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

• Mail box provision

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

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.

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.

• 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.

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.

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.

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

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.

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.

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.

• 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.

• 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 corporatesto set up research facilities of global standard and intiated research programmes.

• 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.

• 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.

• 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.

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

Amlodipine(blood pressure),

Telmisartan (blood pressure –hypertension),

Rosuvastatin(statins),

Heparin (anticoagulant) ,

Ramipril(blood pressure and congestive heart failure)

Sitagliptin (antidiabetic),

Voglibose (antidiabetic).

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.

• 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.

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,opticalglass, semiconductors and intermetaliccompounds.

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 lactoferrinby Agennix.

o Pfter approached EMR for the patent of anticholestrol Lipitor who has already picked up sales in US market over 1$ billion.

• 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.