pharma/bio licensing concerns

mutebabiesBiotechnology

Dec 6, 2012 (5 years and 1 month ago)

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Sughrue Mion PLLC

1

Recent Developments in
Patent Laws in India

Chid S. Iyer


Sughrue Mion, PLLC

Washington D.C.

www.sughrue.com


Prepared for APLF


Chicago, September 21, 2006


Sughrue Mion PLLC

2

India at a glance


Area 3,287,000 sq Km


History


One of the oldest
civilizations


Most major religions
took root in India


Kingdoms and
Principalities until 1947


British rule


East India Company
1600
-
1857


Direct rule 1857
-
1947


Independence 1947



Sughrue Mion PLLC

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India


a giant consumer


Population 1.06 billion


Growth rate 1.5%


Life expectancy 63 yrs


Literacy 61%


Economic indications


52 mobile phones per 1000


7.2 PCs per 1000


20 million Internet users


GDP $645 billion with a growth rate of 6.9%


Per capita income of $529


Substantial middle class


52 million families with incomes $2K
-
$25K per year


(significantly higher figures if purchasing power parity is
considered)



Sughrue Mion PLLC

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India


a giant consumer


Electricity


Installed capacity of 126,000 MW


Food grain productions +200 million
tons


Foreign currency assets $123 billion




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Advantage INDIA


Over 3 million scientific & technical manpower


Over 0.8 million post graduates in science


Over 1 million graduate engineers


0.4 million doctors and


0.3 million graduates in agriculture and veterinary
sciences.



Second only to US in English speaking scientific manpower.


Above factors provides significant advantages in


Drugs & Pharmaceuticals,


Biotechnology,


Information Technology,


Space Industry,


Speciality Chemicals and Petrochemicals, etc.

Sughrue Mion PLLC

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History of Patents in India


1852 British Patent Act


1911: The Indian Patents and Designs Act
promulgated.


Product patent and Process patent in all fields



1950s and 60s. MNCs dominate new formulations


1970s: Patents Act 1970 comes into force in 1972.


Medicines, Food and Agro
-
chemicals removed from
product patent (and put under process patent).


Term of patent
-
Product Patent (for items other than
above) 14 years;


Process Patent 7 years.


1980s: MNC influence declines to some extent.


1990s: MNC influence further declines. Significant
amount of indigenous production and export.


Sughrue Mion PLLC

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History of Patents


1995: WTO


TRIPS comes into effect.


1999
-
2002: TRIPS compliant laws
-



the First Amendment in the Patents Act .


2002: Second Amendment




India’s Patents Law brought in line with TRIPs.


Patent term of 20 years for both product and process
patents, change in burden of proof etc.


Medicines, Food and Agro
-
chemicals to continue to be
under process patenting till 31 Dec 2004.


Product patent in all other areas continues


1
-
1
-
2005: Ordnance passed introducing product
patent in Medicines, Food and Agro
-
chemicals.


Increasing R&D activity expected in post 2005
period.


Sughrue Mion PLLC

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Position Pre
-

2005



Patents granted for
Products

other than medicines,
agro
-
chemicals and food


Only process patents for the above


Mail Box provision for pharmaceutical substance


Examination from 1.1.2005


Exclusive Marketing Rights


5 yr Patent term for pharma and food process patents
and 14 years for others


8

Sughrue Mion PLLC

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Present Position


Post 2005


Amendments

Patentable subject matter includes all
products and
processes

including


Medicines


Diagnostic substances


Intermediate chemical substances for manufacture of
medicine


Fertilizers, insecticides, pesticides, fungicides, weedicides


Sughrue Mion PLLC

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Important Changes


Pre
-
grant opposition


20 year patent term for all
categories


IP Appellate Board Setup



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Any new product or process involving an
inventive Step and Capable Of Industrial
Application



Inventive step is a feature involving technical
advancement or economic significance or a
combination of above


Non obvious to a person skilled in the art

The Patents Act


Post 2005

Definitions

Sughrue Mion PLLC

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Any new invention or technology not
anticipated by publication anywhere in the
world before filing of complete application
and not anticipated by use anywhere in
the world


Patentable Pharmaceutical Substance is
a
ny New (Chemical) Entity Involving one
or more Inventive Step

Definitions

Sughrue Mion PLLC

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Exclusions

Following are not inventions:


Frivolous or contrary to natural laws


Contrary to public order, morality, harmful
to humans, animals, plants and
environment


Mere discovery of a scientific principle


Formulation of an abstract theory


Discovery of living things or non living
substances in nature.


Method of horticulture/agriculture

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Exclusions


Discovery
-

Substance freely
occurring in nature


Substance in nature
patentable may be
patentable when isolated
from its surroundings and
having a technical effect


Sughrue Mion PLLC

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Exclusions



New use and forms



Method of Treatment



Plants, animals and parts thereof
(micoroganisms are patentable under
certain conditions)



Essentially Biological Processes



Computer Programs per se

Sughrue Mion PLLC

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New use and forms

The following are not inventions:


New form of a known substance without
enhancement in efficacy


Mere discovery of new property or new use of a
known substance


Mere use of known process unless it results in a
new product and employs at least a new
reactant



Sughrue Mion PLLC

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Examples of non
-
patentable known substances




Salts



Esters



Ethers



Polymorphs



Metabolites



Pure form


Particle size


Isomers,


Mixtures of isomers
Complexes


Combinations


Other derivatives of
known substance

The above considered to be same substance unless they
differ significantly in properties with regard to efficacy

Sughrue Mion PLLC

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Method of Treatment


Medicinal, surgical, curative,
prophylactic, diagnostic,
therapeutic treatment of animals
and humans not patentable


Treatment of plants patentable


Diagnostic apparatus
-

patentable

Sughrue Mion PLLC

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Living Organisms


Micro organisms
-

patentable


Isolated


Mutated


Adapted


Recombinant


Mandatory deposition required


Source needs to be disclosed


Sughrue Mion PLLC

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Dimminaco Ag Vs Controller of Patents


Patent application filed on 28.1.98


Invention
-

process for preparation of infectious
bursitis vaccine


Controller of Patents refused to allow application
since


end product of the process resulted in
living organism


process not patentable : no patent so far
granted for “living organism


FACTS

Sughrue Mion PLLC

21


Dimminaco Ag Vs Controller of Patents


Patent for process for preparation of infectious
bursitis vaccine


Invention involved live (attenuated) vaccine


Controller of Patents refused to allow application
since


end product of the process resulted in living
organism


process not patentable as it was a “living
organism




Sughrue Mion PLLC

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Dimminaco Ag Vs Controller
of Patents


The Court held that:


the contentions of Controller not justified


Law does not bar processes where the
end
-
product is “living”

Sughrue Mion PLLC

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Impact of Dimminaco


Landmark decision


In consonance with
world patent practice


Most processes in the
biotechnology field will
be patentable:
irrespective of whether
resultant product is living
or non
-
living

Sughrue Mion PLLC

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Living Organisms

Excluded from patentability:


Plants and animals and parts including


Whole e.g. transgenic animals


Organs


Seeds


Varieties and species


Essentially Biological Processes


Sughrue Mion PLLC

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Essentially Biological
Processes


UK Examination Guidelines:



To be judged on the basis of the invention



Non trivial human intervention/contribution

Sughrue Mion PLLC

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Computer Programs


Non
-
patentable


Mathematical methods


Business methods


Algorithms


Sughrue Mion PLLC

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Patentability of Computer Programs


Similar to EP provisions


Computer programs per se not
patentable


Computer programs with technical effect


patentable


No technical effect for simple interaction
between hardware and software

Sughrue Mion PLLC

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Research Exemptions to
Infringement


Inventions may be used
for


Research


Experiments


Education and training


Sughrue Mion PLLC

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Compulsory Licensing


Provisions existed since 1911


None granted so far



Provisions based on (compliant with) TRIPS
and Doha Declaration

29

Sughrue Mion PLLC

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May be granted to any third person
after 3 years of grant of patent


Invention is not worked in India


products not available to the public
at affordable price


if reasonable requirements of the
public not satisfied


Compulsory Licensing

Sughrue Mion PLLC

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Granted on A
pplication by a third
party showing interest


Grant is made after a hearing by the
Controller of Patents

...

Compulsory Licensing

Sughrue Mion PLLC

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Factors considered


Nature of invention


Applicant

s ability & capacity


Whether Applicant has made any
effort to obtain license from Patentee
on reasonable term


Measures taken by the patentee or
licensee


...

Compulsory Licensing

Sughrue Mion PLLC

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Compulsory licensing may also be granted for
national emergency, extreme urgency and public
health crisis


Patentee entitled to reasonable payment on
licensing in all cases

...

Compulsory Licensing

Sughrue Mion PLLC

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Revocation of Patent after two
years from grant of first
compulsory license if
conditions that led to the
license do not change.


Patentee can apply to
terminate license if condition
changes


...

Compulsory Licensing

Sughrue Mion PLLC

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Summary


Patentable subject matter
consistent with most major
jurisdictions


Micro
-
organisms patentable


TRIPS compliant


Major improvement for
Pharmaceutical and Biotech
Industries

Sughrue Mion PLLC

36



Thank You



I thank Mr. Lakshmikumaran of the firm of Lakshmikumaran &
Sreedharan (New Delhi, India) for helping me with the
material on Indian Law