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


FDA STRUCTURE

STRUCTURE


DRUG DEVELOPMENT 101

DRUG DEVELOPMENT TIMELINE


PRE-CLINICAL DEVELOPMENT

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


PROMOTION OF UNAPPROVED PRODUCTS

DRUG ADVERTISING

BIOMEDICAL PRODUCT PROMOTION

PROMOTION TO SUBJECTS


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


ISSUES THAT AFFECT THE IP 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


ISSUES THAT AFFECT THE IP 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


ISSUES THAT AFFECT THE IP 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?


STEPS TO NAMING A DRUG

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

ISSUES THAT AFFECT THE IP 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

ISSUES THAT AFFECT THE IP LAWYER EVERGREENING / LIFECYCLE

MANAGEMENT

EVERGREENING STRATEGIES

ISSUES THAT AFFECT THE IP 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.

PARA IV: TIMELINES

QUESTIONS?

COMMENTS?

QUERIES?

CONCERNS?

INQUIRIES?

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


http://www.ipqpubs.com/news/fda-extends-false-claims-act-to-gmp-violations-in-750-million-gsk-settlement/

























http://www.medscape.com/viewarticle/414871

https://secure.pharmacytimes.com/lessons/200208-01.asp



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Regulatory opportunities for IP attorneys 2010