Source: https://www.pharmapatentsblog.com/2015/11/19/federal-circuit-interprets-two-important-infringement-provisions/
Timestamp: 2019-04-24 10:03:15+00:00

Document:
The accused products are generic versions of Lovenox® (enoxaparin), an anticoagulant used to prevent blood clots.
The Federal Circuit opinion was authored by Judge Wallach and joined by Judge Moore. Judge Dyk concurred-in-part and dissented-in-part.
The district court found no violation of § 271(g), based on its determination that the ‘866 patent related to “quality control release testing” and was “not a method of making enoxaparin” as the statute required.
Although Momenta’s arguments are not without merit, it is more consonant with the language of the statute, as well as with this court’s precedent, to limit § 271(g) to the actual “ma[king]” of a product, rather than extend its reach to methods of testing a final product or intermediate substance to ensure that the intended product or substance has in fact been made.
In light of the foregoing, the ordinary meaning of “made” as used in § 271(g) means “manufacture,” and extends to the creation or transformation of a product, such as by synthesizing, combining components, or giving raw materials new properties. However, “ma[king]” does not extend to testing to determine whether an already synthesized drug substance possesses existing qualities or properties.
Judge Dyk dissented from this portion of the decision.
The routine record retention requirements associated with testing and other aspects of the commercial production process contrast with non-routine submissions that may occur both pre- and post-approval, such as the submission of investigational new drug applications (“INDs”), new drug applications (“NDAs”), supplemental NDAs, or other post-approval research results. …. The routine quality control testing of each batch of generic enoxaparin as part of the post-approval, commercial production process is therefore not “reasonably related to the development and submission of information” to the FDA, and it was clearly erroneous to conclude otherwise.
The conclusion in Momenta I that Amphastar’s commercial use of Momenta’s patented method falls within the safe harbor of § 271(e)(1) would result in manifest injustice. Amphastar points to no case, until Momenta I, extending immunity under § 271(e)(1) to encompass activities related to ongoing commercial manufacture and sale.
Thus, the Federal Circuit affirmed the district court decision granting summary judgment in favor of Teva and affirmed-in-part, vacated-in-part, and remanded the district court decision granting summary judgment in favor of Amphastar.
As noted above, Judge Dyk dissented from the majority’s interpretation of 271(g).
The patent here … is not utilized to identify the product to be made, but rather is used in the manufacturing process. The quality control process of the ’886 patent is an intermediate step to determine which batches of putative enoxaparin must be discarded, and which batches may be incorporated in the final drug product. It is distinctly part of the manufacturing process of the product.
[L]imiting “made” in § 271(g) to “the creation or transformation of a product, such as by synthesizing, combining components, or giving raw materials new properties,” Maj. Op. at 8, would lead to anomalous results. Patents on purification methods or the quality control method at issue here, which may be integral to the regulatory or commercial viability of a product, but which do not create or transform a product, combine components, or confer new properties, could be freely infringed simply by outsourcing those processes abroad. Congress could not have intended to create this loophole when it sought to protect process patent owners from foreign competitors using U.S. manufacturing processes abroad. See generally Eli Lilly & Co. v. Am. Cyanamid Co., 82 F.3d 1568, 1571–72 (Fed. Cir. 1996).
Each independent claim of the ‘866 patent is directed to “[a] method for analyzing an enoxaparin sample.” Now that the court has decided that § 271(g) requires “the creation or transformation of a product” by the patented process, applicants should consider including claims that include making steps, even if the invention primarily pertains to other steps.

References: § 271
 § 271
 § 271
 § 271
 § 271
 § 271
 v. 
 § 271