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COUNTRY’S DEVELOPMENT SHALL DEPEND ON QUALITY

RESEARCH: PATENTS

Dr. V. Sowbhagya Rani*1, Dr. VRC Krishnaiah

2, Dr. K Thyaga Raju

3

1PDF in Law and

2Professor and Dean of Law, Department of Law

3Professor and Head of Biochemistry Sri Venkateswara University, Tirupati 517502 AP,

India.

INTRODUCTION

Biotechnology is playing a major role in the production of novel

compounds, plants, animals, tissues and creating several tools for the

betterment of the society. At present every fellow citizen of India is

speaking about biotechnology and its applications. The biotechnology

process requires sophisticated equipment and sterile environment. It is

expensive and an ordinary citizen cannot think of it. However, several

scientists have made efforts to synthesize and isolate various proteins,

nucleic acids, metabolites, drugs and antibiotics using plants, animals,

fungi and single cell organisms. Compared to western countries our

Indian technology and work output is not on par with them. Though

our scientists are working to generate novel compounds they are

unable to well characterize them due to technological insufficiency. Our ancient society

produced several medicines to cure diseases. But that crude preparation is not accepted as

good product for filing the papers to get patents. At present except in central universities and

institutes the research scholars are least serious about research. So this system is unable to

achieve the goals for the betterment of our society. The difficulties in filing the patent papers

and receiving the patent to our genuine work are discussed in this manuscript.

Origin of patent rights

The World Intellectual Property Rights Organization, WIPO, established in 1974 has

conducted a seminar in 1967 to look after the issues related to trade and Intellectual Property

protection. The WIPO along with World Trade Organization (WTO) conducted an

international earth summit in 1992 and proposal standardization of all commodities related to

World Journal of Pharmaceutical Research SJIF Impact Factor 5.990

Volume 4, Issue 11, XXX-XXX. Review Article ISSN 2277– 7105

*Correspondence for

Author

Dr. Sowbhagya Rani

Vidudala

PDF in Law, Department

of Law.

rvidudala@gmail.com,

Article Received on 14 Sept. 2015,

Revised on 05 Oct. 2015,

Accepted on 26 Oct. 2015,

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Sowbhagya et al. World Journal of Pharmaceutical Research

every country without looking into the economic status, resources and skills. During this

standardization process every creation or finding should get a patent, which is useful to the

concerned individual or company or country. This proposal was almost accepted by 150-170

countries. The standards proposed by WTO and WIPO to all developing countries are very

difficult to fulfill because to achieve the best results it is necessary to invest trillions of

dollars. However, India has accepted the implementation of patent rule by the year 2005.

An expensive research

In advanced biological sciences a single individual should not perform a better research work.

It should require teamwork. At a time no individual can get reproducible results in these

courses. In our country a few institutes are achieving these goals by using the available

technical know-how. Sometimes they too can import the required equipment and chemicals

from outside of the country. This equipment is expensive and a few people may use it. So by

importing the costly equipment, if one cannot use maximum, it is mere waste of our tax

payers’ amount.

Every Indian is talking about the significance of biotechnology and its applications. The

products of biotechnology are useful to the society and it should reach to common man. As

stated above to generate the new products and provide training to various categories of

candidates it is necessary to have fund and better communicating systems like electronic

media, e-journals, internet facility etc. At present to some extent the electronic media is

available. However, the use of repute e-journals is expensive to an individual and even to

institutes. These e-journals are available on payment of dollars. So to purchase a single

journal one has to spend so much of Indian currency. However, some funding agencies are

providing money to purchase them through abroad education institutes.[2]

Problems with patent law

One of the major drawbacks of the patent law is not to publish the new findings in any form.

Here one has to note that if this finding is not getting patent within a short period due to some

clarifications and if the same work is performed by another scientist/individual at the same

time, the total effort of the individual will be mere meaningless. In this case he is neither

publishing it as new finding or able to receive a patent. The patented product is rated for

benefit of the country and individual, however the new finding can get a name to the same

man. Sometimes if he publishes, it may be possible to him even, to receive an award.[3]

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Another setback of the patent law is one has to isolate a compound as novel and it should not

be related to any other in any form. Indian does better work. But they are unable to receive

the recognition. This is due to the non-availability of technology and sometimes even if it is

available in the next-door to him one may not allow him to use it. To get credit to our

country and countrymen the cooperation of all people is required at every stage. If anyone

cannot receive support at the time of need it can generate a great loss not only to him but also

to our country. The facilities that are available due to the public money must be extended to

all those people who are in needy. Just keeping them in the laboratories as monuments it

cannot create a new world. Here it is appropriate to give the example of late Kalpana Chawla

who received training from American Space Centre. She is not originated form USA but

from India. However, she received training from foreign laboratory. If we receive this type

of facility from various agents and agencies of indigenous, it is easy to get best results and it

can pave a way for easy patenting process.

The raw product research and their results cannot get any patent. Every peer member of the

scientific paper/journals is making adverse comments on crude extracts and their results. So,

as stated above, it is necessary to isolate pure compounds and characterize them. After

purification and characterization one can file the papers, with a small description, for patent.

The Indian Patents will be provided to the individuals, associations and companies. It takes

so much of time for awarding patents. Sometimes it may be a big task to get it. Here one has

to have an agency, either government or private, to pay fee to file for patent. To an

individual the patent fee is very high. Once you get a formal approval the patentee has to

proceed to international patents. The results of final products must be on par with the

standards of the developed country. Considering the above mentioned troubles of a scientist

of university it is difficult to him to get a patent for his genuine work, otherwise one has to

sell his goods to others.[4]

Life Sciences Research & Development in India

A. Animal research

Companies related to pharmaceuticals, biotechnology and medical devices are investing in

India as a way to increase research & development productivity, but it is not that expected as

by the scientists.

In biological sciences research animals are used primarily for testing of molecules. The

proteins, nucleic acids, fatty acids and micromolecules are isolated from animals. So it is

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necessary to use animals to generate new animals (Transgenic animals; 4). To achieve the

new results, and for the sake of society, these scientific works are compulsory. But animal

protection agencies are limiting the scientists to use them as source for research work.

Therefore, it is difficult to work without sacrificing the animals however the animal ethical

committee agencies are coming forward to provide license to universities and institutes to

work on animals. In abroad, scientists have isolated genes, propagated them in plants,

animals and microbes. For every new result they are filing papers for patents. After critical

review by peer members it is possible to award the patent. However, in India, the gene

technology research is expensive, of course now due to technical expertise it is becoming

cheap. The budgetary allocation to this science is very meager and it is insufficient to get

reproducible results. However in plant research it is not that difficult to isolate metabolic

products. But the significance of these products must be studied using the animals only. To

avoid the animal experiments, at present, scientists are planning to work on plants or

microbes and are using this data to apply to human. It may not generate good results or may

fail to get patent due to its non-suitability to animal models.[5,6]

B. Healthcare Sector

Healthcare has become one of the largest sectors of the Indian economy, estimated at about

$80B in 2012, and projected to grow at a CAGR of 17% through 2017.[7]

Growth in the

Indian healthcare industry is spurred by rising income levels, growing insurance coverage,

and increasing healthcare spending by both the private sector and the public sector. Broadly

speaking, the healthcare industry consists of three segments: payers (i.e. insurance

companies), providers (i.e. hospitals, clinics etc.) and products (i.e. pharmaceutical, biotech,

and medical device companies). In this article we consider the last of these categories – the

companies that develop the products in the form of pharmaceuticals, biotechnology products

and medical devices. In particular, we focus on the history, current state, and future of

research and development (R&D) within each of these categories in India.

Given the increasing pressures for cost-cutting in the developed markets, R&D expenditure in

the Life Sciences has seen a migration towards Asia—largely China, but also India. The

major driver of the shift has been the need for increased R&D productivity, which had been

declining in the US in the recent past[8]

, and which could benefit from the lower R&D costs in

emerging markets like India. In addition to the cost aspect however, there is now a greater

push towards collaborations and partnerships that tap into India’s talent pool, local

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innovation, as well as the vast patient population, much of which is ―treatment-naïve‖.[9]

This

trend is expected to be bolstered by the government’s efforts to improve infrastructure,

funding, and intellectual property (IP) protection. Due to the history of Life Sciences R&D in

India, the state of the pharmaceutical, biotech and medical device sectors is quite different

from each other.

a. Pharmaceutical sector

The Indian pharmaceutical industry is the world’s 3rd

-largest by volume and 10th

-largest by

value, accounting for about 1.5% of global revenues, growing at a CAGR of about 17%.

Generic manufacturers dominate the Indian pharmaceutical industry and are pivotal in

providing essential drugs at low prices, particularly in the lesser developed economies.

Patented drugs, while growing, comprise only 1% of India’s pharmaceutical market. The

reasons can be traced to the history of India’s pharma industry After India’s independence in

1947, its pharmaceutical sector was dominated by multi-national companies like Johnson and

Johnson, Pfizer and today’s GlaxoSmithKline. The trend changed in 1970 when India passed

the Indian Patent Act, under which substances used in food and pharmaceuticals could no

longer be patented (although the manufacturing process could be for up to seven years from

the date of filing). The Act led to the launch of several domestic companies focusing on

―process innovation‖ to produce drugs using a different process from the one patented, and

laid the foundation for the synthetic chemistry and chemical engineering capabilities that

underpins India’s pharma sector even today. The local companies expanded their scope from

bulk APIs to formulations and finished doses of a wide range of products at a much lower

price-point due to the lack of royalties on them.[10]

However, this ―process patent‖ regime gave way to a ―product patent‖ one in 2005, when

India entered into the Trade Related Intellectual Property Rights (TRIPS) Agreement

administered by the World Trade Organization, under which new chemical entities could be

granted a composition-of-matter patent. The shift has entailed that Indian pharma must

transition from a manufacturing process-centric to an innovation-driven discovery-led model,

a change that is proving to be quite complex.

Nevertheless, India’s pharma industry has been adapting to the change. The new IP regime

has led to an increasing investment in R&D as domestic firms have also increased patenting

in India and abroad. The number of patent filings at the Indian Patent Office has almost

quadrupled between 2002-03 and 2012-13. There has been a significant increase in the focus

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on novel drug discovery, although new dosage forms remain dominant among product

patents.[11]

As global partnerships and alliances grow, it will be interesting to follow their

effect on the Indian pharmaceutical industry.

b. Biotechnology sector

The biotechnology sector is much younger than the pharmaceutical industry, having taken off

only in the mid-1980s. But similar to the pharmaceutical sector, the initial growth in the

biotechnology sector was also fueled by the lenient IP policy that recognized only process,

rather than product, patents. After 2005, while the focus on R&D has grown, the cost-

effective manufacturing processes developed in the past as well as the competitive rivalries

have driven prices down and enabled Indian firms to be the leading supplier of traditional

vaccines worldwide. India’s biotech sector makes up 2% ($4.5B in 2013) of the global

revenues, with a CAGR of 22%.[12]

Healthcare-related biotechnology (biopharmaceuticals, bioinformatics, and bioservices) by

far dominates the overall biotechnology sector, which also includes bioagriculture and

bioindustry. The biopharmaceutical segment, comprised of vaccines, biological therapeutics

(such as insulin and statins), and diagnostics, is the largest one, contributing about 62% to the

total biotechnology sector, followed by bioservices (18%).[13]

India has seen growth in the

bioservices sector as well, and is emerging as a leading destination for clinical trials, contract

research and manufacturing activities, which accounts for revenue generation worth about

US$ 637 million.

Despite initial concerns of the negative effects of the changing IP regime, the overall impact

has been positive. Studies examining the effect of the Agreement on Trade-Related Aspects

of Intellectual Property Rights (TRIPS) found that the innovation outcome (as measured by

patents of Indian biopharmaceuticals) has sharply increased during the transition to TRIPS-

compliant regulation, suggesting that Indian companies have been capable and willing to

transition to the innovation-based business model. Another trend has been global alliances --

biopharmaceutical firms holding cross-border alliances with foreign partners have proved

significantly more successful at enhancing their innovative capability.[14]

Alliances between

global players and local companies are likely to be very well positioned to leverage India’s

strength in the generic biotechnology space.

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c. Medical Devices sector

India’s medical device market, at $3.2B sales in 2013 and an expected CAGR of 15% over

the next 5 years[15]

, is significant but with a large potential to grow. After registering strong

growth between 2010 and 2012, the sharp depreciation of the rupee that took hold from May

2013 has dampened growth in US dollar terms, although the market is still set to remain one

of the world's fastest growing over the next five years.

A growing population with increasing purchasing power, unmet disease needs, and saturation

in the developed markets, has all made India an attractive market for global medical device

companies seeking growth opportunities. But unlike the pharma and biotech sectors, medical

device R&D in India did not benefit from a lenient product-IP regime, and as such, does not

enjoy the same advantages in manufacturing as the other two sectors. However, the lower

cost of labor, availability of educated professionals, and cheaper manufacturing costs are all

factors favoring the development of medical device R&D in India.

Recently, several domestic companies have also are also been developing new products

designed for the local market, and producing cost-effective solutions for it. A good example

is the Aravind Eye Care’s low cost intraocular lenses, producing lenses at about 30% of the

cost of similar international products. BigTec Labs’ no-frills PCR machine costs 1/15 the

traditional PCR systems.[16]

One of the challenges the Indian medical devices market faces is that a vast majority of the

population cannot afford the prices. Only 50-60 million of the over 1 billion population are at

an income level comparable to the Western world’s ―middle-class‖ for which most medical

devices are designed. Health insurance services in India are not nearly as widespread as in the

developed world, although this is starting to change as well. As the medical device sector in

India matures, it is likely that more technologies would be designed for the local needs and at

price points that are affordable to the domestic population.

Final thoughts and Conclusion

In addition to the fast-growing healthcare market in India that is fast-growing, the R&D

capabilities and productivity also present an attractive option for global pharma, biotech and

medical device companies to invest in. As the Indian government is actively trying to

establish an ecosystem that is conducive to innovation and R&D, many of the previous

hurdles, such as lack of infrastructure, unclear or unsupportive regulations, and funding

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shortages, are likely to be mitigated. The Life Sciences R&D sector in India is definitely one

to watch in the next few years.

Bayh-Dole Act was enacted by US government on December 12, 1980 to promote research

and new innovations in universities, institutes, industries and repute laboratories. This act has

given an encouragement to universities to control on their inventions and promote best

business deals as nonprofit organizations. Similar to it the Indian government is planning to

bring an act to the benefit of Indian universities faculty invention protection. It is a welcome

move from the government to encourage the faculty and the student.

The present scenario of India is availability of resources of youth to work hard with

commitment and dedication but the trail of youth on research is going to troughs of waste due

to non availability of financial resources. The government of India used to allocate grants

based on the country’s Gross Domestic product (GDP). For science and research since 2003

onwards it is proposing to allocate at least 2% of GDP but when it come to reality its

allocation is all the time low to other countries such as 0.8%. Because of this our country is

able to generate four scientists out of 10,000 people where as in US and UK its ratio is 76 to

10,000. Even after completion of PhDs in various fields of research the country is unable to

provide resources to attract the young scientists to go for research. One way it is not good to

say that the government is unable to make use of them to benefit the country. The present

need of the Indian continent is to generate more of products from various medicinal plants

and make use of them to cure several disorders of the biological systems. Due to this the

scientists of the other countries are finding the new inventions and patenting them to

generate resources to their country and individual because of availability of funds from

government or industries.

In our country the industrialists search is for the production of only their goods but never

think of basic research and its significance. Their mind set is a set of goal for production

without quality. The main cause for this is from the beginning the Indians accustomed to

work on formulations and supply the goods to the consumer to gain the profit. This has given

lot of scope to not to think about research and its significance, lack of proper allocation for

inventions, avoid of manpower to think about new creations, inculcation of laziness in the

mindset of hard working literates and many more. At present competing with global

industries is posing a threat for new inventions due to lack of proper funding from industries

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and government agencies, and not making use of the talented youth for best results otherwise

it may be mentioned here that the country is unable make use of them to our needs.

When this phenomenon is going on one side the other side the talented youth, by owning the

computer laboratories, is articulating the research to generate more of thesis without thinking

of skill generation in the researchers. From the news dailies it is known that the intellectual

graduates like above are trying to earn easy money ranging from rupees 50,000 to 300,000

without having consequences to society that they prepare thesis to the students to earn

degrees. This sort of practice is generating the students to earn degree without skill and hands

on knowledge. The same is acceptable to various recognized colleges of universities to

strengthen their financial resources and it is in practice to accept them by the examiners after

presentation of data at the time of oral examination. If their data is published in repute

journals its references may lead to unnecessary articulations. All these practices of

malpractice must be avoided, if government shall provide fund to the basic researchers in the

form of consumables for use, during the stay of students in the laboratories. Not providing

fund to the researcher at the right time causes damage to the prestige of countries and further

may not generate patents to the expected mark. In the Current Science the same was

reiterated by Vedpal Malik (2015). Further he mentioned that it may be necessary to open

biotechnology business centers on university or college campuses to generate resources and

strengthen the research facilities to acquire more of patents by innovation of novel

compounds from medicinal plants. Recently on October 7, 2015 Australia’s apex court has

declared unpatentability for an isolated gene, nucleic acid, related breast and ovarian cancer

susceptibility gene BRCA-1. In addition to it several of scientists, eg., Prof CNR Rao, are of

the opinion that the industries in India must look after their research and development sector.

These may pose some problems to pharma industries and their business.

In conclusion, the biochemical and biotechnological work in India is expensive. Every

scientist is striving hard to get the good results with the available resources. The cooperation

of all people is necessary to achieve a better goal. The patenting agencies must help all the

individuals at all the times. To get international patents in biology every person, from

government to heads, must provide support to strengthen our country.

ACKNOWLEDGMENTS

This research was financed by University Grants Commission, New Delhi in the form of

women PDF.

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