[EP furthers this policy of allowing the public to practice expired patents.” 475] 403 F.3d at 1346. (See Ex. 1020 at 1.) SmithKline Beecham Corp., As the XRPD patterns in Dr. Expert’s report demonstrate, following the Example 24/25 synthesis in and other general procedures described EP 475 – therein at best produces a mixture of both Forms A and B of tapentadol HCl. (Ex. – XX. ¶ XX.) The Form A and Form B overlays (generated from the Form A and Form B peaks listed in Table I of the Patent), when placed on the obtained ’364 XRPD patterns below, demonstrate the peaks resulting from the presence of Form A and Form B, respectively. (Ex. XX. ¶ XX.) Additionally, the obtained XRPD patterns contain each of the peaks “unique in the X-ray diffraction diagram, the [Form A] lines with sufficient intensity at i.e. 2-theta values, where Form B does not show lines with significant intensity.” (Ex. 1001 at 2:30-32; Ex. XX. ¶ XX.) As the Patent explains, characteristic ’364 “[s]uch X-ray lines (2-theta values) for Form A in a powder diffraction pattern when measured using Cu Kα radiation at ambient temperature are: 15.1±0.2, 16.0±0.2, 18.9±0.2, 20.4±0.2, 22.5±0.2, 27.3±0.2, 29.3±0.2 and 30.4±0.2.” (Ex. 1001 at 2:32-36.) These characteristic Form A peaks are clearly present in the XRPD patterns obtained by Drs. Expert and Expert2. (Ex. XX. ¶ XX.) Because claim 1 of the Patent requires only Form A” ’364 “crystalline at least [the above] X-ray lines (2-theta values) in a powder diffraction “exhibiting
[EP 475] furthers this policy of allowing the public to practice expired patents.” SmithKline Beecham Corp., 403 F.3d at 1346. (See Ex. 1020 at 1.) As the XRPD patterns in Dr. Expert’s report demonstrate, following the Example 24/25 synthesis in EP 475 – and other general procedures described therein – at best produces a mixture of both Forms A and B of tapentadol HCl. (Ex. XX. ¶ XX.) The Form A and Form B overlays (generated from the Form A and Form B peaks listed in Table I of the ’364 Patent), when placed on the obtained XRPD patterns below, demonstrate the peaks resulting from the presence of Form A and Form B, respectively. (Ex. XX. ¶ XX.) Additionally, the obtained XRPD patterns contain each of the “unique peaks in the X-ray diffraction diagram, i.e. the [Form A] lines with sufficient intensity at 2-theta values, where Form B does not show lines with significant intensity.” (Ex. 1001 at 2:30-32; Ex. XX. ¶ XX.) As the ’364 Patent explains, “[s]uch characteristic X-ray lines (2-theta values) for Form A in a powder diffraction pattern when measured using Cu Kα radiation at ambient temperature are: 15.1±0.2, 16.0±0.2, 18.9±0.2, 20.4±0.2, 22.5±0.2, 27.3±0.2, 29.3±0.2 and 30.4±0.2.” (Ex. 1001 at 2:32-36.) These characteristic Form A peaks are clearly present in the XRPD patterns obtained by Drs. Expert and Expert2. (Ex. XX. ¶ XX.) Because claim 1 of the ’364 Patent requires only “crystalline Form A” “exhibiting at least [the above] X-ray lines (2-theta values) in a powder diffraction
DepoMed-Nucynta-7994364-IPR-draft.docx