Affordable Medicines And Treatment Campaign

    PRICES OF MEDICINES WILL SOON RISE- ACT NOW OR PAY LATER!!


    AFFORDABLE MEDICINES AND TREATMENT CAMPAIGN (AMTC)


Four years ago, millions of people living with HIV/AIDS could not afford the price of antiretroviral (ARV) drugs. The price was between US$10,000 –12,000 (Approx.Rs.4,50,000 – 5,40,000) per annum. By 2003 the prices had come down to US$ 140 (Rs.6300) per annum. How did this miracle happen? The answer lies in the Indian Patents Act, which provides only process patent protection to pharmaceutical inventions. However, after 31st December 2004, one cannot expect a repetition of this miracle because India will have to change its patent law and most of the new medicines will become just as costly as gleevec.

Gleevec the most effective anti-cancer drug cost Rs. 1, 20, 000 per month while the generic version is available less than one tenth of gleevec. An exclusive marketing rights for gleevec threatens the supply of generic drugs in India.

    Act now to keep medicine costs low!



What is a Patent?
A patent is a limited monopoly given to individuals/corporations for a limited number of years for technological inventions /innovations by preventing others from using the patented technology. It is granted at the request of individuals/ corporations by the Patent Office in respective countries. Hence, the patent right is available within the territory of the granting countries. Nearly 97% of the world’s patents belong to developed countries. Broadly patents can be classified into process patent and product patent. A process patent means that the monopoly is on the process of manufacturing the product and not on the product per se. On the other hand, the product patent gives a monopoly on the product itself that prevents others to manufacture, sell, distribute and import the patented product without the authorisation of the patent holder. Hence, a product patent on drugs means that only the patent holder can produce the patented drug in the normal circumstances. Monopoly as a rule results in high price and put the patented drug out of reach of majority of the people in India. On the other hand computation results in low price.

For instance, till 2001 Antiretroviral (ARV) drugs, the only effective treatment for HIV/AIDS, used to cost US$12000 per annum. The Indian drug companies, using the non-availability of product patent in India, could bring down the price to US$140 per annum within three years of their entry into the market. In 2001, the mere announcement of availability of a generic drug forced the multinational Merck to cut down the price of its ARV to US$800 per annum. Presently the generic companies supply these drugs at $140 per annum.

The Future Scenario
Right now, the Indian Patents Act provides only process patents for inventions in the pharmaceutical sector. As a result, more than one person is allowed to make the same drug provided they use different process to make their version of the product (if the process is protected by patent). Further, till 2002, the term of patents for pharmaceutical inventions was only seven years. These two factors enabled competition in the market by permitting more than one producer to produce the same drug. This resulted in the phenomenal growth of pharmaceutical industry in India and increased availability and accessibility of drugs. As a result drugs are available in India at world’s lowest price.

However, India must amend its Patent Act by 31 December 2004 to introduce product patent regime to comply with Trade Related Aspects of Intellectual Property Rights (TRIPS). TRIPS is part of the Final Act of Uruguay Round, which established the World Trade Organisation (WTO). India signed the TRIPS Agreement to become a member of the WTO in 1994.

The TRIPS Agreement prescribes universal minimum standards for seven types of intellectual property rights, including patents. There is a time line for implementation of obligations under the TRIPS Agreement. India amended its Patents Act in 1999 and 2002 to incorporate changes within the Patents Act to comply with the TRIPS Agreement. These changes include extension of patent protection to microorganisms, extension of the term of the patent protection, introduction of exclusive marketing rights for drugs and agro-chemicals, etc. According to the TRIPS Agreement developing countries like India should extend product patent protection to pharmaceuticals and agro-chemicals on or before 1 January 2005. Government is hurriedly trying to introduce an amendment bill in the winter session of the Parliament (December 2004). The present government has adopted the same bill introduced by the previous NDA government.

After the introduction of product patent protection only the patent holder or any authorised person through license can produce the patented drug during the lifetime of the patent. As a result, there would be only one manufacturer producing and distributing the patented product Introduction of product patents means that drug companies in the normal course come out with generic will not be able to do so until the expiry of 20 years of patented life. Further, the implementation of product patents cover all drugs patented on or after 1 January 1995. Hence, the product patent regime reduces the access to many new drugs and compromises the right to health. The impact of product patent in India will not be visible immediately. However, the product patent will reduce the access to new medicines.

Is There a Way?
Yes, certain measures can be incorporated on the Patents Act to ensure accessibility and availability of drugs. India can safeguard its interest by using the manoeuvring space available within the TRIPS Agreement. India has used some of these measures in the last two amendments to the Patents Act safeguard the public interest. However, measures have not been used at the optimum level to take maximum leverage. The main issues with the present amendment bill are:

1. Patentability
The first step in this direction would be to deny usage and dosage patents. Contrary to popular perception, there are many patents on a single drug mainly on their usage and dosage forms. Such multiple patents on a single drug will extend the monopoly beyond the expiry of original patent. A study shows that out of 1035 new drugs approved by the US regulatory authority during 1989-2000 only 35% contains a new chemical entity. However, the bill proposes to provide patents to new use of known medicines.

2. Compulsory License
A second step would be a total revamp of the compulsory licensing system. The present compulsory license regime in the Patents Act is loaded with cumbersome procedural formalities with no fixed time line. Fulfilment of these formalities itself delays the granting of compulsory licensing unreasonably and reduces the compulsory license to an ineffective mechanism to check monopoly.

3. Pre-grant Opposition
The bill proposes to do away with the pre-grant opposition procedure. Pre-grant opposition gives the public to challenge the patent application before the grant of patents. Therefore it is absolutely necessary to block the trivial patents.

➢ PUT RIGHT TO HEALTH ABOVE PATENTS ➢ SAY NO TO USAGE & DOSAGE PATENTS ➢ RETAIN PRE-GRANT OPPOSITION ➢ SAY NO TO TRIPS PLUS PROVISIONS

Other Required Amendments
• New definition for invention
• Changes in the non patentable invention
• Strengthen parallel importation
• No change in the pre grant opposition
• Introduce non voluntary license
• Introduce ceiling on royalty
• Strengthen local working requirements

For more details contact:
AMTC Secretariat, C/o Lawyers Collective, 4 / A, I Floor, MAH Road, Off Park Road, Tasker Town, Shivajinagar, Bangalore 560051 Tel: 51239130 / 1, Fax: 51239289, Email: aidslaw2@lawyerscollective.org

Also see: Information Pack on Patents (3rd Amendment) Act, 2004.