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These excerpts taken from the LLY 10-K filed Oct 21, 2008. Patent
Challenges Under the Hatch-Waxman Act
The Drug Price Competition and Patent Term Restoration Act of
1984, commonly known as “Hatch-Waxman,” made a complex
set of changes to both patent and new-drug-approval laws in the
United States. Before Hatch-Waxman, no drug could be approved
without providing the Food and Drug Administration (FDA)
complete safety and efficacy studies, i.e., a complete
New Drug Application (NDA). Hatch-Waxman authorizes the FDA to
approve generic versions of innovative pharmaceuticals (other
than biological products) without such information by filing an
Abbreviated New Drug Application (ANDA). In an ANDA, the generic
manufacturer must demonstrate only “bioequivalence”
between the generic version and the NDA-approved
drug – not safety and efficacy.
Absent a successful patent challenge, the FDA cannot approve an
ANDA until after the innovator’s patents expire. However,
after the innovator has marketed its product for four years, a
generic manufacturer may file an ANDA alleging that one or more
of the patents listed in the innovator’s NDA are invalid or
not infringed. This allegation is commonly known as a
“Paragraph IV certification.” The innovator must
then file suit against the generic manufacturer to protect its
patents. If one or more of the NDA-listed patents are
successfully challenged, the first filer of a Paragraph IV
certification may be entitled to a
180-day
period of market exclusivity over all other generic
manufacturers.
In recent years, generic manufacturers have used
Paragraph IV certifications extensively to challenge
patents on a wide array of innovative pharmaceuticals, and we
expect this trend to continue. We are currently in litigation
with numerous generic manufacturers arising from their
Paragraph IV certifications on Evista, Gemzar, and
Strattera. For more information on these, see Part II,
Item 7, “Management’s Discussion and
Analysis – Legal and Regulatory Matters.”
Table of Contents
Patent Challenges Under the Hatch-Waxman Act The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as “Hatch-Waxman,” made a complex set of changes to both patent and new-drug-approval laws in the United States. Before Hatch-Waxman, no drug could be approved without providing the Food and Drug Administration (FDA) complete safety and efficacy studies, i.e., a complete New Drug Application (NDA). Hatch-Waxman authorizes the FDA to approve generic versions of innovative pharmaceuticals (other than biological products) without such information by filing an Abbreviated New Drug Application (ANDA). In an ANDA, the generic manufacturer must demonstrate only “bioequivalence” between the generic version and the NDA-approved drug – not safety and efficacy. Absent a successful patent challenge, the FDA cannot approve an ANDA until after the innovator’s patents expire. However, after the innovator has marketed its product for four years, a generic manufacturer may file an ANDA alleging that one or more of the patents listed in the innovator’s NDA are invalid or not infringed. This allegation is commonly known as a “Paragraph IV certification.” The innovator must then file suit against the generic manufacturer to protect its patents. If one or more of the NDA-listed patents are successfully challenged, the first filer of a Paragraph IV certification may be entitled to a 180-day period of market exclusivity over all other generic manufacturers. In recent years, generic manufacturers have used Paragraph IV certifications extensively to challenge patents on a wide array of innovative pharmaceuticals, and we expect this trend to continue. We are currently in litigation with numerous generic manufacturers arising from their Paragraph IV certifications on Evista, Gemzar, and Strattera. For more information on these, see Part II, Item 7, “Management’s Discussion and Analysis – Legal and Regulatory Matters.”
Table of ContentsThese excerpts taken from the LLY 10-K filed Feb 29, 2008. Patent
Challenges Under the Hatch-Waxman Act
The Drug Price Competition and Patent Term Restoration Act of
1984, commonly known as “Hatch-Waxman,” made a complex
set of changes to both patent and new-drug-approval laws in the
United States. Before Hatch-Waxman, no drug could be approved
without providing the Food and Drug Administration (FDA)
complete safety and efficacy studies, i.e., a complete
New Drug Application (NDA). Hatch-Waxman authorizes the FDA to
approve generic versions of innovative pharmaceuticals (other
than biological products) without such information by filing an
Abbreviated New Drug Application (ANDA). In an ANDA, the generic
manufacturer must demonstrate only “bioequivalence”
between the generic version and the NDA-approved
drug – not safety and efficacy.
Absent a successful patent challenge, the FDA cannot approve an
ANDA until after the innovator’s patents expire. However,
after the innovator has marketed its product for four years, a
generic manufacturer may file an ANDA alleging that one or more
of the patents listed in the innovator’s NDA are invalid or
not infringed. This allegation is commonly known as a
“Paragraph IV certification.” The innovator must
then file suit against the generic manufacturer to protect its
patents. If one or more of the NDA-listed patents are
successfully challenged, the first filer of a Paragraph IV
certification may be entitled to a
180-day
period of market exclusivity over all other generic
manufacturers.
In recent years, generic manufacturers have used
Paragraph IV certifications extensively to challenge
patents on a wide array of innovative pharmaceuticals, and we
expect this trend to continue. We are currently in litigation
with numerous generic manufacturers arising from their
Paragraph IV certifications on Evista, Gemzar, and
Strattera. For more information on these, see Part II,
Item 7, “Management’s Discussion and
Analysis – Legal and Regulatory Matters.”
Patent Challenges Under the Hatch-Waxman Act The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as “Hatch-Waxman,” made a complex set of changes to both patent and new-drug-approval laws in the United States. Before Hatch-Waxman, no drug could be approved without providing the Food and Drug Administration (FDA) complete safety and efficacy studies, i.e., a complete New Drug Application (NDA). Hatch-Waxman authorizes the FDA to approve generic versions of innovative pharmaceuticals (other than biological products) without such information by filing an Abbreviated New Drug Application (ANDA). In an ANDA, the generic manufacturer must demonstrate only “bioequivalence” between the generic version and the NDA-approved drug – not safety and efficacy. Absent a successful patent challenge, the FDA cannot approve an ANDA until after the innovator’s patents expire. However, after the innovator has marketed its product for four years, a generic manufacturer may file an ANDA alleging that one or more of the patents listed in the innovator’s NDA are invalid or not infringed. This allegation is commonly known as a “Paragraph IV certification.” The innovator must then file suit against the generic manufacturer to protect its patents. If one or more of the NDA-listed patents are successfully challenged, the first filer of a Paragraph IV certification may be entitled to a 180-day period of market exclusivity over all other generic manufacturers. In recent years, generic manufacturers have used Paragraph IV certifications extensively to challenge patents on a wide array of innovative pharmaceuticals, and we expect this trend to continue. We are currently in litigation with numerous generic manufacturers arising from their Paragraph IV certifications on Evista, Gemzar, and Strattera. For more information on these, see Part II, Item 7, “Management’s Discussion and Analysis – Legal and Regulatory Matters.”
This excerpt taken from the LLY 10-K filed Feb 28, 2007. Patent
Challenges Under the Hatch-Waxman Act
The Drug Price Competition and Patent Term Restoration Act of
1984, commonly known as “Hatch-Waxman,” made a complex
set of changes to both patent and new-drug-approval laws in the
United States. Before Hatch-Waxman, no drug could be approved
without providing the Food and Drug Administration (FDA)
complete safety and efficacy studies, i.e., a complete
New Drug Application (NDA). Hatch-Waxman authorizes the FDA to
approve generic versions of innovative pharmaceuticals (other
than biological products) without such information by filing an
Abbreviated New Drug Application (ANDA). In an ANDA, the generic
manufacturer must demonstrate only “bioequivalence”
between the generic version and the NDA-approved
drug – not safety and efficacy.
Absent a successful patent challenge, the FDA cannot approve an
ANDA until after the innovator’s patents expire. However,
after the innovator has marketed its product for four years, a
generic manufacturer may file an ANDA alleging that one or more
of the patents listed in the innovator’s NDA are invalid or
not infringed. This allegation is commonly known as a
“Paragraph IV certification.” The innovator must
then file suit against the generic manufacturer to protect its
patents. If one or more of the NDA-listed patents are
successfully
challenged, the first filer of a Paragraph IV certification
may be entitled to a
180-day
period of market exclusivity over all other generic
manufacturers.
In recent years, generic manufacturers have used
Paragraph IV certifications extensively to challenge
patents on a wide array of innovative pharmaceuticals, and we
expect this trend to continue. We are currently in litigation
with numerous generic manufacturers arising from their
Paragraph IV certifications on Zyprexa, Evista, and Gemzar.
For more information on these, see Part II, Item 7,
“Management’s Discussion and Analysis –
Legal and Regulatory Matters.”
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