Chapter 19

Intellectual Property Rights: National

and International Perspectives

K. Sita Manikyam and A. Lakshminath

1 Introduction

Intellectual property (IP) has become more important in modern times both
nationally and internationally. The extensive advertising and persuasive sales-
manship of modern business have made increasingly valuable such forms of
property as copyrights, patents and property in designs. The law of IP deals with
legal rights associated with innovative or creative efforts. It covers all rights
resulting from intellectual activity in the industrial, scientific, literary or artistic
fields. IP confers certain kinds of exclusive rights to intellectual capital.
Intellectual property rights (IPRs) are in the process of constant development. As
technology in all fields of human activities is developing exponentially, the field of
IP is also expanding correspondingly. As per the requirements of scientific and
technological progress, new items are getting added to the ambit of IPRs by
extending and expanding the scope of its protection. Bio-patents, software copy-
right, plant variety protections are to name a few, denote the contemporary
developments in the field of IPR. Technological advancements and social evolu-
tions necessitate constant reevaluation of IPR system.
Thus, the main justification for protection of IPRs can be summarized as follows:
• Protection of IP rights is an incentive to human creativity
• It provides necessary stimulation for new Research and Development (R & D)
• IP serves as an instrument for cultural, social, economic and technological
development

K.S. Manikyam (&)

Faculty of Law, Andhra University, Visakhapatnam, India
A. Lakshminath
D.S. National Law University, Visakhapatnam, India
A. Lakshminath
Chanakya National Law University, Patna, India

© Springer Nature Singapore Pte Ltd. 2018 287

B.C. Nirmal and R.K. Singh (eds.), Contemporary Issues in International Law,
[Link]
288 K.S. Manikyam and A. Lakshminath

• New creativity helps create sustainable and competitive businesses locally and
internationally
• IP-based industries contribute significantly to national economies
• IPR is a catalyst in the information technology development.

2 Categories of Intellectual Property

The subject matter of IP is very wide. There are several different forms of rights that
together make up IP. IP can basically be divided into two categories, viz. industrial
property and copyright. Traditionally, a number of IPRs were known collectively as
industrial property. This mainly included patents, trademarks and designs. Now, the
protection of industrial property also extends to utility models, service marks, trade
names, passing off, geographical indications including indications of source or
appellations of origin and the repression of unfair competition. It can be said that
the term ‘industrial property’ is a precursor of the term ‘intellectual property’.
The scientific discovery of the inventor may be protected by the law of patents.
The interests to be reconciled are those of the inventor, the industrial expert who
exploits it, and the public. The first and the last are usually less able to protect
themselves. English law does not give protection to scientific discoveries as such
there must be a process which is patentable. Soviet and Czechoslovak laws go
further than English law in protecting the discoverer of new scientific ideas.
Between the brilliance of the laboratory worker and the successful marketing of a
commodity, there is a wide gap which may require the expenditure of vast sums of
money. A new drug must be subjected to wide clinical trials, and made the subject
of a huge marketing campaign, before profit can be created by sales. Out of many
discoveries, there are few that return gain. Hence the entrepreneur, who must risk
much, drives a hard bargain with the inventor. It is to the advantage of the com-
munity that there should be a government instrumentality, which can guide the
inventor inexperienced in the ways of industry to make the best use of his
discovery.
It is urgent to address the following questions: How can developing countries
use IP as a tool to advance their development strategy? What are the main concerns
surrounding the issues of IPR for developing countries? Is IP directly relevant to
sustainable development and to the achievement of agreed international develop-
ment goals? Are they capable enough, especially the least developed among them,
to formulate their negotiating positions and become well-informed negotiating
partners? Policy makers should address these essential questions in order to be able
to design IPR laws and policies that can suit the needs of their people and negotiate
effectively for future agreements.
19 Intellectual Property Rights: National and International … 289

3 Patents and Public Health1

Following the end of World War II, many developing countries shed their colonial
status and became sovereign states. Most faced serious problems are poverty,
illiteracy, ill health and unemployment. India, Pakistan, and Indonesia, for example,
entered independence with less than one-fifth of their populations being literate.2
One area in which developing countries desperately needed technology was
pharmaceuticals. Developing countries had no research and development capability
in the pharmaceutical sector. They either imported drugs or left their citizens to rely
on varieties of traditional medicine. The problem in importing drugs lay with their
expense. In the 1960s, India, for example, had one of the poorest populations in the
world yet also had some of the highest drug prices. A number of reasons were
responsible for this, including the fact that Western pharmaceutical companies
formed cartels that affected drug prices in developing countries. Another problem
was that pharmaceutical manufacturers in the West were not doing research into the
tropical diseases that affected poor people in developing countries because those
people would not be able to pay for the products that came out of the research.
Faced with continued high drug prices, developing countries like India embarked
on a reform of the patent rules they had inherited from their colonizers.
As these policies began to bite, global pharmaceutical companies like Pfizer
were faced with unprofitable operations in these countries. Essentially, developing
countries were adjusting the rules of the patent game to serve their local industries
in exactly the same way westerners had done. Pfizer and other large pharmaceutical
companies reacted to these developing country initiatives by forming a strategy that
would ultimately see all developing countries adopt patent laws that matched U.S.
patent law.
The AIDS crisis in Africa and other developing countries began to grow to a
scale no one could really comprehend or ignore. In the West, treatment for
HIV/AIDS arrived at the end of the 1980s in the form of antiretroviral therapy.
Antiretroviral therapy is aimed at halting the replication of the HIV in the individual
and allowing the immune system to recover. The treatments have proven to be
highly effective.
When patented antiretroviral therapies first appeared, they were expensive in the
range of US$10,000 to $15,000 per person per year. For people in developing
countries living on one or two dollars a day, the price of antiretroviral therapies
represented a king’s ransom.
The relationship of patents and public health is indeed very complex. It is
important to note that patents are not the only factor that plays an important role in

1
See generally Peter Drahos, “Building Institutions of Hope”, Trading in Public Hope, 592 Annals
18, 2004.
2
S. Salazar, “Intellectual Property and the Right to Health”, WIPO/OHCHR, Intellectual Property
and Human Rights, A Panel Discussion to commemorate the 50th Anniversary of the Universal
Declaration of Human Rights, Geneva, Switzerland, 1999, at 71.
290 K.S. Manikyam and A. Lakshminath

determining access to drugs but other factors, such as infrastructure and profes-
sional support also play significant role. But, at least in principle, patent monopolies
place the companies holding them in a strong position to set prices at high levels,
and this can have a profound impact on the ability of poor people to acquire them.
As noted above HIV/AIDS pandemic has helped to bring some of the issues to the
forefront.

3.1 Novartis Case: A Critique3

In the last three decades, the global gold rush for patents has been dominated by
filings for minor and mostly inconsequential innovations at the expense of break-
through innovation. In large part, this is because weak standards in the patent laws
of developed countries (led by the U.S. and Europe) have explicitly encouraged this
shift. The whittled-down, lobbied-out, stretched-beyond recognition of patent
regime that is characteristic of these countries and other less-developed countries
where they influence the polity is unfortunately the ‘norm’ to which India now finds
itself an ‘outlier.’ But the outlier is a solution: the norm is the problem. A British
Medical Journal report from 2012 succinctly summarizes the global research sit-
uation for new medicines: ‘This is the real innovation crisis: pharmaceutical
research and development turns out mostly minor variations on existing drugs, and
most new drugs are not superior on clinical measures’.
The symbolic opportunity presented by the Supreme Court’s backing of Indian
patent law, however, is a real threat- and pharma CEOs in New York, London and
Basel get it. In the long run, as more countries understand the Indian model,
appreciate its legitimacy, and reflect on its benefits to both public health and
innovation, they might want the same. And if that happens, when that happens, we
may begin to see real, positive change in the way pharmaceutical innovation works.
The Indian Patents Act, 1970 was a game changer. From the perspective of
43 years of experience, we can safely say that it shook up the pharmaceutical
industry and altered it irreversibly. The new, empowered scenario was most vividly
illustrated during the peak of the HIV/AIDS treatment crisis in the first decade of
the twenty-first century, when countries like Brazil, Thailand, South Africa and, of
course, India, took health security into their own hands and legitimately moulded
their domestic patent systems to respond to the crises within. The Indian Patents
Amendment Act of 2005, which gave us the law we have today––a law which was
ratified recently has the potential to change the game once again. A biological
sequence which existed in the natural environment would be now considered as a
discovery but a protein which is artificially engineered and represents a new product
and not normally found in nature would be considered as an invention.4

3
Novartis AG v. Union of India & Ors AIR 2013 SC 1311.
4
Ibid.
19 Intellectual Property Rights: National and International … 291

The text of section 3(d) of the Indian patent act which is the main focus of
interpretation in Novartis case states that the subject matter of an invention should
not be a mere discovery, it should not be new form of a known substance and it
should result in substantial increase in efficacy over the relevant prior art. Under
section 3(d), incremental inventions can be patented, provided they entail demon-
strable novelty and improved usefulness.
In the Novartis case, the court ruled that better bio-availability by itself was not
reason enough for a patent, unless it contributed to more effective treatment. It
appears to be in line with the public health imperative recognized by the Doha
Declaration of the TRIPs agreement. Access must be balanced with the incentive to
create. Pharmaceutical companies invest a great deal of money and effort to produce
new drugs, and if generic companies could simply reverse-engineer them, it could
discourage invention. It could be argued that modifications to minor ends also
deserve their own rewards, but that must be separately worked.
Novartis ruling of the Supreme Court has clarified that it does not mean no
minor variations are patentable that assessment depends on the test of therapeutic
efficacy. Glivec (Gleevec) does not pass that test, at least based on the evidence
presented by Novartis. However, the judgment has left key questions open. For
instance, would reduced toxicity be considered a factor in measuring efficacy, and if
so, does the lower dosage required due to better bio-availability contribute to this?
These ambiguities should be resolved to the extent possible, if India is to have a
balanced and clear policy on pharmaceutical innovation.
Supreme Court restricted the scope for pharmaceutical patents. Where access to
the patented product often stood between good and bad health, and sometimes,
between life and death itself. The ruling might seem somewhat commonsensical to
someone without specialized knowledge of IP. But even for a specialist, a close
look at the judgment would reveal that it is in conformity with traditional patent
concepts and unlikely to impact pharmaceutical innovation in a significant way, as
many have suggested.
However, even outside this national interest perspective, one needs to ask: is the
real purpose of patent law the protection of investment? Or is it meant to protect
ideas that reflect some creative spark and represent a real cognitive advance? It may
be argued that if the real goal is to protect pharmaceutical investments in R&D, we
must do so more directly without torturing our patent regime and diluting its
standards. In any case, the patent regime is thoroughly inefficient in protecting
pharmaceutical R&D.
A more optimal regime would offer protection commensurate with the actual
quantum of R&D investment made by the drug originator. This is an important
point to appreciate, given that many drugs owe their origins to university research
and government funding. Further and more egregiously, drug companies often
claim ‘marketing’ costs as R&D costs.
Further, given the myriad problems with exclusive market protection and
excessive monopoly pricing, generic companies should be free to enter the market
on day one, after paying some compensation to the drug originator. This would
292 K.S. Manikyam and A. Lakshminath

encourage more competition and keep the prices low for the consumer, while at the
same time compensating the drug originator for their R&D investment.5
One of the most useful outcomes of the Supreme Court judgment is a renewed
focus on what innovation is and how it should be rewarded. Behind the headlines
foretelling various levels of doom, the death of innovation in the country, and the
end of research for diseases which matter to us is the popular idea that patents are a
proxy for innovation. After all, patents are widely understood as short-term
monopolies enshrined in the law and provided as incentive to inventors on the
evaluation of publicly disclosed innovation. It would seem as if patents are syn-
onymous with innovation. Except, this is not quite the case.6
When it comes to drug discoveries, only 12–13% drugs are breakthrough drugs,
less than 40% are moderately therapeutic breakthrough drugs and 50% are ‘Me-too’
drugs. Then as far as foreign investment in research and development is concerned,
foreign companies really do not invest in India. They earn much more from a single
market like the US. In fact, many experts argue that in the backdrop of a strong
patent regime, rulings like this will spur innovation because only breakthrough
drugs will give companies the opportunity to recoup their investments. The effort to
balance affordability and innovation is being reiterated across the developing world
—from China to Argentina.7
There are growing legal challenges to patents that have been evergreened with
incremental chemical changes that are without similarly incremental therapeutic
value. The EU is also taking increasing note of big pharma’s efforts to block the
market entry of generics by filing umpteen patent applications for the same med-
icine. A common technique employed, called evergreening of patents, is to make
some modification to the original patented drug, claim it is a new product deserving
a patent in its own right, and secure a fresh patent.
India’s 2005 law guards against such evergreening, by laying down conditions,
in section 3(d), that require the incremental invention to possess both novelty and a
significant increase in drug efficacy for it to be eligible for a patent. All that
happened with the Glivec verdict is that the Supreme Court established that
Novartis failed to show eligibility for patenting under 3(d) for the beta crystalline
form of Imatinib Mesylate.
Better alternative to weakening the patent regime is price control. The Doha
Declaration on Public Health authorizes WTO members to take appropriate mea-
sures to make drugs affordable to their people. Price control is one such measure. It
needs to be used more liberally across the spectrum of patented drugs. This will
allow patent holders to retain their monopoly. The Gates Foundation offers a few
million dollars as a prize for whoever comes up with a vaccine for some disease, on
the condition that the vaccine would bear no IP charge.

5
Shamnad Basheer, “Patent with Purpose”, Indian Express April 3, 2013.
6
“Why Novartis Case Will Help Innovation”, The Hindu, April 15, 2013.
7
“Right Prescription”, Times of India, April 3, 2013.
19 Intellectual Property Rights: National and International … 293

On one hand, we have the AIDS campaign and NGO’s backing India for having
laws which do not allow companies to enjoy extended period of protection so that
those medicines can be easily distributed to most of the developing world. On the
other hand, we have the IP advocates making the argument that companies should
be given extended period of protection so that this will increase profits which in
turn will be spent on research and development for many other lifesaving drugs and
will cure many illnesses.
From the aspect of pharmaceutical industries in the US, we understand that cost
of innovation is related to profits earned. If we separate lifesaving drug to other
drugs and suggest a solution, then only those drugs which are lifesaving, will not
enjoy extended protection and other drugs will. That statement in itself is flawed
because then there is no incentive to research lifesaving drugs, if there is no return
on those investments.
But the current situation demands that access to medicines is a must and of prime
importance and therefore there is so much lobbying behind this as India should
remain the ‘pharmacy of the developing nations’. It is no exaggeration that millions
of patients in developing countries can go to sleep in peace knowing that their drugs
are on the way from India. And the present situation at least from the developing
world perspective and AIDS campaign activists and NGO, etc. India is being
commended for having a ‘A patent law that puts public health first’ This problem
does not have a quick fix and therefore, we need countries to come together with
compassion and solve this situation. The solution will be a middle ground between
access to medicine and heightened IP provisions.
These are exciting times for India because we will see better IP law enforcement
and on the other hand, international investment will increase in the upcoming years.
With all the lobbying and all the politics involved, it can be hoped that the suffering
of individuals due to lack of access to medicines is reduced and a solution is
reached wherein people have access to medicines and yet in the future, India will be
able to comply TRIPS plus provisions.
Indian Judicial system has again proved its ability and strength to block all
attempts from multinational pharmaceutical giants to cash upon the life of thou-
sands of patients those who have been fighting for their life either in hospital bed or
at home. The decision to provide free of cost medicine regardless the company
withdraw its charity is another land mark in this direction. Innovation and patent are
two separate things, innovations should be for serving humanity especially what-
ever in the field of medical science, patents should not have only one objective to
amass profit.

4 Stem Cells—Culturing Life (Therapeutic Cloning)

Stem cell research holds great promise for improving human health by developing
various body organs and replacing the damaged organs with the newly developed
organs. This also raises several ethical, social and legal issues. The issues are
294 K.S. Manikyam and A. Lakshminath

destruction of human embryos to create human embryonic stem cells, comodifi-

cation in human tissues and organs, barriers for economically backward classes, use
of technology for gene line engineering and reproductive cloning, safety and rights
of those donating gametes/blasto-cysts/somatic cells for derivation of stem cells,
umbilical cord cells, foetal tissues for use as stem cells, protect research participants
receiving stem cell transplants and patients at large from unproven therapies or
remedies.
Stem cells are increasingly used for treating diseases like osteoporosis, diabetes,
benign tumours, hepatic and renal failures and even find use in treating congenital
disorders like autism and there are efforts now being made to make the same
facilities available to people in India. India has the highest number of annual births
worldwide and has promise of the largest supply of cord blood in the world.
As far as the medical community is concerned, India is lucky to have it com-
plementing the government in its efforts to promote stem cell research. The Indian
Council for Medical Research (ICMR) draft guidelines for stem cell research in
2004 specifically state that although there must be a regulatory apex body for
monitoring purposes, sources of stem cells can include those derived from foetal
tissue. The preamble to the guidelines is in itself an indication of the nation’s will to
be a world leader in this field. It states, ‘The profound characteristic of a stem cell is
its capacity for extensive self-renewal and retention of multilineage differentiation
potential’. Recent research suggests that human stem cells can give rise to many
different types of cells, such as muscle cells, nerve cells, heart cells, liver cells, limb
cells, hematopoietic cells, etc., giving the hope for major advances in health care.
The era of clinical marrow, tissue and organ transplantation is poised for break-
through with the possibility of stem cell transplantation and therapy. Realizing the
potentials of this new technology in modern therapeutics and biomedical research, it
is strongly recommended that stem cell research and its clinical applications should
be promoted in the country. With more than 15 labs in the country involved in this
work and a 500 crore rupees department of biotechnology budget, 30% of which is
allocated for stem cell-related study, there was more good news when recently,
Histostem—a well known South Korean biotechnology company that is engaged in
developing human cell-based therapy expressed interest in setting up a stem cell
bank in India. The company has developed the technology of mixing cord blood for
transplantation to adult patients and is looking towards to make this treatment
available for patients in India as well. India is certainly exhibiting the potential to
become a global hub for this kind of research.
Thus, it can be seen that India has, by and large, been very supportive of stem
cell research. Some are even optimistic enough to suggest that the biotechnology
boom could result in India being a nucleus for stem cell research.
James A. Thompson’s (of Wisconsin Alumni Research Foundation) isolation of
Human E.S. Cells in 1998 set off a big effort to turn basic technology into treatment
for various diseases. This is viewed as the first major step to isolate the human ES
Cells and grow them in culture and was heralded as one of the greatest scientific
19 Intellectual Property Rights: National and International … 295

discoveries in history. Some scientists complained that the Wisconsin patents are
too broad and the University’s enforcement efforts impeded research. The Geron
Corporation, which financed some of Thompson’s Research projects, has exclusive
commercial rights to heart, nerve and pancreatic cells derived from human ES Cells.
Once created, these ‘blank slate’ cells can be nudged toward developing into
other cell types. Skin cells can ultimately be transformed into brain cells, for
example. That while cells might be specialized to do one thing, they have the
potential to do something else, which really lays the groundwork for all the
excitement about stem cell biology. A surprisingly simple recipe could turn mouse
skin cells back into primitive cells, which in turn could be prodded into different
kinds of mature cells. The work was later repeated with human cells. In theory, those
primitive cells are ‘blank slates’ like embryonic stem cells that can be turned into
any cell in the body. These groundbreaking discoveries have completely changed
our view of the development and cellular specialization. We now understand that the
mature cell does not have to be confined forever to its specialized state.
By reprogramming human cells, scientists have created new opportunities to
study diseases and develop methods for diagnosis and therapy. Turning a skin cell
into a stem cell takes weeks in a lab. Scientists introduce two to four genes that turn
the cell’s own genes on and off. It is a little like rebooting a computer, changing the
cell from running the collection of genes that make it a skin cell into using another
set that makes it a stem cell. The idea of reprograming cells has been put to work in
basic research on disease, through an approach sometimes called ‘disease in a dish’.
The reprogramming allows scientists to create particular kinds of tissue they want to
study, like lung tissue for studying cystic fibrosis, or brain tissue for Huntington’s
disease. By reprogramming cells from patients with a particular disease, they can
create new tissue with the same genetic background, and study it in the lab. That
can give new insights into the roots of the problem. In addition that approach allows
them to screen drugs in the lab for possible new medicines. Mr. Gurdon and Mr.
Yamanaka were awarded Nobel Prize for 2012 for their pioneering work in
transforming the field of ‘regenerative medicine’ the search for ways to cure disease
by growing healthy tissue.8
‘The eventual aim is to provide replacement cells of all kinds, and to be able to
find a way of obtaining spare heart or brain cells from skin or blood cells. The
important point is that the replacement cells need to be from the same individual, to
avoid problems of rejection and hence of the need for immunosuppression’.9

“Nobel Prize for Stem Cell Invention”, The Hindu October 09, 2012.
8

9
Ibid.
296 K.S. Manikyam and A. Lakshminath

5 Information Technologies and IPRS

Electronic information processing and communication is another key technological

field in which tremendous advances have taken place in a very short time. Like
biotechnology, information technology has multiple industrial applications. The
main sources of innovation in Information Communication Technology (ICT) are
the software, hardware, semiconductor and telecommunications industries. But
there are also other types of business involved in the ICT sector that have an interest
in IP regulation including those that do not themselves innovate in this particular
field, such as those which use ICT to provide services or ‘content’ to consumers.
Content providers tend to take a hard line on IP rights, favouring protection as
strong as, if not stronger than, the levels of copyright protection available to
businesses operating in the more conventional environments such as print. On the
other hand, ISPs generally have little reason to favour strong copyright protection of
Internet content, especially given the possibility of finding themselves held liable
for the copyright infringements of their users.
While there is nothing new in patenting telecommunication technologies or
copyrighting books and motion pictures, the ICT revolution has pushed the
boundaries of the IPR system in a number of different ways, and it has the potential
to push them still further. For example, though software programs are, arguably, no
more than a long sequence of binary-coded instructions to a computer, copyright
law nowadays treats them as if they are literary works. In the United States, pro-
grams are now patentable as well. In the United States, it is possible to obtain
patents for computer programs if they produce a tangible effect.
Software and database producers use copyright law not only to protect expres-
sions but also to limit access to information. For example, software developers can
copyright both the source code and object code of their programs. Additional
protection can be secured by keeping the source code secret, and also through
restrictive licences. Developing countries are required, under TRIPS, to protect
software by means of copyright law and semiconductor designs through the sui
generis system. However, TRIPS does not explicitly state that they have to allow
the patenting of programs. It is possible to argue that since patents must be available
for all fields of technology, protection must be extended to computer programs. But
this may not necessarily be the case. The European Patent Convention expressly
prohibits the patenting of computer programs.
Information technology provides both opportunities and threats for the copyright
industries, including the publishing industry, which is the main supplier of edu-
cational and technical knowledge content. It has been argued that technological
developments make it difficult for both authors and publishers to control the dis-
semination and use of works, and to enforce their exclusive rights. In fact, tech-
nology can be employed to assist rights owners in tracking their works, in
facilitating collection and distribution of monies payable to authors. Technological
developments also enable the digitization of copyright works and facilitate access to
many works, which hitherto may have been unavailable to many consumers.
19 Intellectual Property Rights: National and International … 297

6 Traditional Knowledge and IPRS

Traditional knowledge (TK) of the Earth is based on thousands of years’ of

experience. It is developed and preserved by local and indigenous communities for
centuries as a strategy for their survival in the biosphere. TK is often part of the
social fabric and everyday life of a community.
TK includes:
1. Cultural knowledge;
2. Artistic knowledge;
3. Medicinal knowledge;
4. Biodiversity/Natural Resources knowledge;
5. Agricultural knowledge; and
6. Sacred knowledge.
Some important characteristics of TK can be identified as follows:
i. it is transmitted from generations to generations;
ii. in many cases, it is transmitted orally for generations from person to person;
iii. it is being considered by the communities as gift of God and not as a private
property;
iv. such knowledge typically distinguishes one community from another;
v. it is usually impossible to identify the original creator of the information;
vi. it is learned through continuous observation, experience and practice;
vii. it is inseparable part of communal and cultural life of its holders; and
viii. it is usually associated with the biological resources.
No clear formula has been reached to date as to the strategies that should be
devised to protect various forms of TK. There are manifold complex issues that are
impeding the legal recognition, protection and enforcement of rights attached to TK.

6.1 Need to Fill the Vacuum Created by TRIPs and TRIPs

Plus

TRIPs, which was the result of seven years long and arduous negotiations, is
regarded as the most effective international instrument providing for the formal
legal regime on IPR. While TRIPs agreement lays down in detail the kinds of IPR
entitled for protection under its umbrella, it conveniently excludes the TK from the
list of subject matters qualified for IPR protection. This non-inclusion of TK took
place in the agreement even when it extended protection for microorganisms and
microbiological processes.
TK was not even considered for a sui generis protection as in the case of plant
varieties. TRIPs agreement has made protection for plant breeders’ rights (PBRs)
obligatory. To include plant varieties under the regime of IPR, the TRIPs have
298 K.S. Manikyam and A. Lakshminath

lowered the criteria standards and provided for weaker requirements. It substituted
‘distinctiveness’ for the requirements of utility and non-obviousness. Such an
attempt was never endeavoured in the case of TK. There were demands from the
countries including India to accommodate TK as a part of agenda for discussions
and debates on TRIPs negotiations. However, the TK rich developing countries
were not successful in incorporating their interests in the TRIPs due to the diverse
and conflicting views of developed countries from the North. Surprisingly, the post
TRIPs regime also continued the same approach by giving no room for TK in the
ministerial conferences held subsequent to the conclusion of TRIPs agreement.
To value and preserve the heritage of our composite culture is a fundamental
duty of every citizen under Article 51(f) of the Constitution of India. However, we
have not enacted so far any legislation based on this provision for translating this
constitutional objective into realty. Thus, we fail to protect not only the indigenous
knowledge but their culture and heritage also.

6.2 Special Legal and Constitutional Status of TK Holders

In the absence of any law to protect the TK and practices of the indigenous com-
munities, there is no obligation from a purely legal perspective to reward or com-
pensate the communities responsible for the development and maintenance of such
knowledge. This can be better achieved by giving special protection in the constitution
itself to the indigenous and local communities with reference to their knowledge.
The system of IP rights, by principle, exists to encourage innovations and dis-
courage embezzlement of knowledge. The preservation and protection of TK is not
only a key component of the basic right to life and self-identification and a con-
dition for the continuous existence of indigenous and traditional peoples; it is also a
central element of the cultural heritage of humanity.
Now, coming to the national scenario, past experiences reiterate that our tradi-
tional, indigenous and local knowledge and associated resources are being used to
make patented commodities for global trade. India could certainly revoke certain
patents based on our precious TK. But, how long and how many times should Indian
government indulge in this legal battle? Having a law in place to protect TK would
have made it difficult for foreign countries to patent products based on our TK
associated with plants like neem, turmeric, karela, brinjal, etc., so unique to India.
Issues like neem patents and turmeric patents and pomegranate should not recur.
Biopiracy threatens the everyday survival of ordinary Indians who belong to
indigenous and local community and who hold valuable TK. If biopiracy is not
stopped, our unique TK will be continuously threatened, misappropriated and
patented by foreigners. Failure to enact appropriate legislation for the protection
and conservation of TK is costing the country dearly.10

Gavin Stenton, “Biopiracy within the Pharmaceutical Industry: A Stark Illustration of How
10

Abusive, Manipulative and Perverse the Patenting Process Can Be Towards Countries of the
South”, 26(1) Eur. Intell. Property Rev., 2004, pp. 17–26.
19 Intellectual Property Rights: National and International … 299

The government must also develop appropriate policy measures to implement

the recommendations of National Knowledge Commission (NKC). NKC has made
several recommendations on strategies to promote the knowledge systems of tra-
ditional medicine which include transformation of traditional medicine education
by introducing evidence-based approaches, strengthening research on traditional
health systems, strengthening pharmacopoeial standards, promoting traditional
medicine by increasing quality and quantity of clinical trials and certification
process, by digitizing TK and by creating suitable framework of IP rights, by
establishing goals for conservation of natural resources, by promoting international
cooperation, by supporting primary health care in rural areas creating a major
rebranding exercise of Indian traditional medicine.
There are many unresolved technical issues such as the problem of collective
ownership and the modes of enforcement of rights. One reason for lack of clarity
about the rationale for protection stems from the different meanings given to the
concept of protection. Some understand this concept in the context of IPRs, where
protection essentially means to exclude the unauthorized use by third parties. Others
regards protection as a tool to preserve TK from uses that many erode it or nega-
tively affect the life or culture of the communities that have developed and applied
it. Protection has a more positive role in supporting TK based communities
livelihoods and cultures, as proposed by the Organization of African Unity’s
(OAU’s) Model Law and its definition of community rights.
The consideration of TK protection should not overshadow the fact that the
preservation and use of TK require ensuring the survival and improvement of living
conditions and cultural milieu of such communities. Indigenous and local com-
munities must be given right to participation in rule-making process. At the local
level, the local and indigenous communities have interests to ensure that the use,
exchange and benefit sharing aspects respect their customary laws and institutions.
Indigenous communities need to be included and involved at every stage of such
rule-making process involving the issue of access and benefit sharing.

7 Recent Developments

7.1 Lex Genetikos

(a) Cloning: Moving towards the Clonage

The word ‘cloning’ means a ‘viable human or animal cell generated from a
single parent’. A clone is a twin of the individual cloned with a time gap. The
subject burst into the public consciousness in 1997, following the announcement of
successful cloning of ‘Dolly the Sheep’. Subsequently, it captured the attention and
generated worldwide debate.
300 K.S. Manikyam and A. Lakshminath

Cloning remains an ethical issue and the cloning debate involves scientists,
legislators, religious groups, philosophers and many others. In fact, the notion
involves critical issues about identity and individuality, differences between pro-
creation and maintenance, and relationship between generations.
(b) Cryonics: Panacea for Future Immortality or Not?
Cryonics is a practice of using very cold temperatures to preserve human bodies
when ordinary medicine can no longer sustain life, with the hope of reviving them
sometime in the future. However, this practice has in the recent years faced
opposition all around the world as there exists no law which protects the public
health from unburied or untreated corpses.
Thus, taking into consideration the emerging trends and developments in tech-
nology, it is the pressing need of the hour that India formulates a legislation which
can prevent and regulate the practice of cryopreservation.
(c) Assisted Reproductive Technology: Is it a Back-Up Plan?
This refers to methods to achieve pregnancy by artificial or partially artificial
means. It is primarily used in infertility treatment. Technically, laboratory mix-ups
(misidentification, transfer of wrong embryos) are important issues. There are
emotional issues like a relationship between child and a surrogate mother. The
ethics involve in vitro fertilization, surrogacy and sperm donation. Further, the
ethical issues include reproductive discrimination against unmarried individuals,
religious issues and citizenship of children born out of surrogacy.

8 Biotechnology and IPRS

Biotechnology encompasses first, second and third generation biotechnologies. The

first generation includes traditional technologies like beer brewing and bread
making, and the second begins with microbiological applications such as those
developed by Louis Pasteur. Tissue culture and modern plant and animal breeding
also fall within this ‘generation’. The third generation biotechnologies or the ‘new
biotechnologies’ include recombinant DNA (‘gene splicing’), and genomics
(Genomics refers to the mapping, sequencing and analysis of the full set of genes
(i.e. the genome) of different organisms or species). The rate of advancement of
biotechnology varies considerably in developing countries, depending on the
capacity of their research institutions and businesses to generate biotechnological
inventions. For example, Brazil, China, Cuba and India have adopted third gen-
eration biotechnologies.
19 Intellectual Property Rights: National and International … 301

8.1 Lex Pharmacia

(a) Drug Discovery and Patents

It is the process by which drugs are discovered and designed. The process
involves the identification of candidates, synthesis, characterization, screening and
therapeutic efficacy and once a compound has shown its value in these tests, it will
begin the process of drug development prior to clinical trials. Issues include the
entire process of bringing a new drug or device to the market including drug
discovery, product development, preclinical research (microorganisms) and clinical
trials (on humans).
(b) Clinical Trial: Placebo and Nocebio
Clinical trial is the application of scientific method to understand the response of
human or animal biology to a drug. Clinical trials have great potential to benefit the
patient, improving the therapeutic regimes and towards advancement of
evidence-based medical practice. However, the deduction based on clinical trials in
fields is the most difficult scientific and analytical proposition. Thus, in the present
scenario, a need has been felt for the transparency, accountability and accessibility
in order to re-establish the public trust in clinical trials.
Nearly 20% of the human genome is already patented. But in a recent landmark
judgment, Robert Sweet, a senior U.S. federal judge who serves on the United
States District for the Southern District of New York, invalidated 7 of the 23 patents
on two genes BRCA1 BRCA 2. In 2008, the Myriad Genetics won a protracted
battle to retain some European patents on BRCA1; the scope of the patents was
reduced to cover only certain mutations. The two genes are commonly tested for
mutations to determine the risk of developing breast and ovarian cancer. The
Utah-based Myriad Genetics and the University of Utah Research Foundation are
holding the patents. Though patents cannot be granted to ‘products of nature’,
thousands of genes have been patented on the ground that isolated and purified
genes are distinctly different in character and composition from those present in our
body. Significantly, the invalidation of Myriad’s patents has come on the basis of
the very arguments the company’s counterparts had put forth earlier in defence of
gene patents. What is laudable is Judge Sweet’s brilliant assessment of scientific
facts to invalidate every claim of the company. For instance, he refused to accept
that isolated and purified genes are structurally and compositionally different from
those occurring in the body. The verdict also summarily rejects as ‘erroneous’ the
premise that isolated DNA molecules are like any other chemical compound.
Exclusive licences, with some exceptions, are a great barrier to fostering
research. There is no incentive to make diagnostic tests cheaper either; Myriad
charges about $3000 to sequence the two genes to look for cancer-causing muta-
tions. The fact that 10–15% of all inheritable breast and ovarian cancers have a
mutation in these two genes, and about 5000 new cases of both cancers are detected
302 K.S. Manikyam and A. Lakshminath

every year in the European Union makes a strong case against exclusive licences.
The National Institutes of Health (NIH) encourages non-exclusive licences for gene
diagnostics. This currently provides a standard for NIH employees, and may soon
become applicable to those receiving NIH grants.
A recent controversy over the commercial introduction of privately developed
Bt. Brinjal shows once again that politics and civil society pressure and not science
can often become the guiding lights of decision making in this country. In the
process, India missed a golden chance of devising a stable and sound policy on
genetically modified (GM) Crops.

9 India Story—From Strength to Strength

IP law has travelled from the fourteenth-century letters patent to its present form. It
really has the capability of influencing almost all spheres of human life. Patents and
other proprietary rights granted on life like genes, microorganisms raise a lot of
issues which only time can answer. At the same time, a proper balancing of public
and private interests is paramount to maintain the equilibrium. The fact that even a
country like USA, is contemplating measures to regulate patenting of life forms
shows the sensitivity of the issue. Thus, it is very important for our policy makers to
keep abreast of the rapid changes happening globally in this sensitive field so that
they can perform the perfect ‘balancing act’ which adequately protects creativity
and safeguard the interests of the public. Developing countries like India need more
balancing acts which can propel their creativity to new heights and at the same time
promote public interests.
The public sector has become leaner and meaner in most developing countries
and inevitably in the long run, there has to be a closer relationship, more interaction
and greater matching between the business sector and R&D institutions and pro-
ductivity improving centres. This applies especially to the development of IP
capabilities and assets needed for technological upgrading and diversification so as
to gradually fill up the ‘missing middle’, a weakness typical in the enterprise
structure in most developing countries. Large firms, rather than SMEs, account for
about two-thirds of domestic manufacturing output and up to four-fifths of direct
export earnings in most parts of ASEAN. This is due, in part, to the lack of a
dynamic core of SMEs (Small and Medium sized enterprises) as leading, first-rank
subcontractors or joint-venture businesses in their own right. At the same time,
parallel efforts have also to be made to eliminate a variety of unintended biases
against SMEs, and in favour of large firms, in the policy environment in many
countries—including through the so-called ‘perverse incentive syndrome’, and in
the sequencing and timing of various policy measures for economic reform and
restructuring ways and means will also have to be in place to leverage technological
capabilities as well as to share costs and risks, including through the policy-induced
19 Intellectual Property Rights: National and International … 303

promotion of partnerships and alliances in R&D among local firms and/or with
external end users. Such linkages (backward, forward and lateral) have been of
rising importance for IP creation, registration and commercialization in many
countries since the late 1980s. This can be done through Private–Public Partnership.
Trade policy and liberalization constitute only necessary but not sufficient
conditions to growth and development. Trade facilitation and competition are in
fact flanking policies, beyond trade considerations based on traditional comparative
advantage considerations. Whether it is a recovering Japan, China, India or the
ASEAN that will provide leadership in furthering integration in the region, the
geo-economic and geopolitical implications have to be differentiated. Even a small
city-state Singapore has contributed in some manner to bilateral trade arrangements
going outside of the region. In the final analysis, while the economics of trade
liberalization and economic integration remain the underlying logic of the various
modalities, it should be strategically tempered with pragmatism as a second best
policy.