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PATENTING GENES
Can genes be patented?
A gene patent is the exclusive rights to a specific sequence of DNA (a gene) given by a
government to the individual, organization, or corporation who claims to have first identified the
gene. Once granted a gene patent, the holder of the patent dictates how the gene can be used, in
both commercial settings, such as clinical genetic testing, and in noncommercial settings,
including research, for 20 years from the date of the patent. Gene patents have often resulted in
companies having sole ownership of genetic testing for patented genes.
Examples of disease gene patents
Well-known examples of disease gene patents include those covering genes implicated in breast
and ovarian cancers (BRCA1 and BRCA2), colon cancers (HNPCC, FAP), cystic fibrosis
(CFTR), hemochromatosis (HFE) and a growing number of neurological diseases including late-
onset Alzheimer’s disease (Apo-E), Canavan disease, Charcot-Marie-Tooth disease (CMT-1A,
CMT-X), spinal muscular atrophy (SMN1), spinocerebellar ataxia (SCA1–12) and others.
● There are several characteristics of genes and disease gene patents that demonstrate how
the genome is being divided up by small patent claims to overlapping genetic territory.
● First, any one gene may have multiple patents claiming the diagnosis of different
polymorphisms.
● Thus, several patents have been issued for testing of different mutations in the CFTR
gene.
● Further, some diseases (at least the phenotypic expressions of them) are caused by
multiple genes, such as Charcot-Marie-Tooth disease.
● Questions about ownership and access get messy when there are many hundreds of
known mutations in multiple causative genes, as exemplified by BRCA1 and BRCA2, for
which there are at least a dozen US patents on tests of these two genes.
● Finally, patents can issue on the same exact molecular test when it is performed for
different diagnostic or prognostic purposes.
● For example, an Apo-E test, in which the number of E2, E3 and E4 alleles carried by a
patient is assessed, can be performed for each of the following patented uses:
(1) determining whether a patient is at risk of early onset Alzheimer’s disease
(2) assessing an Alzheimer’s disease patient’s prognosis
(3) determining a course of therapy based on pharmacogenetic receptivity and
(4) assessing a patient’s prostate cancer risk.
● Gives companies that patent genes time to look at the genes without competition. These
companies do not have to worry that other companies are competing with them to make
new discoveries. This is especially important for smaller companies that may not have the
financial support to compete with larger, more established companies.
● Encourages research and development in private industry. Patents support innovation and
invention by giving companies rights to gene sequences. The lure of a potential patent
drives and pushes researchers to think more creatively and work harder in order to obtain
a patent for their work.
● Provides opportunities for investment in research and development. Companies, as well
as individuals, can invest in a patented gene. This provides financial support for the
development of useful innovations. It can take hundreds of millions of dollars to
introduce a new drug to the market. Most companies do not have this money and rely on
investors for financial assistance.
Cons:
● Hinders research. Since patents give the owners intellectual property rights on the
patented genome sequence for 17 to 20 years, many people fear that gene patents hinder
research. For example, patents on the BRCA1 and BRCA2 gene variants, which have
been linked to inherited breast and ovarian cancers, belong to Myriad Genetics. The
patents give Myriad Genetics exclusive rights to conduct diagnostic tests on these genes.
This means that other companies are not allowed to work with these genes, missing out
on the potential to make important discoveries on these patented genes.
● Leads to monopolization of genes. Companies that hold gene patents have exclusive
rights to them and may decide to not allow other companies to look at these genes. This
may lead to a monopoly and foster a secretive culture among research companies.
● Slows down medical results. If a company holds a gene patent, they own sole rights to
research and testing on that gene. So if a patient has a test done on that gene, the samples
must be sent to the company owning the gene patent in order to be tested. This could
cause delays in getting test results.
● Patenting a plant gives you the right to stop others from manufacturing, selling or
importing your plant without your permission.
● Additionally, you will get protection for a predetermined period, allowing you to keep
competitors at bay. You can then utilize your invention by yourself.
● Alternatively, you can license your patent for others to practice it or you can sell it. This
can provide important revenue for your business.
● Indeed, some businesses exist only to assemble the authorities they have licensed perhaps
in sequence with a registered design including trademark.
PATENTING ANIMALS
What are Animal Patent and How Does It Work?
Patents can be granted for organisms that aren't found in nature. This isn't to suggest that you
can't patent your mixed-breed dog or cat, or a better dairy cow or pig developed through years of
careful breeding. It is not possible to patent a plant or animal that can be found in the wild.
Animals that can be patented are those that have been genetically modified by humans and so do
not exist in the wild. Because their genomes have been altered with genes or DNA from other
animals or humans, these species are frequently referred to as "transgenic" animals. Scientists
modify these creatures to make them exhibit desirable features for research or experiments.
Key points to remember
● Until the 1980s, it was widely agreed that living things are not patentable. The United
States was the first country to take a look at the matter of patenting living organisms;
● The fact that patenting creates an encouragement for use and for profiting from species is
what makes the legal protection problematic to ethics;
● Animal patenting creates moral but also economic costs.
● 18% of patented animals are not genetically engineered, instead they are principally
PATENTING MICROBES
Patenting of microbes is a process that allows the creators or developers of new and useful
microorganisms, such as bacteria, viruses, fungi, and other microorganisms, to obtain exclusive
rights to use and sell their inventions for a specific period of time. In order to be eligible for a
patent, a microbe must meet several requirements, including novelty, non-obviousness, utility,
and man-made origin.
Patenting of microbes has become increasingly common in recent years, especially in the field of
biotechnology. It provides companies and individuals with an incentive to invest time and
resources into developing new and useful microbes with specific functions. However, patenting
of microbes is also a controversial issue, with some people arguing that it restricts access to
important scientific and medical tools and stifles innovation in the field of microbiology.
Requirements to Attain Microbe Patent
Microbes, such as bacteria, viruses, fungi, and other microorganisms, can be patented under
certain circumstances. In order to be eligible for a patent, a microbe must meet several
requirements, including:
● Novelty: The microbe must be new and not previously known to the public.
● Non-obviousness: The microbe must not be an obvious variation of a previously known
microbe.
● Utility: The microbe must have a specific, useful function, such as producing a particular
chemical or breaking down specific waste products.
● Man-made: The microbe must have been created or modified by human intervention,
rather than being found in nature.
Procedure to Patent Microbes in India
The procedure to patent microbes in India is as follows:
Conduct a Patent Search: Before filing a patent application, it is advisable to conduct a patent
search to ensure that the microbe is new and not already patented.
Prepare a Patent Application: A patent application must be filed with the Indian Patent Office,
including a detailed description of the microbe and its function, as well as any laboratory results
or experimental data that supports its utility.
Examination of Patent Application: The Patent Office will examine the application to
determine if it meets the necessary requirements for patentability, including novelty, non-
obviousness, and utility.
Request for Examination: If the patent application is accepted, a request for examination must
be filed. The examination process can take several years, during which time the patent applicant
may be required to provide additional information or data.
Grant of Patent: If the Patent Office determines that the microbe meets all requirements, a
patent will be granted, providing the patent holder with exclusive rights to use and sell the
microbe for a period of 20 years from the date of filing the patent application.
Maintenance Fees: The patent holder must pay annual maintenance fees to keep the patent in
force.
It is important to note that the process of obtaining a patent for a microbe can be complex and
time-consuming, and it is advisable to seek the assistance of a patent attorney or agent with
experience in this area. Additionally, the rules and regulations surrounding the patenting of
microbes are subject to change, and it is important to stay informed about any updates or changes
in the law.
PATENTING TRANSGENIC / GENETICALLY MODIFIED ORGANISMS (GMO)
GMO Patents: Everything You Need to Know
Genetically modified organism (GMO) patents refer to intellectual property rights that the United
States government issues to inventors of GMOs as a form of protection against infringement. 3
min read
Genetically modified organism (GMO) patents refer to intellectual property rights that the United
States government issues to inventors of GMOs as a form of protection against infringement.
GMOs are food products that have been artificially modified through genetic engineering to
possess new traits and benefits. As the demand for food increases around the world, more GMO
products are being invented, leading to a rise in the number of GMO patents granted.
What Is Covered by the GMO Patents?
GMO patents can provide protection for the following:
● GMO plants
● New plants that are discovered or invented in a cultivated state and can be asexually
reproduced
● Plants that are sexually reproduced by licensees. Their seeds cannot be given or sold to
other parties for planting.
TRADE SECRETS
What is a Trade Secret?
Trade secrets are intellectual property (IP) rights on confidential information which may be sold
or licensed.
A trade secret is any practice or process of a company that is generally not known outside of the
company. Information considered a trade secret gives the company a competitive advantage over
its competitors and is often a product of internal research and development.
To be legally considered a trade secret in the United States, a company must make a reasonable
effort in concealing the information from the public; the secret must intrinsically have economic
value, and the trade secret must contain information. Trade secrets are a part of a
company's intellectual property. Unlike a patent, a trade secret is not publicly known.
Key points to remember
● Trade secrets are secret practices and processes that give a company a competitive
advantage over its competitors.
● Trade secrets may differ across jurisdictions but have three common traits: not being
public, offering some economic benefit, and being actively protected.
● U.S. trade secrets are protected by the Economics Espionage Act of 1996.
● Choose an attorney
● For Register trademark in India under Sec 59(rule 98), you should submit 5 copies of
your trademark along with the application with Form TM-38.
Real-World Examples
There are many examples of trade secrets that are tangible and intangible. For example, Google's
search algorithm exists as intellectual property in code and is regularly updated to improve and
protect its operations.
The secret formula for Coca-Cola, which is locked in a vault, is an example of a trade secret that
is a formula or recipe. Since it has not been patented, it has never been revealed.
The New York Times Bestseller list is an example of a process trade secret. While the list does
factor in book sales by compiling chain and independent store sales, as well as wholesaler data,
the list is not merely sales numbers (books with lower overall sales may make the list while a
book with higher sales may not).
GEOGRAPHICAL INDICATIONS
What is a geographical indication?
A geographical indication (GI) is a sign used on products that have a specific geographical origin
and possess qualities or a reputation that are due to that origin. In order to function as a GI, a sign
must identify a product as originating in a given place.
In addition, the qualities, characteristics or reputation of the product should be essentially due to
the place of origin. Since the qualities depend on the geographical place of production, there is a
clear link between the product and its original place of production.
Copyright could be a style of property law. it’s registered to shield original items of labor like
music, art, literature, cinema/film, photography, or a worm. There are in-depth classes that may
be registered for copyright by the creators. It provides exclusive and complete rights to the
creator of the work.
● The General Agreement on Tariffs and Trade (GATT) was signed by 23 countries in
October 1947, after World War II, and became law on Jan. 1, 1948.
● The GATT held eight rounds in total, from April 1947 to December 1993, each with
significant achievements and outcomes.5
● In 1995, the GATT was absorbed into the World Trade Organization (WTO), which
extended it.
What is the purpose of the General Agreement on Tariffs and Trade (GATT)?
The General Agreement on Tariffs and Trade (GATT) was set up to eliminate protectionism, get
countries trading freely among themselves, and help restore economic prosperity following the
devastation of World War II.
Is the GATT a free trade agreement?
That was essentially its goal. The GATT sought to push the world toward a reality where goods
and services are exchanged among countries without tariffs, quotas, and so forth, and without
favoritism and discrimination.
● The Bill amends the Biological Diversity Act, 2002 to simplify compliance requirements
for domestic companies.
● Users of codified traditional knowledge and AYUSH practitioners will be exempted from
sharing benefits with local communities.
● The Bill removes research and bio-survey activities from the purview of benefit sharing
requirements.
● Benefit sharing will be based on terms agreed between the user and the local management
committee represented by the National Authority.
● The term codified traditional knowledge has not been defined. A broad interpretation
might exempt all local traditional knowledge from benefit sharing requirements.
● The Bill removes the direct role of local communities in determining benefit sharing
provisions.
● The Bill decriminalises offences under the Act and instead provides for a wide range of
penalties. Further, the Bill empowers government officials to hold inquiries and
determine penalties. It may be questioned whether it is appropriate to confer such
discretion to government officials.
Joint Parliamentary Committee Report Summary
The Biological Diversity (Amendment) Bill, 2021
The report of the Joint Parliamentary Committee on the Biological Diversity (Amendment) Bill,
2021 (Chair: Dr. Sanjay Jaiswal) was tabled in Parliament on August 2, 2022. The Bill was
introduced in Lok Sabha on December 16, 2021. The Bill amends the Biological Diversity Act,
2002. The Act provides for the conservation of biodiversity and sharing of benefits from access
to biodiversity and associated knowledge with local communities.
Key observations and recommendations of the Committee include:
Codified traditional knowledge: The Bill exempts access to codified traditional knowledge
from benefit-sharing provisions. However, it does not define the term ‘codified traditional
knowledge’. The Committee observed that most of the traditional knowledge in the AYUSH
system of medicine is codified. It also observed that traditional knowledge registered in the
people biodiversity register may also be taken as codified. This may lead to denial of benefit to a
majority of local traditional knowledge holders. The register is prepared by the local authorities
to document biodiversity as per the provisions of the Act. The Committee recommended that the
term be defined in the Bill. It should be defined as the knowledge derived from authoritative
books specified in the First Schedule of the Drugs and Cosmetics Act, 1940. The Schedule lists
books on Ayurveda, Siddha, and other traditional medicine systems.
Cultivated medicinal plants: The Bill exempts access to cultivated medicinal plants from
benefit-sharing provisions. It provides that the central government may prescribe a manner of
issuing certification of origin for cultivated medicinal plants. The Committee recommended
removing the rule-making power. It instead recommended providing further clarification
regarding the issuance of the certificate in the Bill itself. The Bill should provide that a
certificate of origin will be obtained through an entry into the books of the concerned local
authorities.
Foreign-controlled company: The Bill provides that a company incorporated in India, which is
a foreign-controlled company, will require approval from National Biodiversity Authority for
specified activities. Under the Bill, a foreign-controlled company means a foreign company as
per the Companies Act, 2013, which is under the control of a foreigner. The Companies Act
defines a foreign company as a company or body corporate ‘incorporated outside India’. The
Committee recommended that a foreign-controlled company should instead be defined as a
company incorporated or registered in India, which is controlled by a foreigner as per the
Companies Act.
Promotion of biological resources: The Act provides that funds set up under it will be utilised
for specified purposes including the promotion and conservation of biological resources. It also
requires the central government to formulate national strategies and programmes for the
promotion, conservation, and sustainable use of biodiversity. The Bill removes reference to
promotion of biological resources in the above cases. The Committee recommended that the Bill
should retain provisions for the promotion of biological resources at all such places. It further
recommended that the central government should formulate national strategies and plans in
consultation with the state governments and union territories.
Preservation of habitats: The Act requires the local bodies to set up a Biodiversity
Management Committee within its area for carrying out certain functions. These include: (i)
promoting conservation and sustainable use of biodiversity including preservation of habitats,
conservation of folk varieties, breeds, land races, and microorganisms, and (ii) documentation of
biodiversity. The Bill removes the reference to preservation of habitats. The Committee
recommended retaining the provision for preservation of habitats. It also recommended to
include the conservation of living things in water bodies among the functions.
Penalties: The Bill decriminalises offences under the Act and makes them punishable with a
penalty between one lakh rupees and Rs 50 lakh. Where damage exceeds the amount of penalty,
the penalty will be commensurate with the damage caused. Continuing contravention may
attract an additional penalty of up to one crore rupees. The Committee observed that the penalty
structure should not be too meagre, which may enable violators to escape with a little amount of
penalty. It recommended that the penalty should be proportionate to: (i) gains obtained by
entities, and (ii) the size of the company.