Patent prosecution Guidelines by Intellectual Property Patent Law Firm in India| Filing Patent details of Foreign Patent Application Prosecution History Before Indian Patent Office| Section 8 Compliance for Prosecution of Indian Patent Pharma Applications
Filing Patent details of Foreign Patent Application Prosecution History Before Indian Patent Office| Section 8 Compliance for Prosecution of Indian Pharmaceutical, Biotech, Drug Patent Applications in India| Patent prosecution Guidelines in India
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Patent prosecution Guidelines by Intellectual Property Patent Law Firm in India| Filing Patent details of Foreign Patent Application Prosecution History Before Indian Patent Office| Section 8 Compliance for Prosecution of Indian Patent Pharma Applications
1. ISSUE
MONTHLY
01
JOURNAL OF
DECEMBER
Latest Updates by Tech Corp Legal LLP
TECH NEWS
2013
This issue
Kibow Wins Patent Battle P.1
IPAB Case Study P.2
Patent Prosecution Tips P.3
Upcoming Event P.4
Kibow Biotech Wins Patent Battle in India
Prity Khastgir is a Biotech
2013
The inventive composition of the patent
Intellectual Property Appellate Board (IPAB)
comprises at least one probiotics bacteria of a
upheld Patent Revocation Petition filed by
certain kind, in a certain composition and it is
and Pharmaceutical Indian
Recently,
Patent Attorney at Tech
Gujarat based La Renon Health Care Pvt. Ltd
not a mere admixture and is patentable under
for patent No.224100 granted to Kibow
the Indian Patent Act, 1970. As stated by
Biotech
invention
IPAB “the invention covers a new and
Kidney
inventive composition comprising at least one
New Delhi.
Function” under the provisions of the Indian
probiotic bacteria of a certain kind, in a
She also serves as Director
Patents Act, 1970. However, on the same
certain composition and along with other
at Tech Corp International
day, Intellectual Property Appellate Board
Consultants
Ltd.
(IPAB) revoked Indian Patent granted to
she
Kibow Biotech INC, titled “A process of
Corp
Legal
LLP
(www.techcorplegal.com)
,an
Indian
Intellectual
Property law firm based in
Pte.
(Singapore), wherein
advises
clients
regarding
on
Inc.,
“Compositions
making
13th
for
for
November,
the
patent
Augmenting
pharmaceutical
composition”
freedom to operate (FTO)
bearing patent grant number IN205478 under
studies
additives (such as vitamins etc) that confer
synergistic impact, enabling the augmentation
of
kidney
function.
By
no
stretch
of
imagination can this unique composition be
labeled
as
mere
IPAB
Dismisses
admixture.”
the provisions of the Indian Patents Act,
for
their
new
product or service and
search for possible foreign
IP
rights
that
could
be
1970. The US based Biotech Company Kibow
the
Revocation
Biotech specializes in breakthrough patented
Petition filed by La Renon Health Care
and proprietary probiotic dietary supplements
An order placed by IPAB Vice Chairman S.
for kidney and immune health.
Usha and Technical Member DPS Parmar,
infringed.
agreed with Kinow Biotech that the impugned
Patent clearance searches
Who filed for Patent Revocation?
patent aids in carrying out the kidney function
are
A Gujarat based Indian company La Renon
per se. Particularly, in some embodiments of
Health Care Pvt Ltd had filed for the patent
the
revocation
alleviates the symptoms of uremia; the
rapidly
becoming
a
necessity for any technology
company to enter in India
and in any other foreign
country.
Having
the
Intellectual
Property Appellate Board (IPAB) has upheld
the Patent Revocation Petition filed by
probiotic
composition
increased creatinine or BUN levels in subjects
undergoing
chemotherapy
cancer,
HIV
treatment;
the
or
AIDS
increased
multi-
Gujarat based La Renon Health Care Pvt. Ltd
creatinine or BUN levels in subjects with
for patent No.224100 granted to Kibow Biotech
metabolic syndrome; or the symptoms of
Inc.,
for
increased creatinine or BUN levels in subjects
Augmenting Kidney Function”. The IPAB found that
consuming high protein and low carbohydrate
the granted invention is not obvious in view of the
diets. Subsequently, it makes the invention
the prior art documents cited by La Renon Health
not obvious to a person skilled in the art.
gives her clients insights in
their
and
the
experience
jurisdictional
protecting
petition
invention,
and
intellectual
enforcing
property
rights in several countries.
Care.
for
the
invention
“Compositions
2. Patent Applicant(s)
should comply with
the legal section
requirements of the
Indian Patent Act
Serving Tech
Industry around
the World
India's Patent
Ecosystem:
Encouraging
Strong Patent
Innovation
Patent Prosecution in India is
highly procedural.
Compliance is Mandatory!!
Facts of the Present Case:
Intellectual Property
Appellate Board (IPAB)
Kibow Biotech Inc. is a foreign company
The WIPO publication number of the patent application was
upheld Patent Revocation
based in United States and had filed a
WO/2005/032591.
Petition filed by Gujarat
Civil Suit No.498 of 2011 before the
On
based La Renon Health
Hon’ble
alleging
351/MUMNP/2006 bearing the title “COMPOSITIONS AND
Care
infringement of the impugned patent No.
METHODS FOR AUGMENTING KIDNEY FUNCTION” was
224100
making
filed in India as a national phase application of PCT
pharmaceutical composition” in order to
application No. PCT/US2004/032250 filed on September
curb the competition in the Indian market
30, 2004 before the WIPO. The patent application filed in
from Gujarat-based La Renon Health Care
India is based on PCT application claiming priority from four
Pvt Ltd company who would be the major
US patent applications.
Section 3 of the
Indian Patent
Act
Section 3 of the Indian
Patent Act is related to
non-patentable inventions
and it is very important
section cited by the patent
examiners
during
the
patent prosecution stage
in India.
Madras
titled
High
“A
Court
process
of
competitor in the same field in the Indian
market.
The said suit was dismissed by the
Hon’ble Madras High Court vide order
dated
22.08.2011
due
to
non-
maintainability of the suit under section
599 of the Companies Act as per the
March
28,
2006
the
patent
application
No.
On September 29, 2008 the patent application was granted
patent by the Indian Patent Office.
The granted patent has 10 patent claims
India's Patent
ecosystem: and the independent claim relates to a
Fostering composition for augmenting kidney
function in a subject.
Innovation
provisions of Order 7 Rule 13 Code of Civil
The patent claims relates to at least one probiotic
Procedure. The Hon’ble Court however
bacterium wherein said probiotic bacterium selected from
said the plaintiff is entitled to bring a fresh
Streptococcus thermophilus at about 5 billion to about 20
suit after curing the defects of Section 599
billion colony forming units of said at least one probiotic
of the Companies Act.
bacterium other ingredient being selected from vitamin,
Subsequently, the domestic company Le
mineral, carbohydrate, protein and fats. The dependant
Renon Health Care filed the revocation
patent claims from claim 2- claim 5 depend on the
plea before Intellectual Property Appellate
independent patent claim 1, dependant patent claim 6-
Board (IPAB). La Renon Healthcare has a
patent claim 9 depend on claim 1 and dependant claim
For Healthcare Focused
product under the brand name CUDO with
10 depends on patent claim 9.
Intellectual Property
similar composition and has filed for patent
Strategy, Legal &
registration
Regulatory Consulting
Office, which is pending approval.
After Indian patent examination, only ten claims were
Services:
Historical Facts of Indian Patent
“IN224100”
granted for a composition for augmenting kidney function
On April 14, 2005, the International Patent
wherein
Application number PCT/US2004/032250
Streptococcus thermophilus at about 5 billion to about 20
titled “COMPOSITIONS AND METHODS
billion colony forming units of said at least one probiotic
FOR AUGMENTING KIDNEY FUNCTION”
bacterium other ingredient being selected from vitamin,
was published by WIPO.
mineral, carbohydrate, protein and fats.
Therefore
applicant
the
patent
should
take
proactive steps during the
patent prosecution stage
and comply with the legal
requirements of the Indian
patent act.
www.biocorplegal.com
before
the
Indian
Patent
Details of the Present Case:
in a subject comprising at least one probiotic bacterium
said
probiotic
bacterium
selected
from
3. HAWK-EYE
APPROACH
Current Industry
Patent Trends
Relevance of Section 3(e)
of the Indian Patent Act
for Pharmaceutical &
Drug Companies
As per Section 3(e) of the
Indian Patent Act “a substance
obtained by a mere admixture
Originally filed patent claim were
very broad and related to “A
composition for augmenting kidney
function in a subject comprising at
least
one
probiotic
bacterium
wherein said probiotic bacterium
reduces creatinine and BUN levels
in the subject”.
However, the
patent claims were narrowed down
after
patent
examination.
The
granted independent patent claim
1 has following essential elements
the
prosecution
the
aggregation of the properties of
is KB4, KB19, or KB25.
impugned patent application the
the components thereof or a
patent claim 2 as filed originally
process for producing such
has been merged with claim 1
substance.”
above
is
limited
to
composition comprising a probiotic
bacterium
selected
Streptococcus
from
thermophilus
at
about 5 billion to about 20 billion
cfus of KB4, KB19 or KB25. In
addition, the composition further
history
patent
in
Streptococcus thermophilus strain
illustrated
the
only
After
The independent granted claim as
analysing
resulting
In dependent patent claim 2, the
of
which narrows down the scope of
The above mentioned section
probiotics only to Streptococcus
is a major obstacle for new
thermophilus. Further, patent claim
forms
7 is also merged and reworded
(salts,
polymorphs,
with claim 1 to include about 5
solvates,
billion to about 20 billion cfu of
pharmaceutical
probiotic
substances, unless until the
limitation
in
the
etc)
of
drugs
includes other ingredient being
composition.
patentee illustrates improved
selected from vitamin, mineral,
None of these limitations were
effectiveness
carbohydrate, protein and fats. The
taught in any of the cited prior art
selected
composition is a food and has 5-20
document
Streptococcus
billion cfus. Additionally it claims
combination and hence the ground
that
of
and limitations: A composition for
augmenting
kidney
comprising (a)
probiotic
function
at least one
bacterium
from
thermophilus (b)
at about 5
it
is
a
composition
for
either
alone
obviousness
or
can’t
product.
in
over
For
existing
e.g.,
a
composition of two drugs, i.e.
Paracetamol and Ibuprofen for
be
billion to about 20 billion colony
augmenting
functions.
determined in the present case. It
curing
forming units of said at least
Further, in the detailed description
was further determined that patent
process of preparation thereof
of the patent application it is stated
composition comprises at least
is not
streptococcus thermophilus is a
one probiotic bacteria of a certain
reason that the composition is
probiotic and detail of the same
kind, in a certain composition and
a mere admixture of two drug
are
it is not a mere admixture.
one probiotic
bacterium (c)
other ingredient being selected
from
vitamin,
mineral,
carbohydrate, protein and fats.
kidney
provided
in
the
patent
Prosecution
Process
in
pain
or
patentable for the
resulting
aggregation
This Month’s Patent Prosecution Tip, Section 8(1)
Patent
and
components
application.
fever
of
into
properties
thereof; since Paracetamol is
well known for treatment of
A statement which includes detailed particulars
fever
India: The overall process of patent
of
treatment of pain.
prosecution in India is a bit complicated
anywhere outside India before the filing of the
However, if the mixture of
due to multiple compliances and deadlines
Indian patent application; and
drugs
to
follow
by
the
patent
applicants.
corresponding
patent
applications
filed
and
Ibuprofen
exhibits
for
some
A declaration and undertaking that the patent
unexpected
Understanding why a research needs
applicant
of
synergistic properties in their
patent protection in a particular country,
corresponding patent applications filed in any
action, then such composition
what all processes and drug products can
foreign country after the filing of the Indian
is considered as patentable
be patented or how to build a strong
patent
within
portfolio of patents is very vital for succuss
subsequent
of any biotech ventures. U n d e r S e c t i o n
corresponding patent application.
supported with adequate test
8(1) of the Indian Patents Act, a
A petition can be filed under Rule 137 for condonation
results
patent
of delay and the patent documents may be taken on
synergistic properties of the
record subject to the Controller’s approval in India.
pharmaceutical
provide:
applicant
is
required
to
will
application
patent
provide
filing
i.e.
the
6
details
months
after
filing
results
or
of
the
subject matter. Moreover, the
of
the
patent description should be
molecule
to
confirm
drug
the
or