Appeal No. 2004-0394 Page 6
Application No. 09/915,467
IV. An effective program to reduce pregnancy during Accutane treatment:
The Roche data is based, in part, on cases reported by the “Pregnancy
Prevention Program for Women on Accutane-conducted by the Slone Epidemiology
Unit….” Roche, page 1. In this regard, we note that Elsayed disclose that a survey
conducted by the Slone Epidemiology Unit suggests that a pregnancy prevention
program can be effective to reduce pregnancy during Accutane treatment. Specifically,
as set forth on page 3 of the Decision, footnote omitted:
According to Elsayed (column 1, lines 48-57),
Previous methods for controlling the distribution of drugs have been
developed in connection with Accutane (isotretinoin). Accutane, which is
a known teratogen, is a uniquely effective drug for the treatment of
severe, recalcitrant, nodular acne. A pregnancy prevention program was
developed, and the Slone Epidemiology Unit of Boston University
designed and implemented a survey to evaluate these efforts. The survey
identified relatively low rates of pregnancy during Accutane treatment,
which suggests that such a program can be effective.
Regarding appellant’s emphasis (Request, page 4), that Woodcock noted “exclusive
reliance on ‘human memory’ is not an adequate precaution for managing severe risks,”
we note that the methods of the Elsayed invention “may be desirably and
advantageously used to educate and reinforce the actions and behaviors of patients
who are taking the drug, as well as prescribers who prescribe the drug and pharmacies
which dispense the drug.” See Decision, page 3:
Furthermore, Elsayed discloses (column 3, lines 26-31),
Generally speaking, the methods of the present invention may be
desirably and advantageously used to educate and reinforce the
actions and behaviors of patients who are taking the drug, as well
as prescribers who prescribe the drug and pharmacies which
dispense the drug. … A wide variety of educational materials may
be employed to ensure proper prescribing, dispensing and patient
compliance according to the methods described herein, including,
for example, a variety of literature and other materials, such as, for
example, product information, educational brochures, continuing
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