cost of the generic was Rs. 11,100 in India
- Likewise, Spiriva, a medicine for asthma, enjoys patent protection until 2021 in the U.S., largely due to secondary patents
- All of these secondary patents were rejected in India
- As a result, while the monthly cost of the medicine in the U.S. is over Rs. 19,100, it costs a mere Rs. 250 in India
How Indian patent law helps thwart evergreening practices by pharmaceutical companies?
Some features of the Indian Patent Law
- As per Section 2(1)(ja) of the Patents Act, the product in question must feature a technical advance over what came before that’s not obvious to a skilled person
- Because secondary patents for pharmaceuticals are often sought for trivial variants, they typically fail to qualify as an invention
- Further, when a medicine is merely a variant of a known substance, Section 3(d) necessitates a demonstration of improvement in its therapeutic efficacy
- The provision also bars patents for new uses and new properties of known substances
- This additional requirement is unique to Indian law[and along with Section 2(1)(ja)] ensures that bad patents stay out of the system
These sections are complemented by other exceptions to patentability
- Section 3(e) ensures that patents for combinations of known substances are allowed only if there is synergistic effect
- And Section 3(i) ensures that no exclusivity can be claimed over methods of treatment
- These provisions also extend to biologics
The way forward
- Blockbuster medicines are crucial to the success of public health
- But they have been gamed, and rendered inaccessible to the people and governments who need them
- In order for these medicines to be accessible, there can be no surer way than to enact strong standards that put bad patents where they belong
- Evergreening is any of various legal, business and technological strategies by which producers extend their patents over products that are about to expire, in order to retain royalties from them, by either taking out new patents (for example over associated delivery systems, or new pharmaceutical mixtures), or by buying out, or frustrating competitors, for longer periods of time than would normally be permissible under the law
What is a biologic drug (biologics)?
- A biologic drug (biologics) is a product that is produced from living organisms or contain components of living organisms
- Biologic drugs include a wide variety of products derived from human, animal, or microorganisms by using biotechnology
- Types of biologic drugs include vaccines, blood, blood components, cells, allergens, genes, tissues, and recombinant proteins
- Biologic products may contain proteins that control the action of other proteins and cellular processes, genes that control production of vital proteins, modified human hormones, or cells that produce substances that suppress or activate components of the immune system
- Biologic drugs are sometimes referred to as biologic response modifiers because they change the manner of operation of natural biologic intracellular and cellular actions