Right to Health vis-à-vis Patent

Protection: The Indian

Scenario

Introduction

In India, all drugs were generics before 2005 because there were no product patents
for pharmaceuticals. India became fully TRIPS compliant in 2005 through the
introduction of pharmaceutical patents, with legislation that included safeguards to
protect public health. In particular, section 3(d) of India’s Patent Act was included
to prevent the extension of patent protection through minor product modifications,
unless a ‘significant enhancement of efficacy’ can be demonstrated. Marred by
expensive medicines, disparity with government and the pharmaceutical companies,
increased tax slabs, more import duty, threat to pull out of business and growing
escalation of unrealistic demands while not bridging the supply chain of essential
and affordable drugs is making our mortality rate a number that cannot be
ignored or misrepresented for the sake of public relations.

The judgment in Novartis AG vs. Union of India is a game changer in these

situations. Novartis took legal action against the Indian government to challenge the
constitutionality of section 3(d). When this was rejected, the company sought to have
Imatinib Mesylate, recognised as patentable although it did not have any effective
efficacy. The Novartis case is important because it highlights that it’s no longer
acceptable to the global public that hundreds of millions of people are denied access
to life-saving drugs because of monopoly pricing. And the case shows that
governments in developing countries with some economic and political clout, such as
India’s, are prepared to fight the big pharmaceutical companies.
The right to life and health is a fundamental right guaranteed to every person living in
India and is non-negotiable. India has amended the Patents Act in 1999 and 2002 to
comply with the obligations of Trade-related Aspects of Intellectual Property
Rights (TRIPS). The only pending obligation with regard to TRIPS is the introduction
of product patents to medicines and agro-chemicals. The product patent prohibits
others from making, using, offering for sale, selling or importing the patented product.
As a result, the product patent gives a monopoly to the patent owner for the
production of patented article during the term of the patent (20 years). Therefore,
product patent protection for medicines and agro-chemicals creates monopoly and
eliminates competition in the pharmaceutical market.
Drug companies often abuse the patent monopoly and fix exorbitant prices for the
patented medicines. The introduction of product patent thus reduces accessibility and
affordability of drugs. The net result of the TRIPS accord has been high cost of
medicines and the consequent denial of access to medicines to the poor across the
globe. Further, it has also led to a situation where medicines required to treat diseases
that predominantly occur among the poor are not researched at all. Instead drugs that
are being researched are drugs used for “lifestyle” diseases like impotence, baldness,
obesity, etc . While the pharmaceutical industry claims that high prices are explained
by the massive expenditure on R&D, the truth is that drugs they actually research
have little relevance to real medical needs. Moreover, the kinds of profits that big
pharmaceutical MNCs generate are an indication of profiteering and not just
legitimate profit making.
Before signing of the WTO agreement, and in the ensuing 10 years till date, globally
as well as in the country, diverse contentions have emerged about the impact of
TRIPS compliant Patent Laws on domestic industry – especially in developing
countries. There is, however, a wide consensus that domestic laws, while being TRIPS
compliant, need to make full use of “flexibilities” available in the TRIPS agreement.
This was reiterated in unequivocal terms by the WTO Doha Declaration on TRIPS
Agreement and Public Health (2001), which, inter alia, commented that countries
have the sovereign right to enact laws that safeguard domestic interests. It recognised
the gravity of public health problems in developing countries and clearly provided that
the member countries had the right to protect public health and to promote access to
medicines for all.

Patenting Of Life Saving

Drugs: Revisiting The Debate
The relationship between human rights and intellectual property requires elaboration.
On the one hand, intellectual property does not provide much guidance concerning its
links with other fields of law. On the other hand, human rights treaties show that the
interests of the patent holder are recognised but not as fundamental rights and that the
interests of the community at large come first. TRIPs was adopted as a stand-alone
agreement which makes no mention of the impacts it can have, for instance, in the
field of health. Nevertheless, WTO member-states that are also parties to human rights
treaties cannot draft legislation to implement WTO obligations without considering its
compatibility with other international obligations, such as human rights commitments.
In fact, the UNCESR has specifically indicated in the case of the right to health that
states should not agree to measures that are manifestly incompatible with their
previous international legal obligations.
Even though the formulation of the right to health at the international level is vague, it
gives at least a broad framework within which health policies should fall. Thus, it
imposes on governments to progressively facilitate access to drugs. Since patents on
drugs tend to push prices up, governments have a duty to ensure that the introduction
of product patents does not jeopardize access to drugs. Indeed, not only should states
refrain from taking any steps that limit access to drugs but also they should also
actively pursue better access over time. In this sense, it is doubtful whether the
amendment to the Patents Act of 1970 can stand scrutiny under human rights treaties.
The 1970 Act introduced a number of limitations on the scope of the rights granted to
patent holders with specific public health goals in mind. Dismantling the whole
regime amounts to taking several steps back in terms of access to drugs. This seems
even truer in the context of the HIV/AIDS crisis, where some of the existing drugs are
often available only at prices that are prohibitive for the general public.
The patents bill attempts to put India in compliance with its TRIPs obligations. In the
process, it sets aside some of the most salient elements of the current legal regime
which, together with other instruments such as the Drugs Price Control Order, have
generally served well the interests of the country and its inhabitants. It is likely to
bring about a legal regime that is less favourable from the point of view of access to
drugs for the people of this country.

The rationale for introducing the bill in this form was partly that TRIPs does not
provide much flexibility in the way it can be implemented. This has now been proved
wrong as the examples from South Africa and Brazil indicate. There is today scope
for flexibility within TRIPs itself. Further, TRIPs cannot be implemented in isolation.
India has a number of other international obligations, particularly in the field of
human rights.
As interpreted by UN human rights organs, the right to health requires that countries
progressively take positive steps towards facilitating access. Dismantling the 1970
regime may constitute a violation of India’s obligations under the Covenant on
economic, social and cultural rights. There are thus compelling reasons for redrafting
the patents bill in a way which neither threatens the country’s interests nor constitutes
a potential violation of human rights.

The International Perspective

So far we have dealt with arguments, which says as to why patent regime in India
should be kept out of the purview of medicines. Now we look at the whole discussion
from an International perspective. It can be categorized as follows:

1) United Nations
One key issue at the Special Session of the UN General Assembly (UNGASS) on
Social Development was the right of people to essential medicines at affordable
prices, and how this right is being undermined by patents and the intellectual property
rights regime established by the WTO’s TRIPS Agreement. At the end of the 24th
Session of the United Nations General Assembly Special Session (UNGASS) in
Geneva, governments agreed, after tough negotiations, that they would be allowed to
freely exercise options already available to them under international trade agreements
to protect and advance access to life-saving and essential medicines.
In terms of real progress in addressing the need of developing Countries and poor
people’s access to life-saving drugs, not much was achieved. In terms of bringing to
light the efforts of some of the developed countries in pushing the agenda of
pharmaceutical corporations, quite a bit was achieved.

2) Doha Declaration on Health

The Declaration neither amends the TRIPS Agreement nor provides a basis for
developing Countries to link their patent and health legislations. The Patents
(Amendment) Act, 2002 closely follows TRIPS and in the process does away with
provisions of the 1970 Act that constituted India’s own response to the challenge of
providing exclusive commercial rights in a field concerned with the fulfillment of
basic health needs.
The provisions of the 1970 act and similar legal regimes in other developing countries
have been the source of significant complaints by the private sector pharmaceuticals
industry in developed countries. The US pharmaceuticals lobby estimates that it
currently loses more $1.7 billion annually because of India’s insufficient intellectual
property protection
The Doha Declaration is a direct consequence of the multiple controversies
concerning patents in the health sector, particularly in the context of the HIV/AIDS
epidemics. Its importance is linked to the recognition that the existence of patent
rights in the health sector does not stop from taking measures to protect public health.
More specifically, it affirms that TRIPS should be “interpreted and implemented in a
manner supportive of WTO members right to protect public health and, in particular,
to promote access to medicines for all.” This strengthens the position of countries that
want to take advantage of the existing flexibility within TRIPS. In other words, the
declaration does not open new avenues within TRIPS but confirms the legitimacy of
measures seeking to use to the largest extent possible the in-built flexibility found in
TRIPS.

The declaration focuses mainly on questions related to the implementation of patents,

such as compulsory licensing. Compulsory licensing has long been used as a tool to
regulate the exclusive rights conferred by patents. In the case of health, the rationale is
to make sure that the existence of a patent does not create a situation where a
protected medicine is not available to the public because of non-health related factors.

The Patents Act, 1970 provided an elaborate regime that included both compulsory
licenses and licenses of right . The TRIPS Agreement has not done away with the
notion of compulsory licenses but provides a more restrictive framework than the
current regime in force in India. The recognition in the Doha Declaration that TRIPS
member-states can use the flexibility provided in the agreement and can, for instance,
determine the grounds on which compulsory licenses are granted must thus be
understood in the context of a generally increasingly restrictive international patent
regime.
The declaration has been hailed as a major step forward in the quest for making the
TRIPS Agreement more responsive to the needs of developing countries and more
specifically to individuals who are unable to afford the cost of patented drugs. In fact,
it addresses a number of important issues related to the implementation of medical
patents. However, it fails to take up the much more fundamental questions of the
scope of patentability and the duration of patents in the health sector. The Doha
Declaration remains an important instrument in India for two main reasons. Firstly, at
a political level, India was amongst the most vocal developing countries at the
ministerial conference in putting forward developing Countries’ interests. Secondly,
the declaration was adopted while the joint committee of Parliament was finalizing its
report[xi].

3) Forthcoming WTO Negotiations

At this juncture, the WTO is far from providing a comprehensive response to the
needs of developing Countries in the field of health in general. At the most, the Doha
Declaration provides a temporary respite in some limited areas. The declaration does
not even indicate that negotiations in the new round of trade negotiations will
necessarily go towards a relaxation of the TRIPS requirements in this field. In fact, the
recent aggressive posturing of the US pharmaceuticals industry seems to suggest that
significant lobbying for further strengthening of patent rules is likely to take place in
the future.

On the whole, the Patents (Amendment) Act, 2002 closely follows TRIPS and in the
process does away with provisions of the 1970 Act. Firstly, there has been no official
change in the policy underlying the Patents Act to justify such drastic changes.
Secondly, India’s domestic and international commitments regarding the fundamental
right to health of all individuals have not changed in the past decade .
Thirdly, it appears that the introduction of product patents in 2005 will adversely
affect access to medicines for crores of people. One factor pushing the government in
this direction may have been the desire to favour its own private sector
pharmaceuticals industry. However, it is striking that there is no unanimity on the part
of the industry, which remains today completely or mainly domestic. Some large
companies that produce mainly generic drugs have been completely opposed to
changes in the 1970 Patents Act, some large companies that have developed
significant R and D facilities feel that the new regime may provide them an
opportunity to grow overseas while small companies generally seem to have
understood that they are not important enough to influence policy-making
significantly and must concentrate on surviving either independently or by linking up
with bigger domestic or foreign companies.
Human Health vs. Patent Law
Dear Life in good health and free from disease is the foremost human right and is a
constitutional fundamental. The humbler the Indian human, the higher the state’s duty
to protect the person. In this perspective we may have to examine the impact
of TRIPS (Trade-Related Intellectual Property Rights) Agreement on Indian corpus
juris vis-a-vis the right to life guaranteed under Article 21 of the Constitution, read
with Article 14. Public health laws, national drug policy and the patent system are
intensely inter-related. This was explained by Prime Minister Indira Gandhi while
speaking at the World Health Assembly in Geneva on May 6, 1981. In her words:
“Affluent societies are spending vast sums of money understandably on the search for
new products and processes to alleviate suffering and to prolong life. In the process,
drug manufacture has become a powerful industry.”

She added, on the patent system: “My idea of a better ordered world is one in which
medical discoveries would be free of patents and there would be no profiteering from
life or death.” In this historic session, the participating countries unanimously adopted
a resolution for “Global Strategy on Health for All”. Since then there have been
laudable contributions by science and technology to tackle successfully many health
problem areas.

While there is a substantial unfinished agenda on the health front, new and formidable
challenges have been thrown up by an unequal treaty on all-pervasive economic and
social aspects by the Final Act embodying the results of the Uruguay Round
negotiations. In particular, the TRIPS agreement is the most contentious part of the
Final Act. The aim of this agreement is to enforce globally tough standards in respect
of several forms of intellectual property, which include patents, trade marks,
protection of undisclosed information, and so on, forgetting the goals expressed by
Indira Gandhi in regard to freeing of medical discoveries from the patent system.

A patent is a monopoly right granted by a state to a person to exploit and benefit from
the invention patented by him for a particular period. Thereafter, it passes into the
public domain. According to Justice Rajagopala Ayyangar’s report submitted in 19
59, which report constitutes the basis for the Indian Patents Act, 1970,
“The theory upon which the patent system is based is that the opportunity of acquiring
exclusive rights in an invention stimulates technical progress in four ways: first, that
it encourages research and invention; second, that it induces an inventor to disclose
his discoveries instead of keeping them as a trade secret; third, that it offers a reward
for the expenses of developing inventions to the stage at which they are commercially
practicable; and fourth, that it provides an inducement to invest capital in new lines
of production which might not appear profitable if many competing producers
embarked on them simultaneously. Manufacturers would not be prepared to develop
and prod uce important machinery if others could get the results of their work with
impunity.”
To the same effect is the decision of the Supreme Court in Vishwanath Prasad v.
Hindustan Metal Industries (Justice Jeevan Reddy)
In a cultural milieu where “knowledge is free”, and is transmitted from generation to
generation as a duty, it is incongruous to convert discoveries into “cash and carry”
vulgarity but that is the perversion under pressure from Western Big Business.
“Intellectual Property Rights” conceptually belongs to this money manic bigotry and
TRIPS is the parent of this morally indefensible but virtually glorified anathema.

Even so, in human affairs, minor adjustments, without forsaking fundamentals, may
be necessary for peaceful co-existence. Even the TRIPS text partially acknowledges
this aspect. It is ironic but interesting to recall Thomas Jefferson’s words:

“If nature has made any one thing less susceptible than all others of exclusive
property, it is the action of the thinking power called an idea… No one possesses the
less, because every other possesses the whole of it. He who receives an idea from me
receives instruction himself without lessening mine; as he who lights his taper at
mine, receives light without darkening me.” In Jefferson’s vision, there are no
barriers to the acquisition of knowledge. Nobody owns it, everybody partakes of it –
and the world becomes richer. Alas, his country is the most venal violator of this
value. Our cultural cornerstone, the Rigveda mandates: Let noble thoughts come to us
from every side.” Patenting intellect or its products is sacrilegious and social outrage.

Appreciating the Pro-Health

Right Scenario in Developing
Countries
There are five reasons why it is important for courts in developing countries not to
ignore the right to health when adjudicating pharmaceutical patent cases.

One, the courts have to be more vigilant when scrutinizing legislation aimed at
granting stronger protection to patents. Several bilateral and regional trade agreements
currently pressure developing countries to adopt legislation providing stronger patent
protection, but possibly significantly impeding access to medicines. Courts should be
vigilant and careful when interpreting such laws to ensure that the right to health of
poor patients is not trampled upon. The Kenyan Anti-Counterfeit Act is just one
example of the current expansionist trends in international patent law which, among
other methods, seeks to use border and customs control measures to prevent the
movement of counterfeit goods across international borders.
While such measures might actually be helpful in protecting people from harmful fake
products, such measures can equally restrict access to low-cost generic medicines.
The failure of the Kenyan Anti-Counterfeit Act to clearly distinguish between
counterfeit drugs and generic drugs demonstrates this danger. Thus, where a country
has been compelled to include a similar provision in its patent law by means of a trade
agreement, the provision can be held to be unconstitutional on the basis that it can
potentially impede the enjoyment of the right to health. Similar arguments can also be
made with respect to any other provision incorporated into the domestic patent law
framework that might impede the enjoyment of the right to health.
For instance, where a trade agreement requires a country to provide patent protection
for new forms (or new uses) of known drugs, a court could rule that such a provision
in the patent law would impede the enjoyment of the right to health by permitting
pharmaceutical companies to extend the length of their monopoly rights on essential
medicines. In other words, the fundamental and critical need of providing access to
essential medicines would not be served by extending the lifespan of the instrumental
(monopoly) rights of pharmaceutical companies on essential drugs.

Two, incorporating a right to health perspective into pharmaceutical patent cases

enables a court to properly construe and apply the flexibilities already contained in the
domestic patent law such as provisions on compulsory licenses and parallel
importation. For instance, as seen from the analysis of the Kenyan cases, the tribunal
in the Pfizer case failed to recognize the tension between patent rights and access to
medicines; it is therefore not surprising that it also failed to properly construe and
apply the provisions on parallel importation in the Kenyan patent law.

However, in its decision in the Ochieng case, the Kenyan High Court incorporated a
right to health perspective into its decision and properly construed the provision on
parallel importation. The Kenyan High Court noted that:… [U]ntil the passage of the
Industrial Property Act in 2001 … it was not possible for poor people infected with
HIV/AIDS to access anti-retroviral medication as the only ones available were
expensive branded medicines. Generic anti-retroviral drugs were not available in
Kenya as the existing legislation did not allow parallel importation of generic drugs
and medicines.
Section 58(2) [of the 2001 Act] … allowed the parallel importation of generic drugs.
It is on the basis of this legislation that availability and access to anti-retroviral drugs
has increased and greatly enhanced the life and health of persons such as the
petitioners who have been living with HIV/AIDS. The incorporation of a right to
health perspective can therefore also assist a court in construing patent laws and
flexibilities in a manner that serves the fundamental and critical need of securing
access to medicines.
n addition, a right to health perspective can be quite helpful when a court is
considering the balance of convenience in a case where a pharmaceutical company is
trying to obtain an injunction to prohibit or delay the production of cheaper generic
drugs.
For instance, in the Indian case of Hoffmann-La Roche Ltd. v. Cipla Ltd., the Delhi
High Court refused to grant an injunction sought by Roche against Cipla for the
latter’s production of the former’s patented drug. The Delhi High Court noted that:
The Court cannot be unmindful of the right of the general public to access life-
saving drugs which are available and for which such access would be denied if the
injunction were granted. … The degree of harm in such eventuality is absolute; the
chances of improvement of life expectancy; even chances of recovery in some cases
would be snuffed out altogether if injunction were granted. … Another way of viewing
it is that if the injunction in the case of a life-saving drug were to be granted, the
Court would in effect be stifling Article 21 [of the Indian Constitution], which
provides for the right to life and which forms the bedrock of the right to health in
India] so far as those [who] would have or could have access to Erloticip are
concerned.
Three, courts in developing countries should equally be aware that courtrooms are
now forums for shaping and reshaping global health diplomacy. While multinational
pharmaceutical companies can successfully lobby for stronger patent protection in
international trade forums, poor patients and civil society groups usually rely on
domestic courts to ensure that their interests are protected at the local level.
Consequently, in a situation where more courts in developing countries are adopting a
right to health perspective in pharmaceutical patent cases, it will encourage litigants in
other developing countries to seek the assistance of local courts to protect their right
to health. These local courts may also decide to follow the example of other countries
by incorporating a right to health perspective in pharmaceutical patent cases.
Four, as the impact of non-communicable diseases such as cancer continues to
increase in developing countries, it is obvious that more patients will require access to
expensive but essential drugs in order to sustain a healthy lifestyle. A right to health
perspective will, therefore, ensure that courts are mindful of the importance of the
availability of cheaper generic drugs in the market. The Kenyan High Court in the
Ochieng case was mindful of the need to ensure that generic antiretroviral drugs
remained affordable and accessible.

The court noted that “[m]any of those who are infected with the virus are, like the
petitioners, unemployed and therefore financially incapable of procuring for
themselves the anti-retroviral branded medication that they need to remain healthy.
They are therefore dependent on generic anti-retroviral medication which is much
cheaper and therefore more accessible to them.” If the Kenyan Anti-Counterfeit Act
had been implemented in the form in which it was enacted, it would have jeopardized
the lives of the petitioners and other patients who rely on the availability of cheaper
generic drugs.
Finally, it is important to note that, unlike the situation in industrialized countries
where there are sophisticated mechanisms such as antitrust laws that can be used to
curb the excesses of pharmaceutical companies, in several developing countries the
legal framework to curb anti-competitive activities is either undeveloped,
underutilized, or non-existent.

In several developing countries, the right to health is the only potent weapon that can
be effectively used to ensure that pharmaceutical companies do not abuse their patent
rights. It is essential for developing countries to devise strategies to curtail the current
expansionist trends in international patent law. In the midst of growing demands for
stronger patent laws, the right to health can be utilized to reclaim some policy space
for developing countries to design their national patent laws in a manner that
facilitates access to medicines.
Domestic courts have a major role to play in this regard: when they are adjudicating
disputes involving patents on pharmaceutical products, they can recognize the tension
between patent rights and the right to health and resolve this tension by distinguishing
between the instrumental nature of patent rights and the fundamental nature of the
right to health.

Novartis AG Vs. Union of India:

A Review
In early April, India’s Supreme Court rejected an application by the Swiss
multinational pharmaceutical company Novartis for a patent on a modified version of
the leukemia medication imatinib mesylate. Naturally, the outcome of the case affects
the affordability of the drug. But the core issue was the right of the Indian government
to take account of public health in designing intellectual property rights (IPR)
legislation.
In India, Novartis charges about US$26,000 per patent per year for the drug, marketed
as Glivec (Gleevec in the United States). But generic versions produced by local
companies are available for less than US$2,500. Novartis’s price excludes all patients
except the extremely rich, although the company supplies Glivec for free to some
patients.
The Indian government and civil society groups see this situation as health policy
being held hostage to corporate charity. And to them that is unacceptable. The
Novartis case confirms the right of India’s parliament to implement public health
safeguards available under the Agreement of Trade-Related Intellectual Property
Rights (TRIPS). These include the definition of patentability criteria, the central issue
in this case. Such ‘flexibilities’ mostly revolve around the conditions for market entry
of alternative generic brands — the term generic drug refers to a copy of an original
product whose patent has expired.
In India, all drugs were generics before 2005 because there were no product patents
for pharmaceuticals. India became fully TRIPS compliant in 2005 through the
introduction of pharmaceutical patents, with legislation that included safeguards to
protect public health. In particular, section 3(d) of India’s Patent Act was included to
prevent the extension of patent protection through minor product modifications,
unless a ‘significant enhancement of efficacy’ can be demonstrated. Novartis took
legal action against the Indian government to challenge the constitutionality of section
3(d).
When this was rejected, the company sought to have imatinib mesylate recognized as
patentable. But it did not even purport to demonstrate enhanced efficacy. Novartis
aimed to put a stop to generic competition in the imatinib mesylate market. And it was
also attempting to prevent the export of locally produced, more affordable brands to
other developing countries. In its judgment, the court determined that imatinib
mesylate is not patentable as it ‘fails the test of section 3(d)’.
The Supreme Court judgment has given rise to an enormous amount of global
commentary. Public health advocates and patients greeted the outcome with great
relief. Médecins Sans Frontières, Joseph Stiglitz and various media outlets hailed the
decision. They see it as a good precedent for drug affordability in developing
countries in general. In contrast, Novartis and fellow corporate giants such as
Pfizerreacted with dismay. For example, Novartis is reported to have ‘threatened to
stop supplying India with new medicines’. This overwrought reaction points to a crisis
in their traditional business model. The industry is being reshaped due to issues such
as steadily falling R&D productivity and political mobilisations for access to
medicines for all.
The Novartis case is important because it highlights that it’s no longer acceptable to
the global public that hundreds of millions of people are denied access to life-saving
drugs because of monopoly pricing. And the case shows that governments in
developing countries with some economic and political clout, such as India’s, are
prepared to fight the big pharmaceutical companies. But Novartis and its peers will
not abandon the Indian market in reaction against measures to make drugs more
affordable. India is too important an economy and continues to offer plentiful
opportunities for international pharmaceutical companies. And Indian firms are large-
scale suppliers of low-cost generics to Western markets as well. These firms have an
impact on global industry dynamics, and many collaborate with the international
companies.

India has changed a lot in regards to its pharmaceuticals market. Between

independence in 1947 and the 1970s it was highly dependent on imports of expensive
medicines. But between 1970 and 2005 India abolished product patents on medicines.
The Indian government also put in place industrial policy measures and public sector
research institutions to collaborate with local producers. The result was a strong and
vibrant Indian generic industry.

The entry of generics lowers prices and widens access to medicines. And it is much
more effective in achieving these outcomes than philanthropy or the model of tiered
or differential pricing strategies preferred by multinational companies. The patenting
of trivial modifications, known as ‘evergreening’, is one of a host of ‘life-cycle
management’ techniques employed in response to generics competition.
Nevertheless, the Indian government will continue to face challenges from
international pharmaceutical companies seeking to stifle generic competition. Bayer
recently sought to overturn a precedent-setting compulsory license on another cancer
drug awarded to Hyderabad-based Natco Pharma in 2012. An appeals court in March
this year rejected Bayer’s application. The Novartis and Bayer cases suggest that India
is well placed to defend and extend pharmaceutical and IPR policies aimed at
balancing economic development with public health.
Conclusion
The Doha Declaration on TRIPS and Public Health has set a firm foundation upon
which developing countries can protect their public health needs against the WTO’s
intellectual property policies. The preamble of this declaration addresses the
fundamental concerns purported by developing member states, including a need for
broad recognition of medical goods and diseases where the circumvention of patent
protection rules for matters of public health is expected and necessary.

The Declaration clarifies the right of poorer nations to act outside the market to avoid
higher commodified drug prices by way of drawing on pertinent flexible mechanisms,
including compulsory licensing and parallel imports. Therefore, it is concluded, in
principle, that developing countries are adequately equipped with special provisions to
protect their right to public health and promote access to medicines. While the TRIPS
flexibilities denoted in the Doha declaration have well-guided intent, the abilities of
developing countries to utilize these flexibilities for public health concerns face
onerous internal and external barriers.
Many developing countries continue to lack local production capabilities and
experience difficulties in achieving economies of scale. There is also a lack of
efficient technical expertise to create the needed legislative reform to implement
TRIPS flexibilities, as well as a lack of regulatory and registration capacity for drug
patents and generics. TRIPS flexibilities and the Doha Declaration have set the stage;
however, a greater effort is needed to overcome internal and external constraints.
Without such an effort, the health of the developing world will continue to suffer at
the hands of economic concerns.