Patent Law in Pharmaceutical Industry and Doha Declaration-A study Pharmaceutical Patents (By- Koyel Roy)
Patent Law
in Pharmaceutical Industry and Doha Declaration-A study[1]
Pharmaceutical
Patents
Authored By- Koyel Roy
In 2005, India started allowing
pharmaceutical items to be patented, in accordance with the World Trade
Organization's Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS).
In this era, where ideas and
inventions are valued highly, knowledge is a critical aspect in propelling
development. Inventors not only have a lot of possibilities to show off their
ideas and creative work, but they also have a lot of chances to make money.
People, for example, pay more for an iPhone than is actually required to
manufacture it. This is because a significant portion of the buyer's money goes
to reward inventors and innovators for the iPhone's development.
India produces the most generic
pharmaceuticals in the world. One of the greatest medical success stories is
India's ability to provide affordable HIV therapy. India is one of the world's
leading suppliers of low-cost vaccinations. Indian medicines are preferred over
the world due to their inexpensive cost and great quality. As a result, the
country has earned the title of "World Pharmacy." The pharmaceutical
industry currently accounts for 1.72 percent of the country's GDP. The Indian
pharmaceutical industry is a significant part of the country's international
commerce, offering investors numerous outlets and opportunities.
As attorney Dr Peter Feldschreiber
argues, drug research and development (R&D) "is a high-risk investment
for the pharmaceutical business." The pharmaceutical patent system was designed
and is used to help corporations secure their investment and recover costs
associated with discovering, producing, and marketing new pharmaceuticals,
thereby encouraging future drug research and development.Pharma companies apply
for a patent as soon as a medicine and its innovative mechanism of action are
discovered. The corporation then has a 20-year patent on the product, but
R&D can take up to 15 years, so the patent could be close to expiring by
the time the
product is approved and available on
the market.When the 20-year exclusivity period expires, generic competitors
will be able to enter the market and compete on price with the branded drug.
Companies frequently aim to extend the exclusivity term for a drug by seeking
supplementary patents in order to safeguard their investment.
Feldschreiber emphasizes that these
exclusivity extensions are lawful and "not loopholes in patent law,"
a point echoed by Graham Dutfield, a professor of International Governance at
the University of Leeds School of Law, who says: "These...are valid
practices, which the law allows."
One
of the so-called "intellect-driven" industries is the pharmaceutical
industry.The expense of pharmaceutical testing is high, and the results are
unpredictably unpredictable. The outcomes of the study could lead to the
development of a valuable new product or procedure. Pharmaceutical businesses
must protect their inventions from illicit commercial use by gaining the right
to a patent on the protected product or technique in this highly competitive
sector.Pharmaceutical patents in India can be classified into one of the
following categories:
·
Patents
on drug compounds.
·
Patents
on Technology
·
Patents
on formulations or compositions.
·
Patents
on biotechnology
·
Patents
on polymorphs.
·
Patents
on Synergistic Combinations
·
Patents
on processes.
·
When
a pharmaceutical company develops a therapy for a specific condition, it is
first marketed under a brand name so that doctors may refer patients to it.A
medicine is protected by a patent, which means it can only be manufactured,
marketed, and profited from by the pharmaceutical company that holds the
patent.
·
A
drug's patent typically lasts 7 to 12 years after it has been granted. Before
undertaking clinical trials to establish the efficacy of a treatment, companies
seek for patents. Other companies will be able to manufacture and sell the drug
once the patent expires. Generic medications are drugs that have progressed to
this point in their development.
Background Of Pharmaceutical Patent
In India
The evolution of India's
pharmaceutical industry can be divided into four stages. The first stage is the
time prior to 1970, when foreign corporations controlled the Indian market with
minimal domestic participation. The time between 1970 and 1990 is the second
stage. Several homegrown enterprises began operations during this time. During
this time, the Indian Patent Act of 1970 was enacted. During this time, export
activities were launched. The third stage lasted from 1990 until 2010. During
this time, India's liberalization led to the establishment of foreign
operations by Indian companies. In 2005, the Patents Act was changed, resulting
in the introduction of product patents in India. During this time, India became
a major producer of generic drugs.
Sick people in India and around the
world rely on Indian pharmaceutical companies to conduct research and develop
affordable generic versions of second-line AIDS medications and other
innovative treatments. India has a long history of fighting for public health
protection over intellectual property; during the Uruguay Round of WTO
negotiations, it led developing countries' opposition to the TRIPS agreement,
and it also played a key role in the 2001 WTO ministerial conference in Doha,
which resulted in the adoption of the Doha Declaration on TRIPS and Public
Health. Unlike other developing countries, it has also waited the maximum
amount of time allowed by TRIPS before issuing patents on pharmaceutical
items.India must continue to establish policies that promote access to
medicines in the post-2005 TRIPS setting, not only out of obligation to its own
people, but also as a lifeline for patients in other developing nations.
Regulatory
Framework Of Indian Pharmaceutical Industry Before The Trips Agreement
The focus of India's intellectual
property regime, which it has had to adopt since taking commitments under the
Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement, has
remained on the country's ability to provide mechanisms that ensure that its citizens
have access to medicines at affordable prices. India has a unique position
among developing countries since it has a robust generic pharmaceutical
industry that has been able to supply medicines at some of the lowest rates in
the world. The Patent Act of 1970, which India passed, is largely responsible
for this progress.[2]
This
procedure was aided by two essential provisions.
·
The
first was the establishment of a process patent regime for chemicals, and
·
The
second was the reduction in the length of life patents awarded to
pharmaceutical companies.
The stated goals of the Patent Act of
1970 were to promote the growth of an indigenous Indian pharmaceutical industry
and to ensure that the Indian public had access to low-cost pharmaceuticals.
The Act repealed British Colonial-era intellectual property rules and put an
end to India's acceptance of Western-style "product" patent
protection for pharmaceuticals, agricultural products, and atomic energy.
Manufacturing "process" patents were ignored in favour of
product-specific patents, allowing "Indian Companies" to reverse
engineer or replicate foreign patented medications without paying a licence
price. This allowed India's domestic sector to develop significant capabilities
and lawfully provide a vast number of cheaper "copycat" generic
copies at a fraction of the cost of the drug in the westas long as they used a
production procedure that wasn't the same as the patent owner's Process patents
were protected for seven years instead of the customary fifteen years required
to develop and test new medications under the Act.
TRIPS
Agreement And India’s Pharmaceutical Patent System
India was one of the first countries
to join the General Agreement on Tariffs and Trade (GATT) (GATT). However, it
is clear that GATT favoured wealthy countries over underdeveloped countries.
During the Uruguay Round negotiations, some developing countries, particularly
Brazil and India, proposed that GATT have no business dealing with intellectual
property issues, which should be discussed at the World Intellectual Property
Organization (WIPO), the United Nations Educational, Scientific, and Cultural
Organization (UNESCO), and the United Nations Conference on Trade and
Development (UNCTAD). Despite the fact that countries at different degrees of
development should have their own freedom to decide whether to award patent
rights to certain items, India elected to join the nascent World Trade
Organization during the negotiations (WTO).The TRIPS Agreement entered into
force on January 1, 1995, requiring India, as a WTO member, to give up some of
its long-held positions in the intellectual property field in order to comply
with the TRIPS Agreement's rules. India was granted a 5-year transition
periodFootnote3 and an additional 5-year time to update patent rules on
pharmaceutical patent protection as a developing country. Footnote4 The
influence of the TRIPS Agreement on India's pharmaceutical patent system is
described in the following analysis, which is based on revisions to the Indian
Patent Law of 1999, 2002, and 2005.
The Impact
Of Theworld Trade Organization On Patenting In Pharmaceutical Industries
The World Trade Organization (WTO)
has ushered in a significant paradigm shift in global trade. "One of the
primary reasons for incorporating intellectual property issues into the GATT
framework was the pharmaceutical industry," according to the agreement on
Trade-Related Aspects ofIntellectual Property Rights (TRIPS), which was
negotiated during the Uruguay round trade negotiations of the General Agreement
on Tariffs and Trade (GATT). On April 15, 1994, India signed the GATT, making
compliance with the GATT's standards, including the TRIPS agreement, mandatory.As
a result, India must adhere to the TRIPS Agreement's basic standards for
patents and the pharmaceutical industry. Patent availability for both
pharmaceutical items and process discoveries must now be included in India's
patent legislation. Patents are to be granted for a period of 20 years of
invention of the pharmaceutical product or the process.
To
comply with the TRIPS Agreement, Indian legislation will require mandatory
licence provisions to be restricted and conditional, and the government will
award such licenses only on the merits of each case after allowing the patent
holder an opportunity to be heard. Furthermore, in the case of process patents,
there will be no distinction between imported and domestic products, and the
party who infringes will bear the burden of proof.
Types Of
Pharmaceutical Patents Available To The Inventors
There are four types of
pharmaceutical patents available in India for the inventors. These are as
follows: -
1. Product Patent: -
A product patent grants the original inventor(s) exclusive
rights to a tangible product that they have made. No other manufacturer can
create/manufacture/develop/provide the same product using the same or any other
process if these rights are in existence. Violations of this guideline may
result in patent infringement. Most developed countries, including the United States,
the United Kingdom, France, Germany, and Canada, provide inventors with a
product patent regime. Similarly, the product patent regime is followed by the
majority of nations that have signed the Trade-Related Aspects of Intellectual
Property Rights (TRIPS) agreement.
The main
advantage of a product patent system is that it provides the innovator with a
higher level of protection. The disadvantage, however, is that there are fewer
competitors in such a system. This raises the likelihood of monopoly, which can
be a big issue in developing countries where a large portion of the population
struggles to meet basic needs.
2. Process Patents: -
A process patent is a type of patent that provides protection
to inventors for a specific method of making or manufacturing a product. Most
emerging countries, such as India and Argentina, provide its innovators and
creators with a process patent regime. To put it another way, a process patent
grants protection to a specific manufacturing process rather than the product
itself. The identical product can be made using a different process or by
simply changing the method's parameters.
The main advantage
of a process patent regime is that it gives the government authority over the
monopolies of powerful multinational corporations, allowing it to protect the
interests of the poor. However, there is a risk that such a regime may deter
pharmaceutical businesses from investing their hard-earned money in a
low-profit-margin environment. Compulsory licensing is a prevalent practice in
patent regimes where the government can compel corporations to produce
particular products in the public interest.
3. Product-By-Process-Patents: -
A product-by-process patent defines a product as a product's
manufacturing procedure. When a product cannot be characterized or
distinguished from the prior art without referring to the manufacturing
process, this patent is frequently issued.
Despite the fact
that product-by-process claims are limited and defined by the process,
patentability is determined by the product itself rather than the method of
manufacture. Even though the prior product is created by a different process,
the claim will be unpatentable if the product in the product-by-process claim
is the same or obvious.
4. Formulation Patent: -
The pharmaceutical dosage form of the drug, also known as
composition, is protected under formulation protection. However, the terms
'composition' and 'composition of matter' must not be confused. It's possible
that it'll take on the shape of a drug formulation or a pharmacological class.
It can also be a generic formulation that can be used for a variety of
medications with varied effects. Slow-release technology, transdermal patches,
and other methods are among them. Additionally, when conducting a complete
patent search, it is critical to evaluate the type of patent. It aids in the
narrowing of search results.
How Is
Pharmaceutical Patenting Affecting Public Health Access? -
Various viewpoints exist on the
impact on the Indian pharmaceutical industry and access to critical medicines
both within and beyond the country. India is ranked fourth in terms of
pharmaceutical manufacturing volume due to its high number of enterprises.
While pharmaceutical prescription patents are a vital tool in the discovery process,
those unfamiliar with the patent system as a whole may find it confusing.
Drug
companies regularly misuse patent monopolies, as well as unreasonably high
prices for patented drugs. The introduction of product patents has impeded drug
accessibility. A large number of generic medicines, including vaccines, are
patented in India, making it difficult for the pharmaceutical industry to
develop life-saving drugs.
Exorbitant
drug prices make it difficult for ordinary people to obtain medication, which
contradicts the government's professed purpose of protecting citizens' health.
There is an unmistakable medical-care emergency with insufficiency in terms of
healthcare and the affordability, availability, and accessibility of
pharmaceuticals, especially in a country like India, where a large proportion
of the population lives below the poverty line and healthcare prices are
exorbitant. For India's administration, this is a huge challenge. As a result,
they've adopted a variety of initiatives to safeguard the situation, including
mandatory licensing (in the event of voluntary licence refusal) and parallel
trade policies as alternatives to supporting developing nation governments in
making important medicines more accessible to their citizens. Compulsory
licensing brings competition to the market, which lowers consumer prices of the
patent goods/articles. It provides as an organizational framework for the
numerous pro-health components included in patent laws, first and foremost.
Second, it presents the issue of competing claims between patentees and
customers.
Solution
And Suggestion To The Problem Of Pharmaceutical Patent Affecting The Public
Health Access: -
The Indian Patent Act, which was
passed in 1970, protects generic medication manufacturers in India. The act has
put millions of people's health rights in jeopardy.
Previously, only the most privileged
and rich members of society had access to life-saving drugs, but now they are
available to all of our society's most vulnerable and needy individuals. Under
Indian patent law, the interests of patentees and the demands of the general
public are
intertwined. TRIP's adaptability has
been carefully matched with its severe intellectual property constraints.
Despite the fact that Novartis' claim
was denied by the Indian judicial system, Indian generic businesses went ahead
and sold Glivec for a fraction of the original price.This has made it simpler
for the impoverished in our country to access life-saving pharmaceuticals at a
lesser cost.
Despite TRIPS' provisions to protect
ordinary people's health, it has not been as effective in boosting public
health in developing and least developed nations as it should be. TRIPS should
be modified to require patent holders to sell pharmaceuticals at a lower price
to the impoverished in developing countries.
Benefits Of
Patent In Pharmaceutical Industry: -
Rapid technological advancements have
resulted in the introduction of new and improved pharmaceuticals into the
market in the globalized era. Many developments in the pharmaceutical industry
have resulted in the launch of blockbuster pharmaceuticals, saving the lives of
millions of people. The majority of the profits from these commercially
successful pharmaceuticals are used to fund R&D and the development of new
drugs.
Pharmaceuticals
are one of the industries where innovation has a significant impact on drug
manufacturers' bottom lines, thus these companies are putting more emphasis on
R&D to stay competitive and win market share. The pharmaceutical industry's
success is defined by innovation, yet the risk connected with the launch of new
treatments might jeopardize its existence in the marketplace. Furthermore,
innovation aids pharma companies in differentiating themselves from generic
manufacturing firms to research-based firms. The majority of pharma companies
use innovation to drive growth and provide significant returns on investment.The
cost of developing and launching a new drug on the market is substantial, and
its success or failure is greatly dependent on the industry's need for
innovation. Because the stakes in the sector are so high, pharma companies must
devote a considerable portion of their profits to research and development.
Future Of Pharmaceutical Industry
Instead of producing life-saving treatments, pharmaceutical corporations
are focusing on drugs that increase sales volume and market share, hence
increasing profits.Pharma companies have a finite amount of time to sell their
products as drug discovery becomes more time intensive and expensive. As a
result, the industry's patents on commercially proven drugs are about to
expire.
The corporation will be unable to fund its R&D efforts if patent
protection is not extended. Additionally, extending the patent product lifespan
can allow corporations to devote more resources to research and development and
the development of new treatments. Extended patent protection, on the other
hand, means that these drugs will be more expensive for a longer time.
The
generic players do not invest in innovation, preferring to gain market share by
tweaking current pharmaceuticals and obtaining patents in order to increase
revenue. The patent period for these products should be lowered to stimulate
innovation, but the patent duration for life-saving drugs should be extended.
Pharma
businesses must limit their patent portfolio in the absence of effective patent
protection, resulting in market share erosion. Indian pharma companies must
focus on developing new treatments and preserving their intellectual property
in order to compete with global pharma corporations. It is critical to
safeguard intellectual property in order to commercialize it in the near
future. Because patents are so important to pharmaceutical businesses, they
should concentrate on maintaining and expanding their patent portfolio.
Pharma
businesses have had to deal with a slew of challenges in recent decades,
including lack of efficacy and pre-grant resistance from third parties. As a
result, when the validity of a patent is questioned, patents can help. Indian
firms can also create copyrighted medications through licence agreements with
foreign firms or profit from generic drugs. The pharmaceutical industry's
expansion could be hindered by high research and development costs and a weaker
product patent regime.
Current Drug-Patent System Is Bad Medicine
The paper, released by Tufts University economist Jeo DiMasi, is an
update of his earlier research, the most current of which estimated that the
cost of creating a medication in 2001 was $802 million dollars.A new study
revealed that the cost of producing a new treatment is now 2.6 billion dollars,
causing a minor stir in the media.
Many
health care experts and campaigners questioned the study's methodology after
seeing the 2.6-billion-dollar figure, which will surely be used to justify high
medication pricing. The Tufts Centre for the Study of Drug Development, which
DiMasi directs, receives support from the pharmaceutical industry, which adds
to the issue. The study also makes use of industry-supplied confidential data.Furthermore,
the study itself is not yet public; DiMasi merely issued a set of slides that
summarized the study's principal findings. It's also worth noting that the $2.6
billion
figure only applies to drugs that involve new chemical compounds and did
not rely on any outside funding in the development process, such as research
from the National Institutes of Health (NIH); this category of drugs accounts
for less than a sixth of all new drugs approved each year.
Whether
or whether the study's concerns are correct, $2.6 billion is not a figure that
the pharmaceutical business should be proud of. It means that the expense of
producing a new drug has climbed at a rate about 8% higher than the overall
inflation rate.This rapid rise in expenses is exactly what economists would
predict from a sector that is government-protected from competition. The system
of government-granted patent monopolies gives corporations little incentive to
manage costs and avoid waste, just as the former system of cost-plus contracts
in the military sector led to exorbitant rates for weapons acquired by the
Defense Department. As a result, it's not unexpected that large pharmaceutical
businesses are seeing rapid cost hikes.
The
existing system of drug research has a slew of issues, with bloated development
costs being the least of them. Patent monopolies make it impossible to afford
drugs that would be reasonably inexpensive in a free market. For example, state
governments and insurers are grappling with Gilead Sciences' $84,000 price tag
for Sovaldi, the company's new hepatitis C medicine.
Generic
manufacturers in India, on the other hand, may commercially offer the medicine
for $1,000 each treatment. If we were talking about $1,000 instead of $84,000,
we wouldn't see news pieces, hand-wringing columns, or editorials questioning
whether the government and insurance should be made to pick up the price. Some
other treatments' patent-protected pricing is even more outrageous, with many
new cancer drugs selling for hundreds of thousands of dollars.
In
addition to causing access issues, high patent prices provide pharma
corporations with a strong incentive to misrepresent the safety and
effectiveness of their products in order to increase sales. And they behave in
exactly the way that economic theory predicts. It's rare that a month goes by
without a fresh story about a firm hiding or misrepresenting study findings to
boost sales.
Doha
Declaration On The Trips Agreement And Public Health
At the WTO's Fourth Ministerial
Conference in Doha, Qatar, on November 14, 2001, member nations unanimously
approved the Declaration on the TRIPS Agreement and Public Health.Its goal is
to allay fears that the TRIPS Agreement may make it harder for patients in
developing nations to receive certain drugs.
Patent
rights are granted to inventors in order to encourage research and development.
This includes developing new medications. The TRIPS Agreement, which has been
in effect since 1995, also recognizes governments' authority to take a variety
of steps to qualify or limit intellectual property rights, including for public
health reasons.Some members and public interest groups, however, questioned
whether the TRIPS Agreement's flexibility was sufficient to ensure that it
benefited public health, particularly in terms of promoting inexpensive access
to existing medications while simultaneously encouraging research and
development of new ones. Some of the doubts that arouse in the declaration.
Some of them are: -
·
Different
perspectives were stated on the nature and breadth of the TRIPS Agreement's
flexibility, such as compulsory licensing or parallel imports.
·
It
was questioned whether the WTO and its members would interpret this flexibility
in a wide, pro-public-health manner.
·
There
was some concern about whether governments would be able to fully utilize this
flexibility without fear of being pressured by trading partners or industry.
Effect Of Changes In The Patent Act On Pharmaceutical
Industry
Following the amendments to the India
Patent Act, the need to strike a balance between patent protection and
sustaining competition among pharmaceutical businesses arose. The new product
patent policy, which has been in effect in India since 2005, may result in a
monopolistic position. Prior to the introduction of the notion of product
patenting, generic companies posed a significant threat to major corporations.
The generic drug businesses created the drugs at a low cost, forcing the big
companies to sell their products at a low cost in order to stay in business.However,
with the introduction of the notion of product patenting, the situation has
altered. In such a case, competition law will play a critical role in
preventing market monopolization. The 2002 Competition Act aims to avoid
monopolies in any industry. In the pharmaceutical industry, three types of
competition
difficulties might occur. Mergers and acquisitions, collusion, and the
abuse of a dominant market position are all examples. These factors have the
potential to drive up the cost of medicines to the point where poor patients
will be unable to afford them.As a result, maintaining a balance between
intellectual property protection and competition between enterprises is
critical for the welfare of society.[3]
Problems That The Drug
Patent Poses For Developing Countries
In the recent decade, patents and intellectual property limitations have
become more difficult for developing countries. The discovery and influx of
low-cost generic medications that developing countries require to treat HIV,
tuberculosis, and other infectious diseases is at the Centre of the storm.The
generic pharmaceutical business is critical to the availability of low-cost
medications. The market is especially vital in southern Africa, where there is
a high prevalence of HIV and a paucity of funding for health care and
medicines.
Tensions
have arisen between huge multinational pharmaceutical companies and the
emergence of the generic medicine business. Patents are used by these companies
to safeguard their products' intellectual property. Patents last for 20 years
from the date of registration, according to legislation such as the World Trade
Organization's agreement on Trade-Related Aspects of Intellectual Property
(TRIPS). This allows manufacturers to provide pharmaceuticals exclusively for
that time period, allowing them to recuperate research and development
costs.However, it also gives drug makers the power to control medicine costs.
As a result, many treatments are beyond of reach for the poor, particularly in
developing countries. There are various many challenges which the developing
countries face.[4]
The Indian Generic Drug Market: -[5]
India is a major supplier of generic
drugs to underdeveloped countries. It supplies 20% of the global market for
generic medications and purchases more than 80% of the world's anti-retroviral
drugs each year. It has donated a significant number of critical
pharmaceuticals to international charity and non-profit organizations like
Medecins Sans Frontières, PEPFAR, UNICEF, and the Global Fund.
A
lack of patent obstacles aided India's generic medication manufacturing skills,
which have lowered the cost of certain medicines.However, global patent rules
enacted in the recent decade, including one in India in 2005, prevent the
generic business from producing some pharmaceuticals.
As
a result, India has given some patents to US-made TB, HIV, and hepatitis C
medicines, preventing Indian manufacturers from copying them. India, on the
other hand, has not been constrained by patent laws. Its patent office has
turned down patent applications from prominent pharmaceutical companies like
Novartis and Gilead, which make cancer and hepatitis C treatments,
respectively. This means that Indian companies are permitted to make lower-cost
generic versions of the same products.In addition to the patent issue, India's
ability to create generics could be impeded if it completes an fourteen-year-in-the-making
free trade agreement with the European Union.
A
data exclusivity provision is being negotiated, which will allow pharmaceutical
companies in European Union member countries to keep clinical test data
demonstrating a new drug's safety and efficacy for up to five years before it
can be commercialized. It would imply that generic pharmaceutical businesses would
have to generate their own data before marketing off-patent pharmaceuticals.If
the clause is allowed, it might stifle India's generic business and affect the
pharmaceutical industries in Southern Africa by preventing generic versions of
these pharmaceuticals from being imported.[6]
The FUTURE OF GENERICS: -
Patent laws and drug exclusivity
agreements are a major challenge for the global HIV and AIDS movement. South
Africa and the Treatment Action Campaign fought a long but successful battle to
gain access to more affordable medicines. It used constitutional litigation to
gain access to cheaper generic anti-retrovirals.
Because
of high HIV rates and medicine shortages, other southern African nations such
as Malawi and Zambia rely significantly on low-cost treatment and
generics.Because the future of generic drug manufacture is in jeopardy,
developing countries must investigate other options for southern Africa.
To
prevent generic businesses from losing money, pharmaceutical companies have
long offered "reduced price offers" on anti-retrovirals to developing
countries. These offers are tailored to specific products available in each
country. There is a lack of transparency in terms of which countries are
offered specific prices.Extensive research and development of new medicines and
vaccines is becoming increasingly
necessary. This would allow more businesses to enter the market, ensuring that
pricing remain competitive.
Compulsory
License For Exploiting The Pharmaceutical Patent
An inventor is awarded the essential
protection for a set period of time after acquiring a pharmaceutical patent.
During this time, an inventor has the right to use the invention in whichever
way he sees fit.However, in some circumstances, if the competent authority
provides others a compulsory licence to exploit the patent without the approval
of the patent owner, an inventor is required to allow others the right to use
the innovation. Thus, the patent is used by requiring the patent owner to
enable others to exploit the innovation under the terms of a judgement issued
by the state's competent authority for fair compensation.
Compulsory
licenses for others to exploit a pharmaceutical patent are one type of
exploitation that occurs against the patent owner's wishes and constitutes a restriction
on medication protection. Though it is one of an inventor's rights to exploit
his or her idea, it is also an obligation to utilize the pharmaceutical
invention to meet the state's health needs. If an inventor fails to fulfil this
requirement, the state has the authority to give forced licenses if certain
conditions are met.
Pharmaceutical Patent Abuse: -
Our pharmaceutical industry in the
United States is predicated on a balance between innovation and access. Brand
pharmaceutical companies are rewarded for inventing and developing new
treatments and cures that improve the quality of life for everyone. In return
for the innovation, current law provides brand pharmaceutical companies with 12
years of guaranteed market exclusivity (monopoly) for biologics and 20 years
for each patent. There is also extra monopoly time to incentivize pediatric
drug development and orphan drugs. During the period of patent and marketing
exclusivity, brand drugs are priced and sold free from competition. Once the
exclusivity period expires and the drug is no longer patentable, generic
manufacturers and the emerging biosimilars market are given the option to
produce the identical medicine. When there is more competition on the market,
the price of medicine drops dramatically, and patients benefit from having
cheaper, FDA-approved drugs. Prescription medicine costs have been shown to
drop by more than 60% in the first year after generics hit the market.However,
we're seeing more and more evidence of how the patent system is being used to
skew the scales and delay patient access much beyond what Congress intended.
According to a recent assessment from I-MAK, the top 12 brand pharmaceuticals
on the market last year were covered by a total of 848 patents (71 per drug),
allowing for a 38-year period without generic competition. Here are a few
excerpts from the report:
·
Humira,
the world's best-selling brand medicine, is used to treat arthritis and other
chronic diseases. Since 2002, 132 patents have been on the market, blocking competition
for up to 39 years.
·
The
FDA authorized Revlimid, one of the most often prescribed cancer therapies, in
2005. The patent tangle consists of 96 patents that might provide 40 years of
exclusivity.
·
Due
to the 49 patents issued, diabetes patients who rely on the insulin medication
Lantus may not see a generic option for another 37 years.
Patent and Vaccines for Treatment of
Covid-19: -
Several vaccinations to tackle the
global coronavirus (COVID-19) disease have been created at a rapid pace in a
spectacular accomplishment of science and technology. It is an example of what
can be accomplished for humanity with adequate financing and investment in
research and technology, as well as intellectual property regulations that
encourage innovation. Patents contribute to this incentive. Patents are an
important aspect of a healthy innovation ecosystem because they provide an
incentive for businesses to invest in socially beneficial innovation. Patents
are essential for incentivizing innovation, which includes the development of
novel vaccinations.A patent specification's vital information enables for the
public sharing of knowledge, allowing others to learn from current inventions
and build on them to generate new and potentially life-saving advancements.[7]
There
have been amazing research and innovation efforts to combat the SARS-COV-2
virus and linked sickness since the commencement of the COVID-19 epidemic. This
patent landscape analysis combines results with clinical trial data for
relevant candidate vaccines and medications, and gives early observations on
the patenting activities in the field of COVID-19 vaccines and therapies.[8]
Vaccines
against the coronavirus illness of 2019 (COVID-19) are currently the best
option for combating the pandemic. The global fight against the severe acute
respiratory syndrome coronavirus 2 (SARS-Cov-2) should be viewed as a global
conflict in which no country, particularly low-income ones, can be left behind.
With the emergence of new varieties, this last element may actually enhance the
virus's unrestrained reproduction. The waiver of patent rights for COVID-19
vaccines is one possible approach to limit this problem.For the duration of the
pandemic, until global herd immunity is achieved, India and South Africa asked
the World Trade Organization (WTO) to allow all countries to choose not to
grant or enforce patents and other intellectual property (IP) related to
COVID-19 drugs, vaccines, diagnostics, and other technologies.The US
administration indicated its willingness to liberalize intellectual property
for COVID-19 vaccinations on May 5, 2021.
Although
this is an intriguing topic, its viability is exceptionally difficult and
complicated. As a result, there are differing viewpoints among academics and
clinicians on the true use of patent liberalization. It has been proposed that
an exception be granted to the World Trade Organization's founding accords,
specifically the Agreement on Trade Related Aspects of Intellectual Property
Rights. This request would be predicated on the notion that vaccines against
the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) could be
deemed a "common good" during a pandemic, analogous to water or
air.The aforementioned concepts should be considered in the Roman category of "res
communes omnium," meaning not appropriable and prohibited from legal
trade, according to the Economic Theory of the Commons, which is backed by
Elinor Ostrom, recipient of the Nobel Prize in Economics in 2009.
In
practice, the suspension of patent rights would limit the business models
available to legal COVID-19 vaccine producers. The direct donation of vaccines
from high-income countries, the reduction of production line costs, the
shortening of patent protections, and a series of preferential patent waivers to
countries that manufacture a large percentage of the world's vaccines are all
possible strategies to encourage the waiver of patent protections (e.g.,
India).Solidarity among several governments or other organizations is one of
the other viable alternatives. The programme for COVID-19 Vaccines Global
Access, for example, follows this concept (COVAX). The World Health
Organization, the Global Alliance for Vaccines and Immunization (GAVI), and the
Coalition for Epidemic Preparedness Innovations (CEPI) all endorse the latter
(WHO).[9]