While the patent statute does not provide for product-by-process claims, the courts have long recognized the appropriateness of such claims. See, e.g., In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985); In re Brown, 59 C.C.P.A. 1036, 459 F.2d 531, 535 (1972); In re Steppan, 55 C.C.P.A. 791, 394 F.2d 1013, 1018 (1967). The purpose of product-by-process claims is to allow inventors to claim "an otherwise patentable product that resists definition by other than the process by which it is made."

Indeed, this court itself had articulated that rule: "For this reason, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself." In re Thorpe, 177 F.2d 695, 697 (Fed. Cir. 1985) (emphasis added).

Biogen argues that Amgen is limited to composition claims and is not applicable to the method of treatment claims at issue here. To support this proposition, Biogen relies on general statements in product-by-process cases such as In re Thorpe , 777 F.2d 695, 697 (Fed. Cir. 1985) (applying product-by-process analysis for "an otherwise patentable product ") (emphasis added), and the well-recognized distinction patent law draws between the scope of composition and method of treatment claims. See, e.g. , Ass'n for Molecular Pathology v. Myriad Genetics, Inc. , 569 U.S. 576, 595, 133 S.Ct. 2107, 186 L.Ed.2d 124 (2013) (recognizing the distinct scope for composition and method of treatment claims in the context of 35 U.S.C. § 101 ).

; SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1317 (Fed. Cir. 2006) ("It has long been established that one cannot avoid anticipation by an earlier product disclosure by claiming the same product . . . as produced by a particular process."); In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985) ("If the product in a product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a difference process."); Tri-Wall Containers, Inc. v. United States, 187 Ct.Cl. 326, 408 F.2d 748, 750 (1969) ("It is well established that a product as made by a new process is not patentable unless the product itself is new."). However, a new product may be patented by reciting source or process limitations so long as the product is new and unobvious.

In Scripps Clinic Research Found. v. Grenentech, the Federal Circuit held that "[s]ince claims must be construed the same way for validity and for infringement, the correct reading of product-by-process claims is that they are not limited to product prepared by the process set forth in the claims." 927 F.2d 1565, 1583 (Fed. Cir. 1991) (citing In re Thorpe, 777 F.2d 695 (Fed. Cir. 1985)). The following year, a different panel of the Federal Circuit decided Atlantic Thermoplastics Co., Inc. v. Faytex Corp., 970 F.2d 834 (Fed. Cir. 1992), reh'g en banc denied, 974 F.2d 1299.

Although not referred to in the patent statute, product-by-process claims developed in response "to the need to enable an applicant to claim an otherwise patentable product that resists definition other than by the process by which it is made." See In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985). The Court, however, is not persuaded that the phrase "joined end-to-end outside of living cells" is in product-by-process form.