Novartis Judgement – Boost Or a Bane??

 

Author: Shankar Dev

 

SC delivered a historic judgement on Monday against the Swiss pharma major Novartis to patent its anti-cancer drug Glivec. It’s a benchmark decision for intellectual property cases in India, where many patented drugs are unaffordable for most of its 1.2 billion people. The decision is being hailed by activists and has major implications for multinational pharmaceutical firms.  The decision opens the door for Indian companies to continue to make generics of a large number of drugs that are under patent in the developed world. But on the other side, Novartis’ claim that Section 3(d) of the Patent Act is unconstitutional, had raised the serious question of future investments and research by foreign pharmas in India and may have repercussions on India’s attempts to attract foreign investment.

It costs quite a bit of time and money to develop a new drug. As a matter of fact, it can take up to 15 years to develop a new drug. Because of this, companies are allowed to receive a patent for the drug. This patent protects the manufacturers of the drug from having another company copy their drug. However this patent expires by 10-20yrs. Once the patent expires, other companies are free to copy and produce their own version of the drug (something similar to “SAMSING”, the chinese counterpart of “SAMSUNG”..lol). These copies are called the generic form of the drug. Generic drugs will cost only a fraction of the patented drug. For instance, one month dose offered by Novartis’ Glivec, used to treat chronic myeloid leukaemia and other cancerscosts more than ` 1.2 lakh, while the generic version will be available at 8000.

So to extend their patent rights, big pharmas do some minor changes in proportion or ingredients and again get a new patent so as to avoid losing their cake to generic producers. This process is known as “evergreening”. Novartis altered their old drug in a new form called beta crystalline form and filed an application on July 17, 1998, for grant of a patent for Imatinib Mesylate in beta crystalline form at the Chennai Patent Office. Following some flip-flops the Assistant Collector of Patents and Designs heard all the parties in December 2005 and rejected the patent application. The company then challenged Assistant Collector’s orders and approached the Intellectual Property Appellate Board which subsequently dismissed Novartis’ plea.

After this, Novartis filed writ petitions in the Madras High Court seeking a declaration that Section 3(d) of the Patent Act is unconstitutional. This section states that inventions that are mere “discovery” of a “new form” of a “known substance” and do not result in increased efficacy of that substance are not patentable. It that mandates the need for a substantive innovation while deciding on a case for grant of a fresh patent. However, the High Court dismissed the writ.

Finally the firm moved to SC. On April 1st, SC dismissed the claim of the Swiss firm seeking exclusive rights for manufacturing the cancer drug and  held that ‘imatinib mesylate’ used in Glivec is a known substance and Novartis can’t claim patent over the drug for using this chemical. On referring to section 3(d) the court ruled that “In whatever way therapeutic efficacy may be interpreted, this much is absolutely clear: that the physio-chemical properties of beta crystalline form of Imatinib Mesylate, namely (i) more beneficial flow properties, (ii) better thermodynamic stability, and (iii) lower hygroscopicity may be otherwise beneficial but these properties cannot even be taken into account for the purpose of the test of Section 3 (d) of the Act, since these properties have nothing to do with therapeutic efficacy.The case of the appellant appears in rather poor light and the claim for patent would only appear as an attempt to obtain patent for Imatinib Mesylate, which would otherwise not be permissible in this country.”  By its verdict the SC upheld the constitutionality of Indian Patent Law and is in fully in conformity with international obligations under TRIPS Agreement.

However the verdict is expected to have a dual effect. On one hand, it may compel MNCs to relook at their future launches in the India, on the other, it’s likely to make way for home-grown pharma firms to provide affordable drugs to cancer patients. In a way Novartis response on SC verdict seems legitimate that it discourages innovative drug discovery essential for advancement in medical science along with India’s growing non-recognition of intellectual property rights that sustain research and development for innovative medicines. Here it is worthy to mention that India saw a major boom in pharma sector only after accepting WTO norms (TRIPS) and allowing foreign stakeholders.

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There is a dire need of new invention in medicine as new diseases roots every day. These inventions are not possible without research which needs enormous time, effort and money  also it is impossible to attain heights in the research without private participation. But the private companies are operating for profit. The original company that invented the drug, spent lot of money on establishment, production, research, advertising, etc. We all know how expensive advertising costs can be. Once the patent expires, the population is already aware of the drug. So when companies begin to make copies (generic forms of the drug), they don’t need to spend any money on advertising. That makes the price of the generic drug 30%-80% less than the cost of the brand name drug.

Patriotically speaking, India is one of the world’s largest producer and exporter of medicines and majority of the developing and under-developed countries depend on India for their medical needs. But practically speaking, Indian pharmas just plagiarise the innovations of western pharmas and are lagging much behind in R&D. They just replicate the generic copies of successful products of western companies. So we could well imagine the effects when enthusiastic efforts of overseas firms being curtailed.

On other hand while India has refused protection for Glivec on the grounds that it is not a new medicine, but an amended version of a known compound, the newer form of Glivec has been patented in nearly 40 countries including the United States, Russia and China. So in future India is likely to lose the FDI flow in the sector which may have adverse effect because it is one of the major employers of the country. If the business prospects of the firms are curtailed, they will start to manufacture the drugs in China or Singapore and will export it to India. This will result as a huge disadvantage for the country.

However there are plenty of allegations over the sub-standard products of generic drug industry. India need to regulate the country’s $ 26 billion generic drug industry, the generic drug manufacturers should be pinned down to strict quality standards. The government’s monitoring must be zealous and thorough.

But as people across the world rely on India for supplies of affordable versions of expensive patented medicines, the apex court verdict is welcome news.

 

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For Further Study:

TRIPS

Chapter II of the The Patents Act, 1970 on ‘Inventions not patentable’ reads as:

3. What are not inventions.—The following are not inventions within the meaning of this Act,—

(a) an invention which is frivolous or which claims anything obviously contrary to well established natural laws;

(b) an invention the primary or intended use or commercial exploitation of which could be contrary public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment;

(c)the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature;

(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation.—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 substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;

Pic Courtesy: hajirstony.blogspot.in

 

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