Recent Developments in Patent Laws in India

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

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

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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)

4
India a giant consumer

• Electricity
• Installed capacity of 126,000 MW
• Food grain productions 200 million tons
• Foreign currency assets 123 billion

5
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.

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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.

7
History of Patents

• 1995 WTO TRIPS comes into effect.
• 1999-2002 TRIPS compliant laws-
• the First Amendment in the Patents Act .
• 2002 Second Amendment
• Indias 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 RD activity expected in post 2005
  period.

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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

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9
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

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Important Changes

• Pre-grant opposition
• 20 year patent term for all categories
• IP Appellate Board Setup

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The Patents Act Post 2005 Definitions

• 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

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Definitions

• 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 any New
  (Chemical) Entity Involving one or more Inventive
  Step

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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

15
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

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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

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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
18
Method of Treatment

• Medicinal, surgical, curative, prophylactic,
  diagnostic, therapeutic treatment of animals and
  humans not patentable
• Treatment of plants patentable
• Diagnostic apparatus - patentable

19
Living Organisms

• Micro organisms - patentable
• Isolated
• Mutated
• Adapted
• Recombinant
• Mandatory deposition required
• Source needs to be disclosed

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Dimminaco Ag Vs Controller of Patents
FACTS

• 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

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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

22
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

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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

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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

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Essentially Biological Processes

• UK Examination Guidelines
• To be judged on the basis of the invention
• Non trivial human intervention/contribution

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Computer Programs

• Non-patentable
• Mathematical methods
• Business methods
• Algorithms

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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

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Research Exemptions to Infringement

• Inventions may be used for
• Research
• Experiments
• Education and training

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Compulsory Licensing

• Provisions existed since 1911
• None granted so far
• Provisions based on (compliant with) TRIPS and
  Doha Declaration

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Compulsory Licensing

• 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

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Compulsory Licensing
...

• Granted on Application by a third party showing
  interest
• Grant is made after a hearing by the Controller
  of Patents

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Compulsory Licensing
...

• Factors considered
• Nature of invention
• Applicants ability capacity
• Whether Applicant has made any effort to obtain
  license from Patentee on reasonable term
• Measures taken by the patentee or licensee

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Compulsory Licensing
...

• 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

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Compulsory Licensing
...

• 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

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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

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