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Intellectual Property Rights
 Patents
 Copyright
 Trade Marks
 Geographical Indications
 Industrial Designs
 Extends to the whole of India
 Objective:
 encourage indigenous industrial growth
 Fostering innovation and technology and bringing
new inventions to market for the benefit of
society
 Invention:
 New product or process involving an inventive
step and capable of industrial application
 Includes any new and useful art, process, method
of manufacture
 Product, machine, apparatus, substance or other
article and includes new and useful improvement
 Patentable Inventions: Criteria
 Novelty
 Non-obviousness (Inventive Step)
 Usefulness
 Non-patentable inventions:
 Frivolous
 Contrary to law, injurious to public health
 Formulation of abstract theory
 Discovery of living and non-living substances
 Medicinal, surgical, curative, prophylactic,
diagnostic or therapeutic treatment of human
being or animal
 Method of agriculture or horticulture
 Mere rearrangement of known devices
 Presentation of information
 Traditional knowledge
 Patent is defined as ‘monopoly granted by the
central government to the applicant (subject to
certain conditions) for a limited period
(20years) in lieu of full disclosure of invention
OR
 Exclusive right granted to the owner of an
invention to make use, manufacture and
market the invention within the framework of
law
 Avoids duplication of research
 Updating of latest development in various
fields
 Improvement of technology to provide better
and more economical products
 Serves as an indicator of achievements in
R&D
 Helps to frame business strategy
 Product patent
 Process patent
OR
 Independent Patent
 Patent of an addition
 Can be filed in appropriate Patent Office
 Application may be filed with Provisional
Specifications
 Complete specifications to be filed within 12
months
 Every complete specification shall
 Fully describe the invention and its operation
 Disclose the best method of operation/performing
the invention
 End with a claim/claims defining the scope
 Accompanied with an abstract providing technical
information
 Provisional Specifications
 To establish priority of invention
 Registers the earliest authorship on first cum first
basis
 It has to be followed by complete specification
within 12 months
 Allotment of the application to specific
examiner
 Examiner determines the procedural validity
 Prior art search covering publications in India
and abroad
 First examination report: 18-24 months
 Objections of examiner to be communicated
to the applicant
 On compliance, applicant will be informed
about the acceptance of claims
 Published in Gazette of Patent office
 Opposition by any member of public within 4
months of publication
 Applicant has all the rights and privileges of
an inventor
 Controller of Patent Office shall seal the
patent with the seal of Patent Office
 Manufacture, sale or import of patented
invention without permission from patent
owner
 Suit can be filed in District Court
 Relief includes: damages on account of loss of
profit, seizure of infringing goods
 Civil offence NOT criminal
 Refusal to grant licence
 Imposing unreasonable terms on licences
 Restrictive conditions on use, sale, lease of
patented article
 Meeting demand solely by importation and
not by local manufacturing
 Granted three years after the date of grant of
patent
 Issued for the interest of public to avoid
abuse of patents
 Patent holder imposes unreasonable terms or
conditions on licence
 National emergency with respect to public
health
 Prior to 1999 amendment to PatentsAct,
only process patent was available
 As signatory toTRIPS agreement, India was
given time till 2004 for implementing full
protection for product patent
 Till that time, EMR was granted for some
products
 Trade RelatedAspects of Intellectual
Property Rights
 InternationalAgreement by members of
WTO
 Minimum standards that member countries
have to provide strong IP protection in their
domestic law
 Important challenge: high cost of essential
medicines due to patent protection
 Before adoption ofTRIPS, Indian drug
industry was making low priced generics in
market
 Patent protection may allow pharmaceutical
companies to take advantage of their
monopoly
 Some room for countries to take measures to
protect public health
 2001 Doha Declaration and 2003 decision
enables countries to import pharmaceuticals
under compulsory licence
Patents act 2005

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Patents act 2005

  • 2.  Patents  Copyright  Trade Marks  Geographical Indications  Industrial Designs
  • 3.
  • 4.
  • 5.  Extends to the whole of India  Objective:  encourage indigenous industrial growth  Fostering innovation and technology and bringing new inventions to market for the benefit of society
  • 6.  Invention:  New product or process involving an inventive step and capable of industrial application  Includes any new and useful art, process, method of manufacture  Product, machine, apparatus, substance or other article and includes new and useful improvement
  • 7.  Patentable Inventions: Criteria  Novelty  Non-obviousness (Inventive Step)  Usefulness
  • 8.  Non-patentable inventions:  Frivolous  Contrary to law, injurious to public health  Formulation of abstract theory  Discovery of living and non-living substances  Medicinal, surgical, curative, prophylactic, diagnostic or therapeutic treatment of human being or animal
  • 9.  Method of agriculture or horticulture  Mere rearrangement of known devices  Presentation of information  Traditional knowledge
  • 10.  Patent is defined as ‘monopoly granted by the central government to the applicant (subject to certain conditions) for a limited period (20years) in lieu of full disclosure of invention OR  Exclusive right granted to the owner of an invention to make use, manufacture and market the invention within the framework of law
  • 11.  Avoids duplication of research  Updating of latest development in various fields  Improvement of technology to provide better and more economical products  Serves as an indicator of achievements in R&D  Helps to frame business strategy
  • 12.  Product patent  Process patent OR  Independent Patent  Patent of an addition
  • 13.  Can be filed in appropriate Patent Office  Application may be filed with Provisional Specifications  Complete specifications to be filed within 12 months
  • 14.  Every complete specification shall  Fully describe the invention and its operation  Disclose the best method of operation/performing the invention  End with a claim/claims defining the scope  Accompanied with an abstract providing technical information
  • 15.  Provisional Specifications  To establish priority of invention  Registers the earliest authorship on first cum first basis  It has to be followed by complete specification within 12 months
  • 16.  Allotment of the application to specific examiner  Examiner determines the procedural validity  Prior art search covering publications in India and abroad  First examination report: 18-24 months  Objections of examiner to be communicated to the applicant
  • 17.  On compliance, applicant will be informed about the acceptance of claims  Published in Gazette of Patent office  Opposition by any member of public within 4 months of publication  Applicant has all the rights and privileges of an inventor  Controller of Patent Office shall seal the patent with the seal of Patent Office
  • 18.  Manufacture, sale or import of patented invention without permission from patent owner  Suit can be filed in District Court  Relief includes: damages on account of loss of profit, seizure of infringing goods  Civil offence NOT criminal
  • 19.  Refusal to grant licence  Imposing unreasonable terms on licences  Restrictive conditions on use, sale, lease of patented article  Meeting demand solely by importation and not by local manufacturing
  • 20.  Granted three years after the date of grant of patent  Issued for the interest of public to avoid abuse of patents  Patent holder imposes unreasonable terms or conditions on licence  National emergency with respect to public health
  • 21.  Prior to 1999 amendment to PatentsAct, only process patent was available  As signatory toTRIPS agreement, India was given time till 2004 for implementing full protection for product patent  Till that time, EMR was granted for some products
  • 22.  Trade RelatedAspects of Intellectual Property Rights  InternationalAgreement by members of WTO  Minimum standards that member countries have to provide strong IP protection in their domestic law
  • 23.  Important challenge: high cost of essential medicines due to patent protection  Before adoption ofTRIPS, Indian drug industry was making low priced generics in market  Patent protection may allow pharmaceutical companies to take advantage of their monopoly
  • 24.  Some room for countries to take measures to protect public health  2001 Doha Declaration and 2003 decision enables countries to import pharmaceuticals under compulsory licence

Notes de l'éditeur

  1. Patent is an intellectual property right relating to inventions and is the grant of exclusive right for a limited period by the Government to the patentee, in exchange of full disclosure of his invention.
  2. Bayer Corporation, USA (“Bayer”) had developed Sorafenib Tosyalte (“the Drug”), marketed as Nexavar, and obtained a patent from US authorities (United States Patent Office) in 1999. The drug is a life extending drug which is used for treating patients suffering from advanced stages of kidney cancer (Renal Cell Carcinoma) and liver cancer (Hepatocellular Carcinoma). Bayer was granted a patent for the Drug in India in March 2008. In December 6, 2010, Natco Pharma Ltd (“Natco”) approached Bayer for grant of a voluntary licence. Bayer in a response dated December 27, 2010 rejected Natco’s request for grant of voluntary license and requested Natco to approach within 14 days in case Natco had anything further to add. After the expiration of three years from the date of grant of the Indian patent to the Drug, Natco applied to the Controller General of Patents (“Controller”) for a compulsory license under Section 84 (1) of the Patents Act 1970 (“the Act”) proposing to manufacture and sell the drug at a price of Rs.8800/- per month of therapy. Bayer opposed this application on various grounds, however in March 2012, the Controller granted the first Compulsory License to Nacto to manufacture and sell the drug. A detailed analysis of Compulsory license provision under the Act and the analysis of Controller's order is available in our IP Lab here. Thereafter, Bayer filed an appeal challenging the order of the Controller before the Intellectual Property Appellate Board (“IPAB”). The IPAB, in March 2013, dismissed the appeal and upheld the decision of the Controller. In the order IPAB raised the rate of royalty to be paid by Natco to Bayer from 6% to 7 %. A detailed analysis of the IPAB’s order is given in our hotline here. Bayer challenged IPAB’s order before the High Court of Bombay (“HC”) by way of a writ petition. The HC examined the relevant provisions of the Act and upheld IPAB’s Order.