Patent Post

To patent or not to patent

One of the main objectives of the patents system-to develop new knowledge for prosperity of mankind-is getting diluted. The system is instead helping monopolisation of new knowledge for exploiting mankind. The need of the hour is to grant patents in a way that serves public interest

B K Keayla

The patent system was introduced in the legal scheme during the 19th century with a view to promoting basic inventions, enabling disclosure of inventions for further research and dissemination of the fruits of new research for the benefit of the public. The broad idea behind the system was to ensure availability of new knowledge for prosperity of mankind.

Patent rights are granted by the patent authority under the national law legislated through an enactment of Parliament. The rights are granted to both nationals and foreigners at par and are enforceable for a specified period of time and within the territorial limits of the country. In order to be patentable, an invention needs to meet certain criteria like novelty, non-obviousness and industrial applicability. That is, the invention should be previously unknown to the public, it should contain sufficient innovativeness to merit protection, and should be useful.

The patents system has acquired a unique position in the industrial economy of each country. It is a system which has to be carefully evolved to ensure that exploitation of the consumer does not take place through creation of absolute monopolies over new products. The interests of the patent holders and consumers have to be balanced to ensure achievement of objectives and smooth working of the patents system.

Scope of patentability

This is a core component of the patents system. The definitions of 'patentable invention' and 'patentable pharmaceutical substance' in particular have to be carefully framed to ensure that only subject matter of basic research are patented. Since the patents system prevents third parties from the acts of making, using, offering for sale, selling, or importing products for these purposes without the owner's consent, it is important to carefully frame the patentability as otherwise the system

will deprive effective competition in new products by other industrial enterprises. This scenario will be against public interest. The public health policy and laws, national drug policy and the patents system are intensely

co-related. This aspect should have been kept in view while implementing the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement in amending the Patents Act 1970.

Our former prime minister, the late Indira Gandhi, while speaking at the historic session of the World Health Assembly in Geneva on May 6, 1981 emphatically stated, "My idea of a better ordered world is one in which medical discoveries would be free of patents and there would be no profiteering from life or death." This statement was made not only with regard to India but for the entire world at the World Health Assembly where an important resolution on 'Health for All by 2000 AD' was also unanimously adopted by all countries. Forgetting this resolve, the Uruguay Round of GATT Negotiations, which concluded in December 1993, gave birth to the TRIPS Agreement containing high standards for a universally applicable new patent system to be implemented both by the poor and rich countries alike. Negotiations at the Uruguay Round kept in view only the interests of multinational corporations and not the ailing poor, particularly in developing and under developed countries. The present political regime seems to have totally forgotten the strong statement of their leader about the scope of patentability for pharmaceutical products.

India, being a member of the World Trade Organisation (WTO), was required to amend its Patents Act 1970 to bring its provisions in line with the TRIPS Agreement. The process was completed by amending our Act three times; in 1999, 2002, and 2005. During a debate in Parliament in April 2005 on the final amendments of the Patents Act 1970, several Members of Parliament (MPs) raised issues about 'patentable subject matter for pharmaceutical products' and 'exclusion of patenting of micro-organism'. The Minister for Commerce and Industry realised the importance of the issues raised and assured that they would be referred to a government-constituted Technical Export Group (TEG) for examination. When their report was submitted in December 2006, it was found that the recommendations of the Group were biased and not based on cogent reasons. Some parts of the report were even plagiarised from the submission made before the Group on behalf of the MNCs. So far, no decision has been taken on the report and the critical issues relating to the scope of patentability are still undecided.

Need to define patentability

In the absence of a proper definition of patentable invention, it is observed that patent authorities in India are granting patents on trivial and even unusual patents. (See Box: Patent Parody) So who is responsible for granting such patents? It would be improper to blame the Patent Authorities alone for grant of such patents. The real blame lies with the broad-based provision on patentability stipulated in the amended Patents Act 1970.

The crucial issue is whether the patent system is meant for researchers/scientists or trading enterprises like shopkeepers, dhabas, vendors, etc. The government must get its act together and refer the matter of 'scope of patentability' covering definition of patentable invention, patentable pharmaceutical substance and even patenting of micro-organism to the concerned Parliamentary Committee so that time is not lost in amending our Patents Act. Patentability should be for a real basic invention and not for trivial subject matter. Flooding of patents on trivial matters will only create a crisis and raise costs as in USA.

The problem does not end with the need to modify the 'scope of patentability'. In a recent statement made by a government official, it was observed that the government was thinking of granting patents for encouraging incremental innovations. The statement in question reads as follows: "It may not be prudent to award patents only for a new molecule discovery, something which requires billion of dollars worth of R&D investment. No Indian company can afford it. So we are looking for ways to award patents for discovery of a new form of a known substance which results in the enhancement of the known efficacy of that substance."

With regard to the above statement, it may be emphasised that certain technological innovations to pharmaceutical patented products may qualify for patentability under the patents system. Technological innovations, when they satisfy the prescribed criteria, can and should be protected only through process patents. The other possibility is that if there is significant technical advance over the invention claimed in the first patent, it is possible to grant a dependent patent. Section 91 of the Patents Act 1970 provides for licensing of related patents based on conditions stated therein. These available possibilities are sufficient and could be suitably availed by the industry. The government should not succumb to pressure from multinational corporations to further liberalise the scope of patentability.

It is a fact that the US is also extremely worried about the patent frequency in that country. "No patent examiner has enough time in their life to examine all innovations completely," states John Doll, the US Commissioner for Patents. Even the American Supreme Court has raised the bar for what subject matter deserves to be given a patent. A serious debate is on in the US as to how grant of patents could be contained. Even an important IPR Commission established by UK has suggested containing of patents by the developing countries. The WHO Commission on IPR and Innovations has also made a similar recommendation. These aspects must not be ignored by our government. And before considering further flexibility for patenting of incremental innovation, there should be adequate public debate.

The government must consider in-depth and determine means for containing the scope of patentability. TRIPS review under Article 71 of that Agreement is also over due. There are also a a number of Doha Ministerial Declaration (November 2001) issues pending for decision. Government should also make all efforts with the WTO to have decisions on these long pending issues expedited. This will serve public interest and also strengthen competitive environment and role of domestic enterprises.

(The author is the Convener of the National Working Group on Patent Laws. He can be contacted at wgkeayla@del6.vsnl.net.in)