This document provides an overview of patent law concepts in India, including inventor incentives, patentability requirements, and exclusions. It defines patentable subject matter and exclusions under Indian law. Examples are given to illustrate assessments of a "new form of a known substance" and "enhanced efficacy" under Section 3(d) of the Indian Patents Act. Relevant case citations are also listed. The document is authored by Dr. Kalyan C. Kankanala and intended for private use regarding Indian patent law.

1. Intro to Patent Law – s.
3d
• Dr. Kalyan C. Kankanala
• kalyan@bananaip.com
• Blog: http://sinapse.bananaip.com
• Books: www.kalyankankanala.com
© BananaIP Counsels. 2015.
Private Use is Permitted.

2. Inventor/
Investor
Incentives
Public Domain
Invention
Patent
Patent Regime
Give and Take
Progress of Science and
Technology
Invent
Invest
Disclose
Design
Around

3. Patentability
requirements
Patentable subject matter
Industrial Applicability
Novelty
Inventive Step
Specification
© BananaIP Counsels. 2015.
Private Use is Permitted.

4. Patentable Subject
Matter
Eligible Subjects
Product or Process - Section 2(1)(j)
Exclusions
Sections 3 and 4 - Non-Patentable Subjects/Inventions
© BananaIP Counsels. 2015.
Private Use is Permitted.

5. Exclusions
Section 3(d)
New form of Known Substance
Enhanced/Significant Efficacy
New property
New use
© BananaIP Counsels. 2015.
Private Use is Permitted.

6. Section 3(d)
Explanation:... salts, esters, ethers, polymorphs,
metabolites, pure form, particle size, isomers,
mixtures of isomers, complexes, combinations
and other derivatives of known substance shall
be considered to be the same substance,
unless they differ significantly in properties with
regard to efficacy.
© BananaIP Counsels. 2015.
Private Use is Permitted.

7. Section 3(d)
Examples
New Property: Lower ethers are highly volatile and flammable.
New Use: Use of Metformin for treating fatty liver disorder,
when it is known for diabetes treatment.
New Form: Imatinib Masylate in Beta Crystalline form for
treating cancer, when Imatinib was known for cancer
treatment.
Enhanced Efficacy?
© BananaIP Counsels. 2015.
Private Use is Permitted.

8. Section 3(d)
• Which is the known substance?
• Is the invention a new form of that
substance?
• Does the invention have enhanced
efficacy?
© BananaIP Counsels. 2015.
Private Use is Permitted.

9. Example
Known Analgesics
Morphine - Narcotic
Diclofenac - Non-Narcotic
Invention
morphine-diclofenate
flupirtin and morphine combination
© BananaIP Counsels. 2015.
Private Use is Permitted.

10. Example
Known Substances
• Human Genome
• cDNA sequences for six eye colour variations
• cDNA sequence for hair color
Invention
• Re-combinant DNA Blue-Green eyes and Blonde hair
• Method of introducing the same in Mammalian cells
• Organism with blue eyes and blonde hair
© BananaIP Counsels. 2015.
Private Use is Permitted.

11. Example
Known Substances
PCR
Taq Polymerase
Solid Wax Barrier or Antibody ligation to prevent
DNA synthesis at low temperature
Invention
Chemically modified Taq Polymerase - Inactive at
low temperature, and active at high temperature.
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Private Use is Permitted.

12. Example
•Known Substance
Straws with filtration up to 1 micron
•Invention
Straw with filtration up to 0.2 micron
© BananaIP Counsels. 2015.
Private Use is Permitted.

13. Example
• Known substance
Stent
Taxol
Invention- Stent coated with taxol
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Private Use is Permitted.

14. S. 3(d) V. Other
Requirements
Industrial Applicability
Novelty
Inventive Step
Specification
© BananaIP Counsels. 2015.
Private Use is Permitted.

15. CASE CASE CITATION
Novartis A.G v. Union of India
Civil Appeal Nos. 2706-2716 of 2013 (S.L.P. (C) Nos. 20539-20549
of 2009).
Jeevan Jyoti Health & Welfare Society vs. Union of India & Anr. W.P. (C) 10634/2006.
F. Hoffmann - La Roche Ltd. and Anr. vs. Cipla Limited I.A. 642/2008 in CS (OS) 89/2008.
Takeda GmBH v. Controller of Patents and Designs 293/MUMNP/2008.
Asian Electronics Ltd. vs. Havells India Limited I.A. No. 8205/2009 in CS(OS) 1168/2009.
Otsuka Pharmaceutical Co. Ltd. vs. The Controller General of
Patents & Deputy Controller of Patents & Designs
OA/24/2010/PT/DEL.
Ten Xc Wireless Inc & Anr vs Mobi Antenna Technologies CS(OS) Nos. 1989/2010.
Fresenius Kabi Oncology Limited Vs. Glaxo Group Limited and The
Controller of Patents
ORA/22/2011/PT/KOL.
Fresenius Kabi Oncology Limited Vs. Glaxo Group Limited and The
Controller of Patents
ORA/17/2012/PT/KOL.
Monsanto Technology LLC Vs. The Controller of Patents & Designs
and The Deputy Controller of Patents & Designs
OA/02/2012/PT/DEL., M.P. NOS.35 & 36/2013 IN
OA/02/2012/PT/DEL.
Cima Labs Inc. vs. The Controller of Patents OA/2/2013/PT/KOL.
Merck Sharp and Dohme Corporation and Ors. vs. Glenmark
Pharmaceutical
FAO (OS) 190/2013., C.M. Appl. 5755/2013., 466 & 467/2014.
3M Innovative Properties Company Vs.Venus Safety & Health Pvt.
Ltd.
I.A. No. 20605/2013., I.A. No. 1276/2014 in CS(OS)--2558/2013.
Novartis A. G. vs. Ranbaxy Laboratories Ltd I.A. No. 17139/2014 in CS (OS) No. 2703/2014.
Novartis AG vs. Cipla Ltd I.A. No. 24863/2014 in CS (OS) 3812/2014.
Pfizer Products Inc. vs. Controller of Patents OA/41/2014/PT/MUM.
Telefonaktiebolaget Lm Ericsson ( Publ ) vs. Intex Technologies I.A. No. 6735/2014 in CS (OS) No. 1045/2014.
Gilead Pharmasset , LLC vs. Union of India and Ors WP (C) 687/2015 and CM No. 1222/2015.
© BananaIP Counsels. 2015.
Private Use is Permitted.

16. Available On
© BananaIP Counsels. 2015.
Private Use is Permitted. contact@bananaip.com
Dr. Kalyan’s Book Collection

17. Thank You
Kalyan C Kankanala
kalyan@bananaip.com
© BananaIP Counsels. 2015.
Private Use is Permitted.