1. April 19,2007Markpatent.Org1 DRAFTING & PROCECUTING PHARMA AND BIOTECH PATENTS IN INDIA BY Dr. Rajeshkumar H. Acharya

2. April 19,2007Markpatent.Org2 CHANGED SCENARIO OF INDIAN PATENT Indian Patent Act -2005 Provisions for granting product patent in all fields of Technology including chemicals, food, drugs & agrochemicals

3. April 19,2007Markpatent.Org3 IPA SECTIONS ONE SHOULD KEEP IN MIND WHILE DRAFTING SECTION 2 (1) (j) SECTION 3 (h) SECTION 3 (i) SECTION 3 (j)

4. April 19,2007Markpatent.Org4 SECTION 2 (1) (j) An invention means a new product or process involving an inventive step and capable of industrial application

5. April 19,2007Markpatent.Org5 NON-PATENTABLE INVENTIONS UNDER SECTION 3 (h) A method of agriculture and horticulture

6. April 19,2007Markpatent.Org6 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.

7. April 19,2007Markpatent.Org7 NON-PATENTABLE INVENTIONS UNDER SECTION 3 (j) Plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals;

8. April 19,2007Markpatent.Org8 PHARMA PATENT DRAFTING

9. April 19,2007Markpatent.Org9 DIFFERENT TYPES OF PHARMACEUTICAL CLAIMS Chemical compounds First medical use of novel (inventive) compounds Second medical use of known compounds Swiss Style Method

10. April 19,2007Markpatent.Org10 CHEMICAL COMPOUNDS A compound having the formula R-CH= N-S- X, 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”

11. April 19,2007Markpatent.Org11 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”

12. April 19,2007Markpatent.Org12 SECOND MEDICAL USE OF KNOWN COMPOUNDS “A chemical compound of chemical formula use as a medicine to treat acne”

13. April 19,2007Markpatent.Org13 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)

14. April 19,2007Markpatent.Org14 METHOD “A method for preparation of compound having the formula R-CH= N-S-X comprising steps of taking substance (a) and heating at 60 O C…… adding substance (b)

15. April 19,2007Markpatent.Org15 COMPARISONS OF INDIAN PHARMA PATENTABILITY WITH OTHER COUNTRIES Category of invention JPO EPOUSPTOIPA Chemical entity Yes 1st useYes No 2nd useYesNo Swiss-typeNo needYesNo needNo New methodYes

16. April 19,2007Markpatent.Org16 BIOTECH PATENT DRAFTING

17. April 19,2007Markpatent.Org17 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….

18. April 19,2007Markpatent.Org18 …. 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….

19. April 19,2007Markpatent.Org19 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

20. April 19,2007Markpatent.Org20 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…

21. April 19,2007Markpatent.Org21 Gene sequences, DNA sequences without function – Non Patentable Biological processes for the production of plants and animals – Non Patentable

22. April 19,2007Markpatent.Org22 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.

23. April 19,2007Markpatent.Org23 DEPOSITORY INSTITUTION IN INDIA Microbial Type Culture Collection and Gene Bank (MTCC) - Chandigadh

24. April 19,2007Markpatent.Org24 PRESENT STATUS OF MTCC It has five sections, namely Actinomycetes Bacteria Fungi Yeast Plasmids

25. April 19,2007Markpatent.Org25 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

26. April 19,2007Markpatent.Org26 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).

27. April 19,2007Markpatent.Org27 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.

28. April 19,2007Markpatent.Org28 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.

29. April 19,2007Markpatent.Org29 DRAWING

30. April 19,2007Markpatent.Org30 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.

31. April 19,2007Markpatent.Org31 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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34. April 19,2007Markpatent.Org34 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.

35. April 19,2007Markpatent.Org35 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 C- and/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 N- ter­minal 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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37. April 19,2007Markpatent.Org37 Thank You