Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
Submitted by,
Urmila N Pai
S7 BTE
SCET
Post and pre TRIPS
• Introduction
• Post TRIPS
• Latest news on drug price reduction
• The patents amendments act 1999 and its
complications
...
The WTO is an international organisation that
deals with the rules of trade between nations. As
of February 2014, 160 cou...
Introduction of pharmaceutical product patents
would have a negative impact on the Indian
pharmaceutical industry by hamp...
 But there are still conflicts that new patent act might
reduce generic drugs supplies and lower access to medicine in
In...
• India’s pharma industry accounts for about 1.4
per cent of the global pharma industry in value
terms and 10 per cent in ...
The TRIPS Agreement not only increased the
R&D expenses of the Indian pharmaceutical
industry but has also changed its R&...
Since 2002, Indian companies have increased
investment in R&D in order to overcome the
competition in the world pharmaceu...
 On March 23, 2005, the Indian Parliament passed the Patent
(Amendment) Bill 2005 (Bill No. 32-C of 2005). It was the
thi...
Pharmaceutical companies have to submit test
and clinical data to the national health authorities
to obtain marketing app...
Through TRIPS ,IPR protection is made
possible and it encourages innovation leading
to useful products, investments in ma...
Post TRIPS
• Before TRIPS Indian pharmaceuticals were
floating without any direction and compliance
of urgency.
• Only aft...
• During many decades, Indian pharmaceutical s
were threatened.
• While few visionary like Dr.Reddy’s has
intiated to face...
• The intellectual property /patent awareness
creation and absorption as well as keenness
have largely helped to find a ne...
• When the Uruguay Round Conference
commenced in 1986 the global pharmaceutical
giants had a great scope of conquering the...
• During post trips regime there was the
misappropriation of traditional knowledge
• The cases of neem,turmeric and basmat...
• The enactment of biodiversity act of 2002 , with benefit
the sharing mechanisms, measuring the patenting is also
the dev...
Prices of widely-used expensive anti-diabetic
and cardiac medicines will reduce by as much
as 35% over the next few weeks...
 Amlodipine(blood pressure),
Telmisartan (blood pressure –hypertension),
Rosuvastatin(statins),
Heparin (anticoagulant...
The patents amendments act 1999
and its complications
•As a result of Uruguay round of GATT
which concluded in 1994 and ob...
• The minimum steps are:
• Make a mailbox facility to file product patents
related to drugs ,pharmaceutical and agrochemic...
Mail box provision
• Claim a substance is intended to use as a
drug,pharmaceutical.
• Relating to substances prepared or p...
o In few years, several foreign drug,
pharmaceutical and agrochemical industries like
Novo Nordisk,Chiron cooperation ,Jan...
• Within few years there was a dramatic changes in
India in patenting activity compared to other
developing countries.
• T...
Trips
Trips
Trips
Trips
Trips
Upcoming SlideShare
Loading in …5
×

Trips

231 views

Published on

This is a review on the Trade-Related Aspects of Intellectual Property Rights (TRIPS ) Agreement and its effect on cost reduction of drugs.

Published in: Engineering
  • Be the first to comment

Trips

  1. 1. Submitted by, Urmila N Pai S7 BTE SCET Post and pre TRIPS
  2. 2. • Introduction • Post TRIPS • Latest news on drug price reduction • The patents amendments act 1999 and its complications • Mail box provision
  3. 3. The WTO is an international organisation that deals with the rules of trade between nations. As of February 2014, 160 countries are Members of the WTO. The countries have to undertake 18 agreements for becoming a member of the WTO. Of these, 379 were in force. There are 585 notifications of RTA that had been received by GATT/WTO,among these 379 were in force. INTRODUCTION
  4. 4. Introduction of pharmaceutical product patents would have a negative impact on the Indian pharmaceutical industry by hampering its growth, this was the initial assumption. An industry can’t manufacture by reverse engineering or export drugs whose product patents are in effect. Against or contrary to expectations, the pharmaceutical industry was developing in post TRIPS period.
  5. 5.  But there are still conflicts that new patent act might reduce generic drugs supplies and lower access to medicine in India  India is one of the largest pharmaceutical exporters and a major supplier of affordable and quality generic drugs in the world.  At the same time, India is also one of the poorest developing countries lacking a national health insurance system and suffering from tropical diseases such as malaria and dengue fever.
  6. 6. • India’s pharma industry accounts for about 1.4 per cent of the global pharma industry in value terms and 10 per cent in volume terms. • Among the fastest growing pharma industries in the world, India’s pharmaceutical sector is expected to expand at a compound annual growth rate (CAGR) of 12.1 per cent during 2012–2020 and reach US$ 45 billion.
  7. 7. The TRIPS Agreement not only increased the R&D expenses of the Indian pharmaceutical industry but has also changed its R&D structure. The pharmaceutical industry is a highly R&D- oriented sector. Under the pro-patent regime of the TRIPS Agreement, for pharmaceutical companies, sustainable growth depends on their continuous R&D for developing new drugs and new technologies.
  8. 8. Since 2002, Indian companies have increased investment in R&D in order to overcome the competition in the world pharmaceutical market. Indian pharmaceutical companies are now becoming more R&D oriented. While the Indian government lagged behind the private sector, it recognised the need to radically improve the policy of the pharmaceutical industry in view of TRIPS and making changes to the Patent Act of 1970.
  9. 9.  On March 23, 2005, the Indian Parliament passed the Patent (Amendment) Bill 2005 (Bill No. 32-C of 2005). It was the third amendment to the Indian Patent Act(1970).  The amended Patent Act conforms to requirements set forth by the World Trade Organization's (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).  Since the new law came into effect on January 1, 2005, there have been serious concerns regarding the role of the domestic Indian generic industry in the new product patents regime, and the continued availability of essential medicines at affordable prices. PRE TRIPS
  10. 10. Pharmaceutical companies have to submit test and clinical data to the national health authorities to obtain marketing approval for a new drug.  The national health authorities keep the innovator data confidential against "unfair commercial use" for a certain time period, thus barring generic manufacturers from using the submitted innovator data for the stipulated period.
  11. 11. Through TRIPS ,IPR protection is made possible and it encourages innovation leading to useful products, investments in manufacture ,marketing and consequently impacts trade and economic growth of nation states.  Intially the founders of wto were not aware of the restrictive roles that TRIPS could play in overall development but now 160 members are well positioned to know about economic and noneconomic effects of TRIPS, and access to necessary drugs,which their nation is in need.
  12. 12. Post TRIPS • Before TRIPS Indian pharmaceuticals were floating without any direction and compliance of urgency. • Only after the emergence of trips to a new level, Indian pharmaceuticals woke with the new challenges of intellectual property regime.
  13. 13. • During many decades, Indian pharmaceutical s were threatened. • While few visionary like Dr.Reddy’s has intiated to face the challenges of product patent regime in 1990s by setting up the Drug Development Programme . • But the real action commenced in post 1995.
  14. 14. • The intellectual property /patent awareness creation and absorption as well as keenness have largely helped to find a newborn to set in motion and not to survive but also to show the trend of dominance in pharmaceutical industry that has been showing from few decades. • A good number of pharmaceutical corporates to set up research facilities of global standard and intiated research programmes.
  15. 15. • When the Uruguay Round Conference commenced in 1986 the global pharmaceutical giants had a great scope of conquering the markets that they lost once before years. • And the signing of TRIPS and WTO gave great expectations to the global corporate. • But because of flexibility of TRIPS there dreams of corporates were thwart.
  16. 16. • During post trips regime there was the misappropriation of traditional knowledge • The cases of neem,turmeric and basmati gave alert to law makers to include extreme safety measures to prevent the misappropriation. • The government of India under the auspices of CSIR through NISCAR and TKDL the compliation of traditional knowledge and know how in the field of indigenous wealth.
  17. 17. • The enactment of biodiversity act of 2002 , with benefit the sharing mechanisms, measuring the patenting is also the development of post TRIPS. • The enactment of Plant Variety Protection in 2001. • The Indian pharmaceutical which commenced export of bulk drugs and formulations to least developing countries in late 70’s and 80’s has then emerged as major global player. • The post scenario encouraged the technical and legal professionals to incorporate IP/Patent practices and upgradation of knowledge and work culture. • Almost all major global corporates has setup research facilities in India and have also made mergers and acquisitions.
  18. 18. Prices of widely-used expensive anti-diabetic and cardiac medicines will reduce by as much as 35% over the next few weeks, with the drug pricing regulator, National Pharmaceutical Pricing Authority (NPPA), deciding to bring them under price control. The drugs that will become cheaper include : Gliclazide (antidiabetic) Glimepiride (antidiabetic), LATEST NEWS ON DRUG PRICE REDUCTION
  19. 19.  Amlodipine(blood pressure), Telmisartan (blood pressure –hypertension), Rosuvastatin(statins), Heparin (anticoagulant) , Ramipril(blood pressure and congestive heart failure) Sitagliptin (antidiabetic), Voglibose (antidiabetic).
  20. 20. The patents amendments act 1999 and its complications •As a result of Uruguay round of GATT which concluded in 1994 and obligued that to meet all the provisions of TRIPS. Is was necessary to make changes in the Indian patents act 1970.
  21. 21. • The minimum steps are: • Make a mailbox facility to file product patents related to drugs ,pharmaceutical and agrochemicals. • Provide an option to obtain exclusive marketing rights in drugs pharmaceuticals and agro chemicals. There was a selection of expert group to suggest amendments and they recommend a set of measures to be implemented.
  22. 22. Mail box provision • Claim a substance is intended to use as a drug,pharmaceutical. • Relating to substances prepared or produced by chemical processes including alloys,optical glass, semiconductors and intermetalic compounds.
  23. 23. o In few years, several foreign drug, pharmaceutical and agrochemical industries like Novo Nordisk,Chiron cooperation ,Janssen pharmaceuticals NV,vertx pharmaceuticals, Eli lily etc had contributed to increase the number of patent in India. o A patent was granted for recombinant lactoferrin by Agennix. o Pfter approached EMR for the patent of anticholestrol Lipitor who has already picked up sales in US market over 1$ billion.
  24. 24. • Within few years there was a dramatic changes in India in patenting activity compared to other developing countries. • The patent amendment bill has been made in right direction. • The foreign direct investment has been encouraging. • Some other foreign countries see the India as potential market, and a platform for innovation,research centre and manufacturing facilities.

×