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).

If the product in the 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 different process.” In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985) (internal citations omitted). Taking all the evidence together, the manufacturing process disclosed in the ‘495 Patent appears to yield a product with the Six-Month Erucic Acid that is obvious from the six-month erucic acid range disclosed by the prior product.

For the purposes of validity, the Court considers only the product limitations of a claim, not process limitations or source limitations that add no patentable significance to the end product. See In re Thorpe, 777 F.2d 695, 697 (Fed.Cir.1985). The asserted claims of the '799, '072, and '800 Patents are product-byprocess claims.

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 ).

” Id.;see alsoSmithKline 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 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 different process.”).Purdue looks to the exception we carved out in Amgen: “if the process by which a product is made imparts ‘structural and functional differences' distinguishing the claimed product from the prior art, then those differences ‘are relevant as evidence of no anticipation’ although they ‘are not explicitly part of the claim.’ ”

; 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.

Scripps correctly points out that this statement appears to diverge from our precedent, recognizing that this precedent arose in the context of patent prosecution, not patent infringement. E.g., In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985) (holding that prior art pertinent only to product is proper ground for rejecting product-by-process claims); In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972) (in product-by-process claims the patentability of the product must be established independent of the process); In re Bridgeford, 357 F.2d 679, 682 n. 5, 149 USPQ 55, 58 n. 5 (CCPA 1966) (recognizing that some courts in infringement litigation have construed product-by-process claims as limited to the particular process, but holding that patentability is determined independent of the process). In determining patentability we construe the product as not limited by the process stated in the claims.

"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 different process." In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985).

"[P]roduct-by-process claims are limited by and defined by the process." In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985).