Abstract
Introduction
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 intensifi es. Both sides are
ratcheting up their efforts to gain advantage under various statutory and
regulatory provisions of both patent and drug law
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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-profi le 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?
Decision Resources, Inc. 12-2
Scope
- Hatch-Waxman Act and Procedure: new drug application (NDA);
abbreviated new drug application (ANDA); paragraph I, II, III, and IV certifi
cations; 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
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