Position Pre 2005

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Position Pre - 2005

• Patents granted for
• Products other than medicines, agro-chemicals and
  food
• Patents granted for synergistic compositions
• cosmetics
• Mail Box provision for pharmaceutical substance
• Examination from 1.1.2005
• Exclusive Marketing Rights
• Patent term
• 5 years for pharma and food process patents
• 14 years for others

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Present Position Post 2005 Amendments

• All products and processes patentable including
• Medicines for internal / external use of humans
  or animals
• Substances used in diagnosis
• Intermediate chemical substances used in the
  preparation or manufacture of medicine or drug
• Fertilizers, insecticides, pesticides,
  fungicides, weedicides

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Important Changes

• Patents granted for product patent
• Food products Pharmaceuticals
• Chemicals
• Alloys, semi-conductors, inter-metallic compounds
• Pre-grant opposition
• Uniform patent term of 20 years
• Formation of IP Appellate Board

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The Patents Act Post 2005 Definitions

• Sec. 2(j) Invention
• Any new product or process
• Involves an Inventive Step
• Capable Of Industrial Application
• Sec. 2(ja) Inventive Step Feature involving
• Technical advancement or
• Economic significance or
• Combination of above
• and makes it non obvious to a person skilled in
  the art

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Definitions

• Sec. 2(l) New Invention
• Any new invention or technology
• Not anticipated by publication anywhere in the
  world before filing of complete application
• Not anticipated by use anywhere in the world
• Sec 2(ta) Pharmaceutical Substance
• 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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Discovery vs. Invention

• Substance freely occurring in nature -
  discovery
• Substance in nature patentable when
• isolated from its surroundings and having a
  technical effect

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Exclusions

• Section 3(d) New use and forms
• Section 3(e) Composition
• Section 3(i) Method of Treatment
• Section 3(j) Plants, animals and parts thereof
  and Essentially Biological Processes
• Section 3(k) 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
• results in a new product
• employs at least a new reactant

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New use and forms

• Explanation to 3(d) bars the following forms of
  known substances from patentability

• 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
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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

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Living Organisms

• Micro organisms - patentable
• Isolated
• Mutated
• Adapted
• Recombinant
• Mandatory deposition of the micro organism in an
  IDA
• Source and geographical origin to be disclosed

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Recombinant Micro-organisms
Process and Product Patentable

• Products
• Human insulin
• immunoglubulin
• vaccine
• Blood clotting factor
• Bt-toxin

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Dimminaco Ag Vs Controller of Patents
FACTS

• Patent application filed on 28.1.98
• for 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
FACTS

• Patent for process for preparation of infectious
  bursitis vaccine
• Invention involved live (attenuated) vaccine

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Dimminaco Ag Vs Controller of Patents
FACTS

• Controller of Patents refused to grant patent
• End product involved a living organism
• Process not patentable no patent so far granted
  for living organism

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Dimminaco Ag Vs Controller of Patents
FACTS

• 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 judgement
• 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

Impact of Dimminaco
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Living Organisms

• Section 3(j) excludes from patentability
• Plants and animals and parts
• Whole e.g. transgenic animals
• Organs
• Seeds
• Varieties and species
• Essentially Biological Processes

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Essentially Biological Processes

• Grey Area - between Essentially Biological
  Processes and non-biological processes
• Processes exist where biological reproduction is
  employed
• Steps consisting of direct human intervention
  could warrant patentability

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Essentially Biological Processes

• UK Examination Guidelines suggest the following
• To be judged on the basis of the invention
• Extent of human intervention to be considered
• But human contribution should not be trivial
• Lubrizol / Hybrid plants 1990 OJEPO 71

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Plant Processes

• Patentable Inventions
• Processes involving plants to increase the yield
• Genetic transformation
• Tissue culture methods
• Micro-propagation
• Somatic embryogenesis

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Section 3(k) Computer Programs
a mathematical or business method or a computer
program per se or algorithms

• Thus section 3(k) absolutely bars
• Mathematical methods
• Business methods
• Algorithms

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Patentability of Computer Programs

• Computer programs per se not patentable
• Patenting of computer programs with technical
  effect patentable
• No technical effect when simple interaction
  between hardware and software exists
• Indian provisions similar to EPC provision

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Computer Programs

• Technical character includes
• Technical effect caused program running on
  computer
• Effect beyond the normal interaction of the
  hardware and software
• Effect used for solving a technical problem
• Computer program patentable as a product if it
  possesses the potential of technical effect
• Technical character does not include
• Physical modifications of the hardware

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Research Exemptions

• Exception to Infringement sec. 47(3)
• Inventions may be used without fear of
  infringement for
• Research
• Experiments
• Education and training

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Summary

• Inventions in all fields of technology-patentable
• Micro-organisms patentable
• Exclusions wider than TRIPS
• Patent Amendments a welcome change for
  Pharmaceutical and Biotech Industries

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