New?

New?

The ordinance does not do much more than the amended Indian Patents Act in defining what can or cannot be patented in the name of new, or inventive or capable of industrial application. While Indian law defines an invention as a 'new product or process', that possesses a not so obvious feature, with the potential to be developed or used in industrial applications, it makes no attempt to explain what would be considered 'new' or 'novel' or 'state of the art'. In fact, the proposed amendment only muddies the waters futher. It has added the word 'mere' before the phrase new use. In other words, whereas earlier discovering a new use for an existing drug could not be patented, but now, with the addition of the word 'mere' could mean if the new use for an existing drug was not considered mere, it could be patented. All in all, the definition is broad and vague and analysts argue that this will lead to enormous costs of litigation.

As trips does not elaborate the definition of what constitutes an invention, countries can innovate and define more clearly, what they believe constitutes an invention. For instance, countries can set their rules to differentiate between a non-patentable discovery and a patentable discovery, particularly with reference to genetic material. Industrialised countries have continuously expanded the meaning of invention to serve the interests of companies involved with gene technology. In contrast, Brazil, Argentina and the Andean Pact nations exclude patents on natural substances and their reproduction, since no invention is involved. Both these approaches conform to trips. Therefore, other countries have used this opportunity, provided within trips, to their advantage. India can do this as well.

Countries can also interpret and define 'novelty' according to national priorities. For instance, under us laws, an invention is no longer considered 'novel' once information about it is published either in the us or abroad. But if the information disclosed abroad is 'only' by word of mouth or unpublished, then even if it is sold abroad, it can be patented in the us. This interpretation of novelty discriminates against non- us inventors.

In Brazil
In Brazil, an invention is novel "if it does not form part of state of the art"; state of the art being defined as "to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the filing date of the patent application." France and Pakistan broadly follow the Brazil definition, as do Thailand and uk. China is explicit: "Novelty means, before the date of filing, no identical invention or utility model has been publicly disclosed in publications in the country or abroad, or has been publicly used or made known to the public by any other means in the country, nor has any other person filed previously with the Patent Office, an application which described the identical invention or utility model and was published after the said date of filing."

The basic subject matter of what can be patented, such as pharmaceutical substances, is also somewhat ambiguous. Should it be restricted to new chemical entities (nce), that is to say, the basic chemical molecule that has a certain therapeutic effect? Or, should patenting also be allowed for novel drug delivery systems, basically new ways (such as patches or inhalers) of administering drugs?

And how about innovations like metabolites (a chemical compound created when the patient's body metabolises the active ingredient of a drug) or innovations like polymorphs (includes compounds forming a crystalline structure different from the original molecule)?

Inadequate
The People's Commission on the Review of Legislations amending Patents Act 1970, an independent group chaired by former prime minister I K Gujral, which has been monitoring the patent provisions, argues that the amendment is inadequate. They suggest that the definition of invention must include the concept of basic novel product or process. By restricting invention to basic novelty, it would regulate the applications for patents to a manageable level, argues the commission.

They also say that invention should be further defined to ensure that nothing that is already in the public domain, in the country or elsewhere in the world, is patented. In other words, we should innovate, like the Chinese and others have done, to ensure that we restrict the use of patents to what is legitimate and deserves protection. Patents should not become the route to increase the monopoly of the inventor.

The Indian Drug Manufacturers' Association (idma), the industry association that represents a segment of the industry, wants the amendment to restrict patenting to only nces, or a basic new molecule. Even when it comes to novel drug delivery, idma says that it should be restricted only if the invention is based on a new technology. "Only significantly novel inventions should be granted patents, and we should prevent marginal innovations from being patented," contends Nihchal Israni, chairperson, Intellectual Property Rights Committee, idma and chairman and managing director of Blue Cross Laboratories.

But there are other views. The Organisation of Pharmaceutical Producers of India (oppi), that represents the multinational corporation viewpoint, supports patenting of all of the above, including innovations like metabolites and polymorphs. "Incremental innovations are India's strength. Where it's a low hanging fruit, we should grab with both hands," argues Ajit Dangi, director-general, oppi.

This us-led approach of trips- plus has clearly found favour with the Indian government as well. But can it organise the market here? Does this market wish to be organised? 12jav.net12jav.net