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[24] It is still useful to say a few words at this point about Acorda S-1, because it is referred to
later in the FC Decision when dealing with obviousness. Acorda S-1 is a public financial
document filed by Acorda with the US Securities and Exchange Commission (SEC) issued in the
Fall of 2003. In this document, Acorda summarises its clinical studies respecting the use of
fampridine SR, including studies referred to as MS-F201, which was completed in 2001, and
MS-F202, initiated in early 2003, with results anticipated by the end of March 2004.
These studies were conducted by Acorda in cooperation with Elan, an Irish pharmaceutical
company that then owned at least one patent on fampridine (SR) for use in MS treatment cited by
the experts (see also Patent Number 5,580,580, AB Vol. 2, at p. 490). Elan also supplied the SR
composition to Acorda for the trials. It is worth reproducing paragraphs 123 to 125 of the FC
Decision, which deal with this document in the context of its anticipation analysis:
[123] As stated in the Acorda S-1, MS-F201 was designed to determine the
optimal dose level of fampridine SR and to evaluate possible ways to measure the
effect of the drug, including motor strength, timed walking, and self-reported
fatigue. Subjects with MS received fampridine SR in doses increasing from 10 mg
to 40 mg bid over eight weeks of treatment. The results are described as follows:
The clinical trial demonstrated that doses up to 25 mg twice a day
were well tolerated, and were associated with statistically
significant improvements in walking speed and leg muscle
strength. Most of the improvement in strength and walking speed
was apparent within the first three weeks of the Fampridine-SR
treatment, at doses from 10 to 25 mg twice a day.
[124] The Acorda S-1 describes MS-F202 as a clinical trial designed to compare
doses of 10, 15, and 20 mg bid, and to assess their relative safety and efficacy
over a 12-week treatment period, with a primary endpoint of improvement in
average walking speed using the Timed 25 Foot Walk.
[125] From these descriptions of MS-F201 and MS-F202, the POSITA would
derive the following information:
• Elan was supplying the fampridine SR composition;
• Doses of up to 25 mg bid were associated with statistically
significant improvements in walking speed and leg muscle strength;