Pharmaceutical Patents

THIS CASEBOOK contains a selection of U. S. Court of Appeals decisions that analyze and discuss issues surrounding pharmaceutical patents. * * * Claim limitations directed to printed matter are not entitled to patentable weight unless the printed matter is functionally related to the substrate on which the printed matter is applied. E.g., In re DiStefano, 808 F.3d 845, 848 (Fed. Cir. 2015); In re Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983). While early cases developing this doctrine applied it to claims literally encompassing "printed" materials, e.g., In re Russell, 48 F.2d 668, 669 (CCPA 1931) (claim to phonetically-arranged directory was printed matter), our cases have not limited the doctrine to that particular factual context, e.g., King Pharm., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1279 (Fed. Cir. 2010) (holding that a claimed step of informing someone about an inherent property of a method was printed matter). Rather, we have held that a claim limitation is directed to printed matter "if it claims the content of information." Di-Stefano, 808 F.3d at 848. * * * Claim limitations directed to the content of information and lacking a requisite functional relationship are not entitled to patentable weight because such information is not patent eligible subject matter under 35 U.S.C. 101. See AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1064 (Fed. Cir. 2010) ("This court has generally found printed matter to fall outside the scope of 101."); In re Chatfield, 545 F.2d 152, 157 (CCPA 1976) ("Some inventions, however meritorious, do not constitute patentable subject matter, e.g., printed matter...."); cf. Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1349-50 (Fed. Cir. 2014) ("Data in its ethereal, non-physical form is simply information that does not fall under any of the categories of eligible subject matter under section 101."); Guthrie v. Curlett, 10 F.2d 725, 726-27 (2d Cir. 1926) (stating that the plot of a printed work may be copyrighted but not patented). While the doctrine's underlying rationale is in subject matter eligibility, its application has been in analyzing other patentability requirements, including novelty under 35 U.S.C. 102, e.g., King, 616 F.3d at 1279, and nonobviousness under 35 U.S.C. 103, e.g., In re Huai-Hung Kao, 639 F.3d 1057, 1072-74 (Fed. Cir. 2011). Praxair Distribution, Inc. v. Mallinckrodt Hosp., 890 F. 3d 1024 (Fed. Cir. 2018)