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GeneriKairos® making faster Generics
Factors affecting marketing of a Generic
Drug Product ?
Molecule patent expiry date
Later expiring patents - Need significant
 R&D, might       delay       generic           drug
 development


                     GeneriKairos® making faster Generics
Success of a Generic Drug Product
 First to market on the day of molecule patent expiry
 Focus on challenges like technology and patent
 protection of:
   molecular forms
   process
   formulation patents
   dosage regimen
   method of use

                            GeneriKairos®   making faster Generics
Generic Drug Development
 Exhaustive process
 Interplay of Research & Development Team and
  Intellectual Property Team
 Considerable time is lost in:
   patent searching
   compiling relevant records
   file history analysis
  innovator patent analysis
  prosecution history study
  while development is being carried out at the R&D
                                  GeneriKairos®   making faster Generics
Development of a Generic Drug Product
        Identification of the Potential
                  Candidate



                                               • Prosecution History
             Study of OB Patents               • Patent Family
LAG –TIME
 for R&D                                     • Numerous databases
                  Prior – Art Search         • Access to paid databases
                                             • Around 1,000-2,000 hits

                                          • Identification of Relevant Patents
                   Patent Landscape
                                          • Design-Around Strategy

                            R& D

                     Generic
                      Drug
                     Product                    GeneriKairos® making faster Generics
How Generikairos® helps you…
          Identification of the Potential Candidate




                    Study of OB Patents                       • Prosecution History
                                                              • Patent Family
 GeneriKairos®
                                                      • Numerous databases
  Formulation          Prior – Art Search
                                                      • Access to paid databases
 Patent Reports                                       • Around 1,000-2,000 hits
                         Patent Landscape    • Identification of Relevant Patents
                                             • Design-Around Strategy

                                 R& D

                               Generic
                                Drug
                               Product
                                               GeneriKairos® making faster Generics
Generikairos® Solution
 Provide ready-to-use Formulation Patent Reports for
  Generics on a per-drug basis
 Information pertaining to formulation patents for a
  particular drug product required for Generic Drug
  Development compiled in one place
 Your IP Team can concentrate on giving formulation
  clearance to your drug product based on your in-house
 designing


                           GeneriKairos® making faster Generics
Reports Attractions
 Formulation Patent landscape as a result of comprehensive
  formulation patents prior art search in global data bases and
  scientific literature
 Generic Product filing strategy

 Relevant records Identified

 File history study for key patents

 Suggested design-around strategy

                                    GeneriKairos® making faster Generics
Scope of the Reports
  Specially segregated for US, Canada, EU and PCT to
   meet the requirements for regulated markets

  Can be extended to be used for semi-regulated and
   non-regulated markets through INPADOC Family data
   given in the reports and the formulation patent report
   covering PCT applications.



                             GeneriKairos® making faster Generics
Expertise at Generikairos®
 Highly skilled patent professionals - basic degree of
  masters in Pharmaceutical Sciences
 In-depth knowledge of pharmaceutical sciences and
  formulation-A precondition for thoughtful understanding
  and interpretation of formulation patents.
 Professional work history-Extensive experience in
  formulation patents searching and analysis with various
  generic companies


                             GeneriKairos® making faster Generics
Search Strategies
 Patent searching- An intricate task requiring
  proficiency, scanning vast amount of patents published
  in a wide variety of commercial databases.
 Databases lack consistency in information
 Strategies by innovator companies to avoid patent
  identification, might conspicuously publish their
  patents, or use different names
 Availability of patent information is the prime concern-
  Generic companies

                             GeneriKairos® making faster Generics
Search Strategies (Continued…)
 Our patent professionals use a wide range of search
  strategies in a wide range of databases
 Make the most relevant and reliable patent information
  available to you
 A mixture of appropriate Boolean query, generic
  names, alternate names, mode of action, general
  search terms, patent classification codes



                             GeneriKairos® making faster Generics
Other Services
  www.generikairos.com- Cumulative data for OB, Canada
   Patent Register
  Infringement Analysis
  Claim Mapping
  Prior-Art Search

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Generikairos

  • 2. Factors affecting marketing of a Generic Drug Product ? Molecule patent expiry date Later expiring patents - Need significant R&D, might delay generic drug development GeneriKairos® making faster Generics
  • 3. Success of a Generic Drug Product  First to market on the day of molecule patent expiry  Focus on challenges like technology and patent protection of:  molecular forms  process  formulation patents  dosage regimen  method of use GeneriKairos® making faster Generics
  • 4. Generic Drug Development  Exhaustive process  Interplay of Research & Development Team and Intellectual Property Team  Considerable time is lost in: patent searching compiling relevant records file history analysis innovator patent analysis prosecution history study while development is being carried out at the R&D GeneriKairos® making faster Generics
  • 5. Development of a Generic Drug Product Identification of the Potential Candidate • Prosecution History Study of OB Patents • Patent Family LAG –TIME for R&D • Numerous databases Prior – Art Search • Access to paid databases • Around 1,000-2,000 hits • Identification of Relevant Patents Patent Landscape • Design-Around Strategy R& D Generic Drug Product GeneriKairos® making faster Generics
  • 6. How Generikairos® helps you… Identification of the Potential Candidate Study of OB Patents • Prosecution History • Patent Family GeneriKairos® • Numerous databases Formulation Prior – Art Search • Access to paid databases Patent Reports • Around 1,000-2,000 hits Patent Landscape • Identification of Relevant Patents • Design-Around Strategy R& D Generic Drug Product GeneriKairos® making faster Generics
  • 7. Generikairos® Solution  Provide ready-to-use Formulation Patent Reports for Generics on a per-drug basis  Information pertaining to formulation patents for a particular drug product required for Generic Drug Development compiled in one place  Your IP Team can concentrate on giving formulation clearance to your drug product based on your in-house designing GeneriKairos® making faster Generics
  • 8. Reports Attractions  Formulation Patent landscape as a result of comprehensive formulation patents prior art search in global data bases and scientific literature  Generic Product filing strategy  Relevant records Identified  File history study for key patents  Suggested design-around strategy GeneriKairos® making faster Generics
  • 9. Scope of the Reports  Specially segregated for US, Canada, EU and PCT to meet the requirements for regulated markets  Can be extended to be used for semi-regulated and non-regulated markets through INPADOC Family data given in the reports and the formulation patent report covering PCT applications. GeneriKairos® making faster Generics
  • 10. Expertise at Generikairos®  Highly skilled patent professionals - basic degree of masters in Pharmaceutical Sciences  In-depth knowledge of pharmaceutical sciences and formulation-A precondition for thoughtful understanding and interpretation of formulation patents.  Professional work history-Extensive experience in formulation patents searching and analysis with various generic companies GeneriKairos® making faster Generics
  • 11. Search Strategies  Patent searching- An intricate task requiring proficiency, scanning vast amount of patents published in a wide variety of commercial databases.  Databases lack consistency in information  Strategies by innovator companies to avoid patent identification, might conspicuously publish their patents, or use different names  Availability of patent information is the prime concern- Generic companies GeneriKairos® making faster Generics
  • 12. Search Strategies (Continued…)  Our patent professionals use a wide range of search strategies in a wide range of databases  Make the most relevant and reliable patent information available to you  A mixture of appropriate Boolean query, generic names, alternate names, mode of action, general search terms, patent classification codes GeneriKairos® making faster Generics
  • 13. Other Services  www.generikairos.com- Cumulative data for OB, Canada Patent Register  Infringement Analysis  Claim Mapping  Prior-Art Search