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This excerpt taken from the LLY 10-K filed Feb 22, 2010. Patent
Challenges
In the United States, 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. Before Hatch-Waxman, no drug
could be approved without providing the 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 biologics)
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 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. The FDA is then prohibited from approving the generic
company’s application for a 30- to
42-month
period (which can be shortened or extended by the trial court
judge hearing the patent challenge). If one or more of the
NDA-listed patents are 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. In addition, generic companies
have shown an increasing willingness to launch “at
risk,” i.e., after receiving ANDA approval but before final
resolution of their patent challenge. We are currently in
litigation with numerous generic manufacturers arising from
their Paragraph IV certifications on Alimta, Cymbalta,
Evista, Gemzar, and Strattera. For more information on this
litigation, see Item 7, “Management’s Discussion
and Analysis—Legal and Regulatory Matters.”
Outside the United States, the legal doctrines and processes by
which pharmaceutical patents can be challenged vary widely. In
recent years, we have experienced an increase in patent
challenges from generic manufacturers in many countries outside
the United States, and we expect this trend to continue. For
more information on significant patent challenges outside the
United States, see Item 7, “Management’s
Discussion and Analysis—Legal and Regulatory Matters.”
These excerpts taken from the LLY 10-K filed Feb 27, 2009. Patent
Challenges
In the United States, 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. Before Hatch-Waxman, no drug
could be approved without providing the 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 biologics)
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 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. The FDA is then prohibited from approving the generic
company’s application for a 30- to
42-month
period (which can be shortened or extended by the trial court
judge hearing the patent challenge). If one or more of the
NDA-listed patents are 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. In addition, generic companies
have shown an increasing willingness to launch “at
risk,” i.e., after receiving ANDA approval but before final
resolution of their patent challenge. We are currently in
litigation with numerous generic manufacturers arising from
their Paragraph IV certifications on Alimta, Cymbalta,
Evista, Gemzar, and Strattera. For more information on these,
see Part II, Item 7, “Management’s
Discussion and Analysis − Legal and Regulatory
Matters.”
Outside the United States, the legal doctrines and processes by
which pharmaceutical patents can be challenged vary widely. In
recent years, we have experienced an increase in patent
challenges from generic manufacturers in many countries outside
the United States, and we expect this trend to continue. For
more information on significant patent challenges outside the
United States, see Part II, Item 7,
“Management’s Discussion and Analysis −
Legal and Regulatory Matters.”
Patent Challenges In the United States, 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. Before Hatch-Waxman, no drug could be approved without providing the 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 biologics) 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 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. The FDA is then prohibited from approving the generic company’s application for a 30- to 42-month period (which can be shortened or extended by the trial court judge hearing the patent challenge). If one or more of the NDA-listed patents are 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. In addition, generic companies have shown an increasing willingness to launch “at risk,” i.e., after receiving ANDA approval but before final resolution of their patent challenge. We are currently in litigation with numerous generic manufacturers arising from their Paragraph IV certifications on Alimta, Cymbalta, Evista, Gemzar, and Strattera. For more information on these, see Part II, Item 7, “Management’s Discussion and Analysis − Legal and Regulatory Matters.” Outside the United States, the legal doctrines and processes by which pharmaceutical patents can be challenged vary widely. In recent years, we have experienced an increase in patent challenges from generic manufacturers in many countries outside the United States, and we expect this trend to continue. For more information on significant patent challenges outside the United States, see Part II, Item 7, “Management’s Discussion and Analysis − Legal and Regulatory Matters.” | EXCERPTS ON THIS PAGE:
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