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What is IP, Patents in Pharma Industry

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What is IP, Patents in Pharma Industry by Dr Anthony Crasto, a complete guide for patenting in drug synthesis, discovery, process, polymorphs, AN INSIGHT INTO PCT, DATES, CLAIMS, DEFINITIONS ETC, all you want to know about criteria, method mode, advantages etc, EMAIL ME amcrasto@gmail.com, call +91 9323115463

Published in: Healthcare

What is IP, Patents in Pharma Industry

  1. 1. What is IP, Patents in PharmaWhat is IP, Patents in Pharma IndustryIndustry by DR ANTHONY CRASTO JAN 2015 01/28/15 1
  2. 2. ◦ What is innovation ? ◦ What is intellectual property ? 01/28/15 2 http://drugpatentsint.blogspot.in/ http://fdazilla.com/drugs/generic/ http://ep.espacenet.com http://www.druglead.com/ http://www.accessdata.fda.gov/scripts/cder/ob/ http://chem.sis.nlm.nih.gov/chemidplus/
  3. 3. ◦ Think ◦ Imagine ◦ Create (Creations of the mind)  WHAT WE CREATE OUT OF THIS PROCESS IS INTELLECTUAL PROPERTY – VALUE 01/28/15 3 Innovation and Intellectual Property
  4. 4. Knowledge (IP – Intangible property) is cumulative with each idea building upon the last, whereas Machines (Tangible property) deteriorate and must be replaced 01/28/15 4 Property
  5. 5. Patents Copy Rights© Trade marks® Geographic Indications Protection of undisclosed information Layout designs of integrated circuits Industrial designs 01/28/15 5 Types of IP
  6. 6. 6 What does IP mean?What does IP mean? Trademarks Patents Designs Utility models Includes also: Copyright Unfair Competition Business Secrets Manuals Domain names etc…
  7. 7. That’s all very interesting…That’s all very interesting… But how does IP help my research? Why should I invest in protecting my IP?
  8. 8. BUNDLE OFBUNDLE OF IPIP ASSETSASSETS  A marketing tool  A source of revenue through licensing/acquisition  A crucial component of franchising agreements  Useful for obtaining banks or third party financing  A valuable business asset
  9. 9. BUSINESS AND YOUR IPBUSINESS AND YOUR IP Be proactive: Invest in protecting your bundle of business assets. Be vigilant: Watch for potential infringers – license, acquire Be assertive: Protect your business assets
  10. 10. Forms of Intellectual PropertyForms of Intellectual Property Term Life + 70 years 14 years 20 years 10 years * X ∞
  11. 11. 01/28/15 11 PATENTS ACT 1970PATENTS ACT 1970 PATENT- DEFINITION Exclusive right for being the true and first inventor of a product or process, granted by the govt. for a limited period, to exclude others from making, using, selling or importing the patented product or process without his consent, in exchange of full disclosure of his invention . Term- 20 years from the Date of Filing(S.53)
  12. 12. Patent JurisdictionsPatent Jurisdictions A patent is only valid in the jurisdiction in which it is granted World Intellectual Property Organization (WIPO) ◦ Patent Cooperation Treaty (PCT) ◦ Provides World filing for Patent Application
  13. 13. What is a patent?What is a patent? Is grant by a government or government agency. To an inventor Right to exclude others from ◦ Making ◦ Using ◦ Selling ◦ Offering for sale ◦ importing 01/28/15 13
  14. 14. PatentPatent Exclusive monopoly in exchange for disclosure of invention Disclosure Time-limited Monopoly
  15. 15. Anatomy of a PatentAnatomy of a Patent
  16. 16. 01/28/15 16
  17. 17. Lifecycle of a patentLifecycle of a patent
  18. 18. Publication Vs. PatentPublication Vs. Patent Scholarly Publication  Authorship somewhat negotiable  Must have done the work  Effort paramount  Future ideas can interfere with subsequent patentability  Only directly comparable results can lead to loss in priority Patent  Inventorship a matter of law  “Constructive reduction to practice” encouraged  Conception paramount  Disclosure of ideas for as many future uses as possible strengthens the patent  Results from analogous systems can result in prior art and obviousness rejections
  19. 19. Documenting InventionsDocumenting Inventions Keep a notebook! Keep the pages sequential and clearly dated.
  20. 20. Documenting InventionsDocumenting Inventions Write down your experiments! (especially the ones showing structure of the invention and how to make the invention) = “reduction to practice” Also write down significant ideas! (ditto!) = “conception”
  21. 21. Documenting InventionsDocumenting Inventions Periodically show your notebook to someone else in the lab who is not an inventor (but who has an obligation of confidentiality and can understand what you are telling them). Have that witness sign and date the pages and indicate that they have “read and understood”the content.
  22. 22. 01/28/15 22 Patents are granted for inventions which are technical, that is inventions which are capable of being industrially exploitable What is patentable?
  23. 23. 01/28/15 23 A Product The apparatus for producing the product The process The use What can be patented?
  24. 24. 01/28/15 24 What cannot be patented? Computer programmes Medical and surgical treatments Mathematical methods Business methods Discoveries Aesthetic creations New species of plant or animal Inventions which are contrary to moral standards and public order (e.g. instruments of torture) The human body and any non-separate part/s thereof
  25. 25. InfringementInfringement “Infringement” of a patent occurs when a competitor makes, uses, sells, offers to sell or imports an embodiment of the invention without the permission of the patent owner.
  26. 26. Direct infringementDirect infringement A person directly infringes a patent by making, using, offering to sell, selling, or importing into the US any patented invention, without authority, during the term of the patent. Unlike direct infringement, which does not require knowledge of the patent or any intent to infringe. While the United States Patent Act does not directly distinguish "direct" and "indirect" infringement, it has become customary to refer to describe infringement under 35 U.S.C. § 271(a) as direct infringement, while grouping 35 U.S.C. § 271(b) and 35 U.S.C. § 271(c) together as "indirect" ways of infringing a patent., 28/01/15 26
  27. 27. Indirect InfringementIndirect Infringement Accused has some knowledge and intent 35 U.S.C. § 271(b) "active inducement of infringement “by encouraging, aiding, or otherwise causing another person to infringe. Inducer must be aware of the patent and intend. 35 U.S.C. § 271(c) "contributory infringement," is triggered when a seller provides a part or component that, while not itself infringing of any patent, has a particular use as part of some other machine or composition that is covered by a patent.[3] If there are other valid uses for the product. Only occurs when there has actually been a direct infringement of the patent. There must have been at least one instance where the inducement or contribution resulted in the practice of the patented art. 28/01/15 27
  28. 28. 28 Consequences of infringingConsequences of infringing If you infringe someone else’s patent, you may risk: Injunction, which means that all your products may be removed from the market Destruction of your products Paying damages to the patent owner Being given a fine, e.g. the Kodak vs. Polaroid case Being sentenced to imprisonment (in gross cases)
  29. 29. Type of patents?Type of patents? Utility patents Plant patents Design registration 01/28/15 29
  30. 30. Utility patentsUtility patents Structural or functional aspects of ◦ Products ◦ Composition ◦ Process 01/28/15 30
  31. 31. Utility PatentUtility Patent 01/28/15 31
  32. 32. Plant patentsPlant patents New variety of living plants 01/28/15 32
  33. 33. Plant PatentPlant Patent 01/28/15 33
  34. 34. Design PatentDesign Patent 01/28/15 34
  35. 35. Design registrationDesign registration Ornamental designs of useful objects In US designs are patentable. 01/28/15 35
  36. 36. Is this gives right to marketIs this gives right to market No A separate permission is required to make use ◦ DCA or DCGI approval is required to market pharmaceutical products. 01/28/15 36
  37. 37. 01/28/15 37 The Patent ProcessThe Patent Process Allowance
  38. 38. Approach to Obtaining a Patent &Approach to Obtaining a Patent & CommercializationCommercialization  Disclosure: Ideally when you can describe both what the invention is and what it accomplishes  Evaluation: ◦ Can this invention be patented?  Is there any prior art? Is this invention new, useful, & non-obvious? ◦ Is it worthwhile to patent this invention?  What product could come from this patent? Is there a market for said product?  Provisional application: Preserves worldwide rights against initial disclosure; gives you 1 year to decide whether or not to pursue patent  Initial publication: If you publish prior to filing a provisional application you lose the rights to file internationally DISCLOSURE INITIAL PUBLICATION ~3 MONTHS FILE PROVISIONAL APPLICATION (~$10k) EVALUATE
  39. 39.  Patent Cooperation Treaty (PCT): an international application which claims priority to a provisional US application & have option for protection for up to 111 countries. RE-EVALUATION FILE PCT (~$25K) PCT PUBLICATION 12 MONTHS 8 MONTHS 6 MONTHS Approach to Obtaining a Patent & Commercialization
  40. 40. 12 MONTHS RE-EVALUATE RE-EVALUATE Approach to Obtaining a Patent & Commercialization ENTER NATIONAL PHASE & PROSECUTION(~$20K)  Continuation of marketing/finding a licensee as well as additional publications  National stage applications with expensive examination rounds
  41. 41. DISCLOSURE INITIAL PUBLICATION RE-EVALUATION RE-EVALUATIONRE-EVALUATION Overview of Pathway to Commercialization FILE PROVISIONAL APPLICATION (~$10k) EVALUATION 3 MONTHS FILE PCT (~$25K) PCT PUBLICATION 8 MONTHS 12 MONTHS 6 MONTHS 12 MONTHS ENTER NATIONAL PHASE & PROSECUTION (~$20k) RARELY GET THIS FAR W/O LICENSEE PATENTABILITY & MARKETING EVALUATION MARKETING/SEARCH FOR LICENSEE GENERATE NCD ADDITIONAL PUBLICATIONS W/ INTERESTING ANIMAL DATA, PROTOTYPING, FURTHER COMMERCIALIZATION
  42. 42. Some common termsSome common terms Application Best mode Claims Conception Dependent claim Examiner Failure of others 01/28/15 42
  43. 43. Some common terms …contSome common terms …cont How to make Independent claim Invention Novelty Obviousness Preferred embodiment 01/28/15 43
  44. 44. Some common terms …contSome common terms …cont Prior art Provisional application Specification 01/28/15 44
  45. 45. Some common terms …contSome common terms …cont Application ◦ A written document seeking patent protection filed with patent office. Best mode ◦ A patent application is required to disclose the best means known to the applicant of practicing the invention as of the date of filing the application 01/28/15 45
  46. 46. Some common terms …contSome common terms …cont Claims ◦ A claim is one of the numbered paragraphs that appear at the end of a patent and defines the scope of protection given to the owner of the patent ◦ Each claim is treated separately for purposes of determining validity and infringement. For example, claims may be directed toward apparatus, methods, products, and compositions of matter and new and useful improvements thereof. 01/28/15 46
  47. 47. Some common terms …contSome common terms …cont Conception ◦ is the creation of the mental concept of the invention. Dependent claim ◦ is a Claim+ that makes express reference to and depends on a prior claim ◦ thereby, incorporates by reference all of the recitals of the prior claim 01/28/15 47 +http://www.tms.org/pubs/journals/JOM/matters/matters-9609.html#claim
  48. 48. Some common terms …contSome common terms …cont Examiner ◦ An employee of a patent office to whom an application is assigned for handling prosecution. Failure of others ◦ A secondary test of patentability relevant to the issue of whether an invention is obvious is whether others have failed to come up with the solution previously. 01/28/15 48
  49. 49. Some common terms …contSome common terms …cont How to make ◦ This is part of the obligation to provide a disclosure in the patent application that would enable one skilled in the art to practice the invention without engaging in undue experimentation. 01/28/15 49
  50. 50. Some common terms …contSome common terms …cont Independent claim ◦ is a claim that stands by itself and must be so read in terms of infringement and validity evaluations. This is contrasted with a dependent claim. 01/28/15 50
  51. 51. Some common terms …contSome common terms …cont Invention ◦ in order to have a patentable invention, one must have a development that is  useful,  novel (no single prior art reference shows the identical development), and  unobvious to one skilled in the art at the time the invention was made, 01/28/15 51
  52. 52. Some common terms …contSome common terms …cont Novelty ◦ is present if no single piece of prior art discloses every element of the claimed invention. 01/28/15 52
  53. 53. Some common terms …contSome common terms …cont Obviousness ◦ If the invention could readily be deduced at the time the invention was made from publicly available information (prior art) by a person of ordinary skill in that art, it is obvious. ◦ Prior art may be combined to show that an invention would have been obvious. 01/28/15 53
  54. 54. Some common terms …contSome common terms …cont Preferred embodiment ◦ The preferred embodiment of an invention can usually be interpreted as being recited as the best mode known to the inventor of carrying out the invention. 01/28/15 54
  55. 55. Some common terms …contSome common terms …cont Prior art ◦ The existing body of technological information against which an invention is judged to determine if it is patentable as being novel and unobvious. ◦ It must be early enough in time to be cited against the application. 01/28/15 55
  56. 56. Some common terms …contSome common terms …cont Provisional application ◦ an applicant can file a patent specification complying with standards and get the filing date as a priority date. ◦ for a complete patent application filed within one year thereafter claiming the benefit. 01/28/15 56
  57. 57. Some common terms …contSome common terms …cont Provisional application ◦ The provisional application does not have to contain claims. ◦ The effective filing date of the full application for purposes of avoiding prior art will be the filing date of the provisional application. ◦ but will have the benefit of the date of filing the full application for purposes of the 20 year patent term. 01/28/15 57
  58. 58. Some common terms …contSome common terms …cont Specification ◦ The part of the patent application that precedes the claims and in which the inventor specifies, describes, illustrates, and discloses the invention in detail. 01/28/15 58
  59. 59. Intellectual Property ◦It Starts With An IDEA 01/28/15 59
  60. 60. An invention can only be protected by patent if it is novel (no prior publication of the invention). Therefore, it is essential not to disclose the invention publicly until after a formal patent application has been filed. 01/28/15 60
  61. 61. Any printed publication in a newspaper, scientific journal, or other written form available on an unrestricted basis is considered a public disclosure, as is an oral presentation at a public meeting. Note that an abstract and, in some cases, even a title may act to bar patentability if it discloses all the necessary elements of the invention. 01/28/15 61
  62. 62. Rights and responsibilitiesRights and responsibilities Obtaining and maintaining IP, especially patents require many actions and funds. Patent search Patent filing Handle opposition and objections Renewal of patents Handle infringement Licensing and transfer of IP 01/28/15 62
  63. 63. IP policyIP policy Will IP policy make a difference? Institutes ought to generate their own resources. Hence management will drive research programmes accordingly. Clarity will help faculty in making choices. Who doesn’t like money?01/28/15 63
  64. 64. 01/28/15 64
  65. 65. Patent Filing ProcessPatent Filing Process 01/28/15 65
  66. 66. 66 Patent Application ProcessPatent Application Process (2-5 Years on Average?)(2-5 Years on Average?) 1. Conceive the invention 2. Write the application 3. File the application 4. Meet the application formalities – e.g., declaration, formal drawings 5. Examination process begins 6. Restriction requirement issued – sometimes 7. Substantive Office Action issued 8. Reply filed (usually there will be multiple iterations of this and the above step before an allowance is obtained) 9. Appeal filed 10. Application Allowed 11. Pay necessary fees – file continuations? 12. Patent issues 13. Pay Maintenance Fees
  67. 67. 01/28/15 67
  68. 68. Filing processFiling process Provisional application Non provisional application 01/28/15 68
  69. 69. Provisional applicationProvisional application Specifications ◦ Title ◦ Introduction to the invention ◦ Drawings (if required) ◦ Model (upon request from PO) 01/28/15 69
  70. 70. Non provisional applicationNon provisional application Specifications ◦ Title ◦ Introduction to the invention ◦ Drawings (if required) ◦ Model (upon request from PO) 01/28/15 70
  71. 71. 71 What is a Provisional Application?What is a Provisional Application? Establishes a filing date (earliest priority date) Examination process does not begin Clock does not start running on lifetime of patent Has simpler filing requirements Lower filing fees Claims are not required
  72. 72. Non provisional applicationNon provisional application Specifications ◦ Detailed description ◦ Examples (best mode) ◦ Claim(s) ◦ Abstract 01/28/15 72
  73. 73. Prior art searchPrior art search Patents Literature articles Journals Scientific Presentations 01/28/15 73
  74. 74. Prior art searchPrior art search Patents ◦ US ……….http://www.uspto.gov/ ◦ EU……http://ep.espacenet.com/ ◦ WIPO….http://www.wipo.int/ipdl/en/search/p ct/search-simp.jsp Japan Patent Office http://www.jpo.go.jp/ 01/28/15 74
  75. 75. USPTO WebsiteUSPTO Website www.uspto.gov PATENTS Tab © Copyright 2014 75
  76. 76. Prior art searchPrior art search Patents & Published literature ◦ Scifinder ◦ Prous integrity ◦ Reaxys ◦ Thomson cortellis ◦ Google 01/28/15 76
  77. 77. Prior art searchPrior art search Published literature ◦ www.sciencedirect.com (for elsevier journals) ◦ www.tandf.co.uk/journals/online.asp (for journals of dekker and taylor and francis publishing) ◦ www.ncbi.nlm.nih.gov/entrez/query.fcgi (med line- gives elsevier journals also) 01/28/15 77
  78. 78. Prior art searchPrior art search Published literature ◦ www.aapspharmscitech.org (free full text articles published in AAPS Pharm Sci Tech, an online journal) ◦ http://pubwww.srce.hr/acphee/ (acta pharmaceutica- full text for last 2 years and abst for older journals) 01/28/15 78 http://www.ingentaconnect.com/content;jsessionid=1 3rvsr25ic2q1.victoria (many journals esp british) pubs.acs.org/journals (journals of American Chemical Society) www.blackwell-synergy.com (Blackwell Synergy Publications
  79. 79. 01/28/15 79
  80. 80. Applicant’s expectationsApplicant’s expectations Applicant is always interested in ◦ Low cost to file ◦ Less time in prosecution ◦ Less time in granting ◦ Minimum cost in maintainance All of this is only possible with PCT filing process 01/28/15 80
  81. 81. 01/28/15 81
  82. 82. 01/28/15 82
  83. 83. What is PCTWhat is PCT Patent cooperation treaty A United Nations treaty ◦ Signed in June 1970 ◦ Became operational in June 1978 ◦ Administered by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) in Geneva, Switzerland 01/28/15 83
  84. 84. Purpose of PCTPurpose of PCT To simplify the process of filing foreign patent applications To give every regional and national patent office the benefit of a search and a preliminary report on patentability by a major patent office 01/28/15 84
  85. 85. PCTPCT This system provides ◦ A common filing process. ◦ Minimizes the expenses in filing process. ◦ Gives enough time for an applicant to think and choose the territory he would like to cover. 01/28/15 85
  86. 86. What PCT providesWhat PCT provides There is no “international patent.” The Patent Cooperation Treaty (PCT) functions as a patent application filing system. The applicant must still prosecute the international application in each national or regional office in order to obtain a patent. 01/28/15 86
  87. 87. Traditional filingTraditional filing 01/28/15 87 0 12 File Application Locally File Applications Abroad (Months)
  88. 88. PCT FilingPCT Filing 01/28/15 88 File Demand File First Application File PCT International Search Report/ Written Opinion International Publication 0 12 16 18 International Preliminary Examination (Months) OR 30 20 Enter National Phase Chapter I Chapter II 30
  89. 89. 01/28/15 89
  90. 90. 01/28/15 90
  91. 91. Patent Time LinePatent Time Line © Copyright 2014 91 File Provisional Patent Application $ File US Nonprovisonal and/or PCT Application $$ Patent Application Publishes Enter National Stage $$$ 0 1 yr 18 mo 30 mo 21 yrs (20 from PCT Appl.) 25 yrs Patent Issues Patent Expires Up to 5 years Patent Term Restoration (drugs) 35 USC §156 23 yrs Up to 3 years Patent Term Adjustment for USPTO Delays 35 USC §154 30 mo0
  92. 92. 01/28/15 92
  93. 93. 93 Patent Cooperation Treaty (PCT)Patent Cooperation Treaty (PCT)  Single place of filing  International novelty and patentability search  Final decision for countries TILL 30 MONTHS ONE IS SAFE
  94. 94. 94 International patent systemsInternational patent systems Basic principle:  Patent in each country The systems:  Patent Cooperation Treaty (PCT)  European Patent Convention (EPC)  Other regional systems (OAPI,ARIPO, EURASIAN)
  95. 95. 01/28/15 95
  96. 96. 96
  97. 97. Active PharmaceuticalsActive Pharmaceuticals 01/28/15 97
  98. 98. Five basic patent searchesFive basic patent searches Application number Patent number Assignee name Inventor name Subject search
  99. 99.  By Chemical structure or chemical name  Solid/crystalline/hydrated forms (Physical form)  Purity of the API  Alternate salts  Process  Physicochemical characteristics  Technology 01/28/15 99 Claims..
  100. 100. 01/28/15 100 1. By Chemical structure or Name: 1.1. Claim by large Markush structure – Atorvastatin (US 4,681,893) Atorvastatin • Generally possible for innovators • Entire genus is novel • No clarity on the final target. • Broadest claim possible. • No design around possible. • Invalidation is the only option
  101. 101. 01/28/15 101 1. By Chemical structure or Name: 1.2. Claiming by simple structure – Paroxetine intermediate • Covers limited no of novel compounds. • Covers possible protecting groups and derivatives. • Generally possible when a novel scheme is designed for a known product.
  102. 102. Markush claimsMarkush claims Typically in chemical cases Allows broad claiming of many species of related compounds
  103. 103. Markush groupMarkush group
  104. 104. Markush claimMarkush claim DETAILED DESCRIPTION - 2,3-benzodiazepine derivatives of formula (I) and their acid addition salts are new. X=H, Cl or OCH3; Y=H or halo; Z=methyl or Cl; R=1-4C alkyl or NR1R2; and R1, R2 =H, 1-4C alkyl, 1-4C alkoxy or 3-6C cycloalkyl.
  105. 105. 01/28/15 105
  106. 106. 01/28/15 106 1. By Chemical structure or Name: 1.3. Claiming by Chemical name– Atorvastatin Calcium (US 5,273,995) • Covers one or two specific compounds and its salts. • Narrow in scope • Covers the actual commercial product. • Highly difficult to invalidate the patent. • Generally extends the life cycle of the product.
  107. 107. 01/28/15 107 2. By physical form: 2.1. By Solid form– Montelukast Acid (US 2005/107426) • Broad claim possible, if the compound is already known in a non- solid state. • Provide great value if some of the impurities are washable only by purification of the solid intermediate.
  108. 108. 01/28/15 108 2. By physical form: 2.2. By Crystalline form– Amlodipine free base (US 6680334) • Broad claim possible, if the compound is already known in a non- crystalline form. • Provide great value if non-crystalline form is significantly unstable for processing and pure product can be obtained only from crystalline material. • Can be used as alternate to API salt form if possible. • Generally stands in the litigation even-if the genus claim of compound claim is invalidated.
  109. 109. 01/28/15 109 2. By physical form: 2.3. By Specific parameters– Alfuzosin Base (WO 2006/090268) • Considered as the narrow claim. • Has value only if the known solid forms are protected or all of them are unstable for processing.
  110. 110. 01/28/15 110 3. By Purity: 3.1. By Purity of the API– Candesartan (US 20050250827 A1) 3.1. By Chiral Purity of the API–Armodafinil (WO 2007/103221) • API is known but with less purity. • Provide value if the impurity is a critical & difficult to remove or forms in stability. • Competitors will have to use impure materials and end up regulatory issues
  111. 111. 01/28/15 111 4. Alternate salts: 4.1. Alternate salts: (Desvenlafaxine – US7001920) 4.1. Alternate salts: (Sitagliptin – US2005032804) • Narrow in scope • Covers the actual salt of product. • Considered as easy to invalidate the patent if other salts are already known. • Generally extends the life cycle of the product.
  112. 112. 01/28/15 112 4. Diasteriomer salts: 4.1. Diasteriomer as compound (Eszopiclone -WO07/088073) 4.1. Diasteriomer with purity (Duloxetine-WO06/099459) 4.1. Diasteriomer in crystalline form (Eszopiclone -WO07/088073)
  113. 113. 01/28/15 113 5. Process for Preparation of API : 5.1. Generic process (Ramelteon)
  114. 114. 01/28/15 114 5. Process for Preparation of API : 5.2. Simple process (Paroxetine)
  115. 115. 01/28/15 115 5. Preparation of API : 5.3. Specific process (Duloxetine HCl)
  116. 116. 01/28/15 116 5. Preparation of API : 5.4. Specific process (Ziprasidone HCl)
  117. 117. 01/28/15 117 6. Physicochemical properties : 6.1. PSD of API compound (Ziprasidone HCl -US6150366) 1. A composition comprising crystalline ziprasidone free base or crystalline ziprasidone hydrochloride particles having a mean particle size equal to or less than about 85 μ and a pharmaceutically acceptable diluent or carrier. 6.2. PSD of API compound (Escitalopram -US6916941) Covers non-crystalline solid Atorvastatin salt having bulk density from about 0.05 to 0.4 g/ml; and mean particle size of about 0.5 to 50 microns 6.3. PSD & BD of API compound (Atorvastatin -WO2007100614)
  118. 118. 01/28/15 118 7. Technology: Synthesis of Piperizine ring (Mirtzapine-US 6852855)
  119. 119. 01/28/15 119 7. Technology : Synthesis of Amino acid amides (Levitiracetum-US 2005/0182262)
  120. 120. Patent Grant Procedure (In Brief) Filing of PATENT APPLICATION EXAMINATION & NOVELTY SEARCH ACCEPTANCE OR REFUSAL NOTIFICATION OF “ACCEPTANCE” IN THE GAZETTE OF INDIA (part III section 2) OPPOSITION (if any) GRANT OF A PATENT
  121. 121. Thank You 01/28/15 121Extras…
  122. 122. 01/28/15 122
  123. 123. US patents vs. non-US patentsUS patents vs. non-US patents Foreign patent applications published 18-36 months before US patents issue. After 29 November 2000, the US has published some applications over a range of dates. US will still be a slow publishing country for many applications Tracking foreign patents give insight to what will be publishing in the US as all are part of the same patent family.
  124. 124. A patent familyA patent family Contains all patents/applications that are linked by a common priority application number Includes divisionals, continuations, CIPs Includes members from other countries or treaties Are very useful when answering the most asked question in patents: “Find an English equivalent of this non-English patent.”
  125. 125. 1) Set a goal, dream, imagine! 2) Write it down! 3) Experiment, develop, modify and construct your invention. 4) It’s a SECRET! So...how do you “invent”?
  126. 126. Why would you want one?Why would you want one? Powerful form of protection Protects the idea rather than the implementation No need to show copying. Even an “innocent” infringer can be stopped Patents act as a deterrent to a competitor developing a similar product May strengthen your negotiating position if you infringe someone else’s patent May be a valuable asset in its own right: patents can be licensed and assigned
  127. 127. NoveltyNovelty  An invention is new if it does not form part of the “state of the art”  The state of the art includes all disclosures that were made available to the public before the filing date  This includes written and oral disclosures. Anything that has been sold and anything published online. In other words, the entire stock of publicly available knowledge  A grace period is applicable in the US. So - Sometimes patent protection is viable in the US when it is no longer available in Europe
  128. 128. Inventive StepInventive Step  An invention involves an inventive step if it is not obvious (with regard to the state of the art)  There may be an inventive step if the invention solves a problem, provides a surprising result, provides an increase in speed, efficiency etc..  There must be a technical solution to a technical problem: a divergence from existing technology that would not be developed by routine experimentation or applying known principles
  129. 129. Conclusion ◦ File ◦ File early ◦ Disclose everything that you know ◦ Be ready to negotiate
  130. 130. Commercial exploitationCommercial exploitation Various strategies can be used to extract value from patents:  Exclude your competitors from using the invention  Develop a thicket of patents to deter competitors from even considering your technology  Licensing  Use the patents to participate in a cross-licensing patent pool  Patents as marketing tools  Patents as defensive disclosures
  131. 131. 01/28/15 131 Patent Examining ProcessPatent Examining Process 1. Read1. Read 2. Search2. Search 3. Determine3. Determine PatentabilityPatentability 4. Communicate4. Communicate
  132. 132. A global perspectiveA global perspective Patents are territorial: there is no such thing as an international patent A UK patent can give you the right to stop others from making, selling, using and importing the invention in the UK. It gives no rights in other countries A separate patent is required in each country where protection is required In practice, it is usually sufficient to obtain patents in key territories
  133. 133. 133 PatentsPatents
  134. 134. Famous Patents – TheFamous Patents – The TelephoneTelephone US Patent 174,465 – Alexander Graham Bell “Improvement in Telegraphy” (1876) © Copyright 2014 134
  135. 135. Famous Patents – The Light BulbFamous Patents – The Light Bulb US Patent 223,898 – Thomas A. Edison “The Electric Light Bulb” (1880) © Copyright 2014 135
  136. 136. 136 INDIA….Regional Patent office’sINDIA….Regional Patent office’s JurisdictionJurisdiction Office Territorial Jurisdiction Patent Office Branch, Chennai The States of Andhra Pradesh, Karnataka, Kerala, Tamil Nadu and the Union Territories of Pondicherry and Lakshadweep Patent Office Branch Mumbai The States of Maharashtra, Gujarat, Madhya Pradesh, Goa and Chhattisgarh and the Union Territories of Daman and Diu & Dadra and Nagar Haveli. Patent Office Branch, New Delhi The States of Haryana, Himachal Pradesh, Jammu and Kashmir, Punjab, Rajasthan, Uttar Pradesh, Uttaranchal, Delhi and the Union Territory of Chandigarh. Patent Office, HO Kolkata The rest of India
  137. 137. 137 INDIA……..How to file a patentINDIA……..How to file a patent application?application?  Documents can be filed in the patent office  through online( e-filing) or  www.ipindiaonline.gov.in/online  through post or  can be submitted by hand
  138. 138. 138 GENERAL PROCEDURE FORGENERAL PROCEDURE FOR OBTAINING A PATENTOBTAINING A PATENT  Filing of patent application  Publication after 18 months  Pre Grant Opposition /Representation by any person.  Request for examination  Examination: Grant or Refusal  Publication of Grant of patent  Post Grant Opposition to grant of patent  Decision By Controller
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  140. 140. 140 INDIA….Statutory Fees:INDIA….Statutory Fees: Particular Natural person (Rs) Other than natural person (Rs) For filing patent application 1000 4000 For each sheet of specification in addition to 30 100 400 For each claim in addition to 10 200 800
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