RICHA PANDEY
 Trademark – Brand Names (Crocin)
 Design – Shape/packaging
 Copyright – labels (look & feel)
 Patents
o India became a member of WTO/TRIPS Agreement effective, January
01, 1995
o India was given ten years’ transition period to fully comply with TRIPS
o This was done in three stages effective:
o January 01, 1995
•
•
o
May 20, 2003
•
o
Filing of Black-Box applications
Provision for Exclusive Marketing Rights
Uniform patent term of 20 years
January 01, 2005
•
Grant of product patents in all fields of technology including
drugs, food and chemical substances.
3
 (c) the mere discovery of a scientific principle or the
formulation of an abstract theory or discovery of any living
thing or non-living substance occurring in nature.
 Funk Bros. Seed Co Vs Kalo Inoculants Co. 75 USPQ 280 (1948)


Mixture of six strains of bacteria packaged to be used to inoculate
leguminous plants.
The Supreme Court held that the mixture of the already existing
bacteria is not patentable but a mere discovery of nature
4
Section 3(d):
KNOWN
SUBSTANCE
Mere discovery of a new form of a known
substance which does not result in the
enhancement of the known efficacy of that
substance or mere discovery of any new
property or new use for a known substance
or of mere use of a known process, machine
or apparatus unless such known process
results in a new product or employs at least
one new reactant.
SAME
SUBSTANCE
Unless they differ
significantly in properties
with regard to efficacy
5
 The Apex court observed – “In whatever way therapeutic
efficacy may be interpreted, this much is absolutely clear:
that the physico-chemical properties of beta crystalline
form of Imatinib Mesylate, namely (i) more beneficial flow
properties, (ii) better thermodynamic stability, and (iii)
lower hygroscopicity, may be otherwise beneficial but these
properties cannot even be taken into account for the
purpose of the test of section 3(d) of the Act, since these
properties have nothing to do with therapeutic efficacy”.
KRISHNA & SAURASTRI ASSOCIATES
6
Section 3(e)
“A substance obtained by mere admixture resulting only in the aggregation of
the properties of the components thereof or a process for producing such
substances.”
How to overcome:
- By establishing synergism;
- By incorporating a broad range of the quantity of the ingredients in
the main claim, preferably as ratio/percentages (w/w);
- Technical affidavit having comparative data establishing synergism, if
necessary.
7
 (h) a method of agriculture or horticulture.
 (i) any process for the medicinal,
surgical, curative, prophylactic
[diagnostic, therapeutic] or
other treatment of human
beings 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;
8
 (j) plants and animals in whole
or any part thereof other than
micro organisms but including
seeds, varieties and species and
essentially biological processes
for production or propagation
of plants and animals;
9
 What if your invention falls within these boundaries???
 The biological material shall be deposited at a Depository
Authority under Budapest Treaty if it is not commonly
available to the public.
 The source and geographical origin of the biological
material is to be disclosed in the specification.
 Necessary permission is to be sought from National
Biodiversity Authority if a biological material is used from
India.
11
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

Buruli Ulcer
Chagas disease (American
trypanosomiasis)
Cysticercosis or Taeniasis
Dengue/dengue hemorrhagic
fever
Dracunculiasis or guinea-worm
disease
Echinococcosis
Endemic treponematoses
(Yaws)
Foodborne trematode
infections
Clonorchiasis
Opistorchiasis













Human African trypanosomiasis
Leishmaniasis
Leprosy
Lymphatic filariasis
Onchocerciasis
Rabies
Schistosomiasis
Soil transmitted helminthiasis
Trachoma
Podoconiosis
Snakebite
Hydatid disease or Echinococcosis
African Sleeping Sickness
• Leprosy
• Dengue
• Japanese encephalitis
• Chikungunya
• Soil transmitted helminthiasis
• Lymphatic Filariasis
• Amebiasis
• Rabies
• Leishmaniasis
Worldwide Patent Filings for Neglected Tropical Diseases
2500
2229
2000
1500
1074
1000
940 919
597 578 573 555
513
500
268 248 218
172
136
135
97
0
Neglected Tropical Diseases
96
87
81
56
47
33
28
18
16
12
10
Indian Filings for Neglected Tropical Diseases
50
45
45
40
35
30
25
20
28
21
17
15
15
10
5
6
6
6
4
0
Neglected Tropical Diseases
2
2
2
2
1
1
Comparative Analysis- Patent Filings Worldwide vs. India
Endemic Treponemiasis
Dracunculiasis guinea-worm…
Paragonimiasis
Trichuriasis
Trematodiasis
Buruli Ulcer
Clonorchiasis
Hookworm infection
Tropical Disease Type
Fascioliasis
Amebiasis
Onchocerciasis
Cysticercosis or Taeniasis
Ascariasis
Lymphatic filariasis
Hydatidosis
Leptospirosis
Chikungunya
Helminthiasis
Trypanosomiasis
Rabies
Schistosomiasis
Chagas disease
Trachoma
Leishmaniasis
Japanese encephalitis
Leprosy
Dengue
Worldwide Filings vs. Indian Filings
 The above three charts depict patent filings relating to
neglected tropical diseases and the comparative analysis of
the same worldwide vis-a- vis India.
 It is seen that, w.r.t worldwide filings, there is more
research focus on diseases like Dengue Leprosy, Japanese
encephalitis, Leishmaniasis Trachoma, Chagas disease,
Schistosomiasis Rabies, and Trypanosomiasis.
 In reference to the Indian filings, more focus is on diseases
like Dengue, Leishmaniasis, Japanese encephalitis, Rabies
and Chikungunya.
Overall Patenting Trend
4000
3706
3500
Patent Count
3000
2500
2000
1313
1500
1018
1000
500
2
3
2
55
1921-1930
1931-1940
1941-1950
1951-1960
139
177
1961-1970
1971-1980
267
0
1981-1990
1991-2000
2001-2010
2011-2015
Priority Years
Overall patenting trend shows that maximum no. of patent
applications in the area of neglected tropical diseases
have been filed between 2001-2010 worldwide.
Patenting Trend in India
600
484
Patent Count
500
400
300
200
100
3
5
1971-1980
1981-1990
36
31
0
1991-2000
Priority Years
2001-2010
2011-2015
Patenting trend in India also shows that maximum no. of
patent applications have been filed between
the same decade i.e 2001-2010 in India.
 The patenting activity in the area of compositions and
methods for treating neglected tropical diseases has shown
a drastic rise after 1991 onwards.
 The patenting trend for the same has increased to about
55% after year 2000.
Analysis based on Top 10 Priority Countries -Worldwide
3500
3244
3000
Patent Count
2500
2000
1500
1000
776
404
500
220
203
196
172
160
121
118
AU
JP
BR
DE
FR
WO
RU
0
US
CN
GB
Priority Countries
In the worldwide priority country distribution, United States
tops the chart depicting around 58% priority filings in the
areas of Tropical diseases, followed by China.
Analysis based on Top 10 Priority Countries- India
400
350
339
Patent Count
300
250
200
150
100
49
50
33
26
14
12
11
10
7
7
AU
DE
DK
WO
CU
NA
0
US
EP
GB
IN
Priority Countries
In the priority country distribution for India, United States
tops the chart , followed by European Union
countries.
Analysis based on Top 10 Application Countries- Worldwide
1400
1298
1200
Patent Count
1000
904
870
800
688
589
600
559
400
266
222
204
190
CA
GB
JP
200
0
US
WO
CN
EP
AU
IN
SG
Application Countries
With reference to the Application country analysis, is can be depicted that
around 22% applications show United States as the Application country,
followed by around 16% applications having PCT filings
and China respectively.
Top 5 International Patent Classification (IPCs)
15%
23%
19%
A61K003900
A61P003500
23%
A61P003112
A61K003912
20%
Patent applications classified under IPC
A61K003900, A61P003500 and A61P003112 are
maximum in number.
A61P002900
A61K003900
Medicinal preparations containing antigens
or antibodies (materials for immunoassay)
A61P003500
Antineoplastic agents
A61P003112
Antivirals
A61K003912
Medicinal preparations containing antigens
or antibodies (materials for immunoassay Lipids; Lipoproteins
A61P002900
Non-central analgesic, antipyretic or
Anti-inflammatory agents
Prolific Assignees
Merck & Co Inc
7%
6%
22%
Sanofi- Aventis
8%
Smithkline Beecham
Biologicals/ Glaxo Groups
8%
Pasteur Institute
12%
Pfizer Products Inc.
8%
Abbvie Inc
11%
9%
Abbott Laborataries
9%
University of California
Novartis AG
Gilead Sciences Inc
Merck & Co Inc., Sanofi- Aventis, Glaxo Smithkline Beecham Biologicals,
Pasteur Institute and Pfizer Products Inc. are the most prolific Assignees
working in the area of Neglected Tropical Diseases.
Top 5 Assignees- vs. Application Years
60
50
57
46
Merck & Co Inc
55
46
Sanofi- Aventis
39
Patent Count
40
33
30
25
25 25
Smithkline Beecham
Biologicals/ Glaxo Groups
23
20
13
10
10
5
10 10
14
12
6 6
13
Pasteur Institute
8
5
2
0
1961-1970
1971-1980
1981-1990
1991-2000
2001-2010
2011-2015
Pfizer Products Inc.
Application Years
• Merck Inc and Pfizer Inc are seen active in the area of neglected tropical diseases since
1961 onwards. Comparative activity however dropped over the last decade.
• Patenting activity of Glaxo Smithkline and Sanofi-Aventis has increased during the last 15
years i.e after 2000 onwards.
Top 5 Assignees vs Priority Country Coverage
Merck & Co Inc
140
124
Sanofi- Aventis
120
Smithkline Beecham Biologicals/
Glaxo Groups
Pasteur Institute
100
54
80
42
60
42
35
10
26 191
40
20
5
GB
4
EP
18
2
1
0
US
13
AU
1
6
DE
1
3
24
1
1
1
4
WO
26
2
1
1
IE
FR
HU
1
JP
2
KR
1
1
1
SG
CR
1
1
IT
CA
1
CN
Priority Country Coverage
• Most of the Assignees have United States as their priority country.
• Country coverage of Sanofi-Aventis appears to be wide spread even though their
filings are comparatively lesser than Merck Inc.
 The patenting trend has increased to about 55% post 2000.
 Indian Pharmaceuticals can focus more on neglected diseases like:
• Leprosy
• Chagas disease
• Amebiasis
• Hookworm infection
• Helminthiasis
• Leptospirosis
• Trematodiasis
• Trachoma
• Trypanosomiasis
• Schistosomiasis
• Lymphatic filariasis, etc
 United States tops in priority country as well as
application country wise filings.
 IPC- A61K003900 relating to Medicinal preparations
containing antigens or antibodies (materials for
immunoassay holds more no. of patents.
 Merck & Co Inc., Sanofi- Aventis, Glaxo Smithkline
Beecham Biologicals, Pasteur Institute and Pfizer
Products Inc. are the most prolific Assignees working
in the area of Neglected Tropical Diseases.
 The above findings suggest that the Indian generic
companies can find out the grey areas relating to
various neglected diseases.
 Identify prevalence of such diseases in India and
worldwide and focus their research on compositions
and methods of treating these neglected diseases.
Drug
Company
Acquired/Licensed from
Atorvastatin
Pfizer
Parke Davis
Infliximab
J & J, Merck,Mitsubishi
Tanabe Pharma
New York University School of
Medicine and developed
by Centocor (Jansenn)
Rituximab
Roche & others
IDEC Pharmaceuticals
Oxaliplatin
outlicensed to Sanofi Aventis
inlicensed by Debiopharm
from Nagoya City University
Fasudil HCL
CoTherix
Inlicensed from Asahi Kasei
Carisbamate
Johnson & Johnson
in-licensed from SK Corp
Product
Originator
Licensee
Sub-Licensee
Quad
Gilead Sciences Inc.
HuperzineA
GBR 500
Debiopharm Group
MPP - sublicensed to Shasun Pharmaceuticals
Ltd. Shilpa Medicare Ltd., Hetero Labs Ltd.,
Aurobindo Pharma Ltd.
Shasun Pharma (commercialization)
Glenmark
Sanofi (Co development)
SITAGLIPTI Merck
N
Sun- (commercialization)
Abacavir
MPP- sublicensed to Aurobindo Pharma Ltd.
ViiV Healthcare
MPP- Medicines Patent Pool
DISCLAIMER:
We have taken utmost care and diligent effort to keep the
search
conducted thorough amongst the leading databases, which
however is non-exhaustive.
The landscape report is based on the available bibliographic
data
amongst the leading patent databases and no technical
analysis
is involved in this report.
THANK YOU