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High-Profile Cases Are Questioning the Standards By Which Patents Are Enforceable Read More Inside 'End Strategies to Meet Generics Challenges and Reduce Pharmaceutical Risk'

Posted on: Tuesday, 7 November 2006, 00:01 CST

Research and Markets (http://www.researchandmarkets.com/reports/c44670) has announced the addition of Front-End Strategies to Meet Generics Challenges and Reduce Pharmaceutical Risk to their offering.

Any company with a drug worthy of launch in the U.S. market is vulnerable to patent litigation. Even the mere announcement of litigation against an innovator can drastically dampen sales and share prices. As the risk and complexity of litigation continues to increase, the battle between generics companies and pharmaceutical innovators intensifies. Both sides are ratcheting up their efforts to gain advantage under various statutory and regulatory provisions of both patent and drug law.

Get the Answers You Need to Shape Your Strategy

The Hatch-Waxman Act of 1984 attempted to balance the interests of innovator and generic pharmaceutical companies and caused a surge in patent litigation. More than 20 years later, the pharmaceutical market has grown far more complex. How have innovator and generics companies used provisions under the Hatch-Waxman Act, and how have their strategies changed over the years?

High-profile cases are questioning the standards by which patents are enforceable. What pivotal court decisions are shaping patent and drug laws and forcing innovators to analyze their patent development processes?

The life spans of pharmaceutical patents are shrinking, and proposed legislation threatens to weaken patents even further. Generics companies can begin the process of challenging a patent when a drug is still in early development. How are innovator companies protecting their patents? What are some additional tactics they can adopt? What lessons can be learned regarding how to respond to a generics challenge without mishandling a billion-dollar drug, as happened with Bristol-Myers Squibb and Sanofi -Aventis over Plavix?

Scope

Hatch-Waxman Act and Procedure: new drug application (NDA); abbreviated new drug application (ANDA); paragraph I, II, III, and IV certifications; authorized generics; and the 180-day incentive.

The changing landscape of patent litigation: interaction of patent and drug law, sameness requirements, petitioning the FDA, citizen petition, 505(b)(2) NDA application, "carve-out" and "section viii statement."

Front-end litigation strategies: patent and FDA procedures, positioning for advantage, judicial decisions, launching at risk, and authorized generics.

Outlook: future implications for generic and innovator pharmaceutical manufacturers, regulators, legislators, and enforcement agencies.

Content Outline:

Executive Summary

Strategic Implications

Stakeholder Implications

Generic Pharmaceuticals

The Changing Landscape of Pharmaceutical Patent Litigation Risk

Hatch-Waxman Act

Strategic Use of the Hatch-Waxman Procedure

Hatch-Waxman Procedure

Authorized Generics and the 180-Day "Incentive"

The Growing Challenge to Patents--Interaction of Patent and Drug Law

Coordinating Patent and NDA Submissions

Sameness Requirements

Petitioning the FDA

The Citizen Petition

The Zocor Case--Merck Declines to Sue, then De-Lists Its Patents

"Carve-Out" and "Section viii Statement"

505(b)(2) NDA Application

Biogenerics--"Follow-On" Biologicals

Patent Litigation

Outlook

Tables

Figures

U.S. Courts and Government Agencies

Federal Trade Commission

Food and Drug

Administration

U.S. Congress

U.S. Court of Appeals for the

District of Columbia

U.S. Court of Appeals for the

Federal Circuit

U.S. Patent and Trademark

Offi ce

U.S. Supreme Court

Companies and Organizations:

Abbott

Alpharma

Andrx

Apotex

AstraZeneca

Barr Laboratories

Baxter

Bayer AG

Biotechnology Industry

Organization

Biovail

Bradley

Bristol-Myers Squibb

Dr. Reddy's

eBay

Elan

Eli Lilly

Genentech

Generic Pharmaceutical

Association

GlaxoSmithKline

Greenstone

Impax

IVAX

Janssen

KSR

Lederle Parenterals

Lehman Brothers

MercExchange

Merck

MGI

Mylan

Novartis

Ortho McNeil

Par Pharmaceutical

Pharmaceutical Care and

Management Association

Purdue

Procter & Gamble

Pfizer

Ranbaxy

Sandoz

Sanofi -Aventis

Schering-Plough

Serono

Teleflex

Teva

United States Pharmacopoeia

UnitedHealth Group

Upsher-Smith

Warner-Lambert

Watson

WellPoint

For more information visit http://www.researchandmarkets.com/reports/c44670

Source: Decision Resources

Source: Business Wire

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