Opinion ID: 4310952
Heading Depth: 3
Heading Rank: 1

Heading: A method of increasing walking speed in a

Text: human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release composition of 10 milligrams of 4-aminopyridine twice daily for a time period of at least two weeks, wherein said 10 milligrams of 4- aminopyridine twice daily are the only doses of 4- aminopyridine administered to said patient dur- ing said time period. ’437 patent, col. 27, lines 55–61. Claim 18 requires that the sustained release composition in claim 1 be “a tablet,” id., col. 28, lines 47–48; and claim 22 requires that the tablet of claim 18 “exhibit[] a release profile to obtain a CavSS of about 15 ng/ml to about 35 ng/ml,” id., col. 28, 26 ACORDA THERAPEUTICS, INC. v. ROXANE LABORATORIES, INC. lines 55–57. The parties have not distinguished the claims for purposes of the invalidity issue before us. 8 5 Acorda submitted New Drug Application No. 022250 to the FDA for the use of 10 mg 4-AP extended-release tablets (Ampyra). The FDA granted priority review to that application and approved it on January 22, 2010. According to the approved FDA label, Ampyra “‘is indicated as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed.’” Dist. Ct. Op. at  (citation omitted). “Improvement in walking in MS patients is [the] only approved use” of Ampyra. Id. The “Description” section of the label states that “‘Ampyra (dalfampridine) is a potassium channel blocker, available in a 10 mg tablet strength . . . , formulated as an extended release tablet for twice-daily oral administration.’” Id. (capitalization altered). The “Dosage and Administration” section explains that “‘[t]he maximum recommended dose of Ampyra is one 10 mg tablet twice daily, taken with or without food, and should not be exceeded. . . . No additional benefit was demonstrated at doses greater than 10 mg twice daily and adverse reactions and discontinuations because of adverse reactions were more frequent at higher doses.’” Id. (capitalization altered). Between the time of FDA approval in 2010 and the end of 2015, total sales of Ampyra were $1.7 billion and net income was $998.7 million. Id. at . Net sales of 8 Although the ’826 patent’s claim 7 does not re- quire a regimen of at least two weeks, asserted claim 39 does (claim 39 requires 12 weeks), as do the ’437 patent’s asserted claims 1, 2, 5, 22, 32, 36, and 37; the ’685 patent’s asserted claims 3 and 5; and the ’703 patent’s asserted claims 36, 38, and 45. ACORDA THERAPEUTICS, INC. v. ROXANE LABORATORIES, INC. 27 Ampyra, in dollars, increased at an average rate of 20% per year, and the volume of tablets sold increased at an average rate of 8% per year, despite an increasing price per tablet over that period (2010 to 2015). Id. Acorda also receives royalty payments from licenses to sell Ampyra outside the United States; it has collected at least $135 million from those licenses. Id. Commercial opportunity, however, is constrained because Ampyra is indicated only for improvement of walking. Id. at –17. Ampyra sales revenue is approximately 2–3% of the total sales revenue from the top ten multiple sclerosis drugs. Id. at . Not all multiple sclerosis patients respond to Ampyra. Among multiple sclerosis patients who experience walking difficulties, 15–20% of those patients are prescribed Ampyra. Id. On the other hand, Ampyra is the first and only drug approved for improving walking in multiple sclerosis patients. Id. When Sanofi-Aventis in 2008 conducted a Phase III study to test whether a different potassiumchannel blocker, nerispirdine, would improve walking in patients with multiple sclerosis, it did not find evidence of a “specific significant difference between the responders [and] non-responders that received nerispirdine or placebo” in a timed 25-foot walk. J.A. 726–28 (testimony of Acorda’s expert Dr. Fred Lublin); see Dist. Ct. Op. at .