Syllabus: GS III Awareness in the ﬁelds of IT, Space, Computers, robotics, nano-technology, bio-technology and issues relating to intellectual property rights.
- Evergreening monopolies on medical products is a lucrative game for pharmaceutical corporations. Discuss
The price-lowering eﬀect of competition and domestic manufacturing of medicines can transform how diseases get treated in resource-poor settings.
- Decisions made by Indian patent oﬃces can negatively impact generic competition and supply worldwide, relying on the availability of aﬀordable medicines made in India. Monopolies granted by patent oﬃces on medical products keep prices high and block local manufacturers from supplying low-cost generic drugs.
- In 2005, lawmakers from all political parties amended Indian patent law to ensure that the Indian patent oﬃce did not grant monopolies on old science or for compounds already in the public domain.
- The new law now prevents drug corporations from indulging in “evergreening”, a common abusive patent practice aimed at obtaining separate patent monopolies relating to the same medicine.
- To bring this to the notice of the patent examiners, the amended patent law allowed any person to ﬁle a pre-grant opposition ‘anytime’ before the patent oﬃce decides to grant or reject a patent application.
- The Indian Patent Oﬃces receive an average of 50,000 patent applications a year, examiners often miss critical information about the patent application under consideration.
Evergreening issues in Indian pharmaceutical industries:
- A recent study on pharmaceutical patent grants in India revealed that 7 out of 10 patents are granted in error by the Indian Patent Oﬃce.
- A robust pre-grant opposition system provides an additional administrative layer of scrutiny that prevents the grant of frivolous patents through third parties’ participation in the review process.
- Evergreening monopolies on medical products is a lucrative game for pharmaceutical corporations allowing them to charge high prices.
- The ﬁrst challenge to a pending patent claim on a medicine was ﬁled by Cancer Patient Aid Association (CPAA) before the Indian patent oﬃce.
- CPAA highlighted that the Swiss corporation Novartis’ patent application on Imatinib Mesylate (Gleevec), a life-saving anti-cancer drug, claims a salt form of old medicine, a common practice within the pharmaceutical industry, and should not be considered patentable.
- The pre-grant opposition by CPAA on the cancer drug protected the price reduction from over ₹14 lakh per patient per year from Novartis to less than
₹40,000 per patient per year from generic manufacturers.
- In the last 17 years, generic manufacturers and people living with HIV, DR-TB, and viral hepatitis have also ﬁled several patent oppositions to safeguard generic competition so that quality, aﬀordable generics can be procured by health programmes.
- GSK withdrew the patent application in India and several other countries after the patent opposition in India pointed out that the patent claims did not cover a new invention but simply the combination of two existing drugs.
- Several such challenges before the patent oﬃce have successfully ensured the availability of aﬀordable HIV medicines to millions living across the developing world.
- The 99% reduction in the prices of antiretrovirals following the generic competition, from $10,000 per person per year down to less than $100, has been a critical factor in the expansion of antiretroviral treatment to millions in low and middle-income countries.
The humanitarian medical organisation, Médecins Sans Frontières (MSF), has supported hundreds of pre-grant oppositions in India, working closely with patient groups to safeguard generic competition to increase access to aﬀordable medicines from India.
Source ~The Hindu
Syllabus GS III-Awareness in the ﬁelds of IT, Space, Computers, robotics, nano-technology, bio-technology and issues relating to intellectual property rights.
2. Explain the microRNA-switch controls a gene that regulates nitrate absorption, root development, and stress tolerance.
The gene MADS27, which regulates nitrate absorption, root development and stress tolerance, is activated by the microRNA, miR444, therefore oﬀers a way to control these properties of the plant.The researchers studied this mechanism in both rice (monocot) and tobacco (dicot) plants.
Importance of Nitrogen in plants:
- Nitrogen is one of the most important macronutrients needed for development of a plant. It is a part of chlorophyll, amino acids and nucleic acids, among others.
- It is mostly sourced from the soil where it is mainly absorbed in the form of nitrates and ammonium by the roots.
- Nitrates also play a role in controlling genome-wide gene expression that in turn regulates root system architecture, ﬂowering time, leaf development, etc.
- Thus, while a lot of action takes place in the roots to absorb and convert nitrogen into useful nitrates, the absorbed nitrates in turn regulate plant development apart from being useful as a macronutrient.
Overuse of Nitrogen:
- The presence of nitrates is important for plant development and also for grain production. However, the overuse of nitrates in fertilisers, for instance, can lead to the dumping of nitrates in the soil which leads to accumulation of nitrates in water and soil. This accumulation adds to soil and water pollution and increased contribution to greenhouse gases.
- To avoid this, there should be optimal use of nitrates. Also, since the whole process of nitrate absorption takes place in the roots, a well-developed root system is needed for this to take place optimally.
- At one level, it is known that the hormone auxin is responsible for well-developed roots across all plants. A number of genes are known to help with auxin production, improved nitrate transport and assimilation in plants.
- Several gene regulatory switches that regulate nitrate absorption and root development, such as the microRNA, miR444, are known in monocot plants, such as rice.
- The microRNA ‘miR444’ is speciﬁc to monocots. When this is not made, its target, MADS27, is produced in higher abundance, and it improves biosynthesis and transport of the hormone auxin, which is key for root development and its branching.
- First, it regulates nitrate absorption by switching “on” proteins involved in this process.
- Second, it leads to better development of the roots by regulating auxin hormone production and transport.
- Finally, and somewhat surprisingly to the researchers, it helps in the abiotic stress tolerance by keeping the main stress player proteins “on.”
MADS27 works to improve three factors
- Nitrate absorption
- Root development
- Stress tolerance
with the help of RNA analysis and after ﬁnding to which part of the genome this transcription factor binds.
Tinkering MADS27 expression by genome editing is the next step, so that the modiﬁed plants are acceptable to use directly.The larger goal of this study is to understand how epigenetics plays a role in regulating expression of such important genes.