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Dr Tabrez Ahmad Lectures

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Patent Law: 

Patent Law Dr. Tabrez Ahmad Professor of Law www.technolexindia.com tabrezahmad7@gmail.com http://technolexindia.blogspot.com Friday, October 28, 2011 1 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Slide 2: 

28 October 2011 2 www.technolexindia.com, http://technolexindia.blogspot.com

Slide 3: 

All rights and IPRs in the e-contents of various power point presentation slides/syllabus/pages are reserved in favour of Dr. Tabrez Ahmad and any violation will result in prosecution."Prior Written Affirmative Permission" is required before dealing with or using of any part of the e-contents in any manner whatsoever.© Friday, October 28, 2011 http://iplexindia.blogspot.com 3

Must do before starting the course: 

Must do before starting the course Collect IPR Hons Patent Law syllabus from KLS Library Purchase a Patent Bare Act Get membership http://groups.google.co.in/group/ patentlex Become follower of the Blog: http://iplexindia.blogspot.com Friday, October 28, 2011 http://iplexindia.blogspot.com 4

Agenda: 

Evolution of Patent Law in India Dynamics of Policy Making Current Law and Policy Recent Strategic Policy Interventions and Their Impact Future Plans Conclusion. Friday, October 28, 2011 http://iplexindia.blogspot.com 5 Agenda

PATENT: WHAT IS IT? : 

PATENT: WHAT IS IT? It is a limited right granted by the state to an inventor in respect of an invention to exclude any other person from practicing the invention i.e. manufacturing, using or selling the patented product or from using the patented process, without due permission. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com, 6

WHAT CAN BE PATENTED?: 

WHAT CAN BE PATENTED? Inventions in all fields of technology, whether products or processes, if they meet the criteria of Being patentable subject matter; Novelty; Non-obviousness (inventive step); Industrial application (utility). Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com, 7

Conditions of Patentability: 

Conditions of Patentability Novelty: Invention not known to public prior to claim by inventor Inventive Step: Invention would not be obvious to a person with ordinary skill in the art Industrial Application: Invention can be made or used in any useful, practical activity as distinct from purely intellectual or aesthetic one Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com, 8

SOME EXCLUSIONS FROM PATENTABILITY: 

SOME EXCLUSIONS FROM PATENTABILITY Naturally occurring substances/elements; Diagnostic, therapeutic and surgical methods of treatment of humans or animals; Plants and animals other than μ -organisms; Essentially biological processes for production of plants or animals; Inventions whose use is contrary to public order or morality. Ideas, methods for business, playing games, performing mental acts. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com, 9

PATENT: SPECIAL REQUIREMENT: 

PATENT: SPECIAL REQUIREMENT Disclosure of invention Sufficiently clear and complete so that a person skilled in the art can carry out the invention. A country may require the best mode for carrying out the invention to be disclosed. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com, 10

Law and Regulations: 

Law and Regulations Patents Act, 1970 Amended in 1999 2002 2005 Patents Rules, 2003 Amended in 2005 2006 Friday, October 28, 2011 11 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Legislative Measures -Patents: 

Legislative Measures -Patents From 1.1.1995 Mail-Box for pharmaceutical and agrochemicals products Exclusive Marketing Rights From 1.1.2000 Patent term increased to 20 years Definition of invention – inclusion of inventive step Reversal of burden of proof – on the infringer Mandatory compulsory licence provision for food, drugs and chemicals removed Right of patentee (importation also included) From 1.1.2005 Product patents for food, chemical and pharmaceutical We have met our international commitments Friday, October 28, 2011 12 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Patent Law - Salient Features: 

13 Patent Law - Salient Features Both product and process patent provided Term of patent – 20 years Examination on request Both pre-grant and post-grant opposition Fast track mechanism for disposal of appeals Provision for protection of bio-diversity and traditional knowledge Publication of applications after 18 months with facility for early publication Substantially reduced time-lines Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Safeguards in the Patent Law: 

14 Safeguards in the Patent Law Compulsory license to ensure availability of drugs at reasonable prices Provision to deal with public health emergency Revocation of patent in public interest and also on security considerations Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

TRIPs and Patent Issues: 

TRIPs and Patent Issues “Data exclusivity”: Test data that demonstrates a drug or agrochemical’s safety and efficacy, which is required by a drug regulatory authority for marketing approval. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com, 15

TRIPs Art. 39.3: Protection of Undisclosed Information: 

TRIPs Art. 39.3: Protection of Undisclosed Information “Members … shall protect such [undisclosed test] data against unfair commercial use.” “Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use." Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com, 16

TRIPs and Patent Issues: 

TRIPs and Patent Issues Is there a conflict between TRIPs and the UN Convention on Biological Diversity, protection of traditional knowledge and folklore? (Doha Ministerial Declaration, Para. 19) Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com, 17

TRIPs and CBD: 

TRIPs and CBD No conflict: Both can be mutually supported using national laws and contractual arrangements. May provide civil and/or criminal penalties for misappropriation: Can be adequately enforced, similarly to health, safety and other important regulatory areas. Patent System is effective for promoting innovation and economic development, not regulating misconduct. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com, 18

TRIPs and CBD: 

TRIPs and CBD Conflict: TRIPs must be amended New patent disclosures needed regarding: Source of origin of genetic material Evidence of prior informed consent Evidence of equitable benefit sharing. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com, 19

TRIPs and CBD: 

TRIPs and CBD Members Appear to Share Several Broad Objectives: Provide Authorized Access While Assuring Conservation of Biodiversity Equitable Benefit Sharing for Use of Traditional Knowledge and Genetic Resources Eliminate Erroneously Issued Patents Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com, 20

Beginnings: 

21 Beginnings 1832 Earliest reference: Letter dated 23 September 1835 from Lord William Bentinck, Governor General (GG) to the Advocate General of India (AG). First intention to have separate legislation for each invention. AG’s opinion: GG has no power to grant patents, that being a royal prerogative. GG decided not to pursue the matter further. Exporters from England to India put pressure. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Conflict Over Prerogative Powers: 

22 Conflict Over Prerogative Powers Legal Advisers of East India Company felt: the Legislative Council of India had powers to extend patent rights granted in England to India. GG felt this illogical and also injurious to people of India since a machine in daily use in India could get a patent in England being new in that country. In 1853, the British Parliament enacted a law giving powers to the GG to enact legislations on royal prerogatives with previous sanction of the Crown. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Views within Government on Patenting: 

23 Views within Government on Patenting I look upon India as a country to the circumstances of which the laws of Patent are very inapplicable… … more of injustice, than of justice, would accrue if the millions of India … are to be taxed and harassed, for the imperfect chances of a further reward. – GG, Lord Auckland’s minute dated 3 February 1841 The cases in which patents would be most beneficially granted in India, would be where a Patent had not been obtained in England and could not, owing to climate, prior use, or other local circumstances, pretend to a Patent Right or even possess utility except in India . – Amos, Member, GG’s Council, 5 February 1841 Expedient only to allow of limited monopoly . – Amos, 15 February 1841. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

First Patent Law of India : 

24 First Patent Law of India The Act VI of 1856 on Protection of Inventions in India enacted on 28 February 1856 The inventor should not derive his exclusive privilege from a grant, but he should be entitled to it by law – Select (Drafting) Committee Based on the British Patent Law of 1852 Objectives: encouragement of inventions of new and useful manufacture . To secure the knowledge of the invention from being lost, and … to enable any person … to avail himself of the invention on expiry of the exclusive privilege Only actual inventors, and not importers, entitled to the exclusive privileges. 14 year period. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Repeal and Re-enactment: 

25 Repeal and Re-enactment The Act of 1856 was repealed by Act IX of 1857 since GG had not obtained previous sanction of the Crown. Act XV of 1859 No exclusive privilege to an invention which is of no utility Act XIII (Patterns and Designs Protection Act) 1872 Included designs within the scope. Act XVI of 1883 Novelty not lost if applied for patent within 6 months of disclosure. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

THE INVENTIONS & DESIGNS ACT 1888: 

26 THE INVENTIONS & DESIGNS ACT 1888 Act V of 1888 replaced Act XV of 1859 and its amendments Reasons Experience of 3 decades Patent applications: 33 applications under the 1856 Act and 3417 under the 1859 Act; of which 234 were from Indians No design application Changes in British law in1883 Changes Cheap and graduated fee to correspond with increasing value as the invention becomes popular Compulsory licences Provisions for protection of “New or Original Designs.” Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

THE INDIAN PATENTS & DESIGNS ACT , 1911: 

27 THE INDIAN PATENTS & DESIGNS ACT , 1911 Act II of 1911 Incorporated provisions of 1907 Act of United Kingdom Substituted the expression ‘exclusive privileges' with ‘patent’ Made duration of Indian patent independent of duration of UK patent Established Patent Office under a Controller of Patents and Designs. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Amending Acts: 

28 Amending Acts Amendment in 1920 to enable India to enter into reciprocal arrangements with UK and other dominions for ‘priority’ for the patent. Amendment in 1930 for grant of ‘secret patents’ for defence related inventions and also for incorporating provisions of British Patents and Designs Act, 1919. Amendment in 1945 to provide for filing of application based on provisional specifications. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Patents Enquiry Committee 1948-1950: 

29 Patents Enquiry Committee 1948-1950 A Committee under Dr Bakshi Tek Chand, a retired Judge of the High Court of Lahore was appointed on 1 October 1948 to review the Patent Laws in India, with a view to ensure that the Patent System is made more conducive to national interests than at present. Submitted its report on 30 April 1950 Observed: The Indian Patents System has failed in its main purpose, namely, to stimulate inventions among Indians and to encourage the development and exploitation of new inventions for industrial purposes in the country so as to secure the benefits thereof to the largest section of the public. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Main Recommendations: 

30 Main Recommendations ‘Invention’ to include processes No product patent for chemicals, food, medicine except when made by the invented process ‘Novelty’ to be based on prior knowledge or prior user in India ‘Inventive step’ to be an essential prerequisite ‘Usefulness’ to be judged on technical advancement also Pre-grant opposition not to be a detailed procedure. Patents Bill, 1953, based generally on UK statute of 1949 introduced in Parliament but allowed to lapse . Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Ayyangar Committee 1957-59: 

31 Ayyangar Committee 1957-59 Justice Rajagopala Ayyangar was appointed in April 1957 as one man Committee to advise on revision of law relating to Patents and Designs Submitted final report in September 1959 Observed : Foreigners held 80-90 % of the patents in India They acquired patents not for manufacturing but for protecting their imports India was deprived of goods at cheaper prices Recommended Process patent only for drugs, pharmaceuticals and chemicals Wide compulsory licence provisions Public health concerns given high consideration Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Towards Patents Law 1970: 

32 Towards Patents Law 1970 Based on the Ayyangar Committee recommendations, a Patents Bill introduced on 21 September 1965 Referred to a Joint Parliamentary Committee (JPC) on 25 November1965 Amended Bill introduced in November 1966 Lok Sabha passed, but lapsed in Rajya Sabha Revised Bill introduced in 1967 Passed in 1970. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

1970 Act: 

33 1970 Act No product patent for chemicals, food and medicine No patents for agriculture and horticulture products Compulsory licences Pre-grant opposition procedure Patents to be worked in India. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

On 1970 Act: 

34 On 1970 Act A well debated, development oriented and patriotically processed statute of 1970, with a progressive perspective and successful sequel, passed after a thorough study (based on the Justice Rajagopala Ayyangar Committee report) proved a tremendous national triumph for the consumer and the manufacturer alike… [It proved to be the] finest and most just parliamentary achievement… --Justice V. R Krishna Iyer Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Patent Applications in India 1970-2001: 

35 Patent Applications in India 1970-2001 Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Domestic and Foreign Patent Applications in India, 1970-1999 : 

36 Domestic and Foreign Patent Applications in India, 1970-1999 Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Developments after 1970: 

37 Developments after 1970 Liberalisation of economy – 1991 Joining the World Trade Organisation India became world supplier of generics. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

TRIPS Agreement: 

38 TRIPS Agreement Agreement on Trade Related Aspects of Intellectual Property Rights 1994 Both process and product patent for all inventions including micro-organisms No discrimination as to place of invention, the field of technology and whether products are imported or locally produced Term of patent protection – 20 years Transitory provisions for developing countries. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Change in Domestic Perceptions: 

39 Change in Domestic Perceptions Apex industry organisations advocating greater patent protection CII and ASSOCHAM before Gujral Committee FICCI setting up IIIPD: slogan “Patent or Perish” Many pharma Cos. Like Dr Reddy’s lab and Ranbaxy favoured liberal patent policy R&D organisations like CSIR sensed benefits from patenting Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Three Amendments: 

40 Three Amendments First Amendment in 1999 Introduced transitional facility to receive and hold patent applications of pharmaceutical and agricultural chemical products (mail box) till 1 January 2005 and for grant of Exclusive Marketing Rights for 5 years or till grant of patent. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Second Amendment: 

41 Second Amendment Bill introduced on 20 December 1999 Referred to a JPC on 22 December 1999 JPC held 39 meetings Report submitted on 19 December 2001 Bill passed in 2002 Major changes 20 year patent period Reversal of burden of roof on the infringer Establishment of an Appellate Board Public interest safeguards and measures for protecting Traditional Knowledge. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Third Amendment: 

42 Third Amendment 2005 Based on Observations of JPC Widespread consultations through country wide interactive sessions with interest groups Extensive inter ministerial consultations Removed transitory provisions Introduced various flexibilities provided in the TRIPS Agreement including the Doha Round. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Patent Law - Salient Features: 

43 Patent Law - Salient Features Both product and process patent provided. Term of patent – 20 years. Examination on request. Both pre-grant and post-grant opposition. Fast track mechanism for disposal of appeals. Provision for protection of bio-diversity and traditional knowledge. Publication of applications after 18 months with facility for early publication. Substantially reduced time-lines. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Safeguards in the Patent Law : 

44 Safeguards in the Patent Law Compulsory licences to ensure availability of drugs at reasonable prices Bolar Provision for early manufacture of generics Parallel, import to check prices. Provision to deal with public health emergency. Revocation of patent in public interest and also on security considerations. Provisions to prevent grant of patents based on frivolous or trivial inventions. Provisions to prevent misappropriation of Genetic Resources and Traditional Knowledge. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Patent Protection: Policy Trends: 

45 Patent Protection: Policy Trends Become part of the Global Patent Regime Meet International Obligations. Safeguard the Rights of Patent Holders as also Protect Public Interest. Modernise the Patent Administration. Create Awareness regarding Patents. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

India: Global Player: 

46 India: Global Player India acceded to the Paris Convention on Industrial Property on 7 December 1998. India acceded to Patent Cooperation Treaty also on same date. Plays active role in World Trade Organisation and World Intellectual Property Organisation Doha Round and Public Health Concerns Development Agenda in WIPO Mandatory Disclosure of Source in Patent applications. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Modernization of Patent Administration: 

47 Modernization of Patent Administration Four state-of-the-art integrated IP Office buildings constructed. Rs. 153 crore project implemented. Number of Patent Examiners increased four-fold Patent search facilities improved. IT enabled efficient systems established. E-filing facility for patent applications launched on 18 July 2007. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

…Contd.: 

48 …Contd. Foundation Stone for a National Institute of Intellectual Property Management laid in Nagpur on 20 August, 2007. Indian Patent Office recognized as an International Searching Authority (ISA) and an International Preliminary Examining Authority (IPEA) under the Patent Cooperation Treaty by the World Intellectual Property Organization in early October 2007. 45,000 patent documents uploaded on Patent Office website, viz. http://ipindia.nic.in in November 2007. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Impact: 

49 Impact Time lines for patent and trademark processing reduced. Possible to obtain a patent in 8 months as against 6-8 years earlier and a trade mark in 10-12 months as against 8-10 years earlier. Backlog of over 44,000 patent applications liquidated in the last three years. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Patent Applications 1999-2007: 

50 Patent Applications 1999-2007 Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Slide 51: 

Patent Grants Friday, October 28, 2011 51 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Patent applications 1997-98 – 2006-07: 

52 Patent applications 1997-98 – 2006-07 Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

International Cooperation for Improving Patent Administration: 

53 International Cooperation for Improving Patent Administration Cooperation with WIPO. EU –India Technology and Investment Development Programme. Bilateral Agreements signed with UK Patent Office France European Patent Office USPTO Japan Patent Office Switzerland Germany. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Main Elements of Co-operation: 

54 Main Elements of Co-operation Human Resource Development. Public awareness programmes. Development of IP- profession. Joint studies and research. Exchange of experience in the area of protection of traditional knowledge. Capacity building. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Slide 55: 

55 Way Forward Expansion of modern infrastructure. Four fold increase in human resources. Setting up of comprehensive training, education, research facility. Massive public sensitisation programme. Procurement of additional databases. Digitisation of all records. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Future Milestones: 

56 Future Milestones Commencement of International Searching Authority (ISA) and an International Preliminary Examining Authority (IPEA) functions. Setting up of the National Institute of Intellectual Property Management – training, education, research and IP think tank functions. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Next Phase of Modernisation: 

57 Next Phase of Modernisation Objective: An Efficient, Transparent and User Friendly Patent Office Strategy: Well qualified and trained staff Detailed Patent Manual Easily Accessible Patent database On line processing of all patent applications Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

What is an Invention?: 

What is an Invention? Sec.2(1)(J) “Invention” means a new product or process involving an inventive step and capable of industrial application Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com, 58

Patentable subject matter: 

Patentable subject matter Invention must relates to a Process or Product or both be new (Novel) involves an inventive step be Capable of industrial application not fall under Section 3 and 4 Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com, 59

“NEW” MEANS: 

“NEW” MEANS Invention must not be Published in India or elsewhere In prior public knowledge or prior public use with in India Claimed before in any specification in India Friday, October 28, 2011 60 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Inventive step: 

Inventive step A feature of an invention that involves technical advance as compared to the existing knowledge or have economic significance or both and makes the invention not obvious to a person skilled in the art Friday, October 28, 2011 61 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Industrial application means: 

Industrial application means Invention is capable of being made or used in any kind of industry Friday, October 28, 2011 62 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Section 3 exclusions: 

Section 3 exclusions Section 3(a) Frivolous inventions Inventions contrary to well established natural laws Friday, October 28, 2011 63 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Section 3 exclusions: 

Section 3 exclusions Section 3(b) Commercial exploitation or primary use of inventions, which is Contrary to public order or Morality Examples Gambling machine, Device for house-breaking , Friday, October 28, 2011 64 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Section 3 exclusions: 

Section 3 exclusions Section 3(b) Commercial exploitation or primary use of inventions , which Causes serious Prejudice to health or human, animal, plant life or to the environment Examples Biological warfare material or device, weapons of mass destruction Terminator gene technology, Embryonic stem cell Friday, October 28, 2011 65 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Checks and Balances : 

Checks and Balances Section 3(b) Excludes patents on GMOs – exploitation of which could be contrary public order or morality or prejudicial to human, animal or plant life or health or to the environment Effect : Only genetically modified micro-organisms (GMOs) which do not fall under section 3 (b) are patentable . Friday, October 28, 2011 66 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Section 3 exclusions: 

Section 3 exclusions Section 3 ( c ) Mere Discovery of a Scientific Principle or formulation of an Abstract Theory or discovery of any living thing or discovery of non–living substance occurring in nature Examples Newton’s Laws Superconducting Phenomenon as such Property of certain material to withstand mechanical shock Discovery of micro-organism Discovery of natural gas or a mineral Friday, October 28, 2011 67 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Checks and Balances : 

Checks and Balances Section 3(c) Excludes patents on Naturally occurring Micro-organisms Effect Genetically modified microorganisms (GMOs) are however, patentable. Friday, October 28, 2011 68 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Section 3 exclusions: 

Section 3 exclusions Section3 (d) The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance Friday, October 28, 2011 69 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Section 3 exclusions: 

Section 3 exclusions Section3 (d) Explanation For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixture of isomers, complexes, combinations and other derivatives of known substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy . Examples Crystalline forms of known substance Friday, October 28, 2011 70 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Checks and Balances: 

Checks and Balances Section 3 (d) Explanation Effect Salts, esters, ethers, polymorphs, metabolite, pure forms, particle size, isomers, complexes, combinations and derivatives of a known substance with enhanced efficacy are patentable Friday, October 28, 2011 71 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Section 3 exclusions: 

Section 3 exclusions Section3 (d) Mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus, unless such known process results in a new product or employs at least one new reactant . Examples New use of Aspirin for heart ailments, Mere new uses of Neem Friday, October 28, 2011 72 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Section 3 exclusions: 

Section 3 exclusions Section 3(e) Substance obtained by mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Examples Combiflam [Paracetamol (Antipyretic) + Brufen (analgesic)] Solution of sugar and color additives in water to form a soft drink However, A mixture resulting into synergistic properties of mixture of ingredients however, may be patentable - Soap, Detergents, lubricants etc Friday, October 28, 2011 73 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Checks and Balances: 

Checks and Balances Section 3 ( e ) Effect Substance obtained by mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance are not patentable However Synergistic formulations are patentable Friday, October 28, 2011 74 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Section 3 exclusions: 

Section 3 exclusions Section 3 ( f ) Mere arrangement or re-arrangement or duplication of known devices, each functioning independently of one another in a known way Examples A Bucket fitted with torch, An Umbrella with fan A Clock and radio in a single cabinet A flour-mill provided with sieving Friday, October 28, 2011 75 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Slide 76: 

Section 3(h) Method of Agriculture or Horticulture Examples Cultivation of algae , Producing new form of a known plant, Preparation of an improved soil However, Agricultural Equipments are patentable Section 3 exclusions Friday, October 28, 2011 76 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Slide 77: 

Section 3(i) Any process for medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Examples Removal of cancer tumor Removal of dental plaque and carries Surgical processes Processes relating to therapy Method of vaccination, Blood transfusion Section 3 exclusions However , Treatment performed on tissues or fluids permanently removed from the body Surgical,therapeutic or diagnostic Apparatus or instruments are patentable Friday, October 28, 2011 77 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Section3 exclusions : 

Section3 exclusions Section 3(j) Plants & animals in whole or any part thereof other than micro- organisms, but including seeds, varieties an d species and essentially biological process for production or propagation of plants & animals Friday, October 28, 2011 78 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Section 3 exclusions: 

Section 3 exclusions Section 3(j) Plants & animals in whole Parts of plants & animals Seeds Varieties & species Essentially biological processes for propagation or production of the animals & plants Friday, October 28, 2011 79 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Checks and Balances : 

Checks and Balances Section 3(j) Excludes patents on Plants and animals in whole or any parts thereof, …… including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals Examples Clones and new varieties of plants A process for production of plants or animals if it consists entirely of natural phenomena such as crossing or selection Essentially biological Process Friday, October 28, 2011 80 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

: 

Section 3(k) mathematical method or business method or algorithms or computer programme per se Examples Computer program by itself or as a record on a carrier However New calculating machine combination of hardware and software is patentable Section 3 exclusions Friday, October 28, 2011 81 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

: 

Section 3(l) A literary,dramatic, musical or artistic work or any other aesthetic creation including cinematographic work and television productions These subject-matters fall under the copyright protection Section 3 exclusions Friday, October 28, 2011 82 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

: 

Section 3(m) A mere scheme or rule or method of performing mental act or method of playing game Examples Scheme for learning a language Method for solving a crossword puzzle, Method of learning a language Method of teaching /learning However, Novel apparatus for playing game or carrying out a scheme is patentable Section 3 exclusions Friday, October 28, 2011 83 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Slide 84: 

Section 3 (n) Presentation of information Examples Any manner or method of expressing information whether by spoken words Visual display symbols diagrams Information recorded on a carrier Section 3 exclusions Friday, October 28, 2011 84 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Slide 85: 

Section 3 (o) Topography of integrated circuits . Examples Mask works - circuits layout Section 3 exclusions Friday, October 28, 2011 85 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Slide 86: 

Section 3 (p) Inventions which are Traditional Knowledge or an aggregation or duplication of known properties of traditionally known component or components Examples Traditional Knowledge already in public domain - Wound healing property of Haldi However, Any value-addition using Traditional Knowledge leading to a new process or product ,which is novel with inventive step and industrial applicability , Extraction of Azadirachtin from Neem can be patented Section 3 exclusions Friday, October 28, 2011 86 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Slide 87: 

Section 4 Inventions falling within Section 20(1) of the Atomic Energy Act, 1962 are not patentable Effect Inventions relating to compounds of Uranium, Beryllium, Thorium, Plutonium, Radium, Graphite, Lithium and more as notified by Central Govt. from time to time . Non Patentable inventions Friday, October 28, 2011 87 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Stages from filing to grant of a patent : 

Stages from filing to grant of a patent Friday, October 28, 2011 88 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Obtaining a patent: 

Obtaining a patent File an application for patent With one of the patent offices based on territorial jurisdiction of the place of office or residence of the applicant /agent Pay the required fee Information concerning application form and details of fee available at www.ipindia.nic.in Guidelines for applicants also available on this website Friday, October 28, 2011 89 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Formality Check: 

Formality Check An Examiner checks the formal requirements before accepting the application and the fee – this is done immediately Issue of application number and the cash receipt – this is done the same day In case of receipt of application by post, cash receipt, application number is sent by post within 2-3 days Friday, October 28, 2011 90 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Publication: 

Publication Application is kept secret for a period of 18 months from the date of filing In 19 th month, the application is published in the official journal – this journal is made available on the website weekly Applicant has an option to get his application published before 18 months also In that case, application is published within one month of the request Friday, October 28, 2011 91 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Request for Examination: 

Request for Examination Application is examined on request Request for examination can be made either by the applicant or by a third party A period of 48 months, from the date of filing, is available for making request for examination Friday, October 28, 2011 92 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Examination: 

Examination Application is sent to an Examiner within 1 month from the date of request for examination Examiner undertakes examination w.r.t. whether the claimed invention is not prohibited for grant of patent whether the invention meets the criteria of patentability Friday, October 28, 2011 93 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Issue of FER: 

Issue of FER A period of 1 to 3 months is available to Examiner to submit the report to the Controller 1 month’s time available to Controller to vet the Examiner’s report First Examination Report (FER) containing gist of the objections is issued within 6 months from the date of filing of request Friday, October 28, 2011 94 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Response from the Applicant: 

Response from the Applicant 12 months’ time, from the date of issue of FER, is available to the applicant to meet the objections If objections are met, grant of patent is approved by the Controller – within a period of 1 month Friday, October 28, 2011 95 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Pre-grant Opposition: 

Pre-grant Opposition After publication, an opposition can be filed within a period of 6 months Opportunity of hearing the opponent is also available Friday, October 28, 2011 96 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Examination of Pre-grant Opposition: 

Examination of Pre-grant Opposition Opposition (documents) is sent to the applicant A period of 3 months is allowed for receipt of response Friday, October 28, 2011 97 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Consideration of Pre-grant Opposition: 

Consideration of Pre-grant Opposition After examining the opposition and the submissions made during the hearing, Controller may Either reject the opposition and grant the patent Or accept the opposition and modify/reject the patent application This is to be done within a period of 1 month from the date of completion of opposition proceedings Friday, October 28, 2011 98 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Grant of a Patent: 

Grant of a Patent A certificate of patent is issued within 7 days Grant of patent is published in the official journal Friday, October 28, 2011 99 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

STAGES - FILING TO GRANT OF PATENT: 

STAGES - FILING TO GRANT OF PATENT PUBLICATION OF APPLICATION REQUEST FOR EXAMINATION GRANT OF PATENT 3rd Party Representation Revocation/Amendment OPPOSITION PROMPTLY AFTER 18 MONTHS FROM P.D. WITHIN 48 MONTHS FROM F.D . ALL OBJECTIONS TO BE COMPLIED WITHIN 12 MONTHS IF P.S.IS FILED C.S. TO BE FILED WITHIN 12MONTHS WITHIN 12 MONTHS FILING OF APPLICATION PROVNL. / COMPLETE Decision of Controller EXAMINATION-ISSUE OF FER Appeal Appellate Board Friday, October 28, 2011 100 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Renewal Fee: 

Renewal Fee To be paid within 3+6 months from date of recording in the register [sec 142 (4) ] No fee for 1 st and 2 nd year Renewal fee, on yearly basis, is required to be paid for 3 rd to 20 th for keeping the patent in force Delay upto six months from due date permissible on payment of fee for extension of time Patent lapses if renewal fee is not paid within the prescribed period Friday, October 28, 2011 101 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Conclusion: 

102 Conclusion Pre-Independent policy dictated more by developments in Britain. Now policy formulation is a consultative process involving all stake holders and the civil society – Demand driven. Protection of national interest is the primary concern of Patent Policy. Local needs shape the course of choosing policy options- both domestic and international. Patent Policy dependent on overall economic policy. The policy has been one of balancing developmental concerns ( Compulsory licensing for social interest)with the need for promoting innovations. Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Do you have any question?: 

Do you have any question? Friday, October 28, 2011 103 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com,

Slide 104: 

Friday, October 28, 2011 Dr. Tabrez Ahmad, Blog: http://iplexindia.blogspot.com, 104 Thanks