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DRAFTING & PROCECUTING
PHARMA AND BIOTECH
PATENTS IN INDIA
BY Dr. Rajeshkumar H. Acharya
April 19,2007
Markpatent.Org
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CHANGED SCENARIO OF
INDIAN PATENT
•Indian Patent Act -2005
Provisions for granting product
patent in all fields of Technology
including chemicals, food, drugs &
agrochemicals
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IPA SECTIONS ONE
SHOULD KEEP IN MIND
WHILE DRAFTING
• SECTION 2 (1) (j)
• SECTION 3 (h)
• SECTION 3 (i)
• SECTION 3 (j)
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SECTION 2 (1) (j)
• An invention means a new product or
process involving an inventive step and
capable of industrial application
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NON-PATENTABLE
INVENTIONS UNDER
SECTION 3 (h)
A method of agriculture and horticulture
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NON-PATENTABLE INVENTIONS
UNDER SECTION 3 (i)
Any process for the medicinal, surgical,
curative, prophylactic diagnostic therapeutic
or other treatment of human being 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.
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NON-PATENTABLE INVENTIONS
UNDER SECTION 3 (j)
Plants and animals in whole or any
thereof other than microorganisms
including seeds, varieties and species
essentially
biological
processes
production or propagation of plants
animals;
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part
but
and
for
and
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PHARMA
PATENT
DRAFTING
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DIFFERENT TYPES OF
PHARMACEUTICAL CLAIMS
•
•
•
•
•
Chemical compounds
First medical use of novel (inventive)
compounds
Second
medical
use
of
known
compounds
Swiss Style
Method
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CHEMICAL COMPOUNDS
A compound having the formula R-CH= N-SX, wherein
R is an alkyl group selected from the
group consisting of methyl, ethyl and
isopropyl; and
X is a halogen selected from the group
consisting of chlorine and bromine”
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FIRST MEDICAL USE OF NOVEL
(INVENTIVE) COMPOUNDS
“A chemical compound of chemical formula
R-CH= N-S-X use as a medicine to treat
skin burns”
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SECOND MEDICAL USE OF
KNOWN COMPOUNDS
“A chemical compound of chemical
formula use as a medicine to treat
acne”
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SWISS TYPE
“Use
of chemical compound of
chemical formula R-CH= N-S-X for
producing therapeutic agents for
treating skin burn.” (Swiss-type, current
EPO)
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METHOD
“A method for preparation of compound
having
the
formula
R-CH=
N-S-X
comprising steps of
taking substance (a) and heating at
60O C……
adding substance (b)
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COMPARISONS OF INDIAN
PHARMA PATENTABILITY WITH
OTHER COUNTRIES
Category of
invention
JPO
EPO
USPTO
IPA
Chemical
entity
Yes
Yes
Yes
Yes
1st use
2nd use
Swiss-type
Yes
Yes
Yes
No
No need Yes
Yes
No
No need
No
No
No
New method
Yes
Yes
Yes
April 19,2007
Yes
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BIOTECH
PATENT
DRAFTING
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IN WHAT FORM DO GENES OR DNA
SEQUENCES APPEAR IN PATENT
CLAIMS?
•
•
•
•
the DNA sequence, promoters
enhancers
individual exons
expressed sequences as expressed
sequence tags (ESTs) or cDNAs
• whole transcribed genes as cDNAs
• individual mutations known to cause
disease
Continue….
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….
• polymorphisms
• cloning vectors, formed from bacterial
DNA, expression vectors, also formed
from
• bacterial DNA,
• isolated host cells transformed with
expression vectorsamino acid sequences
(proteins)
• the use of such proteins as medicines
• antibodies, which are used as markers
continue….
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• nucleic acid probes, which are
fragments of DNA that are used to
locate particular parts of DNA
sequences
• methods of identifying the existence
of a DNA sequence or a mutation or
deletion in an individual
• testing kits for detecting genetic
mutations
• whole genomes
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What Indian Patent Office says about
Biotechnological patentablility?
• The living entities of natural origin and
process of manufacture of production
related to living entities – Non patentable
• Any method of treatment such as medicinal,
surgical, curative, prophylactic, diagnostic
and therapeutic – Non patentable
• transgenic animals and plants – Non
patentable
• micro-organisms - patentable
Continue…
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• Gene sequences, DNA sequences
without function – Non Patentable
• Biological
processes
for
the
production of plants and animals –
Non Patentable
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DEPOSITION OF NEW
BIOLOGICAL MATERIALS
If
mew
biological
materials
(microorganism) disclosed in the patent
application, then such materials are
required to be deposited in any of the
International Depositary Authorities (IDA)
recognized under the BUDAPEST Treaty
on or before filing of the application.
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DEPOSITORY INSTITUTION IN
INDIA
• Microbial Type Culture Collection and
Gene Bank (MTCC) - Chandigadh
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PRESENT STATUS OF MTCC
It has five sections, namely
• Actinomycetes
• Bacteria
• Fungi
• Yeast
• Plasmids
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CLAIMS OF DEPOSITED
MATERIAL
•Title:
Medium
for
the
production
of
betacarotene and other carotenoids
from Dunaliella salina (ARL 5) and a
strain of Dunaliella salina for production
of carotenes using the novel media
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•Abstract:
A salt solution complex comprising a non
conventional
salt,
namely
KCl
and
conventional salts such as NaCl and MgSO4
in the proportion defined in the specification
to
generate
biomass
of
higher
carotenogenesis in particular Betacarotene
and its isomers using Dunaliella salina ARL5
in a single stage of active growth. Dunaliella
salina ARL5, a local isolate, has an unique
property of having a wide range of pH and
temperature tolerance which is beneficial in
production terms as it is grown in external
conditions (i.e. outdoors).
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• Claims
1.
A process for culturing Dunaliella salina ARL5
(CCAP 19/36)to produce algae cells having
betacarotene and its isomers as well as a a
high protein biomass by (a) growing Dunaliella
salina ARL5 in an aqueous medium
comprising: a salt solution complex comprising
KCl, MgSO.sub.4 and NaCl wherein the salt
solution complex comprises 0.2M-1M KCl,
0.41M-1.5M MgSO4, 1M-5M NaCl; and (b)
recovering carotenes from said algae cells.
2. The process according to claim 1 wherein the
salt solution complex comprises 0.35M KCl,
0.6M MgSO4 and 2M NaCl.
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METHOD CLAIM
• Title:
METHOD FOR TRANSCRIPTION OF A DNA
SEQUENCE
• Abstract:
A DNA sequence transcribing method involves
labeling a DNA fragment with a fluorescent
substance, subjecting the labeled fragments to
electrophoresis, exposing a gel containing the DNA
fragment to light during electrophoresis, and
detecting fluorescence generated upon exposure.
An image corresponding to a fluorescent image on
the gel is transcribed on a recording medium by
entering a detecting signal in synchronization with
operation of detecting fluorescence on the gel
containing the DNA fragment after electrophoresis.
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DRAWING
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•
Claim:
1.
A method for transcription of a DNA sequence, comprising the steps of:
labeling DNA fragments with a fluorescent sub-stance;
subjecting the labeled DNA fragments to gel electrophoresis to cause
migration of the fragments in the gel in a first direction;
inducing fluorescence of the labeled DNA fragments by
excitation with an optical source by linearly scanning the gel along a
path extending in a second direction perpendicular to said first direction;
detecting the fluorescence generated from the excitation with a
photoelectric device arranged in said second direction to produce a
signal that varies in intensity along the scanning path in accordance
with the fluorescence and outputting the signal;
receiving and recording said output signal with an electro-optical
transfer device on a photosensitive film as an image of the gel
containing the labeled DNA fragments; and
moving one of said electro-optical transfer device and said
photosensitive film relative to the other at a rate corresponding to
a rate of the migration of the DNA fragments within the gel to record a
series of said output signals separated from one another by said
moving.
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CLAIM OF POLYPEPTIDE
SEQUENCE
• Title:
HUMAN E3a UBIQUITIN LIGASE FAMILY
Abstract:
• A polypeptide encoding a protein which is the
full length human ortholog of E3a ubiquitin
ligase. The invention also relates to vector,
host cells, antibodies and recombinant
methods for producing the polypeptide. In
addition, the invention discloses therapeutic,
diagnostic and research utilities for these and
related products.
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• Claims:
1. An isolated polypeptide comprising the
amino acid sequence set forth in SEQ ID
NO: 2.
2. An isolated polypeptide comprising the
amino acid sequence that is at least
percent identical to the amino acid
sequence of SEQ ID NO: 2, wherein the
polypeptide has E3a ubiquitin ligase
activity of the polypeptide set forth in
SEQ ID NO: 2.
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3.
An isolated polypeptide comprising the amino acid sequence
selected from the group consisting of:
the amino acid sequence as set forth in SEQ ID NO: 2 with 1 to 100
conservative amino acid substitution(s), wherein the polypeptide has
E3a ubiquitin ligase activity of the polypeptide set forth in SEQ ID
NO: 2;
the amino acid sequence as set forth in SEQ ID NO: 2 with 1 to 100 amino
acid insertion(s), wherein the polypeptide has E3a ubiquitin ligase
activity of the polypeptide set forth in SEQ ID NO: 2;
the amino acid sequence as set forth in SEQ ID NO: 2 with 1 to 100 amino
acid deletion(s), wherein the polypeptide has an E3a ubiquitin ligase
activity of the polypeptide set forth in SEQ ID NO: 2;
the amino acid sequence as set forth in SEQ ID NO: 2 which has a Cand/or N-terminal truncation up to about 100 amino acids, wherein
the polypeptide has E3a ubiquitin ligase activity of the polypeptide
set forth in SEQ ID NO: 2; and
the amino acid sequence as set forth in SEQ ID NO: 2, with a modification
of 1 to 100 amino acids consisting of amino acid substitutions, amino
acid insertions, amino acid deletions, C-terminal truncation, and Nterminal truncation, wherein the polypeptide has E3a ubiquitin ligase
activity of the polypeptide set forth in SEQ ID NO: 2.
Total: 15 claims
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Thank You
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