Newspaper: The Economic Times
Section: Policy
Date: 8th May 2007
Page No.: 17

The debate on patenting of ‘incremental inventions’ has not ended. In fact, it has just begun, with the patent offices in the country flooded with applications for grant of patents for pharmaceutical substances. Here are two opposing views on the contentious issue

Krishna Sarma

Trivial change may result in significant inventions

NATURA non facit saltum ie, generally nature does nothing in leaps. In his Origin of Species, Charles Darwin referred to this principle as a canon in natural history. Alfred Marshall used this phrase as a header to the introduction to his Principles of Economics. In other words, nature, change and innovation reflect incremental movements in the normal course of events. This also happens in the course of pharmaceutical and vaccine progress. Spectacular breakthroughs (so-called firstin-class products, or new active substances, originating from pioneering approaches) are rare. Change often occurs in molecules that may seem trivial but they bring about tremendous change in benefits to patients. A new medicine may be more effective in improving a medical condition. It can improve patient compliance through better dosage and forms of administration. It can have fewer side effects. Extending the indications of an existing medicine can also represent a significant innovation.

The patent system all over the world encourages the development of these improvements by conferring exclusive rights if they are new, involve an inventive step and are industrially applicable. On the other hand, improvements that are not new, do not involve an inventive step and are not industrially applicable are not patentable. The distinction is clear and significant.

It is unfortunate that the Indian law does not allow second use patents and limits patent protection to salts, esters, ethers, polymorphs and other derivatives of known substances unless it can be shown that they differ significantly in properties with regard to efficacy. This provision has been taken from Article 10(2) (b) of Directive 2004/27/EC of the European Parliament relating to medicinal products for human use. The recent patent rejections emanating from the four offices (at most times triggered by pre-grant oppositions) demonstrate that the term efficacy is being construed in a drug regulatory sense and admittedly patent examiners are ill equipped to appreciate efficacy standards. Patent applicants find it difficult to satisfy efficacy requirements at the stage of filing and prosecution of patent applications as pharmaceutical applications are usually filed at the initial stage of drug discovery and it is much later in the development cycle that efficacy and safety data is generated during clinical trials. There are no clear and transparent guidelines defining efficacy.

This limitation shows lack of clarity in policy goals, as it is a bit like cutting off ones nose to spite ones face. As a reflection of the current level and type of R&D innovations that the Indian pharmaceutical industry is undertaking, one has to merely take a look at the scope of PCT applications filed by them which demonstrates that most of these applications claim incremental inventions like new dosage form and new drug delivery systems. Its also noteworthy that 83 patents on stepwise innovations such as salts, esters and other modifications of existing patents are pending in Brazil, filed by Indian companies. Many innovative Indian pharmaceutical companies have publicly supported that incremental innovations should be protected by a patent. It is pertinent to mention that many Indian companies are currently working with many transnational firms in India developing new salts, derivatives, uses and dosages for existing new drugs. Many significant alliances have been signed in the last few years.

Critics of effective and meaningful patent protection in India are portraying this debate as one concerning access to medicines but the underlying issue is the level of patent protection in India and the extent to which it can favour local generic producers. It is about trade and the conflicting interests of the Indian generic manufacturers on one hand and the innovative pharmaceutical industry on the other hand. The availability of HIV treatments in India before 2005 under the old law (which did not allow patenting of pharmaceuticals at all) proves that lower patent standards in India do not translate into better access to medicines.

The recent, unfounded criticisms of the findings of the Mashelkar Report as well as the re-emergence of old and baseless arguments in favour of the exclusions from patent subject matter do not augur well for the country's objective of transforming into a knowledge society. India is an emerging economy with an important pharmaceutical industry. A strong pharmaceutical patent system in India is consistent with India's own economic growth goals.

 (The author is managing partner, Corporate Law Group)