Regulatory opportunities for IP attorneys 2010

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Regulatory opportunities for IP attorneys 2010

  1. 1. Compliance/ IP 101THE KULKARNI LAW FIRM DARSHAN KULKARNI PHARM.D, MS, ESQ.
  2. 2. TENSIONThe Kulkarni Law Firm, 2010
  3. 3. OUTLINE OF DISCUSSION • FDA Structure • Drug Development 101 • Issues that affect the IP Lawyer o Advertising o Feedback loop o Service Agreements o Drug Naming o Extensions & Exclusivity o Evergreening/ Lifecycle Management o When Generics AttackThe Kulkarni Law Firm, 2010
  4. 4. FDA STRUCTURE
  5. 5. STRUCTUREThe Kulkarni Law Firm, 2010
  6. 6. DRUG DEVELOPMENT 101
  7. 7. DRUG DEVELOPMENT TIMELINEThe Kulkarni Law Firm, 2010
  8. 8. PRE-CLINICAL DEVELOPMENT
  9. 9. MEETINGSThe Kulkarni Law Firm, 2010
  10. 10. IP/REG LAWYERS INVOLVEMENT?The Kulkarni Law Firm, 2010
  11. 11. ISSUES THAT AFFECT THE IPLAWYER ADVERTISING
  12. 12. IP/REG INVOLVEMENT?The Kulkarni Law Firm, 2010
  13. 13. SETTLEMENTS AND FINES $5,300,000,000 False Claims Act Settlements in 2010The Kulkarni Law Firm, 2010
  14. 14. BIOMEDICAL PRODUCT PROMOTION PROMOTION OF UNAPPROVED PRODUCTS PROMOTION TO DRUG SUBJECTS ADVERTISINGThe Kulkarni Law Firm, 2010
  15. 15. FINES AND SETTLEMENTSThe Kulkarni Law Firm, 2010
  16. 16. ISSUE SPOTTING • Publicity decisions: o Milestones reached  Employment/ Contractor Agreements with key personnel  IND/NDA Meetings  Key trial results  Advisory Committee MeetingsThe Kulkarni Law Firm, 2010
  17. 17. OPPORTUNITIES • Trademarking • Trade Dress • Trade Secrets o Inadvertent disclosures • Patents o Statutory bars start tollingThe Kulkarni Law Firm, 2010
  18. 18. ISSUES THAT AFFECT THE IPLAWYER FEEDBACK LOOP
  19. 19. WHERE CAN IP/REG LAWYERS BE INVOLVED?The Kulkarni Law Firm, 2010
  20. 20. CHANGE TRACKING Drug development is not static. There are constant changes in: • Manufacturing o Review change control o Review validations • Clinical feedback o Review pharmacovigilence o Review REMS reports o Review PSURs and other update reports • Evergreening and marketing o Review drug rep notes • Generics attacksThe Kulkarni Law Firm, 2010
  21. 21. DISCUSSIONS • Definitions • REMS • Issue Spotting • OpportunitiesThe Kulkarni Law Firm, 2010
  22. 22. DEFINITIONS • Pharmacovigilance: Keeping track of adverse events associated with a drug for the purpose of data collection and reporting. Tracks: o Expected and unexpected Adverse Events o Serious Adverse Events o Non serious Adverse Events (contentious) • Safety Signal: Adverse events associated with use of a product. Even a single well-documented case report may be a signal There is an assessment in causality by clinicians.The Kulkarni Law Firm, 2010
  23. 23. CLINICAL TRIAL REPORTING• SUSAR o Suspected Unexpected Serious Adverse Reaction report o 7-15 day reporting• CTSUR/ ASR / DSUR o Annual Safety Reports
  24. 24. MARKETED PRODUCT REPORTING• PSUR (Periodic Safety Annual Report) o Typically used for Europe/ Asia. o Courtesy copy given to US FDA o Varying intervals• USPR: o Used in the US o Varying intervals• SUSARs• CBEs
  25. 25. RISK EVALUATION AND MITIGATION STRATEGIES (REMS) • Approval pending periodic results. • More direct connection between clinicians and industry. • Typical components include: o medication guide, o communication, o elements to assure safe use, o implementation systemThe Kulkarni Law Firm, 2010
  26. 26. ISSUES THAT AFFECT THE IPLAWYER SERVICE AGREEMENTS
  27. 27. WHERE CAN IP/REG LAWYERS BE INVOLVED?The Kulkarni Law Firm, 2010
  28. 28. SERVICE AGREEMENTS WITH IP ISSUES • Confidentiality Agreements: CDA/ NDAs • Employment/ Individual Contractor Agreements • Supplier Agreements o API Suppliers • Research Agreements o Master Services Agreements o Preclinical University Agreements o Clinical Trial AgreementsThe Kulkarni Law Firm, 2010
  29. 29. TYPICAL IP ISSUES THAT NEED TO BE ADDRESSED • Confidentiality • Publication rights • Data ownership o Bayh Dole • Data protection rights o Who gets to control IP meets & bounds o Who gets to protect in court • JurisdictionThe Kulkarni Law Firm, 2010
  30. 30. ISSUES THAT AFFECT THE IPLAWYER DRUG NAMING
  31. 31. NAMES• Chemical Name (almost never clinically used) o e.g. (±) - 2 - (p - isobutylphenyl) propionic acid• Generic Name (Granted by USAN Council) o e.g. Ibuprofen• Brand Name (Company created) o e.g. Motrin
  32. 32. IP INVOLVEMENT?The Kulkarni Law Firm, 2010
  33. 33. STEPS TO NAMING A DRUG
  34. 34. ISSUE SPOTTING• ISMP and medication safety• Global uniformity• Turf wars:
  35. 35. OPPORTUNITIES• Trademarking o Trademarking drug names o Branding ("the purple pill")• Trade Dress associated with certain drugs: o Inhalers (Advair) o Branding ("the purple pill") o Valium shape
  36. 36. ISSUES THAT AFFECT THE IPLAWYER EXTENSIONS & EXCLUSIVITY
  37. 37. WHERE CAN IP/REG LAWYERS BE INVOLVED?The Kulkarni Law Firm, 2010
  38. 38. PATENT TERM RESTORATION• Allows for recouping patent term lost due to regulatory approval.• Max: 5 years + the patent life after product approval < 14 years. One-half the period in clinical trials (from IND effective date to NDA filing date) + Entire period of FDA review = Patent Term Restored
  39. 39. MARKETING EXCLUSIVITY• 7 years: Orphan Drug• 5 years: New Chemical Entity• 3 years: Change in a product.• 6 month (add on): Pediatric Exclusivity• 180 days: 1st generic manufacturer to file a complete ANDA containing a Paragraph IV cert. challenging a listed patent.
  40. 40. ORPHAN DRUG EXCLUSIVITY• 7 year exclusivity• Orphan Drug: treating < 200,000 pts in the US/ year• Exclusivity for the condition
  41. 41. NEW CHEMICAL ENTITY• 5 years protection o Starts after NDA Approval• New Chemical Entity: o the first approval for a drug product, no salt or ester of which has ever received FDA approval• FDA will not accept ANDAs and 505(b)(2) applications.• May accept Para IV certification.
  42. 42. CHANGES IN A PRODUCT• 3 years of exclusivity• Requires the conduct of new clinical studies that are judged to be essential for approval of the change• Examples of changes: o new dosage form (eg, XR version) o a new use or indication, o a new salt or ester of a drug product, o a change in strength
  43. 43. ISSUES THAT AFFECT THE IPLAWYER EVERGREENING / LIFECYCLE MANAGEMENT
  44. 44. EVERGREENING STRATEGIES
  45. 45. ISSUES THAT AFFECT THE IPLAWYER WHEN GENERICS ATTACK
  46. 46. WHERE CAN IP/REG LAWYERS BE INVOLVED?The Kulkarni Law Firm, 2010
  47. 47. ORANGE BOOK• List all patents in the orange book• Must certify and notify the patent holder that: o Para I: no patents listed in the Orange Book on the RLD o Para II: there is a patent listed in the Orange Book, but it has expired o Para III: there is a listed, non expired patent on the RLD. The ANDA applicant does not plan to market its product prior to patent expiration. o Para IV: Patent is invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the generic product.
  48. 48. PARA IV: TIMELINES
  49. 49. QUESTIONS? QUERIES? INQUIRIES? CONCERNS? COMMENTS? CONFUSION?DIFFICULTY?
  50. 50. REFERENCES • FDA Extends False Claims Act to GMP Violations in $750 Million GSK Settlement, http://www.ipqpubs.com/news/fda-extends-false-claims-act-to-gmp- violations-in-750-million-gsk-settlement/ • Naming, Labeling, and Packaging of Pharmaceuticals, http://www.medscape.com/viewarticle/414871 • Pharmaceutical Patent and Exclusivity Complexity: Implications for Generic Product Introductions, https://secure.pharmacytimes.com/lessons/200208-01.aspThe Kulkarni Law Firm, 2010

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