Patent Protection issue- Novartis, Glivec

KanneBalaji 

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 1/10^th 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.