Section 3d ppt

Intro to Patent Law – Section 3(d)

Dr. Kalyan C. Kankanala

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© BananaIP Counsels. 2015. Private Use is Permitted.

Inventor/ Investor

Incentives

Public Domain

Invention

Patent

Patent RegimeGive and Take

Progress of Science and Technology

Invent

Invest

Disclose

Design

Around

Patentability Requirements

Patentable subject matter

Industrial Applicability

Novelty

Inventive Step

Specification


Patentable Subject Matter

Eligible Subjects

Product or Process - Section 2(1)(j)

Exclusions

Sections 3 and 4 - Non-Patentable Subjects/Inventions


Exclusions

Section 3(d)

New form of Known Substance

Enhanced/Significant Efficacy

New property

New use


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.


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?


Section 3(d)

• Which is the known substance?

• Is the invention a new form of that substance?

• Does the invention have enhanced efficacy?


Example

Known Analgesics

Morphine - NarcoticDiclofenac - Non-Narcotic

Invention

morphine-diclofenateflupirtin and morphine combination


ExampleKnown 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


Example

Known Substances

PCRTaq PolymeraseSolid 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.


Example

•Known Substance

Straws with filtration up to 1 micron

•Invention

Straw with filtration up to 0.2 micron


Example

• Known substanceStentTaxol

Invention- Stent coated with taxol


S. 3(d) V. Other Requirements

Industrial Applicability

Novelty

Inventive Step

Specification


CASE CASE CITATION

Novartis A.G v. Union of IndiaCivil 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.


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Kalyan C Kankanala

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