[Ip-health] Novartis's excuses fail once again

Baker, Brook b.baker at neu.edu
Thu Sep 29 18:12:37 PDT 2011


ActUp Paris held a vibrant demonstration at Novartis Headquarters on September 28, protesting Novartis's continued attacks on section 3(d) of India's Amended Patents Act 2005.  In response to the demonstration, Novartis sent the following misleading statement to journalists:

An unauthorized protest today at Novartis Headquarters in Rueil–Malmaison falsely portrayed the rationale and potential impact of our patent case in India. In response, we would like to outline our position.

Acknowledging innovation by granting a patent is unrelated to the access to medicines issue. Improving access to medicines is a matter of making medicines available.

Novartis believes that Section 3(d), the Indian legal paragraph intended as a hurdle for 'evergreening', is not applicable at all to Glivec, our life-saving breakthrough drug for cancer. Glivec has been granted a patent in nearly 40 countries – including China, Russia, Taiwan and all major developed countries – and we believe the same should be the case in India.

The beta crystal form of Imatinib mesylate is the active ingredient of the genuine breakthrough medicine Glivec. No other drug comprising Imatinib was available anywhere in the world before Glivec was launched. The patent filing claiming the beta crystal form of Imatinib mesylate relates to the genuine product and represents the very first patent right filed in India claiming Glivec. The patent relates to the form developed by Novartis, whereas other forms offered by the Respondents, such as the alpha form sold by Cipla or the H1 form patented by Hetero Drugs, are not at all affected. Only by ignoring these facts one can arrive to the misconception of 'evergreening' when referring to the present patent right.

In regard to the effect on other treatments, our legal action will in no way impact access to medicines to poor countries. Some groups are confusing the issue by drawing conclusions that the case will affect essential generic medicines produced in India for the developing world.

Pharmaceutical products have been patentable in India since 2005. Furthermore, independent of the legal outcome in our case, the current generic drugs will continue to be available because of the grandfather clause transition system. The grandfather clause of the Indian patent law stipulates that patent owners cannot prevent the sale of generic products that were available in India before 2005.

Medicines can be made available through access safeguards in international agreements and, in the case of essential and life-saving medicines, special pricing arrangements in developing countries can, and must, be made. In addition, more attention should be paid to other barriers to access such as lack of diagnosis, infrastructure and distribution.
It is frankly unbelievable that Novartis continues to assert that access to medicines is not impacted by the granting of a patent monopoly.  In the ordinary course of events, obtaining a patent gives the right holder authority to exclude others from making the patent product or using a patented process.  That right to exclude in turns gives rise to monopoly pricing power, especially in the pharmaceutical contexts, where Big Pharma companies price at whatever the market will bear and do so to make more money selling to rich elites than by selling larger quantities at lower prices that poor people and poor countries might afford.  In economic jargon, these excluded patients are called a dead-weight cost – in the real world, they are merely called dead, in Novartis's case of a treatable cancer.

The fact that Novartis's Glivec has been patented in 40 other countries is irrelevant to the Indian case.  Those countries had existing patent regimes that required pharmaceutical patents at the time of the original patenting of Imatinib mesylate, and they also allow easy patenting of new forms, formulations, and combinations of existing compound.  India denied patent protection to pharmaceutical products at the time Novartis's original compound was patented in those other countries and nothing in the TRIPS Agreement required India to grant patents retroactively before the effective date of TRIPS.

Even though it's true that Imatinib mesylate was not previously incorporated into a workable medicine before the follow-on discovery of its beta crystalline form, that distinction is irrelevant to the application of India's patent law, which does not allow patenting of new forms of existing chemical entities unless they show significant improvement in therapeutic effect.  The general compound, Imatinib mesylate was previously patented in many countries before the effective date of the TRIPS Agreement and before India was obligated to provide product patent protections even through its so-called mailbox provisions (holding application post-1995 through 2005 until the new Patent Act came into effect).  True, there was no evergreening by Novartis of an existing medicine, but there have been evergreening attempts re the patent on Imatinib mesylate.  Contrary to Novartis's assertion, one can evergreen a patent and/or a patented medicine.

In its most outrageous lie, Novartis argues that its legal action will in no way impact access to medicine in poor countries.  To the contrary, Novartis is attacking section 3(d)'s strict requirement of what must be proven to allow patenting of a new form of an existing compound.  Section 3(d) has been interpreted by the Indian Patents Office and several courts to require that there be "a significant enhancement of [therapeutic] efficacy," which would exclude patents based merely on improved bioavailability, better stability, longer shelf-life, etc.  Blocked by this interpretation, Novartis is now trying to convince the Indian Supreme Court to interpret section 3(d) to have a very low standard re efficacy.  If Novartis were to succeed, there would be many more patents based on trivial modifications of existing chemical entities and their formulations, there would be much higher monopoly pricing because of exclusion of generic competition, and there would undoubtedly be  a negative impact on access to medicines for poor patients not only in India but in the rest of the developing world.

Near the end of its statement to journalists, Novartis is correct that there are lawful mechanisms for gaining access to medicines, including compulsory licenses.  What it doesn't say is that it is a member of trade associations that criticized Thailand in 2006-2007 when it issued lawful compulsory licenses on AIDS and heart medicines.

Finally, Novartis hauls out the old petard that additional attention should be paid to diagnosis, infrastructure, and distribution rather than to its attempts to weaken section 3(d).  Access-to-medicines activists have had long-lasting campaigns on all of these issues, but that does not mean that patent monopolies and high prices do not have a first-order adverse effect on access to life-saving and life-enhancing medicines.

In its earlier, unsuccessful lawsuit against the constitutionality and TRIPS-compliance of section 3(d), Novartis was more honest in its press releases.  It argued that it should be able to garner monopolies and exclude generic competitor in countries like India that had growing elite and middle-income classes that could afford more expensive medicines.  Although Novartis always touts its Glivec access initiative, that initiative fails to reach and serve the vast majority of cancer patients whose lives would be saved or extended by Glivec.  Monopoly prices for the few and inadequate donation programs for the many is not a viable solution to the medicines needs of developing countries like India that face growing crises with respect to infectious diseases, neglected diseases, and now chronic non-infectious diseases.

Hopefully, Novartis's disinformation campaign will not mislead reporters and other opinion leaders.

Professor Brook K. Baker

Health GAP (Global Access Project)
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115 USA
Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa
(w) 617-373-3217
(cell) 617-259-0760
(fax) 617-373-5056
b.baker at neu.edu



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