regulatory opportunities for ip attorneys 2010
TRANSCRIPT
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 Attack
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SETTLEMENTS AND FINES
$5,300,000,000 False Claims Act Settlements in 2010
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PROMOTION OF UNAPPROVED PRODUCTS
DRUG ADVERTISING
BIOMEDICAL PRODUCT PROMOTION
PROMOTION TO SUBJECTS
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ISSUE SPOTTING
• Publicity decisions:
o Milestones reached
Employment/ Contractor Agreements with key personnel
IND/NDA Meetings
Key trial results
Advisory Committee Meetings
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OPPORTUNITIES
• Trademarking
• Trade Dress
• Trade Secrets
o Inadvertent disclosures
• Patents
o Statutory bars start tolling
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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 attacks
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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.
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CLINICAL TRIAL REPORTING
• SUSAR o Suspected Unexpected Serious Adverse Reaction report o 7-15 day reporting
• CTSUR/ ASR / DSUR
o Annual Safety Reports
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
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 system
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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 Agreements
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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 • Jurisdiction
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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
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
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
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.
ORPHAN DRUG EXCLUSIVITY
• 7 year exclusivity • Orphan Drug: treating < 200,000 pts in the US/ year • Exclusivity for the condition
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.
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
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.
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.asp
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