Patenting
Biotechnological Inventions - microorganisms, plants, animals and other
biological processes and products
Patent laws of most
countries are solely based on non-biological objects and inventions. Since
biotechnology involves application of technology on biological organisms, viz.,
microorganisms, plant and animals and biological material of DNA, RNA and
proteins, patenting of biotechnological inventions and processes for the
development or manufacture of a product or solution is a real world problem.
Whether living organisms, such as, microorganisms, plants or animals, or
naturally occurring substances, such as DNA and proteins, cloning and
bioinformatics can be regarded as an invention is very controversial.
Concept
of Novelty in Biotechnological Inventions
In the case of
biotechnological inventions, the assessment of novelty is carried out in the
same manner as for other inventions. For the purpose of ascertaining novelty
during the examination, the prior art is to be considered.
According to Section 2
(1) (j) of the Act, an "invention" means a new product or process
involving an inventive step and capable of industrial application. An invention
will be patentable only if it is new in the light of prior art, or is not
anticipated by prior art. The prior art includes all information and knowledge
relating to the invention, which is available in any publication before the
date of the patent application.
Concept
of Inventive Step in Biotechnological Inventions
The Manual of Patent
Office Practice & Procedure has set out the guidelines for assessment of
Inventive Step of inventions. An invention should possess an inventive step in
order to be eligible for patent protection. As per the Patents Act, an
invention will have inventive step if the invention involves (a) technically
advanced as compared to existing knowledge or (b) having economic significance
or (c) both, and that makes the invention not-obvious to a person skilled in
the art.
Concept
of Industrial application in Biotechnological Inventions
To be patentable an
invention must be useful and capable of industrial application. As per Section
2(1) (ac) of the Act, the expression “capable of industrial application”, means
that the invention is capable of being made or used in an industry”. The application
should disclose the usefulness and industrial applicability of an invention in
a distinct and credible manner.
Patenting
Microorganisms
For over 200 years living
organisms were excluded from patent laws; life forms were considered a ‘product
of nature,’ not a human invention.
Before 1980, Patents were given for inventions based on microbiological
processes. No patent was given for the living entities, which were considered
to be the products of nature. First patent based on microorganisms was made by
Louis Pasteur on 28 January 1873, for the process of fermenting beer. Louis
Pasteur received US Patent on 22 July 1873, for ‘yeast, free from organic germs
of disease, as an article of manufacture’.
The products of nature
doctrine prohibited patentability of materials existing in nature, including
living matter. So one could secure patents for fermentation processes and purification
of naturally occurring chemical or biological compounds as well as patents for
microorganisms as a culture or in combination with a carrier. The product
claims for microorganisms were not patentable because they comprised of living
materials. The non-patentable status of living organisms changed with the
landmark decision of the Supreme Court, USA, in Diamond v. Chakraborty in 1980.
Ananda Chakrabarty’s invention of a new Pseudomonas bacterium genetically
engineered to degrade crude oil was rejected by US Patent Office, but the
Supreme Court decision went in favour of Chakrabarty in a landmark case,
Diamond (USPTO commissioner) v Chakrabarty (inventor). Chakrabarty’s
Pseudomonas bacterium was a manipulated version that contained four plasmids controlling
the breakdown of hydrocarbons and thus was ‘a new bacterium with markedly
different characteristics from any found in nature’. The Supreme Court stated
that new microorganisms not found in nature were either ‘manufactured’ or
‘composition of matter’ and thus patentable. Thus it was not a ‘product of
nature’ and can be patentable.
Following Chakrabarty
case, European Patent Office (EPO) and the Japanese Patent Office (JPO) also
started granting patent protection for microorganisms in 1981. The Government
of India permitted patenting of microorganisms in India under the Patents
(Second Amendment) Bill, 2002 and the microorganisms and microbiological
inventions can be patented in India provided the strain is new.
Inventor has to deposit
the new strain in any recognized international depository as per the Budapest
Treaty. The Budapest Treaty on the
International Recognition of the Deposit of Microorganisms for the Purposes of
Patent Procedure, or Budapest Treaty, is an international treaty signed in Budapest,
Hungary, on 1977. The treaty is administered by the World Intellectual Property
Organization. The treaty allows ‘deposits of microorganisms at an international
depositary authority to be recognized for the purposes of patent procedure’.
Usually, in order to meet
the sufficiency of disclosure, patent applications must disclose the
subject-matter of the invention in a sufficiently clear and complete manner to
be carried out by the person skilled in the art. Regarding any invention involving microorganisms,
it is impossible to describe it completely. As a result, in the cases of
inventions involving microorganisms, a deposit of biological material must be
made in a recognized institution. The Budapest Treaty ensures that a patent
applicant need not deposit the biological material in all countries where he /
she wants to obtain a patent, instead, needs to deposit the biological material
only at one recognized institution and this deposit will be recognized in all
countries obliging the Budapest Treaty.
Such institution is recognized as International Depositary Authority
(IDA). The range of materials that can
be deposited under the Budapest Treaty includes: cells (such as bacteria,
fungi, eucaryotic cell lines, spores), genetic vectors (plasmids or bacteriophage
vectors or viruses) containing a gene or DNA fragments, organisms used for
expression of a gene.
There are 34
International depositories for deposition of microbial cultures. In India,
Microbial Type Culture Collection and Gene Bank (MTCC) at the Institute of
Microbial Technology (IMTECH), Chandigarh, is a recognized international
depository of microorganisms.
Patenting
Plants
The US Plant Patent Act
(PPA), enacted in 1930, allowed patenting of asexually propagated plants. Over 6,500 of such plant patents have been
granted for ornamental and fruit trees. In 1985, the US Board of Patent Appeals
allowed patent protection for asexually, sexually or in vitro propagated
plants. Following the principle established in the Chakrabarty case, it was
decided that US utility patents could be granted for genetically modified
plants also. Among transgenic plants, herbicide- resistant cotton, canola,
soybean and insect-resistant potato, cotton, maize, etc. are patented.
In Japan also plant
patents are allowed. Plant patents have
been granted by European Patent Office from 1989.
Life forms of plants and
animals except microorganisms are not patentable in India. Also a method or
process of agriculture and horticulture is non-patentable. However, methods for
rendering plants free of diseases or putting an additive value to a plant can
be patented.
India and many other
countries do not protect plants by strict patenting system. But there is a
mandate in the TRIPS Agreement that plant varieties must be protected. Thus
India has enacted ‘Protection of Plant Varieties and Farmers’ Rights’ (PPVFR)
Act, 2001, a sui generis system of plant variety protection.
The model for this was
the UPOV Act, an International Convention of the Union for the Protection of
New Varieties of Plants for the protection of new varieties of plants in Paris
in 1961 and came into force in 1968. Under the UPOV, a plant variety qualifies
for protection when it meets three essential criteria, (i) distinctiveness,
(ii) uniformity and (iii) stability, and the variety should be new in
commercial sense. Application for its protection can be filed in the country
where developed or in any other UPOV member country.
The Indian PPVFR Act is
in place but yet to be enforced. This act tends to provide a balance between
the rights of breeders and farmers. Plant variety protection (PVP) may be
provided to new varieties, extant varieties (already in cultivation or of
common knowledge) or farmers’ varieties. The essential features are same as
distinctiveness, uniformity, stability for extant and farmer’s varieties, but
novelty feature is included in the newly developed variety. It will provide
maximum protection for 18 years to trees and vines and 15 years to other crop
varieties.
Patenting
Animals
In 1980s, US Patent
Office examined whether multicellular animals could be patented. In 1987,
patent application for a products-by- process patent on a method of inducing
polyploidy in oysters as well as the resulting oysters was rejected by USPTO. On 1988, USPTO issued the first patent on
transgenic non-human animal ‘Harvard Mouse’ developed by Philip Leder and
Timothy Stewart. The ‘Harvard Mouse’ was created through a genetic engineering
technique of microinjection. To the fertilized egg, a gene known to cause
breast cancer was injected and then this egg was surgically implanted into the
mother. The resulting transgenic mice were extremely prone to breast cancer.
European patent was issued in 1992. By 2002, more than 300 patent applications
for transgenic animals have been filed but so far few have been granted by EPO.
EPC, Rule 23c states that
inventions concerning biological materials, such as DNA, microbiological
process, plants, and animals are patentable only if ‘the technical feasibility
of the invention is not confined to a particular plant or animal variety’. EPC
has stated that certain inventions are excluded from patentability whose
exploitation is contrary to ordre public or morality. They are processes for cloning human beings;
processes for modifying the germ line genetic identity of human beings; use of
human embryos for industrial or commercial purposes; and processes for
modifying the genetic identity of animals which are likely to cause them
suffering without any substantial medical benefit to man or animal, and also
animals resulting from such processes.
In Japan, animals became
patentable after 1988 when the ‘Harvard Mouse’ patent was issued by USPTO. By
the end of 1998, nineteen animal patents were issued by JPO, majority of them
the products of genetic engineering.
Indian Patents Act has
excluded the following from patentability
• Section 3(j), plants and animals as a whole or any part
thereof other than microorganisms but including seeds, varieties and species
and essentially biological processes for production or propagation of plants
and animals
• Section 3(i) ‘any process for medical, surgical, curative,
prophylactic (diagnostic, therapeutic), or other treatment of human beings, or
any process for a similar treatment of animals to render them free of disease
or to increase their economic value or that of their products’.
In pursuance to the TRIPS
Agreement, human beings or treatment procedures are neither patentable in India
nor anywhere else. Modified animals are patentable in USA, Japan, Korea, Hungary,
South Africa and few other countries. Patent offices of USA, Japan and
Australia grant patents on human body parts such as limbs, organs and tissues.
The making of human body parts is an invention since they exist in nature, but
modified or isolated body parts are viewed as multicellular organisms and
treated as such for patentability if they meet the statutory requirements.
Patenting
other biological processes and products
Inventions arising from
biological research can mean nucleic acids, proteins, kits for the manipulation
or use of DNA or proteins in the laboratory or in medicine, diagnostic kits,
pharmaceuticals, microarrays, pieces of software for bioinformatics analysis,
or industrial-scale processes for the production of food or medicine. Biotechnology also deals with inventions for
models of diseases and methods of drug
discovery, such as the ‘Harvard Mouse’ or ‘OncoMouse’
·
Cloning
Cloning is the process of
transferring nucleus of an adult multicellular organism’s cell to an
unfertilized egg of the same species. In
Transgenic cloning a particular gene is added to the nucleus of an adult organism
cell and then this nucleus is transferred to an unfertilized egg of the same
species. Dolly, the first mammal sheep, was created in 1997 by cloning.
Creation of animals by cloning is patentable in some countries. However,
patenting of human cloning issue varies in different countries. Japan banned
human cloning in 2001, but in July 2004, Japan Government Science Council
permitted limited cloning of human embryos for scientific research. Britain and
South Korea also allow cloning of human embryos for therapeutic purposes.
United States prohibits human embryo cloning but allows patenting of animal
cloning.
·
Biological
Compounds
Biological compounds,
such as DNA, RNA and proteins are naturally occurring. The ability and methods
to isolate genes and produce proteins they encode has enormous commercial
impact and is vital for the survival and success of biotechnology industry.
Under US patent law, DNA
sequences are considered chemical compounds by USPTO and are patentable as
compositions of matter. As per USPTO isolated and purified DNA molecule that
has the same sequence as a naturally occurring gene is different from the
naturally occurring compound as it is processed through purifying steps that
separate the gene from other molecules naturally associated with it and hence
eligible for patent protection. If a patent application discloses nucleic acid
molecular structure only for a newly discovered gene, and no utility, the
claimed invention is not patentable since one of the requirements of a patent
is utility.
As per EPO, definition of
biotechnological invention is invention that concerns ‘a product consisting of
or containing biological material or a process by means of which biological
material is produced, processed or used’. This includes DNA- related
inventions, such as an isolated DNA fragment and the gene it encodes or DNA
sequence analysis protocols and its software products. The definition of
biological material is ‘any material containing genetic information and capable
of reproducing itself or being reproduced in a biological system’. The biological
materials, such as, DNA, protein, plasmids, are patentable if the materials are
isolated from its natural environment or produced by means of a technical
process.
Indian Patent Act allows
inventions on isolation for a substance like DNA. Gene sequences are patentable
if function of the has been ascribed.
The JPO points out that
since ‘the aim of the patent law is to develop industries, only inventions that
are useful or having industrial applicability are patentable’.
·
Expressed
sequence tags (ESTs)
An EST is part of a
sequence from a cDNA molecule of expressed gene and can be used to identify and
locate an expressed gene. The patenting of ESTs is highly controversial. In
1998, the first ‘EST patent’, ‘Human Kinase Homologs’ was issued to Incyte Pharmaceuticals
Inc by USPTO. By 1998 patent claims for over 1.2 million DNA sequences were
filed.
The patentability of ESTs
and DNA fragments were studied by the Trilateral Patent Offices (USPTO, EPO,
JPO) and is summarised as: Isolated and purified nucleic acid molecule-related
inventions, including full-length cDNAs and SNPs, of which function or
specific, substantial and credible utility is disclosed, which satisfy
industrial applicability, enablement, definiteness and written description
requirements would be patentable as long as there is no prior art (novelty and
inventive step) or other reasons for rejection.
·
Bioinformatics
and Patenting
Bioinformatics
encompasses all aspects of biological information: acquisition, processing,
storage, distribution, analysis and interpretation. pPatent offices have
created separate units for bioinformatics. There are three basic types of
inventions on bioinformatics which can be patented.
1. Tools of Bioinformatics
Computer software is one
of the central tools of bioinformatics. In the USA, if a claim contains a
mathematical algorithm, but is limited to a practical application in the
technological arts, it might be patentable only if it meets patentable utility.
In Europe, EPC
disqualifies computer programs from patentability. Also excluded are aesthetic
creations, discoveries, scientific theories, mathematical methods and other
activities that are essentially non-technical in character. Despite this,
applicants obtain patents covering computer programs by not claiming computer
programs ‘as such’. The computer programs are patentable as long as they are
technical in nature.
2. The Methods of Bioinformatics
Patenting of
bioinformatics methods is especially relevant because classical biotechnology
claims, e.g. methods for generating a tangible such as RNA, DNA or protein do
not provide satisfactory protection for the true product of bioinformatics -
information.
In the USA, business
methods are patentable subject matter, but they are unpatentable ‘as such’
under the EPC. A patentable business method (or computer program) at EPO must
have technical elements - it must be at least partly computer implemented.
3. The Product of Bioinformatics
Bioinformatics produces
information. In Europe, information as
such is unpatentable because of its abstract nature. However, EPO has allowed
claims directed to data due to the technical content. In the USA, claims have been obtained to
business methods and to methods in which the resulting product is information.
The applicant must ensure
that, if information is to be claimed, it is claimed in a technological nature.
For example, nucleic acid and protein sequence data, which is a primary data
that lack any annotation is non patentable. However, elements of information of
this type can be combined with other sources of data to provide useful further
information, such as the function of a gene or a polypeptide. This information
is technical and may concern diagnosis of diseases, therapy, biotechnology,
genetic engineering, etc and can be patented. Data can be technical if they
provide functional information of any useful sort.
Under the Indian Patents
Act, Section 3 (k) a mathematical or business method or a computer program per
se or algorithms are not inventions and hence unpatentable.
Justification
for Protection - Why consider patenting?
Our world is moving from
an economy based industry to one based on information. So protecting ideas becomes increasingly
important. Ideas can be captured and passed on as information and then it can
be transferred from one place to another much more easily and quickly than
physical objects. The economic value of information is greatest when it relates
to an idea, rather than that of a physical object, such as a manufacturing
plant or commercial product. Because information about ideas is so valuable and
so easy to obtain and use, protecting ideas becomes a paramount concern. Here come the important of Intellectual Property
Rights, where the ideas, inventions and information can be patented.
Legally protecting
discoveries and inventions through patents provides an incentive for
researchers and businesses to undertake scientific inquiry for financial
benefit in return. Likewise, it results in competitors, thus bringing new
products to the market rapidly. On the other hand, permitting an inventor or
company to exclude others from making and using an invention can result in
higher costs for consumers or a delay in advances in the field.
For companies, patenting
is the more attractive choice rather than keeping it as a secret because it
enables the companies to profit. Due to the tight budgets and financial
accountability, pursuing patent protection for scientific discoveries and
inventions is also important for academic researchers, as patents can generate
prestige and income for them and also their institute.
In the present era,
patenting of biological organisms, cloning, genomics, bioinformatics are highly
important aspect areas and has become the core of biotech companies. During
earlier periods, biotechnological inventions were interpreted by different
patent offices of the world in different ways.
Now unification of ideas has emerged in some cases while differences
still persist on stem cell research, human cloning, etc. Let us hope in the
near future, these issues and confusions will be solved and common grounds will
be laid as per the TRIPS regulations.
References
·
Patenting of Biological Material and
Biotechnology, 2005, HS Chawla, Journal of Intellectual Property Rights, Vol
10, pp 44-51
·
Patenting inventions arising from
biological research, 2004, Matthew T Latimer, Genome Biology 6:203
·
Patenting
of microorganisms: Systems and concerns, 2010, Ramkumar Balachandra Nair, Pratap
Chandran Ramachandranna, Journal of Commercial Biotechnology,16, 337 – 347
