Ever-greening in Pharmaceuticals: Strategies, Consequences and Provisions for Prevention in USA, EU, India and Other Countries

Abstract

Pharmaceutical research and development is an expensive, time consuming and uncertain process that may take 8-10 years to complete. Patent clock starts much before a new drug is approved for marketing and significant amount of time may be lost in the review and approval process by regulatory bodies. So in order to recoup the considerable time and resources invested in the drug development and approval process the pharmaceutical companies depend on exclusivity provisions granted by the regulatory bodies. There are several official and unofficial methods to extend term of a patent beyond 20 years, Official methods include provisions by some regulatory bodies such as Data exclusivity, Orphan drug exclusivity, Paediatric exclusivity and the 180-day exclusivity (Hatch Waxman Act, U.S. Food and Drug Administration), Supplementary protection certificate (European Medical Agency), whereas unofficial methods include altering or reformulate the existing compound to obtain a new patent by utilising polymorphism, creating combinations, stereo-selective/chiral switches, conversion to NDDS, OTC switching, authorised generics, etc. This article aims at highlighting the strategies used by Pharma giants to extend the term of their patent portfolio in order to maintain their monopoly for extended periods and the regulatory provisions in different countries to check these practices.

Full text

Ever-greening in Pharmaceuticals: Strategies, Consequences and
Provisions for Prevention in USA, EU, India and Other Countries
Arun Kumar* and Arun Nanda
Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, India
*Corresponding author: Arun Kumar, Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, India, Tel: +01262 393 596; E-mail:
arun356y@gmail.com
Received date: Sep 16, 2016; Accepted date: Apr 07, 2017; Publish date: Apr 18, 2017
Copyright: © 2017 Kumar A, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted
use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
Pharmaceutical research and development is an expensive, time consuming and uncertain process that may take
8-10 years to complete. Patent clock starts much before a new drug is approved for marketing and significant
amount of time may be lost in the review and approval process by regulatory bodies. So in order to recoup the
considerable time and resources invested in the drug development and approval process the pharmaceutical
companies depend on exclusivity provisions granted by the regulatory bodies. There are several official and
unofficial methods to extend term of a patent beyond 20 years, Official methods include provisions by some
regulatory bodies such as Data exclusivity, Orphan drug exclusivity, Paediatric exclusivity and the 180-day
exclusivity (Hatch Waxman Act, U.S. Food and Drug Administration), Supplementary protection certificate
(European Medical Agency), whereas unofficial methods include altering or reformulate the existing compound to
obtain a new patent by utilising polymorphism, creating combinations, stereo-selective/chiral switches, conversion to
NDDS, OTC switching, authorised generics, etc. This article aims at highlighting the strategies used by Pharma
giants to extend the term of their patent portfolio in order to maintain their monopoly for extended periods and the
regulatory provisions in different countries to check these practices.
Keywords: Patents; Ever-greening; Generics; Drug exclusivity
Ever-greening
Ever-greening refers to the various ways wherein the patent holder
attempts exploit the loopholes in patent laws and related regulatory
processes in order to maximize their monopoly especially over
bestseller drugs by ling disguised or artful patents on previously
patented invention just before the end of the term of the parent patent.
ese additional patents are meant to protect the following aspects:
• Combinations of two or more drugs;
• Dosing rage and dosing route;
• Biological targets for old molecule;
• Delivery proles, mechanism of action;
• Derivatives and isomeric forms;
• Screening methods, dosing regimen;
• Packaging;
•Dierent methods of treatment [1].
Ever-greening is a strategy acquired by the innovator companies to
recover high costs incurred by them in Research and Development and
as a means to legally protect any minor modications that are
intentionally made to the parent patent just to obtain multiple patents
on the same drug and hence extend the overall term of the patent to
enjoy monopoly for extended periods of time. In simple words, a
company launches a drug product and obtains patent protection for it
and just before the end of the term of that patent; the company les a
new patent for a minor modication in the original molecule that
extends the overall term of patent protection which ultimately
contributes to their monopoly. Hence, extending the patent protection
period delays or prevent the entry of the generic versions of the drug
which can aect the budget for public health and nally the patient.
Example of ever-greening: Consider an innovator rm named SA
Pharmaceuticals which formulates a new molecule for the cure of a
specic disease. SA Pharmaceuticals applies for patent protection for
the new molecule on 10 April, 2005. Once the application is approved
by the patent oce, it will result in a patent that will provide protection
for the next twenty years (starting from the date of application) up to
10 April, 2025. If on 1 February 2010, SA Pharmaceuticals les a
second application before the patent oce, for a minor improvement
in the previously patented molecule and that application is also
approved, it will result in patent protection that will end on February 1,
2030. In this case a generic manufacturer may launch generic version
of the parent molecule aer 10 April 2025 but excluding the
modications that SA Pharmaceuticals had made to the original
molecule, for which the patent protection term is set to end on 1
February, 2030.
Patent Term Extension Strategies Followed by the
Innovator Firms Involve
e 30 month stay provision (USA)
For every new drug, it is compulsory to prove that the product is
safe and eective in order to obtain regulatory approval from the Food
and Drug Administration (FDA). Once approved, the drug gets entry
into FDA’s publication called Orange Book also called Approved Drug
Products with erapeutic Equivalence Evaluations (TEE), which
serves as a reference for the generic manufacturers who wish to launch
the generic versions of the drug aer the end of the term of patent
Kumar and Nanda, Pharm Regul Aff 2017, 6:1
DOI: 10.4172/2167-7689.1000185
Review Article OMICS International
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ISSN: 2167-7689
Volume 6 • Issue 1 • 1000185
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protection. Additional patents that are linked to the parent patent are
also too listed in the Orange Book [2].
e Hatch-Waxman amendment (1984) of the Food, Drug and
Cosmetics Act requires a generic drug manufacturer planning to
market generic version of a previously patented drug, to le an
Abbreviated New Drug Application (ANDA). e generic applicant
needs to satisfy that the generic is equivalent in activity when
compared to the branded drug. e generic manufacturer also needs to
certify that:
• Para I certication: e drug is not patented;
• Para II certication: e drug patent has already expired;
• Para III certication: e generic will enter the market only when
the patent expires;
• Para IV certication: e patent is invalid or will not be infringed
by the generic.
If generic applicant wishes to go for the Para IV certication, then it
must intimate the decision to the patent holder. If paragraph IV
certication is used the brand name company within 45 days from the
receipt of the notice can exercise its right to challenge the generic
applicant. If brand name company decides to challenge the generic
application, the law automatically puts a stay on further generic
approval for the next 30 months or until the hearing is resolved or the
patent lapses. Although the provision aims at protecting the interests of
innovator rms, still companies have misused this provision. US
Federal Trade Commission (FTC) analysed that approx. 72% of
innovators exploited the provision [3].
Redundant extensions and creation of ‘next generation
drugs’
e dierent attributes of drug development that can be patented
include delivery proles, methods of manufacture, chemical
intermediates, formulations, packaging, biological targets, mechanism
of action and method of medical treatment, etc. Oen the innovator
rms utilise one of these attributes to obtain additional patents shortly
before the end of the term of primary patent. Hence, if a brand-name
drug company formulates a new molecule for treating of a specic
disease, the company is eligible to obtain patent protection for various
attributes of the parent drug, these additional patents covering
dierent aspects of the same drug will add to the overall term of the
parent patent and will restrict a generic drug company to launch
generic version.
Example: When the patent for Prilosec was near expiry,
AstraZeneca in order to maintain the monopoly of the blockbuster
drug Prilosec launched Nexium which was the same drug with minor
changes in design and colour [4].
Switching to over-the-counter (OTC)
Drug products that do not require professional supervision and can
be safely administered by the patient status the innovator just needs to
shows the ratio of safety to benet to the FDA and whether it will be
easy for the patient to self-administer the drug product. OTC status
encompasses many benets major of them being the opportunity for
direct advertising to consumers through dierent forms such as
advertising in television, magazines, retail displays, brochures, and
packaging without any restrictions which apply on prescription drugs
which maximizes himself and are easily available without prescription
are known as Over the Counter drugs. e process of reclassication of
a prescription drug to Over the Counter is termed as Rx to OTC
switch. Opting for OTC review is another strategy used by the
innovators in order to maximize their monopoly over highly lucrative
drug molecules. To get OTC the innovator’s monopoly, therefore the
OTC drug being from the innovator company would be preferred and
this would eectively undercut the demand for generic version in the
market [5].
Example: Nasacort 24 h (Sano) which was originally developed as
intranasal steroid was switched for OTC in 2014 for the treatment of
allergies [6].
Pay for delay or reverse payments
is is one of the anti-competitive practices that are followed by
innovator rms to prevent or delay the entry of cheaper generic
versions until their generic version of the drug has been rmly
established in the market. e innovator rm signs an agreement with
the renowned generic manufacturers to delay or give up the launch of
generic version of drug. Pay for delay arrangements is a kind of
settlement agreement between the innovator company and a generic
manufacturer in which the latter agrees to refrain from marketing its
generic version for a specied period of time in return for huge
payments from the innovators. ese pay-for-delay arrangements
eectively block the entry of generics and thwart the generic
competition until the innovator’s drug establishes itself in the market.
is type of arrangement is unlawful and Federal Trade Commission
or similar agencies constantly look out for such deals [7].
Example: Servier was ned an amount of €330 million for delaying
entry of generic high blood pressure medicine perindopril in the
market, in 2013, Johnson & Johnson and Novartis were ned €16
million for delaying entry of generic version of pain-killer fentanyl [8].
Establishment of generic units by innovator companies
Pharma giants in order to compete with the generic players are
showing an ever increasing interest in setting subsidiary generic units
and entering partnerships with major generic manufacturers and
building a position in generics before the competition from of rival
generic players rise. Over the past decade, Big Pharma has acquired
small generic units to expand their business model. Particularly the
following three categories of partnerships are observed:
Examples: AstraZeneca and Indian generic manufacturer Torrent
Pharmaceuticals signed up and agreement in 2010 under which
Torrent will manufacture and supply generic versions for AstraZeneca’s
emerging markets.
Novartis established Sandoz as a subsidiary unit for manufacturing
generic drugs and Novartis’s prot in generics rose to $7.5 billion (until
2009), Novartis acquired generic business in oncology which further
added to this prot [9].
Brand migration
Brand migration is another ever-greening technique wherein the
innovator companies release a successor drug with a dierent brand
name and with minor changes such as changes in design, colour
dosage etc. to extend the overall term of highly lucrative blockbuster
drugs in order to maintain the monopoly for longer durations.
Innovator companies invest heavy amounts in the promotion of such
new brand drugs.
Citation: Kumar A, Nanda A (2017) Ever-greening in Pharmaceuticals: Strategies, Consequences and Provisions for Prevention in USA, EU,
India and Other Countries. Pharm Regul Aff 6: 185. doi:10.4172/2167-7689.1000185
Page 2 of 6
Pharm Regul A, an open access journal
ISSN: 2167-7689
Volume 6 • Issue 1 • 1000185

Nexium case: AstraZeneca’s Prilosec was a blockbuster and the most
protable Proton-Pump Inhibitor (PPI) of its time which was used to
treat heartburn. By 2000, Prilosec sales reached $6 billion and it
became the most prescribed drug in the world. Prilosec was to go o
patent in the year 2001 which meant a huge loss to AstraZeneca’s
monopoly. Astra Zeneca rather than investing in incremental
innovation for the existing drug invested huge amounts of money in
the promotion of its successor drug ‘Nexium’ claiming that it was more
eective than even Prilosec and other drugs in the same category.
However, later clinical trials revealed that 40 mg of Nexium was being
compared to 20 mg of Prilosec. No studies were conducted to compare
40 mg of Prilosec to 40 mg of Nexium [4].
Combination of two or more drug products
Another strategy that is gaining popularity among innovators is
launching combination of two or more drugs and in fact United States
and European Union have laws to provide supplementary patent
protection on such combinations. Innovator rms are combining the
soon to go o-patent product with another drug to provide treatment
for two closely associated medical conditions.
is type of combinations may attain same position which the
branded drug attained during the exclusivity period and such follow-
on products provide a tough competition to the generics. Also huge
amounts of money is being pumped the brand name company to
ensure that their product is prescribed over the older versions, no
matter if the combined product lacks experimental evidence of
enhanced ecacy or safety [10].
Example: Venlafaxine earlier marketed as Efexor had some major
side-eects. But these side eects were substantially reduced when the
drug was administered in extended release form. In spite of the fact
that combination of Venlafaxine with and extended release version of
venlafaxine to overcome the side eects may seem to be obvious still
two separate patents were granted by the patent oce for the two
versions of venlafaxine which in turn delayed entry of generics by two
and a half years. However, at last the ever-greening patent was later
declared invalid.
Defensive pricing strategies
Once the drug goes o-patent the generic companies start selling
cheaper version of branded drug which is way too cheaper. Further the
prices of generic version may drop below 40% or more within two
years.
Innovators however have devised competitive strategies through
which they respond to the increasing generic competition by
decreasing the price of their generic version or by introducing
improved generic versions at a much lower price that may leave a
generic competitor a generation behind [11].
Innovator de-lists reference listed drug from orange book
In USA every innovator drug that is patented gets entry into the
Orange book (Approved drug products with therapeutic equivalence
evaluation), and before a generic gets approved it is necessary for the
ANDA ler to prove that the generic version is comparable to
innovator drug in bio-equivalence.
So the innovator drug serves as a reference for the launch of new
generics and therefore de-listing is another tactic used by most of the
innovator drug companies to signicantly delay the entry of generics.
Example: Glenmark Generic Ltd vs. Ferring B.V
Ferring owned patent for DDAVP tablets, containing active
ingredient as desmopressin acetate, Ferring applied to FDA for
delisting the patent from orange book, in an eort to thwart
Glenmark’s marketing of launching its generic version. Subsequently
Glenmark petition against the de-listing was accepted and the
Glenmark’s generic was approved [12].
Convert to Novel Drug Delivery System (NDDS)
Switching to Novel drug delivery systems by modifying a drug to
use a dierent route of administration or developing its controlled,
sustained or immediate release forms is another strategy used by
innovators by which the NDDS may be patented. is eectively
means the innovator continues to enjoy the price monopoly for the
new patent term.
Example: Laboratories Fournier S.A. developed and obtained patent
on immediate release composition of Fenobrate in the year 2008,
while the rst patent for the original Fenobrate was granted in 1973,
aer this several other compositions of fenobrate were also granted
patents, and thus thwarted generics competition.
Eects of ever-greening
As soon as a drug goes o-patent, generic manufacturers are free to
launch generic version of the o-patented drug and with the entry of
generic versions the price of the branded drug inevitably falls. e
huge dierences in the price of the generics and the branded drug
encourage consumers to shi to the cheaper and widely available
generic versions.
Example: In January 2002, when Glucophage (oral antibiotic), went
o-patent, within two months approximately 80% of prescriptions
prescribed the generic version which rose to 90% within the next six
months [3].
Innovator company
Innovator drug companies pour huge amounts of money in drug
Research and Development.
Only four to ve molecules screened out of thousands reach the
clinical trial and out of these only one molecule is nally approved for
marketing by the regulatory body. With such low probabilities, it is
reasonable for innovators to look out alternatives in order to recover
the costs incurred by them during the research and development and
regulatory approval of the drug. Although there are provisions in
patent laws that are specically enacted to provide innovators sucient
exclusivity period to enjoy the monopoly but with time and with the
rise in the number of generic drugs industries such attempts to exploit
the loopholes in the regulatory laws to extend the monopoly over the
market have become more aggressive. Ever-greening may seem
lucrative but it can also bounce back and produce results opposite to
that desired by the company. Consider a case where an innovator
company desires to extend the patent term through by obtaining
patent on successor drugs; the company incurs substantial costs even
though the successor product is just a minor modication of the parent
product, and if the successor drug fails to show any improvement in
the known ecacy the company will bear heavy loss.
Example: Schering-Plough owned a patent for Claritin, just before
the drug went o patent, Schering-Plough in 2002, launched Clarinex
Citation: Kumar A, Nanda A (2017) Ever-greening in Pharmaceuticals: Strategies, Consequences and Provisions for Prevention in USA, EU,
India and Other Countries. Pharm Regul Aff 6: 185. doi:10.4172/2167-7689.1000185
Page 3 of 6
Pharm Regul A, an open access journal
ISSN: 2167-7689
Volume 6 • Issue 1 • 1000185

as successor drug to replace Claritin. Due to delay in FDA approval for
Clarinex, generic manufacturers got the opportunity to launch the
generic versions of Claritin and as a result when Clarinex got
approved, Schering-Plough was unable to attract consumers for the
successor drug Clarinex. Schering-Plough faced double
disappointment as they invested huge amounts in the research and
development of Clarinex [3].
Generic drug companies
Since the generic company has to spend less on Research and
Development, they are able to provide drugs at prices manifold lower
than branded drugs. Consequently, the generics signicantly reduce
the market share of the branded drugs, which compels the innovator
rms to adopt unethical practices of ever-greening. Generic drug
companies play a very important role as cheaper generic versions of
the costly branded drugs are the only hope to save lives in under-
developed and developing countries. Innovator rms exploit the
loopholes in the patent laws to acquire additional patents over the
parent patent to retain its exclusivity in the market. us, these
additional patents for trivial modications fortify the parent patent
and signicantly delay the entry of generic competitors which in turn
directly aects public health.
e consumer
e consumer appears to be the biggest loser in the battle of pricing
between the branded drug and the generic drug manufacturers. Entry
of 5-6 generic companies in the market lowers the price of the drug up
to 70-80% which ultimately benets the consumer, whereas if the
generic drug entry is thwarted, the patient is le with no choice but to
buy the highly priced branded drug. us, when an innovator rms
les and obtains patent over minor modications for the so called
improved successor drugs and obtains extended periods of exclusivity,
the launch of generics is delayed and great injustice is done to patients
since they could have opted for cheaper generic versions [3].
Provisions in USA, European Union, India and Other
Countries to Prevent Ever-greening
United States of America
In USA the Hatch-Waxman Act (Patent Term Restoration Act) of
1984 was enacted to create a balance between the generic and brand
drug industry through certain provisions useful for both the generic
manufacturer and the innovator companies. e act includes a
provision to reward a generic manufacturer who rst challenges the
innovator’s patent.
e rst generic applicant, if successful in challenging a patent is
rewarded with a 180-day exclusivity period, which provides generic
manufacturer an opportunity to exclusively market its products. e
180 days exclusivity period is in recognition of the public interest in
encouraging generic manufacturers to launch generic versions of the
branded drug and to challenge bogus and stall undue monopolies
enjoyed through bogus patents.
rough the Hatch-Waxman Act, 1984 introduced a new procedure
under which an ANDA application (Abbreviated New Drug
Application) can be led by the by generic drug manufacturer to the
US Food and Drug Administration (FDA) looking for marketing
authorisations for the generic versions.
e underlying fact behind the scheme is that if the innovator drug
is already approved then, to obtain market authorisation and to launch
its generic version, a generic company is required to demonstrate an
identical biological eect rather than repeating clinical trials all over
again. To balance the interests of the innovator companies, the act
requires generic applicant to choose one of the four certications in
relation to the patent status of the competing generic drug:
• Para I: Drug is not patented;
• Para II: Drug patent have expired;
• Para III: Patent will expire by the time the generics drug hits the
market;
• Para IV: Patent won’t be infringed or the patent is invalid [13].
European Union
In European Union the patent laws are still too lenient and there are
not much laws concerning ever-greening, however ever-greening in
European Union is considered as the abuse of dominant position and is
counted under the scope of Article 102 from the Treaty on the
Functioning of the European Union (TFEU). e consideration of
ever-greening under Article 102 is still uncertain as it lacks clarity
between the lawful and unlawful abuse of the abuse of the dominant
position in relation to ever-greening as patent laws being specic to a
country therefore a community law such as the Article 102 cannot
challenge a country’s patent law, this is the major allegation made by
those convicted of the abuse of dominant position.
More over patent is an exclusive right granted to the patentee and
the patentee has the right to exploit the patent for monopoly so this
does not necessarily count as the abuse of dominant position. Ever-
greening seems to be forced t into the scope of article 102, so this
article needs a narrow and clear denition to t ever-greening since
the present denition is too broad and the exploitation of the provision
seems inevitable [14].
India
Data exclusivity and patent term extension: India has seen a strong
lobby against inclusion of data exclusivity provisions for
pharmaceuticals, pharmaceuticals and agro-chemicals sectors are
deprived of data exclusivity provisions since it is believed to be in the
interest of the ourishing generic industry, inclusion of such provisions
will have a huge impact on the generic industry and will result in the
delayed entry of cheaper versions of branded drugs. Inclusion of the
data exclusivity provision in the Indian IP regime will also bring with it
the concept of patent term extension.
India introduced product patents for pharmaceuticals in 1995 by
signing the TRIPS agreement and as a part of its TRIPS and WTO and
commitments amended its Patent Act in three phases in 1999, 2002
and 2005. With the 2005, India introduced new patentability standards
which were further restricted by the inclusion of a unique provision,
Section 3(d). Under this new provision, new forms of already known
substances were not granted a patent unless they are proved to have
enhanced the known ecacy of that already known substance.
e statutory intent behind inducting section 3(d) was to curb the
unethical practices of ever-greening. Section 3(d) restricts the
patentability of certain new forms of older substances unless they
satisfy the requirement of enhanced ecacy criteria. Hence, Section
3(d) laid down higher patentability standards for new forms of already
known substances and has proved as an eective provision in checking
Citation: Kumar A, Nanda A (2017) Ever-greening in Pharmaceuticals: Strategies, Consequences and Provisions for Prevention in USA, EU,
India and Other Countries. Pharm Regul Aff 6: 185. doi:10.4172/2167-7689.1000185
Page 4 of 6
Pharm Regul A, an open access journal
ISSN: 2167-7689
Volume 6 • Issue 1 • 1000185

the unethical practices followed by innovators to extend the patent
term [1].
Section 3(d) states:
“e mere discovery of a new form of a known substance which
does not result in the enhancement of the known ecacy of that
substance or the mere discovery of any new property or new use for a
known substance or of the mere use of a known process, machine or
apparatus unless such known process results in a new product or
employs at least one new reactant”.
e Novartis vs. Union of India case study: Just one year aer its
induction into the Indian Patent Act, Section 3(d) came to test. In
2006, Novartis patent application for beta crystalline form of imatinib
mesylate was rejected by the Madras Patent Oce. e patent oce
decision was based on the fact that imatinib mesylate (which was a pre
1990s molecule) was a known compound and the beta crystalline form
was just a derivative of imatinib mesylate. Novartis even failed to show
proof to support its claim of enhanced ecacy over the parent
compound, hence, the application by Novartis failed to pass the
patentability standards laid down by Section 3(d). Novartis hoping for
reversal of the decision, appealed against the decision of patent oce
to IPAB (Intellectual Property Appellate Board), and alleged that the
Section 3(d) is constitutionally invalid and against the terms of TRIPS.
Court decided to deal only with the constitutional validity issue and
le the issue of TRIPS compatibility issue to the dispute settlement
body of the WTO citing that it court lacked jurisdiction over the issue.
Court upheld the constitutional validity of Section 3(d) and on TRIPS
compatibility the court said that Section 3(d) was craed utilising the
exibilities oered by the TRIPS framework. IPAB upheld the Madras
High Court’s decision that the beta crystalline form of imatinib
mesylate may be considered novel and inventive but failed to
demonstrate enhanced ecacy over imatinib mesylate and hence
cannot be granted a patent. Novartis appealed before the Indian
Supreme Court against the IPAB decision. e Supreme Court upheld
the Madras High Court decision and agreed with the IPAB ruling that
Novartis failed to show enhanced therapeutic ecacy over the parent
compound, and hence failed to pass the test laid down by Section 3(d).
e Indian Supreme Court further held that the enhanced ecacy
standard is as per the exibilities oered by TRIPS framework [15].
Other countries
India’s measure to redene and redesign patent laws received strict
opposition from the United States and the European Union. While on
the other hand, countries like Argentina, Philippines, Brazil, China,
Indonesia, Malaysia, ailand and South Africa have either emulated
or strongly favoured following India’s path. India’s patent reforms had
a remarkable extraterritorial impact. Moreover, others countries are
closely monitoring the Indian stand on utilising the exibilities oered
by the Trade Related aspects of Intellectual Property Rights (TRIPS)
framework [16].
e Philippines: e Philippines Congress in 1997 enacted a law,
known as Republic Act 8293, which aimed at prescribing a TRIPS
compliant IPR law. In 2008, Section 22 of this act was amended by the
country’s congress; the section lists conditions for non-patentable
inventions as:
“In the case of drugs and medicines, the mere discovery of a new
form or new property of a known substance which does not result in
the enhancement of the known ecacy of that substance, or the mere
discovery of any new property or new use for a known substance, or
the mere use of a known process (is non-patentable) unless such
known process results in a new product that employs at least one new
reactant”.
e amended Section 22 of the Republic Act 8293 incorporates the
same language as that of Section 3(d) into the patent law of the
Philippines. e Section 22 was adopted by the Philippines
government in an eort to increase availability of cheaper drugs its
population which comprises of a large low income class [15].
Argentina: In Argentina three joint resolutions were published in
May 2012 by Ministry of Health, Ministry of Industry and National
Institute for Industrial Property, which revised and restricted the
patentability of derivatives of pharmaceutical products. e resolutions
were applied to all the pending and future patent applications.
Argentina’s joint resolutions are considered even stricter than India’s
Section 3(d) in the sense that they preclude Innovator rms from
patenting dierent attributes of the same drug [15].
Brazil: Recently new guidelines were draed by the Brazilian Patent
Oce to restrict the patentability of new forms of already known
compounds (polymorphs) or new property or new use of a known
process which makes exactly similar sense as that Section 3(d).
Japan: Japan’s new patent legislation mentions the subject matter as
the new use of a drug can be patented only if the usage is absolutely
novel and its use must be clearly dierentiated over the original drug.
Mexico: Mexico IP law in Article 19 (Mexican Industrial Property
Law, 1991) mentions the same language as that of Section 3(d).
European Patent Oce also prescribed new guidelines regarding
patentability of polymorphs. For the polymorphs to be considered as
inventive the patentee needs to produce data regarding extraordinary
technical eect compared to already known compound [17].
Conclusion
Since drug development involves a lot of unknown risks and behind
every successful drug molecule there is an extensive research and
development which consumes several years, patent clock starts much
early in drug development. Most of the countries provide a 20-year
exclusivity for a patented drug, considerable amount of this time is lost
during the regulatory application and approval process, so it is natural
for any innovator rm to resort to undue practices such as ever-
greening so as to recover the heavy costs incurred by them, but with
time these practices have become too aggressive, Corporate rms are
not in any way humanitarian in their approach, even though they pose
to be, their sole motive is to maintain their monopoly by increasing
number of patents in their patent portfolios. To check this practice
some countries have included certain provisions in their patent laws to
extend the overall life of the patent so as to recover some of the time
lost during regulatory processes, but in turn innovators rms have
found loopholes in laws and even started exploiting these ocial
provisions.
In developed countries like USA and that of the European Union
the patent laws are too lenient to check ever-greening practices, while,
with the Novartis case India gave a clear and strong indication that it
would not risk life of poor patients and the public health by permitting
ever-greening of drug patents. e judgment in Novartis case also gave
a strong message to the world and the innovator rms that India will
provide extended market monopoly to pharmaceutical companies only
Citation: Kumar A, Nanda A (2017) Ever-greening in Pharmaceuticals: Strategies, Consequences and Provisions for Prevention in USA, EU,
India and Other Countries. Pharm Regul Aff 6: 185. doi:10.4172/2167-7689.1000185
Page 5 of 6
Pharm Regul A, an open access journal
ISSN: 2167-7689
Volume 6 • Issue 1 • 1000185

if a medicine is genuinely shown to be innovative and there is a
signicant enhancement in the ecacy.
e decision prevents the attempts of pharmaceutical companies
who wish to seek ever-greening of patents in India by ling patent on
dierent attributes of the same drug to enjoy extended monopoly and
delay of the availability of cheap generic versions. is would certainly
facilitate early entry of generic medicines into the market and the
impact would be felt not only in India but also across other countries
that depend on Indian generic medicines.
Consequentially, threats and veiled attacks are mounted on the
Indian Patent system by United States and European Union to remove
Section 3(d); United States even classied India as a ‘Priority Foreign
Country’ a tag that is generally given to the worst intellectual property
oenders.
Argentina and the Philippines amendments can be seen as a sign
that India’s Section 3(d) wave is spreading to other parts of the world
especially among the developing countries. Patents are considered to
present one of the biggest barriers in the access to lifesaving medicines.
ere is a growing concern that patent protection for pharmaceutical
products can limit the lifesaving medicines beyond the reach of large
section of the world population. Despite the dierent types of remedies
that are available, the strongest response to the issue of ever-greening
can only be made available by availing the exibilities oered by the
patent system.
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Citation: Kumar A, Nanda A (2017) Ever-greening in Pharmaceuticals: Strategies, Consequences and Provisions for Prevention in USA, EU,
India and Other Countries. Pharm Regul Aff 6: 185. doi:10.4172/2167-7689.1000185
Page 6 of 6
Pharm Regul A, an open access journal
ISSN: 2167-7689
Volume 6 • Issue 1 • 1000185