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Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
Regulatory opportunities for IP attorneys 2010
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Regulatory opportunities for IP attorneys 2010

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  • 1. Compliance/ IP 101THE KULKARNI LAW FIRM DARSHAN KULKARNI PHARM.D, MS, ESQ.
  • 2. TENSIONThe Kulkarni Law Firm, 2010
  • 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. FDA STRUCTURE
  • 5. STRUCTUREThe Kulkarni Law Firm, 2010
  • 6. DRUG DEVELOPMENT 101
  • 7. DRUG DEVELOPMENT TIMELINEThe Kulkarni Law Firm, 2010
  • 8. PRE-CLINICAL DEVELOPMENT
  • 9. MEETINGSThe Kulkarni Law Firm, 2010
  • 10. IP/REG LAWYERS INVOLVEMENT?The Kulkarni Law Firm, 2010
  • 11. ISSUES THAT AFFECT THE IPLAWYER ADVERTISING
  • 12. IP/REG INVOLVEMENT?The Kulkarni Law Firm, 2010
  • 13. SETTLEMENTS AND FINES $5,300,000,000 False Claims Act Settlements in 2010The Kulkarni Law Firm, 2010
  • 14. BIOMEDICAL PRODUCT PROMOTION PROMOTION OF UNAPPROVED PRODUCTS PROMOTION TO DRUG SUBJECTS ADVERTISINGThe Kulkarni Law Firm, 2010
  • 15. FINES AND SETTLEMENTSThe Kulkarni Law Firm, 2010
  • 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. OPPORTUNITIES • Trademarking • Trade Dress • Trade Secrets o Inadvertent disclosures • Patents o Statutory bars start tollingThe Kulkarni Law Firm, 2010
  • 18. ISSUES THAT AFFECT THE IPLAWYER FEEDBACK LOOP
  • 19. WHERE CAN IP/REG LAWYERS BE INVOLVED?The Kulkarni Law Firm, 2010
  • 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. DISCUSSIONS • Definitions • REMS • Issue Spotting • OpportunitiesThe Kulkarni Law Firm, 2010
  • 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. CLINICAL TRIAL REPORTING• SUSAR o Suspected Unexpected Serious Adverse Reaction report o 7-15 day reporting• CTSUR/ ASR / DSUR o Annual Safety Reports
  • 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. 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. ISSUES THAT AFFECT THE IPLAWYER SERVICE AGREEMENTS
  • 27. WHERE CAN IP/REG LAWYERS BE INVOLVED?The Kulkarni Law Firm, 2010
  • 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. 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. ISSUES THAT AFFECT THE IPLAWYER DRUG NAMING
  • 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. IP INVOLVEMENT?The Kulkarni Law Firm, 2010
  • 33. STEPS TO NAMING A DRUG
  • 34. ISSUE SPOTTING• ISMP and medication safety• Global uniformity• Turf wars:
  • 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. ISSUES THAT AFFECT THE IPLAWYER EXTENSIONS & EXCLUSIVITY
  • 37. WHERE CAN IP/REG LAWYERS BE INVOLVED?The Kulkarni Law Firm, 2010
  • 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. 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. ORPHAN DRUG EXCLUSIVITY• 7 year exclusivity• Orphan Drug: treating < 200,000 pts in the US/ year• Exclusivity for the condition
  • 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. 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. ISSUES THAT AFFECT THE IPLAWYER EVERGREENING / LIFECYCLE MANAGEMENT
  • 44. EVERGREENING STRATEGIES
  • 45. ISSUES THAT AFFECT THE IPLAWYER WHEN GENERICS ATTACK
  • 46. WHERE CAN IP/REG LAWYERS BE INVOLVED?The Kulkarni Law Firm, 2010
  • 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. PARA IV: TIMELINES
  • 49. QUESTIONS? QUERIES? INQUIRIES? CONCERNS? COMMENTS? CONFUSION?DIFFICULTY?
  • 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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