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Dr. Ravi Dhar & Nikhil Dhar on Intellectual Property. Part I- Understanding Patents in Detail


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Detailed Description about what are Patents, How to Write them, Components of Patenting etc., how Patent offices function, how to do Prior Art Search and FTOs etc

Detailed Description about what are Patents, How to Write them, Components of Patenting etc., how Patent offices function, how to do Prior Art Search and FTOs etc

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  • 1. Dr. Ravi Dhar & Nikhil Dhar on Intellectual Property Part-I: Patents ( ( April 19, 2014 RD_ND_Patents_2014 1
  • 2. ACKNOWLEDGEMENTS DBT/ BIRAC/ NII/ US Embassy/ IPO/ USPTO/ EPO/ WIPO/ JPO/ Boston University,USA/ NIH, USA/ MIHR, UK/ Various websites & Journals/ Skyquestt Consulting Pvt. Limited, India/Colleagues & (Indian Patent Act: 99.html) April 19, 2014 RD_ND_Patents_2014 2
  • 3. Intellectual Property • Patents • Trademarks • Copyrights • Protection of Plant Varieties • Geographical Indicators April 19, 2014 RD_ND_Patents_2014 3
  • 4. Sections • Definition? • Specifics of a Patent • Components of writing a Patent • What is Novelty? • What is Non-obviousness? • What is Utility? • What is Obviousness? • What are Claims April 19, 2014 RD_ND_Patents_2014 4
  • 5.  Terms PCT National Phase April 19, 2014 RD_ND_Patents_2014 5
  • 6. Patents (General) April 19, 2014 RD_ND_Patents_2014 6
  • 7. What is a Patent? Legal protection on an act of Intellect (i.e., inventions like drugs, vaccines, bio-markers, medical devices, an industrial designs etc.) that confers the creator of an invention the sole right to make, use and sell invention for a set period of time” Thus it restricts any other person to repeat the effort unnecessarily. Innovations may be tangible or intangible April 19, 2014 RD_ND_Patents_2014 7
  • 8. April 19, 2014 RD_ND_Patents_2014 8
  • 9. Legal Protection of Inventions & Business!! Scientific Investigations Innovations (Legal protection=Patent) Product Industry/ Business Service to people Royalties Pump back some money for investigations April 19, 2014 RD_ND_Patents_2014 9 Reward
  • 10. Famous Quotes about Innovations  “No one asks you to throw Mozart out of the window. Keep Mozart. Cherish him. Keep Moses too, and Buddha and Lao Tzu and Christ. Keep them in your heart. But make room for the others, the coming ones, the ones who are already scratching on the window-panes” - Henry Miller (1891-1980) American author.  "I never perfected an invention that I did not think about in terms of the service it might give others... I find out what the world needs, then I proceed to invent." - Thomas Edison  "We were young, but we had good advice and good ideas and lots of enthusiasm" - Bill Gates, founder of Microsoft Corporation  "Our success has really been based on partnerships from the very beginning.“ - Bill Gates (Accomodation + Need + Enthusiasm + Partnerships) April 19, 2014 RD_ND_Patents_2014 10
  • 11. Characteristics of a Patent Novelty : Something new & non-existent in prior art (previously existing knowledge) Non-obvious/ Inventive Step : An idea is non-obvious if it would not be discovered by one of ``ordinary skill in the art'' when the idea was needed Utility : Usefulness of an invention April 19, 2014 RD_ND_Patents_2014 11
  • 12. Story of Axel Patent Revenue generated US $ 700 million April 19, 2014 RD_ND_Patents_2014 12
  • 13. Functional Definition “A grant made by government that confers the creator of an invention the sole right to make, use and sell invention for a set period of time” Thus it restricts any other person to repeat the effort unnecessarily. Innovations may be tangible or intangible April 19, 2014 RD_ND_Patents_2014 13
  • 14. “Patent protection does not result in owning the invention by the inventor but protects, others from repeating the effort which has already been made” “ Patent System Adds fuel to interest to the fire of the genius” - Abraham Lincoln April 19, 2014 RD_ND_Patents_2014 14
  • 15. Patents April 19, 2014 RD_ND_Patents_2014 15  Patents are exclusive property rights for intangible creations of the human mind  Patents exist only in laws of sovereign states  Patents can be enforced only to the extend that application has been made  Patents are granted covering the territory of an individual state  Patent rights are limited in duration
  • 16. April 19, 2014 RD_ND_Patents_2014 16 This could be boring; no variety
  • 17. Patent : An Open Letter Document  Derived from Latin litterae patentes  An official document by which certain privileges, rights, ranks or titles were conferred or publicly announced  They carried the seal of sovereign grantor on the inside, rather than being closed by a seal on the exterior  The openness was in no way connected with disclosure of an Invention – this happened much later in 1331 onwards for skilled artisans from abroad. April 19, 2014 RD_ND_Patents_2014 17
  • 18. April 19, 2014 RD_ND_Patents_2014 18
  • 19. Why Patent ?  Avoid Repetitions  Monetary Compulsion  To Inflate Ego  Protect interest of country April 19, 2014 RD_ND_Patents_2014 19
  • 20. Reasons for Patenting (contd.)  Opportunity to license or sell the invention  Strong market position  Increase in negotiating power  Exclusive rights  Higher returns on investments  Positive image for your enterprise April 19, 2014 RD_ND_Patents_2014 20
  • 21. Types of Patents Invention any new technical solution relating to a product, a process or improvement thereof. Utility Model any new technical solution relating to the shape, the structure, or their combination, of a product, which is fit for practical use. Design any new design of the shape, the pattern or their combination, or the combination of the color with shape or pattern, of a product, which creates an aesthetic feeling and is fit for industrial application. April 19, 2014 RD_ND_Patents_2014 21
  • 22. •Provisional Patent Application •Non-provisional (Utility) Patent Application Design Patent Application •Plant Patent Application •International Application April 19, 2014 RD_ND_Patents_2014 22
  • 23. Characteristics of Patents Novelty Inventive Step (=non-obviousness) Industrial Application (=utility) A patent has a life of 20 years It has to be renewed periodically by payment of money April 19, 2014 RD_ND_Patents_2014 23
  • 24. Characteristics of Patents (expand) (Hypothetical) Novelty : A Flying Car/ A Spray Formulation of Anti-biotic Inventive Step : No visible blades used for flying/ Absorption of Antibiotic against rotavirus through skin Utility : For rapid movement in cities/ Curing Flu April 19, 2014 RD_ND_Patents_2014 24
  • 25. April 19, 2014 RD_ND_Patents_2014 25
  • 26. Patent Related Terminology  Novelty  Prior Art  Non-Obviousness (inventive step)  Utility  Claims & Disclosure  Search  Fee & Annuity  Examination Report  Gazette  Patent document (Important: go through April 19, 2014 RD_ND_Patents_2014 26
  • 27. Patent Drafting • India April 19, 2014 RD_ND_Patents_2014 27
  • 28. Components in Drafting a Patent  Field of Invention  Background of Invention  Object of Invention/ (Problem-Solution Approach)  Summary of Invention  Detailed Description  Description of Drawings  Experimental Procedures  Results  Claims  Abstract (RD/NII/2008) April 19, 2014 RD_ND_Patents_2014 28
  • 29. Expansion of the components  Field of Invention = Title  Background of Invention** = Why, how, what is known  Object of Invention = e.g., To develop a efficient pain killer  Summary of Invention = Summary  Detailed Description = Expand  Description of Drawings = On separate sheets  Experimental Procedures = Detailed one  Results = As you discuss in a publication; mention utility  Claims = Leave this for Attorney  Abstract = Brief Summary (**Object of Invention as in Indian patents = Disclosure as in USA) (RD/NII/2008) April 19, 2014 RD_ND_Patents_2014 29
  • 30. Patents (contd.) Novelty : Something new & non-existent in prior art (previously existing knowledge) Non-obvious/ Inventive Step : An idea is non-obvious if it would not be discovered by one of ``ordinary skill in the art'' when the idea was needed Utility : Usefulness of an invention April 19, 2014 RD_ND_Patents_2014 30
  • 31. Definitions: Novelty : matter described in application has not been published or discussed before in India or abroad Inventive Step: the invention is not obvious to a person skilled in Art in the light of prior publication/knowledge/ document Utility/ Industrial Application: it should be used in industry April 19, 2014 RD_ND_Patents_2014 31
  • 32. April 19, 2014 RD_ND_Patents_2014 32
  • 33. PRIOR ART April 19, 2014 RD_ND_Patents_2014 33
  • 34. What can be Prior Art?  Any Publication related to invention  Any material available to public  Oral Disclosure  Hence Filing date of Patent/ Invention is essential  Enablement: A document must enable an average skilled person to practice the invention claimed April 19, 2014 RD_ND_Patents_2014 34
  • 35. Prior Art Issues (Take Precautions!!!)  Do not discuss your scientific findings having a technology component/ invention in a public meeting, in a pharmaceutical company meet, in press or other electronic media  In-house presentations within the scientific organization/ NII/THSTI/RCB or places which gives funding e.g., DBT is o.k.  Technology part should be discussed in a non-disclosure manner/format April 19, 2014 RD_ND_Patents_2014 35
  • 36. Prior Art Issues  Breadth of Claims  Nature of Invention  State of Prior Art  Level of Skill in Art  Level of Predictability  Amount of Direction/Guidance in Specification  Presence/Absence of Working examples  Quantity of Experimentation Needed or Expected April 19, 2014 RD_ND_Patents_2014 36
  • 37. Prior Art April 19, 2014 RD_ND_Patents_2014 37
  • 38. Why search Patent information?  Avoid duplication of R&D work  Identify specific new ideas and technical solutions, products or processes  Identify the state-of-the-art in a specific technological field in order to be aware of the latest development  Assess and evaluate specific technology and to identify possible licensors  Identify alternative technology and its sources  Locate of sources of know-how in a specific field of technology or in a given country  Improvement of an existing product or process  Development of new technical solutions, products or processes  Identify existing or prospective industrial property rights (validity, ownership, ...), particularly to avoid infringement actions  Assess novelty and patentability of own developments with a view of applying for a domestic or foreign industrial property right  Monitor activities of competitors both within the country and abroad  Identify a market niche or to discover new trends in technology or product development at an early stage. April 19, 2014 RD_ND_Patents_2014 38
  • 39. DIFFERENT TYPES OF PATENT SEARCHES April 19, 2014 39RD_ND_Patents_2014
  • 40. 1. What is the patent search? 2. Kinds of patent search 3. Exercises 4. Key Concepts in searching • What do we search • The process of patent search 5. Creating & Refining Search Queries 6. Databases to retrieve the Technology Information • Patent database • Non-Patent Databases 7. How to use patent databases 8. Exercise April 19, 2014 40RD_ND_Patents_2014
  • 41. What is Patent Search  To retrieve information to answer specific questions  To search and analyze relevant patents in product development step or  Prior to patent application process to make sure the patentability of invention To get current technology information and future trend of specific technology area April 19, 2014 41RD_ND_Patents_2014
  • 42. Kinds of Patent Search Patentability Search Freedom-To- Operate Search Validity/Invalidity search State-of-the Art search April 19, 2014 42RD_ND_Patents_2014
  • 43. • Is a given invention (claimed in a patent application) patentable? Patentability Search • Do patent rights exist on which a given product risks infringing? Freedom-To-Operate Search • Is a given patent valid? Validity/Invalidity Search • Which technologies exist in a given field of technology? • Who is active in a given field of technology? State-of-the Art Search April 19, 2014 43RD_ND_Patents_2014
  • 44. Patentability Search/Novelty Search 1. Done to identify patents and non-patent literature 2. Recommended to be done before writing and filing the patent specification, and therefore, 3. Sometimes called a pre-application search April 19, 2014 44RD_ND_Patents_2014
  • 45. A clearance search which concentrates on uncovering enforceable patents that may act as “roadblocks” to commercialization of a product or service Uses Guide product design decisions. Identify patents that may need to be licensed Freedom-To-Operate Search (FTO) April 19, 2014 45RD_ND_Patents_2014
  • 46. Validity/Invalidity Search 1. Search is done to invalid some claims of a particular patent 2. The search can provide some prior art references that disclose claims that are infringed by the subject disclosure 1. Determine the enforceability of patents owned by you 2. Prepare an opposition/invalidity procedure against others’ patents 3. Prepare a defence against lawsuits claiming infringement of others’ patents April 19, 2014 46RD_ND_Patents_2014
  • 47. State-of-the-Art Search 1. Search is executed in order to determine existing solutions and potential competitors within a given technological field 2. The search includes not only patent documents but also non patent literature 1. Plan R&D activities more efficiently 2. Decide whether to enter a market 3. Determine which areas are not sufficiently covered by existing players April 19, 2014 47RD_ND_Patents_2014
  • 48. Concepts in Searching What we search Any Relevant Information In any type and part of document From any place From any time period Technology Information Patent Scientific and Technical information April 19, 2014 48RD_ND_Patents_2014
  • 49.  Scholarly publications: • Handbooks, textbooks, encyclopaedias, journals, dissertations, conference proceedings, technical reports  Industry/trade publications: • Industry reviews, disclosure publications  Newspapers  Websites •Technology blogs, researchers’ websites Scientific and technical information April 19, 2014 49RD_ND_Patents_2014
  • 50. Process of Patent Search Purpose of search Scope of search Data Extraction Selection of keywords Preparation of search queries Searching and Reviewing April 19, 2014 50RD_ND_Patents_2014
  • 51. Constructing a keyword search What is known about the invention?  Problems to be solved  Solution proposed for this problem • Features of the solution • Functions of the solution April 19, 2014 51RD_ND_Patents_2014
  • 52. Creating and Refining Search Queries 1. Truncation or Wildcard operators These type of operators stand for an unspecified number of characters in a queries Wildcard Meaning Use in Patent collections Example ? (Question Mark) Represent to exactly one character Left, right, and internal use supported “t?re” will pick up “tyre” and “tire”) * (Asterisk) Represent to unlimited number of characters Left and/or right, internal “File*” will pick up file or files etc. April 19, 2014 52RD_ND_Patents_2014
  • 53. 2. Proximity operators Proximity operators search: • Based on the distance by number of terms separating two keywords, and • Also find words in the same paragraph Operators Meaning Example SAME Terms must be in the same paragraph, in any order ADJ Terms should be next to each other and in order specified NEAR Terms should be next to each other and in any order April 19, 2014 53RD_ND_Patents_2014
  • 54. 3. Boolean Operators Major Boolean operators are AND, NOT, and OR which can be used in all collections Operators Meaning Example AND Two term must exist OR Any one term or two terms must exist NOT A term following “NOT” must be excluded April 19, 2014 54RD_ND_Patents_2014
  • 55. Databases to retrieve the Technology information Free Patent databases US Patent and TradeMark Office (USPTO) URL: Espacenet URL: WIPO (World Intellectual Property Organization) URL: Patent Lens URL: Freepatents online URL: April 19, 2014 55RD_ND_Patents_2014
  • 56. April 19, 2014 56RD_ND_Patents_2014
  • 57. April 19, 2014 57RD_ND_Patents_2014
  • 58. April 19, 2014 58RD_ND_Patents_2014
  • 59. April 19, 2014 59RD_ND_Patents_2014
  • 60. April 19, 2014 60RD_ND_Patents_2014
  • 61. April 19, 2014 61RD_ND_Patents_2014
  • 62. April 19, 2014 62RD_ND_Patents_2014
  • 63. April 19, 2014 63RD_ND_Patents_2014
  • 64. April 19, 2014 64RD_ND_Patents_2014
  • 65. April 19, 2014 65RD_ND_Patents_2014
  • 66. April 19, 2014 66RD_ND_Patents_2014
  • 67. April 19, 2014 67RD_ND_Patents_2014
  • 68. April 19, 2014 68RD_ND_Patents_2014
  • 69. April 19, 2014 69RD_ND_Patents_2014
  • 70. For Chemical structure searches • PubChem • ChemSpider For Sequence search • Patent Lens • PubMed April 19, 2014 70RD_ND_Patents_2014
  • 71. April 19, 2014 71RD_ND_Patents_2014
  • 72. April 19, 2014 72RD_ND_Patents_2014
  • 73. April 19, 2014 73RD_ND_Patents_2014
  • 74. April 19, 2014 74RD_ND_Patents_2014
  • 75. Paid Patent Databases • Thomson Innovation URL: • Questel Orbit URL: • STN URL: April 19, 2014 75RD_ND_Patents_2014
  • 76. April 19, 2014 76RD_ND_Patents_2014
  • 77. April 19, 2014 77RD_ND_Patents_2014
  • 78. April 19, 2014 78RD_ND_Patents_2014
  • 79. Non-Patent Databases Google scholar Scirus DeLCON April 19, 2014 79RD_ND_Patents_2014
  • 80. Obviousness April 19, 2014 RD_ND_Patents_2014 80
  • 81. Obviousness • Obviousness, means that “a person having ordinary skill in the art” would not know how to solve the problem at which the invention is directed by using exactly the same mechanism. • The obviousness standard prevents the patenting of relatively insignificant differences between the invention and the prior art • The invention must provide one or more new and unexpected (surprising) results April 19, 2014 81RD_ND_Patents_2014
  • 82. Obviousness (contd) • Prior art can be combined in an obviousness determination, that is, more than one reference can be cited by the examiner as showing different features of the invention which, taken together, render the invention obvious • Obviousness is inherently a subjective determination, as the examiner cannot be, or know the mind of, the hypothetical “one skilled in the art.” April 19, 2014 82RD_ND_Patents_2014
  • 83. Non-obvious to Whom? • A patent will NOT be issued if a person having ordinary skill in the field of the invention would consider the invention obvious at the time of creation • The law considers a person having ordinary skill in the art to be a worker in the field of the invention who: – Has ordinary skill – Is totally knowledgeable about all the prior art in his or her field • Pure Fantasy, but no other realistic way to determine non- obviousness – The PTO creates a hypothetical person and tries to weigh the obviousness of the invention against the knowledge this hypothetical person would possess April 19, 2014 83RD_ND_Patents_2014
  • 84. Examples of Obviousness** • Non-obvious: Slight Physical Changes – Dramatic Result – Sometimes, a very slight change in chemical entity, or shape, slope, size, material can produce a patentable invention that operates entirely differently and produces totally unexpected results (e.g., hCG + M.w as anti-cancer vaccine??) • Non-obvious: New Use Inventions – Do not involve any physical change to old invention – Must be different use of known product or process and produce new, unexpected results ( e.g., aspirin which is a pain killer now used as anti-diabetic??) • Obvious: Different Element, Similar Function – Courts have held that substituting a different, but similarly functioning, element for one of the elements in a known combination creates a novel invention but an obvious one. April 19, 2014 84RD_ND_Patents_2014
  • 85. “If we posed the problem to 100 people skilled in the art, would all 100 have to come up with the solution that appears in the patent? Would 90 be enough? 50? 10? 1? More complex --- and quite germane (=related) to what I regard as a central problem of how patents are granted and enforced --- is the question of what happens if the 100 people come up with 10 or 100 different solutions, all or most of which are at least as good as the patented idea, and yet few, if any are exactly that idea”. How obvious is ``obvious''? April 19, 2014 RD_ND_Patents_2014 85
  • 86. Obviousness 35 U.S.C. § 103 (a) “A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which the said subject matter pertains” April 19, 2014 RD_ND_Patents_2014 86
  • 87. Obviousness Please see the following articles in Nature:- April 19, 2014 RD_ND_Patents_2014 87
  • 88. Non-obviousness : The Relevant Prior Art Two classes of Prior Art for Non-obviousness •Common general knowledge •Enhanced knowledge •Hidden or imputed knowledge •Prior application April 19, 2014 RD_ND_Patents_2014 88
  • 89. Issues on Obviousness [Nature September 2009 “Obvious to whom? Issue of non-coated tablet] April 19, 2014 RD_ND_Patents_2014 89 The approach consists in: identifying the closest prior art, the most relevant prior art; determining the objective technical problem, that is, determining, in the view of the closest prior art, the technical problem which the claimed invention addresses and successfully solves; and examining whether or not the claimed solution to the objective technical problem is obvious for the skilled person in view of the state of the art in general.
  • 90. CLAIMS April 19, 2014 RD_ND_Patents_2014 90
  • 91. Claims Claims are the parts of a patent which define the boundaries (2,3,4) of patent protection Patent claims are the legal basis for patent protection They form a protective boundary line around your patent that lets others know when they are infringing on your rights The limits of this line are defined by the words and phrasing of your claims 1 3 4 2 April 19, 2014 RD_ND_Patents_2014 91
  • 92. Claims April 19, 2014 RD_ND_Patents_2014 92 (*Pwil-2 Protein widely expressed in tumors) *
  • 93. Claims Scope of claim: Each claim should have only one meaning which can be either broad or narrow, but not both at the same time. In general a narrow claim specifies more details than a broader claim. Having many claims, where each one is a different scope allows you to have legal title to several aspects of your invention. April 19, 2014 RD_ND_Patents_2014 93
  • 94. Claims April 19, 2014 RD_ND_Patents_2014 94
  • 95. Characteristics of Claims Be Clear Your claim must be clear so that you do not cause the reader to speculate about the claim. If you find yourself using words such as "thin", "strong", "a major part", "such as", "when required", then you are probably not being clear enough. These words force the reader to make a subjective judgment, not an objective observation. Be Complete Each claim should be complete, so that it covers the inventive feature and enough elements around it to put the invention in the proper context. Be Supported The claims have to be supported by the description. This means that all the characteristics of your invention that form part of the claims must be fully explained in the description. In addition, any terms you use in the claims must be either found in the description or clearly inferred from the description. April 19, 2014 RD_ND_Patents_2014 95
  • 96. Structure of Claims (1) A claim is a single sentence composed of three parts:-  the introductory phrase  the body of the claim  and the link that joins the two The introductory phrase identifies the category of the invention and sometimes the purpose for example, a machine for waxing paper, or a drug composition. (2) The body of the claim is the specific legal description of the exact invention which is being protected. The linking consists of words and phrases such as: which comprises including consisting of consisting essentially of Note that the linking word or phrase describes how the body of the claim relates to the introductory phrase. The linking words are also important in assessing the scope of the claim as they can be restrictive or permissive in nature. Example, "A drug injecting device" is the introductory phrase, "comprising" is the linking word, and the rest of the claim is the body. April 19, 2014 RD_ND_Patents_2014 96
  • 97. Patent Search Exercises: Aids/ Tutorials • _bis_ge_03/wipo_ip_bis_ge_03_15-annex1.pdf • April 19, 2014 RD_ND_Patents_2014 97
  • 99. Patent Search/Prior Art Search April 19, 2014 RD_ND_Patents_2014 99
  • 100. Patent Search Strategy April 19, 2014 RD_ND_Patents_2014 100
  • 101. Free On-line Patent Databases April 19, 2014 RD_ND_Patents_2014 101
  • 102. Charged on-line databases April 19, 2014 RD_ND_Patents_2014 102
  • 103. General Search for Beginners April 19, 2014 RD_ND_Patents_2014 103
  • 104. Advanced Search April 19, 2014 RD_ND_Patents_2014 104
  • 105. Search Results April 19, 2014 RD_ND_Patents_2014 105
  • 106. Clustering April 19, 2014 RD_ND_Patents_2014 106
  • 107. Patent Families Each patent issuing authority/country may have different regulations for the same patent filed elsewhere A group of patent equivalents make up a patent family Members of closely related patent family have common priority number & date The online database will have a single record only ( patents/patentfamily.pdf) April 19, 2014 RD_ND_Patents_2014 107
  • 108. “Basic Patent” The first family member identified for abstracting & indexing into database It has no legal meaning The basic for one-database producer may not be basic for another producer April 19, 2014 RD_ND_Patents_2014 108
  • 109. Patent Family & Timeline US Application PRIORITY JP Application Patent Family GB Application GB Granted Patent US Application (Pre-grant) US Granted Patent JP Application GB Application 0 ??1812 Priority filing Additional filings Published applications Published granted patents RD/BIRAC/2012April 19, 2014 RD_ND_Patents_2014 109
  • 110. Patent Family- (contd.) Complexity arises due to:- a) Divisional applications: if results are too broad for the patent, and it is split into one or more to claim different inventions b) Continuation : results from second or subsequent application being filed while the original one is pending c) Continuation-in-part : a result of second or subsequent application being filed, which includes new material, while the original is pending April 19, 2014 RD_ND_Patents_2014 110
  • 111. Terminology Application A document consisting of the specification of the invention and an oath in which the inventor declares that he believes himself to be the original and first inventor of the subject matter in the application Claims Brief descriptions, in legal terms, of the subject matter which the applicant regards as his invention Continuation In the U.S., a later application claiming the same invention filed while the original application is pending. The original filing date is used for determination of prior art Continuation-in-part In the U.S., a second application for the same invention, usually to introduce improvements not covered in the original application. The original filing date is used for prior art April 19, 2014 RD_ND_Patents_2014 111
  • 112. Terminologies Defensive Publication Publication of the details of an invention in the Official Gazette or in the other publications to prevent others from obtaining a patent on the invention. Design patent A type of patent issued in the U.S. for inventive designs of a purely ornamental or aesthetic nature. Designated states In application filed at the European Patent Office or the World Intellectual Property Organization, the courtiers in which the invention will be protected. Division In the U.S., an additional application derived from an earlier application that claims two or more inventions, as determined by the patent examiner. The original date is used for determination of prior art. April 19, 2014 RD_ND_Patents_2014 112
  • 113. Terminologies (contd) Equivalents All the patent publication within a patent family relating to a specific invention. Granted patent A legal document giving an inventor the right to exclude others from making, using, or selling the invention according to the laws governing patents in a country. Kind codes Codes indicating the stage of the published patent document, e.g., unexamined application, examined application, granted patent. April 19, 2014 RD_ND_Patents_2014 113
  • 114. Terminologies (contd) Patent family What was previously known in a given area of technology that lead to the development of an invention. Priority application The application with the earliest date, when an inventor files for a patent in more than one country. Reassignment The assignee transfers ownership of patent right to another party. Reissued patent In the U.S., the result of an application by the patent owner to make corrections in the specifications or claims of the patent. A new patent number is assigned, but the original expiration date is maintained. April 19, 2014 RD_ND_Patents_2014 114
  • 115. Terminologies(contd) Unexamined application In some countries, the first publication level for a patent document in which application has not undergone full examination for novelty and non-obviousness. Utility model In Japan and Germany legal protection for minor inventions that do not necessarily meet the novelty or non-obviousness criteria of regular patents. April 19, 2014 RD_ND_Patents_2014 115
  • 116. Patent Specifications They are dynamic documents and often modified to meet requirements of each jurisdiction (=country or area) This could disentitle an inventor his/her specific contribution e.g., method of medical treatment claims is valid in the USA but not in India or Europe or New Zealand April 19, 2014 RD_ND_Patents_2014 116
  • 117. April 19, 2014 RD_ND_Patents_2014 117 Patent Rules
  • 118. Patent Reforms Act – 2007 (U.S.A.) On April 18, 2007, bipartisan legislators in both the Senate and House of Representatives introduced sweeping patent reform measures in legislation termed the Patent Reform Act of 2007. The reform measures include modifying some of the following provisions:  First-to-file rights and elimination of interference proceedings;  Reform to make it easier to file a patent application without the inventor's cooperation;  Limitation of damages to only the economic value of the improvement as compared to the prior-art;  Specific limitations on when damages may be trebled for willfulness;  Post-grant opposition proceedings with a reduction in the litigation estoppel (A bar preventing one from making allegations or a denial that contradicts what one has previously stated as truth) effect;  Limitations on patent venue;  Authority to the PTO director to create further regulations.  Although couched in terms of the importance of patents and patent quality. The thrust of many of the measures are clearly directed at "limiting litigation abuses." Although a detailed analysis has not been completed, the two versions appear virtually identical. April 19, 2014 RD_ND_Patents_2014 118
  • 119. 5/25 of USA : A New Patent Rule “First to invent System” USPTO: New Patent Application can have 5 independent claims & 25 total claims (effective date November 1, 2007) {on hold ?} This rule is being slapped to improve quality of Patents USPTO believes that many applicants abuse current examination process by filing too many applications with related inventions April 19, 2014 RD_ND_Patents_2014 119
  • 120. Why search patent information?  Avoid duplication of R&D work  Identify specific new ideas and technical solutions, products or processes  Identify the state-of-the-art in a specific technological field in order to be aware of the latest development  Assess and evaluate specific technology and to identify possible licensors  Identify alternative technology and its sources  Locate of sources of know-how in a specific field of technology or in a given country  Improvement of an existing product or process  Development of new technical solutions, products or processes  Identify existing or prospective industrial property rights (validity, ownership, ...), particularly to avoid infringement actions  Assess novelty and patentability of own developments with a view of applying for a domestic or foreign industrial property right  Monitor activities of competitors both within the country and abroad  Identify a market niche or to discover new trends in technology or product development at an early stage. April 19, 2014 RD_ND_Patents_2014 120
  • 121. Who are the main user groups of patent information?  Industry, and in particular R&D intensive industry  Research and development institutions  Governmental authorities  Small and medium-size enterprises  Individual inventors  Professionals in the field of industrial property, e.g., administrators of technical libraries, patent agents, researchers, producers of data banks  Educational institutions and university students April 19, 2014 RD_ND_Patents_2014 121
  • 122. What is the scope of ``an art''? (Sort of background of an invention; example Computer Application) “All computer science? A topic roughly equivalent to one course at the undergraduate level? The subject of a PhD thesis? One important criterion is that we must consider people actually practicing the art, not those thinking about the art. Thus, an academic researcher may not be a good, or even acceptable, model for a person of ordinary skill in the art. Apparently, a better model would be a person with a BS degree in Computer Science who writes code for a living. In some cases, e.g., a patent involving locking algorithms for database systems, we might take the proper model to be someone who had had an appropriate MS-level course, database systems in this example”. April 19, 2014 RD_ND_Patents_2014 122
  • 123. Explanation of scope of art April 19, 2014 RD_ND_Patents_2014 123
  • 124. Patent Application Information Retrieval (PAIR) A system that displays information regarding patent application status. There is both a Public and Private side to PAIR. “ Public PAIR ” only displays issued or published application status. To access Public PAIR, you need only have a patent, application, or publication number that you wish to search. “Private PAIR” is the Patent Application Information Retrieval system developed to provide secure access for customers who want to view current patent application status electronically via the Internet. Private PAIR provides secure real-time access to pending application status and history using digital certificates issued from the USPTO's Public Key Infrastructure. To access Private PAIR, you must be a registered patent attorney/agent, an Independent Inventor, or a person granted limited recognition, have a customer number, have a digital PKI certificate to secure the transmission of the application to the USPTO. April 19, 2014 RD_ND_Patents_2014 124
  • 125. What is PAIR (SOPs) #Date Content description3205-14-2001Mail Notice of Allowance3105-14- 2001Notice of Allowance Data Verification Completed3005-14-2001Notice of Allowability2910-06-2000Case Docketed to Examiner in GAU2809-27-2000Mail BPAI Decision on Appeal - Reversed2709-27-2000BPAI Decision - Examiner Reversed2610-25-1999Mail Miscellaneous Communication to Applicant2510-25- 1999Miscellaneous Communication to Applicant - No Action Count2407-16- 1999Remand to the Examiner by BPAI2302-21-1997Mail Reply Brief Noted by Examiner2202-21-1997Reply Brief Noted by Examiner2112-26-1996Date Forwarded to Examiner2012-18-1996Reply Brief Filed1911-13-1996Mail Examiner's Answer1810-28-1996Examiner's Answer to Appeal Brief1707-17- 1996Date Forwarded to Examiner1607-12-1996Appeal Brief Filed1507-12- 1996Request for Extension of Time - Granted1404-15-1996Notice of Appeal Filed1303-27-1996Mail Advisory Action (PTOL - 303)1203-26-1996Advisory Action (PTOL-303)1103-13-1996Date Forwarded to Examiner1003-11- 1996Amendment after Final Rejection901-16-1996Mail Final Rejection (PTOL - 326)801-11-1996Final Rejection710-19-1995Date Forwarded to Examiner609-22- 1995Response after Non-Final Action509-22-1995Request for Extension of Time - Granted404-20-1995Mail Non-Final Rejection304-03-1995Non-Final Rejection202-03-1995Case Docketed to Examiner in GAU101-26-1995Application Captured on Microfilm April 19, 2014 RD_ND_Patents_2014 125
  • 126. Events • Amendment • Non-final rejection • Final rejection • Appeal brief • Appeal to the Board of Patent Appeals and Interferences (BPAI) April 19, 2014 RD_ND_Patents_2014 126
  • 127. Example : A Method for Diagnosing Cancer Bibliographic data Description Claims Mosaics Original Document INPADOC legal status Publication number :WO2006066826 (A1)(patent of invention) Publication date :2006-06-29 Inventor(s) :NAYERNIA KARIM [DE];ENGEL WOLFGANG [DE] Applicant(s) :GEORG AUGUST UNI GOETTINGEN [DE]; NAYERNIA KARIM [DE];ENGEL WOLFGANG [DE] Classification: - international: C12Q1/68; C12Q1/68; Application number : WO2005EP13600 20051216 2006-06-29 Priority number(s) :EP20040030123 20041220 (Source: esp@cenet database — WIPO - esp@cenet) April 19, 2014 RD_ND_Patents_2014 127
  • 128. April 19, 2014 RD_ND_Patents_2014 128
  • 129. Claims April 19, 2014 RD_ND_Patents_2014 129 (*Pwil-2 Protein widely expressed in tumors) *
  • 130. April 19, 2014 RD_ND_Patents_2014 130 (Based on Indian Application: 466/DEL/IN of 2/3/2005: “Novel Nucleotide Sequences”) Search Report
  • 131. “Patent protection does not result in owning the invention by the inventor but protects, others from repeating the effort which has already been made” “ Patent System Adds fuel to interest to the fire of the genius” - Abraham Lincoln April 19, 2014 RD_ND_Patents_2014 131
  • 132. Gene Patenting April 19, 2014 RD_ND_Patents_2014 132
  • 133. Gene Patenting View # 1 on Claims (In Favour): Gene is DNA of Defined and Specific Function Gene is Isolated due to Human Technical Intervention Hence a Gene should be Afforded Legal Protection (US Code Section 35 (100-101) View # 2 on Claims (In Opposition): Genes are discoveries and not inventions and should not be owned by any individual or organization Genes are discoveries & not inventions & hence not new Gene isolation and cloning is well established and a person skilled in art can fish it out. April 19, 2014 RD_ND_Patents_2014 133
  • 134. April 19, 2014 RD_ND_Patents_2014 134 ?? Under New Laws; gene patenting now requires mention of utility as a very Important attribute
  • 135. April 19, 2014 RD_ND_Patents_2014 135 Players who Generate Patents
  • 136. Key Players in Patenting  Inventors / PIs/ Scientists / An individual-s  An Organization/s where the inventor works  Funding agency  The Patent Office April 19, 2014 RD_ND_Patents_2014 136
  • 137. Patent Office Sell Technology/ Technology Transfer Inventor/ PI Upscale Technology Funding Agency Organization Commercialize the product Earn Royalty Share Royalty April 19, 2014 RD_ND_Patents_2014 137 **
  • 138. April 19, 2014 RD_ND_Patents_2014 138 Historical
  • 139. Thomas Jefferson,U.S. Patent Act of 1793 & Firsts in Patenting!  Thomas Jefferson was the first Patent Examiner  In 1790, the cost to obtain a patent was between $4 and $5.  The first U.S. patent was granted on July 31, 1790, to Samuel Hopkins of Pittsford, for an improvement in "the making of Pot ash and Pearl ash by a new Apparatus and Process."  Mary Kies of Killingly, Conn., was the first women to obtain a patent. In 1809 she received a patent for a way to weave "straw with silk or thread."  Chester Carlson was a patent agent who tired of having to make multiple copies of patent applications using the only duplication method available at the time: carbon paper. In 1959 he came up with a new copying system and took it to IBM for evaluation. The "experts" at IBM determined potential sales to be only 5,000 units because people wouldn’t want to use a bulky machine when they had carbon paper. Carlson’s invention was the xerography process, the company founded on the system is Xerox.  Abraham Lincoln, congressman from Illinois, received Patent No. 6,469 for "A Device for Buoying Vessels over Shoals." The idea of the invention was that if a ship ran aground in shallow waters, the bellows would be filled with air, and the vessel, thus buoyed, would float clear. The model Lincoln whittled can be seen at the Smithsonian's National Museum in Washington.  Mark Twain (Samuel L. Clemens) received Patent No. 121,992 for "An Improvement in Adjustable and Detachable Straps for Garments." He later received two more patents: one for a self-pasting scrapbook and one for a game to help players remember important historical dates. April 19, 2014 RD_ND_Patents_2014 139
  • 140. First Patent on Genetically Modified Organism DIAMOND v. CHAKRABARTY, 447 U.S. 303 (1980) DIAMOND, COMMISSIONER OF PATENTS AND TRADEMARKS versus CHAKRABARTY. CERTIORARI TO THE U.S. COURT OF CUSTOMS AND PATENT APPEALS. No. 79-136. Argued March 17, 1980. Decided June 16, 1980. (Respondent filed a patent application relating to his invention of a human-made, genetically engineered bacterium capable of breaking down crude oil, a property which is possessed by no naturally occurring bacteria) April 19, 2014 RD_ND_Patents_2014 140
  • 141. Patent Laws Each country has it’s own set of laws April 19, 2014 RD_ND_Patents_2014 141
  • 142. Compulsions for framing laws a) Domestic/ Regional (political or otherwise) b) International Obligations : International pulls & pressures (TRIPs) c) Financial/ Regional/ local etc April 19, 2014 RD_ND_Patents_2014 142
  • 143. What is Patentable ? USA : “Anything under the Sun” “First to invent” Europe : Discoveries, scientific theories & math. Models, aesthetic creations, presentation of information, inventions contrary to “order public” & those contrary to morality, plant & animal varieties, production of plants and animals India : Go to ( [Note: EPO, Japan, India “ First to File”] April 19, 2014 RD_ND_Patents_2014 143
  • 144. What is not Patentable in India !  Frivolous claims contrary to well-established natural laws  Anything contrary to law or morality, or injurious to public health  Mere arrangement or rearrangement or duplication of known devices, each functioning independently of one another in a known way  A method or process of testing the process of manufacture for rendering the machine, apparatus or other equipment more efficient or for the improvement or restoration of the existing machine, apparatus or other equipment or for the improvement or control of manufacture  A method of agriculture or horticulture April 19, 2014 RD_ND_Patents_2014 144
  • 145. What is not Patentable in India? (contd.)  Inventions related to atomic energy  Computer software  Aesthetic creations  Discoveries, scientific theories, mathematical methods  Schemes, rules or methods for performing mental acts playing games or doing business (business methods)  Presentation of information  Methods of treating humans or animals through surgery, or therapeutical diagnostics  Animals and plants, and biological methods for rearing/growing them (however, microorganism is patentable in India)  Products made by chemical synthesis foods, medicines  Process patents for drugs (reverse engineering) but when novel, permitted April 19, 2014 RD_ND_Patents_2014 145
  • 146. Controversial Cases on Patents in India? Case Study: Initiatives for Medicine, Access & Knowledge (I-MAK)(A US Based Non-Profit Organization) Vs Abbott Laboratories, U.K. “Heat Stable forms of a medicine named Aluvia, in Tablet form (formulation of Kaletra : an HIV Drug-pre; 1995 Drug) should not be Patented as per pre-1995 Indian Patent Laws according to Section 3 (d)” [Article 3 (d) allows serious modifications but not the frivolous ones] (TOI: 25/08/2007) April 19, 2014 RD_ND_Patents_2014 146
  • 147. Controversial Cases on Patents in Australian Patent Office? 2008: Australia's patent office admitted to being "uncomfortable" about granting a patent to a group from Seoul National University Industry Foundation that includes the disgraced researcher Woo-Suk Hwang as one of the inventors. The patent application is for a stem cell line, which the group of 18 researchers claimed was produced by a procedure known as somatic cell nuclear transfer but has since been revealed to have been created by parthenogenesis (the development of an embryo in the absence of fertilization). Although the application made false claims about the method used to create the stem cell line, this did not alter the status of the product: "it is generally accepted that the line of stem cells exists and is a new invention. But it is now generally accepted that they were not derived by somatic cell nuclear transfer but by another process called parthenogenesis." "The Patents Act requires IP Australia to be satisfied that there is an invention [...] that [has] not been discovered before. The new line of stem cells is such an invention." Nature Medicine: 14(12), December, 2008 April 19, 2014 RD_ND_Patents_2014 147
  • 148. April 19, 2014 RD_ND_Patents_2014 148 Some Statistics
  • 149. April 19, 2014 RD_ND_Patents_2014 149 n/wipi/pdf/941_2011_section_a.pdf
  • 150. April 19, 2014 RD_ND_Patents_2014 150 Share of Patent Offices in total patent applications (Source: WIPO Statistics Database, October 2011) (1995) United States of America : 21.8%; China : 1.8% Japan : 35.2%; Korea : 7.5% European Patent Office : 5.8%; Others : 28.0% (2010) United States of America : 24.8%; China : 19.8% Japan : 17.4%; Korea : 8.6% European Patent Office : 7.6%; Others : 21.8%
  • 151. April 19, 2014 RD_ND_Patents_2014 151 Application data availability IP type Estimated world totals based on Data available for Data coverage Patents 135 offices 88 offices 97% Utility models 60 offices 46 offices 99% Trademarks 169 offices 115 offices 87% Industrial designs 130 offices 104 offices 96%
  • 152. Information about Patent Offices Worldwide (RD: 12/11/2012) (Worldwide 7.3 million patents) Country/ region # Employees # of Patent Examiners Total filings in 2004 Total filings in 2010 Remarks EPO$ 6500 3500 181000 1,30,000 Heavy backlog USPTO$ 7300 3000 250000 5,00,000 Heavy backlog JPO$$ (Japan) 2651 1358 400000 3,50,000 Very slow in assessment SIPO$$S, * (China) 4400 2000 100000 3,80,000 Joined IPR regime recently; gearing up KIPO* (Korea) 1517 728 160000 1,50,000 No backlog; outsource jobs IPO$$$$, * (India) 200 135 17500 40,000 Heavy backlog; Need more staff; modernized Latin America ? ? ? ? Setting up with help of EPO Africa Setting up with help of EPO Note : Trilateral Offices being planned between China, Korea & India April 19, 2014 RD_ND_Patents_2014 152
  • 153. Patents in Force World Wide as in 2010 EPO : 8.3% USA : 32% Japan : 22% China : 24% Korea : 9.6% India : 2.5% April 19, 2014 RD_ND_Patents_2014 153 [Title “Chimeric gene constructs for generation of fluorescent transgenic ornamental fish”: US Patent Application No. : 20040143864 dated July 22, 2004] GloFish®™
  • 154. International Patent Filings – 2008-2013 S. No. Country Patent Filed - 2008 1. Japan 28,774 2. Germany 18,428 3. Republic of Korea 7,908 4. France 6,867 5. China 6,089 6. United Kingdom 5,517 7 Netherlands 4,349 8. Sweden 4,114 9. Switzerland 3,832 10. Canada 2,966 11. Italy 2,939 12. Finland 2,119 13. Australia 2,028 14. Israel 1,882 15 Republic of Korea 7,908 16. India 766 17. Singapore 578 18. Brazil 451 19. South Africa 382 20. Turkey 367 21. Mexico 210 22. Malaysia 177 April 19, 2014 RD_ND_Patents_2014 154
  • 155. Patents in Force in India Action 1999-2000 2002-03 2004-05 2005-06 2006-07 Application filed 4824 11,466 17,466 24,415 28,882 Application Examined 2824 9538 14,813 11,569 14,119 Patents Granted 1881 1379 1911 4320 7359 April 19, 2014 RD_ND_Patents_2014 155 (Source: Indian Patent Office)
  • 156. Indian Patent Office as International Search Authority The Indian Patent Office has now designated as the International Searching Authority (ISA) and International Preliminary Examining Authority (IPEA) by the World Intellectual Property Organization (WIPO) which consists of more than 170 member countries. The recognition of India as an ISA and IPEA puts India in a coveted league of only 15 nations and organizations currently recognized at a global level. April 19, 2014 RD_ND_Patents_2014 156
  • 157. April 19, 2014 RD_ND_Patents_2014 157
  • 158. Please see World IP Today:- April 19, 2014 RD_ND_Patents_2014 158
  • 159. April 19, 2014 RD_ND_Patents_2014 159 Source : WIPO
  • 160. April 19, 2014 RD_ND_Patents_2014 160
  • 161. April 19, 2014 RD_ND_Patents_2014 161
  • 162. April 19, 2014 RD_ND_Patents_2014 162 GM Crops
  • 163. Drugs Going Off Patent Regime April 19, 2014 RD_ND_Patents_2014 163 Total : US $ 10 b (
  • 164. April 19, 2014 RD_ND_Patents_2014 164 ( Total: US $ 9.7 billion
  • 165. Number of drugs with patents expiring in 2000-04 (Grouped by treatment category) Treatment category 2000 2001 2002 2003 1. Cancer and cancer related treatments 5 6 4 2 2. Anti-infective treatments 2 6 2 3 3. Central nervous system treatments 6 2 2 5 4. Cardiovascular/cerebro-vascular treatments 13 13 6 17 5. Respiratory treatments 5 3 4 5 6. Endocrine, nutritional, metabolic and immunity treatments 3 2 2 3 7. Topical treatments 5 1 3 7 8. Hormonal treatments 1 4 1 5 9. Musculo-skeletal and connective tissue treatments 1 0 1 0 10. AIDS and AIDS related treatments 2 2 0 1 11. Analgesic treatments 1 5 5 1 12. Digestive system treatments 5 1 5 0 13. Blood disorder treatments 0 0 0 0 April 19, 2014 RD_ND_Patents_2014 165
  • 166. Mode of Drug Action April 19, 2014 RD_ND_Patents_2014 166 Certain drugs work by interacting with receptors, special sites on the surface of body cells. Drugs may bind to a specific receptor, possibly preventing naturally occurring chemicals from binding to the receptor. In so doing, if a drug enhances cell activity, it is called an agonist; if it blocks cell activity, it is called an antagonist.
  • 167. Sale of Pharmaceutical Products for Lifestyle Diseases in India (Jan-Dec 2007) S. No. Segment Value in Rs. Crore %growth in value % growth in volume 1. Cough & Cold 1020.23 5.78 2.13 2. Diabetes 437.73 39.33 27.75 3. Cardio-Vascular (cholesterol lowering drugs) 304.19 35.09 31.25 4. Cefixime Oral Sol (anti-infective) 295.10 9.46 9.19 5. Cephalo Comb Injection (surgery) 286.23 36.46 35.44 6. Conv. Iron Liquid 284.73 9.11 7.19 7. Ciprofloxacin Oral Solids (strong anti- biotic) 274.50 -2.14 -3.24 8. Calcium Oral Solids 262.41 16.73 10.49 9. Diclo.comb.oral Solid (pain killer) 231.72 11.08 10.67 (Total : Rs. 3396.84 ) (Source: ORG; TOI – 17.03.2008) April 19, 2014 RD_ND_Patents_2014 167
  • 168. Drug Price Competition and Patent Term Restoration Act (U.S.A.) Statutory and Regulatory Citations The patent term restoration statute can be found at 35 U.S.C.ß 156 et seq. PTO published its regulations on March 24, 1987. These regulations can be found at 37 C.F.R. Part 1. FDA published its regulations on March 7, 1988. These regulations can be found at 21 C.F.R. Part 60. FDA published a Memorandum of Understanding governing information exchanges and cooperation between the two agencies in the May 12, 1987 Federal Register (52 Fed. Reg. 17,830). April 19, 2014 RD_ND_Patents_2014 168
  • 169. Gazette of India: Patents = Federal Register in USA April 19, 2014 RD_ND_Patents_2014 169
  • 170. Ever-greening of Patents April 19, 2014 RD_ND_Patents_2014 170
  • 171. Drug Price Competition and Patent Term Restoration Act (U.S.A.) Eligibility Assistance on Applications To obtain patent term extension, an application must satisfy certain eligibility criteria, including: (1) the patent has not expired, (2) the patent has never been extended, (3) the application is submitted by the patent owner or its agent, (4) the product has been subject to a regulatory review period with FDA or USDA before its commercial marketing or use, and (5) the permission for commercial marketing or use represents the first permitted commercial marketing or use of the product under the provision of law under which the regulatory review occurred (but for products produced using recombinant DNA technology, excluding animal drug products, the product can be the first permitted commercial marketing or use of a product produced under that technology), or if the product is a veterinary drug product, the product cannot be claimed in any other patent which has been extended and, if previously approved for use in non-food producing animals, must not have received patent term extension for that use. April 19, 2014 RD_ND_Patents_2014 171
  • 172. Ever greening of Patents “Evergreening, in one common form, occurs when the brand- name manufacturer literally “stockpiles” patent protection by obtaining separate 20-year patents on multiple attributes of a single product. These patents can cover everything from aspects of the manufacturing process to tablet color, or even a chemical produced by the body when the drug is ingested and metabolized by the patient” Primary uses Processes and intermediates Bulk forms Simple formulations Composition of matter April 19, 2014 RD_ND_Patents_2014 172
  • 173. Ever greening of Patents (contd.) Expansive numbers of uses Methods of treatment Mechanism of action Packaging Delivery profiles Dosing regimen Dosing range Dosing route Combinations Screening Methods Chemistry Methods Biological Target Field of use April 19, 2014 RD_ND_Patents_2014 173
  • 174. Patent Landscaping April 19, 2014 RD_ND_Patents_2014 174
  • 175. Patent Landscaping April 19, 2014 RD_ND_Patents_2014 175
  • 176. Freedom-to-operate search (FTO) April 19, 2014 176RD_ND_Patents_2014
  • 177. Freedom-To-Operate Search (FTO) A clearance search which concentrates on uncovering enforceable patents that may act as “roadblocks” to commercialization of a product or service Uses Guide product design decisions. Identify patents that may need to be licensed April 19, 2014 177RD_ND_Patents_2014
  • 178. WHAT WE SEARCH FOR FTO Existing claims of patents currently in force (existing “active” claims) Subject matter that may appear in claims of patents entering (or re-entering) into force in the future (future “active” claims) April 19, 2014 178RD_ND_Patents_2014
  • 179. WHERE WE SEARCH FOR FUTURE ACTIVE CLAIMS Document Types • Claims in patent applications • Claims in patents lapsed or withdrawn reinstatement • Description in patent applications amended claims • Description in patents amended claims April 19, 2014 179RD_ND_Patents_2014
  • 180. Remember IP rights are specific to different jurisdictions, a FTO analysis should relate to particular countries or regions where you want to operate April 19, 2014 180RD_ND_Patents_2014
  • 181. STRATEGIES FOR OBTAINING FREEDOM TO OPERATE (FTO) April 19, 2014 181RD_ND_Patents_2014
  • 182. In- licensing • Taking a written authorization from the patent holder to use the patented technology for specified period of time in a specified markets Cross- licensing • When two companies exchange licenses in order to be able to use certain patents owned by the other party. Inventing around • Guiding research or making changes to the product or process to avoid infringement on the patent(s) owned by others Patent pools • Where two or more companies practicing related technologies put their patents in a pool to establish a clearinghouse for patent rights April 19, 2014 182RD_ND_Patents_2014
  • 183. Patent Landscaping Process (1)  Patent landscapes are used to:  Gain competitive insight  Identify gaps and clusters in technology  Assess self portfolios vis-à-vis competition  Develop future R&D strategies  Identify new application areas of existing patents  Develop a licensing strategy  Develop new products and improve existing products  Determine commercial value of patents  Identify fundamental invention vis-à-vis improvements  Monitor patent activity in particular geographic markets NII/P&OTT/RD/2008April 19, 2014 RD_ND_Patents_2014 183
  • 184. Patent Landscaping Process (2) Part A (Overview)  Scan all patents of interest from Patent websites  Screen Patents of Interest  Map Patents It is the visualized expression of total patent analysis results to understand patent information effectively. Patent Map is produced by gathering related patent information of a target technology field & analyzing these data by different criteria and presenting results by using graphical tools. However, the type of patent map is created depends upon the question that is trying to be answered. Patent Maps allow us to identify acquisition target, patent cross licensing targets, future competitive treats & potential of licensing in and out. Thus Patent Maps allow us to track, monitor, discover, spot, assess, guard and see patent activities in a certain area.  Freedom to Operate  Mitigate April 19, 2014 RD_ND_Patents_2014 184
  • 185. Patent Landscaping Process (3) Part B (Basic Information) Define Scope Perform Search Map Trends Analyze Patents Select Patents of Interest Design Around Investigate Owners Mitigate Infringement Display Results Part C (Watch Competition) Understand Competitors IP Identify Trends in Competitors IP Identify Unprotected Areas Avoid Infringement Part D (Seek Strategic Positions) Licensing Agreements Patents Joint Ventures April 19, 2014 RD_ND_Patents_2014 185
  • 186. Patent Pools April 19, 2014 RD_ND_Patents_2014 186
  • 187. Patent pool for neglected diseases Pharmaceutical giant GlaxoSmithKline (GSK) will share the patented knowledge it uses to develop medicines for neglected tropical diseases (NTDs) — including malaria and tuberculosis — with other drugs companies, governments and non-governmental organizations. Andrew Witty, GSK's chief executive, proposed the voluntary 'patent pool' in a 12 February speech, and called on other drugs firms to open up access to intellectual property relevant to NTDs. Starting this year, Witty announced, GSK will also cap its prices for patented medicines in poor countries at 25% of what it charges in developed countries. It will also reinvest 20% of the profit it makes from selling medicines in poor nations into health-care infrastructure projects in those countries. Source: Nature News Published online 18 February 2009 | Nature 457, 949 (2009) | doi:10.1038/457949e News in Brief April 19, 2014 RD_ND_Patents_2014 187
  • 188. Patent Pooling A patent pool is a consortium of at least two companies agreeing to cross-license patents relating to a particular technology. The creation of a patent pool can save patentees and licensees time and money, and, in case of blocking patents, it may also be the only reasonable method for making the invention available to the public. (Note: Competition law issues are usually important when a large consortium is formed. Patent pooling has recently become a hotly debated field) April 19, 2014 RD_ND_Patents_2014 188
  • 189. Patent Pooling Identify relevant parties Gain agreement between parties (e.g., need to access many Patents) Letter of intent Independent evaluation of Patents Develop operating model Regulatory authority approval Sign full agreement Go live April 19, 2014 RD_ND_Patents_2014 189
  • 190. Patent Pooling for HIV/AIDS drugs  WHO efforts (UNITAID)  Air Tax etc April 19, 2014 RD_ND_Patents_2014 190
  • 191. April 19, 2014 RD_ND_Patents_2014 191
  • 192. April 19, 2014 RD_ND_Patents_2014 192
  • 193. April 19, 2014 RD_ND_Patents_2014 193 Patents & Economy
  • 194. Patents Generate Economy Examples: India : ( USA : NIH : 20,000 technologies/2000 generate $$ “AXLE” shuttle vector example BU : 2000 technologies/ 15 generate US $100m April 19, 2014 RD_ND_Patents_2014 194
  • 195. Generation Money by IPR: an example (Money Loss by USA in India due to lack of protection of IPR in 2000)  Motion pictures 80%  Sound Recordings and Musical Compositions 40%  Computer Programs: Business Applications 76%  Computer Programs: Entertainment Software 82%  Books (US$22 million) Not Available  Motion pictures 7.3%  Sound Recordings and Musical Compositions 24.5%  Software 292.8%  Books 21.0% April 19, 2014 RD_ND_Patents_2014 195
  • 196. Patents and Recession Yes, it has affected filing and technology transfer April 19, 2014 RD_ND_Patents_2014 196
  • 197. April 19, 2014 RD_ND_Patents_2014 197 Patents generate revenue: do you agree ? Only 5-12% of patents get commercially exploited!
  • 198. April 19, 2014 RD_ND_Patents_2014 198 Patenting leads to business & need uniform International rules for Trading World Trade Organization World Intellectual Property Organization
  • 199. April 19, 2014 RD_ND_Patents_2014 199 Share of Patent Offices in total patent applications (Source: WIPO Statistics Database, October 2011) (1995) United States of America : 21.8%; China : 1.8% Japan : 35.2%; Korea : 7.5% European Patent Office : 5.8%; Others : 28.0% (2010) United States of America : 24.8%; China : 19.8% Japan : 17.4%; Korea : 8.6% European Patent Office : 7.6%; Others : 21.8%
  • 200. Patent Offices fall under: Ministry of Commerce and Industry Department of Industrial Policy and Promotion Controller General of Patents Designs and Trade Marks (INDIA) April 19, 2014 RD_ND_Patents_2014 200
  • 201. April 19, 2014 RD_ND_Patents_2014 201
  • 203. April 19, 2014 RD_ND_Patents_2014 203
  • 205. Department of Industrial Policy & Promotion (DIPP) is the nodal Department in the Government of India for all matters concerning WIPO. April 19, 2014 RD_ND_Patents_2014 205
  • 206. Patent Activity in India PSUs : 12% MNCs : 28% Indian Private Industry : 60% April 19, 2014 RD_ND_Patents_2014 206 ? ?
  • 207. Patent filing process (India) Filing : Complete Specifications Examination Allowance Issuance Maintenance Refusal/ Appeal !! Publication Opposition If yes, go to Revise April 19, 2014 RD_ND_Patents_2014 207
  • 208. April 19, 2014 RD_ND_Patents_2014 208
  • 209. April 19, 2014 RD_ND_Patents_2014 209 Patent Filing Documents & Drafting
  • 210. Patent Filing Documents (INDIA) (Form 1): Application form in triplicate (Form 2): Provisional or complete specification in triplicate. If the provisional specification is filed it must be followed by complete specification within 12 months (15 months with extension) Drawing in triplicate (if necessary) Abstract of the invention (in triplicate) Information and undertaking listing the number, filing date and current status of each foreign patent application in duplicate (Form 3): Priority document (if priority date is claimed) (Form 5): Declaration of inventorship where provisional specification is followed by complete specification or in case of PCT convention application Power of attorney (if filed through Patent Agent) Fee in cash/by local cheque/by demand draft in favor of Controller of Patents) April 19, 2014 RD_ND_Patents_2014 210
  • 211. Drafting of Claims (1) 1. Interview the inventor 2. Inventor knows best about his invention 3. Record Interview on Camera, if possible 4. Demand sketches 5. While evaluating invention, first of all draft broadest claims 6. The broadest claim is a claim that is narrower only at the point of novelty than any prior art reference one is aware of 7. Once a point of novelty is in mind, decide on the type of claim (product- new or improved compound or composition of matter) / method of use/ process of manufacture, reconsider/ revise the claims 8. While interpreting claims, consider other claims in the patent with patent differentiation in mind 9. Ask the following: is the claim too broad or too narrow or problematic 10.Consider how claims affect each other 11.When in doubt, ask inventor to again explain it April 19, 2014 RD_ND_Patents_2014 211
  • 212. Drafting of Claims (2) Statutory Provisions — Basic Principles: The Statute Omnibus Claims Statutory Classes Claim Forms and Formats: Placement After Specification Numbering and Order Preamble Transition from Preamble to Body Body of the Claim Format and Punctuation Dependent Claims Independent Claims Multiple Dependent Claims April 19, 2014 RD_ND_Patents_2014 212
  • 213. Drafting of Claims (3) Fees Payable for Claims Apparatus or Machine Claims: Elements of These Claims Order of Elements Tying Elements Together “Whereby” and “Means” Clauses Method or Process Claims: Elements of Method Claims April 19, 2014 RD_ND_Patents_2014 213
  • 214. Drafting of Claims (4) Order of Steps Article of Manufacture Claims: Product-by-Process Claims Design Claims Plant Patent Claims Composition of Matter Claims — Chemical Cases: “Markush” Expressions Special Claims for Chemical Cases New Use Claims Jepson-Type Claims Generic and Species Claims of Varying Scope: Claiming Different Classes of Invention in One Patent Non-art Rejections: Duplicate Claiming April 19, 2014 RD_ND_Patents_2014 214
  • 215. Drafting of Claims (5) Undue Multiplicity Old Combination; Over-claiming Aggregation Printed Matter Incomplete Vague and Indefinite Prolixity New Matter Claiming Biotechnology Inventions Thoughts on Claim Drafting: Review of Some Basics April 19, 2014 RD_ND_Patents_2014 215
  • 216. How to file a Patent (ABROAD) Direct Route for National Phase: Seek permission from IPO, India ; 6-months time period PCT Route: Uniform examination agency 18-32 months Go to National Phase e.g., USA, Europe, Singapore, China Role of Patent Attorney & deficiencies in India? April 19, 2014 RD_ND_Patents_2014 216
  • 217. Strategy 1 The traditional way to apply for a patent is to file a standard Patent Application (now called a non-provisional) with the PTO without a prior art search. This way can sometimes be a roll-of-the-dice approach. Without a search of relevant art, one cannot develop a proper strategy for applying for a patent. While it may be one of the cheapest strategies, there is a chance that the cost of filing could have been avoided. However, if your idea is truly one of a kind, this could be the best approach. Strategy 2 A variation on Strategy 1 is to perform a patentability search prior to filing the non-provisional application. While no search can generate a 100% of the relevant art or prevent a rejection by the PTO, a search can help determine what is out there and shape the best strategy for prosecution. Strategy 3 The newest and possibly the most attractive strategy is to file a Provisional Patent Application. This is a great tool for inventors. When you invent something, you generally have 1 year to file an application with the PTO, or lose the right to do so. A provisional application allows you to file the disclosure of your invention with the office, establish a priority date and gives you another year to file your non-provisional application. This strategy also gives you a year to determine if there is a market for your invention while employing the title 'Patent Pending' on your invention. April 19, 2014 RD_ND_Patents_2014 217 Patent Prosecution Strategy
  • 218. Form No. Section and rule Title 1 2 3 1. 1.A Sections 5(2), 7, 54, 135 and rule 39 Section 7(1A); rule 20(1) Application for grant of a patent. Application for grant of patent on an application corresponding to an International application under PCT. 2. Section 10; rule 13 Provisional/Complete Specification. 3. Section 8 and rule 12. Statement and undertaking. 4. Sections 8(2), 9(1), 25(1), 28(4), 43(3), 53(3) and rules 12(4), 13(6), 24(5), 56(1), 73(3) or 130. Request for extension for time. 5. Section 10(6) and rule 13(6). Declaration as inventorship. 6. Sections 20(1), 20(4), 20(5) and rules 34(1), 35 or 36. Claim or request regarding any change in applicant for patent. 7. Section 25 and rule 55. Notice of opposition to grant of a patent. 8. Sections 28(2), 28(3) or 28(4) and rules 66, 67, 68. Request or claim regarding mention of inventor as such in a patent. 9. Section 43 and rule 73(1). Request for sealing of a patent. 10. Section 44 and rule 75. Application for amendment of patent. 11. Sections 51(1), 51(2) and rules 76, 77. Application for direction of the controller. 12. Section 52(2) and rule 79. Request for grant of patent. 13. Section 57 and rule 81(1). Application for amendment of the application for patent/complete specification. 14. Sections 57(4), 61(1), 63(3), 78(5) and 87(2) and rules 49(1), 52(3), 81(3)(b), 85(1), 87(2), 98(1), 101(3) or 124 and also section 87 (2) as modified by section 24C. Notice of opposition to amendment/restoration/surrender of patent/grant of compulsory licence or revision of terms thereof or to a correction of clerical errors. 15. Section 60 and rule 84. Application for restoration of patents. 16. Section 68 and rule 89. Application for registration of a document. 17. Sections 69(1) or 69(2) and rules 90(1) and 90(2) Application for registration of title/interest in a patent or share in it or registration of any document purporting to affect proprietorship of the patent. April 19, 2014 RD_ND_Patents_2014 218
  • 219. 18. Sections 84(1), 91 or 92(1) and rules 47, 96 and also sections 84 and 92 as modified by section 24C. Application for compulsory licence. 19. Section 11B and Rule 24(1). Request for examination of application for patent. 20. Section 85(1) and rules 47, 96, and also section 85(1) as modified by section 24C. Application for revocation of a patent or exclusive marketing right. 21. Section 88(4) and rules 51, 100 and also section 88(4) as modified by section 24C. Application for revision of terms and conditions of licence. 22. Section 94 and rule 102(1) and also section 94 as modified by section 24C. Request for termination of compulsory licence. 23. Rules 109 and 112. Application for registration of Patent Agent. 24. Section 130 (2) and rule 117. Application for the restoration of the name in the register of Patent Agents. 25. Sections 77(1)(f), 77(1)(g) and rules 130(1) or 130(2). Application for review/setting aside controller’s decision/order. 26. Sections 127, 132 and rule 135. Form of authorisation of a Patent Agent/or any person in a matter or proceeding under the Act. 27. Section 24A and rule 40. Application for grant of exclusive marketing rights. 28. Rule 46. Form for the grant of exclusive marketing rights. 29. Section 146(2) and rule 131(1) Statement regarding the working of the Patented invention. 30. Section 39 Request for permission for making patent application outside India April 19, 2014 RD_ND_Patents_2014 219
  • 220. Documents Needed to File an Application Application for grant of patent in Form 1; Form 2 accompanied by two copies of the complete patent specification; Two sets of the drawing figures, if any, one set of which should be in thick A-4 size white sheets; Duly stamped power of attorney in Form 26 authorizing the agent; Declaration of the inventorship signed by the applicant in Form 5; Priority documents, if any, if not in English, English translation thereof; The Statement and Undertaking regarding corresponding foreign filings in Form 3; and Proof for the applicant’s right to apply for patent. To obtain a lodgment date, what is required is: The Specification; Name and address of the applicant; Name(s) and addresse(s) of the Inventor(s); and The priority details.April 19, 2014 RD_ND_Patents_2014 220
  • 221. Patent Prosecution in India Application Applicant Publication Representation Examination Grant Opposition Renewal April 19, 2014 RD_ND_Patents_2014 221
  • 222. April 19, 2014 RD_ND_Patents_2014 222 Patent Filing Process In Patent Offices
  • 223. Patent filing process (EPO) Filing Search Request for Examination Substantive Examination Announcement of Grant Publication of Patent Maintenance If opposed : revocation Refusal Withdrawal Publication April 19, 2014 RD_ND_Patents_2014 223
  • 224. Patent filing process (USPTO) Filing Examination Notice of Allowance Patent Issuance Maintenance Opposition / Interference Office action/ rejection/ abandonment Patent withdrawal April 19, 2014 RD_ND_Patents_2014 224
  • 225. Patent Application Process in U.S.A. Contact a Law Firm Study Law Firm Brochure Study Schedule of Fee Fix a Meeting with Attorney to discuss: Invention, Patent application process and Fee arrangements Conduct Patentability Search and Opinion Preparations for filling of Patent Application Prepare an Information disclosure Statement Attend to the Notice to file missing parts Notice to comply with Sequence rules Office action and response to office action (amendment) Notice of allowance Final rejection Amendment after rejection Appeal Continuation application Abandon the Application April 19, 2014 RD_ND_Patents_2014 225
  • 226. Patent Application Process in U.S.A. Extension applications Continuation Divisional Continuation-in-part Reissue Continued Prosecution Application April 19, 2014 RD_ND_Patents_2014 226
  • 227. PCT April 19, 2014 RD_ND_Patents_2014 227
  • 228. Patent Cooperation Treaty “The Patent Cooperation Treaty (PCT) of 1970 is an international patent law treaty. It provides a unified procedure for filing patent applications to protect inventions in each of its Contracting States – 137 countries. A patent application filed under the PCT is called an international application or PCT application. A Patent Cooperative Treaty (PCT) patent application is a means to delay filing in individual foreign countries for up to 30 months from the U.S. filing. The PCT patent application does not mature into a patent. Rather, an application must still be filled in each individual country”. [List of PCT countries:] April 19, 2014 RD_ND_Patents_2014 228
  • 229. Documents for filing Patents PCT Route By PCT Route:  Complete Specification  Drawings (if any)  Priority Documents  Abstract  International Search Report  International Preliminary Examination Report  WIPO Publication  Power of Attorney April 19, 2014 RD_ND_Patents_2014 229
  • 230. PCT Filing Procedure File PCT application in Indian Patent Office Ask for International Preliminary Examination Report Choose National Phase Countries e.g., USA, UK, China, Japan, Singapore 1st written opinion issued; If favorable Publication of PCT after 18 months from the priority date by WIPO Response to written opinion (Modify/ delete/ improve claims) Local Patent Laws applicable April 19, 2014 RD_ND_Patents_2014 230
  • 231. University US federal funding for life sciences research (1998-2001) $ billion Biotechnology patents granted by the USPTO (1998-2001) Biotechnology applications submitted to the USPTO (1998-2001) Disclosed technology transfer deals with biotechnology firms (1998-2002) University of California system (Oakland, CA, USA) 2.97 757 330 23 University of Texas (Austin, TX, USA) 1.39 202 71 10 Johns Hopkins University (Baltimore, MD, USA) 1.19 258 107 13 Washington University (St. Louis, MO, USA) 1.04 125 37 3 University of Pennsylvania (Philadelphia, PA, USA) 0.98 138 50 4 Harvard University (Cambridge, MA, USA) 0.79 127 42 9 Stanford University (Stanford, CA, USA) 0.74 137 60 14 Columbia University (New York, NY, USA) 0.70 141 37 1 Cornell University (Ithaca, NY, USA) 0.50 136 49 0 Massachusetts Institute of Technology (Cambridge, MA, USA) 0.20 81 32 13 Rockefeller University (New York, NY, USA) 0.18 154 56 5 (Sources: National Science Foundation, US Patent and Trademark Office (USPTO), Recombinant Capital) April 19, 2014 RD_ND_Patents_2014 231
  • 232. April 19, 2014 RD_ND_Patents_2014 232
  • 233. April 19, 2014 RD_ND_Patents_2014 233 (
  • 234. April 19, 2014 RD_ND_Patents_2014 234
  • 235. April 19, 2014 RD_ND_Patents_2014 235 Indian Patent Office
  • 236. April 19, 2014 RD_ND_Patents_2014 236
  • 237. April 19, 2014 RD_ND_Patents_2014 237 Patent Applications related To Micro-organisms Deposit at IMTECH, Chandigarh
  • 238. Patent Search Databases Free Databases Restricted but Free Databases RaDius (US Federal Govt. Site) USPTO private PAIR System April 19, 2014 RD_ND_Patents_2014 238
  • 239. Patent Search Databases (contd.) Subscription/Paid Databases Thomson Innovation Delphoin ( MicroPatent ( Dialog ( PatentCafe ( Big Patents India ( April 19, 2014 RD_ND_Patents_2014 239
  • 240. Organization of Patent Offices April 19, 2014 RD_ND_Patents_2014 240
  • 241. April 19, 2014 RD_ND_Patents_2014 241 Organization of European Patent Office
  • 242. April 19, 2014 RD_ND_Patents_2014 242
  • 243. April 19, 2014 RD_ND_Patents_2014 243
  • 244. April 19, 2014 RD_ND_Patents_2014 244
  • 245. Various Components of IP-Activities April 19, 2014 RD_ND_Patents_2014 245
  • 246. April 19, 2014 RD_ND_Patents_2014 246
  • 247. April 19, 2014 RD_ND_Patents_2014 247
  • 248. Thank You & Good Luck ACKNOWLEDGEMENTS Several websites; DBT/ BIRAC/ NII/ US Embassy/ IPO/ USPTO/ EPO/ WIPO/ JPO/ Boston University,USA/ NIH, USA/ MIHR, UK/ Various websites & Journals & (Indian Patent Act: April 19, 2014 RD_ND_Patents_2014 248