INTELLECTUAL PROPRTY RIGHTS

AN OVERVIEW AND IMPLICATION IN

PHARMACEUTICAL INDUSTURY

INTRODUCTION:
Intellectual property (IP) refers to any original creation associated with human
intellectual property, such as art, literature, creativity or invention. Intellectual
property (IPR) refers to the legal rights given to inventors or inventors to protect their
inventions or reproductions within a certain period of time. These laws give the
creator/designer or himself the right to use all his works/creations for a certain period
of time. As we all know, intellectual property plays an important role in today's
business world. In the end, it was also decided that intellectual studies related to
innovation should be carefully evaluated in order to create public benefit from
innovation. In addition to the investments required to bring new technologies to
market, research and development (R&D) costs are also increasing. The risks for
technology developers have become very high and therefore the need to protect
information from unauthorized use has become a priority. Stop measures that would
save R&D and other related resources, at least for now. costs too. as access to
sufficient Profitable R&D capital. Intellectual property is a powerful tool to protect
the investment, time, money and energy invested by the IP inventor/creator because it
gives the producer/creator the right to use his/her production/design for a certain
period of time. . of your time. Therefore, intellectual property helps the economic
development of the country by promoting healthy competition, promoting economic
development and economic growth. This review provides a brief overview of
intellectual property rights, with a particular focus on medicine.

BRIEF HISTORY:
Legal and regulatory frameworks for intellectual property exist in Europe. The patent
licensing model began in the fourteenth century. Compared to other European
countries, Britain is technologically advanced in some areas and can attract engineers
in other areas of specific content. The first known legal action took place in Italy.
Venice can be considered the cradle of heritage because most of the policy thinking in
this area was done there; The world's first policies and procedures were developed
here, and other countries followed suit. Patent law in India is over 150 years old. The
first Law was the Law dated 1856, which was based on the British patent system and
stipulated a 14-year patent period with the Institution, with later amendments.

TYPES OF INTELLECTUAL PROPERTIES:

There are many types of intangible assets, some of the most common assets are listed
below.
Patents:
Patents are the rights of entrepreneurs and are often issued by government agencies
such as the United States Patent and Trademark Office. A patent gives the inventor
exclusive rights over an invention, which may be a design, process, improvement, or
physical development such as a machine. Technology and software companies usually
have patents on their designs. For example, the personal computer patent was filed in
1980 by Steve Jobs and three other colleagues at Apple Inc. (AAPL).

Copyright:
Copyright gives exclusive rights to authors and creators of original works. The right
to use, copy or publish its products. Like filmmakers, writers' works are protected by
copyright. Copyright also states that the original creator can authorize anyone to use
the work through an agreed-upon license.
Trademark:
A trademark is a symbol, phrase, or symbol that represents a product that is
identifiable and legally distinct from other items. The trademark is transferred
exclusively to the company; This means that the brand belongs to the company and
therefore no one can use or copy it. Marketing is often associated with the name of a
company. For example, the Coca-Cola logo and brand name are owned by The Coca-
Cola Company (KO).
Franchise:
Franchise is the purchase of goods by a company, an individual or a licensee of a
person (called a franchisee), which allows the company (franchiser) to use its name,
trademark. ), expertise and process. A franchisee is usually a small business owner or
entrepreneur who operates a store or franchise. This license allows the seller to sell
products or provide services under the company name. In return, the franchisee pays
the franchiser an operating fee and an ongoing licensing fee. Examples of companies
using the franchise business model are United Parcel Service (UPS) and McDonald's
(MCD).
Trade Secrets:
A trade secret is a company's non-public information about a process or practice that
provides a commercial advantage or benefit to the company or the owner of the trade
secret. Trade secrets must be well protected by the company and are often the result of
the company's research and development (R&D); this is why some employers are
required to have a non-disclosure agreement (NDA). A trade secret can be a design,
model, recipe, model or proprietary process. Trade secrets are used to create business
models that differentiate the company's offerings to customers by providing a
competitive advantage.
Digital Assets:
Digital Assets are considered intellectual property. This includes proprietary software
code or algorithms and online digital content.

ROLE OF UNDISCLOSED INFORMATION IN IP:

Although protecting undisclosed information is the most important part of protecting
business, R&D organizations, and other relevant intellectual property rights, it is the
issue least understood and rarely discussed by those involved in property matters.
Unpublished information, commonly referred to as trade secrets or confidential
information, including recipes, patterns, compositions, processes, materials, procedure,
method or procedure. Protecting unpublished information or trade secrets is nothing
new to humans. At every stage of development, humans have developed ways to keep
important information secret, often by restricting information to family members.
Laws regarding various aspects of intellectual property rights are at varying levels of
usage in India, but there is no specific law to protect confidential information/trade
secrets or confidential information.
The push for globalization or international trade weakened from the 1950s to the
1980s, and many countries, including India, were able to get by without using
authoritarianism by respecting intellectual power. The global economy driven by the
pharmaceutical, pharmaceutical, electronics and IT industries has led to significant
investments in R&D. This process is characterized by short-term products, time and
high-risk reverse engineering by competitors. The industry is starting to realize that
trade secrets are not enough to protect technology. Patents, trademarks, copyrights,
etc. Unless there are laws and regulations on the subject, it will be difficult to benefit
from the benefits of innovation. Intellectual property has become an important part of
the World Trade Organization (WTO)

BASIC PRINCIPLES OF PATENTS:

Patent is the recognition of the form of intellectual property rights contained in an
invention. Patents are granted for patent-able inventions that meet the invention and
use requirements under the stringent control and challenge criteria laid down in the
Indian Patent Act, 1970, but there has been no significant assessment of the validity of
the patent.
Most countries have created laws to protect intellectual property in their laws. Unless
otherwise provided by law, protection is provided to the manufacturer/designer in a
country (e.g. India) or a region (e.g. EU) where protection is limited and does not
apply to other countries or regions. For example, a patent issued in India is valid only
in India but not in the United States.
The main reason to patent an invention is to make money from exclusivity; for
example, the inventor or his agent must have a monopoly if:
(a) The inventor considers the following events: the significant inventive customer.
(b) If the patent attorney describes and claims the invention in the patent specification
document, the resulting patent will be for the patentee to provide a commercial
printing specification.
Patent holders can exercise their exclusivity by commercializing the patented
invention themselves or by licensing it to third parties.

Non Eligibilty:
The following are not eligible for a patent:
(i) An invention or invention that claims something obvious or contrary to the laws
created by nature. a principle of invention or intended use that may be unlawful or
immoral or harmful to public health.
(ii) a discovery, scientific theory or mathematical methods.
(iii) the discovery of something new or novel using only known processes when
known processes do not lead to new products or using known processes, machines or
devices, or using known processes, machines or devices, unless it uses at least one
new reactant problems.
(v) Preparation or restoration or copying of known materials, each working
independently.
(vi) Agricultural farming or horticultural method.
(vii) ) Any medical, surgical, therapeutic, preventive, diagnostic, curative or other
medical treatments or any procedure involving the treatment of similar conditions of
animals for the purpose of preventing harm to the animals. increased economic value
of the disease or its products.
(viii) Inventions related to atomic energy.
(ix) Useful inventions are always known.

RATIONALE OF LICENCE:
Intellectual property (IP) refers to creations of the mind, such as inventions, literary
and artistic works, designs, symbols, names, and images used in commerce. The
rationale behind licensing in intellectual property lies in the need to balance the
interests of creators and the public. When individuals or entities create intellectual
property, they are granted exclusive rights to use and exploit their creations for a
limited period. However, licensing allows them to extend certain usage rights to
others.
Licenses serve as legal agreements that permit third parties to use, distribute, or
modify the intellectual property within the specified terms and conditions. This
arrangement enables the IP owner to generate revenue, expand the reach of their
creation, and encourage innovation through collaboration. It also facilitates the
efficient allocation of resources and encourages the dissemination of knowledge.

ROLE OF PCT IN INTELLECTUAL PROPERTY:

The Patent Cooperation Treaty (PCT) is an international treaty that streamlines the
process of filing patent applications across multiple countries. It plays a crucial role in
the field of intellectual property by providing a unified and simplified procedure for
filing patent applications in different member countries. The key roles of the PCT in
intellectual property include:

Simplified Filing Process: The PCT simplifies the international filing process by
allowing applicants to file a single international patent application that is recognized
by all member countries. This initial filing provides a basis for seeking protection in
multiple jurisdictions.

International Search and Examination: The PCT facilitates an international search

and examination process, helping applicants assess the patent-ability of their
inventions on a global scale. This assists in making informed decisions about pursuing
patent protection in specific countries.

Extended Decision Time: The PCT provides applicants with an extended time frame
before they need to decide in which countries they want to pursue patent protection.
This allows for a more thorough evaluation of the commercial viability of the
invention.

Cost Savings: By streamlining the application process and providing a centralized

mechanism for certain patent-related activities, the PCT can result in cost savings for
applicants seeking international patent protection.
 MANAGEMENT OF INTELLECTUAL
PROPERTY IN PHARMACEUTICAL PROPERTY

Medicines and pharmaceutical products fit the global business definition better than
other technology areas and often require strong intellectual property management.
Knowing that the cost of bringing a new drug to market can cost the company
between $300 million and $1 billion, plus all the risks associated with the
development phase, no company is willing to risk its intellectual property rights
without the possibility of going public. come back. . Creating, acquiring, protecting
and managing intellectual property should become business activities as much as
supporting resources and money. We will certainly witness a change in knowledge
that will require a special basis for intellectual and medical tools in the decision-
making process.
Competition in the global pharmaceutical industry is based on scientific knowledge
rather than technology, and company success often depends on research and
development. As a result, the pharmaceutical industry has invested in R&D as a
proportion of total sales; Data shows this could be as high as 15% of sales. One of the
key challenges in business is managing innovation risk while trying to gain an
advantage over competing organizations. The risk of failure in drug development is
high, as development of potential drugs does not meet stringent safety standards and
is sometimes halted years after investment. For drugs that show clear improvement, it
will take 8-10 years from the time the product was first mixed. As product patents
become an important tool in protecting intellectual property, pharmaceutical
companies need to shift their R&D focus by developing new processes to create
known drugs to create new drug molecules and new drug entities (NCEs). After the
success of many short-term treatments in the 1980s, research and development
focused on long-term (change) conditions. When looking for an international business,
one must ensure that the requirements of different regulatory bodies are met.
Referrals to regulatory agencies appear to have nearly tripled in the last decade. It's
also now taking longer for regulators to approve new drugs. Therefore, the patent
protection period is short and more efforts are required to obtain sufficient benefits.
The situation will be more serious, especially for drugs produced by biotechnological
methods that use genes. Industrialized countries are likely to soon seek longer-term
protection for medicines. Many governments will also increase price controls to
achieve public goals. This shows that, on the one hand, the production, production
and marketing of pharmaceuticals must be reduced, and on the other hand, it is
necessary to prepare for lower income so that costs can be recovered in a longer
period of time. Therefore, it is clear that the pharmaceutical industry must overcome
many conflicts. Many different strategies have been developed over the last 10-15
years to control costs and achieve commercial benefits. Outsourcing R&D activities,
establishing R&D partnerships and establishing effective partnerships are some of
these.

NATURE OF PHARMACEUTICAL INDUSTURY:

The race to unlock the secrets of the human genome has created an explosion of
scientific knowledge and fueled the creation of new technologies that are
revolutionizing the business of drug development. Bio-pharmaceuticals will deal with
a specific condition and the ultimate goal will be personalized medicine as each
person will have their own genome map stored in the map. The doctor will analyze
the information on the chip and make medicine accordingly. One of the most
important issues regarding intellectual property is the protection of such personal
information. Medicines produced through biotechnology will increasingly enter the
market. The preservation process of these drugs is slightly different from drugs used
without biotechnology. The type of organism used in the production of the drug or
vaccine must be specified in the patent document. The situation is simple if the
disease is known and reported in the literature that most scientists consult. However,
many new ones were discovered, developed and placed in international warehouses
under the Treaty of Budapest. The databases of these repositories should also be
consulted when conducting a new research. Companies do not usually go for
publishing their work, but it is good to make it a practice not to disclose the invention
through publications or seminars until a patent application has been filed.
While dealing with microbiological inventions, it is essential to deposit the strain in
one of the recognized depositories who would give a registration number to the strain
which should be quoted in the patent specification. This obviates the need of
describing a life form on paper. Depositing a strain also costs money, but this is not
much if one is not dealing with, for example cell lines. Further, for inventions
involving genes, gene expression, DNA, and RNA, the sequences also have to be
described in the patent specification as has been seen in the past. The alliances could
be for many different objectives such as for sharing R&D expertise and facilities,
utilizing marketing networks and sharing production facilities. When participating in
R&D, it is always desirable to conclude an agreement based on issues such as
ownership of intellectual property in different countries, sharing of the costs of
acquiring and managing intellectual property and revenue generated from it,
processing of trade secrets, processing of trade secrets, etc. IP accounting. The
company's specialty is solutions that are created before and during collaboration but
are not resolved in plan. It is worth noting that the merger will be effective if the
intellectual property is stronger than that of the relevant partners. There may be more
to the deal. Many pharmaceutical companies will soon utilize the services of
universities, private R&D institutions and government R&D organizations involved in
promising research in India and abroad. All of the above will help. Particular attention
should be paid to protecting the confidentiality of the research.
The current situation in the pharmaceutical industry shows that intellectual property is
inappropriately promoted and abused by competition and health. The pharmaceutical
industry is risk-free and innovation is the opposite of good public spending. This is an
injustice that cannot be corrected by law alone. While Congressional efforts to close
loopholes in existing laws and new laws to curb drug use may provide some relief, he
believes antitrust laws need to be properly enforced. Although antitrust law already
examines certain transactions undertaken by pharmaceutical companies, in addition to
mergers and acquisitions and non-compete agreements, there are other practices that
need to be addressed. Patenting small components of old drugs, modifying old drugs
to obtain new patents, and using advertising and marketing to influence entry into the
generic drug market are all areas where protection policy can help provide stability.
New balance of reward and control competition.
Herbal products containing medicines, in addition to their commercial value, are an
important part of human health in many developed and developing countries. The
world market for these drugs has reached US$60 billion, with annual growth of
between 5% and 15%. Although medicines based on traditional knowledge are not
patent-eligible, it is generally accepted that they are. Researchers or companies may
also claim intellectual property rights by making minor changes to biological
resources and/or traditional knowledge. The rapid increase in plant-related patent
applications is a clear indicator of this trend. Patent applications in the field of natural
products, medicinal plants and herbal medicines are made according to the intellectual
property law of each country (such as food, drug and cosmetic law). Medicinal plants
and other botanical products are a primary target for patent applications as they attract
great interest from the global herbal and cosmetic industry.

SPECIAL FEATURES OF DRUG PATENT

SPECIFICATIONS:
Writing patent specifications is a professional skill that takes time to learn and
requires a good combination of research, knowledge and experience. The claims
contained in the patent specification constitute the spirit of the patent seeking legal
ownership. The discovery of new properties in known materials cannot be patented. If
someone can put the device to practical use, they have made a patentable invention.
The invention of a product known to withstand the effects of technology cannot be
patented, but railway ties made from this product are likely to be patented. A product
may not be new, but it has been discovered to have new features. If it shows some
new benefit when combined with other known drugs, it can be patented. That's why
no one has used this combination before to produce pesticides, fertilizers or medicines.
The manufacturer will create a new model, but the model is unknown. In this case, the
definition, features and production of the product will play an important role.
The patent-able point is that the known substances used in the product have a good
working relationship when brought together. In this case, no chemical reaction occurs.
It has only limited protection. Any use of the combination resource by others is
outside the scope of the patent. For example, the aqua regia patent will not prevent
anyone from mixing two acids in different proportions and obtaining a new patent. In
many countries (the United States is an exception), medical treatments for use on
humans and animals cannot be patented because they are not considered
commercially viable. In case of new pharmaceutical use of a known substance, one
should be careful in writing claims as the claim should not give an impression of a
method of treatment. Most of the applications relate to drugs and pharmaceuticals
including herbal drugs. A limited number of applications relate to engineering,
electronics, and chemicals. About 62% of the applications are related to drugs and
pharmaceuticals.

CONCLUSION:
In conclusion, intellectual property rights (IPRs) play a pivotal role in shaping the
landscape of the pharmaceutical industry. The protection of innovations through
patents, trademarks, and other IP mechanisms not only incentives research and
development but also fosters competition and ensures the availability of diverse and
high-quality drugs for the benefit of society. The delicate balance between promoting
innovation and safeguarding public access to essential medicines underscores the
significance of well-crafted IP policies.
In the pharmaceutical sector, the implications of intellectual property rights are
profound. Patents, in particular, provide innovators with exclusive rights to their
discoveries, encouraging substantial investments in research. However, this
exclusivity also raises concerns about access to affordable medicines, especially in the
context of life-saving drugs.
Striking the right balance between rewarding innovation and ensuring public health is
an ongoing challenge. Generic competition, data exclusivity, and the role of
international agreements like TRIPS (Trade-Related Aspects of Intellectual Property
Rights) influence how pharmaceutical companies operate. Collaborative efforts, such
as technology transfers and licensing agreements, emerge as crucial strategies to
address global health needs while respecting intellectual property rights.
In navigating the complex terrain of intellectual property rights in the pharmaceutical
industry, policymakers, industry stakeholders, and advocacy groups must collaborate
to create a framework that fosters innovation, promotes fair competition, and
addresses public health imperatives. A nuanced approach that considers both the
incentives for research and the imperative of affordable healthcare is essential for
realizing the full potential of intellectual property in advancing pharmaceutical
science and ensuring widespread access to essential medications.
 BIBLOGRAPHY

 World Trade Organization (WTO). (1994). Agreement on Trade-

Related Aspects of Intellectual Property Rights (TRIPS).
 Grabowski, H. G., & Kyle, M. (2007). Generic competition and
market exclusivity periods in pharmaceuticals. Managerial and
Decision Economics, 28(4-5), 491-502.
 Gold ER, Kaplan W, Orbinski J, Harland-Logan S, N-Marandi S.
(2011). Are patents impeding medical care and innovation? PLoS
Medicine, 8(3), e1001006.
 Cookson, C., & Mcnamee, A. (2010). Drug patents and the impact of
intellectual property rights on pharmaceuticals. Journal of Generic
Medicines, 7(2), 109-116.
 Reichman, J. H. (2012). Access to knowledge and global public goods:
Intellectual property rights in a knowledge-based society. Oxford
University Press.
 Hemphill, C. S., & Sampat, B. N. (2012). Evergreening, patent
challenges, and effective market life in pharmaceuticals. Journal of
Health Economics, 31(2), 327-339.
 Singh R. Vol. 1. New Delhi: Universal Law Publishing Co. Pvt. Ltd;
2004. Law relating to intellectual property (A complete
comprehensive material on intellectual property covering acts, rules,
conventions, treaties, agreements, case-Law and much more).
 New Delhi: Department of Science and Technology (DST),
Government of India; 2002. Anonymous. Research and development
statistics.
 Shukla S. Patents: An Introduction. Indian Pharm. 2004;3:14–7
 Kartal M. Intellectual property protection in the natural product drug
discovery, traditional herbal medicine and herbal medicinal products.
Phytother Res. 2007;21:113–9
 Lexchin J. Intellectual property rights and the Canadian
pharmaceutical marketplace: Where do we go from here? Int J Health
Serv. 2005;35:237–56.
 Mrudula BS, Durgadevi NK, Madhavi BR, Tejeswi B, Durga PV.
Intellectual property rights pinpoint at IPR spotlights coveted R and D.
Drug Inv Today. 2009;2:197–201.
 Glasgow LJ. Stretching the limits of intellectual property rights: Has
the pharmaceutical industry gone too far? IDEA J Law Technol.
2001;41:227–58.