ROLE OF INTELLECTUAL PROPERTY RIGHTS IN BIOTECHNOLOGY AND

PHARMACEUTICAL INDUSTRIES

Ajeet*

S. D. College of Pharmacy and Vocational Studies, Muaffarnagar, U.P., India,

PIN-251001

*
E-mail for correspondence: ajeet_pharma111@rediffmail.com

ABSTRACT

The main objective of this review is to highlight and explore the inter-relationship and the
functioning of the intellectual property right in the pharmaceutical and biotechnology
industry. The rising tide of patent applications can be witnessed globally in this industry as
the need for such protection and licensing has become imperative so as to safeguard the rights
of the inventor and also to encourage and promote new talents, inventions and innovations
which can be a boon for the economy. The field of biotechnology is an upcoming science
which is still at the initial stage of establishing a foundation but it promises a revolution in
the fields of medicine, agriculture, pharmaceuticals and industrial sector amongst other
sectors of the economy along with contribution to the GDP growth.

GRAPHICAL ABSTRACT
INTRODUCTION

Intellectual property refers to the exclusive rights granted by the State over creations of the
human mind, in particular, inventions, literary and artistic works, distinctive signs and
designs used in commerce. Intellectual property is divided into two main categories:
industrial property rights, which include patents, utility models, trademarks, industrial
designs, trade secrets, new varieties of plants and geographical indications; and copyright and
related rights, which relate to literary and artistic works.

Industrial property (IP) rights are extremely important for the pharmaceutical industry. The
use of the IP system by SMEs in the pharmaceutical industry depends largely on the business
strategy of a company, its size, resources, innovative capacity, competitive context and field
of expertise. Research-based, innovation-led companies that seek to develop new drugs
improve or adapt existing drugs or develop new pharmaceutical/medical equipment or
processes, tend to rely heavily on the patent system to ensure they recover the investments
incurred in research and development. Companies that rely on licensing in or licensing out of
pharmaceutical products will need to be knowledgeable about the patent system to so that
they are able to negotiate fair and balanced licensing contracts. SMEs in the pharmaceutical
industry may use the wealth of information contained in patent documents as a crucial input
to their R&D work, to get ideas for further innovation, to ensure their "freedom to operate" or
to find out when a patent is due to expire opening the door for the introduction of generics.

Confidential information, protected as trade secrets, is also important for many companies, as
is the valuable know-how or undisclosed test data relating to new or improved drugs.
Understanding the trademark system is important for companies selling branded products.
Industrial designs, plant variety protection and copyright and related rights are generally less
relevant to most SMEs in the pharmaceutical sector but this could vary depending on the
product line and strategy of each company.

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides

for minimum norms and standards in respect of the following categories of intellectual
property rights: -

a. Copyrights and related rights

b. Trademarks
 c. Geographical Indications
d. Industrial Designs
e. Patents
f. Lay out designs of integrated circuits
g. Protection of undisclosed information (trade secrets)

The Agreement sets out minimum standards to be adopted by the parties, though they are free
to provide higher standards of protection. A transition period of five years is available to all
developing countries to give effect to the provisions of the TRIPS Agreement. This period
ended on 1.1.2000. No transitional period is available, however, for grant of national
treatment and most-favoured-nation treatment. Countries that did not provide product patents
in certain areas of technology as on 1.1.1995, can delay the grant of product patents in those
areas for another five years i.e. upto 1.1.2005.

Where a country does not make available patent protection for pharmaceutical and
agricultural chemical products as on 1.1.1995, they have to provide a means for accepting
applications for such inventions (mailbox), apply applicable priority rights and provide
exclusive marketing rights (EMRs) for such products. The EMRs have to be provided in
India only if a set of conditions have been met, i.e. where a patent application has been filed
after 1.1.1995 in any WTO Member, patent and marketing approval granted in that Member
country, an application has been filed in the mailbox in India and marketing approval
obtained in India. The EMR is available for five years from grant or till the patent is granted
or rejected, whichever is earlier. The Patent (Amendment) Act, 1999 was passed in March
1999 to provide for mailbox and EMR facility. The state of play
of India’s obligations under TRIPS arising as on 1.1.2000 in respect of the seven IPRs
covered under TRIPS is briefly given below1-5.

(a) Copyrights and related rights

In the area of copyright and related rights (i.e. rights of performers, producers of phonograms
and broadcasting organizations), the Agreement requires compliance with the substantive
provisions of the Berne Convention. Computer programmes are to be protected as literary
works, the term of protection for copyrights and right of performers and producers of
phonograms is to be no less than 50 years. In case of broadcasting organisations, however,
the term of protection is to be at least 20 years. India is already a signatory to the Berne
Convention and our laws conform to the provisions of the Convention. India’s copyright law
has been amended and in some ways exceeds the requirements of the TRIPS Agreement, for
example, on the period for copyright protection (which is 60 years in India). The law was
amended in December 1999 to grant 25-year term of protection for neighbouring rights.

(b) Trademarks

The Trade and Merchandise Marks Act 1958 was in its essential features in accordance with
TRIPS, except that it did not cover service marks in its scope. This has been done by
replacing it with the Trademarks Act 1999. We are now fully compliant with our TRIPS
obligations.

(c) Geographical Indication

The Agreement contains a general obligation that parties shall provide the legal means for
interested parties to prevent the use of any means in the designation or presentation of a good
that indicates or suggests that the good in question originates in a geographical area other that
the true place of origin of the good. We currently provide protection to geographical
indications through passing off action in courts or through certification marks. However, to
provide better protection to geographical indications a new law "The Geographical Indication
of Goods (Registration & Protection) Act, 1999 has since been enacted.

(d) Industrial Designs

Obligations envisaged in respect of industrial designs are that independently created designs
that are new or original shall be protected. There in an option to exclude from protection,
designs dictated by technical or functional consideration, as against aesthetic consideration
which constitutes the coverage of industrial designs.

(e)Patents

The basic obligation in the area of patents is that, inventions in all fields of technology
whether products or processes shall be patentable if they meet the three tests of being novel,
involving an inventive step and being capable of industrial application. In addition to the
general security exception, which applies to the entire TRIPS Agreement, specific exclusions
are permissible from the scope of patentability. These are available in the areas of inventions
whose commercial exploitation is to be prevented to protect public order or morality, human,
animal plant life or health or to avoid serious prejudice to the environment. In addition, we
can exclude from patentability diagnostic, therapeutic and surgical methods for the treatment
of human and animals, plants and animals other than microorganisms, and essentially
biological process for the production of plants and animals other than non-biological
processes.

To meet our TRIPS obligations as on 1.1.2000, the Patents (Second Amendment) Bill, 1999
has been introduced in the Parliament in December 1999 and is before the Joint Committee of
theHouses.

In respect of plant varieties, there is an obligation to provide for protection either by patents
or by an effective sui generis system or by any combination thereof. The Agreement does not
spell out the elements of an effective sui generis system and it is left to each Government to
determine the elements, which could be deemed to be providing effective protection. A
decision has been taken to put in place a sui generis system as it is perceived to be in our
national interest. A Bill in this regard is before the Joint Committee of the Houses of the
Parliament.

Patentable subject matter-

Under many national laws, patentable subject matter is defined negatively, i.e. by
providing a list of what cannot be patented. However, there are important differences
between countries in terms of what may represent unpatentable subject matter. For example,
patent legislation in some countries includes some of the following as unpatentable subject
matter:

 Discoveries and scientific theories;

 Aesthetic creations (which may be protected by industrial designs);
 Schemes, rules and methods for performing mental acts;
 Newly discovered substances as they naturally occur in the world;
 Inventions the exploitation of which is contrary to "public order" or morality;
 Diagnostic, therapeutic and surgical methods of treatment for humans or animals (but
not products for use in such methods);
  Plants and animals other than microorganisms, and essentially biological processes
for the production of plants or animals other than non-biological and microbiological
processes.

In the pharmaceutical industry, types of inventions that are patentable in many countries (as
long as the other criteria are met) include new pharmaceutical compounds, new or improved
products for diagnostics, new dosage forms of known therapeutics, microorganisms, novel
combinations of known compounds, processes and methods used for manufacturing a
particular product, new and/or improved manufacturing equipment and new and/or improved
drug delivery mechanisms or technologies. The list is by no means exhaustive and not all of
the above are patentable in all countries.

The novelty requirement

An invention is new (or novel) if it does not form part of the prior art. The prior art is, in
general, all the knowledge that has been made available to the public prior to the filing date
(or priority date) of the relevant patent application or (in the United States) prior to when the
invention was "made". The definition of "prior art" differs from country to country. In many
countries, any invention made available to the public anywhere in the world in written form,
by oral communication, by display or through use constitutes the prior art. Thus, in principle,
the publication of the invention in a scientific journal, its presentation in a conference, its use
in commerce or its display in a company's catalogue before the filing date (or priority date) of
the application claiming that invention would constitute acts that could destroy the novelty of
such invention and render it not patentable.

It is important to note, however, that in some countries, there is a grace period (usually of 6
or 12 months from the public disclosure of the claimed invention by the inventor) during
which an applicant may file an application without the novelty being destroyed by such
disclosure.

The inventive step/non-obviousness requirement

An invention is considered to involve an inventive step (or to be non-obvious) when, having

regard to the prior art, the invention would not have been obvious to a person skilled in the
particular field of technology. The non-obviousness requirement is meant to ensure that
patents are not granted on developments that a person skilled in the relevant art could easily
deduce from what already exists.

Industrial applicability/utility requirement

To be patentable, an invention must be capable of being used in industry (or meet the
utility requirement). This means that the invention cannot be a mere theoretical phenomenon,
but it must be useful and provide some practical benefit. The term "industry" is used in the
broad sense, meaning anything distinct from purely intellectual or aesthetic activity, and
includes, for example, agriculture. In biotechnology, the utility requirement has become
particularly important in the context of the patenting of genetic sequences over which
possible industrial applications are unclear. Some countries require that the utility be well
established and asserted for the claimed invention in a specific, substantial and credible
manner.

The disclosure requirement

According to the applicable national or regional legislation of most countries a patent

application must disclose the invention in a manner sufficiently clear and complete for the
invention to be carried out by a person skilled in the specific technical field (enabling
disclosure requirement). For example, a patent application for a new pharmaceutical product,
must include enough practical information so that anyone familiar with the relevant technical
field is able to follow the indicated steps and replicate and produce an effective copy of it. In
some countries, patent legislation requires the applicant to disclose the "best mode" for
practicing the invention. For inventions involving microorganisms, many countries require
that, if the microorganism is not accessible to the public and the claimed invention cannot be
described in such a way to comply with the enabling disclosure requirement without having
access to that microorganism, such microorganism be deposited at a recognized depositary
institution, which is capable of maintaining the microorganism in a live culture for a
prescribed period of time.

Patents in the life sciences

To comply with requirements under the TRIPS Agreement of the World Trade Organization,
most countries allow for the patenting of microorganisms and, as explained above, often
require the deposit of a sample of the microorganism at a recognized depositary institution
when necessary to comply with the enabling disclosure requirement. Some countries exclude
plants and animals (other than microorganisms) from patentability. Biological materials
that have been purified and isolated from their natural environment or produced by means of
a technical process are patentable in many jurisdictions. National patent law in many
countries may also list some specific types of inventions that are excluded from patentable
subject matter, such as processes for cloning human beings or processes for modifying the
germ line genetic identity of human beings.

Depending on the country, plant varieties are protected either by the patent system, by a sui
generis protection system for new varieties of plants or by a combination of the two.

Patents on improved variations and new uses

In many countries, improvements made to existing products are patentable, as are also new
uses of a patented product, provided all the patentability requirements are met. In the
pharmaceutical industry, it is not uncommon for companies to file patent applications for new
therapeutic indications of a known drug. But such protection is not available in all
jurisdictions. In addition, companies often file applications on new formulations or delivery
methods of a drug, new and improved manufacturing processes, reduced dosage regimens,
new versions of the active compound or other variations that meet the patentability
requirements.

(f) Layout Designs of Integrated Circuits

India is a signatory to the international agreement administered by WIPO on this subject

known as the Washington Treaty. The main obligations of the Washington Treaty are also
incorporated in the TRIPS Agreement with some enhancement and cover the protection of
the intellectual property in respect of lay-out designs that are original in the sense of being the
result of their creator's own intellectual efforts. The obligations include national treatment to
foreign right holders and a term of protection for 10 years. A Bill in this regard was
introduced in the Parliament in December 1999 and is awaiting passage.
(g) Protection of undisclosed information

The Agreement provides in this area that natural and legal persons shall have the possibility
of preventing information lawfully within their control from being disclosed to, acquired by
or used by others without their consent in a manner contrary to honest commercial practices.
Further, parties are required to protect against unfair commercial uses, undisclosed or other
data obtained as a condition of approving the marketing of pharmaceutical or of agricultural
chemical products.

INDIAN PHARMACEUTICAL INDUSTRY

The Indian pharmaceutical sector has come a long way, being almost non-existent
before 1970 to a prominent provider of healthcare products, meeting almost 95 per
cent of the country's pharmaceuticals needs.

The Industry today is in the front rank of India’s science-based industries with wide ranging
capabilities in the complex field of drug manufacture and technology. It ranks very high in
the third world, in terms of technology, quality and range of medicines manufactured. From
simple headache pills to sophisticated antibiotics and complex cardiac compounds,
almost every type of medicine is now made indigenously.

Playing a key role in promoting and sustaining development in the vital field of medicines,
Indian Pharma Industry boasts of quality producers and many units approved by
regulatory authorities in USA and UK. International companies associated with this sector
have stimulated, assisted and spearheaded this dynamic development in the past 53 years and
helped to put India on the pharmaceutical map of the world.

The Indian Pharmaceutical sector is highly fragmented with more than 20,000
registered units with severe price competition and government price control. It has
expanded drastically in the last two decades.

There are about 250 large units that control 70 per cent of the market with market leader
holding nearly 7 per cent of the market share and about 8000 Small Scale Units
together which form the core of the pharmaceutical industry in India (including 5
Central Public Sector Units). These units produce the complete range of pharmaceutical
formulations, i.e., medicines ready for consumption by patients and about 350 bulk
drugs, i.e., chemicals having therapeutic value and used for production of pharmaceutical
formulations.

Following the de-licensing of the pharmaceutical industry, industrial licensing for

most of the drugs and pharmaceutical products has been done away with. Manufacturers are
free to produce any drug duly approved by the Drug Control Authority. Technologically
strong and totally self-reliant, the pharmaceutical industry in India has low costs of
production, low R&D costs, innovative scientific manpower, strength of national
laboratories and an increasing balance of trade.

The total Indian production constitutes about 13 per cent of the world market in value terms
and, 8 per cent in volume terms.

The per capita consumption of drugs in India, stands at US$3, is amongst the lowest in the
world, as compared to Japan- US$412, Germany- US$222 and USA- US$191.

Current Status4

India's US$ 9.4 billion pharmaceutical industry is growing at the rate of 14 percent per year.
It is one of the largest and most advanced among the developing countries.
The Indian pharmaceutical industry can reach a market size of US$ 11.6 billion by 2009.

A beginning has been made with the signing of General Agreement on Tariffs and Trade in
January 2005 with which India began recognizing global patents. Soon after, the
Indian pharmacy market became a sought after destination for foreign players. Foreign
direct investment into the country’s pharmacy industry touched US$ 172 million during
2005-06 having grown at a CAGR of 62.6 per cent during the period beginning 2002-06.

The sector recorded strong growth in the second quarter ended September 2006, driven by
launch of new generic drugs with 180 days exclusivity period in the US market. The top ten
pharmacy companies reported an impressive 57 per cent growth in consolidated net profit at
US$ 314.3 million, as against US$ 200.7 million in the same quarter of the previous
year, while consolidated net sales were up 51 per cent at US$ 1.7 billion.
 Company Profit( per cent)
Ranbaxy Labs 167.2
Dr Reddy’s Labs 65.8
Cipla 5.2
Nicholas Piramal 473.9
Sun Pharma 35.8
Lupin 26.8
Cadila Healthcare 66.4
Torrent Pharma 313.7
Glenmark 74.5
Biocon 26.1

There are 74 U.S. FDA-approved manufacturing facilities in India, more than in any other
country outside the U.S, and in 2005, almost 20 per cent of all Abbreviated New
Drug Applications (ANDA) to the FDA were filed by Indian companies.

Growth in other fields notwithstanding, generics is still a large part of the picture. London
research company Global Insight estimates that India’s share of the global generics market
will have risen from 4 per cent to 33 per cent by 2007.

The focus of the Indian pharma companies is also shifting from process improvisation to
drug discovery and R&D. the Indian companies are setting up their own R&D setups and are
also collaborating with the research laboratories like CDRI, IICT etc.

Emerging Trend

The Indian pharmaceutical industry is now discovering new opportunities of growth in

clinical research, contract research, manufacturing and innovation opportunities. This path
can lead the Indian pharmaceutical industry to huge success endeavors.

Indian Pharmaceutical Industry: Post 2005 scenario

• Global pharmacos expected to launch 200-250 new drugs over next 8-10 yearstotaling an
estimated US$ 3-5 billion
• FDI inflow grew over six fold from US$ 60.7 mn in 2003 to US$ 340 mn,
infiscal year 2004

• Bristol Myers Squibb, Boehringer Ingelheim and Eisai without Indian presenceearlier,
have made recent foray

• Indian firms tying up with foreign companies to in-license drugs

Research & Development4

Research & Development is the key to the future of pharmaceutical industry. The
pharmaceutical advances for considerable improvement in life expectancy and health all over
the world are the result of a steadily increasing investment in research. There is considerable
scope for collaborative R & D in India. India can offer several strengths to the international R
& D community. These strengths relate to availability of excellent scientific talents who can
develop combinatorial chemistry, new synthetic molecules and plant derived candidate drugs.

The R & D expenditure by the Indian pharmaceutical industry is around 1.9 per cent of the
industry’s turnover, which is a little low as compared to foreign research based
pharmaceutical companies. However, now that India is entering into the Patent protection
area, many companies are spending relatively more on R & D.

When it comes to clinical evaluation at the time of multi-center trials, India is providing a
strong base considering the real availability of clinical materials in diverse therapeutic areas.
According to a survey by the Pharmaceutical Outsourcing Management Association and
Bio/Pharmaceutical Outsourcing Report, pharmaceutical companies are utilizing
substantially the services of Contract Research Organizations (CROs). Indian
Pharmaceutical Industry, with its rich scientific talents, provides cost-effective clinical trial
research. It has an excellent record of development of improved, cost-beneficial
chemical syntheses for various drug molecules. Some MNCs are already sourcing these
services from their Indian affiliates.

Domestic Demand

The industry has enormous growth potential. Factors listed below determine the rising
demand for pharmaceuticals.

• The growing population of over of a billion

• Increasing income

• Demand for quality healthcare service

• Changing lifestyle has led to change in disease patterns, and increased demand for
new medicines to combat lifestyle related diseases

More than 85 per cent of the formulations produced in the country are sold in the domestic
market. India is largely self-sufficient in case of formulations. Some life saving, new
generation under-patent formulations continue to be imported, especially by MNCs, which
then market them in India. Overall, the size of the domestic formulations market is around
Rs160 billion and it is growing at 10 per cent per annum.
Demand for drugs for treatment of lifestyle-related diseases such as diabetes, cardiovascular
diseases, and central nervous system are on the increase. There are around 700,000
new cases of cancer each year and total of around 2.5 million cases. It is estimated that there
are around 40 million people in India with diabetes and the number is rising, 5.1
million HIV/AIDS patients, and 14 million tuberculosis cases. According to industry reports,
while the Indian pharmaceutical industry witnessed a growth of 7 percent, the cardio-
vascular segment recorded 15 to 17 percent growth and anti-diabetes segment of over 10-12
percent growth.

Exports

Over 60 per cent of India’s bulk drug production is exported. India’s pharmaceutical exports
are to the tune of Rs87 billion, of which formulations contribute nearly 55 per cent and the
rest 45 per cent comes from bulk drugs. In financial year 2005, exports grew by 21 per cent.
The Indian pharmaceutical market has been forecasted to grow to as much as US$ 25 billion
by 2010 as per Organization of Pharmaceutical Producers of India (OPPI) estimates.
However, Espicom’s market projections forecast more modest but stable annual market
growth of around 7.2 per cent, putting the market at US$ 11.6 billion by 2009.

Revenue from Export- India accounts for less than two per cent of the world market for
pharmaceuticals, with an estimated market value of US$10.4 billion in 2007 at consumer
prices, or around US$9 per capita. India currently represents just U.S. $6 billion of the
$550 billion global pharmaceutical industry but its share is increasing at 10 percent a year,
compared to 7 percent annual growth for the world market overall. Also, while the Indian
sector represents just 8 percent of the global industry total by volume, putting it in fourth
place worldwide, it accounts for 13 percent by value, and its drug exports have been
growing 30 percent annually. Cipla, Nicholas Piramal, Ranbaxy, Zydus Cadila, Dr.
Reddy’s are the few Indian pharmaceutical companies, which are known at the global level
due to their quality products.

BIOTECHNOLOGY AND ITS GROWING IMPORTANCE

Biotechnology is a field of applied biology that involves the use of living

things in engineering, technology, medicine, and other useful applications. Modern use
of the term includes genetic engineering as well as cell- and tissue culture technologies. The
concept encompasses a wide range of procedures (and history) for modifying living
organisms according to human purposes - going back to domestication of animals, cultivation
of plants, and "improvements" to these through breeding programs that employ artificial
selection and hybridization.

The United Nations Convention on Biological Diversity defines biotechnology as: "Any
technological application that uses biological systems, living organisms, or derivatives
thereof, to make or modify products or processes for specific use." Biotechnology draws on
the pure biological sciences (genetics, microbiology, animal cell culture, molecular
biology, biochemistry, embryology, cell biology) and in many instances is also
dependent on knowledge and methods from outside the sphere of biology (chemical
engineering, bioprocess engineering, information technology, and biorobotics).

Conversely, modern biological sciences (including even concepts such as molecular ecology)
are intimately entwined and dependent on the methods developed through biotechnology and
what is commonly thought of as the life sciences industry.

Biotech is emerging as a sector witnessing exponential growth witnessed in sub-sectors such

as Bio-informatics sector, Industrial Biotech Sector, Agri-Biotech Sector, Research Services
Sector, Bio-Suppliers and most importantly one of the main applications of Bio-technologies,
the Bio-Pharmaceutical Sector. Since the existence of the growing Biotechnology
industry cannot be ignored hence it becomes imminent that large-scale investment also takes
place for the required purpose of Research and Development (R&D) in this sector.
Presently, the need for biotechnological techniques, processes and procedures has
arisen to such an extent because of the advance in technologies and the scientific
discoveries and inventions. Hence Bio-technology has become one of the emerging spheres
and technologies in India as well on a global level.

PRESENCE OF THE BIOTECHNOLOGY SECTOR IN INDIA

There appears to be a common trend that economies worldwide as well as the Indian
markets have attracted major players in the field of biotechnology. The rising tide of
firms dealing in Biotechnological products and services has been noticed over the last
decade in India. The two significant factors, which lie at the base of India‘s biotechnology
potential, are the scientific and technical pool of human resources and secondly the rich
biodiversity of the country6.

Since India depicts an interesting demographic profile and a large agricultural base, India
being mainly an agrarian economy, it also affords a large market base for new biotechnology
products since being a developing economy it has a wide scope for the utilization and
the implementation of these resources because of its cost competitive manpower, well
developed and integrated scientific infrastructure and is globally recognized as a producer
of low cost, high quality bulk drugs and formulations and other biotech products and services
which holds a promising market7. As per an authentic survey conducted in the years 2003-04
it was deduced that the presence of the biotech industry in India was approximately
worth US$ 720mn. This sector showed promising returns and a high growth factor hence
subsequent surveys and studies enumerated a growth by 39%. This could be witnessed in the
years 2007-08, as this Sector had become one of the fastest growing and emerging,
technological, knowledge-based industries showcasing a turnover of almost US$ 2.13
billion and further in 2008-09, the biotechnology industry in India was estimated to be worth
US$ 2.51 billion8.

Presently, India holds 2% of the market share in the global biotech sector as it has the
appropriate market and base for the rapid growth and evolution of this industry. This may
play a cardinal role in the economic development and advancement of the country. It is also
predicted by market analysts and economic advisors that an approximate increase in the total
worth of this industry would reach upto US$ 4.5 billion by the year 2010 in India and an
employment creation of 1 million.

INTELLECTUAL PROPERTY RIGHTS AND THE CHALLENGES TO INDIAN

PHARMACEUTICAL INDUSTRY9

The Indian pharmaceutical industry has changed remarkably over the last 50years, from
being traders in imported drugs in the fifties, to major bulk drug producers by the eighties.
During this transitional period Indian pharmaceutical units have learnt the technology of bulk
drug production by their own research and adaptation, and today they produce more than 250
bulk drugs, emphasizing on import substitution and use of indigenous raw materials. At
present the Indian pharmaceutical industry has about 300 large units, 1700 medium-size units
and about 8000 small-scale units throughout the country.

The Indian law on this subject is contained in the Patents Act, 1970 (a law made by the
Indian Parliament) as amended from time to time. In pharmaceutical industry what is
patentable is an invention for making a product, and not a discovery in the field of
fundamental science. In a discovery nothing new is created. On the other hand, an invention
is creation of a new entity, or a new process, though this usually involves utilization of
scientific discoveries. The basic requirement for patentability under the Patents law is that the
invention should be new and useful, that is, it must have novelty and utility, vide Bishwanath
Prasad Radhey Shyam v.Hindustan Metal Industries Once an invention is patented the
patentee gets exclusive right to use it, though he may sell or lease it to another. Infringement
of the patent can be prevented by an injunction in a civil suit.
TRIPs, the Agreement on Trade-Related Aspects of Intellectual Property Rights is an
International treaty by the World Trade Organization (WTO) which sets down minimum
standards for most forms of intellectual property (IP) regulation within all member countries
of the World Trade Organization. It was negotiated at the end of the Uruguay Round of the
General Agreement on Tariffs and Trade (GATT) treaty in 1994. After India signed the
General Agreement on Trade and Tariff (GATT) and the Trade Related Aspects of
Intellectual Property Rights Agreement, 1994 (TRIPS) and became a member of the World
Trade Organization (WTO). As India is a signatory to the TRIPS Agreement and is a member
of WTO, the Patents Act is amended in 2005 to make it confirm to these international
agreements. Under Article 70(8)(9) of the TRIPS Agreement regarding pharmaceutical
industry, India has the following obligations:

(a) To recognize in principle all kinds of inventions in the area of pharmaceutical and
agricultural chemical products in accordance with Article 27 of the Agreement.

(b) To provide a mechanism by which applications can be filed for new inventions as
understood in Article 27 in these areas from 1-1-1995.

(c) To apply the test of patentability as laid down in the Agreement irrespective of the law of
the country on the date of filing, at the time when patent is granted or rejected.

(d) To provide patent protection for a period of 20 years, from the date of filing once the
parties decide to grant the patent.

(e) In the case of product patent applications in these areas, grant exclusive marketing rights
for five years or until patent is granted or rejected, whichever period is shorter.

Granting of exclusive marketing rights is subject to three conditions:

(i) product patent for the invention has been granted by another member country;

(ii) market approval is obtained in such other member country; and

(iii) market approval from the country/member granting exclusive marketing right is granted.

Before the recent amendment Section 5 of the Indian Patents Act, 1970 Expressly prohibited
product patents and only permitted process patent. After the implementation of TRIPS, the
Patents (Amendment)Act, 2005 repealed it and therefore gave way to product patents as well.
The difference between process patent and product patent is that under a process patent,
medicine or drugs which have been patented can be manufactured by another manufacturer
but by using a different process. However, in a product patent drugs which have been
patented cannot be manufactured by any process. Thus, product patent is a much stringent
restriction than process patent. In consequence of India signing the TRIPS Agreement and
WTO India accepted the product patent from 1-1-2005 in accordance with the obligation
under Article 27(1) of the TRIPS. It is open to a country signing the TRIPS Agreement to
exclude from patentability inventions which are necessary to protect morality, order or health
or avoid serious prejudice to the environment, but such exclusion can only be in areas where
the majority of member States are also prohibiting the commercial exploitation and denying
protection.

The implementation of the TRIPS Agreement will give rise to factors that can put access to
medicines out of reach for millions of people in the developing world. The TRIPS Agreement
obliges WTO Members to adopt and enforce high standards of intellectual property rights
protection, which were derived from the standards used in developed countries. Conforming
to TRIPS – by recognizing and strengthening protection of intellectual property rights over
pharmaceutical products and processes – will cause problems for developing countries.
Implementation of the TRIPS Agreement may lead to high drug prices, low access to
medicines and a weakening of pharmaceutical industries in the developing countries. It is
feared that patent protection for pharmaceutical products and processes will have the effect of
reducing or eliminating competition from generic production of medicines. There are about
10 industrialised countries with the pharmaceutical industry and research base, capable of
developing new chemical entities or new medicines. The multinational drug companies in
these countries own most of the pharmaceutical technologies and products through patents.
The minimum term of 20-year patent protection required by TRIPS effectively allows a
pharmaceutical company a monopoly over the production, marketing and pricing of patent
protected medicines. It will be able to keep the price of the drug high during the protection
period, free from competition. By virtue of TRIPS protection, no generic equivalent can come
into the market until expiry of the 20 years, denying patients cheaper alternatives. Domestic
manufacturing of pharmaceutical products in developing countries will come to a standstill.
Developing countries are able to produce new medicines by a process of reverse engineering;
that is, researchers in developing countries may develop a new process different from the
process invented (and protected by patent) to manufacture the new medicine or chemical
entity. Reverse engineering is possible only in countries where the patent law protects
processes but not products. The TRIPS Agreement extends the scope of patent protection to
both products processes. It would therefore be possible to apply for patent rights over
products for 20 years, and thereafter, further periods of 20 years each could be applied for
products covered by patented processes. Developing country pharmaceutical producers will
find themselves pushed out of the market, having to compete with the large MNCs. For the
smaller producers in the developing world, which specialise and depend on manufacturing
cheaper generic alternatives, this would no longer be possible at least, until the expiry of the
20-year period. The TRIPS Agreement further requires patents to be granted, regardless
whether the products are imported or locally produced. The means that patent holders can
merely import their product, without having to work the patent in the country granting the
right. This will mean that a MNC can supply global markets under the patent monopoly,
exporting the finished product instead of transferring technology or making foreign direct
investment. This is contradictory of the argument of TRIPS proponents that strict patent
regimes will increase the flow of technology and investment into developing countries. The
TRIPS Agreement, in its present form, contains certain provisions that can be used to limit
patent rights. These limitations or exceptions are to be effected through national legislation,
in order to curb abuses of intellectual property rights and anti-competitive practices, and
generally, to offset the negative impact of patent monopolies. Two of the most important
measures include the right of government to grant compulsory licenses and the application of
the principle of exhaustion of intellectual property rights, which allows for parallel
importation of patented products.

National Pharmaceutical Policy, 2006 Announced

The National Pharmaceutical Policy, 2006 has been announced, it is focusing on research and
drug development with clinical trials. The policy lays emphasis on developing human
resources in pharmaceutical sciences by opening more institutions on the pattern of the
National Institute of Pharmaceutical Education and Research (NIPER). The policy aims at
providing a better access to anti-cancer and anti-HIV/AIDS drugs to the patients.

Hon,ble Minister Shri Paswan said the draft National Pharmaceutical Policy, 2006 seeks to
rationalise the excise duty on pharmaceuticals. It also seeks to streamline the system of bulk
procurement of drugs by the Government besides promoting the generic medicines. The
Minister said consumer awareness campaigns would be launched to educate the masses on
the new policy. Drugs would be made available to the poor, especially the families living
below the poverty line. He said the new policy encourages production of critical bulk drugs in
India with emphasis on good manufacturing practices. There would be a Settlement
Commission for settling old dues under the Drugs (Prices Control) Order, 1979. A Drug Price
Monitoring Awareness and Accessibility Fund (DPMAA Fund) would be set up along with
pharma parks. Shri Paswan said the policy lays greater thrust on pharma exports and on
improving the retail system for an efficient network for distributing drugs. A Pharmaceutical
Advisory Forum would be set up at the national level besides an advisory committee in the
National Pharmaceutical Pricing Authority(NPPA) at its head office and five in different
regions. These would be headed by the NPPA Chairman.

In addition to the existing 74 drugs and their formulations, the 354 drugs with specified
strength as mentioned in the National List of Essential Medicines (NLEM), 2003 have also
been included in the draft Pharmaceutical Policy. Apart from the cost plus method, other
systems of price control like negotiated prices, differential prices, reference prices and bulk
purchase price have also been proposed. He said the raw material cost would be obtained
from the manufacturers, central public enterprises in the pharmaceutical sector, import data
and market sources.

Govt. disclosed that the Maximum Allowable Post-manufacturing Expenses (MAPE),

presently 100 per cent over the manufacturing cost, is proposed to be revised as follows:

(a) 150% in general

(b) 50% additional MAPE for R&D intensive companies which fulfill the laid down
standards.

(c) For existing 74 drugs under price control MAPE would continue to remain at 100% for
one year in order to avoid a sudden increase in prices. It would be increased thereafter on the
above pattern.

(d) Based on the given percentage of MAPE, prices would be fixed for all drugs in the cost
plus price control system.
(e) Maximum Retail Price (MRP) would be inclusive of all taxes as in the case of all other
packaged commodities.

(f) Some exemptions have been provided for certain drugs from the price control-new drugs
developed in India through product patent, process patent and new drug delivery systems
would be exempted from price control for 5 years. This will boost R&D in India.
Simultaneously, vaccines and biological drugs, drugs for sale to hospitals only, drugs whose
MRP is at Rs. 1 per capsule / tablet and generic formulations fulfilling the prescribed norms
would be exempted.

(g) A new Drugs (Prices Control) Order would be issued under the Essential Commodities
Act 1955 to replace the existing DPCO, 1995.

(h) Re-structuring and strengthening of the National Pharmaceutical Pricing Authority

(NPPA) – greater computerization and better monitoring.

(i) Price Monitoring Cells in the State Drug Controller Offices with funding from
Government of India.

(j) Drugs (Price Management and Distribution) Act to be enacted for effective regulation of
drug prices and for handling health emergencies – it will also provide compounding of minor
offences.

(k) Trade Margins on generic-generic drugs, would be fixed (15% – wholesalers and 35%-
retailers).

(l) Change in the name of Department of Chemicals and Petrochemicals to reflect

Pharmaceuticals also (Name proposed is – Department of Chemicals, Petrochemicals and
Pharmaceuticals).

(m) Draft policy along with Cabinet Note has been circulated to all Departments for their
comments. On receipt of their comments it would be put up before the Cabinet.
INTELLECTUAL PROPERTY RIGHTS AND BIOTECH INDUSTRY

In India, the pharma industry is one of the first to reap the benefits of biotechnology. Human
health biotechnology products account for about 60 percent of the domestic market, while
bio-drugs, vaccines and diagnostics have significant market shares as well. Consequently,
Indian pharma is beginning to benefit from enhanced IP protection of their products. An
example is Ranbaxy's NDDS for ciprofloxacin that it licensed to Bayer for $65 million plus
royalties. Other Indian research-based companies have earned about $70 million from R&D
milestone payments.

Intellectual Property (IP) is central to the biotechnology industry, and brings with it a
dimension, facilitating collaborative activity, whether it is a drug discovery or clinical or
market-related trials. Essentially, collaborative activity is the synergy between India's ability
to provide conditions for research, clinical trials and development, technological lead and
capital availability in developed nations. The successful translation of these synergies into
commercially viable applications and marketable products critically depends on the
compatibility of regulations that deal with the registration and protection of intellectual
property, originating from the collaborative process. Affordability and accessibility to the
products of biotechnology are also the two key factors central to the advancement of this
sector. Policies that foster a balance between sustaining innovation and facilitating
technology diffusion has been addressed with substantial progress in terms of support for
R&D, human resource generation and infrastructure development.

Over the past decade, India has shown excellence in scientific performance as evidenced by
number and quality of publications made each year in international journals. However, its
technological and commercial performance is low as indexed by the number of patents issued
per unit of investment made in R&D. Realising the potential and relevance to the needs of
society, the Department of Biotechnology (DBT) has emphasised the development of all
facets of IPR with relation to biotechnology.

Importance of IP protection

A streamlined and efficient patent protection, in addition to the industry's maturing

relationship with capital markets are the hallmarks of America's global leadership in
biotechnology. In contrast, most developing countries do not have strong IPR regimes and
suffer negative effects of "brain drain". The reason being, lack of effective copyright laws,
which force scientists and technicians to immigrate to countries, where their research is
protected from unfair exploitation by competitors.

Both Japan and Mexico saw a tripling of US pharmaceutical investments and R&D after they
improved patent laws. In fact, over the past years, the stumbling block for global investors,
looking for tie-ups with Indian firms has been the perception that India's IPR norms are too
lenient. "The prime reason Singapore is chosen over India is because they protect Intellectual
Property Rights. Companies take their R&D and clinical trial operations to Singapore
because they see clarity in regulation, besides other financial benefits," notes the CEO of a
prominent pharmaceutical company, based in Singapore.

Global IP regulations

Even though, the WTO TRIPS agreement provides a foundation for IPR protection,
enforcement is lacking in many parts of the world. The basic obligation in the area of patents
is that inventions in all fields of technology, whether products or processes, shall be
patentable if they meet three criteria - being novel, involving an inventive step and being
capable of industrial application.

Additionally, a patent can be granted for any invention that meets the patentability conditions
in all fields of technology, irrespective of the place of invention. Over and above, in the
general security exception, which applies to the entire TRIPS Agreement, only specific
exclusions are permissible from the scope of patentability. Such exclusions span research
areas, whose commercial exploitation should be prevented to protect public order, human,
animal and plant welfare, and to avoid environmental damage.

Biotechnology patent applications experience numerous restrictions, primarily, due to the

undefined scope and complex nature of the technology. Deciding the scope of patent
protection for inventions is a difficult task, as it raises a number of technical and ethical
issues. To begin with, biotechnology is an intimidating amalgamation of biology and
chemistry and claim interpretations. They force a judge or patent examiner to grapple with
rather fundamental issues, such as the significance of the term 'human' when describing a
protein. Next, it raises important policy questions, such as, the degree to which a legal
monopoly should be granted to an innovator, whose significant contribution could be
diminished by the consequent development of a competitor product or technique.

Article 27 of TRIPS agreement concerns the availability, scope and use of IPR in making
distinctions between material produced by biological processes and by non-biological routes;
only the latter is considered patentable. Natural material of any kind is not patentable and
article 27(3) (b) makes it clear that member states are entitled to exclude plants and animals
but not micro-organisms from the scope of patentability. However, it is unclear whether
TRIPS permits member states to exclude biological substances like genes and cells.
Currently, two schools of thought exist. The first school states that there is no scientific basis
to support the patenting of genes and genomes, which are discoveries at best, while the
second school states that characterisation of genes is not straightforward, so it does constitute
an inventive step and therefore should be patentable. However, despite the apparent
controversy, British Prime Minister Tony Blair initiated an Anglo-American agreement with
President Bill Clinton to protect the 100,000 genes of the human genome, to ensure non-
patentability. The agreement aimed at preventing entrepreneurs profiting from gene patents
and so the benefits of research were freely available worldwide to combat disease.

While US companies far outpace their competitors the world over, US patent applicants
experience tremendous problems with the inability or unwillingness of the US Patent and
Trademark Office (USPTO) to examine biotechnology or pharmaceutical inventions in a
single patent application. Using an administrative process called "restriction practice," the
USPTO forces applicants to divide the claimed technology into several different inventions,
only one of which can be pursued in the original application.

Few companies can devote such funds to a single technology. Small companies and start-ups,
in particular, cannot afford the number of applications necessary to obtain complete coverage
for their inventions. As investors and industrial collaborators refuse to invest in unprotected
concepts, intermittent patent protection can delay or halt the development of a promising
therapeutic or diagnostic product. Along with this, multiple patent applications often create
uncertainty in the market, as aspects of a single discovery, obtain protection over a period of
years, rather than simultaneously.

Currently, The United States Patent and Trademark Office is struggling to interpret
biotechnology patent claims, and efforts are being made to reform the restriction practice
that, in turn, would improve patent quality, efficiency and will be necessary for international
harmonisation of rules.

IP scenario in India

India needs to implement strong patent legislation, data exclusivity, and improve IPR
infrastructure and enforcement in order to achieve its potential as an R&D powerhouse. The
much-delayed second amendment to India's 1970 patent law was passed in May 2002,
welcoming the extension of pharmaceutical patent protection from seven to twenty years.
With this change, India fulfilled part of its commitment to the international community by
protecting intellectual property. The Bill, however, makes broad ambiguous allowance for
compulsory licensing, and is unclear about patent protection for imports.

Data exclusivity is a prerequisite to the protection of research efforts, decisions on where to

conduct clinical trials and amount of foreign investment in the pharmaceutical and biotech
sectors. In 1984, the US enacted the Hatch-Waxman Act, which provides a five-year data
exclusivity for new molecular entities (NMEs). According to the US National Institutes of
Health (NIH), lack of data exclusivity is the primary reason why India ranks ninth, (as
compared to China which ranks second), in funding given to countries outside the US by the
NIH. In 2002, China adopted data exclusivity provisions as part of its WTO ascension, which
provides six years of protection commencing from the date of marketing approval in China.

Indian pharmaceutical companies and researchers, especially in the biotechnological sector,

would benefit from increased diffusion of knowledge that results from international
partnerships and increased integration. Fortunately, data exclusivity is an administrative
protection, which can be easily implemented without passage of legislation. Requiring the
government to treat test data as the exclusive property of the firm that generated it, (for a
fixed period of time), is an effective method of providing protection, while legislators draft
laws to complete the legal IP framework. The National Biotech Policy provides a framework
and strategic direction to different sectors in order to accelerate the pace of development of
biotechnology in India over the next ten years. For the sector of IPR, the key strategic actions
include:

Scientific Manpower, which encourages science graduates to pursue law for a better
understanding of IPR related issues and inclusion of the same in the curriculum of law
colleges to facilitate filing of international patents, license negotiation and dispute
resolutions.

Budget allowances of Rs 50 crore as Innovative Development Fund to enable research

scientists at academic laboratories to develop scientific innovations from a concept to a form
that is licensable. This fund should be under the administration of the DBT and the grants
may be capped at Rs 50 lakhs per project.

Given the stress under which the Indian judicial system operates and taking into account the
backlog of cases, experts feel that the existing system is not efficient enough to handle IPR
related disputes.

Judges might not be well-versed with the technical know-how of IPR related issues, thus
fuelling a need for an arbitration council to redress IPR disputes and showcase India as the
next hub for contract research, clinical trials and contract manufacturing.

In 2005, India's Minister for Commerce and Industry, formed a Technical Expert Committee
to investigate the patentability of new chemical entities and micro-organisms, which the
Parliament did not consider when it passed the Patents (Amendment) Act.

Several ambiguous provisions in the patent laws have widened the scope of opposition in
India and one such nebulous provision is Section 3(d). This states that new forms, properties
or use of a known substance or discovery renders it un-patentable. Furthermore, salts, esters,
ethers, polymorphs, metabolites, isomers, mixtures of isomers, complexes, combinations and
other derivatives are considered the same substance unless their properties and efficacy differ
significantly.

Although India has many of the core ingredients for a successful innovation system, to
maintain development of the biotechnology sector, progress is warranted in the areas
mentioned. Early implementation of a strong pharmaceutical patent regime would strengthen
India's R&D sector, attract more foreign investment, and provide a basis for Indian firms to
begin tackling diseases that have a serious effect on the country.
CASE STUDY10

Many claim that more people do not have access to life-saving drugs because of high prices
and that patent rights both increase prices and stand in the way of getting treatment to those
who need it. Both of these claims are false.

Drugs that cure AIDS and many other diseases are available precisely because of patent
protection. Patent protections encourage research and development by offering the possibility
that a pharmaceutical company's investment will be repaid, a powerful incentive to
companies to invest millions and millions of dollars into risky research and development of
these medications. Without patent protection, other manufacturers could copy new drugs
immediately. Since their costs are minimal, they can offer their versions at a reduced price,
seriously hurting the ability of the company that developed the drug to recoup its costs.

In addition, those years in which a company's patented products are protected can help
generate the funding that makes research into the next generation of drugs possible.

Drug companies are not only doing the research that has helped so many, they are ensuring
that drugs reach those most in need through donations. In 2003 alone, the U.S.
pharmaceutical industry donated more than $1.4 billion in medicines and services to people
in more than 40 least developed countries.

Drug companies also are helping poorer countries through a variety of innovative public-
private partnerships. These partnerships include the African Comprehensive HIV/AIDS
Partnership in Botswana, in which the government of Botswana, the Bill & Melinda Gates
Foundation, and the Merck Company support prevention programs, health-care access, and
treatment of HIV/AIDS, with Merck donating two antiretroviral drugs for treatments. The
Onchocerciasis Control Program, in turn, has greatly reduced transmission of "river
blindness" throughout West Africa by combining a spraying program and the donation of the
drug Mectizan by Merck & Co., Inc.

These are but some examples of the ways in which the research-based drug industry has
regularly lowered its prices to the poorest nations of the world and has increased drug
companies' partnership with governments and with nongovernmental organizations to ensure
that drugs reach those in need.
Generic medicines and copycat drugs are not always the answer for those seeking an
alternative to a patent-protected drug. Generics, independently developed drugs that contain
the same active substance as the original brand-name drug, are marketed in accordance with
patent law and identified either by their own brand name or by their internationally approved
nonproprietary scientific name. Copycat drugs usually simply copy the original drug
manufacturer in the countries with weak intellectual property protection.

Patented drugs often have passed much more rigorous licensing requirements than so-called
generics. Why "so-called"? Because not all drugs that claim to be so are identical and not all
are subject to the stringent inspection process that guarantees that they contain the same
amount of active ingredients and work in the same way. Manufacturers of some of these
drugs have not had to invest in the extensive testing required of the research-based industry
even before their drug can be marketed. Of course, there are many reliable manufacturers of
generic drugs. The United States, for instance, has a thriving generic drug industry, fully
regulated and inspected by the U.S. Food and Drug Administration.

Building on the enormous investment already made by the research-based pharmaceutical

industry, copycat drugs can lower drug prices, but they do nothing to guarantee that new
drugs will be available when they are needed. Copycat drugs do nothing to ensure that
scientific innovation translates into new treatments that may be less toxic and more effective.
Rather, they reduce incentives to research and thus discourage new products. And make no
mistake: The manufacturers of generic or copycat drugs are not in business to be generous;
they, too, are reaping profits. Their profits, however, are not being used to further scientific
knowledge and find new cures.

Patents are not the problem that people assume them to be, either. A recent study published in
Health Affairs found that "in 65 low- and middle-income countries, where four billion people
live, patenting is rare for 319 products on the World Health Organization's Model List of
Essential Medicines. Only 17 essential medicines are patentable, although usually not
actually patented." If this large amount of life-saving drugs is either off-patent (meaning that
the company that originally invented them no longer has an exclusive claim because the
patent has expired) or not patented, then patents cannot be the problem in getting drugs to
people.
Price is not always the issue, either. When people cite prices as a problem, they often are
comparing apples and oranges. Prices include various factors: training of health care
personnel in the use of the drug, explanatory materials to make it safer for the consumer, even
shipping and handling can be included or not. If one drug seems cheaper but shipping costs
are not included, the effective cost may be identical to that of a patented drug. Certainly, a
government-sponsored drug company can provide lower prices to the citizens of that country,
since the government is paying a large percentage of the actual cost.

There are issues that need to be addressed, including how to encourage even more innovation,
especially for drugs with limited markets or which treat diseases mostly prevalent in low- and
middle-income countries. Developed countries can offer tax incentives to encourage
innovation in such areas, much as the Orphan Drug Bill in the United States does. (This U.S.
law, administered by the Food and Drug Administration, deals with medications used to treat
diseases and conditions that rarely occur. Since there is little financial incentive for the
pharmaceutical industry to develop such medications, "orphan drug status" gives a
manufacturer specific financial incentives to develop and provide such medications.)
Government research dollars can be used to do basic research, as the National Institutes of
Health does in the United States.

Public-private partnerships are showing the way in innovation: The Medicines for Malaria
Venture (MMV -- see "Malaria: Partnering to Find a Cure") and the International AIDS
Vaccine Initiative (IAVI) are two good examples of such partnerships. MMV, for instance,
has 21 drug development projects to ensure that the next generation of treatment is available
when drug resistance overtakes current malaria treatment options. As an article in the
Washington Post recently suggested, "These entities are in effect nonprofit virtual drug
companies configured to discover and develop drugs and vaccines for neglected diseases."

Cheap drugs are no bargain, if they do not cure the disease and if they contribute to drug
resistance that may make the drug useless for everyone. Violating or bypassing patent
protections is a short-term solution that threatens the long-term health of the world's citizens
by removing the incentives and discouraging the innovation we need.
CONCLUSION

Responsibilities and Resources would make an important beginning in the transition of

efficient and effective use of pharmaceutical in building a prosperous and healthy India.

The Indian pharmaceutical industry shall ensure that essential drugs at affordable
prices are available to the vast population of this sub-continent and also continue providing
employment for millions. India shall implement all the rules and regulations, which guide,
monitor and control the activities of the providers of the healthcare system in the
country and shall Corporate Catalyst India India’s Pharmaceutical Industry examine the
way to bring them up to international standards. The government should implement the
recommendations of Mashelkar committee and constitute the Central Drug Authority at the
earliest. The basic course of education should be designed to ensure that the newly qualified
pharmacist has the necessary knowledge and skills to commence practicing
competently in a variety of settings including community and hospital pharmacy and the
pharmaceutical industry. Continuing professional development must then be a lifelong
commitment for every practicing pharmacist. Concept of National schools of pharmacy
should be established to develop and introduce model curriculum. Pharmacists should
become knowledgeable to participate in medication management and outcome monitoring.
Pharmacy profession should orient concept of pharmacy practice at community and hospital
pharmacies through appropriate training and compensation. The pharmacy profession will
make the clinical trial industry in India to grow to over a billion dollars in the next five years
and position itself as a destination of choice for CRO services by way of strict
implementation of patent laws, single window clearance of clinical trial protocols by
regulatory clearances and shall accord industry status to this sector. India will emerge as a
major global player in the field of pharmaceuticals exports and as a provider of quality
medicines at low costs. It shall also emerge as a major player in the generic drugs market in
USA and Europe. India shall attain new heights in herbal drugs research in shaping Indian
Systems of Medicine into a popular system of medicine of the future for holistic health care
and ensuring health care for all - especially for the welfare of the poor.
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