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Not new enough?

Is the Section 3(d) of the Patents Act tripping away from TRIPs? Katya Naidu explores the opinions of industry leaders in the light of the judgement on Glivec

Being 'new and improved' is not enough to be credited with a patent under the Indian Patents Act. Novartis' cancer drug Glivec was denied a patent by the Indian Patent Office, as it did not conform to Section 3(d) of the Indian Patents Act 2005, which introduced the "improved efficacy" hurdle for patentability for new forms of known compounds. While challenging this decision, Novartis had also questioned the constitutionality of Section 3(d). The lawmakers went by the rulebook when the Madras High Court recently dismissed Novartis' petition.

Dis-section

The section which is exclusive to Indian legislature, and hence, has become an example to many other developing countries in the process, claims that, "For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy." This essentially translates to the fact that drugs, for which forms are changed, are not patentable. And thus, Glivec in its beta crystal form was refused a patent. "Section 3(d) provides that a new form of a known substance would not be patented unless it differed significantly in properties regarding efficacy," says Anand Grover, an advocate representing Cancer Patients Aid Association.

"Section 3(d) excludes important developments in the form of incremental innovation, ultimately denying patients in India new and better medicines" - Ranjit Shahani Vice-Chairman and Managing Director Novartis India

However, Novartis has a different opinion on the Section. "Drug substances can occur in various physical forms, including liquid, semi-solid, amorphous and crystalline; and the crystalline forms themselves can vary significantly. Drawing an analogy from this, the element carbon can exist as soot, graphite or diamond, depending on how it was crystallised. The same element and yet what a difference in terms of value and utility," says Ranjit Shahani, Vice-Chairman and Managing Director, Novartis India and President of Organisation of Pharmaceutical Producers of India (OPPI).

The 'green' revolution

"Indian law permits only 'incremental innovation'. This ensures balance between the interests of the consumer and the innovator" - D G Shah Secretary General Indian Pharmaceutical Alliance (IPA)

The Section aims to prevent ever-greening, which is an infamous practise in many countries, wherein companies try to increase the patent life of a drug by making changes in the drug. "Section 3 (d) is introduced to prevent patent holder keeping a patent alive beyond 20-year patent period by trivial changes," comments D G Shah, Secretary General, Indian Pharmaceutical Alliance (IPA). Ever-greening is famous in the West, which also has regimes supporting minor changes. "The liberal patenting regime in the USA permits any 'trivial change' to be patented, whereas the Indian law permits only where there is 'incremental innovation'. This is good for the progress of science and ensures balance between the interests of the consumer and the innovator," adds Shah.

Incidentally, the patent for Glivec is recognised in about 40 countries, including many Asian countries. "Although Glivec has been awarded a patent for the beta crystal form in nearly 40 other countries, including China, Russia and Taiwan, the Indian Patent Office said that the application did not satisfy its requirements for 'novelty and inventive step'," says Shahani. But there are quite a few arguments which go against the reasoning that a patent, which is respected in many countries, should also be valued in India. "Patent is granted in each individual country depending on the patent law, which is applicable in that country. It is not open to an applicant to ask that patent be granted in any particular country on the ground that it has been granted in another country," refutes Grover. Shah shares the same opinions on the issue, pointing out that "Novartis claims that patent for Glivec is granted in 35 countries, implying thereby that it is not granted in 170 other countries!"

There have also been accusations that Section 3(d) does not conform to the TRIPs agreement. But these have been contested as well. IPA, in its written submission to the Chennai High Court asserts that Section 3(d)does not violate TRIPs and that the agreement gives countries the freedom of discretion to decide what can be patented and what cannot. The application took into account the patent laws of various WTO member countries and the survey showed that the exceptions to patentability provided for in their domestic legislations go much beyond the exceptions provided in Articles 27.2 and 27.3 of the TRIPs Agreement. There are more than 11 countries where there is a blanket ban on the grant of patents for mere discovery. In this scenario, IPA feels that Section 3(d) takes a middle path for the grant of patents. "Section 3(d) avoids taking an extreme position, but follows a commendable middle path. It is therefore submitted that Section 3(d) is constitutionally valid and the amendment to the section ought to be upheld," the application says.

Red for R&D

Though there are many opinions supporting Section 3(d), it is not completely fool proof. The law states that the new form of a medicine will get a patent only if there is an enhancement from the known efficacy. Words like efficacy and enhancement are subjective terms and cannot be defined easily. "It will be impossible to lay down a precise percentage or rule to determine the enhancement of efficacy, keeping in mind the diverse nature of medicines, chemicals and diseases," as written in IPA's submission to the Chennai High Court. The word "improvement" is also subjective and has been left to the discretion of the Controller for several decades. Similarly, novelty, non-obviousness, utility, new form or enhancement of the known efficacy are also subjective terms. It was submitted by the IPA that these are core concepts and fundamental issues which cannot be defined, making the judgment a matter of debate.

Also, Novartis believes that since Section 3(d) is not in favour of changes that are made to drugs, it will dampen R&D in the country. "Section 3(d) excludes important developments in the form of incremental innovation, ultimately denying patients in India new and better medicines. Effective patent systems help patients because incentives are in place that stimulate long-term research and development efforts needed to develop better medicines and ground-breaking therapies like Glivec," says Shahani. "Lack of respect for international intellectual property laws will serve as a limiting factor on India's desire to expand its research-based pharmaceutical industry," he added. He also said that Novartis prioritises its investments in R&D in countries, which respect intellectual property. And China, which has made great progress on this front has been recognised as an important R&D destination and the company has announced a centre there.

However, Novartis is not the only MNC in India that is affected by the Section. A number of patent filings by Pfizer and Astrazaneca stand to be refused, in accordance with the Section. In spite of these issues, few people seem concerned that the Section might disturb R&D in India. "There will be no adverse effect on research in India at all. The issue of research in India is entirely different from patenting on small changes in India. Companies do research in India because of the quality and price. Any research done here can be patented in any country according to the law applicable in the country," says Grover. On the contrary, Shah feels that it will benefit research in India. "It will encourage domestic pharmaceutical companies to strive for real innovation and not run after trivial changes, as has happened in the USA," he declares.

katya.naidu@expressindia.com