U.S. Pat. No. 8,663,685 B2
March 10, 2016
Brief Summary: IPR against US 8,663,685B2 encompassing Acorda’s Ampyra® product (dalfampridine (4-aminopyridine)) used in the treatment of multiple sclerosis (2015 full-year sales of $436 million) instituted on obviousness grounds based on IPO filing document (“S-1”) describing 4-aminopyridine clinical trial.
Summary: This IPR decision relates to US 8,663,685B2 encompassing Acorda’s Ampyra® product (dalfampridine (4-aminopyridine)) used in the treatment of multiple sclerosis (2015 full-year sales of $436 million). A previously-filed petition (IPR2015-00720) on the ‘685 patent was denied on Aug. 24, 2015, the Board concluding the Petitioner had not shown alleged prior art posters to have been “sufficiently accessiblt to quality as a ‘printed publication’ under § 102(b).” IPR2015-00817 directed to US 8,007,826, also relating to Ampyra® was also denied but IPR2015-01853 is pending, as are IPR2015-01850 and IPR2015-01858 against US 8,440,773 and 8,354,437, respectively. Here, ADROCA presented three obviousness arguments against claims 1-8; 2-5; and 1, 6 and 7 using different combinations of three alleged prior art references (or just one of the references against claims 1 and 8) and three Declarations. Claim 1 of the ‘685 claims “[a] method of improving walking in a 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 the sustained release composition further comprises one or more pharmaceutically acceptable excipients.” Dependent claims 2, 5 and 6 require the sustained release composition to “provide a mean Tmax in a range of about 2 to about 6 hours”, “provide an average plasma concentration at steady state…of about 15 ng/ml to about 35 ng/ml”, and that the drug be “dispersed in a rate of release controlling polymer”, respectively. The petition included the construction of “certain terms” but the Board found construction not to be necessary for their analysis. The first question considered was whether the alleged prior art (document S-1 pertaining to an IPO (apparently Acorda’s)) was publicly available as required by § 311(b) (“may request to cancel…claims…under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications”; In re Hall, FC 1986; Kyocera (FC 2008) (those “skilled in the subject matter…exercising reasonable diligence, can locate it”)). The Board determined “that the S-1 was publicly accessible to the public interested in the art as of September 30, 2003” (e.g., “the SEC Digest explains how to obtain a copy of the S-1, as of the SEC Digest’s publication date”; unlike in Liberty Mutual (CBM2013-00009, Paper 68 (PTAB Feb. 11, 2014) in which “the petitioner…provided little or no information as to how once could locate the 10-K form at the SEC by any means”). The Board also explained it would not use its discretion to deny institution based on the earlier IPR denial because it did not consider whether S-1 was a printed publication in that decision nor the merits based on S-1. Based on S-1’s disclosure of a clinical trial of 4-aminopyridine, ADROCA was found to be reasonably likely to prevail (e.g., “even if the S-1 does not unequivocally establish the efficacy of the 10 mg twice-per-day dosage…At this point, it is enough that S-1 suggests that such a method would work…” and, “Patent Owner has not persuaded us that an ordinary artisan would have known of its post-filing results” as of the ‘685 filing date). The combination of S-1 with two other prior art documents were also considered persuasive as to the establishment of a reasonable likelihood to prevail. Accordingly, the IPR was instituted.