INDIA’S NEW PRODUCT PATENT REGIME: AN ANALYSIS OF RANBAXY … · INDIA’S NEW PRODUCT PATENT REGIME: AN ANALYSIS OF RANBAXY’S R & D EXPENDITURE AND BUSINESS ... 2006, the nexus

IRJC

International Journal of Social Science & Interdisciplinary Research

Vol.1 Issue 11, November 2012, ISSN 2277 3630

185

INDIA’S NEW PRODUCT PATENT REGIME: AN ANALYSIS OF

RANBAXY’S R & D EXPENDITURE AND BUSINESS

STRATEGIES IN THE POST-TRIPS PERIOD

GEETANJALI DESHMUKH*; DR. S.S.SAHASRABUDHE**

* Management Faculty

Chh. Shahu Institute of Business Education and Research

(SIBER)Kolhapur, India.

** Principal, ATSS College of Business Studies & Computer

Application. Pune.

ABSTRACT

Non-recognition of product patents for drugs under the Indian Patent Act, 1970 was largely

responsible for the rapid growth of the indigenous Indian pharmaceutical industry. The recent

signing of the TRIPs agreement, however, reverses the patent law followed since the 1970s. The

firms that have developed knowledge and capabilities in reverse engineering-based R&D in the

past are required to reorient themselves for R&D-based innovation to survive and compete in a

regulated and open market. The principal objective of this research paper is to investigate the

strategies adopted by one of India’s leading pharmaceutical company, viz, Ranbaxy Laboratories

Ltd., in response to the new and challenging business environment brought about by the

introduction of the new patent regime. The study reveals that Ranbaxy adopted a “High-Risk-

High- Returns” strategy, both in R&D as well as in its attempt to become a global company.

Eventually, the increasing expenditure on risky R&D, patent challenges with inadequate returns,

high cost Acquisitions in foreign markets and setting own manufacturing & selling facilities

abroad in order to increase its geographical presence, took its toll on the financial health of the

company. Consequently, Ranbaxy had to redefine its business model and in 2008 the company

brought in Daiichi Sankyo Company Ltd. to create a strategic combination of an innovator and

generic powerhouse.

KEYWORDS: IP(Intellectual Property), IPR(Intellectual Property Rights), R&D(Research &

Development),TRIPs(Trade-Related Aspects of Intellectual Property), NDDS(Novel Drug

Delivery System), NCE(New Chemical Entity),CRAMS( Contract Research and Manufacturing

Services).

______________________________________________________________________________

1. INTRODUCTION

The level of IPR (Intellectual Property Rights) influences the corporate sector in more than one

ways. For example, the level of patent protection in a country greatly influences the domestic

pharmaceutical industry in terms of its growth, R&D (Research & Development) investment,

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technology and export capacity and the overall business strategies employed by the firms. In case

of the Indian pharmaceutical industry, it was the lack of strong IP(Intellectual Property)

protection that was responsible for its remarkable growth. The passing of the Indian Patent Act,

1970, which did not recognise product patents for vital areas like food, drugs and atomic energy,

fuelled the rapid growth of the indigenous industry. The foundation of the success experienced

by the Indian pharmaceutical industry at the later stage was laid down in the 1970s. The recent

signing of the TRIPs agreement (Agreement on Trade –Related Aspects of Intellectual Property),

however, reverses the patent law followed since the 1970s. The firms that have developed

knowledge and capabilities in reverse engineering-based R&D in the past are required to reorient

themselves for R&D-based innovation to survive and compete in a regulated and open market.

This has serious implications for the Indian pharmaceutical firms.

Several studies have been conducted by industry experts, academicians, various governmental as

well as pharmaceutical industry bodies ASSOCHAM,IDMA,BDMA; banks like the EXIM

Bank and the Deutche Bank; international organizations like the United Nations . These research

papers, reports and studies undertaken, show the growth of the Indian pharmaceutical industry ,

its export performance, R&D activity , while some have analysed the emerging business

opportunities/challenges before the Indian pharmaceutical industry in the post-TRIPS era . To

mention a few from among the reviewed literature- Lanjouw (1998) discusses the various

theoretical implications for a developing country of introducing product patents for

pharmaceuticals using India as an example.1 Nauriyal and Sahoo (2007) focus on the

performance of the Indian pharmaceutical industry during the deregulated period from 1995 to

2006, the nexus between R&D expenditure and growth performance of the pharmaceutical

industry and specifies a model to evaluate the performance in the light of the patent, R&D

expenditure and the marketing strategies of the firms in the industry.2

Dinar kale (2007), in his

working paper explores the motives and patterns of internationalization by the Indian

pharmaceutical firms directed towards expansion in foreign markets and accessing new

technologies.3

Greene (2007) in his working paper presents an overview of India’s

pharmaceutical industry and its evolution from almost non-existent to one of the world’s leading

suppliers of generic drugs.4

Chaturvedi, Kalpana and Chataway, Joanna (2006) examine the

contemporary strategic approaches adopted by Indian leaders for integrating new knowledge and

capabilities in order to develop innovation competencies for tomorrow.5

Rao.M.B.and Guru

Manjula in “WTO and International Trade”, provide complete framework of the TRIPS

Agreement.6

ASSOCHAM’S “ White Paper on IPI-Quest for Global Leadership”(2006)

highlights India’s global competitive strategy, industry partnership & alliances, CRAMS &

clinical trials and drug discovery & development.7

EXIM(2007)Bank’s research finding’s

suggest that the growth momentum of the IPI, after the challenges posed by the WTO regime,

has gained momentum and many Indian pharmaceutical companies have not only shown good

performance domestically but have also been able to establish their foothold in overseas

markets.8

Chaudhuri,Park & Gopakumar(2010)in a study commissioned by the United Nations

Development Programme (UNDP) analyse the role of both, the Indian pharmaceutical industry

and the Indian legal system in its contribution as a supplier of affordable medicines, five years

after having complied with the TRIPS Agreement, focusing mainly on the future of affordable

generic HIV/AIDS drugs supplied by Indian generic producers.9

Annual Report (2003-2004)

Department Of Chemicals And Petrochemicals Ministry Of Chemicals & Fertilizers Government

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Of India New Delhi, shows the performance of the pharmaceutical industry in production,

exports and imports.10

With the objective of understanding the implications of re-introduction of

product patents for pharmaceuticals in India, this research paper carries out an in-depth analysis

of the R&D expenditure and business model adopted by one of India’s top pharmaceutical

company, viz, Dr.Redyy’s Lab ( henceforth referred to as DRL) and includes the R&D

expenditure, business strategies, internationalization motives and patterns adopted by DRL in

the post-TRIPS period under the new product patent regime.

1.2 METHODOLOGY ADOPTED:

The basic objective of this research paper is to study whether the TRIPS-compliant Patent regime

has resulted in significant changes in the R&D expenditures of Ranbaxy and also to Investigate

the strategies and behavioural patterns adopted by this company in response to the new IP

regulatory framework brought about by the introduction of the new patent regime in the post-

TRIPS period.

In order to complete the present research and analyse the data in the right perspective, the Desk-

Research method and Survey method have been adopted. In this, access to the various sources of

information was of immense use in compiling and analysing the data. Similarly self- constructed

questionnaire was sent to the selected pharmaceutical company. On the basis of the feedback

received from the respondent, the data has been analysed.

The scope of this research paper is confined to the Indian Pharmaceutical industry and the

implications of the new product patent regime on the R&D aspect. It focuses on one of India’s

top pharmaceutical company, viz, Ranbaxy Laboratories Limited (Ranbaxy). With the

implementation of product patents in India in January 2005, investing in R&D became inevitable

for the pharmaceutical companies. Under the new product patent regime, a shift in the model of

R&D investment by Indian companies from core process research to new drug development and

novel drug delivery systems (NDDS) became very significant.

1.3 RESULTS AND DISCUSSION -

Research & Development is the key to the future of pharmaceutical industry. The pharmaceutical

industry is a science–based knowledge-driven industry, which depends heavily on R&D for new

products to fuel its growth. However the costs involved in R&D are exorbitant. For instance, cost

of developing one new drug in the US increased from $54million in 1970 to $231 million in

1990. Moreover R&D activity is characterized more by failure than by success. Recent studies

indicate that 1 out of 5000-10,000 compounds synthesized during applied research eventually

reaches the market. Other estimates indicate that of 100 drugs that enter clinical testing phase

1(3), about 70 complete phases I, 33 complete phase II and 25-30 clear phase III. Only two-

thirds of the drugs that enter phase III a re ultimately marketed. Because of these reasons and due

to the protected policy regime, the R&D investment in India has been very low and started

picking up only in the 1990s (N.Lalitha, 2003).

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The R&D expenditure of Ranbaxy was negligible during the pre-TRIPS period( Rs.35.01 crores

in1995). This was because, with process patents being recognized under the Patents Act of 1970,

the Indian pharmaceutical industry did not invest highly on R&D of drugs as the legal provisions

allowed production of generic drugs. However, with the impending TRIPS Agreement, change in

patent laws and policy scenario, the industry was forced to re-visit its business strategy thereby

recognizing the importance of R&D and gradually started increasing its investments in R&D in

order to ensure long term sustainable growth and remain competitive at the global level This fact

is corroborated by the data laid down in Table 1, which indicates a steady impressive increase in

R&D expenditure of Ranbaxy.

TABLE 1: R & D EXPENSES (Rs.Crore)

YEAR R & D EXPENSES

1995 35.01

1996 36.58

1997 45.79

1998 49.87

1999 52.28

2000 45.64

2001 55.39

2002 73.39

2003 77.12

2004 192.17

2005 276.13

2006 399.66

2007 639.33

2008 483.82

2009 460.51

2010 471.38

Source- CMIE, Prowess Database

Graph 1: R & D EXPENSES (Rs.Crore)

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The company steadily increased its R&D expenditure from Rs.35 crores in 1995 to Rs. 45.64 in

2000, which is a percentage increase of over 30% within a period of five years. During the next

seven years, the R&D expenditure increased from Rs.55.39 crores in 2001 to a whopping

Rs.639.33 crores, again a percentage increase of 1054 % between 2001 and 2007. However the

R&D expenditure dropped to Rs.483.82 crores in the year 2008, with a further decline in 2009

(Rs.460.51) and 2010 (Rs.471.38).(Source: CMIE, Prowess Database ). The reason behind this

drop is that after the first successful NDDS product ciprofloxacin, there were hardly any other

returns from the huge R&D investments Ranbaxy was making.

BUSINESS STRATEGIES

With the re-introduction of product patents, the Indian pharmaceutical industry has been forced

to adopt new business strategies and R&D model,post 2005. In order to face the challenges

posed by TRIPS and to move forward, Indian pharmaceutical companies have evolved

distinctive business models and are going for a combination of co-operate & compete strategy.

The Indian pharmaceutical companies have three strategic choices:

i. to compete,

ii. to collaborate

iii. to follow a combination of Competitive & Collaborative strategies.

Companies with high annual revenues, R&D capabilities and requisite infrastructure are going

for the combination of co-operate & compete strategy.

The emerging business models being adopted by Ranbaxy in response to the changed business

environment have been discussed below.

Ranbaxy is seen adopting a combination of Competitive & Collaborative strategies.

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Ranbaxy’s Competitive Strategies:

1) NDDS : -

The R&D focus is to modify existing drugs so as to develop new formulations, that can be

patented and sold at a higher price. The new formulations include Novel Drug Delivery System

(NDDS) such as, developing a controlled or extended release formulation of existing oral

therapies to reduce side effects or increase patient compliance; developing alternative delivery

routes, including oral as opposed to injectibles, to increase patient convenience and compliance;

and enhancing purification of product to reduce dosing and side effects.

Ranbaxy developed NDDS for ciprofloxacin. It is also actively involved in developing NDDS

in several other therapeutic areas such as gastric retention.

In the area of NDDS, Ranbaxy recorded the most noteworthy success. The firm was able to

develop an improved version of one the new generation antibiotics, viz. ciprofloxacin, which was

developed by Bayer AG and was under patent protection until 2003. Ranbaxy Laboratories was

able to produce a once-a-day formulation instead of the multiple-dose a day therapy promised by

the Bayer formulation. The Ranbaxy formulation assured better patient-compliance and was

hence, considered to be a major step forward. Bayer recognised the improvement and entered

into a licensing agreement with Ranbaxy for its version of ciprofloxacin. Under the agreement,

Ranbaxy Laboratories received US$ 65 million from Bayer over a four-year period, with an

initial payment of US $ 10 million. The agreement allowed Bayer AG to have the worldwide

marketing rights over ciprofloxacin, except in India and the CIS countries where Ranbaxy

Laboratories had the marketing rights.

In 2001, significant progress was made by the company towards developing platform

technologies and products in the area of Oral-Controlled Release system. Ranbaxy initiated the

process of clinical development of its once-a-day formulations of Ofloxacin by filing an IND

application with the US FDA in late 2001.

2) Non Infringing Processes: -

The originator company need not list process patents with the US FDA. So for a generic

company applying for an ANDA, certification for such patent is not required. To delay the

generic entry, the originator company usually takes patents for a large number of processes. In

such a case, the generic manufacturer can develop a non-infringing process i.e. a process that

does not infringe the one patented by the originator company and enter the market with higher

price and margins.

Ranbaxy’s non-infringing process on Cefuroxime Axetil enabled Ranbaxy to be its sole seller for

almost one and a half years in the US market.

3) New Chemical Entites : -

Although by mid-1009s , Indian pharmaceutical companies started investing in R&D with focus

on developing New Chemical Entities (NCEs),none of these companies were involved in the

entire process of drug discovery and development because they were not ready for the start-to-

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end model of NCE research. The limitations came in the form of lack of requisite skills and

funds required for NCE research. So the Indain companies developed a model whereby they

developed a molecule upto a certain stage and then licensed out to partners from developed

nations, mostly MNCs with skills and huge investment capabilities.

Ranbaxy licensed out its NCE RBx 2258 for the treatment of cancer to Schwarz Pharma AG.

This NCE has now been dropped from clinical trials.

4) Patenting Strategy :-

This includes a mixed strategy of both positive as well as defensive patenting.

Ranbaxy uses a patent system to secure its own products which are presently based on NDDS,

polymorphs or novel combinations.

Source- Questionnaires by researcher, Gehl Sampath (2005), Rajnish Kumar Rai(2008),Dhar &

Gopakumar(2006)

Ranbaxy’s Collaborative strategies –

1) In-Licensing Arrangements:-

Under in-licensing, the company acquires the rights to a product from a third party.

Since Indian companies do not have enough new drugs for the domestic market and they can no

longer take drugs from MNCs, they are looking for in-licensing arrangements with MNCs to

lauch their products in India. The arrangements are either pure marketing relationships or local

productiona dnsharing profit margins with the MNC. This strategy helps Indain companies to

bring novel medications to the country at reasonable prices and also makes regulatory procedure

easier and faster.

Agreement between Ranbaxy and K. S. Biomedix Ltd accords Ranbaxy exclusive marketing

rights for TransMID, a biopharmaceutical product used in the treatment of brain cancer in India

with an option to expand this to China and other South East Asian countries (IBEF and Ernst and

Young, 2004b, p. 26).

Co-marketing alliances are taking place not only among Indian and foreign producers, but also

among Indian producers. Recently, Jupiter Bioscience entered into a 10-year co-marketing

agreement with Ranbaxy, under which the company would license out to Ranbaxy five generic

peptide drugs worth US$ 3 billion at innovators price. It is believed that this tie-up helps Jupiter

Biosciences to bring its products to international market rapidly, as Ranbaxy already has strong

presence in the global market.

Ranbaxy and Cipla, have entered into a strategic partnership to jointly market a select basket of

drugs. The alliance will bring forth their strengths in the strongly emerging cardiovascular and

perennial anti-infectives market.

2) Collabarative R&D :-

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Glaxo SmithKline and Ranbaxy have a collaborative R&D arrangement for the development of

new drugs in the areas of infective diseases and diabetes. Ranbaxy and Avestagen Laboratories

have collaboration for the production of NCEs using biotechnological techniques.

Ranbaxy has entered into a collaborative programme with MMN, Geneva for an anti-malarial

molecule, Rbx 11160; and also with Vectura, adrug delivery company for development of

platform technologies in the areas of oral controlled release system.

3) CRAMS-

ONE of the most important collaborative strategy that has emerged recently is CRAMS.

In 2005, CRAMS market in India was valued at USD532.10 million, of which contract

manufacturing accounted for 84% of the total market,while the remaining 16% was accounted by

contract research (excluding clinical trials). Both the segments of CRAMS have registered a

robust growth rate of over 40% in 2005 over the previous year (Cygnus Research).

GlaxoSmithKline has tied with Ranbaxy to work on lead compounds until second round of

clinical trial are completed.

Source : Questionnaires by researcher, Gehl Sampath (2005), Rajnish Kumar Rai(2008)

FACTOR ANALYSIS OF EMERGING STRATEGIES

On the basis of the information collected regarding the business strategies adopted by Ranbaxy,

a detailed Factor-Analysis is carried out . The analysis is based on –

1- Domestic Strengthening

2- Strategic Business and

R&D Choices

3- Globalization Patterns

TABLE 2- FACTOR RATING

HIGH RISK LOW RISK

NCE RESEARCH NDDS

HIGH STAKE PATENT CHALLENGES IN

FOREIGN COUNTRIES

CHALLENGING MNC PATENTS

IN INDIA

HIGH COST AQCUISITIONS NON- INFRINGING PROCESSES

OWN MANUFACTURING & SELLING

FACILITY

SPECIALITY GENERICS

IN-LICENSING

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OUT-LICENSING

COLLABORATIVE R&D

CRAMS

CO-MARKETING & STRATEGIC ALLIANCES

TIE-Ups, JV & ALLIANCES

TABLE 3- SHOWING MARRKET SHARE OF RANBAXY FROM 2000-2009

YEAR MARKET SHARE

2000 5.89

2001 5.7

2002 5.77

2003 7.88

2004 8.96

2005 8.88

2006 7.45

2007 6.49

2008 5.78

2009 5.65

Source- CMIE, Prowess Database

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TABLE 4- DOMESTIC STRENGHTENING

COMPANY PERFORMANCE BASED ON MARKET

SHARE

(2005-2010)

DOMESTIC POSITION

Ranbaxy Sharp decline

From 8.8%(2006) to 5.65%(2009)

Weakened

Source- Based on Researchers own analysis

Interpretation- The above Table shows that Ranbaxy’s share in the domestic market declined and

the company lost its position as market leader (to Cipla).

TABLE 5 -STRATEGIC BUSINESS AND R&D CHOICES OF RANBAXY

A) COMPETITIVE STRATEGIES:

RANBAX

Y

NDDS ✔

NCE ✔

HIGH STAKE PATENT CHALLENGES IN FOREIGN COUNTRIES ✔

CHALLENGING MNC PATENTS IN INDIA ✖

NON- INFRINGING

PROCESSES

✔

SPECIALITY GENERICS ✖

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B) COLLABORATIVE STRATEGIES:

LICENSING DEALS:

i) IN-LICENSING ✔

ii) OUT-LICENSING ✔

COLLABORATIVE R&D ✔

CRAMS ✔

CO-MARKETING &

STRATEGIC ALLIANCES

✔

Source- Based on Researchers own analysis

TABLE 6: GLOBALIZATION PATTERN

MODE RANBAXY

HIGH COST AQCUISITIONS ✔

TIE-Ups, JV & ALLIANCES ✔

OWN MANUFACTURING &

SELLING FACILITY ✔

Source- Based on Researchers Own Analysis

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TABLE 7: ON THE BASIS OF THE FACTOR RATING AS GIVEN IN TABLE 1, THE

INTERPRETATION IS AS FOLLOWS-

HIGH RISK LOW RISK

NCE RESEARCH NDDS

HIGH STAKE PATENT CHALLENGES IN FOREIGN

COUNTRIES

NON- INFRINGING PROCESSES

HIGH COST AQCUISITIONS IN-LICENSING

OWN MANUFACTURING & SELLING FACILITY CO-MARKETING & STRATEGIC ALLIANCES

COLLABORATIVE R&D

CRAMS

OUT-LICENSING

TIE-Ups, JV & ALLIANCES

Source- Based on Researchers Own Analysis

HIGH COST AQCUISITIONS-

Further, in order to expand its global footprint and diversify its product portfolio, Ranbaxy also

acquired a number of foreign generic drug manufacturing companies.

Acquisition History of Ranbaxy

1995 Ohm Laboratories (USA)

2000 Basics (Germany) Bayers generic business

2004 RPG Aventis (France)

2005 18 generic products of Efarmes S.A. (Spain)

2005 Veratide from P&G (Germany)

2006 Unbranded generic business of GSK in Italy and Spain

2006 Trepia in Romania

2006 Mundogen GSK subsidiary in Spain

2006 Belgian company Ethimed NV

2006 Sentek’s Autoinjector business (US)

2006 Unbranded generic business of Allen SpA, a division of Glaxo SmithKline (Italy)

2006- Be Tabs pharmaceuticals, the 5th

largest generic company in South Africa for

US$70 Mn. (Ref: Company Annual Reports)

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1.4 CONCLUSION-

The above analysis indicates that Ranbaxy adopted a “High-Risk-High- Returns” strategy, both

in R&D as well as in its attempt to become a global company.

Eventually, the increasing expenditure on risky R&D, patent challenges with inadequate returns,

high entry costs in foreign markets, numerous acquisitions by the company to increase its

geographical presence took its toll on the financial health of the company.

Consequently, in 2008, Ranbaxy redefined its business model. The company brought in Daiichi

Sankyo Company limited as a majority to create a strategic combination of an innovator and

generic powerhouse. The inability to cope up with these financial troubles is believed to be an

important factor behind the decision of the Indian promoters of Ranbaxy, the Singh family, to

relinquish their control to Daiichi Sankyo. According to the Report of Ministry of Commerce &

Industry, 2008, pp. 42-43, this may have been good for Ranbaxy which needed an influx of funds

but whether this has a positive impact from the point of view of access to medicines is

questionable. Ranbaxy’s activities may be re-oriented to suit the interests of the MNC that

acquired it rather than the generic requirements of developing countries .

Thus,in June 2008, Ranbaxy entered into an alliance with one of the largest Japanese innovator

companies, Daiichi Sankyo Company Ltd., to create an innovator and generic pharmaceutical

powerhouse. The combined entity now ranks among the top 20 pharmaceutical companies,

globally. The transformational deal will place Ranbaxy in a higher growth trajectory and it will

emerge stronger in terms of its global reach and in its capabilities in drug development and

manufacturing.

FUTURE PROSPECTS

By 2012, Ranbaxy hopes to be one of the top 5 generics producers in the world. The Company

will focus on increasing its momentum in the generics business in its key markets of US, Europe,

BRICS and Japan through organic and inorganic routes.

Japanese market offers new growth avenue for Indian generic players. Amongst the key markets

outside the United States and Europe, the Japanese market offers potential to drive significant

growth in the medium term. With healthcare reforms aimed to reduce healthcare budgets and

generic friendly policies being adopted by the Japanese Government, the pharmaceutical market

is gradually opening up to generics. The current generic penetration in Japan, estimated at 6-7%,

is amongst the lowest in the world. As a result, despite being the second largest pharmaceutical

market in the world, the Japanese market ranks only as the sixth largest generic market. The

Japanese Government has set a target of reaching a generic penetration of 30% by 2012,

implying strong growth potential in the market.

The Japanese pharmaceutical market is characterised by a complex regulatory framework,

thereby creating a high entry barrier. Thus, partnerships with local generic companies and/or

acquisitions of local companies are emerging as the likely route to gain presence. Indian generic

players have also made inroads in the Japanese market. The generic pricing in the market

however remains favourable as compared to markets in Europe and the United States. Lupin,

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Ranbaxy and Cadila Healthcare are amongst the front runners. While Lupin gained access in the

Japanese market through the acquisition of Kyowa Pharmaceuticals in 2007. Ranbaxy is

exploring opportunities of marketing its generic products through Daiichi’s distribution network

post its acquisition by the latter.

REFERENCES

1. Lanjouw ,Jean (1998): Introduction of Pharmaceutical Product Patents in India: Heartless

Expliotation of the Poor and Suffering?”, Working Paper 6366,National Bureau of Economic

Research. Available at http:/www.nber.org/papers/w6366.

2. Nauriyal, D.K. and Sahoo, D.(2007): The New IPR Regime and Indian Drug and Pharmaceutical

Industry : An Empirical Analysis . Available at

www.usitc.gov/publications/332/working_papers/EC200705A

3. Kale, Dinar ( 2007): Internationalisation Strategies of Indian Pharmaceutical firms”, IKD

Working Paper No.23, Open University Research Centre on Innovation,Knowledge &

Development

4. Greene, William(2007):The Emergence of India’s Pharmaceutical Industry and Implications for

the U.S. Generic Drug Market, Office Of Economics Working Paper (No.2007-05-A) U.S.

International Trade Commission Available at

www.usitc.gov/publications/332/working_papers/EC200705A.

5. Chaturvedi, K.,& Chataway,J., (2006). Strategic integration of knowledge in Indian

pharmaceutical firms: Creating competencies for innovation. International Journal of Business

Innovation and Research, 1(1-2), pp. 27–50.

6. Rao,M.B. and Guru,Manjula : WTO and International Trade. Vikas Publishing House.

7. Quest for Global Leadership- White Paper on Indian Pharma Industry by ASSOCHAM (14th Nov

2006). Available at www.cygnusindia.com/Articles/Indian_Pharma_Industry

8. Indian Pharmaceutical Industry:Surging Globally, Export-Import (Exim)Bank Of India.

Occasional Paper No. 119. Quest Publications August 2007. Website : www.eximbankindia.In

9. Chaudhuri, Park and Gopakumar(2010), “ Five Years Into The Product Patent Regime: India’s

Response, United Nations Development Programme , www.undp.org/poverty, pp 85.

10. The Department of Chemicals & Petrochemicals, Ministry of Chemicals and Fertilizers- Annual

Report (2003-2004).

11. Company website(www.drreddys.com)

12. Company Annual Reports.

13. CMIE, Prowess Database

14. Lalitha,N. (2003). Trips And Pharmaceutical Industry : Issues And Prospects. Gujarat Institute

Of Development Research, Ahmedabad. Available at -

http://www.iprsonline.org/ictsd/docs/ResourcesHealthArticleLalitha.doc

15. Sampath, G. (2006).India’s Product Patent Protection Regime: Less or More of “PILLS FOR

THE POOR”. United Nations University (#2006-019)-Maastricht Economic and Social Research

and Training Centre on Innovation & Technology.

16. Rai, R.K. (2008). Battling with TRIPS: Emerging Strategies of Indian Pharmaceutical Industry

Post –TRIPS”.

17. Dhar,B. & Gopakumar, K.M. (2006).Post-2005 TRIPS scenario in patent protection in the

pharmaceutical sector:The case of the generic pharmaceutical industry in India. International

Centre for Trade and Sustainable Development (ICTSD) and United Nations Conference on

Trade and Development (UNCTAD).

http://www.usitc.gov/publications/332/working_papers/EC200705A

http://www.eximbankindia.in/

http://www.undp.org/poverty,%20pp

http://www.drreddys.com/

http://www.iprsonline.org/ictsd/docs/ResourcesHealthArticleLalitha.doc

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INDIA’S NEW PRODUCT PATENT REGIME: AN ANALYSIS OF RANBAXY … · INDIA’S NEW PRODUCT PATENT REGIME: AN ANALYSIS OF RANBAXY’S R & D EXPENDITURE AND BUSINESS ... 2006, the nexus