The overview of Intellectual Property Rights and its implications

in Pharmaceutical Industry.
Intellectual property rights (IPR) have been described as concepts, ideas, and creative
expressions on the basis of which the willingness of the public to grant property status is
based. IPR grants inventors or developers of that property some exclusive rights in order to
allow them to reap commercial profits from their creative efforts or reputation. There are
many ways of protection of intellectual property, such as patents, copyrights, trademarks, etc.
A patent is an invention that meets the standards of global novelty, non-obviousness and
industrial application. IPR is a prerequisite for innovation or imagination to be properly
defined, prepared, promoted, made and thus covered. Depending on its area of expertise, each
industry should develop its own IPR policies, management style, tactics, and so on.
Currently, the pharmaceutical industry has an evolving IPR strategy that requires a better
focus and approach in the next era. Drugs and pharmaceuticals suit the definition of
globalization more closely than any other technical sector and need to have a good IP
framework. Knowing that the expense of bringing a new drug on the market will cost a
business between $300 million and $1000 million, along with all the related risks at the stage
of growth, no company would want to risk becoming a public property for its IP. IP
formation, acquisition, security, and management must become a corporate operation in the
same way that capital and funds are collected. In the overall decision-making process, the
information revolution which we are sure to undergo will require a special pedestal for IP and
care. In the global pharmaceutical industry, competition is driven by scientific expertise
rather than manufacturing know-how, and the success of a business would rely to a large
extent on its R&D efforts. Therefore, as a percentage of overall revenue, spending in R&D in
the drug industry is very high; estimates indicate that it may be as much as 15 percent of
sales. Managing creative risks is one of the main issues in this field, as one aims to achieve a
competitive edge over rival organizations. The risk of failure in pharmaceutical R&D is
associated with high costs due to the production of potential medicines that are unable to
meet strict safety requirements, which are terminated, often after several years of investment.
The documents to be sent to the regulatory authorities have, it is known, almost tripled in the
last ten years. Furthermore, it now takes even longer for regulatory authorities to approve a
new drug. Consequently, the patent protection period has been shortened, contributing to the
need for additional efforts to gain adequate income. In the case of drugs produced through the
biotechnology path, the situation may be more serious, especially those involving gene use. It
is inevitable that the developed world will soon continue to pursue more drug protection. In
order to achieve public targets, it is also likely that many governments will exercise more and
more price regulation. This will, on the one hand, demonstrate the need for lower drug
growth, manufacturing and marketing costs, and, on the other hand, entail preparing for lower
profit margins in order to recover costs over a longer period of time. It is also clear that many
contradictory criteria have to be waded through by the drug industry. During the last 10 to 15
years, several different techniques have emerged for cost control and trade advantage. Some
of these are the procurement of R&D operations, the creation of R&D collaborations and
strategic alliances. An explosion of scientific knowledge has produced the race to discover
the secrets of the human genome and has sparked the production of new technologies that are
altering the economics of drug development. Biopharmaceuticals are likely to enjoy a special
location, and personalized drugs will be the ultimate target, as everyone will be mapped and
processed in a chip with their own genome. Doctors will look at the chip(s) for details and
prescribe it accordingly. The security of such personal information databases will be a
significant IP problem associated with this. Increasingly, biotechnologically produced
medicines will enter the market. The method of defence for such drugs would be slightly
different from traditional drugs that are not biotechnologically advanced. The current state of
the pharmaceutical industry suggests that, at the detriment of competition and consumer
protection, IPRs are being unjustifiably improved and exploited. The drug industry's lack of
risk and creativity underscores the inequity that occurs at the cost of public goods. It is an
injustice that, through constitutional change alone, cannot be healed. Although Congressional
attempts to close loopholes in current laws may provide some mitigation, together with new
legislation to curb the pharmaceutical industry's further unfavourable business practices,
antitrust law must step in properly. Although some business practices used by the
pharmaceutical industry, such as mergers and acquisitions and agreements not to compete,
have been adequately scrutinized by antitrust legislation, there are many other practices to be
discussed. The granting of patents on minor elements of an old drug, the reformulation of old
drugs to secure new patents, and the use of ads and the creation of labels to raise barriers to
generic market entrants are all ways in which antitrust law will help to stabilize the balance
between innovation incentives and the protection of competition. It is clear that IP and IPR
management is a multidimensional challenge and calls for several different actions and
methods that need to be coordinated with national legislation and international treaties and
practices. It is no longer driven solely by a national viewpoint. IP and its related rights are
severely affected by the needs of the consumer, market reaction, costs involved in converting
IP into a business venture, and so on. In other words, considerations of trade and commerce
are relevant in the management of the IPR.  Different forms of IPR demand different
treatment, handling, planning, and strategies and engagement of persons with different
domain knowledge such as science, engineering, medicines, law, finance, marketing, and
economics. Each industry should evolve its own IP policies, management style, strategies,
etc. depending on its area of specialty. Pharmaceutical industry currently has an evolving IP
strategy. The pharmaceutical industry has an emerging IP strategy at the moment. Therefore,
because the risk of any IPRs being invalid exists, antitrust law needs to step in and ensure that
invalid rights are not illegally claimed in order to create and retain unconstitutional, though
restricted, monopolies within the pharmaceutical industry. In this sense, several problems still
need to be resolved.
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