INTELLECTUAL PROPERTY RIGHTS: AN OVERVIEW AND

IMPLICATIONS IN PHARMACEUTICAL INDUSTRY

By- Touqeer Ajaz Qamar

L21LLBU0008
LLB HONS.
BATCH- 2021-2024
 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. 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
labor connected to 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..
 BRIEF 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 favorable terms. Italy is where copyrights were originally
recognized.
 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 modeled on the British patent system
and established a 14-year patent period.
TYPES OF INTELLECTUAL PROPERTIES
A range of intellectual endeavors can be protected by IP, including
 (i) Patents.
 (ii) Industrial designs are features that are applied to products in any shape,
configuration, surface pattern, the 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 license 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, and literary, musical, dramatic,
and aesthetic works.
 (v) Geographical indications are indicators that place a good's quality,
reputation, or another attribute primarily due to its geographic origin in the
country's territory or a specific region or locality within that territory.
ROLE OF UNDISCLOSED INFORMATION IN
INTELLECTUAL PROPERTY

 Although it may be the most crucial type of protection for businesses, R&D
institutions, and other organizations 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, program, 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.
RATIONALE OF PATENT
 Under the rigorous examination and opposition procedures outlined in the
Indian Patents Act, of 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.
 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
 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.
INTELLECTUAL PROPERTY MANAGEMENT
IN THE PHARMACEUTICAL INDUSTRY
 Drugs and medicines, more than any other technology field, best fit the criteria
of globalization 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.
 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 PHARMACEUTICAL INDUSTRIES
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.
Everyone 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
utilized while creating a medicine or vaccination in the patent document.
Landmark Case- Novartis v. Union of
India (2013)
 In this case, Novartis Pharmaceutical Company has applied for patenting a
drug ‘Gleevec’ which was rejected by the Indian patent office. Novartis
challenged all the rejections in the apex court.
 It was held by the Supreme Court that the substance that was sought to be
patented by Novartis was a modification of an already known drug that was in
the public domain since 1993 thus it lacks novelty requirement under patent
law. As well Novartis has also not shown any evidence of any therapeutic
efficacy of its modified medicine over the already existing drug which is a
mandatory condition under section 3 (d) of the Patents Act, of 1970.
 The court thus held that there was no invention done and a mere discovery of an
already existing drug does not amount to invention. The application was
accordingly dismissed by the court.
 Landmark Case- Bayer Corporation vs Union of
India (2014) Bombay HC(Compulsory License Case)
 Bayer Corporation patented a cancer medicine ‘Nexavar’. Indian patent office exercised its
rights and granted a compulsory license of Nexavar to Natco Pharma. Ltd. for producing a
generic version of it. The patent office has also directed Natco to pay royalties to Bayer, to
donate 6000 free medicine to the public, to manufacture the medicine locally, and to sell the
medicine only in India and not to assign manufacturing of it to others. Meanwhile, Bayer was
manufacturing the same medicine for a comparatively higher price than what Natco offered
to the public. Aggrieved by the patents controller’s decision Bayer moved to IPAB (Intellectual
property appellate board) and filed an application which got rejected. Bayer now filed an
appeal before the board which was also rejected.
 Bayer Corp. then filed an appeal before The Bombay High Court which held that compulsory
licensing of life-saving drugs falls within the right of the Indian patents office as well as the
rule of making available of patented drugs at an affordable price for the general public
should be maintained as per section 82(1)(b) under The Patents Act, 1970.
 “The judgment passed by The Bombay High Court was later upheld by The Supreme Court.”
CONCLUSION
 It is clear that managing IP and IPR requires a variety of activities and
techniques, all of which must comply with local laws and international
conventions and standards. It is no longer solely influenced by a national
viewpoint. The market's demands, reaction, the expense of converting IP into a
business enterprise, and other factors significantly impact 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 practices, business models,
etc.
 A 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 IPRs are illegal.
In this context, there are still a lot of issues to be handled.