Written by: ADITYA RAJ ,B.A LL.B (HONS.) ,GALGOTIAS UNIVERSITY
ABSTRACT
Ideas, innovations, and creative expressions that the public is ready to grant property status to are considered intellectual property rights, or IPRs. In order to enable the owners of intellectual property to profit commercially from their creations or reputation, intellectual property rights
(IPR) grant the owners of that property certain exclusive rights. Intellectual property is protected under a number of different laws, including patent, copyright, trademark, etc. An innovation that meets the requirements of worldwide uniqueness, non-obviousness, and industrial use is recognized with a patent. Better invention or creativity identification, planning, commercialization, rendering, and protection are all dependent on intellectual property rights
(IPRs). Depending on its area of expertise, each industry should have its own IPR policies,
management style, strategies, and so forth. The IPR strategy used by the pharmaceutical sector
is currently changing, and in the future years, a better emphasis and approach will be needed.
INTRODUCTION
Any original work of human mind, whether it be artistic, literary, technological, or scientific,
is considered intellectual property (IP). The legal right granted to an inventor or creator to keep
their idea or innovation secret for a predetermined amount of time is known as intellectual
property rights, or IPR For a certain amount of time, these legal rights grant the inventor/creator
or his assignee the sole right to make full use of their innovation. The importance of intellectual
property in the modern economy has long been established. Additionally, it has been unequivocally proven that the innovation's intellectual effort deserves recognition in order for
the public good to result from it. The expenses of research and development (R&D) have skyrocketed, and this has led to a corresponding increase in the investments needed to introduce
new technologies to the market. Because technology developers now have very high stakes in
their work, it is necessary to secure knowledge from unauthorized use, at least temporarily, in
order to recover R&D expenses and other related costs and generate enough revenue to fund
ongoing R&D expenditures. Since it gives the creator/inventor an exclusive right to use his
creation for a set amount of time, intellectual property rights (IPRs) are an effective tool for
protecting the time, money, and effort that the creator/inventor has invested in creating an
intellectual property. IPR thus supports a nation's economic development by fostering healthy
competition, industrial progress, and economic prosperity. The current review provides a
concise synopsis of IPR, with a focus on drugs.
BRIEF HISTORY
Europe is where the rules and regulations pertaining to intellectual property originated. The
fourteenth century saw the beginning of the patent granting trend. England was technologically
more advanced than other European nations in several areas, which attracted foreign artisans
on favourable terms. Italy is where copyrights were initially recognized. Venice can be regarded as the birthplace of the intellectual property system because it was here that most legal thought took place, leading to the creation of world's first laws and institutions, which eventually spread to other nations. In India, the Patent Act dates back more than 150 years. The first is the 1856 Act, which established the 14-year patent period and was modelled on the British patent system. It was followed by a number of other acts and modifications.
TYPES OF INTELLECTUALPROPERTIES AND THEIR DESCRIPTION
The phrase "Intellectual Property" currently refers to much more than only patents, trademarks,
and industrial designs, which were the only types of property that were protected under it initially. Technology advancement is enhanced by IPR in the following ways:
(A) It offers a system for dealing with infringement, copying, and unapproved usage.
(B) Because all intellectual property is published, with the exception of trade secrets, it gives
the general public access to a wealth of knowledge. IP protection can be pursued for a range of creative endeavors, such as
(i) Patents
(ii) Features of any form, arrangement, surface pattern, line composition, and colour applied to an object, whether 2-D (such as textiles) or 3-D (such as toothbrushes), are referred to as industrial designs.
(iii) A trademark is any name, mark, or logo that is used to conduct business for any good or service and to identify the supplier or manufacturer. Trademarks are tradable and refundable. A trademark exists only because the goodwill of the good or service it represents exists.
(iv) Copyright pertains to the material manifestation of ideas and covers computer software, audio recordings, theatrical, musical, artistic, and photographic works.
(v) Geographical indications are indicators that designate a good as coming from a country, area, or place within that country, where a certain attribute of the good— such as its quality, reputation, or other attribute—is primarily related to its geographical origin.
When an invention meets the requirements of worldwide uniqueness, non-obviousness, and
industrial or commercial applicability, it is granted a patent. Patents may be issued for both
goods and procedures. A patent had a 14-year duration from the date of filing under the Indian
Patent Act of 1970, with the exception of procedures for making drugs and food, for which the
period was either 7 years from the date of filing or 5 years from the date of the patent, whichever
came first. Food and medicine products did not receive any product patents. Without the
requirement for registration, a copyright created in one of the Berne Convention's member
nations is immediately protected in all of the member nations. India has excellent copyright
laws on par with those of any other nation, and it is a signatory to the Berne Convention.
However, in nations that are not signatories to the Berne Convention, copyright will not always
be granted. As a result, copyright might not strictly speaking be regarded as a territorial right.
IPR may be given, sold, or transferred just like any other property.
ROLE OF UNDISCLOSED INFORMATION IN INTELLECTUAL PROPERTY
Though it is arguably the most significant type of protection for businesses, R&D centres, and
other organizations involved in IPR, the protection of concealed knowledge is least well-known
to and discussed by IPR participants. Generally referred to as trade secrets or confidential
knowledge, undisclosed information encompasses any formula, pattern, compilation, program,
device, method, technique, or procedure. Protection of trade secrets and confidential
information is nothing new to humans; throughout history, people have developed strategies to
keep valuable information private, usually by sharing it only with close relatives. There is no
distinct legislation in India that protects trade secrets, confidential information, or concealed
knowledge, despite the fact that laws pertaining to all forms of intellectual property are being
implemented at varying stages.
From the 1950s to the 1980s, there were few globalization or internationalization pressures,
and many nations—including India—managed to get by without implementing robust
intellectual property rights (IPR) laws. The chemical, pharmaceutical, electrical, and IT
industries have propelled globalization, which has led to significant R&D expenditure. The
product cycle is shortened throughout this process, and there is a significant chance that rivals
will reverse engineer it. Businesses realized that trade secrets were insufficient to protect
technological advancements. Benefiting from breakthroughs was challenging without
standardized laws and regulations governing copyright, patents, trademarks, and other related
matters. IPR gained significance within the World Trade Organization (WTO) in this way.
RATIONALE OF PATENT
Intellectual property rights (IP) in inventions are recognized by patents, which are awarded for
novelty and utility after rigorous review and opposition procedures. While most nations have
national IP protection frameworks in place, patents are only enforceable in the jurisdiction in
which they are sought. An innovation is primarily patented in order to profit from exclusivity,
which may be used by the inventor or their assignee to market the creation or provide a license
to a third party. Certain inventions, though, such as those that are frivolous or against natural
law, scientific ideas, mathematical techniques, or materials derived by mixing, do not qualify
as patents. Inventions pertaining to agriculture, medicine, atomic energy, and traditional
knowledge are among the other non-patentable categories of inventions.
RATIONALE OF LICENSE
In a license agreement, the licensor grants permission to the licensee to carry out specific tasks
that would be illegal otherwise. A patent license is legal since the licensor gives the licensee
specific rights over the patent. Additionally, "know-how," such as technical or business
knowledge, may be licensed by the licensor. The licensor gains from breaking through barriers
in international marketplaces, creating income, and expanding into new areas. Savings on
R&D, speedy market exploitation, and the newest products are advantages for the licensee.
MANAGEMENT OF INTELLECTUAL PROPERTY IN PHARMACEUTICAL INDUSTRIES
Drugs and pharmaceuticals are the technology sector that most closely fits the definition of
globalization and so require a robust intellectual property regime. Given that bringing a new
drug to market might cost a business anywhere from $300 million to $1000 million, not to
mention all the dangers involved throughout the development phase, no business wants to take
the chance of its intellectual property becoming publicly owned without sufficient profits.
Intellectual property (IP) creation, acquisition, protection, and management need to become
corporate activities on par with resource and money raising. We can be certain that the coming
knowledge revolution will require that intellectual property be given significant consideration
and standing during the entire decision-making process.
Scientific knowledge, not industrial expertise, drives competition in the global pharmaceutical
sector, and a company's success will mostly depend on its research and development (R&D)
activities. Consequently, the pharmaceutical business invests a hefty portion of its overall
sales—up to 15%, according to reports—in research and development. Managing creative risks
while trying to obtain a competitive edge over competing firms is one of the major problems
in this field. Pharmaceutical research and development carries a significant risk of failure, with
promising medications that fail to fulfil strict safety criteria sometimes having their
development put on hold after years of investment. After the molecule is first produced, it takes
approximately 8 to 10 years for a drug to overcome development obstacles. Drug businesses
will need to refocus their R&D efforts from developing innovative techniques for
manufacturing well-known medications to developing novel drug molecules and new chemical
entities (NCEs) when product patents become the primary means of IP protection. Following
a phase of effectively treating numerous short-term disorders, research and development efforts
began to concentrate on long-term (chronic) diseases in the 1980s. One must make sure that
standards from various regulatory authorities are met when searching for a worldwide market.
It is acknowledged that within the past ten years, the number of documents required to be
submitted to regulatory bodies has nearly tripled. Furthermore, it now takes regulatory bodies
a lot longer to approve new drugs. As a result, the duration of patent protection is shortened,
necessitating greater work in order to generate sufficient revenue. For medications created by
biotechnology, particularly those that make use of genes, the situation might be more dire. It's
conceivable that the developed world will soon begin advocating for extended medication
safety. To achieve public objectives, it's also conceivable that numerous governments would
implement increasing amounts of price regulation. This would highlight the need for lower
costs associated with drug development, manufacture, and marketing, but it would also make
lower profit margin planning necessary in order to recover expenses over an extended period
of time. It follows that the pharmaceutical sector must navigate a maze of contradictory
regulations. Over the past ten to fifteen years, a wide variety of solutions for cost containment
and trade advantage have emerged. Among these include contracting out R&D work, creating
strategic alliances, and building R&D collaborations.
NATURE OF PHARMACEUTICAL INDUSTRY
Drug development's economics have changed as a result of the rush to unravel the human
genome, which has resulted in an explosion of scientific knowledge and new technology. It is
anticipated that biopharmaceuticals would offer customized medications, with physicians
depending on the data contained in chips. One significant IP concern is the safeguarding of
databases containing personal information. New strains are deposited with international
depository authorities in accordance with the Budapest Treaty, and the microbial strains
utilized in the development of pharmaceuticals or vaccines must be disclosed in patent filings.
Before disclosing their work, companies ought to file a patent application. R&D partnerships
can be established for a number of reasons, including pooling resources for production
facilities, marketing networks, and R&D know-how. Formal contracts addressing matters such
as intellectual property ownership, cost sharing, trade secrets, bookkeeping, and stronger IP
portfolio are recommended. The pharmaceutical sector is confronted with unjust practices that
compromise customer welfare and competition. Antitrust law must be utilized to address tactics
such patenting tiny components of outdated medications, reformulating ideas for new patents,
and developing advertising and brand names, even though legislative improvements and new
legislation can be helpful. With a $60 billion global market, traditional medicine, which uses
natural botanical items, plays a key role in providing healthcare to people. Traditional
knowledge-based medications are not patentable, although businesses and researchers
frequently assert intellectual property rights (IPR) over biological resources and/or traditional
knowledge. This trend is demonstrated by the rapid increase of patent applications pertaining
to herbal medicine.
SOME SPECIAL ASPECTS OF DRUG PATENT SPECIFICATION
Writing patent specifications is a specialized talent that calls for expertise in science,
technology, and law. The main component of a patent is its claims, which serve to safeguard
the invention. Although the finding of novel qualities in an existing material is not patentable,
an invention may be created if a useful application is found for it. If a chemical shows novel
results when combined with other well-known substances, it may be patented together. If two
known compounds can be combined to create a useful product and have a working relationship,
this could be covered by a patent. With 62% of applications having a medication or
pharmaceutical component, they are the most common uses.
CONCLUSION
It is clear that managing intellectual property rights (IPR) and intellectual property (IP)
involves a variety of tasks and techniques that must be in line with international treaties,
national laws, and best practices. It is no longer solely motivated by a national viewpoint. IP
and related rights are significantly impacted by market demands, consumer reaction, the price
of converting IP into a business enterprise, and other factors. To put it another way, trade and
commerce factors play a significant role in IPR management. distinct IPR types necessitate
distinct approaches, management, preparation, and tactics, as well as the involvement of
experts in several fields, including science, engineering, medical, law, finance, marketing, and
economics.
Depending on its area of expertise, each industry should have its own IP policies, management
style, strategies, etc. The IP approach used by the pharmaceutical sector is currently changing.
Antitrust law must therefore intervene to ensure that invalid rights are not being unlawfully
asserted to build and sustain illegitimate, albeit limited, monopolies within the pharmaceutical
business, given the greater likelihood that some IPR may be invalid. Many issues in this context still need to be handled.
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