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NANOTECHNOLOGY HYPOTHETICAL
EMERGING IP RIGHTS COMMITTEE
18TH NOVEMBER, ADELAIDE
AGENDA
Welcome address by Mr. Pravin Anand (5 minutes)
Mr. Seong-Ki-Kim’s special remarks, (5 minutes)
Discussion on the Country Reports (30 minutes)
Hypothetical (1 ½ hours)
Presentation by Mr. Seong-Ki-Kim on the WIPO developments in the field of nanotechnology (20 minutes)
Questions and Answers (30 minutes)
o Inventors: Amit Bose, professor at John Doe University,
USA and his father Alok Bose, professor in Delhi University
o Invention: Applied for Indian patent for Nanocurcumin along
with process for producing it
o Curcumin is a polyphenol found in turmeric and has anticarcinogenic properties
o They applied the ‘Top-Down’ method to synthesize tiny
nanoparticles of curcumin.
o These particles have hydrophobic interiors and hydrophilic
exteriors
o This property leads to higher bioavailability of nanocurcumin,
due to improved aqueous solubility
o Prior Art:
o Curcumin has significant anticarcinogenic properties.
o Insoluble, hence a need to consume high doses – 12
to 20 grams
o Unbearable to the palate
o Pre-grant opposition filed by Ajanta Natural Extracts Ltd:
- Who claimed to be applicants for Indian patent for
reconstituted product of curcumin marketed as
Biocurcumax
- Novelty of biocurcumax lay in its enhanced
bioavailability, better absorption into blood.
- Ajanta claimed Nanocurcumin not novel being simply
smaller than curcumin, a known substance
- Its increased bioavailability is an obvious outcome of
the process for its preparation
o Revocation claim:
o Society for Protection of Turmeric (SPOT) alleged it was
an attempt to secure illegal monopolies over an Indian
biological resource.
o Approached National Biodiversity Authority (NBA) to
revoke patent on account of violation of the following
provisions of the Indian Biological Diversity Act.
o Section 3 - Mandatory NBA permission for procurement of
biological resource
o Section 4 –Prevents transfer of research results of
biological resources in India to a non-citizen
o Section 6 – Prevents IPR application based on Indian
Biological Resource
o Special Tribunal formed to mediate dispute between
Amit/ Alok Bose (Mr. Kowit Somwaiya), SPOT (Mr. You
Gang Yoon) and Ajanta (Mr.Kazuaki Okimoto).
o Composition of Tribunal:
o Patent Controller- Mr. Yu Lan Kuo,
o A representative of NBA- Mr. S Majumdar,
o Attorney General of India- Mr. Seong Ki Kim and
o A retired Judge of the Indian Supreme CourtMr. Pravin Anand
o Asked to invite representations from each of the third
parties
o File a report outlining their recommendations for an
effective resolution of dispute
MINISTRY OF LAW AND JUSTICE
(Legislative Department)
New Delhi, the 5th February, 2003/Magha 16, 1924 (Saka)
The following Act of Parliament received the assent of the
President on the 5th February, 2003, and is hereby published for
general information:
THE BIOLOGICAL DIVERSITY ACT, 2002
No. 18 OF 2003
[5th February, 2003]
Title:A COMPOSITION TO ENHANCE THE
BIOAVAILABILITY OF CURCUMIN
Abstract:The invention relates to the best mode of deriving
optimal benefits from administration of Curcumin in human
beings through innovatively enhanced bio-availability
achieved through optimally admixing an innovatively
derived portion of a volatile portion of turmerone to
curcumin. The final extract of curcumin is innovatively
encapsulated and dispensed in ingestible forms to
supplement and complement clinical nurtition.
Presentation I
YUASA AND HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
November 18, 2007
Opposition
filed
by
YUASA
AND
HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
Ajanta of Arjuna Natural Extracts Ltd
Kazuaki Okimoto
Patent Attorney
Yuasa & Hara
[email protected]
YUASA AND HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
Ajanta filed an opposition against a
patent application filed by the father
and son team on the ground of lack of
novelty and inventive step.
13
YUASA AND HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
1. Nanocurcumin is not novel by virtue of simply being smaller than
curcumin, a known substance; as the reproduction of a known
product at an atomic scale does not meet the requirements of
novelty and inventive step under the Indian Patent Act.
2. The increased bioavailability of curcumin on account of its
greater absorption into the bloodstream was possible through a
number of methods, such as the one used in the preparation of
Biocurcumax and was thus an obvious outcome of the process
for preparing Nanocurcumin.
3. On account of the existence of Biocurcumax in the market,
Nanocurcumin cannot be said to have overcome a previously
unsolved technical drawback.
4. The reduction of Curcumin to Nanocurcumin is obvious and
cannot be said to be patentable as such.
YUASA AND HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
Lack of Novelty and Inventive Step
YUASA AND HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
curcumin exhibits therapeutic effects in a human body
= well-known in the art
A lot of approaches made to enjoy the effects of
curcumin through oral administration.
Insolubility of curcumin
a top-down approach, by which structures are made
smaller and smaller until they reach a nanometric
scale
a bottom-up approach, by which elements are selected
on a nanoscale and are assembled to form a
substance or mechanism.
YUASA AND HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
WO/2006/12932 with the publication date
of July 12, 2006
“Curcumin is not simply an alternative to non-steroidal
anti-inflammatory drugs (NSAIDS), which also have
anti-inflammatory and cancer chemopreventive
properties.”, “Despite its impressive array of beneficial
bioactivities, the bioavailability of curcumin in animals
and man remains low.”, and “Oral administration of
curcumin also inhibits the initiation of radiation-induced
mammary and pituitary tumors.”, at Background Art”.
YUASA AND HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
It is recognized to be well known for those skilled in the
art to reduce the size of curcumin to be as small as
possible to enjoy the therapeutic effects of curcumin
through oral administration.
YUASA AND HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
WO/2006/12932 discloses the invention of a mixture of
the essential oil of turmeric and curcumin to enhance
the bioavailability of curcumin to enjoy the therapeutic
effects of curcumin through oral administration.
YUASA AND HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
Incentive and Motivation
Search for an alternative material for use as the
essential oil.
Attempt to replace the essential oil with other possible
material to enjoy more therapeutic effects of curcumin.
A hydrophilic material could be easily selected by
those skilled in the art to enhance solubility to
bloodstream.
YUASA AND HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
WO/2006/12932
“in order to derive full benefits from the administration
of curcumin in human subjects, ways and means to
enhance its bioavailability needs to be explored. The
present invention is an effort in this direction. It was
found that when the essential oil of turmeric was
added to curcumin, the bioavailability of curcumin is
significantly enhanced. Accordingly, a composition of
curcumin admixed with a suitable proportion of
turmerone (the main component of the turmeric
essential oil) is provided.”
YUASA AND HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
It is recognized to be a matter of design for those
skilled in the art to select a hydrophilic polymer as the
exterior of the particle.
YUASA AND HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
Therefore, it is recognized that the subject invention
could have been easily carried out by those skilled in
the art by modifying the particle structure of the
essential oil and curcumin in the mixture to that of
hydrophilic exterior and curcumin, by choosing a
suitable polymer as the hydrophilic exterior in place of
the essential oil, to enhance its bioavailability for
enjoying the therapeutic effects of curcumin.
YUASA AND HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
Conclusion
It is recognized to be well known for those skilled in the art to
reduce the size of curcumin to be as small as possible to
enjoy the therapeutic effects of curcumin through oral
administration.
It is also recognized that the subject invention could have
been easily carried out by those skilled in the art by modifying
the particle structure of the essential oil and curcumin in the
mixture to that of hydrophilic exterior and curcumin, by
choosing a suitable polymer as the hydrophilic exterior in
place of the essential oil, to enhance its bioavailability for
enjoying the therapeutic effects of curcumin.
YUASA AND HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
Conclusion
The application filed by the father and son team is not
patentable on the ground of lack of novelty and inventive step.
YUASA AND HARA
LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
Thank you for your attention !
Kazuaki Okimoto
Patent Attorney
Yuasa & Hara
[email protected]
Presentation II
APAA 54th Council Meeting 2007, Adelaide, Australia
Emerging Intellectual Property Rights Committee
NGO’s views on Curcumin
case in India
November 18, 2007
Yuh-Gang YOON, Ph.D.
Patent Attorney
Zenith Patent & Law Firm
1. Introduction
•
The participation of NGOs in Convention of Biological
Diversity (CBD) took place more slower than climate issue.
•
More than 150 countries signed on Biological Convention at
the UNCED in Rio de Janeiro (June 1992).
•
•
The USA is not a party to the CBD.
This woke up NGOs to think that there must be something in
CBD if USA is so frightened of it
2. Background of CBD
•
Conservation and sustainable use of biological diversity is
important for protection of environment.
•
Genetic erosion, genetic engineering, extinction of species,
destruction of ecosystem, and man-nature linkages were fused
into one concept “biodiversity.”
•
This gives the birth of treaty “the Convention of Biological
Diversity”
3. Demands by NGOs
• To establish a system of protected areas and promote the recovery of
threatened species (so-called in-situ conservation)
• To establish facilities such as herbaria and gene banks (ex-situ conservation)
• To use components of biological diversity in a sustainable way
• To integrate biodiversity considerations in national decision-making
• To adopt economically and socially sound incentives for the conservation and
sustainable use of biological resources
• To promote research and public education
• To assess and minimize adverse impacts on biodiversity
• To share with countries, indigenous groups and local communities which
provide genetic resource the benefits which arise from the utilization of these
resources
• To facilitate access to genetic resources and (bio)technology for other parties
4. Point of argument on curcumin case in India
•
•
•
•
The source of curcumin being used in the preparation of Nanocurcumin is an
Indian variety of turmeric (Curcuma longa) which is a biological resource, for
the procurement of which no permission has been taken from the NBA as is
mandatory under Section 3 of the IBDA;
Section 4 of the IBDA prevents the results of any research relating to
biological resources occurring in or obtained from India from being
transferred to any person who is not a citizen of India without the prior
permission of the NBA
Section 6 of the IBDA also prevents the filing of an application for intellectual
property rights based on an Indian Biological Resource without the prior
approval of the NBA
section 3 or section 4 or section 6 shall be punishable with imprisonment for a
term which may extend to five years, or with fine which may extend to ten
lakh rupees (Section 55 of IBDA)
• 5. Unpatentable according to Section 25 of Indian Patent Act
•
•
•
- In the specification of Indian patent application, the source or
geographical origin of biological material used for the invention
was not completely disclosed or wrongly mentioned
- The invention is anticipated from a knowledge, oral or
otherwise, available within any local or indigenous community
in India or elsewhere.
5. Recommendation by NGOs
•
There is a need for the further development of the Access and Benefit
Sharing (ABS) process.
•
Basic biological research is seriously hampered by many of the current
national ABS regulations.
•
•
•
All countries are encouraged to ensure that measures are taken against the
illicit use of biological resources within their jurisdiction.
Mutual trust, cooperation and communication among all countries are
essential to settle down the conflict in ABS process.
Thank you
• Contact
– TEL : +82-2-888-3066
– FAX : +82-2-888-3678
– E-mail : [email protected]
Presentation III
RESPONSE OF ALOK BOSE AND AMIT BOSE
represented by
Kowit Somwaiya, LawPlus Ltd.
submitted to
SPECIAL TRIBUNAL
PATENT APPLICATION FOR NANOCURCUMIN
Opposition of Arjuna Natural Extracts Ltd. (Ajanta)
Claim of the Society for Protection of Turmeric (SPOT)
2007 APAA EMERGING IP RIGHTS
Adelaide, Australia, 18th November 2007
I. RESPONSE TO AJANTA (1)
NANOCURCUMIN
Alok Bose & Amit Bose
BIOCURCUMAX
Ajanta
1.
Synthesization of
nanoparticles of curcumin
and special polymers
1.
2.
Nano-scale structure of 50- 2.
100 mn in diameter
Mixture (blend) of
extracted curcumin crystals
and essential oil of turmeric
Large-scale structure
compound
II. RESPONSE TO AJANTA (2)
NANOCURCUMIN
Alok Bose & Amit Bose
3. Hydrophobic interior and
hydrophilic exterior
resulting in highly
improved solubility to
aqueous media
BIOCURCUMAX
Ajanta
3. Insoluable nature to
aqueous media
4.
4.
5.
Much better absorption due
to high solubility (can
easily pass from gut to
bloodstream)
5.
High bioavailability as a
Poor absorption due to
insoluable nature
Poor bioavailability due to
poor absorption
III. RESPONSE TO SPOT (1)
Section 3 of the IBDA
•
•
Procurement of Biological Resources needs permission from the
NBA only if it is for:-
Research
Commercial Utilization
Bio-survey and Bio-Utilization
But the NBA permission requirement applies to only:-
Non-Indian citizen
Indian citizen who is not a resident of India
Facts and Response
•
•
•
Amit Bose did not denounce his Indian citizenship
Amit Bose pays Indian tax and thus is a resident of India
Application will be amended:
-
to drop the name of Amit Bose
to add full disclosure of the Biological Resources (Curcuma longa)
IV. RESPONSE TO SPOT (2)
Section 4 of the IBDA
•
Prevents a transfer of a result of any research relating to
Biological Resources to a non-Indian person without
prior permission of the NBA
•
Transfer does not include publication of research papers
Facts and Response
•
•
Amit Bose holds dual citizenships (Indian + US)
Applicants are willing to amend application to drop the
name of Amit Bose
V. RESPONSE TO SPOT (3)
Section 6 of the IBDA
•
Prevents filing of an application for intellectual property
rights based on Biological Resources without prior
approval of the NBA
•
Section 6 (1) allows obtaining approval from the NBA
after the patent application is accepted
Facts and Response
•
Full disclosure of Biological Resources will be added to
the application
VI. NANOCURCUMIN IS
PATENTABLE
•
•
New and different substance than the prior act
•
•
•
•
Has novelty
Nanocurcumin particles + special polymers vs curcumin
crystals + essential oil
Has higher inventive step (non-obvious)
Has industrial applicability
Applicants can amend application to comply with the IBDA
-
to drop Amit Bose
to add full disclosure of Biological Resources
Presentation IV
NATIONAL BIODIVERSITY AUTHORITY, INDIA
We have perused their patent application made
jointly by the BOSES and the specification
accompanying the application. It is indicated in
their application In vitro and animal studies have
recently shown that Curcumin has significant
anticarcinogenic properties. They state that more
specifically curcumin appears to have significant
inhibitory effects in both the promotional and
progression stages of colon cancer as well as the
ability to induce apoptosis in human leukemia
cells, a variety of B lymphoma cells and others. It
has also been found in certain instances to inhibit
some skin cancers.
It is stated that the team used special polymer to
synthesize tiny nanoparticles of curcumin about 50-100
nanometers in diameter. The nanoparticles have
hydrophobic interiors and hydrophilic exteriors. The
hydrophobic core traps the nanocurcumin, while the
hydrophilic exteriors make the nanoparticles soluble in
water or any other aqueous media. By this way, the
nanoparticles can pass easily from the gut to the
bloodstream. Once in the blood, the curcumin leaks out
as the polymers slowly degrade. The higher bioavailability
of nanocurcumin due to improved aqueous solubility
overcomes the need to consume doses as high as 12
gms and the problems associated with its unbearable
after-taste.
The Tamil Nadu-based Society for Protection of Turmeric (SPOT)
made a representation to us seeking our intervention for a rejection
of the Nanocurcumin patent application for, inter alia, the following
reasons:
1.The source of curcumin being used in the preparation of
Nanocurcumin is an Indian variety of turmeric (Curcuma longa) which
is a biological resource, for the procurement of which no permission
has been taken from the NBA as is mandatory under Section 3 of the
IBDA;
2.Section 4 of the IBDA prevents the results of any research relating to
biological resources occurring in or obtained from India from being
transferred to any person who is not a citizen of India without the
prior permission of the NBA; whether for monetary consideration or
otherwise. This requirement has also been clearly violated in that the
synthesization of the nanoparticles of curcumin took place in the
laboratory of Alok Bose in Delhi and the results were transferred to
Amit Bose, a US citizen prior to the joint filing of the patent
application in respect of the same in India.
3.Section 6 of the IBDA also prevents the filing of an application for
intellectual property rights based on an Indian Biological Resource
without the prior approval of the NBA.
AT THE OUTSET WE STATE THAT WE ARE NOT CONCERNED WITH THE
INVENTION AND ITS MERITS UNDER THE PATENT LAWS AND FOR THE
PURPOSE OF THE COMPLAINT WE WILL CONSIDER
THE PROVISIONS OF SECTIONS 3, 4 AND 6 OF THE ACT FOR THE
DISPOSAL OF THE APPLICATION BY BOSES AND THE COMPLAINT OF
SPOT.
Section 3 provides that (1) No person referred to in sub section (2) shall,
without previous approval of the National Biodiversity Authority, obtain any
biological resource occurring in India or knowledge associated thereto for
research or for commercial utilization or for bio survey and bio utilization.
(2) The persons who shall be required to take the approval of the National
Biodiversity Authority under sub section (1) are the following, namely:
(a) a person who is not a citizen of India;
(b) a citizen of India, who is a non resident as defined in clause (30) of section 2
of the Income tax Act, 1961;
(c) a body corporate, association or organization(i) not incorporated or registered in India; or
(ii) incorporated or registered in India under any law for the time being in force
which has any non Indian participation in its share capital or management.
LITERATURE STUDIES GO TO SHOW THAT - BECAUSE OF ANCIENT
TRADE, THE ORIGIN OF TURMERIC CANNOT ACCURATELY BE
RECONSTRUCTED; PROBABLY SOUTH EAST ASIA OR SOUTH ASIA. A
RELATED SPECIES, C. XANTHORRHIZA, GROWS ON JAWA, WHERE IT IS
CALLED TEMU LAWAK; IN TASTE, IT IS EQUIVALENT TO C. DOMESTICA.
“Probably originating from India, turmeric has been used in India for at least
2500 years. It may have been cultivated first as a dye, with use as a spice
coming later.
Origins
The exact origin of turmeric is not known but it originates from South or
Southeast Asia, most probably from western India.
Turmeric is a sterile plant, and does not produce seed. It is thought to have
arisen by selection and vegetative propagation of a hybrid between the wild
turmeric (Curcuma aromatica), native to India, Sri Lanka and the eastern
Himalayas and some other closely related species”
http://www.plantcultures.org/plants/turmeric_history.html
NO EVIDENCE IS FILED BY SPOT THAT GOES TO PROVE THAT THE
TURMERIC USED BY AMIT BOSE OCCURRED IN INDIA.
BOTH ALOK BOSE AND DELHI UNIVERSITY DO NOT
FALL IN THE CATEGORY UNDER
SUBSECTION (2) OF SECTION 3 OF THE ACT.
THUS THERE IS NO VIOLATION OF SECTION 3 BY ANY OF THE BOSES.
SECTION 4 OF THE ACT PROVIDES THAT NO PERSON SHALL, WITHOUT
THE PREVIOUS APPROVAL OF THE NATIONAL BIODIVERSITY AUTHORITY,
TRANSFER THE RESULTS OF ANY RESEARCH RELATING TO ANY
BIOLOGICAL RESOURCES OCCURRING IN, OR OBTAINED FROM, INDIA
FOR MONETARY CONSIDERATION OR OTHERWISE TO ANY PERSON WHO
IS NOT A CITIZEN OF INDIA OR CITIZEN OF INDIA WHO IS NON RESIDENT
AS DEFINED IN CLAUSE (30) OF SECTION 2 OF THE INCOME TAX ACT, 1961
OR A BODY CORPORATE OR ORGANIZATION WHICH IS NOT REGISTERED
OR INCORPORATED IN INDIA OR WHICH HAS ANY NON INDIAN
PARTICIPATION IN ITS SHARE CAPITAL OR MANAGEMENT.
IT IS STATED IN THE APPLICATION THAT THE BOSES
ARE JOINT INVENTORS AND THEY ARE ENTITLED TO AND HAVE MADE
APPLICATION FOR PATENT JOINTLY AND THE CLAIMS OF THEIR PATENT
APPLICATION ARE BASED ON THE SUCCESSFUL RESULTS
OF THEIR WORK. NO EVIDENCE IS MADE AVAILABLE
TO SHOW THAT NONE HAS ASSIGNED TO THE OTHER ANY
PART OF THE INVENTION.
BEING JOINT INVENTORS THE BOSES MADE THE PATENT APPLICATION
JOINTLY AND THERE IS NO EVIDENCE OF TRANSFER OR
OTHERWISE BY ANY OF THE BOSES IN CONTRAVENTION
OF SECTION 4 OF THE ACT.
SECTION 6(1) PROVIDES THAT NO PERSON SHALL APPLY FOR
ANY INTELLECTUAL PROPERTY RIGHT, BY WHATEVER NAME
CALLED, IN OR OUTSIDE INDIA FOR ANY INVENTION BASED ON
ANY RESEARCH OR INFORMATION ON A BIOLOGICAL
RESOURCE OBTAINED FROM INDIA WITHOUT OBTAINING THE
PREVIOUS APPROVAL OF THE NATIONAL BIODIVERSITY
AUTHORITY BEFORE MAKING SUCH APPLICATION.
PROVIDED THAT IF A PERSON APPLIES FOR A PATENT,
PERMISSION OF THE NATIONAL BIODIVERSITY AUTHORITY MAY
BE OBTAINED AFTER THE ACCEPTANCE OF THE PATENT BUT
BEFORE THE SEALING OF THE PATENT BY THE PATENT
AUTHORITY CONCERNED:
PROVIDED FURTHER THAT THE NATIONAL BIODIVERSITY
AUTHORITY SHALL DISPOSE OF THE APPLICATION FOR
PERMISSION MADE TO IT WITHIN A PERIOD OF NINETY DAYS
FROM THE DATE OF RECEIPT THEREOF.
WE HAVE CONSIDERED THE APPLICATION UNDER SECTION 6(1) OF
THE ACT AND OUR FINDINGS UNDER SECTION 6 ARE AS UNDER:
1. WHILE THE LAW PROVES THAT NO PERSON SHALL APPLY FOR
ANY INTELLECTUAL PROPERTY RIGHT, BY WHATEVER NAME
CALLED, IN OR OUTSIDE INDIA FOR ANY INVENTION BASED ON
ANY RESEARCH OR INFORMATION ON A BIOLOGICAL RESOURCE
OBTAINED FROM INDIA WITHOUT OBTAINING THE PREVIOUS
APPROVAL OF THE NATIONAL BIODIVERSITY AUTHORITY
BEFORE MAKING SUCH APPLICATION, BUT THE SAME IS
SUBJECT TO THE PROVISO THAT IF A PERSON APPLIES FOR A
PATENT, PERMISSION OF THE NATIONAL BIODIVERSITY
AUTHORITY MAY BE OBTAINED AFTER THE ACCEPTANCE OF
THE PATENT BUT BEFORE THE SEALING OF THE PATENT BY
THE PATENT AUTHORITY CONCERNED.
WE HAVE CONSIDERED THE APPLICATION UNDER SECTION 6(1) OF
THE ACT AND OUR FINDINGS UNDER SECTION 6 ARE AS UNDER:
2. UNDER THE AMENDED PATENTS ACT THE PROVISIONS FOR
ACCEPTANCE AND SEALING HAVE BEEN DONE AWAY WITH AND A
PATENT PROCEEDS TO GRANT UPON SUCCESFULLY
PROSECUTING THE PATENT APPLICATION.
THE PATENT APPLICATION IS OPPOSED BEFORE GRANT AND WE
HAVE ASCERTAINED FROM THE CONTROLLER OF PATENTS THAT
A PATENT IS YET TO BE GRANTED BY THEM. THUS THE TIME
FOR MAKING AN APPLICATION BEFORE US HAS NOT EXPIRED.
WE ARE THEREFORE UNABLE TO FIND ANY VIOLATION OF THE
PROVISIONS OF SECTION 6 OF THE ACT.
WE THEREFORE REJECT THE
REPRESENTATION MADE BY
SPOT INASMUCH AS THE
SAME IS WITHOUT MERIT AND
THE ALLEGATIONS ARE
UNSUBSTANTIATED.
Presentation V
APAA 54th Council Meeting 2007
Alelaide, Australia
Emerging Intellectual Property Rights Committee
Decision of Opposition
made by Indian Patent Office
Yulan Kuo, Partner
Formosa Transnational, Attorneys at Law
The nanocurcumin compound claimed by the father
and son team is a new substance different from the
prior art curcumin composition, and having
novelty and inventive step over the prior art
curcumin composition.
Summary of Decision of Opposition
1.
The nanocurcumin compound claimed by the father
and son team comprises nanocurcumin particles with
hydrophilic polymer outershells. The nanocurcumin
compound has nano-scale structure and improved
solubility in aqueous solutions. The bioavailability of
the nanocurcumin compound is increased due to its
improved solubility in aqueous solutions.
2.
The prior art curcumin composition is an admixture of
curcumin crystals and the essential oil of tumeric. The
curcumin crystals have large-scale structures and
insolubility nature. The curcumin crystals have poor
bioavailability due to its insolubility nature. The
bioavailability of the curcumin crystals in the prior art
curcumin composition is enhanced by the synergistic
effect of the essential oil.
3.
The nanocurcumin compound is a new
pharmaceutical product different from the prior
art curcumin composition, and having novelty and
inventive step over the prior art curcumin
composition.
Description of the Claimed Invention
The father and son team researched on the preparation of nanoparticles
of curcumin to overcome the problem posed by the insolubility of
curcumin and make it readily usable in therapy. The team used special
polymer to synthesize tiny nanoparticles of curcumin about 50-100
nanometers in diameter. The nanoparticles have hydrophobic interiors
and hydrophilic exteriors. The hydrophobic core traps the nanocurcumin,
while the hydrophilic exteriors make the nanoparticles soluble in water or
any other aqueous media. By this way, the nanoparticles can pass easily
from the gut to the bloodstream. Once in the blood, the curcumin leaks
out as the polymers slowly degrade. The increasing bioavailability of
nanocurcumin due to improved aqueous solubility overcomes the need to
consume doses as high as 12 gms and the problems associated with its
unbearable after-taste.
Description of the Prior Art Curcumin Composition
The prior art application WO2006/12932 discloses a composition having
curcuminoid with an essential oil of tumeric to enhance the bioavailability of
curcumin and to increase the biological activity of curcumin, wherein the curcumin
is the main constitute of curcuminoid. The curcumin has insolubility nature in the
aqueous solutions and hence poor bioavailability. The essential oil of tumeric is itself
bioactive, and thus is expected to synergistically enhance bioactivity of curcumin.
Curcuminoid is extracted from turmeric, and curcumin is the major component of
curcuminoid, occupying 95% weight ratio of curcuminoid. The essential oil of
tumeric is obtained as a by-product during extraction of curcuminoid from
turmeric. In the composition, the essential oil of tumeric is present in an amount
sufficient to cause an enhancement of bioavailability of curcumin when the
composition is administered to a human. The enhancement of bioavailability of the
curcumin ranges from about 5-fold to about 16-fold compared to a composition of
curcuminoid alone. The composition is marketed as Biocurcumax capsule.
Patentability of the claimed Nanocurcumin compound over the prior
art curcumin composition disclosed in WO2006/12932
1. The prior art curcumin composition is a blend (admixture) of
curcumin crystals and the essential oil of tumeric. Curcumin
crystals have large-scale structure and insoluble nature for
aqueous media. Curcumin crystals have poor bioavailability to a
human due to their insolubility in the aqueous solutions. In the
prior art curcumin composition, the essential oil is bioactive itself,
and the bioavailability of curcumin crystals is enhanced by the
synergistic effect of the essential oil of tumeric. A composition of
curcumin crystals alone has poor bioavailability due to its
insoluble nature.
2.
As to the nanocurcumin compound claimed by the father
and son team, the claimed nanocurcumin compound has
interior nanocurcumin particles with hydrophilic polymer
outershells. The hydrophilic polymer outershells make the
nanocurcumin particles soluble in water or any other
aqueous media. By this way, the nanocurcumin particles can
pass easily from the gut to the bloodstream. Once in the
blood, the curcumin leaks out as the polymer outershells
slowly degrade. The hydrophilic polymer outershells of the
nanocurcumin particles improve the aqueous solubility of
the nanocurcumin particles compound, and thus increasing
the bioavailability of it to a human.
3-1 The bioavailability of curcumin crystals of the prior art
composition is enhanced by the synergistic effect of the
essential oil of tumeric, which is another component in
the prior art composition. The claimed nanocurcumin
particles itself has higher bioavailability due to its
improved solubility.
3-2 The claimed nanocurcumin compound has nano-scale structures
constituted by the interior nanocurcumin particles with
hydrophilic polymer outershells. The curcumin crystals in the
prior art compound are pure curcumin and have larger-scale
structures. The claimed nanocurcumin compound is
nanocurcumin particles with hydrophilic polymer outershells,
while the prior art curcumin composition is a blend (admixture)
of curcumin crystals and the essential oil of tumeric. The
components of the claimed nanocurcumin compound are
different from those of the prior art curcumin composition. As
such, the claimed nanocurcumin compound is a new
pharmaceutical product over the prior art curcumin
composition.
Presentation VI
72
Emerging IP Rights Committee
APAA 54th Council Meeting
Adelaide, Australia
Nano Technology Hypothetical on Curcumin
- Presentation on behalf of Attorney General of India -
Seong-Ki Kim, Esq.
Lee International IP & LAW Group
Seoul, Korea
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Contents
I.
The Biological Diversity Act of 2002 (BDA)
II.
Investigation into Facts
III.
Application of BDA to Facts
IV.
Suggestion for Settlement of the Dispute
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I. The Biological Diversity Act of 2002 (BDA)
- Sec. 3 of BDA
• A non-Indian citizen needs a previous approval from the National
Biodoversity Authority (NBA) for obtaining any biological
resources occuring India
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I. The Biological Diversity Act of 2002 (BDA)
- Sec. 4 of BDA
• No person shall transfer the result of any research relating to
any biological resources occuring in or obtained from India to
a person who is not a citizen of India
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I. The Biological Diversity Act of 2002 (BDA)
- Sec. 6 of BDA
• A patent application for any invention based on any research
or information on a biological resource obtained from India
needs a prior approval of NBA before filing
• If a patent has been filed, a permission of NBA may be obtained
after acceptance of the patent
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I. The Biological Diversity Act of 2002 (BDA)
- Sec. 7 of BDA
• An Indian citizen who is not of a local people and communities
of the area needs prior intimation to State Biodiversity Board
for obtaining any biological resource for commercial utilization
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II. Investigation into Facts
7
- The source of Curcumin used in the preparation of
Nanocurcumin is a biological resource obtained from India
- No approval for obtaining a biological resource has been
taken from NBA on behalf of Amit Bose, one of the two
co-applicants of the pending patent application
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II. Investigation into Facts
8
- We need further information on facts:
• Whether Amit Bose got (and used) turmeric samples to produce
nanoparticles of curcumin?
→ If not, no violation of Sec. 3 of BDA
→ If yes, further investigation is required to determine whether
a prior intimation to State Biodiversity Board has been taken for
obtaining a turmeric sample or not
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III. Application of BDA to Facts
9
- Further investigation into facts is required in relation to
violation of Sec. 3, Sec. 7 of BDA need
- It seems that Sec. 4 and Sec. 6 of BDA violated
* In relation to Sec. 4 and Sec. 6 Alok Bose is subject to imprisonment
up to five years or criminal fine up to ten lakh rupees
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IV. Suggestion for Settlement of the Dispute
It is suggested that the parties, Amit Bose, Alok Bose, SPOT,
NBA, the Patent Controller and State Biodiversity Board of
Kerala agree to settle the case on the following terms:
1. Amit Bose agrees to transfer his share of the title to the patent
application to Alok Bose and destroy all records containing any
technical information obtained during preparation of patent
application on nanocurcumin
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IV. Suggestion for Settlement of the Dispute
2. Upon NBA’s approval and permission, Alok Bose agrees to deposit in
the National Biodiversity Fund as provided in Sec. 21 (3) of BDA a
20 % of any income from the subject patent application including any
patents granted on the subject patent application as the profit sharing
provided in Sec. 21 of BDA
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IV. Suggestion for Settlement of the Dispute
3. Upon Alok Bose’s application, NBA agrees, by a majority of votes of
the members, to grant a permission for a filing of a patent application
on the nanocurcumin invention
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IV. Suggestion for Settlement of the Dispute
4. All the parties agree not to file a civil or criminal complaints or
under the BDA prosecute a case raised under the BDA
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Thank You!
[email protected]
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