3 DR Acharya

DRAFTING & PROCECUTING PHARMA AND BIOTECH PATENTS IN INDIA
BY Dr. Rajeshkumar H. Acharya

April 19,2007 Markpatent.Org 1
CHANGED SCENARIO OF INDIAN PATENT

Indian Patent Act -2005 Provisions for granting product patent in all fields of Technology including chemicals, food, drugs & agrochemicals
IPA SECTIONS ONE SHOULD KEEP IN MIND WHILE DRAFTING

SECTION 2 (1) (j) SECTION 3 (h) SECTION 3 (i) SECTION 3 (j)
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.
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;
April 19,2007 Markpatent.Org
part but and for and
PHARMA PATENT DRAFTING

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)
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)
COMPARISONS OF INDIAN PHARMA PATENTABILITY WITH OTHER COUNTRIES

Category of invention Chemical entity 1st use 2nd use JPO Yes Yes Yes
EPO
Yes Yes No
USPTO
Yes Yes No
IPA
Yes No No
Swiss-type New method

April 19,2007
No need Yes Yes Yes

Markpatent.Org
No need Yes
No 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.
. 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.
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
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.
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).
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.
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.
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.
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

3 DR Acharya

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DRAFTING & PROCECUTING PHARMA AND BIOTECH PATENTS IN INDIA

BY Dr. Rajeshkumar H. Acharya

CHANGED SCENARIO OF INDIAN PATENT

IPA SECTIONS ONE SHOULD KEEP IN MIND WHILE DRAFTING

SECTION 2 (1) (j)

NON-PATENTABLE INVENTIONS UNDER SECTION 3 (h)

NON-PATENTABLE INVENTIONS UNDER SECTION 3 (i)

NON-PATENTABLE INVENTIONS UNDER SECTION 3 (j)

part but and for and

PHARMA PATENT DRAFTING

DIFFERENT TYPES OF PHARMACEUTICAL CLAIMS

FIRST MEDICAL USE OF NOVEL (INVENTIVE) COMPOUNDS

SECOND MEDICAL USE OF KNOWN COMPOUNDS

A chemical compound of chemical formula use as a medicine to treat acne

COMPARISONS OF INDIAN PHARMA PATENTABILITY WITH OTHER COUNTRIES

Swiss-type New method

No need Yes Yes Yes

BIOTECH PATENT DRAFTING

IN WHAT FORM DO GENES OR DNA SEQUENCES APPEAR IN PATENT CLAIMS?

What Indian Patent Office says about Biotechnological patentablility?

DEPOSITION OF NEW BIOLOGICAL MATERIALS

DEPOSITORY INSTITUTION IN INDIA

PRESENT STATUS OF MTCC

CLAIMS OF DEPOSITED MATERIAL

CLAIM OF POLYPEPTIDE SEQUENCE

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