Introduction: Evergreening of patents
Intellectual property is a type of
intangible property, while a patent
subset of intellectual property. Granting a patent gives the inventor the legal
right to prevent others from producing, using, or selling your invention for a
limited period of 20 years. In the Novartis case, Novartis challenged IPAB's
rejection of its beta crystal patent application. It is useful to recognize a
variety of pharmaceutical product patents that have caught the attention of
those who use the word perennial to describe the monitoring of pharmaceutical
companies' patents. Therefore, this document focuses on the permanent
evergreening of patents: blessing or ruin, with reference to the case of
The Novartis case is the only historical case that deals with the concept of the
perennial in such detail. Therefore, Novartis' interpretation of section 3 (d)
will have lasting effects on innovative pharmaceutical companies seeking the
protection of their intellectual property rights in India. Despite the legal
battle, the meaning of greater effectiveness has not been resolved for future
cases, as the Supreme Court verdict left it open for interpretation.
Manufactured by the pharmaceutical company Novartis, Glivec (imatinib mesylate) is
recommended for chronic myeloid leukemia, one of the most common blood cancers
in Eastern countries. After more than a decade of legal battles over its
patentability, the Supreme Court of India issued its final decision on April 1,
2013, rejecting the Swiss pharmaceutical giant's appeal.
In 2006, the Indian
Patent Office first rejected Glivec's patent under section 3(d) of the Indian
Patent Law, arguing that it was only a modified version of an existing drug, Imatinib,
and therefore the drug was not innovative. Novartis responded by
filing lawsuits against the Indian government, but the final verdict in April
2013 puts an end to the battle. In fact, the Supreme Court said that although
the bioavailability of the drug had improved, it did not demonstrate greater
efficacy and that Glivec was not patentable.
Evergreening is a major concern of generic drug manufacturers, as it seeks to
gain protection for another 20 years based on small changes in the current
composition of existing drugs. The process does not produce any increase in the
therapeutic efficacy of the drug. In many countries, minor reformulations can
qualify for patent protection. The result is that it prevents competition in the
market and is considered harmful to the market and consumers.
The concept of Evergreening seeks to extend the term of protection without requiring an
inventive step. There are several methods of Evergreening a patent, one of
these methods is the combination of two drugs in which small changes are made to
the chemical composition of the existing drug. Other processes are the
introduction of new uses of existing drugs, long-release formulations of
existing drugs that have patents and chiral change, which means that the new
drug has a different molecular orientation.
In this way, companies can extend
the term of protection and charge more for drugs while defending costs incurred
in research and development as no cost has been incurred for such compositions
as it is only a minor combination or modification of existing drugs. Due to the
lack of generic drugs, the verity translates into an increase in the cost of
healthcare for consumers.
The persistence of patents primarily affects consumers
in underdeveloped and developing countries who cannot afford the brand name
drugs that can save them from deadly diseases.
Diseases such as HIV AIDS,
tuberculosis, etc. they are a great threat to these countries. These nations
lack the financial capacity to purchase branded drugs and have to rely on
generic forms of drugs. Most African nations depend on Indian generic companies
for essential life-saving drugs. Hence, the generic industry of India is a boon
to most of the African nations.
On the other hand, it has been stated that evergreening helps in the promotion
and protection of new research.
While there are only minor changes to the
existing drug, there are some improvements to existing drugs. Companies support
the evergreen strategy because certain costs and risks are linked to the new
types of emerging drugs. Medicines also do not apply to the patent, although
there are also improvements to existing medicines.
One of the largest Swiss multinational pharmaceutical companies, i.e. Novartis
International AG in 1998 filed an application under the TRIPS agreement with the
Indian Patent Office in Chennai to obtain a patent for an anticancer drug
Glivec used in the treatment of leukemia chronic myeloid (CML) and
gastrointestinal stromal cancer (GIST) discovered in the beta-phase crystalline
form imatinib mesylate. This drug is known for its use in cancer treatment and
is patented in more than 35 countries.
When Novartis applied for a patent, the grant was limited to methods or
processes and not products in India, as specified in section 5 of the Patents
Act of 1970. Section 5 of 2005 was repealed after the Patents Act (Amendment)
and patents have been issued for methods or processes, but also for
products.Section 3 of the Indian Patents Act 1970 is the key provision for
deciding patentable grounds in India and provides non-patentable arguments when
it comes to registration.
Section 3 (d) of the law seeks to prevent a term
generally referred to as patent perpetuity by ensuring that only generic
formulations that have substantially improved efficacy are patented. The purpose
of granting a patent for incremental innovations is to encourage the sequential
development of existing products, which brings better products to market.
Provided for in article 226 of the Indian Constitution, Novartis filed two
motions in writing in the 2006 Madras High Court.
The appeals subsequently
argued that section 3(d) of the 1970 Patents Act was illegal as it did not
comply with the TRIPS Agreement and also violated Article 14 of the Indian
Constitution and the other against the order of the Madras Patent Office. In
2007 the Madras High Court referred the case to the IPAB (Intellectual Property
Court of Appeal). The IPAB finally listened to this appeal and dismissed it on
the grounds that the invention met ingenuity and not obviousness requirements,
but the product's patentability was impaired by section 3(d) of the 1970 Patents
The IPAB decision aims to prevent the permanence of the already approved
product by introducing minor modifications and to provide Indians with quick
access to life-saving drugs. Subsequently, Novartis filed the Special Leave
Petition (SLP) with the Supreme Court of India in 2009 against an order passed
by the IPAB under Section 136 of the Indian Constitution.
Novartis' Glivec Case
The Novartis Glivec case has drawn industry onlookers worldwide to the media.
Novartis appealed to the Supreme Court to secure a patent for its cancer
medicine, Glivec, based on incremental development leading to greater efficacy.
The controversial issue here is that incremental improvement can be viewed as an
increase in effectiveness.
Also, in 2009, a previous decision was taken on the Glivec case, which was
subsequently challenged, because the operation was far
also for general population. But pharmaceutical firms' analysts
cautioned that a policy of this sort might damage India's position in world
commerce. Dr Ajay Kumar Sharma, Pharmaceutical and Biotechnology Associate
Director, Health Research, Frost & Sullivan, South Asia and the Middle East,
says, These decisions send the wrong signals and will destroy the industry in
the long run. They are short-sighted by nature since they do not plan.
Novartis filed a Special Leave petition (SLP) on 10 August 2009 challenging the
Indian Intellectual Property Appeals Board (IPAB) Supreme Court of India's
decision to uphold the Indian Patent Office 's 2006 beta-crystal denial patent
for Glivec. Glivec has been granted patents in nearly 40 other countries,
including China, Russia and Taiwan, but for India the IPAB refuses it. IPAB
agrees that Glivec fulfils international innovation and inventiveness criteria
but does not agree that Glivec satisfies the requirements of section 3(d) of the
Indian Patent Act 2005. This law imposed a new obstacle to make patenting of new
types more effective. We assume that Section 3(d), the Indian legal clause,
intended as a perennial barrier, does not apply to the groundbreaking drug
Glivec, which has changed the lives of rare cancer patients.
Novartis V. Union Of India
The Novartis case is one of the emblematic cases in which the concept of
perennial has been discussed in detail. The Novartis claim posed a great threat
to the poor around the world because most of the generics come from the Indian
generic drug industry. India has been called the pharmacy of the developing
. Therefore, a change in Indian politics would surely affect the rest of
the world. A survey indicates that 80% of antiretroviral drugs come from India,
which is used to treat patients from more than 30 countries. In addition, the
Indian population is mostly poor and cannot afford branded drugs. Therefore, the
generics industry in India must be protected.
Novartis AG is a Swiss-based pharmaceutical company. In 1994 the company
filed a patent on the free Imatinib basis. Subsequently, in 1998, Novartis also
filed a patent application with the Chennai Patent Office claiming a patent on
its cancer drug Imatinib Mesylate (in beta crystalline form) also known as
Gleevec. Gleevec is an enhancement of the free base drug of Imatinib. Novartis
did not obtain the patent for this drug, but the application was submitted to
the provisions of the mailbox.
As a result, the application was suspended until
Meanwhile, in 2002 Novartis applied for an EMR grant. EMRs are used to provide
exclusive marketing rights for a specified period or until a decision is made on
the patent application. In November 2003, Novartis received EMRs. Following the
granting of the EMRs, the company filed infringement lawsuits against generic
companies that produced generic versions of Gleevec. Courts have issued
injunctions against generic companies such as Cipla, Ranbaxy and others.
has caused a huge price increase for Gleevec in India. In 2005, the Indian
Patent Law replaced section 3 (d) to address the perennial issue. When the
patent office opened Novartis' application in 2005, many companies challenged it
at the pre-licensing stage. After reviewing the opposition received, the Indian
Patent Office denied Novartis a patent on the Section 3 (d) touchstone.
Novartis has been informed that the active substance of the new drug Gleevec is
already known and is therefore covered by section 3 (d). In response to the
objection in section 3 (d), the company provided an affidavit in support of its
claim. The affidavit indicated that the beta crystalline form of imatinib
mesylate had a higher bioavailability, which means that the rate at which the
drug is absorbed is greater. Therefore, Novartis' patent application was
rejected for failing to meet the improved efficacy test.
The active ingredient, imatnib mesylate in beta crystalline form, was believed
to be a known substance as described in the above patent. Although the affidavit
submitted in support of the claim indicates that it has higher bioavailability,
the Comptroller was dissatisfied with the content of the affidavit. Following
the denial, two written petitions were filed with the Madras High Court
challenging the earlier decision along with the constitutionality of section 3
The constitutionality argument in section 3 (d) was based on two
- Section 3 (d) is arbitrary, vague and illogical and therefore violates
Article 14 of the Indian Constitution.
- Section 3 (d) violates the obligations of the TRIPS Agreement in India
Secondly, the Madras High Court has declared that it has no jurisdiction to
decide on these matters. However, the Court has jurisdiction to rule on the
constitutionality of Article 3 (d). Novartis argued that section 3 (d) provides
unguided discretion to the patent owner to decide the greatest efficacy of any
drug. Novartis has argued that this arbitrary and unguided discretion
constitutes a violation of the equal protection provisions contained in Article
14 of the Indian Constitution. The government attorney said industry experts
have clearly established what enough efficiency improvement is and that there is
good understanding among the members of the patent office.
Furthermore, if the application has been unduly rejected, the irregularity can
be corrected by going to the appeal bodies. The Madras High Court has ruled that
Section 3 (d) of the Indian Patent Act 1970 does not violate Article 14 of the
Indian Constitution as it is not vague, arbitrary, or ambiguous. The Court
stated that the purpose of not giving a fixed definition to the term greater
is that Parliament wanted the criteria to be applied based on the
facts and circumstances of the case. Furthermore, legislators are not experts in
the field of intellectual property, so it is necessary to grant that power to
the patent office.
The Court also noted that: It is not a violation of Article 14 of the Indian
Constitution, as we have taken into account the objective that the Amending Act
was intended to achieve, namely to avoid permanence; Provide easy access to the
citizens of this country to medicines that save lives and fulfill their
constitutional obligation to provide good medical care to their citizens..
However, before the Madras High Court could rule on the Novartis case, a new
forum called the IPAB was formed to deal with the appeals arising from the
Comptroller rulings. And the matter was referred to the IPAB. The IPAB found
that the application met the novelty criteria and no evidence but did not meet
the requirements for enhanced effectiveness set out in section 3 (d) of the
Thus, Novartis submitted a special license application to the Supreme Court of
India in 2009 under section 136 of the Indian Constitution. Novartis argued that
section 3(d) should be interpreted fairly for Novartis to be granted a patent.
It was further claimed that Section 3(d) of the Indian Patent Act is
inconsistent with the requirements of India's TRIPS Agreement. In addition to
these matters, the court had to determine the true meaning of section 3(d) and
whether Novartis' application merits patent protection.
Whether Section 3(d) is in compliance with TRIPS Agreement Obligations
The Novartis Supreme Court has recognized that India, as a member of the WTO,
is bound by its obligations under the TRIPS Agreement. Several articles of the
TRIPS Agreement have been reviewed for compliance. The Doha Declaration on
Public Health was also considered when discussing this issue. The Supreme Court
found that the changes undertaken in 1999, 2002 and 2005 introduced notable
changes to the patent law regime and aligned Indian patent law with the TRIPS
agreement. The Court relied on the statement of the objects and purposes of
these amendments and concluded that these amendments were introduced to align
Indian law with that of TRIPS.
The Court also noted that section 3 (d) was introduced with the objective of
preventing evergreen. Parliamentary debates were also analyzed to see the
subject of article 3 (d) of the law. One of the legislators used the example of
Gleevec and said that these brand name drugs are much more expensive than their
generic counterparts. He also pointed out that the Novartis Gleevec app is
simply timeless and cannot be called an invention. Lawmakers were also
concerned about the problems of generic drug unavailability in other
jurisdictions. Therefore, it is clear from parliamentary debates that section 3
(d) was introduced to address the evergreen issue.
It should also be noted that
the criteria for patentability have not been defined in the TRIPS agreement.
Under the flexibility of TRIPS, India is free to decide its own patentability
criteria based on its specific national interests. Therefore, Section 3 (d) can
be said to comply with TRIPS. Additionally, the Supreme Court has ruled that you
can appeal to the WTO Dispute Panel in case of disagreement.
Interpretation Of Section 3(D)
The court carefully interpreted the
terms known substance
. The court held that documented
means a proven and established
fact. The court used the Oxford dictionary to clarify the meaning of the term
. This means the ability to achieve the desired effect as
defined by the dictionary. In the case of drugs, it can only have therapeutic
efficacy. Although the exact meaning of the term therapeutic efficacy is
unknown and the court has left it to future courts to decide the actual meaning,
considering the facts and circumstances of each case.
Greater effectiveness would mean that the properties of new drugs would have to
be different from existing ones. A slight change in the inherent properties of
existing drugs will not qualify for a patent. An appropriate way to demonstrate
greater efficacy may be through empirical research. Novartis AG presented three
arguments in support of improving effectiveness; First, he argued that the new
drug has more beneficial flow properties; secondly, it has been claimed that it
has better thermodynamic stability, and thirdly it has been claimed that it has
30% more bioavailability.
In applying this interpretation to Novartis'
application, the court found that it does not meet the requirements of section 3
(d) as it lacks therapeutic efficacy. Therefore, Novartis cannot obtain a patent
for its drug Gleevec. It should be noted that the Supreme Court does not hold
that greater bioavailability cannot equate to greater efficacy, but instead held
that Novartis could not establish the same by providing relevant data and
empirical research. This case is a simple assertion by the Supreme Court of
India that patent rights cannot prevail over the rights of humans to obtain
Supreme Court Decision
First, the court examined the prior art issue by examining the Zimmerman patent
and related academic publications. It is clear from the Zimmerman patent that imatinib mesylate itself is not new and does not count as proof of the invention
as set forth in paragraphs 2 (1) (j) and 2 (1) (ja) of the Patent Act since
1970. The court has then investigated the beta-crystalline form of imatinib
mesylate and wrote that:
for argumentative purposes, it can be recognized as
new, which means it is not known from the Zimmermann patent. Now the
beta-crystalline form of imatinib mesylate, a medicinal substance and a
polymorph of imatinib mesylate, is explicitly contained in section 3 (d) of the
act with its clarification.
Applying 3 (d) of the Statute, the Court agreed to define efficacy
as therapeutic efficacy
, as the subject-matter of both the patent is therapeutic
value combination. The court also acknowledged that physical potency of imatinib
beta-crystalline mesylate becomes enhanced when contrast with other
formulations, and so in the free initial position, the beta-crystalline form
with imatinib mesylate is 30% more bioavailable than imatinib.
The Supreme Court of India has thus in effect affirmed the view that there is
new proof of greater efficacy under the Indian Patent Act for the granting of
pharmaceutical patents in addition to checking the standard measures of novelty,
inventiveness and applicability. The Court was ensured to point out that
during a transitional period in Indian patent law, the patent application in
question was filed, particularly with respect to Section 5, which prohibited
product patents and incorporation of the Section 3 (d), for which jurisprudence
does not yet exist.
The Court was also concerned that the decision was
restrictive: We found that the product in question, the beta-crystalline form
of imatinib mesylate, does not meet the test set out in section 3 (d) of the
statute, but that does not mean that Section 3 (d) excludes patent protection
for all incremental chemical and pharmaceutical developments.
Reactions to the Novartis Judgement
It is one of the most rigorously analyzed tests in the world. Some saw this
process as a win for the healthcare sector, while others see it as a defeat for
intellectual property rights holders. Pharmaceutical companies, developed
nations and other legal critics have condemned the lawsuit as it discourages
innovation and research. Novartis AG has also issued a press release and said
this will discourage the discovery of innovative drugs that are essential for
the advancement of medical science for patients. Other large pharmaceutical
companies such as Pfizer have also reacted negatively to the ruling stating that
it will affect the environment for innovation and investment in India.
described it as creating new and stricter patentability standards for granting
patents in India. This could force large pharmaceutical companies to outsource
to other markets such as China. Novartis has also established its new biomedical
research institute in China. Chip Davis, representative of PRMA (Pharmaceutical
Research and Manufactures of America) commented that:
environment is deteriorating, and the Indian government does not recognize the
value of innovation and strong intellectual property. India has failed to
promote a broader range of medicines and therefore ran the risk of curbing the
kind of inventions that lead to the creation of new medicines.
On the other side of the debate are the people who support affordable drugs and
the NGOs who push for better healthcare facilities. They claimed that this
sentence is a great relief for millions of people who can survive with the help
of generic drugs. Most underdeveloped and developing countries have praised the
decision, saying it is a win-win for poor patients seeking drugs. The author is
of the opinion that due deference should be accorded to the ruling of the
Supreme Court of India, as it is an independent body with the power to decide
taking into account the socio-economic conditions of the country.
The Supreme Court did not impose any additional burden on patent applicants, but
simply explained section 3 (d) of the law. Additionally, Novartis was
granted a fair hearing to substantiate its request. Section 3 (d) should not be
understood to exclude all incremental innovations, but rather affects the
perennial growth of patents.
The ruling received wide support from international organisations and advocacy
organisations, such as Doctors without Borders, WHO, etc., who welcomed the
decision against pharmaceutical patents emerging. Some experts have indicated
that this stringent patent clause could theoretically encourage creativity, as
pharmaceutical companies would need to invest more on research and development
to find new medicines instead of repackaging existing compounds.
The Supreme Court's decision is to avoid the endless evergreening of generic
drugs and to offer relief to those who cannot afford life-saving drugs because
these life-saving drugs are sold at a very high price and are often expensive.
The Supreme Court ruled that India is a developing country and that the
availability of cheaper medicinal products is essential to the lives of one
Section 3(d) of the Patents Act of 1970 forbids the acquisition
of secondary patents from some major pharmaceutical firms from making minor
changes to existing technologies. Novartis could not show that the therapeutic
efficacy of imatinib mesylate's beta crystalline form is more comparable to
that of imatinib mesylate's therapeutic effect. Novartis' appeal for patent was
then denied by the Supreme Court.
Novartis' interpretation of section 3 (d) will have lasting effects on
innovative pharmaceutical companies seeking the protection of their intellectual
property rights in India. After the Novartis case, the Patent Office also denied
other patent applications on the grounds of section 3 (d). An example is that of
Boehringer, a German company, which filed an application for the protection of
its HIV drug nevirapine. In response to the above request, Patient Advocacy
Groups filed pre-grant objections based on Novartis' interpretation of
efficacy. On the other hand, Boehringer claimed that the new form of the drug
has an additional stable particle size allocation that leads to greater
stability. But the application was rejected due to lack of evidence showing
greater therapeutic efficacy than known forms.
Uncertainty about what constitutes a substantial improvement in effectiveness
has discouraged innovators seeking their IP protection in India. These companies
have always relied on the method to go to market first and then maintain patent
protection with improved versions of the drugs. The strict test of better
efficacy will discourage them from going to the Indian market. These companies
invest so much capital to invent new drugs and then try to recoup the money they
have invested in research and development of new drugs.
Academics argue that India's generic business protection policy could harm India
in the long run. This will directly affect the entry of new drugs into the
market and consequently Indian consumers will be affected. These companies will
have to shift their investments to other countries where policies are more
flexible. Therefore, it is necessary to clarify what is meant by efficiency
However, the need to formulate an alternative method other than compulsory
licensing to minimize prices in developing countries like India is still largely
neglected at this time. It goes without saying that the verdict in the Glivec
case will be significant, with the potential to influence how India is viewed by
major pharmaceutical companies. India, as a growing sector, is and will continue
to be an important part of Big Pharma's plans, regardless of such decisions. And
the degree of their involvement will be determined by the nature of the
following sentences. Pharmaceutical companies around the world seek clarity on
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