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Patents : An Overview
Patent
 An intangible asset
 For single invention
 Monopoly for 20 years
 Territorial right
 Granted by the government
Non-patentable Inventions
 Sections 3 and 4 of the Indian Patents Act provide a list of inventions which are not
considered patentable even if they qualify all criterion of patentability:
 Inventions which are frivolous are not patentable
Brain Buzzer- a machine that if you bite it will send vibrations to the brain and will keep
you awake Issued in 1998- Thinky Corporation of Tokyo, Japan
 Inventions which claim anything contrary to well established natural laws
Eg: A perpetual motion machine was claimed that gives output without any input
 Inventions contrary to public order or Morality or causing serious prejudice to
human, animal, or plant life or health or to the environment
Eg: Method or Apparatus of food adulteration, Devices creating industrial or domestic
pollution
 Discovery of any living thing or non-living substance or 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 is not patentable
Eg: Discovery of new species of animals, Newtons Law
 Mere discovery of new form of a known substance not resulting into enhancement
of the known efficacy of that substance. Salts, esters, ethers, polymorphs,
metabolites etc of the known substance
 Eg: Drug ‘A’ is known to treat disease ‘X’ in its orally consumable form. If new form
‘B’ of drug ‘A’ is developed in injectable form. Mere new form B would be
unpatentable. New use of neem.
 A substance obtained by a mere admixture resulting only in the aggregation of the
properties of the components thereof or a process for producing such substance.
However, A mixture resulting into synergistic properties of mixture of ingredients
however, may be patentable - Soap, Detergents, lubricants etc
 Mere arrangement or re-arrangement or duplication of known devices each
functioning independently of each another in a known way.
Eg: A Bucket fitted with torch, An Umbrella with fan
 A method of agriculture or horticulture
But Agricultural Equipments are patentable
 Any process for treatment of human beings or any process for a similar treatment
of animals .
Eg: Naturopathy, Sound Therapy, Acupressure/ Acupuncture, method of removal
dental plaque and curing dental problems, method of doing operations in the
operation theatre
 Plants and animals in whole or any part thereof other than micro-organisms
Bcoz Plants are protected under Plant Varieties Protection and Farmers Rights Act 2003
 A mathematical or business method or a computer program per se or algorithms
Eg: Method of doing businesses such as Amway, Chain marketing etc. are not
patentable
 A literary, dramatic, musical or artistic work or any other aesthetic creation
whatsoever including cinematographic works and television productions
They all are protected under Copyright’s Act
 A mere scheme or rule or method of performing mental act or a method of playing
a game
Eg: Yoga techniques, Abacus, Vipashyana
 A presentation of information
Since presentation of information does not have industrial application, hence it is not
patentable
A speech instruction in the form of printed text is not patentable
 Topography of integrated circuits
Integrated circuits are protected under Semiconductor Integrated Circuit Layout-
Design Act 2000
 An invention which in effect, is traditional knowledge or which is an aggregation of
known properties of traditionally known component or components
 Inventions relating to Atomic energy are not patentable
Patent Specification: Contents
 It is a techno legal document
 It is an application that is to be submitted to the IPO
 It discloses the invention and its enablement
 It is to be drafted in the manner prescribed by IPO
 Title:
Should be short and precise
 Field of Invention:
A statement of the field of art to which the invention is related
 Background of the Invention:
Earlier known process, products, documents, publications, patents, papers, accepted Ph.D. thesis etc available
at the time of filing.
Drawbacks of the earlier known process, products
 Object of the Invention:
Purpose of the invention
 Summary of the Invention:
Highlights of the invention, Advantage of the invention
 Brief Description of the Drawings:
Figure names and numbers
 Detail Description of Invention:
Mention all the embodiments of the invention. Details of the components, chemicals,
solvents in the statement of invention, description of mechanical part, arrangements,
mechanisms .
Source of biological material if used in the invention
 Examples:
Examples should be extracts from the records, as done in the laboratory, giving best
mode of performance of the invention
 Claims:
Claims form very important part of the specification as they form the basis to
determine the infringement of the patent, the extent of protection and the rights of
the inventors. Hence it is very important to draft the claims very carefully. It defines
the legal boundary of the invention.
 Abstract:
Not more than 150 words
Should give gist of the invention and the novelty.
Reference to the drawing if any
Types of Patent Applications
 Provisional Application
 Ordinary or Complete Application
 Convention Application
 PCT International Application
 PCT National Phase Application
 Patent of Addition
 Divisional Application
NBA Approval for Patent Filing
 National Biodiversity Act is to conserve the rich biodiversity of the country. The act
was implemented in 2003 under the auspices of the National Biodiversity Authority
(NBA)
 The patent applicant should disclose the source and geographical origin of the
biological material when used in an invention
 NBA may, while granting approval, impose benefit sharing fee or royalty for
commercialization of any rights arising out of the biological resources obtained
from India
 Mandatory for the applicant to obtain permission from NBA for a patent to be
granted
 If not an objection might be raised by the examiner
 Approval is mandatory only if the biological material is included under the definition of
“Biological Resources” under the BDA act.
 "biological resources" means plants, animals and micro-organisms or parts thereof,
their genetic material and by-products (excluding value added products) with actual or
potential use or value, but does not include human genetic material.
 Exceptions to biological resources:
Value Added products: Value added products are defined as “value added products means
products which may contain portions or extract of plants and animals in unrecognizable
and physically inseparable form.”. For example, products such as wheat flour , tobacco dust,
allicin-enriched garlic extract, were considered as value added product by the Indian Patent
Office
Bio-waste: NBA approval is also not required for, inventions that use/ disclose Bio-waste.
Biowaste is generated after the economic use of the biological resource/material is
exhausted and is therefore not covered under the definition of “Biological resources”.
Synthetically prepared biological material: Inventions that use synthetically prepared
biological material, can also be filed without seeking prior approval from NBA. Such
material for example includes materials such as enzymes, pigments, gums, sucrose etc
 Biological materials imported to India do not require NBA permission
 Appropriate application form (Form 3, Rule 18) for such permission is available on
the website of the National Biodiversity Authority.
 The Patents Act further complements the Biodiversity Act in that failing to
disclosure or false disclosure of the source and geographical origin of biological
resource may amount to a ground for opposition or even revocation of the patent
grant.
Procedure for filing a patent in India
https://www.trademarkiso.com/patents/registration-process/
 Provisional or Complete specification Filing
 If provisional is filed then complete specification is to be filed within 12 months
 Publication occurs within 18 months from the date of filing or priority as the case may
be
 One can apply for early publication on payment of additional fees
 After publication, examination of the patent application occurs for which request for
examination is mandatory
 FER is generated by the examiner to which response is to be filed within 6 months from
the date of FER
 Examiner may either accept or arrange hearing for the patent application filed
 After hearing controller may either grant or refuse the patent
 Pre-grant opposition can be filed by any person in between publication and grant of
patent.
 Post-grant opposition can filed by the interested person within one year from the date
of grant of the patent
International Treaties: IPR
Paris Convention
Adopted in 1883 and is applicable for to industrial property in the widest sense, including
patents, trademarks, industrial designs, utility models, service marks, trade names,
geographical indications and the repression of unfair competition.
Objective of the Convention:
 National Treatment
As regards the protection of industrial property, each Contracting State must grant
the same protection to nationals of other Contracting States that it grants to its own
national
 Right of Priority
This right means that, on the basis of a regular first application filed in one of the
Contracting States, the applicant may, within a certain period of time (12 months for
patents and utility models; 6 months for industrial designs and marks), apply for protection
in any of the other Contracting States. These subsequent applications will be regarded as if
they had been filed on the same day as the first application
International Treaties: IPR
 The Convention lays down a few common rules that all Contracting States must follow
Patents granted in different Contracting States for the same invention are independent of each other.
The inventor has the right to be named as such in the patent
TRIPS:
 Trade-Related Aspects of Intellectual Property Rights: International agreement between different
countries
 TRIPS came into force in 1995, as part of the agreement that established the World Trade
Organization (WTO)
 As IP gained importance, tensions were raised between the countries for protection of IP and hence
TRIPS came into existence
 Decides the framework of IP protection
 It frames the IP system in terms of innovation, technology transfer and public welfare
 what the minimum standards of protection are for intellectual property rights that members should
provide
 which procedures members should provide for the enforcement of those rights in their own
territories
International Treaties: IPR
WIPO:
 World Intellectual Property Organization, headquarters in Geneva, Switzerland
 To promote the protection of intellectual property throughout the world through
cooperation among States and, where appropriate, in collaboration with any other
international organization
 To ensure administrative cooperation among the Unions
PCT:
 Patent Cooperation Treaty: The Treaty regulates in detail the formal requirements
with which international applications must comply
 It makes possible to seek patent protection for an invention simultaneously in each
of a large number of countries by filing an "international" patent application.
International Patent Filing Procedure
Patent Commercialization
1. Licensing
– Exclusive
– Non exclusive
– Sole
– Cross licencing
2. Joint venture
3. Assignment/Sale of Rights
4. Starting a business with the patented product
Compulsory Licensing
 A government allows someone else to produce a patented product or process
without the consent of the patent owner or plans to use the patent-protected
invention itself
 Application after expiry of three years from the date of grant
 Circumstances under which it is granted:
-Reasonable requirements of public not met
-Patented invention not available to public at reasonable cost
-Patented invention not worked in India
 Application to be made by any person including licensee
 To be filed with the controller
Bayer v/s Natco
 First CL granted to Natco in India for the drug Nexavar for the treatment of Kidney
cancer in 2012
 Bayer had been granted patent in India in 2008
 In 2011 Natco approached IPO for CL of drug Nexavar on the basis of reasonable
requirement not being met and not available at affordable prices
 Cost of Bayers drug was Rs 2.8 lacs for one month course
 Cost of Natco’s generic version drug was 8800 for one month course
 CL was granted to Natco pharma with 6-7 % royalty on the net sales to the bayer
Patent Infringement
 Infringement of a patent consists of the unauthorized making, using, offering for
sale or selling of any patented invention
 Violation of monopoly rights constitutes an infringement
 Claim to claim analysis is done for essential elements
 Legal status to be checked
Eg: A+B= C (one process)
X+Y=C (another process)
Since the components used in both the process to obtain C are different, there is no
infringement
Eg: A formulation contains A+B+C for treating fever is patented by company X
Other Formulation contains A+B+C+D for treating fever is patented by company Y.
Y is infringing X’s patent
Types of Infringement:
1) Direct infringement
when the infringing device or process may be similar or equivalent to the claimed
invention (performs substantially the same function, in substantially the same way and
to achieve substantially the same result.
2)Indirect infringement: a) Induced infringement b) Contributory infringement
Person assisting or helping other person to use patented product/process
Contributory infringement is triggered when a seller provides a part or component
that, while not itself infringing any patent, has a particular use as part of some other
machine or composition that is covered by a patent.
3) Wilful infringement:
Person is aware about the existing patent but intentionally uses the same
product/process.
Once proved, have to pay substantial penalties
Patent Infringement: Exceptions
 Government Use
 Research Purpose
 Supply of patented drugs to government run health institutions
Jurisdiction
 District or High court
Who can apply for infringement?
 Patentee
 Co-owner
 Assignee
 Exclusive licensee
Remedies:
 Temporary Injunction
 Permanent Injunction
 Damages
Novartis vs. Cipla
 Novartis had 5 patent for the drug Onbrez ( used to treat chronic obstructive
pulmonary disease)
 In 2014, the Defendant launched a generic version of Onbrez and in the process
petitioned to have the Plaintiff’s patents revoked. It contended that the disease has
reached an ‘epidemic’ stage and the monopoly of the Plaintiff was limiting the
extent of the drug.
 In light of that requested the Central Government to revoke the patent under
Section 92 (3) (compulsory license under special circumstances) and Section 66
(patents which are prejudicial to public) of the Patents Act.
 Defendant contended that the Plaintiff was not manufacturing the drug locally and
imported only limited quantities through a licensee.
 Plaintiff then filed a case before the Delhi HC claiming patent infringement and
damages.
 Delhi High court barred the Defendant from making or selling generic copy of the
Plaintiffs drug by granting temporary injunction to the Plaintiff.
 Defendant had previously also stated that there was a shortage of the drug and
inadequacy thereof. However, the HC observed that the Defendant failed to provide
any proof or figures for such claims.
 In 2017, Cipla filed an appeal against this order. However, the appeal was dismissed
on similar grounds. The 2017 Appeal further divided into the implications of a drug
being imported and whether the extent of imports was sufficient to meet the
demands in India.
 Novartis also sort damages from Cipla

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IPR-Patents.pptx

  • 1. Patents : An Overview
  • 2. Patent  An intangible asset  For single invention  Monopoly for 20 years  Territorial right  Granted by the government
  • 3. Non-patentable Inventions  Sections 3 and 4 of the Indian Patents Act provide a list of inventions which are not considered patentable even if they qualify all criterion of patentability:  Inventions which are frivolous are not patentable Brain Buzzer- a machine that if you bite it will send vibrations to the brain and will keep you awake Issued in 1998- Thinky Corporation of Tokyo, Japan
  • 4.  Inventions which claim anything contrary to well established natural laws Eg: A perpetual motion machine was claimed that gives output without any input  Inventions contrary to public order or Morality or causing serious prejudice to human, animal, or plant life or health or to the environment Eg: Method or Apparatus of food adulteration, Devices creating industrial or domestic pollution  Discovery of any living thing or non-living substance or 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 is not patentable Eg: Discovery of new species of animals, Newtons Law  Mere discovery of new form of a known substance not resulting into enhancement of the known efficacy of that substance. Salts, esters, ethers, polymorphs, metabolites etc of the known substance  Eg: Drug ‘A’ is known to treat disease ‘X’ in its orally consumable form. If new form ‘B’ of drug ‘A’ is developed in injectable form. Mere new form B would be unpatentable. New use of neem.
  • 5.  A substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance. However, A mixture resulting into synergistic properties of mixture of ingredients however, may be patentable - Soap, Detergents, lubricants etc  Mere arrangement or re-arrangement or duplication of known devices each functioning independently of each another in a known way. Eg: A Bucket fitted with torch, An Umbrella with fan  A method of agriculture or horticulture But Agricultural Equipments are patentable
  • 6.  Any process for treatment of human beings or any process for a similar treatment of animals . Eg: Naturopathy, Sound Therapy, Acupressure/ Acupuncture, method of removal dental plaque and curing dental problems, method of doing operations in the operation theatre  Plants and animals in whole or any part thereof other than micro-organisms Bcoz Plants are protected under Plant Varieties Protection and Farmers Rights Act 2003
  • 7.  A mathematical or business method or a computer program per se or algorithms Eg: Method of doing businesses such as Amway, Chain marketing etc. are not patentable  A literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever including cinematographic works and television productions They all are protected under Copyright’s Act  A mere scheme or rule or method of performing mental act or a method of playing a game Eg: Yoga techniques, Abacus, Vipashyana  A presentation of information Since presentation of information does not have industrial application, hence it is not patentable A speech instruction in the form of printed text is not patentable
  • 8.  Topography of integrated circuits Integrated circuits are protected under Semiconductor Integrated Circuit Layout- Design Act 2000  An invention which in effect, is traditional knowledge or which is an aggregation of known properties of traditionally known component or components  Inventions relating to Atomic energy are not patentable
  • 9. Patent Specification: Contents  It is a techno legal document  It is an application that is to be submitted to the IPO  It discloses the invention and its enablement  It is to be drafted in the manner prescribed by IPO
  • 10.  Title: Should be short and precise  Field of Invention: A statement of the field of art to which the invention is related  Background of the Invention: Earlier known process, products, documents, publications, patents, papers, accepted Ph.D. thesis etc available at the time of filing. Drawbacks of the earlier known process, products  Object of the Invention: Purpose of the invention  Summary of the Invention: Highlights of the invention, Advantage of the invention
  • 11.  Brief Description of the Drawings: Figure names and numbers  Detail Description of Invention: Mention all the embodiments of the invention. Details of the components, chemicals, solvents in the statement of invention, description of mechanical part, arrangements, mechanisms . Source of biological material if used in the invention  Examples: Examples should be extracts from the records, as done in the laboratory, giving best mode of performance of the invention
  • 12.  Claims: Claims form very important part of the specification as they form the basis to determine the infringement of the patent, the extent of protection and the rights of the inventors. Hence it is very important to draft the claims very carefully. It defines the legal boundary of the invention.  Abstract: Not more than 150 words Should give gist of the invention and the novelty. Reference to the drawing if any
  • 13. Types of Patent Applications  Provisional Application  Ordinary or Complete Application  Convention Application  PCT International Application  PCT National Phase Application  Patent of Addition  Divisional Application
  • 14. NBA Approval for Patent Filing  National Biodiversity Act is to conserve the rich biodiversity of the country. The act was implemented in 2003 under the auspices of the National Biodiversity Authority (NBA)  The patent applicant should disclose the source and geographical origin of the biological material when used in an invention  NBA may, while granting approval, impose benefit sharing fee or royalty for commercialization of any rights arising out of the biological resources obtained from India  Mandatory for the applicant to obtain permission from NBA for a patent to be granted  If not an objection might be raised by the examiner
  • 15.  Approval is mandatory only if the biological material is included under the definition of “Biological Resources” under the BDA act.  "biological resources" means plants, animals and micro-organisms or parts thereof, their genetic material and by-products (excluding value added products) with actual or potential use or value, but does not include human genetic material.  Exceptions to biological resources: Value Added products: Value added products are defined as “value added products means products which may contain portions or extract of plants and animals in unrecognizable and physically inseparable form.”. For example, products such as wheat flour , tobacco dust, allicin-enriched garlic extract, were considered as value added product by the Indian Patent Office Bio-waste: NBA approval is also not required for, inventions that use/ disclose Bio-waste. Biowaste is generated after the economic use of the biological resource/material is exhausted and is therefore not covered under the definition of “Biological resources”. Synthetically prepared biological material: Inventions that use synthetically prepared biological material, can also be filed without seeking prior approval from NBA. Such material for example includes materials such as enzymes, pigments, gums, sucrose etc
  • 16.  Biological materials imported to India do not require NBA permission  Appropriate application form (Form 3, Rule 18) for such permission is available on the website of the National Biodiversity Authority.  The Patents Act further complements the Biodiversity Act in that failing to disclosure or false disclosure of the source and geographical origin of biological resource may amount to a ground for opposition or even revocation of the patent grant.
  • 17. Procedure for filing a patent in India https://www.trademarkiso.com/patents/registration-process/
  • 18.  Provisional or Complete specification Filing  If provisional is filed then complete specification is to be filed within 12 months  Publication occurs within 18 months from the date of filing or priority as the case may be  One can apply for early publication on payment of additional fees  After publication, examination of the patent application occurs for which request for examination is mandatory  FER is generated by the examiner to which response is to be filed within 6 months from the date of FER  Examiner may either accept or arrange hearing for the patent application filed  After hearing controller may either grant or refuse the patent  Pre-grant opposition can be filed by any person in between publication and grant of patent.  Post-grant opposition can filed by the interested person within one year from the date of grant of the patent
  • 19. International Treaties: IPR Paris Convention Adopted in 1883 and is applicable for to industrial property in the widest sense, including patents, trademarks, industrial designs, utility models, service marks, trade names, geographical indications and the repression of unfair competition. Objective of the Convention:  National Treatment As regards the protection of industrial property, each Contracting State must grant the same protection to nationals of other Contracting States that it grants to its own national  Right of Priority This right means that, on the basis of a regular first application filed in one of the Contracting States, the applicant may, within a certain period of time (12 months for patents and utility models; 6 months for industrial designs and marks), apply for protection in any of the other Contracting States. These subsequent applications will be regarded as if they had been filed on the same day as the first application
  • 20. International Treaties: IPR  The Convention lays down a few common rules that all Contracting States must follow Patents granted in different Contracting States for the same invention are independent of each other. The inventor has the right to be named as such in the patent TRIPS:  Trade-Related Aspects of Intellectual Property Rights: International agreement between different countries  TRIPS came into force in 1995, as part of the agreement that established the World Trade Organization (WTO)  As IP gained importance, tensions were raised between the countries for protection of IP and hence TRIPS came into existence  Decides the framework of IP protection  It frames the IP system in terms of innovation, technology transfer and public welfare  what the minimum standards of protection are for intellectual property rights that members should provide  which procedures members should provide for the enforcement of those rights in their own territories
  • 21. International Treaties: IPR WIPO:  World Intellectual Property Organization, headquarters in Geneva, Switzerland  To promote the protection of intellectual property throughout the world through cooperation among States and, where appropriate, in collaboration with any other international organization  To ensure administrative cooperation among the Unions PCT:  Patent Cooperation Treaty: The Treaty regulates in detail the formal requirements with which international applications must comply  It makes possible to seek patent protection for an invention simultaneously in each of a large number of countries by filing an "international" patent application.
  • 23. Patent Commercialization 1. Licensing – Exclusive – Non exclusive – Sole – Cross licencing 2. Joint venture 3. Assignment/Sale of Rights 4. Starting a business with the patented product
  • 24. Compulsory Licensing  A government allows someone else to produce a patented product or process without the consent of the patent owner or plans to use the patent-protected invention itself  Application after expiry of three years from the date of grant  Circumstances under which it is granted: -Reasonable requirements of public not met -Patented invention not available to public at reasonable cost -Patented invention not worked in India  Application to be made by any person including licensee  To be filed with the controller
  • 25. Bayer v/s Natco  First CL granted to Natco in India for the drug Nexavar for the treatment of Kidney cancer in 2012  Bayer had been granted patent in India in 2008  In 2011 Natco approached IPO for CL of drug Nexavar on the basis of reasonable requirement not being met and not available at affordable prices  Cost of Bayers drug was Rs 2.8 lacs for one month course  Cost of Natco’s generic version drug was 8800 for one month course  CL was granted to Natco pharma with 6-7 % royalty on the net sales to the bayer
  • 26. Patent Infringement  Infringement of a patent consists of the unauthorized making, using, offering for sale or selling of any patented invention  Violation of monopoly rights constitutes an infringement  Claim to claim analysis is done for essential elements  Legal status to be checked Eg: A+B= C (one process) X+Y=C (another process) Since the components used in both the process to obtain C are different, there is no infringement Eg: A formulation contains A+B+C for treating fever is patented by company X Other Formulation contains A+B+C+D for treating fever is patented by company Y. Y is infringing X’s patent
  • 27. Types of Infringement: 1) Direct infringement when the infringing device or process may be similar or equivalent to the claimed invention (performs substantially the same function, in substantially the same way and to achieve substantially the same result. 2)Indirect infringement: a) Induced infringement b) Contributory infringement Person assisting or helping other person to use patented product/process Contributory infringement is triggered when a seller provides a part or component that, while not itself infringing any patent, has a particular use as part of some other machine or composition that is covered by a patent. 3) Wilful infringement: Person is aware about the existing patent but intentionally uses the same product/process. Once proved, have to pay substantial penalties
  • 28. Patent Infringement: Exceptions  Government Use  Research Purpose  Supply of patented drugs to government run health institutions Jurisdiction  District or High court Who can apply for infringement?  Patentee  Co-owner  Assignee  Exclusive licensee Remedies:  Temporary Injunction  Permanent Injunction  Damages
  • 29. Novartis vs. Cipla  Novartis had 5 patent for the drug Onbrez ( used to treat chronic obstructive pulmonary disease)  In 2014, the Defendant launched a generic version of Onbrez and in the process petitioned to have the Plaintiff’s patents revoked. It contended that the disease has reached an ‘epidemic’ stage and the monopoly of the Plaintiff was limiting the extent of the drug.  In light of that requested the Central Government to revoke the patent under Section 92 (3) (compulsory license under special circumstances) and Section 66 (patents which are prejudicial to public) of the Patents Act.  Defendant contended that the Plaintiff was not manufacturing the drug locally and imported only limited quantities through a licensee.  Plaintiff then filed a case before the Delhi HC claiming patent infringement and damages.
  • 30.  Delhi High court barred the Defendant from making or selling generic copy of the Plaintiffs drug by granting temporary injunction to the Plaintiff.  Defendant had previously also stated that there was a shortage of the drug and inadequacy thereof. However, the HC observed that the Defendant failed to provide any proof or figures for such claims.  In 2017, Cipla filed an appeal against this order. However, the appeal was dismissed on similar grounds. The 2017 Appeal further divided into the implications of a drug being imported and whether the extent of imports was sufficient to meet the demands in India.  Novartis also sort damages from Cipla