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BIOLOGICAL PATENTS:

A biological patent is a patent relating to an invention or discovery in biology. It can be a composition of


matter, a method for obtaining or using one or more thereof, or a product combining such things. Even
when a natural biological substance itself is patented (apart from any associated process or usage), this
has been permitted in the US as long as they are sufficiently "isolated" from their naturally-occurring
states. Prominent historical examples of such patents on isolated products of nature include
adrenaline, insulin, vitamin B12, and unmodified genes (the latter becoming its own notable
controversy as of late).

HISTROY
The 1970s marked the first time when scientists patented methods on their biotechnological
inventions with recombinant DNA. It wasnt until 1980 that patents for whole-scale living
organisms were permitted. In Diamond v. Chakrabarty, the U.S. Supreme Court established the
patentability of living matter, provided it was truly "man-made." The subject for this particular
case was a genetically-engineered bacterium that was specifically modified to help clean up and
degrade oil spills.
Since that 1980 court case, there has been much patenting of biological matter. Companies and
organizations, like the University of California, have patented entire genome. In 1998, the U.S. Patent and
Trademark Office (PTO) issued a broad patent claiming primate (including human) embryonic stem cells,
entitled "Primate Embryonic Stem Cells" (Patent 5,843,780). On 13 March 2001, a second patent
(6,200,806) was issued with the same title but focused on human embryonic stem cells.
Recently, there has been a slowdown and backlash against patenting biological material worldwide.

CONTROVERSY
Some believe that natural occurrences are not invented and thus should not be patentable. This is
especially true if the biological matter being patented can be found in humans, such as sequences of
DNA, which invokes a range of political and ethical arguments. The legal reasons for the
controversy can vary by different countries' standards for patentability. In the US, an invention
must have some "utility" but not necessarily an identified industrial application. According to
Nielson and Whittaker (2002), the notion of utility is less specific, it means it is useful. Beyond
utility/usefulness, the US also requires that inventions be new/novel and non-obvious.
Many outside the United States feel that the patenting of stem cells was rash and are seeking to reverse
patent rulings. In December 2006, Germany made an important precedent when it annulled the validity of
a stem cell patent. The German Federal Patent Court declared that anything made from human
tissue cannot be patented. The European Patent Office has ruled that certain stem cell lines, derived
from destruction of human embryos, were not to be granted a European patent. Worldwide, people are
questioning the validity of stem cell patents. Wisconsin Alumni Research Foundation has sought to gain
approval for its US patent in Europe without success.
The backlash against stem cell patents is also occurring in the United States, but to a lesser degree.
Currently, an appeal against the patents is being processed by two non-profit organizations: The
Foundation for Taxpayer & Consumer Rights and Public Patent Foundation along with molecular

biologist Jeanne Loring of the Burnham Institute. They are fighting the validity of the patents by arguing
that two of the patents cover a technique published in 1992, already patented by an Australian scientist.
Another claim is that the techniques tied up with the patents are rendered obvious under a 1990 paper and
two textbooks.
Advocates who speak against biological patents suggest that the techniques and processes
associated with the discovery could be patentable but not the actual biological matter itself. For
example, an advocate against biological patent would suggest that a gene associated with cancer should
not be patented, but the test used to detect the gene could be.

EFFECTS ON RESEARCH
Some believe that the increase in patenting biological information leads to inefficiency in research. Many
scientists are coming up against patent thickets, which are masses of information that they must obtain
permission (and often pay large fees to utilize) before they can ever work with the information. Michael
Heller and Rebecca Eisenberg (2005) explain that there is a recent trend of patenting more and more steps
along the research path. This creates a "tragedy of the anticommons," whereby "each upstream patent
allows its owner to set up another tollbooth on the road to product development, adding to the cost and
slowing the pace of downstream . . . innovation". A report shows that notwithstanding escalating funding,
in the past half-decade biomedical innovation has slowed markedly. The number of drugs approved by the
Food and Drug Administration has fallen below previous eras. The technologies approved, it continues,
are less influential than previous innovations approved. The current trend of patenting what previously
were thought of as basic science insights have raised the financial bar for other scientists wanting to use
such insight. The overall trend of more patents may be slowing innovation.

GENE PATENT: an example of Biological Patent


A gene patent is a patent on a specific isolated gene sequence, its chemical composition, processes
for obtaining or using it, or a combination of such claims. Gene patents are a prominent subset of the
broader category of biological patents. Patents on genes have only been granted on isolated gene
sequences with known functions, and these patents cannot be applied to the naturally occurring genes
in humans or any other naturally occurring organism. There are no patents on "your genes" and no
one can own "your genes".

HISTROY
The United States has been patenting chemical compositions based upon human extractions for over 100
years. The first patent for such a chemical was granted on March 20, 1906 for adrenalin. Judge
Learned Hand justified permitting patents on purified natural substances on the rationale that they can
become substantially more useful than their non-extracted or less-pure states. Insulin followed adrenaline
as the second patent in 1923. Vitamin B12 was also patented (by Merck), prior to which it was
difficult for people with deficiencies to get sufficient doses.
But prior to the 1970s it was almost unheard of to submit an application to the United States Patent and
Trademark Office (USPTO) for an organism. The United States Supreme Court in Diamond v.
Chakrabarty clarified that as long as the organism is truly "man-made," such as through genetic
engineering, then it is indeed patentable. As a rule, raw natural material is generally rejected for patent
approval by the USPTO. It is only after a DNA product is isolated and purified (or modified) that a patent

is considered. Over three million gene related patents have been applied for in the United States alone.
(All pending applications are made public at 18 months after filing unless otherwise requested by the
applicant.)
As of 2010, 40,000 patents exist on an estimated 2,000 human genes, or about 20 percent.

CONTROVERSY
There is particular political and ethical controversy over whether these patents advance technology
by providing scientists, companies, and universities with an incentive to create, or hinder
technology via litigation or threat of litigation. There is also controversy over whether and to what
extent companies controlling gene patents hinder basic and/or clinical research. Finally, there is
controversy over the price of medical treatments and diagnostics that are protected by gene
patents.
While there is some controversy concerning the patenting of isolated genes and the way those
patents are used, and there is controversy concerning patents on the diagnostic uses of genes (the
real source of dispute in the Myriad court case), there is less controversy about patents on genes that
are used to manufacture therapeutic proteins (for example, the protein therapeutic drug candidate that
is the subject of the early part of the movie 'Extraordinary Measures' was covered in part by a classic gene
patent, US Patent 6,770,468 ). There is also little controversy concerning the role of gene patents in
the chemical industryfor instance in the manufacture of enzymes used in consumer products or
industrial processes. In descriptions and enactments of the controversy over "gene patents", it is rare to
find references to these everyday uses of genes and gene patents.

Gene Patents ruled invalid by a U.S. federal court; ruling


being appealed
A complaint against Myriad Genetics and the US Patent and Trademark Office filed in 2009 by
professional medical organizations, doctors, and patients, all represented by the American Civil
Liberties Union, sought to invalidate and discontinue all patents for naturally-occurring genes,
which have thus far been issued on the grounds that such genes are "isolated and purified" to a
non-naturally-occurring state. Myriad owns some of its patents; some were licensed from University of
Utah. Specific claims, but not all claims, in seven of Myriad's 23 patents on BRCA1 and BRCA2 were
challenged in the complaint. The challenged claims covered the isolated genes as well as diagnostic
methods.
Many people working in the patent field had predicted that the courts would throw out this case.
However, the case was accepted, and all the challenged claims were ruled invalid on March 29, 2010 by
United States District Court Judge Robert W. Sweet, a judge in the U.S. District Court for the Southern
District of New York.
The claims that had not been challenged still stand.
Judge Sweet's 152page decision ruled that the challenged claims to the isolated gene sequences had been
"improperly granted" because they claimed unpatentable subject matter; the claims to the diagnostic
methods were found invalid under the recent In re Bilsky decision. Because the case could be decided

with patent law, Judge Sweet did not look at the challenge on First Amendment grounds and dismissed
them without prejudice. In his decision handed down March 29, 2010, Judge Robert W. Sweet of the
United States District court of the Southern District of New York, rejected the legal equivalency between
'chemical compositions' like purified adrenaline and DNA. In his opinion Judge Sweet said: "The
information encoded in DNA is not information about its own molecular structure incidental to its
biological function, as is the case with adrenaline or other chemicals found in the body...this
informational quality (of DNA) is unique among the chemical compounds found in our bodies, and it
would be erroneous to view DNA as 'no different' than other chemicals previously the subject of
patents....DNA, in particular the ordering of its nucleotides, therefore serves as the physical
embodiment of laws of nature - those that define the construction of the human bodythe preservation
of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the
challenged composition claims are to unpatentable products of nature."
The decision could prove far-reaching for the biotechnology field.
However, on March 30, 2010, Myriad announced that it will appeal the decision.

INDIAN PATENT MECHANISM:BIOTECHNOLOGY PATENT FACILITATING CELL


Intellectual property protection plays an important role in gaining advantageous position in the
competitive game for economic growth. India enjoys a large asset of R&D personnel and infrastructure
facilities. Scientists and policy makers need information and facilities for protecting the products of
intellectual power of Indian Scientists. As a step in this direction, a Biotechnology Patent Facilitation Cell
was established by the Department of Biotechnology (DBT) in July1999.
Biotechnology Patent Facilitating Cell, a single window awareness -cum - facilitation mechanism,
established under Department of Biotechnology, Ministry of Science and Technology, aims to
create awareness and understanding about Intellectual Property Rights (IPRs) among scientists
and researchers, by arranging workshops, seminars, conferences, etc. at all levels and for
introducing patent information as a vital input in the process of formulation of R&D programmes
in biotechnology and providing patenting facilities to biotechnologists in the country, for filing
Indian and foreign patents on a continuous basis.
Objectives
BPFC has been established with the following objectives:

Creating awareness and understanding among biologists and biotechnologists, relating to patents
and the challenges and opportunities in this area including arranging workshops, seminars,
conference, etc., at all levels.
Introducing patent information as a vital input in the process of promotion of R&D programmes
in biotechnology and biology.
Providing patenting facilities to biologists and biotechnologists in the country for filing Indian
and foreign patents on a sustained basis.
Keeping a watch on development in the area of IPR and make important issues known to policy
makers, bio-scientists, biotech industry, etc.

Achievements
During few years of its existence, BPFC has carved out a unique identity of its own among the biologists
and biotechnologists in the country; with several achievements in the field of technology development in
the Indian context. BPFC has facilitated filing more than 100 Indian and international patent applications
out of which more than 10 patents have been granted. BPFC now look forward to Industry for taking up
of these technologies to the market and to the consumers.
Patents Granted so far
Inventor Title of Invention International Patents Dr. Asis Datta,
SLS, JNU Seed storage protein with nutritionally balanced amino composition. (3 US Patents)
Dr. Rup Lal
Department of Zoology,
University of Delhi A Process for development of cloning vectors. (2 Patents, Europe, USA)
Dr. Debi P. Sarkar
Delhi University
South Campus
A targeted drug delivery carrier (1 Patent, USA)
A Process for Producing a targeted gene for drug delivery carrier(1 Patent, USA)
Prof. A. N. Maitra,
Deptt. Of Chemistry
University of Delhi,' Particles of below 109 mm highly mono-disposed drug loaded medical
systems (1 Patent, USA)
Indian Patents Dr. Padma Sridhar
Department of
Microbiology
Osmania University
Hyderabad
Process of producing Cephamycin-C by Solid state formation, Process for continuous production
of Cephamycin-C by formation, Process of producing Cephamycin-C by submerged batch
fermentation (3 Patents)
Dr. Rekha Hari Das, CBT, Mall Road, Near Jubilee Hall Process for Preparing transfer vector
PCTB1 to PCTB4 for the purpose of expressing proteins for commercial use (1 Patent)

Awareness Creation
Series of national roving seminars are organized on Patenting in Biotechnology and IPR in
Biotechnology at various institutions and universities around the country, in collaboration with
World Intellectual Property Organization (WIPO), Geneva, to enhance the awareness of the
scientists about the inventions, process of patenting, issues in IPR in biotechnology and the
strategic importance of the IPR in post-GATT era.
Training of Scientists
In order to promote basic understanding of patents and other IPR-related issues among the Indian
scientists, and to analyze issues in the area of patenting in biotechnology, department has initiated oneweek refresher courses on IPR in biotechnology for officers and scientists at the National Law School of
India University, Bangalore which will be held four times in a year. The four such courses were held
during the last financial year. Through these training programmes it is intended to create awareness about
the need for protection of intellectual property generated by the scientists in biotechnology and its
identification, utilization, IPR regime in the country and outside, the procedures and nuances of writing

patent documents with description and claims and issues associated with the protection of live forms,
international patenting, product patents etc.

Patenting Nanotechnology- the Challenges posed to the Indian patent regime


Introduction
The Indian patent regime, originating from as early as 1856, has morphed into one of the most
competent mechanisms of the modern era. Having been subject to remodeling and amendments of
sorts since its inception, the present Indian Patent Act stands fulfilling nearly all the requirements
clamped down by the globalized patent regimes, as encapsulated in the TRIPS mandate, as also the
Patent Co-operation Treaty, 1970. A patent refers to the protection accorded to any new and useful
invention. The quintessence of the Patents Act lies in the norms laid down, to be satisfied in order
for a patent to be granted for an invention. The invention should be novel, should involve some
inventive step, and should possess some degree of industrial applicability. Filing of applications,
framing provisional and complete specifications, redress of infringement grievances, grant of
compulsory directions, secrecy directions and revocation of patents, among several other minor
topics are found within the gamut of the Indian Patent Act.
In tandem with the changes in society, an operative change in technology has been witnessed. As newer
avenues emerge, Science unfailingly throws challenge after challenge in the path of law, as each new
mechanism knocks on the doors of the Intellectual Property system, seeking protection therein.
Protecting some of these technologies are often grey areas in the Indian Patent system. One such
avenue, which has kicked up much consternation, is the field of nanotechnology. The factor that
makes nanotechnology unique is that it uses a process distinct from that of traditional forms of
technology. Most top down manufacturing processes take the help of the top down process
wherein larger blocks are broken down into smaller ones.
There are two main ways of applying nanotechnology so far: one is the top-down approach, whereby
structures are made smaller and smaller until they reach a nanometre scale using larger elements.
The other approach is the bottom-up approach, by which elements at the Nanoscale are chosen and
assembled to form some sort of matter or mechanism. This way of manipulating matter at the atomic
level obviously bears the potential of enormous developments. Why nanotechnology? The extent of the
scientific demand and commercial worth of the branch of science pertaining to nanotechnology warrants
an examination into the feasibility of the present patent regime in protecting the inventions arising in the
aforementioned branch of knowledge. Between 1997 and 2002, the quantum of nanotechnology
patents had increased by an astounding 600%. World over, patent offices are clamoring to develop
methods to deal with nanotechnology. The subject encompasses a plethora of other disciplines within its
gamut, such as chemistry, biology, physics, computer science, material science, engineering, medicine
and even electronics. It becomes imperative that a completely new paradigm be explored, to cull out
effective patent protection mechanisms. The grey areas, phrased in the form of questions include the
following:

Can these products be patented at all?


Are these products and processes obvious, granted that molecular drugs and bulk metal catalysts
are known elements?
Can the Indian patent Office do the needful with regard to protecting nanotechnology?

The promises of nanotechnology are large. Given what is at stake and the high expectations put on the
burgeoning industry, it is imperative for the current patent doctrines to effectively respond to new
technology. Nanotechnology investors face uncertainty about the extent of their patent rights. Patents with
broad claims, that lack reference to scale, on traditional products, might allow traditional patent holders to
exact royalties from their nanoscale counterparts. Furthermore, bargaining between the traditional and
nanoscale manufacturers might break down because of the diverging valuations that the parties place on
their assets.
Nanotechnology- Learning the Ropes
Nanotechnology the technology of the smallest objects is slowly but surely progressing. The first
products making use of nanotechnology are appearing on the market, amongst others: tennis
racquets, ski wax, and sun burn crme. The European Patent Office has granted about 80,000 patents
on inventions in the field of nanotechnology. Hitherto, European academic literature has had hardly any
attention for the patenting of nanotechnology. This is remarkable in view of the fact that nanotechnology
raises new and important questions of law, as well as questions relevant for the development of
nanotechnology industry in Europe. Well-known examples of nanotechnology are nano-carbon tubes
and bucky-balls for making extremely rigid constructions, quantum dots which can be applied as
markers for labeling purposes, and dendrimers that may be used for drug delivery purposes. The
EPO defines nanotechnology as follows:
"The term nanotechnology covers entities with a controlled geometrical size of at least one functional
component below 100 nanometres in one or more dimensions susceptible to make physical, chemical or
biological effects available which are intrinsic to that size. It covers equipment and methods for
controlled analysis, manipulation, processing, fabrication or measurement with a precision below 100
nanometres."
The general definition is that Nanotechnology refers to the science, building, visualizing and
manipulating at the nanometer scale. Put simply, nanotechnology is the science and technology of
building things from the bottom, upwards- one atom, or one molecule at a time. It stands to be the
diametric opposite of traditional industrial technologies, which operate from the top, downwards. Raw
materials in quintessential forms of traditional industries are broken down and machined into precisely
crafted products, by removing the unwanted segments of the same. It was introduced by Richard
P.Feynmann, a 1965 Nobel Laureate, in a lecture entitled Theres plenty of room at the bottom
However, this method differs greatly from natural processes in one way or the other. Every object on
earth consists of molecules, cells and miniscule organelles. Based on the particular configurations, a
construction of these molecular structures can create objects of astonishing size, like the coral reef, or a
redwood tree, or even the human brain. This approach produces results which would normally seem
impossible. It is often seen that these processes are taken for granted. A simple example for this is the
human body. It begins as a single cell, but evolves into a mature human being consisting of 75 trillion
complexly arranged cells. The molecular machinery responsible for this amazing, feat of production is
capable of such results because it performs operations in parallel.
This process, thus, serves as a kind of an existence proof for nanotechnology. Of course, putting these
natural molecular machines to work is in effect, nothing new, as every living being does so constantly.
But, where nanotechnology differs is, in the fact that it attempts to transcend the realm of the natural. Full
fledged nanotechnology successfully exercises complete control over the physical structure of the matter,
akin to what is done by a word processor over the form and content of textual matter.

Using nanotechnology, production would be carried out by large numbers of tiny devices, operating in
parallel, in a fashion similar to molecular machinery already found in living organisms. These
nanodevices wouldnt have to be made out of protein or other substances extractable from the natural
environment, but can be constructed out of whatever fashion is most suited to their task. Popularly known
as assemblers, these miniscule devices would be capable of manipulating individual molecules rapidly
and precisely. Instead of weaving cloth this method would seize individual atoms using selectively sticky
manipulator arms, and then plug those atoms together until chemical bonding occurs. By repeating
these steps according to a programmed set of instructions, a nanotechnologicial approach would be able to
synthesize materials faster, and at a lower cost.
Besides such efficient and powerful manufacturing capabilities, there exist more sophisticated
applications. For instance, specially designed nanodevices, the size of bacteria might be programmed to
destroy arterial plaque, or fight cancer cells, or repair cellular damages caused by aging. Finishing with
these tasks, the element shall be induced to self destruct, or remain in a surveillance mode, or cause, in
some cases, to integrate with the body cells itself. In addition to treating diseases, the technology would
be exceptionally useful in producing drastically enhanced mental, physical and sensory abilities.
Substantial changes in human morphology would be possible and even copying thoughts and memories,
and actually storing them, would soon be reality, thanks to nanotechnology.

Patenting Nanotechnology- Challenges posed to the Indian Patent Regime


Even though many patents on nanotechnological inventions have been granted, little has been written
about how easy or how hard it is to obtain nanotechnology patents and which problems and peculiarities
an applicant encounters. Therefore, the patentability of nanotechnology is here discussed in more detail.
The analysis of nanotechnology patenting is a necessary input to the more fundamental questions
concerning the patenting of nanotechnology. A patent is granted for any invention, based on any kind of a
technology as given under A.27 of the TRIPS agreement, as long it satisfies the norms of novelty,
inventive step and industrial application. Emerging technologies present newer challenges in the path of
granting patents. The challenges posed are one too many to discuss in entirety, but a select few, in
pertinence with the Indian patent regime are thus dealt with:

A. The nature of the technology itself


The TRIPS agreement mandates that patents shall be accorded to inventions based on any technology,
whatsoever. However, it is unfortunate that India lags behind in this regard. The Indian patent regime is
not accommodative towards the idea of granting patents to inventions in the field of biotechnology, and
nanotechnology. The need of the hour is to patent these inventions, as the threat of infringement is
imminent, particularly on account of the usefulness of the invention. Nanotechnology is not confined to a
single field of endeavour but exploits the peculiar properties of matter at the nano-scale level, across a
plethora of areas in modern engineering. It dabbles with fields such as semiconductor design,
biotechnology, materials science, telecommunications, and textiles, even though the patent is held by a
firm that works in only one of these industries.
Emerging technologies have always been at daggers drawn, with the issue of patentability. Huge amount
of patents are being filed for already patented inventions, with the only difference being that they are
mere improvements in that field. In the past when the software boom captured the commercial arena of
technological use the patents were not allowed for software developments. Biotechnology was also not
considered as patentable and many of the inventions therein were ineligible for patenting as they involved
the human body, by virtue of the fact that they dealt with the human body. This trend had changed after
the case of Diamond v Chakraborty. Here, a genetic engineer Ananda Mohan Chakraborty had

developed a bacterium capable of breaking down crude oil which is proposed to treat in oil spills.
Initially, the patent was rejected however subsequently the Supreme Court in a majority opinion held that
a live human made micro organism is a patentable subject matter and is a manufacture therefore
patentable under the Act and it was further observed in this case that any thing under the sun can be
patentable.
The World Intellectual Property Rights Organization (WIPO) identifies certain complexities
regarding nanotechnology. One problem, which is, to a certain extent, shared with a number of other
emerging technologies is that the granted claims are overly broad, due at least in part to a lack of
available prior art, which could allow patent holders to lock up huge areas of technology. In this
context, there is also a perceived risk of overlapping patents.

B. Lack of technical knowledge


Few individuals are equipped with sufficient knowledge with regards to nanotechnology. Knowledge
driven economies like Europe and the USA have also expressed their inabilities with regard to the subject.
India isnt far behind, where this issue is concerned. This lack of knowledge and understanding would
hamper the advancement of the field. Either patents may simply Not be issued altogether due to the lack
of knowledge, or, the construction of claims and their scope would be put through indiscriminate
questioning because the examiners fail to grasp the nuances of the invention altogether.
Another consequence of the lack of knowledge is that the patents granted would be far too wide, or too
loosely defined, making it difficult to enforce the granted patent. The Indian patent offices are not
equipped with the individual and organizational structure, to deal with nanotechnology. While
information on different technology, branches are made available to the patent offices, there is next to
nothing on nanotechnology. Conquering ignorance in the field of nanotechnology is a major challenge to
the Indian patent regime. Further, the gamble of not knowing the utility of an invention is a major
challenge to the Indian Patent Regime.

C. Novelty and Identifying Prior Art


The broad scope of nanotechnology arises on account of the fact that manipulation of materials or
particles at the atomic level applies to a wide array of fields. This multi-dimensional feature causes the
identification of previously distinguishable technological fields. Identifying prior art itself, is a tedious
task, posing another challenge to the Indian Patent Regime. This is especially so in the case of
nanotechnology. The absence of a proper prior art database is the major drawback in the Indian patent
regime. Since the crux of nanotechnology vests mainly on the size factor, a number of size related
questions arise: how do nanoscale inventions relate to prior art that does not specifically relate to a nano
size? Could such prior art anticipate a nanoscale invention? Could prior art that refers to micro or larger
scale take away the novelty of a nano scale invention? Is size alone enough to confer novelty upon an
invention? What happens if size ranges mentioned in a prior art document and a nano scale patent
application overlap? An invention is only anticipated if it has been described completely and inclusive of
all its elements in the prior art. If the prior art refers only to the micro or larger scale the nano scale
equivalent is generally not anticipated.
Novelty is evaluated against the available prior art. The multidisciplinary nature of nanotechnology
results in the bridging of different fields of application, which makes it difficult to cull out the element of
novelty altogether. Since novelty depends on the extent of prior art, it is necessary for a strong database of
prior art. The Indian patent database ought to be made stronger. Akin to the Traditional Knowledge
Database (TKD), there ought to be one with fully updated information, pertaining to nanotechnology, in

India. If the prior art does not refer to size, could it be true that a nano scale invention can be anticipated?
Is the novelty of the nano scale invention destroyed simply because it is covered by the terms of a prior
art document? This is not necessarily the case. In the first place, the prior art is destructive of novelty if it
contains an enabling disclosure.
Even if a nano scale invention is covered by the terms of a prior art document, it may still be novel if the
person skilled in the art cannot practice the invention without knowledge of the claimed invention or
engaging in inventive activity. If it is not clear to the person skilled in the art how to manufacture a nano
scale variant of the prior art invention, this could well be enough to preserve the novelty of the nano scale
invention. While the patentability of nanotechnology invention can be questioned in certain cases, the
existing patent law framework gives enough inroads to confer novelty upon most nano scale inventions.
This mainly derives from applying well-known patent principles to nano scale inventions.

D. Inventive Step
An invention must involve an inventive step, making it non-obvious to a person skilled in the art. Even if
a nanoscale invention is novel over the prior art, the inventive step requirement must be met. The first
question one would ask is as to whether in nanotechnology inventions, downsizing in itself is not an
obvious step for the person skilled in the art to take. From the decision of the Technical Board of Appeal,
USA in case T 0070/99 (about micro scale analytical devices), it can however be derived that mere
downscaling does not give rise to an inventive step. On what grounds, then, could one deem the existence
of an Inventive step in a Nanotechnology invention? An inventive step may reside in the fact that other
processes have to be used to arrive at the nano scale products than is the case with bigger products. The
other processes must of course not be obvious to the person skilled in the art, confronted with the problem
of producing at nano scale.
If there is an unexpected function at the Nanoscale, it could be construed as an inventive step. The crux is
that the unexpected function must solve a problem stated in the patent. Such unexpected results have been
known to occur in nanotechnology. Carbon nanotubes can, for instance, depending on their construction,
carry a much bigger current per surface unit as opposed to traditional metal conductors. The unexpected
function must not be a mere side or bonus effect. If there are good reasons for a person skilled in the art to
go down the road of the invention, then the occurrence of the unexpected bonus effect does not
contribute towards inventiveness.

E. Industrial Application
For an invention to be patentable, it must be capable of use in any kind of industry. Since nanotechnology
is still in its infancy and many applications have not progressed beyond the laboratory stage, one couldnt
possibly fathom the extent of plausible industrial application. The nature of nanotechnology inventions
often points the way to their industrial applicability: nanotubes for making light and strong constructions,
nano drug delivery systems, or nanotechnology used to create high electric conductivity are self-evidently
industrially applicable. In India, the problem that nanotechnology presents is that it is a technology that is
completely unknown and presents a picture of potentials that are yet to be explored. The Indo-US joint
forum on science and technology has identified this area of intense cooperation.
.

F. Enablement Issues
The patents act requires an inventor to disclose the best way of manufacturing his invention, to enable a
person skilled in the art to do the same, post expiry of the patent. A major problem posed by
nanotechnology to the present patent regime, is that the scope of the invention and the field of knowledge

itself is far too wide. Expressing and explaining the contents of the invention in full detail is next to
impossible. The quintessence of the criterion of sufficiency of disclosure is thus encapsulated:
1. That the invention is disclosed in a way that allows it to be practiced, and
2. That the (teaching of the) invention must be reproducible.
The first requirement implies that the person skilled in the art on the basis of the disclosure can rework
the invention without an undue burden. Reproducibility indicates that the result of the invention can be
reached over and again and not just on the basis of chance or only with a smaller or larger degree of
predictability. If the examining or opposition division has no way of knowing or inferring the
practicability of a nanotechnology invention, let alone its practicability across an entire range, it may very
well require the patent applicant or patentee to beef up its disclosure and provide more detailed
instructions for the reworking of the invention. Additionally, the fact that the invention produces the
claimed results in a repeatable way may pose problems for nanotech inventors. In nanotechnology,
analytical methods, tools and metrologies are often not available to the person skilled in the art. Without
these the reproducibility of an invention may be difficult to ascertain. An inventor would thus be obliged
to disclose these in the patent in order to make his claims verifiable.

Suggestions- The measures to allow the patent regime to rise to the challenges
Till date, India has been very laid back in terms of research and development in the field of
nanotechnology even though research and development and the possible commercial benefits of
Nanotechnology are clear to all. The possible reasons for the same could be that at the moment the true
characteristics and use of the technology has not been properly understood. The other reason is that
even though the Indo-US civil nuclear deal is one of the most important steps for the energy
requirements of India, but the government has been so busy in formulating policies and rules on
this technology that little attention is being paid to other technologies. The patent if properly granted
facilitates more and more innovations in the field to which the invention belongs however the growth
retards once the patents are wrongly granted or rejected.
At present the Indian Patent Act has no provision that even incidentally touches the field of
nanotechnology. There have been no guidelines or regulations framed with respect to regulating this
technology even though the TRIPS agreement specifically provides that intellectual protection must be
extended to all fields of science so that it encourages more research and innovations. The need of the hour
is to firstly formulate a plan for increasing the research and development in the field of nanotechnology,
secondly to provide for funding and special incentives for research in this field. One of the methods or
possible solution to the present problem of patenting Nanotechnology can be addressed by bringing
amendments in the Indian Patent Act that may not be exhaustively directed to nanotechnology
however they must have some mechanism to recognize the field of nanotechnology and formulate
a comprehensive regulatory plan that deals with Nanotechnology providing for research, possible
hazards and a framework for regulating the same.
Sweeping changes ought to be brought, in the Indian Patent Regime, to rise to the occasion, and take on
newer technologies with ease. A few of these suggestive measures may be put to use for the same:

Patent applications are to be examined by a team of examiners, as opposed to a single examiner,


as multiple inspections would prove better in understanding the claims
Creation of a database of prior art, akin to the Traditional Knowledge Database.
One single organized and centralized command centre must be established, for the sake of
nanotechnology patenting. This would ensure uniformity in patent claim interpretation.

Training to personnel on a periodical basis would help meet the challenge of lack of information
on the subject.
Creating expanded prior art databases would be prudent mechanisms to help ascertain the
elements of novelty and inventive step.
The patent offices must be open to accepting wider claims as the case shall prove, in order to
accommodate technologies in their nascent stages.

Conclusion
Nanotechnology will be an important part of our lives, providing us with the ability to do things on an
atomic and molecular scale. To succeed as a business, companies that develop new discoveries and uses
for nanotechnology will need patent protection. With a carefully developed patent strategy, the Indian
Patent Regime can successfully rise to the challenge thrown in by Nanotechnology. Though the grey areas
are numerous to count, the same should not act as a bar to the grant of patents to the inventions arising out
of nanotechnology. Laws are enacted for society, by society, and works in society. It would be
unfortunate to allow our legal systems to remain redundant, while science and technology take giant
leaps. Science depends on law, to protect its new creations. A development in law, is thus, not too much
to ask in the light of an advancement in Science.

BIOLOGICAL PATENTS
AND
INDIAN PATENT MECHANISM

By
VARSHA SINGH
REG NO.: 20070002
B.Tech , Biotechnology (6th Semester)

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