Intellectual Property Rights: An Overview And Implications In Pharmaceutical

Industry

Name- Touqeer Ajaz Qamar

Roll No- L21LLBU0008
Course- LLB HONS.
Submitted to- Dr. Mohd Umar
Date- 31/03/2023
 TABLE OF CONTENTS

CONTENTS
S.NO

1 INTRODUCTION
2 BRIEF HISTORY

3 TYPES OF INTELLECTUAL
PROPERTIES AND THEIR
DESCRIPTION
4 ROLE OF UNDISCLOSED
INFORMATION IN INTELLECTUAL
PROPERTY
5 RATIONALE OF PATENT

6 PATENT COOPERATION TREATY'S

FUNCTION
7 INTELLECTUAL PROPERTY
MANAGEMENT IN THE
PHARMACEUTICAL INDUSTRY
8
THE PHARMACEUTICAL
INDUSTRY'S NATURE
9 SOME UNIQUE FEATURES OF DRUG
PATENT SPECIFICATION
10 CONCLUSION
INTRODUCTION
Intellectual property (IP) refers to any creative work of the human mind, including works of
art, literature, technology, and science. The term "intellectual property rights" (IPR) refers to
the legal privileges granted to the inventor or creator to safeguard their work for a
predetermined amount of time.1 These legal rights allow the inventor or creator, or his
assignee, the only right to fully exploit their idea or creativity for a specific amount of time. It
is widely acknowledged that IP is essential to the modern economy. Also, it has been
unequivocally proven that the intellectual labour connected to the innovation deserves to be
given the respect it deserves in order for it to serve the greater good. The price of research
and development (R&D) has increased dramatically with a corresponding increase in
investments needed to introduce a new technology to the market. Because the stakes for
technology developers have increased significantly, it is now expedient, at least temporarily,
to protect knowledge from unauthorised use in order to ensure that R&D and other related
costs are recovered and that there are sufficient profits to support ongoing investments in
R&D. Since it gives the innovator or creator an exclusive right to use his invention or product
for a specific amount of time, intellectual property rights (IPR) are a powerful instrument for
protecting the inventor or creator's investments in time, money, and effort. By enabling
healthy competition, industrial progress, and economic expansion, IPR thereby contributes to
the economic development of a nation. The current review provides a succinct summary of
IPR with a focus on medicines.2

BREIF HISTORY
The administrative processes and rules governing intellectual property (IPR) originated in
Europe. Throughout the fourteenth century, patents were increasingly common. England was
technologically more sophisticated than other European nations in various areas, which it
used to entice artists from outside Europe with favourable terms. Italy is where copyrights
were originally recognised. Since Venice was the first place in the world to create laws and
institutions governing intellectual property, it can be said that Venice is the birthplace of the
IP system. Other nations soon followed. The Indian Patent Act dates back more than 150
years. The first was established by the 1856 Act, which was modelled on the British patent
system and established a 14-year patent period.

1
. Singh R. Law relating to intellectual property (A complete comprehensive material on intellectual property covering acts,rules, conventions,
treaties, agreements, case-Law and much more).
Vol. 1. New Delhi: Universal Law Publishing Co. Pvt. Ltd.; 2004
2
Anonymous. Research and development statistics. New Delhi:Department of Science and Technology (DST), Government of
India; 2002
TYPES OF INTELLECTUAL PROPERTIES AND THEIR DESCRIPTION
Initially, the word "Industrial Property" only applied to patents, trademarks, and industrial
designs, but today, the definition of "Intellectual Property" is far broader. The following ways
that IPR advances technology:
(A) It offers a procedure for dealing with unlawful use, piracy, and infringement.
(b) As all kinds of IP are published, with the exception of trade secrets, it gives the
general public access to a wealth of information.

A range of intellectual endeavours can be protected by IP, including

(i) Patents.
(ii) Industrial designs are features that are applied to products in any shape, configuration,
surface pattern, composition of lines, and colour, whether they are 2-D, like textiles, or 3-D,
like toothbrushes.
(iii) Trademarks are any name, mark, or logo used in commerce to identify the maker or
provider of a good or service and to identify goods or services. You can purchase, sell, and
licence trademarks. A trademark is only as good as the reputation of the commodity or
service it represents.
(iv) Copyright pertains to the expression of ideas in material form, which includes computer
software, audio recordings, literary, musical, dramatic, and aesthetic works.
(v) Geographical indications are indicators that place a good's quality, reputation, or other
attribute primarily due to its geographic origin in the country's territory or a specific region or
locality within that territory.
When an invention satisfies the requirements of general novelty, non-obviousness, and
industrial or commercial use, a patent is granted. Products and processes are eligible for
patent protection. According to the Indian Patent Act of 1970, a patent had a period of 14
years from the date of filing, with the exception of preparation techniques for medications
and food products, for which the term was either 7 years from the date of filing or 5 years
from the date of the patent, whichever came first. Drugs and food products were not the
subject of any product patents. A copyright created in one of the Berne Convention's
signatory nations is immediately protected in all other signatory nations without the
requirement for registration. India is a Berne Convention signatory and has excellent
copyright laws that are on par with those of any nation. But, in nations that are not signatories
to the Berne Convention, the copyright will not be unassigned. Copyright might not be
regarded as a territorial right in the strict sense as a result. IPR can be given, sold, or
transferred just like any other property.3

3
Anonymous. Research and development in industry: An overview.
New Delhi: Department of Scientific and Industrial Research,
Government of India; 2002.
ROLE OF UNDISCLOSED INFORMATION IN INTELLECTUAL
PROPERTY
Although it may be the most crucial type of protection for businesses, R&D institutions, and
other organisations working with IPR, protection of concealed knowledge is both the least
understood and least discussed by IPR participants. Unreleased information encompasses any
formula, pattern, compilation, programme, device, method, technique, or process. It is often
referred to as trade secret information or confidential knowledge. Preservation of trade
secrets and undisclosed information is nothing new for humans; throughout its history, people
have developed strategies to keep sensitive information hidden, frequently by limiting access
to their immediate family. In India, laws governing all types of IPR are in various levels of
implementation, but there is no specific legislation that just protects unreleased information,
trade secrets, or private information.4
During the 1950s and the 1980s, there were not many acute pressures associated with
globalisation or internationalisation, and many nations, like India, were able to operate
without implementing a robust IPR system. R&D spending has increased as a result of the
globalisation led by the chemical, pharmaceutical, electronic, and IT industries. The product
cycle, length, and significant risk of rival reverse engineering are characteristics of this
method. Industries eventually understood that trade secrets were insufficient to protect a
technology. Without standard laws and regulations governing patents, trademarks, copyright,
and other intellectual property rights, it was difficult to profit from breakthroughs. IPR rose to
prominence inside the World Trade Organization (WTO) in this way.

RATIONALE OF PATENT
Under the rigorous examination and opposition procedures outlined in the Indian Patents Act,
1970, patents are granted for patentable inventions that meet the requirements of novelty and
utility. However, there is not even a prima-facie presumption as to the validity of the patent
that has been granted.5
The majority of nations have put in place national systems to protect IPR that fall under their
purview. Except in the case of copyrights, the inventor's or creator's protection is limited to
the territory where protection is sought and is not applicable in other countries or regions,
such as India or the European Union. An Indian patent, for instance, is legitimate not in the
USA, but solely for India. The primary goal of obtaining a patent for an innovation is to
profit from exclusivity, which would grant the inventor or his assignee a monopoly.

PATENT COOPERATION TREATY'S FUNCTION

4
Bainbridge DI. Intellectual property. New York: Longman; 2002.
5
Anonymous. The Design Act. 2000 along with Design Rules 2001.
New Delhi: Universal Law Publishing Co. Ltd.; 2004
In 1978, the global Patent Cooperation Treaty (PCT) came into effect. By designating the
countries of interest in the PCT application, an inventor from a member country contracting
state of PCT can simultaneously obtain priority for his or her invention in all or any of the
member countries without having to submit a separate application in each of the countries of
interest. The Geneva-based World Intellectual Property Organization (WIPO) oversees the
coordination of all PCT-related operations.
It is necessary to submit a separate patent application in every nation of interest in order to
get priority in those countries and protect an invention there. In some situations, this must be
done within a certain amount of time. On the other hand, inventors of PCT participating
nations can simultaneously get priority for their ideas without having to submit separate
applications in the countries of interest, saving them the initial costs associated with filing
fees, translation, etc. Also, the method offers much more time for member countries to file
patent applications. According to the Paris Convention, you have 12 months from the date of
your initial filing to obtain priority in other nations. The time allotted under the PCT could
range between 20 and 31 months in length. Furthermore, the created search report also helps
inventors to confirm that the claimed invention is original under the PCT system. The creator
may choose to use preliminary examination before filing in other nations to be doubly certain
that the innovation qualifies for patent protection.

INTELLECTUAL PROPERTY MANAGEMENT IN THE

PHARMACEUTICAL INDUSTRY
Drugs and medicines, more than any other technology field, best fit the criteria of
globalisation and require a robust IP infrastructure. No company wants to take the chance that
its intellectual property will end up in the public domain without receiving adequate
compensation, given that the price of introducing a new drug to the market could cost it
anywhere from $ 300 million to $1 billion in addition to all the risks involved during the
developmental stage. The development, acquisition, protection, and management of IP must
be integrated into company operations in a similar way as resource and capital acquisition.
The knowledge revolution that we will undoubtedly experience will need for a special
position for intellectual property (IP) and treatment in the overall decision-making process.6
The success of a corporation will mostly depend on its R&D activities since scientific
understanding rather than manufacturing expertise drives competition in the global
pharmaceutical market. Hence, R&D expenditures as a percentage of total sales, the pharma
business accounts for a fairly high amount; some sources put that number as high as 15%.
The management of creative risks while attempting to obtain a competitive edge over
competing businesses is one of the major problems in this sector. With the development of
possible medications that are unable to fulfil the strict safety criteria, being abandoned,

6
Anonymous. The Trademarks Act 1999 along with trade Marks
Rules 2002. New Delhi: Commercial Law Publisher (India) Pvt.
Ltd.; 2004.
sometimes after many years of investment, there is a large cost associated with the risk of
failure in pharmaceutical R&D.7

THE PHARMACEUTICAL INDUSTRY'S NATURE

The rush to discover the human genome's mysteries has resulted in a wealth of new scientific
knowledge and sparked the creation of cutting-edge technologies that are changing the
economics of medication development. 8Everyone will have their own genome mapped and
saved in a chip, therefore biopharmaceuticals are likely to have a special place in the future
with tailored therapies as the end objective. Doctors will examine the data on the chip(s) and
issue prescriptions if necessary.
The protection of such personal information databases would be the key IP issue involved.
More and more pharmaceuticals created using biotechnology will enter the market. Such
pharmaceuticals will have a slightly different protection process than those ordinary drugs
that have not undergone biotechnological development. It is necessary to list the microbial
strains utilised while creating a medicine or vaccination in the patent document. The situation
is straightforward if the strain is well-known and has been described in the literature that
scientists typically consult. The Budapest Treaty requires that numerous novel strains be
lodged with international depository authority as they are continuously identified and created.
The databases of these depositories should also be checked when conducting a novelty
search.
Businesses typically don't publish their work, but it's a good idea to make it a rule to hold off
until a patent application has been submitted before disclosing the innovation through
publications or seminars.

SOME UNIQUE FEATURES OF DRUG PATENT SPECIFICATION

7
Beier FK, Schricker G. IIC studies: Studies in industrial property
and copyright law, from GATT to TRIPS – the agreement on trade
related aspects of intellectual property rights.
8
Bently L, Sherman B. Intellectual property law. Oxford: Oxford
University Press; 2001.
Drafting patent specifications requires a high level of professional ability that must be
developed over time and requires a strong balance of legal, technological, and scientific
knowledge. Any patent specification's claims are what give the patent its essential legal
proprietary status. A known material cannot be patentable when a new property is discovered
in it. A practical use of the property qualifies as an innovation that might be eligible for
patent protection.
A railway sleeper built of the material could very easily be copyrighted, but the finding that a
known substance can tolerate mechanical shock would not be patentable.
Even though a material may not be new, a new property has been discovered in it. If it is
combined with some other known compounds and produces a novel result, it might be
possible to patent the combination. The cause is because no one has ever utilised that
combination to create a pesticide, fertiliser, or medication in the past. It's entirely feasible that
someone has invented a novel molecule whose exact structure is unknown. The description of
the chemical, together with its qualities and the process used to create it, will be crucial in
this situation.9

CONCLUSIONS
It is clear that managing IP and IPR requires a variety of activities and techniques, all of
which must be in compliance with local laws as well as international conventions and
standards. It is no longer solely influenced by a national viewpoint. The market's demands, its
reaction, the expense of converting IP into a business enterprise, and other factors have a
significant impact on IP and its related rights. In other words, the administration of IPR must
take into account issues relating to trade and commerce. Various IPR forms require distinct
handling, planning, and strategies, as well as the involvement of people with a variety of
specialised knowledge, including science, engineering, medicine, law, finance, marketing,
and economics. Every sector should have its own IP rules, management practises, business
models, etc. An developing IP strategy is now used by the pharmaceutical business. Antitrust
law must therefore intervene to prevent the wrongful assertion of invalid IPR in order to
create and sustain illegitimate, if temporary, monopolies within the pharmaceutical business,
given the greater likelihood that some IPR are illegal.
In this context, there are still a lot of issues to be handled.

9
Angell M. The Pharmaceutical Industry.