Saturday, December 1, 2007

Novartis: Patent Issue for Glivec


A Chennai court has rejected a challenge to the patent law filed by Novartis in a law-suit against the Indian government, the Cancer Patient Aid Association (CPAA) and some generic drug manufacturers in India. While the aid organizations have declared the ruling as a victory for the “right of patients over patents”, Novartis claims that the verdict will have long term negative consequences for the development of better medicines.

Novartis had claimed a patent for their anti-cancer drug Gleevec (known in India as Glivec). The cost of Glivec for a patient for one year is around 1.4 million INR, while other companies sell the generic version of the drug at about 1/10th of that price. The patent was denied by the Court on the basis of Section 3d of the Indian patent law which disallows patents for incrementally small innovations.
Had the case gone in favor of Novartis, it would have prevented the generic manufacturers from producing the drug at all. This case was very keenly followed by the international pharmaceutical industry, global relief organizations working for greater access to public health and generic drug manufacturers. There are about 9000 patent applications pending before the courts, most of them reflecting a scenario similar to this one. The way these cases are settled would thus have a profound influence on the production and sale of drugs for a wide range of diseases affecting the world.

This issue involves many powerful players with conflicting interests, with each trying to influence patent protection clauses for their own benefit. This article is an attempt to understand the view points of these various stake holders on the broader issues of patent protection and its consequences to (a) research and development investments by pharma firms, and (b) access to life saving drugs by the needy.

Linked to this is the vibrant growth of Indian generic drug manufacturers’ role in producing medicines for export to developing countries, and even to developed nations. As all these issues are inter-connected I will address them as a whole and, when it is relevant , discuss specific items. This article is organized as follows: I first present brief background information to understand the issues and then present different view points, and finally offer my perspective on the matter.

To start with, let us understand the issue of pharmaceutical patents in the Indian context. A patent is an exclusive right granted by the Government for an invention. This invention can either be (a) a product or (b) a process that offers a new way of doing or making something. Once the patent is granted, the invention cannot be commercially made, used, distributed or sold without the patent owner’s consent. The validity of the patent is for a fixed period, usually 20 years, during which the patent holder can exclusively profit from the invention. Therefore, it is understandable that large amounts of money are spent to obtain and protect patents.

Patents for pharmaceutical substances can be of two types (a) Product patents, which are given for a given chemical substance, say a drug, or (b) Process patents, which are for a specific way of manufacturing the substance. In the former case, the product patent allows the patent holder to profit exclusively from the drug, whose manufacture by any method is disallowed to others. In the process patent, however, others are forbidden only from producing the drug by the patented method but are free to manufacture it by another process of their own devising, which in turn could be patented.

For a long period of time, India granted only process patents for pharmaceuticals. Therefore pharma companies were free to devise a non-infringing process to manufacture a drug even if it was protected by a (process) patent in India. This changed when India became a member of WTO. As part of its obligation to comply with the TRIPS agreement, the Indian Patent Act now allows a product patent to be granted for a period of 20 years if it satisfies internationally accepted criteria for patentability. However, the amended law also includes, in Section 3(d), a provision that is unique to the Indian Act which states that patents would not be given for “incremental innovations”, i.e., new forms, uses or minor modifications of existing drugs unless they have a demonstrated greater “efficacy” than the earlier known one.

Given the current evolving phase of Indian patent laws, and the ambiguity of terms like “incremental” and “efficacy”, Novartis and other multinational drug manufacturers, as well as the groups opposing their patent claims, strengthen their arguments through self-serving interpretations of the Act. These technicalities and the nuances of patent laws appear obscure and are not the primary interest of this article. Those interested can refer to Novartis for Novartis’ point of view and to Medicine Sans Frontiers for the alternate argument.

The main concern of this article is to reconcile two opposing views. On one hand many people believe that is ethically untenable that patent law should offer the inventor company exclusive rights and monopoly on their invented product, giving them the freedom to make large amounts of profits from their product at a price fixed by their own choice, thereby leaving people who cannot afford the medicine to suffer, or even to die. On the other hand, pharmaceutical industries claim that protecting innovation, and the gain through innovative products, is the foundation for R&D investments made in the pharmaceutical sector. Without patent protection, the latter view goes, there would be no innovation and no new medicines.

There do exist some provisions which individual governments can exercise to provide medicines for those who cannot afford the prices dictated by the pharma companies. These are in place, at least theoretically, to enable the supply of essential medicines to poor countries and poor people. Section 3d of the Indian patent law is one such provision introduced by the Indian government for public health safeguards. This clause forbids the issue of patents for incremental innovation.

There is no clear consensus on what actually falls into the purview of incremental innovation. Section 3d is aimed to protect genuine improvement by barring frivolous tweaking being passed under the garb of innovation. It was introduced to prevent a practice termed "ever greening"--- i.e., drug companies making minor modifications to existing drugs so as to re-patent them at the end of their patent period, and selling them as new and improved products.

However, Novartis has argued that most medical progress happens through incremental innovation. And if the Indian law does not recognize these advances, it would negatively affect the development of better medicines.

On the other hand, Medicine Sans Frontiers, one of the leading NGO voices against Novartis, feels that allowing patents on minor modifications would actually be a disincentive for companies to address new medical challenges, for it would be more profitable to work on minor changes for patents than in investing on breakthrough innovation. And as an aside, it also argues that pharmaceutical research is driven by market potential, and as people in developing countries do not have the purchasing power to attract research funds for the serious diseases that affect them, pharmaceutical research primarily focuses on anti-wrinkle creams and anti-obesity drugs.

However, while I admit that research funding decisions are based on a cost-benefit analysis to maximize profit earnings, I believe that the typical culture of a research organization will certainly not be driven by such narrow attitudes. Furthermore, working towards incremental innovation and original inventions are usually not two exclusively different paradigms. In fact, most breakthrough inventions are achieved as one quantum leap in an incrementally innovational process.

As regards the other problem, of research focus areas not being relevant to the concerns of developing nations, this could be better achieved by working out innovative collaborations with pharma companies, than by denying them patent protection and depriving them of their profits.

Let us consider the Indian example. For a pharmaceutical company, the Indian market is not a homogenous entity. While there exists a large population of poor people with limited or no access to health care, there also exists a sizeable affluent population. A blanket protection against high drug prices, in the name of the poor, resulting in medicines being offered at cheap prices to affluent people cannot be a rational policy. Hence the Indian government can try to work on a differential pricing arrangement with pharma companies for the different markets that India comprises. The Indian government (or alternate monitoring/regulatory global bodies) can in return persuade the pharma companies to invest the profits gained from the affluent section of its population in medical research of concern to the country.

Research organizations like Novartis should work collaboratively with generic drug manufacturers, without claiming monopoly rights for critical drugs, to enable greater medical access to the entire population. The generic pharma companies in turn should reward the inventor by sharing a part of their profits for drugs within the patent regime sold in developing countries and the patent-expired drugs they sell to developed nations. Both players can thereby evolve a workable business strategy based on mutual trust.

Let us now consider the much-discussed issue of public access to drugs. Sustainable access to medicines in developing countries is a complex issue. Improving access to healthcare depends on a variety of factors
existence of trained healthcare staff and infrastructure
accessibility of the healthcare facility and quality of care
availability of affordable medicines
cultural acceptability of treatment(e.g. Islamic groups opposition to the polio vaccination drive in India recently)
and other factors.

The availability of medicines at reduced, off-patent, prices is just one aspect to this complex problem. That said, it is however a significant factor and a genuine commitment to address it is needed.

In the Glivec case, Novartis asserts that it is strongly committed to ensure that all patients have access to the medicine they need, and claims that 99% of the people who need Glivec are given the medicine free of cost through the Glivec International patient assistance program(GIPAP). However, this cannot be extended across the spectrum of other patented medicines. I believe corporate donations are not a sustainable solution to the problem. On this issue, all international pharmaceutical companies should come forward to work with government or non-governmental organizations for greater public access of patented medicines. This should not be just regarded as a public relations exercise to demonstrate their corporate social responsibility. A few things that these pharmaceutical companies can do are to

· offer not to file for patent protection for certain drugs in very poor countries and work with the respective government to enable access to the medicines that are needed locally. Such an act will gain them greater respect and credibility in the eyes of public.

· collaboratively work with drug manufacturers in poor nations to deal with
Infrastructure and stock-out contingencies.

An open attitude harmonizing corporate patent profit objectives with the privileges conferred to generic drug manufacturers, and concern for a general access to health care with an acknowledgement of the obvious buying power of the Indian affluent class, would facilitate policy development on a case by case basis for individual drugs. Upon such learning from individual cases can be evolved a generic strategy to attack this most important health case issue of our time.

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