Drugs and Their Patenting-Human Health- For RAS/RTS Mains

Intellectual property:- is regarded as creation of mind in the form of patents for invention or copyright for literary and Art works in the form of Trademark and geography  indicators.

copyright:- includes nobles, poems ,films, musical work, artistic work such as drawing, painting, Photograph structural

Trademark :– it is a distinctive sign which is identified with certain goods or services as those produced by a specific person or Enterprises.The system has consumers identified and purchase a product or service because its nature is indicated by its unique trademark

Geographical indication:- it is an indicator used on goods that has a specific geographical Origins and posses qualities, reputation or character that attributes to that place of origin .The most common Government of India geographical indicator includes the name of the place of origin and name of goods. Geographical indicator may be used for all varieties of products with natural, agricultural and manufacturing. It may consist of geographical name or traditional designation used for the products which have a specific qualities and characters that areessentially due to Geographic environment in which they are produced for example:- Kullu shawls of Himachal Pradesh, Darjeeling Tea, Mugha silk of Assam ,Kanchipuram silk of Tamilnadu and other GI’s

Patent:- it is an exclusive right granted for an invention which is a product for a process that provides in general a new way of doing something Oasis a new technological solution to a problem a patent provides protection for invention which is granted to unlimited period upto 20 years

National Pharmaceutical Pricing Authority(NPPA)

  • It is under department of ministry of chemical and fertilizers .It is interested with the task of fixation or revision of prices of pharmaceuticals products and enforcement of provisions of drug price control order and monitoring enforcement of prices and the drug price control order 2013.
  • It authorises NPPA that in extraordinary circumstances if it considered necessary in Public Interest it can fix the price of any drugs for a period as it deams fit.  So the new law allowed NPPA to fix prices cap of drugs and this class applied to both drugs which are a part of National list of essential medicines or even outside of it.
  • In this context also looking into the ascent role that in the area of Public Health which is a social rights as government intervention become necessary especially when high prices makes medicine unaffordable and  also put huge financial burden in terms of out of pocket expenditure, this measure was used recently by nppa to fix the prices of widely used expensive antidiabetic and Cardiac medicine even not listed under National list of essential medicines.
  • National list of essential medicine is one of the key Health Care delivery system which includes acceptable and affordable quality medicines at all the levels of Health Care system.
  • Realising this Government of India Ministry of Health and Family Welfare decided to have its own essential medicine list.
  • To address the issue of changing disease ,privileges treatment modalities, introduction of new medicines and identification of therapeutic profile of some medicines, Ministry of Health and Family Welfare consider the need for updating the NLEM.

Primary purpose of NLEM is to promote the rational use of medicine, considering three important aspects:-

  1. cost
  2. safety
  3. efficiency

The central drugs standard control organisation is the national regulatory authority that evaluate the safety efficiency and quality of drugs in the country.


Generic drugs and their significance

  • Generic drugs are identical to a brand name drugs in chemical composition ,doses,route of Administration,Bio availability, safety and efficiency.
  • Although genetical drugs are chemically identical to their branded counterparts and frequently as effective as branded medicines ,but much cheaper and  sold at substantially discount from the price of branded name Drug. The Price of branded name Drug Company maybe 10 times higher than its generic counterpart.
  • This is cost incurred on the Clinical Research done by the Original drug manufacturer and also the advertisement cost of the branded drugs and as the brand name Drug Company has already spent considerable time in research , so generic companies are not required to conduct any Clinical Research.
  • Branded drugs are produced by only company granted patent whereas generic drugs are produce by many companies.
  • The competition in generic drugs is also another reason for low cost of generic drugs .Generic drug are marketed after the expiry date of patent and other exclusive rights .
  • Because of their low price generic drugs are often the only medicine that the poorest can access in particular life saving drugs ,anticancer drugs .
  • So that generic drug is effective and safer as branded drugs

Novratis vs Union of India case

  • Cognizant of patenting practice:- Parliament introduces a significant and important provision to prevent evergreening and granting of frivolous patent under section 3D of Indian Patent Act.
  • Section 3D of Patent Act stated the protection of Indian Masses in the Indian patent law,  it disallowed patenting of new forms of drugs with no substantive advancement, unless the new drug exhibit a significant enhancement in efficiency.
  • Evergreening is the practice of pharmaceutical companies to obtain patent on frivolous or minor change to non-drug and thereby establish a monopoly over a drug.
  • The Swiss pharmaceutical company is fighting for the patent of its anticancer drug GLIEVEC on the basis of increase bioavailability of the new drug in the cancer patient, but it lost its 7 year long battle as it could not with stand the test on the basis of enhanced Efficiency i.e. enhanced  theraputical efficiency.
  • So was rejected the patent even from the Supreme Court of India. It is the landmark judgement which will act as a deterance even for other multinational pharmaceutical companies not to involve in unfair practices of Evergreenery of patents.
  • India is leading producer of generic drugs in the world which is not only important for Poor patients in India, but also act as a lifeline of patent in the developing world especially in poor’s part of Africa to provide cheaper drugs including anticancer drug and life saving drugs


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