MGMT5601

GLOBAL BUSINESS AND MULTINATIONAL ENTERPRISE

IMPACTS OF EVERGREENING STRATEGIES OF PATENTS ON

THE PHARMACEUTICAL INDUSTRY
STUDENT NUMBER: 5084259

NAME: CHIA CHEN LIN

STUDENT NUMBER: 5088203

NAME: FRANCESKA TOADER

STUDENT NUMBER: 5081152

NAME: SHARATH RAVISHANKAR

FACULTY
LECTURER: Ms. ESHA MENDIRATTA
TUTOR: Ms. ESHA MENDIRATTA
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DAY: WEDNESDAY

TIME: 3:30PM TO 5:00PM

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MGMT5601 GLOBAL BUSINESS AND MULTINATIONAL ENTERPRISE

TABLE OF CONTENTS
EXECUTIVE SUMMARY

page 3

INTRODUCTION

page 4

METHODOLOGY

page 4

BODY

page

Evergreening..page 5
Types of Evergreening Strategies..page 5
Future Implications of Evergreening.page 9
Managerial

Implicationspage

CONCLUSION

page 11

REFERENCE

page 12

APPENDICES

page 14

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EXECUTIVE SUMMARY
This paper analyses the effect of the process known as evergreening on the global
pharmaceutical industry in recent years by looking at secondary sources and analysing them
through theoretical frameworks.
The introduction gives a brief overview on definitions of patents and evergreening
and what effects it has had over the industry in general.
The main points of discussion around evergreening in the pharmaceutical industries are
the five main strategies used by companies to prolong patents, as follows:
1. Redundant extensions and creation of next generation drugs which result in
superfluous variation to a product and then patenting it as a new application
2. Prescription to OTC switch
3. Exclusive partnerships with cream of generic drug players in the market prior to
patent expiry thus significantly enhancing the brand value and interim earning
royalties on the product
4. Defence pricing strategies practice wherein the innovator decrease the price of the
product in line with the generic players for healthy competition
5. Establishment of subsidiary units by respective innovator companies in the generic
domain before the advent of rival generic players
The above presented strategies show what ways companies choose for bending the law in
order to get profit maximization, and knowledge of these strategies gives managers a better
understanding of what to expect from competitors, and how to avoid legal issues.
From research, it has been shown that continuous evergreening will lead to:
inaccessibility to cheaper medicine and improper pricing of medical products, increase in
litigation, ineffective competition and constant increase in investment for innovation. The
most important managerial implication is the fact that the significant change in market
structure requires evergreening to be viewed as a strategy-policy game that provides the best
analytical tools for coping with this sort of process.
To conclude, organizations should implement effective strategies towards sustenance of
evergreening or implement divergent approaches in ensuring innovation as a distinctive
capability.

INTRODUCTION
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Patents can be defined as exclusive rights granted for the invention of a product or
process which provides a new approach to solving a problem. This protection usually lasts for
a period of 20 years, limited duration, to the owner of the invention which can be a person or
an organisation (WIPO, 2015). It is highly valued with the pharmaceutical companies as it
solidifies the protection of their blockbuster drug. Many pharmaceutical companies file for
patents on the existing patented-product before its initial patent expiration, this strategy of
extending the term of the patent of the products or innovative discoveries in order to maintain
market dominance, is called evergreening (Bansal, et al., 2009). It has been filing for
obtaining patents on the existing products with minor improvements or changes. Such a
protection gives them opportunity to have or retain market monopoly. With many aliases such
as stockpiling, layering, life-cycle management or line extension, it has been
observed as an abusive practice that hampers generic medications and adversely affects the
public (Thomas, 2009). Extending the given patent to maintain monopoly in production has
been termed as evergreening by experts. The notion of extending the patent for a given
products has led to prospects of effective analysis pertaining to the way forward. Thus, this
paper will evaluate the implications of evergreening on the pharmaceutical industry.

METHODOLOGY
This paper is based on secondary sources of research i.e. data analysed and reviewed
from other primary sources of data such as other research articles, documents and websites.
The information collected is then critically reviewed to our application of theoretical
frameworks in the aspects of global business and multinational enterprise in relation to the
evergreening process in the pharmaceutical industry in recent years.

MGMT5601 GLOBAL BUSINESS AND MULTINATIONAL ENTERPRISE

BODY
Although evergreening is the main strategy, which is followed by many pharmaceutical
companies by changing treatment methods, manner of the products packaging, altering the
product on molecular levels, mode of delivery, dosage etc., it consists of many other skilled
strategies to achieve extension on the term of the patent. Given the fact that there are many
legal frameworks that strictly govern the process of patenting these strategies do venture
through them (Bansal, et al., 2009).
1. Redundant extensions and creation of next generation drugs which result in
superfluous variation to a product and then patenting it as a new application
(Bansal, et al., 2009).
Patenting of drugs can be done for the drug on the whole or for its other
aspects varying from combination of the formula of the drug to manufacturing method
to type of application, and patents for each will have a different expiration date.
Additional patents are filed for the only when the existing patents are inching towards
expiration which does not allow other drug companies to sell their products that use
the same active ingredient. Also to ensure that the new patented product will make the
consumers purchase them, would be to have a convincing amount of common features
of the successful products (Midha, 2015). This can be observed in the case of Indian
Supreme courts rejection of Novartiss patent application for a drug called Glivec,
under the patent law section 3(d) which prevents patentability of combinations or
previously patented compounds, for the treatment of leukemia in 2013. Some of the
countries such as South Africa and China are also considering this practice.
Indian government is concerned with providing an easy access to the drugs
and healthcare for their citizens. They are also worried about the threat of
pharmaceutical companies practicing evergreening in developing countries as most of
their drug companies produce generic drugs (Boscheck, 2015). The pharmaceutical
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industry policies is different from emerged and emerging economies (Boscheck,
2015). Some researchers claim that jurisdictions in the US and EU is relatively lenient
i.e. have a lower standard for patent process and easily allows additional patents. The
evidence shows the impact of evergreening on the public health and the cost on low
quality of patents, US government is determined to improve its patent quality (Vawda,
2014).
2. Prescription to OTC switch (Bansal, et al., 2009).
OTC or over the counter drugs are those that are deemed safe for use by the
general public without a prescription from a medical practitioner (U.S. Food and Drug
Administration, 2015). The switch from prescription to over the counter is a
reclassification process, known as Rx to OTC, achievable in two ways (a.) OTC drug
review or (b.) by the manufacture of the drug submitting additional information to the
new drug application (NDA). This is done by gather information of the prescription
drug and submitting the additional information through a NDA to the Food and Drug
Administration (FDA) for the consideration of its OTC status. The FDA reviews the
labelling of the OTC drugs to assess the risk versus benefit of the drug, considering
that there is no professional supervision for its usage (Midha, 2015).
3. Exclusive partnerships with cream of generic drug players in the market prior to
patent expiry thus significantly enhancing the brand value and interim earning
royalties on the product (Bansal, et al., 2009).
An agreement between the innovator company and generic drug companies,
where the generic drug companies gets paid by the innovator company to delay or not
at all allow certain drugs from entering the market for a specific period of time. These
agreements is an anticompetitive practice also known as Pay for Delay agreements
(Midha, 2015). Anticompetitive practices is tackled by the Federal Trade Commission
(FTC) that stops and prevents these unfair business practices as it reduces competition
which leads to increase in prices due to monopoly of the trade and quality suffers due
to reduced levels of innovation and service (Federal Trade Commission, 2015).
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There are two forms of violations; Horizontal Conduct and Single Firm
Conduct:- (Federal Trade Commission, 2015)
i.
Horizontal Conduct: An illegal practice of interaction of the
competitors as a group to take market control leading to the price fixes,
ii.

market divides and rigged bids (Federal Trade Commission, 2015).

Single Firm Conduct: A companys attempt to acquire monopoly status
in the market through unlawful or unreasonable or aggressive methods.
By maintaining a dominant position it will discourage new entrants and

Figure 1. Porters Five Forces that Shape Industry Competition (Porter, 2008)

excludes existing competition (Federal Trade Commission, 2015). This can be

related to Porters five forces that shape the industry competition, which
defines competition and the drivers of profitability. The framework helps to
identify the forces of competition and the underlying causes that anticipates
new competition and profitability (Porter, 2008).
By establishing monopoly, the new entrants of the industry get
highly discouraged. This will put tremendous pressure on the
investments required to set-up research and development centres and to

MGMT5601 GLOBAL BUSINESS AND MULTINATIONAL ENTERPRISE

start work on a new drug, generic or innovative, from scratch (Porter,
2008).
4. Defence pricing strategies practice wherein the innovator decrease the price of the
product in line with the generic players for healthy competition (Bansal, et al.,
2009).
In order to ensure healthy competition amongst competitors of the innovator
company, the generic companies can conduct business with their generic drugs but at
lesser cost than the innovators price. However, the innovator company can often gain
a lead advantage by reducing the price of the drug which the other generic companies
are competing with, forcing them to reduce their rates, and introducing an improved
drug that moves them further ahead.
5. Establishment of subsidiary units by respective innovator companies in the
generic domain before the advent of rival generic players (Bansal, et al., 2009).
Increasing interests of big pharmaceutical companies in order to dominate the
pharmaceutical market use diversification strategies such as set-up of subsidiaries
which predominantly cater to the generic drug market and to basically undercut the
new rival generic companies. This has been observed in many Big Pharmas who
adopt this strategy to expand their business model horizontally, for example, Novartis
through Sandoz, AstraZeneca through Torrent in India and Glaxo SmithKline through
Dr.Reddys in India and Aspen PharmaCare in South Africa (Bansal, et al., 2009).

Implications in the future if evergreening process continuous

Such approaches of evergreening mainly focused towards the extension of the
privileged position of the patentee. With market exclusivity of the patents held, there is the
concept of monopoly in production and exclusivity in enjoying the given profits. Hence, the

MGMT5601 GLOBAL BUSINESS AND MULTINATIONAL ENTERPRISE

different implications of evergreening that emanate from both the immediate and more longterm implications such as:Inaccessibility to cheaper medicine and improper pricing of medical products:
Monopoly over market exclusivity, in the pursuit of profit maximization, will lead to
individualized pricing. And without competition there will not be price wars that will
influence reductions of drug prices (Midha, 2015).
Increase in litigation: With evergreening, many pharmaceutical companies will get
litigated especially when it comes to trespassing patent rights by other drug companies
(Thomas, 2009).
Ineffective competition: Patents offer organizations within the pharmaceutical
industry with a difficult path towards control of production and profitability. The concept that
no other company can produce the given medicine denotes that the patent holder has no rivals
(Midha, 2015).
Increased investment for innovation: Innovation is integral for sustenance of
effective product development. From the evaluation of the pharmaceutical industry, the
reliance on research and development is crucial for innovation. The implementation of the
evergreening approach leads to extensive investment into innovation (Midha, 2015).

Managerial implications
According to (Bansal, et al., 2009) an industry which is highly control centric, the
pricing and output decisions is highly influenced by fellow competitors or rivals. Hence,
businesses such as GlaxoSmithKline, maintain their pricing to the industry standard to ensure
profitability. Pharmaceutical companies operate in an oligopolistic market structure where
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they determine the prices, although decisions of outputs and pricing require industrial
analysis and effective management. The implementation of evergreening results in a
significant change in the structure of the sector. Most experts emphasize that evergreening
results in the creation of major sector leaders in terms of profit and production dominance.
The significant change in market structure requires evergreening to be viewed as a strategypolicy game that provides the best analytical tools for coping with this sort of process. A
more emphatic managerial approach that is reliant on corporate governance and employee
centric operational approach (Granstrand & Tietze, 2015).
As seen in the previous section, there are many strategies for evergreening, but there
is also a fair amount of response strategies, all of which are listed in Appendix 1.
The continuous extension of the use of evergreening calls for policy analysis and
research, which in turn requires clear definitions, operationalization and typologies. However,
if evergreening is found to harm innovation in the long-run, there might be major issues in
trying to find effective policy remedies that can add to the countering effects of strategies
against it (e.g. add to the market forces) (Granstrand & Tietze, 2015).

CONCLUSION
The notion of evergreening in the pharmaceutical sector has led to distinctive
outcomes for the organizations. As an aspect that denotes extension of the patents, it has led
to diverse outcomes for both the management and the organizations operating in the sector. It
is well known that in pharmaceutical industries sometimes bend the legal system to their own
benefit in order to get large profits. The reason for such behavior is that they seek to increase
shareholders return, especially through patents. Because of this fight for financial incentives,
companies will always try and come up with ways to protect their intellectual property rights
through many fields of innovation, such as technology or legal mechanisms. Hence,
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evergreening and bootstraping patent portfolios which might alternatively be viewed
simply as an astute use of legal rules will continue, even if there one could argue that the
use of such procedures can simply be a smart way of using laws to your own benefit.
From the above analysis (and the table in Appendix 1), it is imperative that
organizations within the sector implement effective strategies towards sustenance of
evergreening or implement divergent approaches in ensuring innovation as a distinctive
capability.

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REFERENCES

Bansal, I. S., Sahu, D., Bakshi, G. & Singh, S., 2009. Evergreening - A Controversial Issue in
Pharma Milieu. Journal of Intellectual Property Rights, Volume 14, pp. 299-306.
Boscheck, R., 2015. Intellectual Property. [Online]
Available at: http://download.springer.com/static/pdf/884/art
%253A10.1007%252Fs10272-015-0546-y.pdf?originUrl=http%3A%2F
%2Flink.springer.com%2Farticle%2F10.1007%2Fs10272-015-0546y&token2=exp=1444785742~acl=%2Fstatic%2Fpdf%2F884%2Fart
%25253A10.1007%25252Fs10272-015-054
[Accessed 2015].
Federal Trade Commission, 2011. Authorized Generic Drugs: Short-Term Effects and LongTerm Impact. [Online]
Available at: https://www.ftc.gov/sites/default/files/documents/reports/authorizedgeneric-drugs-short-term-effects-and-long-term-impact-report-federal-tradecommission/authorized-generic-drugs-short-term-effects-and-long-term-impactreport-federal-trade-commission.pdf
[Accessed 2015].
Federal Trade Commission, 2015. Federal Trade Commission - Anticompetitive Practices.
[Online]
Available at: https://www.ftc.gov/enforcement/anticompetitive-practices
[Accessed 2015].
Granstrand, O. & Tietze, F., 2015. IP STRATEGIES AND POLICIES FOR AND AGAINST
EVERGREENING. [Online]
Available at:
http://www.ifm.eng.cam.ac.uk/uploads/Research/CTM/working_paper/2015-01Granstrand-Tietze.pdf
[Accessed 2015].
Midha, D. S., 2015. STRATEGIES FOR DRUG PATENT EVER-GREENING IN THE
PHARMACEUTICAL INDUSTRY. International Journal of Pharmaceutical
Sciences and Business Management, 3(3), pp. 11-24.
Porter, M. E., 2008. Harvard Business Review - The Five Competitive Forces That Shape
Strategy. [Online]
Available at: http://elibrary.kiu.ac.ug:8080/jspui/bitstream/1/510/1/Michael%20Porter
%20-%20The%20Five%20Competitive%20Forces%20that%20Shape
%20Strategy.pdf
[Accessed 2015].
Thomas, J. R., 2009. Congressional Research Service. [Online]
Available at: http://www.ipmall.info/hosted_resources/crs/R40917_091113.pdf
[Accessed 2015].
U.S. Food and Drug Administration, 2015. FDA - U.S. Food and Drug Administration.
[Online]
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Available at:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/u
cm052786.htm
[Accessed 2015].
Vawda, Y. A., 2014. After the Novartis Judgement - 'Evergreening' will never be the same.
Law, Democracy and Development, Volume 18, pp. 305-316.
WIPO, 2015. World Intellecctual Property Organisation. [Online]
Available at:
http://www.wipo.int/edocs/pubdocs/en/patents/450/wipo_pub_l450pa.pdf
[Accessed 2015].

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APPENDICES
Appendix 1. The strategy-policy matrix for patent based evergreening (Granstrand &
Tietze, 2015).
Evergreening policies

For

Against

Reduction of statutory duration

Reducing the scope of protection

Reducing patentable subject matter

Increasing the inventive step requirement

Increasing patenting fees for sequential

Patent term restoration

Injunctions

Delaying

licenses,

concessions,

and/or substitute patents

approvals, litigation etc.

Evergreening strategies
For

Search and research for strategic

patents

and

patent

fences

Market power abuse intervention

Compulsory licensing

Abandoning the patent system

Against
Invalidation

Invent around
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Patent or license acquisition

Patent pooling and cross-licensing

elements in the business innovation

Partnering

system, typically by

Use of general bargaining power

Ignore and/or infringe

Delay entry until patent expiration

Abandon

Fragmentation

and

complementary

patenting

resources

Follow-on/

continuous

patenting

of

improvements,

of
and

sequential

product/process
features

and

applications for the innovation and its

entry

and

related

commercial operations and R&D

related complements

Aggregation

and

patenting

of

substitute resources and products/

technologies, typically by blocking
patents and patent fencing outside the
own product area

Sequential

patent

blanketing and

patent flooding

Multi-protection, combining patents

with other IPRs

Grant-back licensing

Deterring litigation and litigation

threats, possibly using NPEs

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16