Indian Patent Law and Practice

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Indian Patent LawandPractice
Rajeev Ranjan Chief (Joint Secretary) National
Manufacturing Competitiveness Council Ministry of
Commerce Industry Government of India
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Protection of IPRs in India

• There is a well-established statutory,
  administrative and judicial framework to
  safeguard intellectual property rights in India
• India is a signatory to various International IP
  treaties and conventions and has taken steps to
  comply with its obligations.
• Recent amendments in the Patents Act and Rules
  have set up a new product patent regime in
  chemicals, foods, drugs and agrochemicals
• The importance of IP protection has been realized
  by legislators, courts, and the industry.

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Importance of Patents

• Important source of Scientific Technical
  Knowledge
• More than 40 million Patent Documents and 1
  million
• being added every year
• AN OCEAN OF SCIENTIFIC AND TECHNOLOGICAL
  INFORMATION
• OPEN TO PUBLIC FOR FREE USE AFTER TERM EXPIRES
  OR CEASES TO BE IN FORCE
• Avoids duplication of research and Acts as a
  stepping Stone for Scientific Research.
• Identifies emerging technologies,research areas
  and business opportunities
• REASONABLE ASSURANCE FOR COMMERCIALIZATION OF
  THE INVENTION

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Significance of Patents for Industry

• Patent is an important tool for creation,
  up-gradation and protection of technology
• Helps industry to improve existing technology to
  give cheaper and better products
• A healthy patent system induces capital
  investment in new lines of production and
  encourages FDI, stimulating thereby
  technological development economic growth

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AREAS OF INTEREST FOR INDUSTRY

• Improvement of the quality of the old product
• Manufacturing of a new product
• Increasing production
• Create Corporate Identity
• Enhancing Negotiating Skills and Access to
  Finance
• Avoiding Unnecessary litigation

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Significance of Patents for Enterprise

• Patents can give valuable information for -
• Planning R D
• Planning strategic protection for an enterprise,
• Forging strategic alliances,
• Blocking competitors and
• Identifying possible collaborators
• Catalyst in evolving a positive image
• of the enterprise
• Patent as a Tool for International Trade
  Cooperation
• Measure of Companys Success
• Tool for increasing negotiating power
• Helps to emerge as a Pre-eminent Player in the
  market

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Working of Patented Inventions - Objectives

• Patents are granted -
• To encourage inventions
• To secure that the inventions are worked in India
  on a commercial scale and to the fullest extent
• To ensure that the patents do not impede
  protection of public health and nutrition
• And act as instrument to promote public interest
  specially in sectors of vital importance for
  socio- economic and technological development of
  India
• Patents are not granted merely to enable the
• patentee to enjoy right for importation

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• It is ensured that-
• Patent System does not prohibit Central Govt to
  take measures to protect public interest
• Patent Right is not abused by the patentee
• Patentee does not restrain trade or adversely
  affect the international transfer of technology
• Benefits of the Patented Inventions are made
  available at reasonably affordable prices to the
  public
• Protection and enforcement of Patent Right is
  aimed at-
• Promotion of technological innovation
• Transfer and dissemination of technology
• Mutual advantage of producers and users of
  technological knowledge
• Ensuring social economic welfare and balance
  of lights and Obligations

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ROLE OF GOVERNMENT

• To enhance IP literacy
• To set up Modernised IP System
• To provide for effective enforcement of IPRs
• To create infrastructure for providing industries
  and Institutions with need-based RD facilities
• Training on IPR issues
• Organising utility workshop on IPRs

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Challenges before IP Administration

• To meet the TRIPs obligation in phased manner
• Required legislative changes
• To revamp the IP Administration-capacity building
• Required modernization
• Simplification of procedures
• Improving performance and efficiency
• To spread IP culture through awareness programmes
  
• Enforcement issues

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Patents Act 1970 Salient Features

• Only process patents for food, pharmaceuticals
  and chemical products.
• Product and process patents in all other areas
• Term of patent variable (7 / 14 years)
• Elaborate public interest provisions (compulsory
  licensing, Licence of right, Government use)

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Indias TRIPS Obligations Three stage
implementation

• From 1.1.1995
• Mail-Box
• for pharmaceutical and agrochemicals products
• EMR (Exclusive Marketing Rights)
• From 1.1.2000
• 20 years term,
• Definition of invention
• Reversal of burden of proof
• Modification of compulsory licence provision
• Right of patentee (include importation also)
• From 1.1.2005
• Product patents for food, chemical and
  pharmaceutical

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TRIPS OBLIGATIONS MET IN PHASED MANNER

• 1999-First Amendment - The Patents (Amendment)
  Act, 1999 - made effective from 1.1. 1995.
• mail-box for product patent applications and
  grant of exclusive marketing rights (EMRs), from
  1.1. 1995
• 2002-Second amendment - The Patents (Amendment)
  Act, 2002 - made effective from 20.5. 2003
• complied with obligations relating to rights of
  patentee, term of patent, compulsory licensing,
  reversal of burden of proof
• 2005 - Third amendment - Patents (Amendment) 2005
  - Effective from 1.1.2005
• Introduction of product patent for foods, drugs
  and chemicals

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3rd Amendment Main features

• Legislative Obligations
• Product patent protection for invention in all
  fields of technology
• Deletion of EMRs provisions and inclusion of a
  provision for safeguarding existing EMRs
• Para 6 Doha Declaration on TRIPs and Public Health

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3rd Amendment contd.

• Administrative Issues
• Restructuring timelines
• Progressive reduction through rules
• Removal of sealing procedure
• User friendly provisions
• Simplification of procedures/Reduction of forms
• Early publication on request
• Extension of grace period for inventors (6 months
  to 12 months)
• 6 months Extension for renewal of patent
• Modified opposition procedures
• Strengthening of security provisions

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Results of Changes in the Patent System

• Pharma industry 10 billion dollar industry
• Size of drug industry in India today
• About 20,000 manufacturing units providing
  employment to approximately 33 Lakhs people
• Ranked 4th in terms of volume and 13th in terms
  of value world wide
• RD expenditure over Rs.1000 crores

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PATENT LAW ISSUES THAT KEY STAKEHOLDERS ARE
CONCERNED ABOUT
Key stakeholders
Are concerned about impact of IPR
The real issues at the core of the debate are
Pharmaceutical drug prices Pharmaceutical
drug Availability Availability of new cures
Drug prices will increase We will not have access
To drugs
Consumers
Overall health of the public will be
impacted Could impact FDI employment Generation
Bio piracy
India would give away too Much in adopting a
TRIPS Complaint regime
Government
Impact on domestic and export Revenues Impact on
innovation New business opportunities
Pharmaceutical companies
Growth and profitability will be adversely impact
Global innovative companies
Impact on markets Impact on innovation
Growth and profitability will be impacted
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STRATEGY TO MEET CHANGING SCENARIO ON IPRS-
Capacity Building in Patent Offices

• Administrative changes
• Human Resource Development
• Modernization and Infrastructure
• Revamping and Reengineering of Procedures
• Comprehensive computerisation

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AGENDA FOR PATENT OFFICE MODERNISATION

• Simplification of Rules and Procedures
• Preparation of Manual of Patent Office Procedure
  (MOPOP)
• Establishment of Virtual Patent Office
• Development of Information Technology Strategic
  Plan (ITSP)
• Development of modified patent examination
  procedure

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INFRASTRUCTURE DEVELOPMENT

• Newly constructed integrated IPO Buildings
  inaugurated at
• Delhi, (29.8.05) , Kolkata (28.10.2005), Chennai
  (21.1.2006), Mumbai having both Patent Office and
  Trade Marks Registry at one location

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Locations of the Patent Offices

• The Patent Office, Intellectual Property Office
  Building, CP-2  Sector V, Salt Lake
  City,Kolkata-700091, Phone [phone], 1946,
  1987, FAX-033-2367-1988, Email-
  kolkata-patent_at_nic.in (Covers Eastern region)
• The Patent Office,Intellectual Property Office
  Building,G.S.T. Road, Guindy, Chennai-600032,
  Phone [phone], FAX [phone],Email c
  hennai-patent_at_nic.in (Covers Southern region)
• The Patent Office, Intellectual Property Office
  Building,Plot No. 32, Sector 14, Dwarka, New
  Delhi-110075,Phone [phone],FAX[phone]
  920-40, Email  delhi-patent_at_nic.in (Covers
  Northern region)
• The Patent Office, Intellectual Property Office,
  Todi Estates, 3rd Floor,Lower Parel (W), Mummbai
  400013,Phones [phone], (022)
  24925092,Fax [phone], Email
  mumbai-patent_at_nic.in (covers Western region)

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MODERNIZATION AND INFRASTRUCTUR E

• New IPO Buildings are
• World class IPO Buildings
• With corporate look
• With all modern amenities like
• Computerization of procedure
• Networking of offices (Wide Area Network)
• Setting up a network of computers (Local Area
  Network)
• Improving search facilities (through internet and
  ISDN Lines)
• Infrastructure development (digitization of
  records)
• Online filing facility

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WEBSITE
http//www.ipindia.nic.in
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STATUTORY TIMELINES FOR GRANT OF PATENTS (EARLIER
SCENARIO)

• 15 (12 3) months time to file complete
  specification after provisional application
• 33 (48-15) months to file request for examination
  
• 18 months time for examiner to examine the
  application
• 12 months time for applicant to meet the
  requirements and put the application in order
• 9 (6 3) months for filing request for sealing
  including 5 ( 41) months for filing opposition
  Total 104 months !!

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CURRENT TIMELINES

• 15(123)Months time to file complete
  specification after provisional -reduced by 3
  months
• Within 36 months from the date of priority to
  make request for examination- reduced by 24
  months
• 1 month time for examiner to examine the
  application - reduced by 17 months
• 4 months time for applicant to meet the
  requirements and put the application in order -
  reduced by 8 months
• 5(41) months for filing opposition - removed.
• 9(63) months for filing request for sealing -
  removed along with 5(1) months for opposition
• Total 52 months (Earliest possible can be 9
  months)

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TREND RELATING TO EXAMINATION OF APPLICATIONS
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Patent Office Statistics
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Patenting Trend in India
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Patent Office Revenue/Expenditure
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MILE-STONES ACHIEVED

• Infrastructure in four existing offices
  modernised
• 292 additional posts created including 227 posts
  of patent examiners
• 160 new Patent Examiners recruited
• Basic level of computerisation achieved - Front
  office automation software, Query System,
  Examination Library module developed, Website
  launched
• Business Process Re-engineering (BRP) and
  Information Technology Strategic Plan (ITSP)
  prepared

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MILE-STONES ACHIEVEDCONTD.

• Computer training to officers and staff - first
  phase completed
• Training of all the New Examiners completed
• CD ROMs, technical books and journals for
  improving search facilities procured
• Weeding out of over 3 lakh old records completed
• New integrated IP buildings have been recently
  inaugurated at Delhi (29.8.2005), Kolkata
  (28.10.2005), Chennai (21.1.2006) and Mumbai IP
  building is also expected to be inaugurated
  shortly.
• Intellectual Property Training Institute set up
  at Nagpur

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MILE-STONES Achievedcontd.

• Work manual of IP offices prepared and updated.
• Digital database of over 1 lakh patent records
  and 80, 000 design records prepared and being put
  as a searchable database on the website.
• On line search facility have been established
• Current out put of patent offices has nearly
  quadrupled from 2824 cases in 1999-2000 to over
  12000 cases in 2005-06.
• Examination reports are being issued now within
  three months of filing request for examination
  earlier this was taking over five years.
• IT enabled and users friendly Patent Offices
• Development of Dynamic Website/Portal

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OPPORTUNITIES

• Indian pharmaceutical companies set to become
  innovation driven
• Boost to Research and Development
• Stage set for
• Strategic alliances and partnerships
• Joint Ventures and In-licensing deals
• Marketing, Research and Manufacturing tie ups
• Collaborative partnerships particularly in the
  area of research
• Acquisitions and Mergers

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INDIAN PHARMACEUTICAL INDUSTRY IN PRODUCT PATENT
ERA

• India is one of the top five manufacturers of
  bulk drugs and among top 20 pharmaceutical
  exporters
• Strengths of the Indian Pharmaceutical Industry
• Cost Competitiveness
• Strong manufacturing base 70 plus
  USFDA approved
• 
  manufacturing facilities
• Good infrastructural facilities for
  RD
• Strong marketing distribution network
• Competence in chemistry and process
• development
• Projected exports of domestic pharma products -
• 4 billion by 2010
• 6 billion by 2015

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INDIAN PHARMACEUTICAL INDUSTRY PRODUCT PATENT ERA

• Public funded pharmaceutical research picking up
• Venture capitals and private equity funding
  research and development and clinical trials
• India as a global outsourcing hub
• Pharma RD outsourcing More than 100
  multinationals setting up RD labs
• IPR services outsourcing More than half a dozen
  companies set up facilities in India to provide
  IPR related services
• Alliances happening primarily in two areas
• Between Indian companies in the generics space
• Between MNCs and Indian companies in RD Generic
  market opportunity
• Drugs worth 80 billion going off-patent in next
  two years offering a huge opportunity for
  alliances in the global market
• Mergers and Acquisitions

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CHALLENGES - PRODUCT PATENT ERA

• Patent and pricing
• 97 of drugs including 350 life-saving
  drugs in India are off-patent
• CL provisions to be implemented in
  case of national
• emergencies or health crisis
• Task force for Drug Price Control
• Alternative therapeutics (Science and Traditional
  Knowledge together)
• Standardize globally acceptable
  pharmocological and
• safety studies

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ADVANTAGE INDIA

• Abundant scientific and technical manpower, hence
  strong intellectual capital
• Large and Diverse patient base to conduct
  international clinical trials
• US FDA/WHO compliant manufacturing facilities
• Strong base in bulk drugs manufacture
• Entrepreneurial skills
• 15 of Pharmaceutical RD Scientists in USA are
  of Indian origin, hence good network
• In short, all the ingredients for becoming
  globally dominant

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POSITIVE IPR POLICY WILL RESULT IN

• India emerging as strong global player
• Dramatic increase in exports
• Development of Strong ancillary industry
• Increased flow of FDI
• Increased employment opportunities
• Investment in RD innovation

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Thanks