India

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Indias IPR Policy on Biotechnology

• Intellectual Property of Biotech Processes Main
  Regulatory and Legal Aspects

Presented by Vidya B. Mehrish Dua Associates,
India (vidyamehrish_at_duaassociates.com) on
February 16, 2006 Forum AIDIC, BIOTECH
GROUP BIOTECH PROCESSES OVERVIEW
WORKSHOP, MILANO, ITALY
Dua Associates, India
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Overview of Presentation

• What is Biotechnology?
• Why is Biotechnology Important for India?
• Indian Government Initiatives
• Potential Areas for Investment in the Indian
  Biotechnology Sector
• Intellectual Property Rights of Biotechnology
  (Legal Frame Work)

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What is Biotechnology?

• Biotechnology includes
• Recombinant DNA and Genetic Engineering
• Cell Cultures
• Waste Treatment and Utilization
• Enzymes and Biocatalysts
• Fuels
• Nitrogen Fixation
• Fermentation and Pharmaceuticals

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Why is Biotechnology Important for India?

• For a country like India, biotechnology is a
  powerful enabling technology that can
  revolutionize agriculture, healthcare, industrial
  processing and environmental sustainability .
• Biotechnology as a business segment for India has
  the potential of generating revenues to the tune
  of US 5 million and creating one million jobs by
  2010 through products and services.
• Clinical development services can generate in
  excess of US 1.5 billion while bio-services or
  outsourced research services can garner a market
  of US 1 billion over this time scale.

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Why is Biotechnology Important for India?

• With approximately 200 industries, the growth of
  the biotech sector in India has been rapid.
  Current estimates indicate that the industry grew
  by 39 annually to reach a value of US 705
  million in 2003-2004.
• Currently, the bio-pharma sector occupies the
  largest market share of 76 followed by bio-agri
  8.42, bio-services 7.70, industrial products
  5.50 and bio-informatics 2.45.
• The current policy review envisages an annual
  turnover of US 5 billion by 2010.

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Indian Government Initiatives

• Import Duty Exemption (Promotion of Import Duties
  on key RD, contract manufacturing / clinical
  trial equipment and duty credit)
• Tax Deduction on RD Expenditure (Extending the
  150 weighted average tax deduction on RD
  expenditure under section 35 (2AB) of the Indian
  Income Tax Act until 2010).
• Priority Sector Lending (Enable lending by Indian
  banks to biotech companies as priority sector
  lending).
• Customs Duty Removal (Remove customs duty on raw
  materials imported into India, that go into
  making the finished product is imported duty
  free).
• Simplification of Procedures (Simplification and
  streamlining of procedures for import, clearance
  and storage of biological, land acquisition,
  obtaining environmental and pollution control
  approvals would be simplified and streamlined
  within shorter time frame lines through
  consultations with various central and state
  government departments).
• Fostering Inter-Company Relationships (The Indian
  Government further intends to make efforts to
  remove hurdles for contract research especially
  for input output norms and tax on revenue
  generated through contract research / RD).
• Developing Communication Systems (One significant
  feature of the biotech industry is the fluidity
  and variety of its inter-company relationships,
  traditionally much greater than in other
  industries).

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Potential Areas for Investment in the Indian
Biotechnology Sector

• Agriculture and Food Biotechnology
• Industrial Biotechnology
• Preventive and Therapeutic Medical Biotechnology
• Regenerative and Genomic Medicine
• Pharmaco-genomics
• Bio-engineering and Nano-biotechnology
• Bio-informatics and IT Enabled Biotechnology
• Clinical Biotechnology and Research Services

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Intellectual Property Rights of Biotechnology
Legal Aspects

• In India, a patent can be obtained only for an
  invention which means a new product or process
  involving an inventive step and capable of
  industrial application.
• In order to be patentable, an invention must
  concern a new and useful manner of manufacture.
  The word manufacture applies not only to things
  made but to the practice of making, to principles
  carried into practice. Essentially, if the
  starting material remains unaltered by the
  process, and the end product also remains the
  same as the starting material, the process is
  understood as no manufacture from the
  patentability perspective.
• To be patentable an invention must have (i)
  technical advancement over existing knowledge,
  (ii) economic significance, (iii) or both which
  makes the invention not obvious to a person
  skilled in the art. If the subject matter of the
  invention is novel, non-obvious and the invention
  has industrial applicability, it can be patented
  in India. Indian Patents Act, 1970 2(j).

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Intellectual Property Rights of Biotechnology
Legal Aspects

• Changes to Indian legislation in keeping with
  international legislative framework
• Subsequent to the enactment of TRIPS, Indian
  Patent law has changed in the following ways
• A uniform twenty (20) years for all patents
  granted after May 20, 2003
• A reciprocal arrangement with all convention
  countries, union of countries and
  inter-governmental organizations
• Products made patentable in all fields of
  technology from January 1, 2005
• The extension of the rights of the patentee
• For product patent applications on
  pharmaceuticals and agro-chemicals filed before
  January 1, 2005, under the mail box system,
  request for examination is to be filed within
  thirty six months from the date of priority.

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Intellectual Property Rights of Biotechnology
Legal Aspects

• Rights of patentee for mail box applications
  extend from the date of grant of patent.
• For patents granted on mail box applications
  which include Biotechnology inventions, patent
  holder is entitled to receive reasonable royalty
  from such enterprise which has made significant
  investment and has been producing and marketing
  the concerned product prior to January 1, 2005
  and which continues to manufacture the product
  covered by the patent on the date of grant of
  patent and no infringement proceedings can be
  instituted against such enterprise.

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Intellectual Property Rights of Biotechnology
Legal Aspects

• Compulsory licenses are available for manufacture
  and export of patented pharmaceutical products to
  any country which has insufficient or no
  manufacturing capacity in the pharmaceutical
  sector for the concerned product to address
  public health problems subject to the condition
  that compulsory license has been granted by such
  country or such country by notification allows
  importation of patented pharmaceutical product
  from India.
• A major concern of pharmaceutical industries
  concerning amendments in the compulsory license
  procedure is that it can be granted to any
  interested person if the patented invention is
  not available to the public at a reasonable
  affordable price. The term Affordable is a
  relative term which however, has not been
  defined.

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Intellectual Property Rights of Biotechnology
Legal Aspects

• Yet another concern is that amended act allows
  generic manufacturers who were producing and
  marketing products of a mail box patentee before
  January 1, 2005 to continue doing so on payment
  of a reasonable royalty.
• Bolar provision included making, using or
  selling patented product before expiry of the
  term of patent for obtaining regulatory
  approvals. Bolar provision now includes
  Importing. Thus, while considerable period of
  the patent holder is wasted in obtaining
  regulatory approvals, the generic producer has
  advantage that immediately on expiry of the term
  of patent, he can commence production.

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Intellectual Property Rights of Biotechnology
Its Regulatory Framework

• Legislative framework The Drugs and Cosmetics
  Act, 1940 and the Drugs and Cosmetics Rules, 1945
  as amended from time to time, regulate
  recombinant pharma products.
• Authorities The Drugs Controller General of
  India (DCGI), the State Drugs Controller and the
  Recombinant Drugs Advisory Committee (RDAC)
  constituted by the Ministry of Health and Family
  Welfare regulate the recombinant pharma products.
  
• Steps involved in the approval process of
  a biotechnology product -
• Proposal (examination of proposal in light of the
  bio-safety regulation and guidelines)
• Approval of Review Committee on Genetic
  Manipulation (RCGM) (Examination of information
  for RD work, approval of pre-clinical trial
  based on evaluation of data physico-chemical and
  biochemicals characterization of the process and
  the final product
• Genetic Engineering Approval Committee Drugs
  Controller of India (Approves Clinical Trials and
  Containment Facilities and Evaluates Clinical
  Trials)

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Intellectual Property Rights of Biotechnology
Its Regulatory Framework

• Approval for Manufacture and Marketing
  (Currently, there are multiple regulators,
  multiple ministries, lack of coordination, lack
  of a linear progression in the responsibilities
  of a regulator and lack of a linear progression
  in the approval process and committees working
  outside their areas of expertise).
• Proposals to streamline the process
• The Institutional Bio-Safety Committee will
  monitor all development work (up to 20 litres)
  and recommend to RCGM for Animal Toxicity Tests
  (ATT) Scale Up.
• RCGM will evaluate the recombinant technology and
  grant permission for scale up RD, review and
  approve for pre-clinical animal toxicity tests
  and evaluate ATT data and recommend to DCGI for
  Human Clinical Trial (HCT).
• DCGI will permit Human Clinical Trials, review
  Human Clinical Trial Data, grant permission for
  Manufacture and Marketing of the product and
  inspect the facility where the product is
  manufactured.
• GEAC will review the manufacturing process to
  ensure that the LMO (Living Modified Organism) is
  inactivated during the process and send its
  recommendations to the Drugs Controller General
  of India within the specified time.

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Future Proposals by the Indian Government to
further steam-line the Regulatory Aspect of the
Indian Biotechnology sector

• National Biotechnology Regulatory Authority
• In-service Center for Training of Professionals
• Guidelines for Transgenic Research
• Special Regulatory Cell
• Review Committee on Genetic Manipulation (RCGM)
  Evaluation of Recombinant Technology

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