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Multinationals, Patents &
MonopoliesPharmaceutical Industry In India
A Managerial Economics Report
Submitted to:
Prof. Saina Baby
Submitted By:
Group No. 11
NAME PRN NO.
Anant Maheshwari 12020841119
Sandeep Kumar Agrahari 12020841095
Raunak Vasandani 12020841071
Nakul Mallikarjun 12020841083
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What is a monopoly?
A situation in which a single company controls all or nearly all the supply of a giventype of product or service in the market.
This would happen in the case that there is a barrier to entry into the industry that
allows the single company to operate without competition (for example, vast
economies of scale, Patents, or governmental regulation).
Types of Monopolies:
1. Perfect MonopolyAlso referred to as Absolute Monopoly, there is only a single seller of product having no
close substitute not even remote one in this case. There is absolutely zero level of
competition. Such monopoly is practically very rare.
2. Imperfect MonopolyAlso, called Relative Monopoly or Limited monopoly, it refers to a single-seller market
having no close substitute. It means in this market, a product may have a remote substitute.
So, there is fear of competition to some extent.
E.g. Telecom Industry (e.g. Vodafone) is having competition from fixed landline phone
service industry (e.g. BSNL).
3. Private MonopolyWhen production is owned, controlled and managed by the individual, or private body or
private organization, it is called private monopoly.E.g. Tata, Reliance, Bajaj, etc. groups in India. Such type of monopoly is profit-oriented.
4. Public MonopolyWhen production is owned, controlled and managed by government, it is called public
monopoly. It is welfare- and service-oriented. So, it is also called as 'Welfare Monopoly'.
E.g. Railways, Defence, etc.
5. Simple MonopolySimple monopoly firm charges a uniform price or single price to all the customers. He
operates in a single market.
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6. Discriminating MonopolySuch a monopoly firm charges different price to different customers for the same product. It
prevails in more than one market.
7. Legal MonopolyWhen monopoly exists on account of trademarks, patents, copy rights, statutory regulation
of government etc., it is called legal monopoly.
Music industry is an example of legal monopoly.
8. Natural MonopolyIt emerges as a result of natural advantages like good location, abundant mineral resources,
etc.
E.g. Gulf countries have a monopoly in crude oil exploration activities because of plenty of
natural oil resources.
9. Technological MonopolyIt emerges as a result of economies of large scale production, use of capital goods, new
production methods, etc.
E.g. Engineering goods industry, Automobile industry, Software industry, etc.
10. Joint MonopolyA number of business firms acquire monopoly position through amalgamation, cartels,
syndicates, etc, it becomes joint monopoly.
E.g. Actually, pizza making firm and burger making firm are competitors of each other in fast
food industry. But when they combine their business, which leads to reduction in
competition. So they can enjoy monopoly power in market.
Pharmaceutical Industry in India
http://en.wikipedia.org/wiki/Pharmaceutical_industryhttp://en.wikipedia.org/wiki/Indiahttp://en.wikipedia.org/wiki/Indiahttp://en.wikipedia.org/wiki/Indiahttp://en.wikipedia.org/wiki/Pharmaceutical_industry7/30/2019 Managerial Economics Report_Group No 11_Sec B
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The Pharmaceutical Industry in India is the world's third-largest in terms of volume and
stands 14th in terms of value.
The number of purely Indian pharma companies is fairly low.
Cheap labour and expertise in reverse-engineering new processes
The Indian Pharmaceutical Industry is mainly operated as well as controlled by dominant
foreign companies having subsidiaries in India due to availability of cheap labour in India at
lowest cost. Our expertise in reverse-engineering new processes for manufacturing drugs at
low costs also plays its part in this regard.
Share in Global Market + Offerings
In terms of the global market, India currently holds a modest 1-2% share, but it has been
growing at approximately 10% per year.
India gained its foothold on the global scene with its innovatively engineered generic drugs
and active pharmaceutical ingredients (API).
It is now seeking to become a major player in outsourced clinical research as well as
contract manufacturing and research. Whats noteworthy is that there are 74 U.S. FDA -approved manufacturing facilities in India, more than in any other country outside the U.S.
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Major pharma players in India:
Following are some examples of both, major Indian players and Multinational ones who are
functioning in India:
Indian: Abbott India ltd, Ranbaxy, Dr. Reddy's Laboratories, Sun Pharmaceutical,Cadila Healthcare etc.
Multinational: Pfizer, GlaxoSmithKline, Sanofi Aventis, Merck, Johnson and Johnsonetc.
Government Involvement
The government started to encourage the growth of drug manufacturing by Indian
companies with the Patents Act in 1970.
In fact, the Indian Pharma Industry got a further impetus with policy changes and
liberalisation that was brought about by P.V. Narasimha Rao and Manmohan Singh enabledthe industry to become what it is today.
TRIPS Agreement:
http://en.wikipedia.org/wiki/Government_of_Indiahttp://en.wikipedia.org/wiki/Government_of_India7/30/2019 Managerial Economics Report_Group No 11_Sec B
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The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) isan international agreement administered by the World Trade Organization (WTO)
that sets down minimum standards for many forms of intellectual property (IP)
regulation as applied to nationals of other WTO Members. It was negotiated at the
end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in1994.
TRIPS contains requirements that nations' laws must meet for copyright rights,including the rights of performers, producers of sound recordings and broadcasting
organizations; geographical indications, including appellations of origin; industrial
designs; integrated circuit layout-designs; patents; monopolies for the developers of
new plant varieties; trademarks; trade dress; and undisclosed or confidential
information. TRIPS also specifies enforcement procedures, remedies, and dispute
resolution procedures. Trade-Related Aspects of Intellectual Property Rights (TRIPS)
is expected to have the greatest impact on the pharmaceutical sector and access to
medicines.
The most detailed and comprehensive multilateral agreement on intellectual property yet
negotiated, TRIPS Agreement lays down norms and standards for the following types of
intellectual property:
Copyright and related rights Trademarks Geographical indications Industrial Design Patents Undisclosed information Lay out design of integrated circuits. Control of Anti-Competitive Practices in contractual Licences.
MARKET STRUCTUE BEFORE TRIPS:
Indian pharmaceutical industry is considered to be one of the largest and fastgrowing industries among the developing countries of this century.
The industry is now much advanced from its initial stage and is currently the fourthlargest producer of pharmaceuticals and thirteenth largest in terms of domesticconsumption globally.
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The industry has earned tremendous achievements in the complicated field of drugmanufacturing and technology.
Almost all types of drugs are manufactured now in India. During 1947 Indian drug market was utilized by the multinational companies
basically importing drugs manufactured in their country. This has been done mainly due to the Patent and Designs Act of 1911. Under these circumstances they began to import finished formulations of drugs
into the local Indian markets
After independence in 1948, India promulgated her first industrial policy resolutionincluding pharmaceutical industry as an essential industry in the country thereby
bringing it under the central regulations.
Moreover, the inadequacy of indigenous technology hindered the production ofmodern drugs locally.
Therefore, the government invited FDI to enhance production. This created asituation where in several major foreign subsidiaries were instituted in India within a
short time span.
Nevertheless, these foreign entities did not bring major investments to the countryto enhance productivity instead, they started importing bulk drugs processing it to
formulations.
A major portion of the pharmaceutical patents in the country was vested with MNCsoutside India.
They were distinctly benefited by the patent law, technology, financial resources
and their brand names which helped them to clearly establish their monopoly in
Indian markets resulting in a situation where drug prices were so high in India when
compared to the rest of the world.
It was in 1954 that the government established Hindustan Antibiotic Ltd. which isthe first public sector drug manufacturing company in India. Later, government
established Indian Drugs and Pharmaceutical Limited. These ventures did help to
increase drug production and improve manpower, but the size of the national sector
continued to remain very small.
1970-1985 Due to some very important strategies initiated by the government the
pharmaceutical industry had undergone drastic changes during this time.
Furthermore, the introduction of Drug Price Control Order of 1970 was a major stepto slow down the multinational control over the industry and helped to boost a self-
reliant traditional market.
In addition, the Drug Policy of 1978 enhanced the availability of drugs at a relativelyreasonable price.
Under these circumstances researches were done resulting in the development ofnew processes for numerous drugs and many manufacturing companies were
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established in India during that period. Besides, the DPCO limited the cost on drugs
and was able to ensure that the lifesaving drugs were readily available in Indian
market at affordable prices.
During the 1980s due to the introduction of some important industrial and tradepolicies by the government, India had become a major pharmaceutical producermeeting the country's domestic needs. Thereafter the domestic sector in the country
had taken control of a considerable portion of the local market.
India signed the general agreement on tariffs and trade on 1994 and became a partyto the agreement on TRIPs joining the WTO.
MARKET STRUCTURE AFTER TRIPS:
One of the basic apprehensions of the re-introduction of product patent protectionin pharmaceuticals in India has been that product monopolies will lead to very high
prices.
180 new drugs have been introduced in the Indian market between 1995 and 2010 MNCs involved have monopolies for 33 drugs. What has attracted widespread attention is Indias success as a pharmaceutical
exporter. What is less noticed is that imports of finished formulations have been
rising sharply.
For matured generics, the MNCs are entering into alliances with Indian companiesfor manufacturing. But for patented drugs, MNCs are importing these from their
home countries Switzerland USA, France etc rather than manufacturing these
in thecountry. With the taking over of some Indian companies, the aggregate market share of the
MNCs in India has dramatically increased from less than 20% to 28% in 2010. The
MNCs are on the way to dominating the industry again.
he days of product monopolies and high prices are back in India. The MNCs havestarted marketing new patented drugs at exorbitant prices particularly for life
threatening diseases such as cancer.
Imports of high priced finished formulations are expanding rapidly withmanufacturing investments lagging behind.
The aggregate market share of the MNCs in the formulations market has gone updramatically with the taking over of some Indian companies by the MNCs.
The Patent Act, 1970
Provisions of the 1970 Act, which helped the National Pharma industry to grow at a double
digit pace have already been discussed and debated widely. Special amended provisions for
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pharmaceuticals, deleting product patenting (retaining process patenting), introducing
Licences of Right, liberal Compulsory Licensing provisions, reduction of patent protection
period from 14 years to 7 years (from date of application) and 5 years (from date of sealing)
in the Patent Act, 1970, virtually kept pharma patents out of protection and open for
commercialization for anyone at will. Consequently, there was no interest for internationalapplicants to file pharma patent applications in India. While being active in "reverse
engineering", with a weak patent system, the Indian Pharma Industry was not at all keen on
innovative research and patenting.
Compulsory licensing
A limitation/compulsory license with respect to the exclusive right of reproduction is valid
only if it is limited to:
Certain special cases Provided that such reproduction does not conflict with thenormal exploitation of the work of the author
Does not unreasonably prejudice the legitimate interests of the author A flexible interpretation of this provision can make the C.L. under this provision more
useful
Certain special cases that are worth mentioning:
Policy objectives of national legislator have to be taken into account WTO paneldecision is not acceptable.
No conflict with normal exploitation. Not all exploitation, but normal exploitation there is a conflict only when there is
substantial market impairment. Markets that are neither developed, nor licensed to
develop, will then fall beyond the scope of this
Do not unreasonably prejudice with the legitimate exploitation. Kingpin balancing public and individual interests.
Evergreening of Patents
Evergreening is the practice of pharmaceutical companies to obtain patents on frivolous or
minor changes to known drugs and thereby establish or extend their monopoly over a drug.
Evergreening can be described as the situation where shortly before a patent expires, one
reapplies a slightly different version of the invention to restart another 20 years of
protection for what in fact is the same subject matter. Whereas the case described here
below is a typical post-grant issue, this one is rather borderline. The evergreening of
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patents mainly roots in a failure to prevent too small amendments to existing inventions to
be (re-)granted a patent.
Gleevec (Novartis)- Case
In 1997, Novartis AG, a pharmaceutical company based in Switzerland, filed a patent
application in the Chennai (Madras) Patent Controllers office for the beta-crystalline
of imatinib mesylate, brand name Glivec(Gleevec) on the ground that it invented the
beta crystalline salt form (imatinib mesylate) of the free base, imatinib.
Novartis patent application was kept in the mail-box and not opened until 2005 as
the TRIPS Agreement permitted developing countries such as India that did not
provide product patent protection to pharmaceuticals and agrochemicals to
introduce such product patent protection from 1 January 2005.
In the meantime, Novartis had obtained Exclusive Marketing Rights (EMR) for
marketing Gleevec in India. On the basis of this, it obtained orders preventing some
of the generic manufacturers from manufacturing and selling generic versions of the
medicine. At that time, Novartis was selling Gleevec at USD 2666 per patient per
month. Generic companies were selling their generic versions at USD 177 to 266 per
patient per month.
In 2005, India amended its patent law to comply with its obligations under the TRIPSAgreement to provide process and product patent protection in all fields of
technology, including pharmaceuticals and agrochemicals. Cognisant of patenting
practices, Parliament introduced a significant and important provision to prevent
evergreening and granting of frivolous patents section 3(d).
After the 2005 amendment to the patent law, CPAA and other generic companies
filed pre-grant oppositions against Novartis patent application for imatinib
mesylate, claiming, among other things, that Novartis alleged invention lacked
novelty, was obvious to a person skilled in the art, and that it was merely a new
form of a known substance that did not enhance the substances efficacy, andwas thus not patentable under section 3(d). These arguments were based on the fact
that Novartis had already been granted a patent in 1993 in the United States and
other jurisdictions for the active molecule, imatinib, and that the present application
only concerned a specific crystalline form of the salt form of that compound.
In 1997, Novartis AG filed a patent application for the beta-crystalline of imatinibmesylate, brand name Glivec.
the petition was kept in a mail box till 2005 as per the TRIPS agreement . In the meantime, Novartis had obtained Exclusive Marketing Rights (EMR) for
marketing Gleevec in India
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On the basis of this, it obtained orders preventing some of the generic
manufacturers from manufacturing and selling generic versions of the medicine. At
that time, Novartis was selling Gleevec at USD 2666 per patient per month. Generic
companies were selling their generic versions at USD 177 to 266 per patient per
monthAmendment in Law and its effect:
In 2005, India amended the law and allowed process patent. Parliament introduced an important provision to prevent evergreening of patents
section3(d)
CPAA(Cancer Patients Aid Association) and other generic companies filed pre-grantoppositions against Novartis patent application for Gleevec
argued that different crystalline forms of imatinib mesylate did not differ inproperties with respect to efficacy, and thus the various forms of imatinib mesylate
must be considered the same substance under section 3(d)
Rejection of patent
In June 2006, Patent Controller refused the patent saying that this application lacknovelty.
The patent rejection meant that generic companies could manufacture and markettheir generic versions of the drug, both in India and abroad
Filed petition against Government of India, CPAA, and four Indian genericmanufacturers
For the constitutional validity of sec 3(d) Against Patent Controller to refuse to grant Novartis a patent In April 2007, the Government of India notified the IPAB (The Independent Payment
Advisory Board) to hear appeals relating to this patent
Constitutional validity of section 3(d) upheld by Madras High Court [August
2007]
Novartis primary contention in its challenge to the constitutional validity of section3(d) was that the use of the term efficacy in section 3(d) is vague and ambiguous
because there was no clarity as to what constituted enhancement of efficacy and
significant enhancement of efficacy
The Government of India, CPAA and generic companies argued that section 3(d) isnot in violation of the equality provision of the Indian Constitution as the concept of
efficacy is well-known to persons in the pharmaceutical industry and it is impossible
to lay down a one size fits all standard to determine what constitutes a significant
enhancement of efficacy.
Madras High Court Verdict We have borne in mind the object which the Amending Act wanted to achieve
namely, to prevent evergreening; to provide easy access to the citizens of this
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country to life saving drugs and to discharge their Constitutional obligation of
providing good health care to its citizens
IPAB discussion and verdict the IPAB overturned the Patent Controllers findings on novelty and inventive step
and held that the beta-crystalline form of imatinib mesylate was new and involvedan inventive step.
However, the IPAB held that Novartis alleged invention did not satisfy the test ofsection 3(d) in as much as Novartis did not provide data to show that the beta-
crystalline form of imatinib mesylate exhibited significantly enhanced therapeutic
efficacy over imatinib mesylate, the known substance
And the court rejected the petition.
Nexavar:- Case
Nexavar is the name under which Sorafenib is marketed. It has been co-developed and is
co-marketed byBayerandOnyx Pharmaceuticals.
Its used for the treatment ofAdvanced Renal Cell Carcinoma (primary kidney cancer) and
Hepatocellular Carcinoma (advanced primary liver cancer).
Bayer had obtained a patent (IN215758) for Nexavar in India during 2008.
Compulsory Licensing in India:
The first-ever compulsory license in India was given by the Indian Patent Controller P. H.
Kurian on March 9, 2012, to Natco Pharma, to manufacture a generic version of Bayer's anti-
cancer drug Nexavar (Sorafenib Tosylate).
Bayer, of course, challenged that verdict and in the ruling that came out recently, on the 6 th
of September 2012, the Intellectual Property Appellate Board (IPAB) in Chennai, issued its
first ever compulsory licence to Natco, a local generic drug manufacturer, effectively endingthe German drugmaker's monopoly in India on the drug for treating kidney and liver cancer.
So, basically, Natco won the right to make the drug under a provision of the Indian Patents
Act allowing a compulsory licence on drugs that are not available at affordable prices.
Why everyones making such a big deal about this entire issue, you may ask. The answer to
that is precisely this
Prior to the compulsory licensing, patients needed to spend $5,500 (approximately Rs.
280,000) per month for obtaining Nexavar. The compulsory license reduced the price of
Sorefanib Tosylate by 97 percent in the Indian market from over to $175 per month.
http://en.wikipedia.org/wiki/Bayerhttp://en.wikipedia.org/wiki/Bayerhttp://en.wikipedia.org/wiki/Bayerhttp://en.wikipedia.org/wiki/Onyx_Pharmaceuticalshttp://en.wikipedia.org/wiki/Onyx_Pharmaceuticalshttp://en.wikipedia.org/wiki/Renal_cell_carcinomahttp://en.wikipedia.org/wiki/Hepatocellular_carcinomahttp://en.wikipedia.org/wiki/Hepatocellular_carcinomahttp://en.wikipedia.org/wiki/Renal_cell_carcinomahttp://en.wikipedia.org/wiki/Onyx_Pharmaceuticalshttp://en.wikipedia.org/wiki/Bayer7/30/2019 Managerial Economics Report_Group No 11_Sec B
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Topic of Debate:
The issue of compulsory licensing is highly debatable.
On one hand some believe that it will open up the field for the generic industry to providemore affordable drugs and build on its reputation as the 'pharmacy of the world'.
Then, there are others who feel that it will affect innovation and that Indias position in the
world pharmacy market will get undermined by such a stringent interpretation of
intellectual property rights. In fact, at Alchemy 2012, the Management Conclave of SIBM-
Bangalore, in the Indovation category of discussion, we had a speaker from Merck
Pharmaceuticals who shared the same view and said this wasnt a step in the right direction.
Global Pharma Leaders
Pfizer New York City, New York. Johnson & Johnson New Brunswick, New Jersey. F. Hoffmann La Roche Basel, Switzerland. GlaxoSmithKline plc London, UK. Novartis International AG Basel, Switzerland. Sanofi S.A Paris, France. AstraZeneca plc London, UK. Abbott Laboratories Abbott Park, North Chicago, Illinois. Merck & Co. Whitehouse Station, New Jersey. Bayer AG Leverkusen, Germany.
Global Pharma Market (2009)
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Indian Pharma Leaders
Ranbaxy Dr. Reddys Laboratories Cipla Sun Pharma Industries Lupin Labs Aurobindo Pharma Cadila Healthcare GlaxoSmithKline plc. Aventis Pharma
Indian Pharma Market
Company Size ($ Billions) Market Share (%) Growth Rate (%)
Total Pharma Market 6.9 100 9.9
Cipla .36 5.3 13.4
Ranbaxy .34 5.0 11.5
Glaxo Smithkline .29 4.3 -1.2
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Piramal Healthcare .27 3.9 11.7
Zydus Cadila .24 3.6 6.8
Indias Pharma Sectors Current Scenario
Spends $ 23 billion on R&D. 160,348 Researchers. 1,234 Patents. Affordable drugs. Domestic Market at $ 19.22 billion. Local & Foreign Players. Stiff Competition. The Indian pharmaceutical industry continues to witness 12-14% growth year-on-
year driven by increasing expenditure of healthcare; changing disease profile and
rising disposable income levels.
New product introductions contribute to around 6-8% of the total growth. The industry structure remains highly fragmented, with top ten pharmaceutical
companies accounting for only 35% of total pharmaceutical sales. However, the
leading players continue to retain their market share owing to their strongdistribution reach, strong field force and new product launches.
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References:
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741816.html
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india-4472
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xavar_natco_419547
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