Intellectual Property Rights of Pharmaceuticals

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Intellectual Property Rights of Pharmaceuticals

  1. 1. INTELLECTUAL PROPERTY RIGHTS OF PHARMACEUTICALS Presented by- HEMANGA HAZARIKA M. Pharm 2nd Semester Roll no- MP/13/02 Dept. of Pharmaceutics Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17
  2. 2. INTRODUCTION According to the WIPO, “IP refers to creation of the mind, inventions, literary and artistic works and symbols, names, images and designs used in commerce” Divided into two categories 1) Copyright 2) Industrial property Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17 2
  3. 3. THE LEGISLATION COVERING IP IN INDIA ARE Copyright: The Copyright Act of 1957 Last amended in 1994 Design: The Design Act 1911 IT: The Information Technology Act 2000 Patent: The patent Act 1970(Changes bought in 1994) Trademark: The Trade Merchandise Mark Act 1958 Communication: Communication Bill 2000 Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati 17 3
  4. 4. COPYRIGHT- IN INTERNATIONAL CONTEXT Berne convention(1886) Universal Copyright Convention(UCC )(1952) Paris revision in 1971 World Intellectual Property Organization(WIPO) Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17 4
  5. 5. COPYRIGHT- IN INDIAN CONTEXT Copyright in 1847 was passed by the Governor General of India In 1911 the law of copyright was codified in England The Governor General of India enacted the Indian copyright Act of 1914 to make some modification to the whole of the 1911 Act Copyright Act 1914 was again modified after independence which in force even today was passed in the Indian Parliament in 1957 Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17 5
  6. 6. Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17 6
  7. 7. INDUSTRIAL PROPERTY Patents Trademarks Industrial designs Geographic indication of source Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17 7
  8. 8. PATENTS The first congress adopted a Patent Act in 1790 in the US The first patent was issued under this Act on July 1790; to Samuel Hopkins of Vermont for a potash production technique The first legislation in India relating to patent was the Act of 1856 In 1888 new legislation was introduced Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17 8
  9. 9. ADVANTAGES OF PATENTING Incentives to individual Encourage innovation Inspiration for the future generation Gets the benefits of the research Patented products useful to a number of people become available to the public Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17 9
  10. 10. FILING OF PATENT APPLICATION WITH INDIAN PATENT OFFICE  Covering indicating the list of documents  Application for grant of patent in Form 1  Complete specification in Form 2, comprising Description Claims Drawings Abstract  Statement and undertaking in Form 3  Power of Attorney in Form 26(in original)  Declaration of inventorship in Form 5  Certified true copy of the Priority document  Requisite statutory fees Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17 10
  11. 11. NON PATENTABLE INVENTIONS Contrary to public order The mere discovery of a scientific principle Obtained by a mere admixture Method of agriculture or horticulture Surgical technique for hand surgery Atomic energy Living thing and non-living things occurring in nature Mathematical or business methods Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17 11
  12. 12. Tuesday, April 29, 2014 Girijananda Chowdhury Institute of pharmaceutical Science, Azara, Guwahati-17 12
  13. 13. Tuesday, April 29, 2014 Girijananda Chowdhury Institute of pharmaceutical Science, Azara, Guwahati-17 13
  14. 14. PATENT FACILITATOR CENTERS IN INDIA Technology Information, Forecasting & Assessment Council (TIFAC), New Delhi Intellectual Property Management (IPM) Division, CSIR, New Delhi National Research Development Corporation (NRDC), New Delhi Patent Information System (PIS), Nagpur National Information Centre, New Delhi Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17 14
  15. 15. PATENT-IMPACT ON PHARMACEUTICAL INDUSTRY BAD  Competition from MNCs  Litigation  Price rise GOOD  Growth of Pharma Ind.  More resources would be devoted to basic research  Global research industry  Outsource Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17 15
  16. 16. RECENT PATENT DISPUTES AND LITIGATIONS IN INDIA  Patent application for Imatinib mesylate (Gleevec) was rejected by Patent office and also by IPAB  A Compulsory License has recently been granted to Sorafinib of Natco against Naxaver of Bayer, who has been granted a patent in India  Bayer has been found by Controller General of Patents to have:  Not made the medicine available in sufficient quantities to patient  Priced the medicine exorbitantly (Rs. 2,80,000/- as against Rs. 8,800/- of Natco)  Not worked in the territory of India  In the meantime, Cipla has reduced the price below that of Natco Tuesday, April 29, 2014 Girijananda Chowdhury Institute of pharmaceutical Science, Azara, Guwahati- 17 16
  17. 17. Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17 17
  18. 18. E.g. of selected Indian process patents on novel drug delivery systems Indian patent number Title of the patent 189017 A method for preparing sustained release microparticles 187188 A method of producing sterile ophthalmic gel drop preparation 182866 A method of preparing sustained release excipient 178710 A process for producing oral sustained release opioid formulation 178449 A process for making transdermal device for controlled/regulated administration 184719 Implant injection device 186948 A process for preparation of controlled release formulations of nimesulide Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17 18
  19. 19. TRADEMARK Legislation is the Trademark Act 1994 Certification marks are given for compliance with defined standards (eg. ISO 9000) Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17 19
  20. 20. DESIGN Essential requirements for the registration of design- New, original and not previously published or used in any country Applicable to any industrial process Features should be judged solely by the eye Should not include any trademark or artistic work Distinguishable from any known design Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17 20
  21. 21. Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17 21
  22. 22. GEOGRAPHICAL INDICATION India as a member of WTO enacted the Geographical Indication of Goods Act 1999 has come into force wef 15th Sept 2003 Geographical indications ensures that none other than those regd. As authorized uses are allowed to use popular product name Darjeeling tea become the first GI tagged product in India in 2004-05 Since then by 2010. 132 had been added to the list Tuesday, April 29, 2014 Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17 22
  23. 23. CONCLUSION There has been a growth in patent activities in India after TRIPS existence India’s leading drug companies, they couldn't survive as global players without significant R&D capabilities Considerable improvement in research investment has been observed after implementation of TRIPS of WTO There is an urgent need for SMEs to develop a collaborate research culture with public and privately funded research orgs for their survival Tuesday, April 29, 2014 Girijananda Chowdhury Institute of pharmaceutical Science, Azara, Guwahati- 17 23
  24. 24. REFERENCES 1) Bedi Neena et al. Patenting and R&D in Indian Pharmaceutical Industry: Post- TRIPS Scenario. Journal of Intellectual Property Rights; Vol 18, March 2013, pp 105-110 2) Janodia D. Manthan et al. Impact of Patents in Pharma Industry’s Competency: A viewpoint of Pharmaceutical Companies of India; Journal of Intellectual Property Rights; Vol 14, September 2009, pp 432-436 3) Nair G. Gopakumar . Intellectual Property Rights in Pharma Industry. Pharma Times; Vol 44, July 2012, pp 31-43 4) Kulkarni Suhas et al. Analysis of Patent Filing Procedure in India. Pharma Times; Vol 44, July 2012, pp 23-26 5) Prabu S. Lakshmana et al. Intellectual Property Rights and its Development in India; Pharma Times; Vol 44, July 2012, pp 19-22 Tuesday, April 29, 2014 Girijananda Chowdhury Institute of pharmaceutical Science, Azara, Guwahati- 17 24
  25. 25. Tuesday, April 29, 2014 Girijananda Chowdhury Institute of pharmaceutical Science, Azara, Guwahati- 17 25

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