INTRODUCTION:

In accordance with its commitments under the World Trade Organization's Agreement on Trade-
Related Aspects of Intellectual Property Rights (TRIPS), India started allowing pharmaceutical
items to get patents in 2005. The Indian government did this by adding a contentious clause to
the patent legislation, Section 3(d), which seeks to restrict the issuance of "secondary"
pharmaceutical patents, or patents on novel formulations of already-existing substances and
medications.

There has been a lot of disagreement on Section 3(d). The Indian Patent Office's (IPO) decision
to deny a secondary patent on Novartis' cancer medicine "Gleevec" (imatinib mesylate) and to
cite Section 3(d) as one of the reasons for rejection was one notable case that attracted
international attention to 3(d). Health activists launched a campaign against Novartis and in
favour of the provision when the pharmaceutical company questioned the legitimacy of Section
3(d) and appealed the IPO's ruling. The Intellectual Property Appellate Board affirmed the
validity of 3(d), and in the end, the Indian Supreme Court in 2013 supported the decision to
reject the Gleevec patent.

TRIPS, PHARMACEUTICAL PATENTS AND SECTION 3(D):

During the Uruguay Round trade discussions in the late 1980s and early 1990s, India was one of
the nations that protested TRIPS the most. Once the "trade-IP" linkage was established and
TRIPS negotiations got underway, India adamantly resisted the subsequent requirement that all
countries permit pharmaceuticals to be patented. India opposed the inclusion of rules on
countries' intellectual property policies and practises in the international trade regime. Product
patents have been outlawed in India since 1970, notwithstanding the availability of method
patents.

Although product patents have been outlawed in India since 1970, process patents were still
allowed. Since there was no patent protection in India and the indigenous pharmaceutical
industry had significantly developed, TRIPS was seen as a severe danger. Perhaps not surprise,
India took the longest possible time to make pharmaceutical items patentable—2005—after
being obliged to approve drug patents but given a transition period first. India is among the few
nations that has chosen to extend the pharmaceutical patenting deadline till 2005 by using the
whole transition period. In addition, starting in 1999, India started receiving applications in the
mail to be reviewed starting in 2005 when the product patent regime was in effect, grudgingly
complying with the nation's new international duties.

The Indian government incorporated Section 3(d), a clause that creates a high barrier for
secondary patents, in 2005 when it introduced the final modifications to the Patents Act to permit
pharmaceutical patents. In particular, 3(d) states that a large number of secondary patents are not
regarded as innovations and are hence ineligible for patents.

In order to specifically address worries that additional patents on substances already in use would
be used to prolong market exclusivity and postpone generic competition, Section 3(d) was put
into place. According to Basheer and Reddy, the Minister of Commerce inserted 3(d) to stop
"ever-greening" at the time the patent legislation was being finalized. The creators of 3(d) sought
a compromise that would permit patents on modified versions of existing substances as long as
they proved advantages ("efficacy") over the previous, known substance. Some actors desired a
more stringent approach, such as outlawing all secondary patents. A government-appointed
commission that was instructed to report on whether India should restrict patents on all
"incremental innovations" later backed this middle ground.

In order to secure a pharmaceutical patent in India, applicants must thus fulfil Section 3(d)
requirements in addition to standard criteria that are applicable in all nations, such as originality
and inventive step. As stated in the introduction, Section 3(d) has drawn a lot of attention; yet,
both advocates and detractors have a tendency to overstate its consequences. We shed fresh light
on India's new pharmaceutical patent system and the function of 3(d) using micro-level data.

PHARMACEUTICAL PATENTS IN INDIA:

In the context of pharmaceutical patents in India, novelty refers to the requirement that an
invention claimed in a patent application must be new or not previously disclosed or made
available to the public before the filing date of the patent application.
To be considered novel, an invention must not have been disclosed in any way, either through
publication, public use, or sale, before the date of filing of the patent application. This
requirement is in line with the international standards for patentability, as set out in the
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

In the pharmaceutical industry, novelty is particularly important because drug development often
involves incremental improvements or modifications to existing drugs. Therefore, obtaining a
patent for a new drug or a new use of an existing drug requires demonstrating that the invention
is novel and not obvious.

In India, the patentability of pharmaceutical inventions is subject to certain additional

requirements, such as demonstrating enhanced therapeutic efficacy, and complying with the
provisions of the Indian Patents Act, 1970. To obtain a patent in India, an applicant must
demonstrate that the invention is novel, non-obvious, and has industrial applicability.

VARIOUS TYPES OF PHARMACEUTICAL PATENTS:

Pharmaceutical patents play a crucial role in the industry, incentivizing research and
development, and promoting innovation. In recent years, there have been several trends in India
with regard to novelty in pharmaceutical patents. Here are some of the notable ones:

1. Combination Therapies: Combination therapies are becoming increasingly popular in

the pharmaceutical industry, as they often offer more effective treatments than individual
drugs. As a result, many pharmaceutical companies are seeking patents for new
combinations of existing drugs. However, the novelty of such combinations can be
challenging to establish, and it is important for patent applications to provide sufficient
evidence of their effectiveness. Combination Therapies: Combination therapies involve
the use of two or more drugs to treat a disease, often resulting in greater efficacy and
fewer side effects than individual drugs. With the increasing number of drugs available,
there has been a growing interest in developing new combinations of drugs to treat
various diseases, including cancer, HIV/AIDS, and cardiovascular diseases.
Pharmaceutical companies are seeking patents for new combinations of existing drugs. However,
establishing the novelty of such combinations can be challenging. The patent application must
provide sufficient evidence of the effectiveness of the new combination, including data from
clinical trials.

2. Biologic drugs: Biologic drugs, which are derived from living organisms, are a rapidly
growing sector of the pharmaceutical industry. They are complex and often require
significant research and development to bring to market. As a result, many
pharmaceutical companies are seeking patents for biologics, which can provide
significant commercial advantages. However, obtaining patents for biologics can be
challenging due to the complex nature of these drugs and the stringent regulatory
requirements for their approval.

Biologic drugs are derived from living organisms, such as bacteria, yeast, or mammalian cells,
and are increasingly used to treat a wide range of diseases, including cancer, autoimmune
disorders, and infectious diseases. Biologics are often complex and require significant research
and development efforts, including large-scale manufacturing facilities and stringent regulatory
approval processes.

In India, the development of biologics is gaining momentum, and many pharmaceutical

companies are seeking patents for these drugs. However, obtaining patents for biologics can be
challenging due to the complex nature of these drugs and the stringent regulatory requirements
for their approval. The patent application must clearly demonstrate the novelty and non-
obviousness of the biologic drug and provide sufficient evidence of its efficacy and safety.

3. Personalized Medicine: Personalized medicine, which involves tailoring treatments to

individual patients based on their genetic makeup, is an area of growing interest in the
pharmaceutical industry. As a result, many companies are seeking patents for
personalized treatments, such as gene therapies or personalized cancer treatments.
 However, the novelty of such treatments can be difficult to establish, and it is important
for patent applications to provide sufficient evidence of their effectiveness.

Personalized medicine involves tailoring treatments to individual patients based on their genetic
makeup, lifestyle, and other factors. The aim of personalized medicine is to provide more
effective and targeted treatments, thereby reducing side effects and improving patient outcomes.

There is growing interest in personalized medicine in India, with many companies seeking
patents for personalized treatments such as gene therapies or personalized cancer treatments.
However, establishing the novelty of personalized treatments can be challenging, and the patent
application must provide sufficient evidence of the effectiveness of the personalized treatment in
clinical trials.

4. Drug Delivery Systems: Drug delivery systems, such as inhalers, patches, and implants,
are becoming increasingly sophisticated, allowing for more targeted and efficient drug
delivery. As a result, many pharmaceutical companies are seeking patents for new drug
delivery systems, which can provide significant commercial advantages. However,
obtaining patents for drug delivery systems can be challenging, as the novelty of such
systems must be clearly established.

Drug delivery systems involve the use of various technologies to deliver drugs to specific target
sites in the body, such as tumors or specific organs. The development of new drug delivery
systems is a critical area of research in the pharmaceutical industry, as it can improve the
efficacy and safety of drugs while reducing side effects.

In India, there is increasing interest in developing new drug delivery systems, such as inhalers,
patches, and implants. Pharmaceutical companies are seeking patents for new drug delivery
systems that can provide significant commercial advantages. However, obtaining patents for
drug delivery systems can be challenging, and the patent application must clearly establish the
novelty and non-obviousness of the drug delivery system.
 5. Artificial Intelligence: Artificial intelligence (AI) is becoming increasingly important in
the pharmaceutical industry, with applications ranging from drug discovery to clinical
trial design. As a result, many companies are seeking patents for AI-based technologies,
such as machine learning algorithms and predictive models. However, obtaining patents
for AI-based technologies can be challenging, as the novelty and non-obviousness of
such technologies must be clearly established.

Artificial intelligence (AI) is becoming increasingly important in the pharmaceutical industry,

with applications ranging from drug discovery to clinical trial design. AI-based technologies,
such as machine learning algorithms and predictive models, can help pharmaceutical companies
identify new drug candidates, optimize clinical trial design, and improve patient outcomes.

Many companies in India are seeking patents for AI-based technologies. However, obtaining
patents for AI-based technologies can be challenging, as the novelty and non-obviousness of
such technologies must be clearly established. The patent application must provide sufficient
evidence of the effectiveness of the AI-based technology, including data from clinical trials or
other experiments.

Overall, the pharmaceutical industry in India is undergoing significant changes, with new trends
emerging in the areas of combination therapies, biologics, personalized medicine, drug delivery
systems, and artificial intelligence. These trends present both opportunities and challenges for
pharmaceutical companies seeking to obtain patents and remain competitive in the global
market.

The pharmaceutical industry in India is undergoing significant changes, with new trends
emerging in the areas of combination therapies, biologics, personalized medicine, drug delivery
systems, and artificial intelligence. These trends present both opportunities and challenges for
pharmaceutical companies seeking to obtain patents and remain competitive in the global
market.
CONCLUSION:

In the long run, various tenets of the patent system may be examined economically in order to
enhance the incentives for technological innovation and diffusion. The uniformity of the patent
system, considered as providing all inventions within the field with the same level of
consideration.

Matter is a well-known illustration of a principle that needs to be evaluated. It is unclear if the

"one size fits all" premise of the existing patent system should be retained given the diversity of
discoveries across businesses and disciplines of technology in terms of cost, as well as the
presence of other forms of protection or market circumstances.

Given that technology and economic cycles in software and pharmaceuticals are very distinct
from one another, should patent protection for these two industries be granted indefinitely? What
are the alternatives to this uniform strategy, and what are the benefits and disadvantages of those
options over the existing one? The potential for adjusting the level of protection to the value of
the innovation is another area that should be looked into in the long run. This already applies to
renewal costs.

There is an incentive for inventors to cease renewing protection once the value drops below a
particular level and let them expire so that the innovation enters the public domain since
patentees must pay to maintain their patents in effect. Such a strategy might be routinely applied
to other patent characteristics, such as breadth, which have an impact on the level of protection.
Petty patent systems, which offer more limited and affordable protection than regular patent
systems, serve in part this goal.

Since patents are crucial to market-based innovation systems, it is important to analyze patent
systems' capacity to promote innovation and technology dissemination using economic criteria in
a more systematic manner. Despite significant changes in patent regimes over the past 20 years,
no systematic economic analysis has been done with the intention of guiding policy decisions.

The emergence of new technologies, the importance of service-type innovations, the expansion
of markets in the production and dissemination of knowledge, the entry of new nations into the
technological scene, increased globalization, the convergence of different technology domains
(such as biotechnology and ICT), fostered by the emergence of broad-band communication,
which results in overlap, and other factors will all pose new challenges to the patent system in
the future.

The significance of patents in this context won't diminish, but the circumstances in which they
function to promote innovation and spread will change. If patent systems have already been the
subject of policy-oriented economic study, they will be better equipped to handle these
difficulties.