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Patent related case studies Dr Urmila M. Aswar & Miss Shradha H. Dept. of Pharmacology, SIOP, Narhe

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Patent related case studies

Dr Urmila M. Aswar&

Miss Shradha H.Dept. of Pharmacology, SIOP, Narhe

Case Study - 1

Novartis Vs Union of India and others

4/8/2015 2

Novartis

Gleevec

1993 (Imatinib)

2006 Sec . 3(d)

2007, 2009

1998 (Imatinib Mesylate)

Final decision 2013

Novartis

Chronic myeloid

leukemia

4/8/2015 3

The case was to patent Gleevec in India

Parameter Gleevec Generic

version of

Gleevec

Company Novartis Natco (local

company)

Nature Expensive Least

expensive

Cost 1 tablet -

2200 Rs

1 tablet -

500 Rs

Preference 16000 people 300000 people 4/8/2015 4

Case study – 2

Basmati Rice

4/8/2015 5

Golden

BasmatiRaw

Basmati

Silky Raw Basmati

Basmati Rice

4/8/2015 6

Patenting Authority

US Patent

International market

Kasmati Texmati

American Company: RiceTec Inc, (Basmati 867)

Patent application1995 US Patent in 1997

4/8/2015 7

Opposed by Government of India

In 2000 re-examination /indepthanalysis of application by high level inter-ministerial group

Patent cancelled in 2000 andIndia won the case on basis ofviolation of GI under TRIPS.

Case study – 3

NEEM (Azadiracta indica)

• N – Natures

• E - Eco Friendly

• E - Economical

• M - Miracle

4/8/2015 8

4/8/2015 9

1971Robert

Larson

Pesticidal neem

extract (1985)

Multinational chemical

corporation, W R

Grace and Co

Sold in 1988

4/8/2015 10

1990

• Multinational chemical corporation, W R Grace and Co (Neem-based bio-pesticides )

1994

• European Patent Office (EPO) granted a patent

1995• Opposed By Vandana Shiva of the

Research Foundation for Science, Technology and Ecology(RFSTE)

2000• EPO revoked patent on the basis of

lack of inventive step and novely.

Case study – 4

Turmeric ( Curcuma longa)

4/8/2015 11

4/8/2015 12

(1993) Patent application by University of Mississippi

Medical Center

(1995) USPTO granted patent for use of turmeric in wound

healing

Opposed by India's

Council of Scientific and

Industrial Research(CSIR)

1997 Patent cancelled

Case study - 5

Natco vs Bayer case of compulsary

license

4/8/2015 13

Vs

4/8/2015 14

• Patent grant by India

• Natco and voluntary license

• Patent application

• Bayer invented Sorafenib

1990 1999

20082011

Cost and Patient Benefitted

• Cost of Naxaver by Bayer: Rs 2.85 L / month

• Patient: 2%

• BY Natco: Rs 8900/ month.

• Free to needy

4/8/2015 16

Natco filed application for compulsory license

2012 Natco received grant for compulsory

license (6% royalty)

2013 modification in royalty 7%

Sec -84