IPR IN PHARMACEUTICALS- ROADMAP FOR INDIA

RICHA PANDEY

Trademark – Brand Names (Crocin)Design – Shape/packagingCopyright – labels (look & feel)Patents

WTO/TRIPS AND INDIA

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

• Filing of Black-Box applications• Provision for Exclusive Marketing Rights

o May 20, 2003• Uniform patent term of 20 years

o 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

SEC-3 WHAT IS NOT AN INVENTION?

Section 3(d):

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.

5

KNOWN SUBSTANCE

SAME SUBSTANCE

Unless they differsignificantly in properties

with regard to efficacy

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”.

APEX COURT OBSERVED ON EFFICACY

6KRISHNA & SAURASTRI ASSOCIATES

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.

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(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

SEC-3 WHAT IS NOT AN INVENTION?

(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

SEC-3 WHAT IS NOT AN INVENTION?

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.

BIOLOGICAL INVENTIONS

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Neglected tropical diseases and conditions covered by WIPO Research are listed below.

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 Fascioliasis Paragonimiasis

Human African trypanosomiasis

Leishmaniasis Leprosy Lymphatic filariasis Onchocerciasis Rabies Schistosomiasis Soil transmitted helminthiasis Trachoma Podoconiosis Snakebite Hydatid disease or

Echinococcosis African Sleeping Sickness

Prevalence of Neglected Diseases in India and South Asia

• Leprosy• Dengue• Japanese encephalitis• Chikungunya• Soil transmitted helminthiasis• Lymphatic Filariasis• Amebiasis• Rabies• Leishmaniasis

Worldwide Patent Filings for Neglected Tropical Diseases

Dengu

e

Lepr

osy

Japa

nese

enc

epha

litis

Leishm

aniasis

Trach

oma

Cha

gas di

seas

e

Schi

stos

omiasis

Rabies

Trypa

noso

miasis

Helm

inth

iasis

Chiku

ngun

ya

Lep

tosp

iros

is

Hyd

atid

osis

Lym

phat

ic fi

larias

is

Ascar

iasis

Cystic

erco

sis or

Tae

nias

is

Oncho

cerc

iasis

Ameb

iasis

Fasc

iolia

sis

Hoo

kwor

m in

fect

ion

Clono

rchi

asis

Burul

i Ulcer

Trem

atod

iasis

Trich

uriasis

Parag

onim

iasis

Dracu

ncul

iasis gu

inea

-wor

m d

i...

Endem

ic T

repo

nem

iasis

0

500

1000

1500

2000

2500

2229

1074940 919

597 578 573 555 513

268 248 218 172 136 135 97 96 87 81 56 47 33 28 18 16 12 10

Worldwide Patent Filings for Neglected Tropical Diseases

Neglected Tropical Diseases

Indian Filings for Neglected Tropical Diseases

Den

gue

Leishm

ania

sis

Japa

nese

ence

phal

...

Rabie

s

Chikungu

nya

Lepr

osy

Schisto

som

iasis

Lym

phat

ic fi

larias

is

Lep

tosp

iros

is

Chag

as d

isea

se

Cystic

erco

sis

Ameb

iasis

Hoo

kwor

m in

fec.

..

Hel

min

thia

sis

Trem

atod

iasis

0

5

10

15

20

25

30

35

40

45

5045

28

21

1715

6 6 64

2 2 2 2 1 1

Indian Filings for Neglected Tropical Diseases

Neglected Tropical Diseases

Comparative Analysis- Patent Filings Worldwide vs. India

Dengue

Japanese encephalitis

Trachoma

Schistosomiasis

Trypanosomiasis

Chikungunya

Hydatidosis

Ascariasis

Onchocerciasis

Fascioliasis

Clonorchiasis

Trematodiasis

Paragonimiasis

Endemic Treponemiasis

Comparative Analysis- Patent Filings Worldwide vs. India

Worldwide Filings vs. Indian Filings

Tro

pic

al

Dis

ease

Type

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

1921-1930

1931-1940

1941-1950

1951-1960

1961-1970

1971-1980

1981-1990

1991-2000

2001-2010

2011-2015

0

500

1000

1500

2000

2500

3000

3500

4000

2 3 2 55 139 177 267

1018

3706

1313

Overall Patenting Trend

Priority Years

Pate

nt

Count

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

1971-1980 1981-1990 1991-2000 2001-2010 2011-20150

100

200

300

400

500

600

3 531

484

36

Patenting Trend in India

Priority Years

Pate

nt

Count

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 Country Distribution- Worldwide

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.

US CN GB AU JP BR DE FR WO RU0

500

1000

1500

2000

2500

3000

3500 3244

776

404220 203 196 172 160 121 118

Analysis based on Top 10 Priority Countries -Worldwide

Priority Countries

Pate

nt

Count

Analysis based on Top 10 Priority Country Distribution- India

US EP GB IN AU DE DK WO CU NA0

50

100

150

200

250

300

350

400

339

4933 26 14 12 11 10 7 7

Analysis based on Top 10 Priority Countries- India

Priority Countries

Pate

nt

Count

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

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.

US WO CN EP AU IN SG CA GB JP0

200

400

600

800

1000

1200

1400 1298

904 870

688589 559

266 222 204 190

Analysis based on Top 10 Application Countries- Worldwide

Application Countries

Pate

nt

Count

Top 5 IPCs

Patent applications classified under IPC A61K003900, A61P003500 and A61P003112 are maximum in number.

23%

23%20%

19%

15%

Top 5 International Patent Classification (IPCs)

A61K003900A61P003500A61P003112A61K003912A61P002900

A61K003900Medicinal preparations containing

antigens or antibodies (materials for immunoassay)

A61P003500 Antineoplastic agents

A61P003112 Antivirals

A61K003912Medicinal preparations containing

antigens or antibodies (materials for immunoassay - Lipids; Lipoproteins

A61P002900Non-central analgesic, antipyretic orAnti-inflammatory agents

Description of IPCs

Prolific Assignees

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.

22%

12%

12%9%

9%

8%

8%

8%

7%6%

Prolific Assignees

Merck & Co Inc

Sanofi- Aventis

Smithkline Beecham Bio-logicals/ Glaxo Groups

Pasteur Institute

Pfizer Products Inc.

Abbvie Inc

Abbott Laborataries

University of California

Novartis AG

Gilead Sciences Inc

Top 5 Assignees- vs. Application Years

1961-1970 1971-1980 1981-1990 1991-2000 2001-2010 2011-20150

10

20

30

40

50

60

46

33

10 10

46

25

13

5 6

14

25

52

68

39

1310

57

25

12

55

23

Top 5 Assignees- vs. Application Years

Merck & Co Inc

Sanofi- Aventis

Smithkline Beecham Biologicals/ Glaxo Groups

Pasteur Institute

Pfizer Products Inc.

Application Years

Pate

nt

Count

• 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

US GB EP AU DE WO IE FR HU JP KR SG CR IT CA CN

0

20

40

60

80

100

120

140124

5

26

4 64

1

35

1

19

1 3 2

26

1 1 2 1

42 42

2 1

11 1

10

1

18

1

24

1 1

54

13

11

Top 5 Assignees vs Priority Country Coverage

Merck & Co Inc

Sanofi- Aventis

Smithkline Beecham Biolog-icals/ Glaxo Groups

Pasteur Institute

Pfizer Products Inc.

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.

Conclusion 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

Patent Licenses – World wide

Product Originator Licensee Sub-Licensee

Quad Gilead Sciences Inc. MPP - sublicensed to Shasun Pharmaceuticals Ltd. Shilpa Medicare Ltd., Hetero Labs Ltd., Aurobindo Pharma Ltd.

Huperzine-A

Debiopharm Group Shasun Pharma (commercialization)

GBR 500 Glenmark Sanofi (Co development)

SITAGLIPTIN

Merck Sun- (commercialization)

Abacavir ViiV Healthcare MPP- sublicensed to Aurobindo Pharma Ltd.

Licensing – Indian Pharmaceutical Companies

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