Regulatory opportunities for IP attorneys 2010

Compliance/ IP
101
THE KULKARNI LAW FIRM
DARSHAN KULKARNI
PHARM.D, MS, ESQ.

TENSION

The Kulkarni Law Firm, 2010

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

STRUCTURE


DRUG DEVELOPMENT TIMELINE


MEETINGS


IP/REG LAWYERS INVOLVEMENT?


ISSUES THAT AFFECT THE IP
LAWYER ADVERTISING

IP/REG INVOLVEMENT?


SETTLEMENTS AND FINES

$5,300,000,000
False Claims Act Settlements in 2010


BIOMEDICAL PRODUCT PROMOTION
PROMOTION OF
UNAPPROVED PRODUCTS

PROMOTION TO DRUG
SUBJECTS ADVERTISING


FINES AND SETTLEMENTS


ISSUE SPOTTING

• Publicity decisions:

o Milestones reached
 Employment/ Contractor Agreements with key
personnel
 IND/NDA Meetings
 Key trial results
 Advisory Committee Meetings


OPPORTUNITIES

• Trademarking

• Trade Dress

• Trade Secrets
o Inadvertent disclosures

• Patents
o Statutory bars start tolling


LAWYER FEEDBACK LOOP

WHERE CAN IP/REG LAWYERS BE
INVOLVED?


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


DISCUSSIONS

• Definitions
• REMS
• Issue Spotting
• Opportunities


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.


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


LAWYER SERVICE AGREEMENTS

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


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


LAWYER DRUG NAMING

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

IP INVOLVEMENT?


ISSUE SPOTTING

• ISMP and medication safety

• Global uniformity

• Turf wars:

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

LAWYER EXTENSIONS
& EXCLUSIVITY

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

LAWYER EVERGREENING / LIFECYCLE
MANAGEMENT

LAWYER WHEN GENERICS ATTACK

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.

QUESTIONS?
QUERIES?
INQUIRIES?
CONCERNS?

COMMENTS?
CONFUSION?
DIFFICULTY?

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


Regulatory opportunities for IP attorneys 2010

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