Generic Launches and Risk Mitigation

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Generic Launches and Risk Mitigation

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Generic Launches and Risk Mitigation

  1. 1. GENERIC LAUNCHES AND RISK MITIGATION Supriya Ramacha Copyright 2012 BananaIP Website: www.bananaip.com Blog: www.bananaip.com/sinapse-blog
  2. 2. AGENDA  Product launch  Risks in product launch  Risk mitigation strategies
  3. 3. PRODUCT LAUNCH - GENERIC
  4. 4. PRODUCT LAUNCH  Risk free route Patent expiry Work around  At-risk route Challenge/Infringe
  5. 5. RISKS IN PRODUCT LAUNCHES
  6. 6. BACKGROUND  Patent Rights  Make  Use  Sell  Offer for sale  Import  Territorial  Term
  7. 7. PATENT RISKS  Standard Patent Term  Term extensions Patent office delays Regulatory delays
  8. 8. US-TERM EXTENSIONS  Patent process-Patent term adjustments (PTA) One day extension - every day delayed Objective = 17 years Types A delays (failure to act-14-4-4-4 rule) B delays (pendency beyond 3 years) C delays (special situation)
  9. 9. EXAMPLE  Billy owns a US patent application for a drug “X” filed on Jan 1st 2002, for which he receives the first office action on June 1st 2003. The patent is issued on Jan 1st 2005. Silly, a generic drug maker, wants to launch “Y,” the generic version of the drug.  Launch date?
  10. 10.  Bopi files a US patent application for a drug “Alpha” filed on Jan 1st 1998, for which it receives the first office action on June 1st 2000. The patent is issued on Jan 1st 2005. Dopi, a generic drug maker, wants to launch “Beta,” the generic version of the drug.  PTA?
  11. 11. EXAMPLE  Billy’s application for a drug “X” filed on Jan 1st 2002 receives the first office action on June 1st 2003.  Billy’s patent is issued on March 1st 2007 after paying the issue fee on Sept 1st 2006  Silly’s Launch date ?  Wyeth Vs Kappos case
  12. 12. PATENT TERM EXTENSIONS  Regulatory process-Patent term extensions (PTE) 1/2 Testing phase + Approval phase  Calculation max of 5 years extension NMT 14 years of potential marketing exclusivity
  13. 13. EXAMPLE  Mandoz files for a US patent on “Mentos” on April 1st 2000. The patent is issued on July 1st 2002. It subsequently files an IND application effective on July 1st 2003.  Mandoz files an NDA on July 1st 2005 and receives approval on July 1st 2006.  Possible extension?  Actual extension?  Launch date?
  14. 14. PTEs depends on the no. of potential exclusive marketing term available.
  15. 15. EXAMPLE  Mandoz files for a US patent on “Mentos” on April 1st 2000. It files an IND application effective on July 1st 2002. The patent was issued on July 1st 2003.  Mandoz files for an NDA on July 1st 2005 and receives NDA approval on July 1st 2006.  Possible extension?  Actual extension?  Launch date?  Sprycel Tablets, Dasatinib,US6596746
  16. 16. PTE  Calculation Does not include anytime before the date of patent issue  Total patent term= Standard patent term + PTA + PTE
  17. 17. EUROPE  Regulatory process- Supplementary protection certificate (SPC) SPC Term= (1st MA date - patent filing date) - 5 years. territorial Calculation 5 years max (+6 months) NMT 15 years of potential marketing exclusivity  Total patent term = Standard Patent term + SPC
  18. 18. EXAMPLE  Dizer, a French applicant, obtains a national marketing approval on Jan 1st 2000, for a product protected by a patent with the filing date of Jan 1st 1990.  Dizer has also received a marketing approval in Britain on Jan 1st 1997.  Launch date?
  19. 19. EXAMPLE  Banana & Co. files for a patent in France on Jan 1st 1998 for a drug “Todi” and receives a national marketing approval on Jan 1st 2001. It also files for a patent in Spain on Jan 1st 1999 and receives a marketing approval in Spain on Jan 1st 2000.  Launch date in France?
  20. 20. REGULATORY HURDLES IN GENERIC LAUNCH Copyright 2012 Brain League
  21. 21. REGULATORY HURDLES  Regulatory exclusivities Data exclusivity Other exclusivity
  22. 22. US EXCLUSIVITIES  Data exclusivity- 5 years (+1.5 to 2 years)  Other exclusivity- New clinical study exclusivity-3 years Orphan drug exlusivity-7 years Pediatric exclusivity-6 months
  23. 23. EUROPE  Currently- 6 or 10 years (+1 to 3 years)  New- 8+2+1 regime  Current- (2001/83/EC Directive)  New- (2001/83/EC Directive as amended by 2004/27/EC)
  24. 24. RISK MITIGATION STRATEGIES
  25. 25. RISK MITIGATION STRATEGIES  Risk free launches Identify blocking patents- FTO analysis Understanding expiry  Infringement/ Challenging Identify evidences – Invalidation  Work around Technology Landscaping
  26. 26. FTO ANALYSIS Copyright 2012 Brain League
  27. 27. EVALUATE FTO  Search Patent databases-blocking patent/application  Analysis Infringement
  28. 28. ANALYSIS  Infringement factors Territorial Term Claims
  29. 29. TECHNOLOGY LANDSCAPE ANALYSIS
  30. 30. ©2011Intellecture (www.intellectureindia.com)
  31. 31. TECHNOLOGY MAP
  32. 32. THANK YOU FOR MORE DETAILS VISIT WWW.BANANAIP.COM/SINAPSE-BLOG A Property of BananaIP

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