As shown above with respect to claim 1, inherently discloses EP 475 tapentadol HCl Form A. The Patent admits that the Form A polymorph has a ’364 monoclinic form, stating: structure analysis of Form A of (-)-(1R,2R)-3-(3 “Crystal dimethylamino-1-ethyl-2 -methylpropyl)-phenol hydrochloride showed monoclinic crystals.” (Ex. 1001 at 2:54-56.) Moreover, as confirmed by Dr. Expert, form “the shape of a polymorph’s crystals is an inherent characteristic of that i.e. – – particular polymorph. Said differently, the same polymorphs as confirmed by – XRPD patterns will invariably exhibit the same crystalline shape.” (Ex. XX ¶ – XX.) Consequently, because inherently discloses tapentadol HCl Form A, EP 475 and Form A is known to have a monoclinic form, also inherently discloses EP 475 tapentadol HCl Form A having a monoclinic form, anticipating claim 4. Atlas 190 F.3d 1342, 1347 (Fed. Cir. 1999) (“[T]he discovery Powder Co. v. Ireco Inc., of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.”). Additionally, in the ANDA litigations discussed above with respect to claim 3, the Patent Owner admitted: The phrase form” is a term of art in the field of “monoclinic crystallography. Its plain meaning is described in the scientific literature. J. Glusker & K. Trueblood, See, e.g., Crystal Structure
As shown above with respect to claim 1, EP 475 inherently discloses tapentadol HCl Form A. The ’364 Patent admits that the Form A polymorph has a monoclinic form, stating: “Crystal structure analysis of Form A of (-)-(1R,2R)-3-(3 dimethylamino-1-ethyl-2 -methylpropyl)-phenol hydrochloride showed monoclinic crystals.” (Ex. 1001 at 2:54-56.) Moreover, as confirmed by Dr. Expert, “the form – i.e. shape – of a polymorph’s crystals is an inherent characteristic of that particular polymorph. Said differently, the same polymorphs – as confirmed by XRPD patterns – will invariably exhibit the same crystalline shape.” (Ex. XX ¶ XX.) Consequently, because EP 475 inherently discloses tapentadol HCl Form A, and Form A is known to have a monoclinic form, EP 475 also inherently discloses tapentadol HCl Form A having a monoclinic form, anticipating claim 4. Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999) (“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.”). Additionally, in the ANDA litigations discussed above with respect to claim 3, the Patent Owner admitted: The phrase “monoclinic form” is a term of art in the field of crystallography. Its plain meaning is described in the scientific literature. See, e.g., J. Glusker & K. Trueblood, Crystal Structure
DepoMed-Nucynta-7994364-IPR-draft.docx