A case for 'Swiss-type' claims in Indian Patents Act

India should seriously consider including utility patents, particularly in the pharmaceutical sector, in the yet-to-be passed new patent legislation, so that in the emerging post-2005 scenario, the country will have its rightful place as a major contributor to the global pharmaceutical industry, says M. D. Nair.

INDIA, while in the process of amending its Patents Act, needs to seriously consider accepting ``Swiss-type" claims, defined as claims for new therapeutic uses of known molecules, considering the country's compulsions to encourage discovery of new uses for traditional medicines and clinical research.

The efforts and resources needed to pursue this approach are well within the means of Indian pharmaceutical companies, and therefore, it will be prudent to accept such claims on new uses of known molecules, while granting patents.

As the sun sets on the Indian Patents Act 1970, and a new era dawns on January 1, 2005, there are genuine concerns and apprehensions on the impact of the new scenario on industrial and R&D activities in India. Even long before that, India needs to put in place a balanced legislation that will fully utilise the provisions under TRIPS that are beneficial to India.

In the past, India's stance on matters related to Intellectual Property Rights and their protection has been to ensure that its consumer is not exploited by the monopolies provided by the patent system, which have been largely dominated by the R&D based pharmaceutical companies in the U.S., Western Europe and Japan.

The Patents Act 1970, which does not allow product claims for pharmaceuticals and curtailed the validity period to seven years from the date of filing or five years from the date of sealing of the patent, whichever is shorter, was meant to encourage the development and growth of the indigenous industry and make pharmaceutical products affordable to patients.

The TRIPS agreements have both mandatory and discriminatory provisions. The latter has the latitude for interpretations by the member countries in a manner that will be beneficial to them. For example, there is scope to adopt suitable definitions for patenting micro-organisms, genes and DNA sequences, plant varieties, and claims for new uses for known compounds for treating medical problems.

Swiss-type claims

A seemingly unambiguous feature of the patent system is the requirement of absolute novelty if an invention is to be deemed patentable. And yet, the U.S. had always maintained that the discovery of a new use for a known molecule has inventive merits, if such use does not form part of the state of the art, and hence, is patentable. Such innovations are no less beneficial than the original research to discover the first use. As a corollary, if a known substance is, for the first time, shown to have medicinal uses, in spite of lack of absolute novelty, such inventions will qualify for a utility patent.

The dispute in the minds of many other countries arose, as they felt that a new therapeutic use of a substance will be construed as a method of treatment of a human or animal body and hence, prima facie, such discoveries are not patentable, according to TRIPS. The European Patent Office and the Swiss Patent Office sorted out this issue in the early 1980s, with the latter proposing the following type of claim.

"Use of a compound X in the manufacture of a medicament for the treatment of disease Y." Such claims are called the "Swiss-type" claims. Patents relying on such claims have been the subject of several litigations in recent times in many countries, involving important drugs, such as Taxol. The protagonists of the permissibility of Swiss-type claims argue that efforts to discover new medicinal uses of marketed drugs will be encouraged only if they can be claimed and protected.

A large number of drugs in the market today have indications that are different from the ones for which they were discovered and in some cases patented; for example, the use of Aspirin in cardiac diseases, Metronidazole for anaerobic infections, Carbamazepine for epilepsy, Minoxidil for baldness or even Viagra for erectile dysfunction.

Among some of the issues that need sorting out, in this regard, are related to enforcement modalities of such second use patents. For example, how can a product already in the market be precluded from the new use and be the subject matter for an infringement suit? In the U.K., the Court of Appeal, in a case - Bristol-Myers-Squibb v Baker-Norton Pharmaceuticals - criticised the European Patent Office (EPO) for its granting ``claims with no thought as to how they would be enforced".

The global scene

While the U.S. had always granted patents based on "Swiss-type" claims, other countries have been slow in accepting the standards of patentability for the new use of a known molecule. The English Court of Appeal in the Bristol-Myers-Squibb case decreed that the scope of second medical use should be restricted to new, but distinctly different therapeutic applications and not for new modes of administration.

In a landmark decision, the New Zealand Court of Appeal ruled in favour of "Swiss-type" claims in a patent, providing a legal precedent to other courts including in other countries. Several other cases in the European courts and the U.S. also have endorsed "Swiss-type" claims. It has, however, been pointed out that a distinction may be made between a new benefit of a known use of a known molecule, example, a new Taxol formulation that reduces unwanted neutropenia, and a totally new use.

The balance at the moment among the various countries in North America, West Europe and Japan as well as New Zealand is in favour of allowing "Swiss-type" claims. Malaysia is one of the few developing countries that has incorporated in its patent law a provision for accepting claims drafted as uses of compounds to treat medical problems.

The Indian scene

Notwithstanding the grey areas, India has a strong reason to debate whether it is in the interest to provide for "Swiss-type" claims as patentable subject matter. The compulsions that would warrant such a pro-active approach are based on Indian capabilities, opportunities and limitation of resources, needed for drug discovery, development and marketing.

The emerging pharmaceutical R&D scenario in India has several constraints in the context of global models and approaches for new drug discovery. None of the Indian companies or national laboratories has the total capabilities, skill or adequate resources for the development of new drugs from concept to market.

In the prevailing western model of new drug research, it is estimated that the costs involved in drug discovery and marketing for a new molecule is as high as $600 million, figures outside the reach of any Indian company or consortium of companies. It would be prudent to work towards discovery of new indications for marketed drugs or known molecules, where the costs for such efforts could be a fraction of what it costs for total drug development.

To succeed in such ventures, one needs a rational approach at the pre-clinical stage of testing for new indications and optimal clinical acumen to capitalise on the serendipitous observations in the clinic, particularly of unexpected side-effects.

A second reason would be the potential of developing products based on traditional systems of medicine, where a whole area of new therapeutic applications beckons attention for development. In fact, in this area, India needs to evolve less stringent standards of patentability to capitalise on the country's rich and long heritage of knowledge in healthcare practices and products.

A third and equally important reason for allowing "Swiss-type" claims would be to support and encourage individual inventors and the small and tiny sector of the industry, which can exploit their research and techno-entrepreneurial skills to patent new uses of known molecules at affordable costs to themselves. Even if they do not have the skills, infrastructure and resources to develop and market the products, they can resort to the licensing route to reap adequate rewards.

In conclusion, India should seriously consider including "Swiss- type" claims; in other words, utility patents, particularly in the pharmaceutical sector, in the yet-to-be passed new patent legislation, so that in the emerging post-2005 scenario, the country will have its rightful place as a major contributor to the global pharmaceutical industry.

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