The federal district court in Wilmington, Delaware, has held invalid for obviousness four Acorda Therapeutics patents related to its multiple sclerosis drug Ampyra®. The court did uphold the validity of one patent in the 89-page ruling issued on Friday, after it conducted a four-day bench trial in September 2016 and considered the parties’ "extensive" post-trial filings (Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., March 31, 2017, Stark, L.).
Acorda Therapeutics, Inc., and Alkemes Pharma Ireland Limited (collectively, "Acorda") sued Apotex Corp., Apotex Inc., Mylan Pharmaceuticals Inc., Roxane Laboratories, Inc., and Teva Pharmaceuticals, USA, Inc. (collectively, "Apotex" or "Defendants"), alleging infringement of multiple patents relating to Acorda’s drug Ampyra®, which uses 10 mg dalfampridine extended release tablets to improve walking in patients with MS. Dalfampridine, also known as fampridine, 4-Aminopyridine, or "4-AP," the active ingredient of Ampyra®.
Patent No. 5,540,938 ("the ‘938 patent" or the "Elan Patent"), relates to the use of a sustained-release formulation of4-AP, administered once or twice daily, to treat neurological diseases including multiple sclerosis. Patent Nos. 8,007,826 ("the ‘826 patent"), 8,663,685 ("the ‘685 patent"), 8,354,437 ("the ‘437 patent"), and 8,440,703 ("the ‘703 patent") (collectively, the "Acorda Patents") relate to the use of 10 mg sustained-release formulations of 4-AP to treat walking impairments in individuals with MS. Ampyra® was the first FDA-approved use of 4-AP, having approved it in January 2010. Acorda has been marketing and selling Ampyra® in the United States since March 2010. Its annual net sales in the United States were $133.1 million in 2010, and increased to $436.9 million in 2015. Total sales were $1.7 billion by the end of 2015, with net income from those sales totaling $998.7 million.
The Defendants each filed an ANDA, under the Food, Drug, and Cosmetic Act, seeking the FDA’s approval to manufacture, sell, or use the generic dalfampridine (10 mg) oral extended release tablets before the patents-in-suit expire. Each defendant stipulated that their proposed products infringe the asserted claims of the patents-in-suit, but argued that those patents are invalid for obviousness. The court held that Defendants failed to show obviousness for the Elan Patent, but did meet their burden of showing that the Acorda Patents are invalid for obviousness.
Elan Patent. With respect to the Elan Patent, the court determined that certain prior art established that a person of ordinary skill in the art "would have had a reasonable expectation of success of administering 4-AP to achieve a therapeutic effect in MS patients," and that there would be a "viable therapeutic window for the drug (i.e., a range of doses at which the drug was both non-toxic and had therapeutic effects)." However, the court found that the record did not support the necessary predicate for obviousness that a person of ordinary skill in the art would also have a sufficient expectation of success in developing a sustained-release formulation of 4-AP to treat MS. Defendants had to establish that the approach taken by the Elan Patent represented an "identified, predictable solution" that produced an "anticipated success," the court noted, citing KSR Int 'l Co. v. Teleflex, Inc., 550 U.S. 398, 415, 421 (2007). Without the benefit of hindsight, the court found, the record did not support such a finding. Thus, Defendants did not meet their burden of establishing the invalidity of the Elan Patent due to obviousness.
Elan Section 112 defenses. Defendants also contended that the Elan Patent should be found invalid for lack of adequate written description and/or lack of enablement, under 35 U.S.C. §112. After noting that Defendants waived these defenses by not proffering evidence at trial, the court found that even absent waiver, the defenses would fail. "To the extent Defendants have articulated their Section 112 invalidity theory, it is a theory based on contingencies which, given the Court's findings, have not been satisfied," the court held.
Acorda Patents. The Acorda Patents’ asserted claims are directed to a method of administering a 10-milligram dose of4-AP twice per day, for either two weeks or twelve weeks, to improve walking in a human with multiple sclerosis. Defendants contended that the prior art taught four limitations, which supported the conclusion that the Acorda Patents are invalid for obviousness: the use of 4-AP to improve walking; the use of a 10 mg/twice-daily dosage; the use of stable dosing; and the inherent pharmacokinetic limitations. After an exhaustive review of the record, including the prior art and the parties’ experts, the court agreed, holding that the prior art would have given a person of ordinary skill in the art "a reasonable expectation of success in combining these limitations." Thus, it held that the asserted claims of the Acorda Patents are invalid.
Secondary nonobviousness indicia. Acorda argued that four secondary considerations render the Acorda Patents nonobvious: commercial success, unexpected results, failure of others, and long-felt but unmet need. The court rejected each of these arguments. Thus, while the court found Ampyra® to be a commercial success, with a nexus between that success and the features claimed in the Acorda Patents, it held these findings to have "little probative value to the obviousness inquiry" because the Elan Patent "blocked" competitors from practicing the Acorda Patents. Thus, the evidence of secondary considerations was not sufficient to overcome the obviousness finding as to the Acorda Patents, the court held.
The case is 1:14-cv-00882-LPS.
Attorneys: Jack B. Blumenfeld (Morris, Nichols, Arsht & Tunnell LLP) for Acorda Therapeutics Inc. and Alkermes Pharma Ireland Ltd. John C. Phillips, Jr. (Phillips, Goldman, McLaughlin & Hall, PA) for Roxane Laboratories Inc. and Teva Pharmaceuticals USA Inc. Mary Matterer (Morris James LLP) for Mylan Pharmaceuticals Inc.
Companies: Acorda Therapeutics Inc.; Alkermes Pharma Ireland Ltd.; Roxane Laboratories Inc.; Teva Pharmaceuticals USA Inc.; Mylan Pharmaceuticals Inc.
MainStory: TopStory Patent DelawareNews
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