shutterstock_90590239In companion cases related to the generic version of enoxaparin marketed by Momenta and Sandoz, the CAFC decided:1

1. Neither Teva’s nor Amphastar’s enoxaparin products infringe under 35 U.S.C. § 271(g)2 because they are not “made by” Momenta’s patented process, and
2. Amphastar’s use of Momenta’s patented method is not protected by the 35 U.S.C. § 271(e)(1) safe harbor.

Momenta brought suit against Teva and Amphastar asserting that (i) Teva’s importation into the U.S. of an enoxaparin product would infringe Momenta’s ‘886 patent under 35 U.S.C. § 271(g), (ii) Amphastar’s manufacture in the U.S. of enoxaparin infringes the ’886 patent under 35 U.S.C. § 271(a), and this infringement does not fall within the safe harbor of 35 U.S.C. § 271(e)(1)3, and (iii) Amphastar’s sale of enoxaparin in the U.S. infringes the ‘886 patent under 35 U.S.C. § 271(g).4

The decision explains that Teva does not manufacture enoxaparin in the U.S., but rather imports the product into the United States.5 Unlike Teva, Amphastar manufactures its enoxaparin product within the United States, and Momenta asserted that Amphastar uses its patented method as an intermediate step in the multi-step process of manufacturing its drug.6

The crux of the decision relating to infringement under Section 271(g) lies in whether Teva’s and Amphastar’s enoxaparin products are “made by” Momenta’s patented “method of analyzing.”

Claim 1 of US ’886 recites (in part) “A method for analyzing an enoxaparin sample for the presence or amount of a non naturally occurring sugar …” In deciding non-infringement under Section 271(g), the Court noted7 that:

1. “All of the asserted claims of the ‘886 patent are directed to ‘[a] method for analyzing an enoxaparin sample.’”
2. “Use of the word ‘analyzing’ indicates practicing the claimed invention requires that the enoxaparin already be ‘made.’”

In considering Momenta’s arguments8, the court concluded that the ordinary meaning of “made” as used in § 271(g) means “manufacture” and extends to the creation or transformation of a product, such as synthesizing, combining components, or giving raw materials new properties.9 However, the court stated that “ma[king]” does not extend to testing to determine whether an already synthesized drug substance possesses existing qualities or properties.10

Citing to its previous decision in Housey11, where the court held that a product was not “made by” a process patented in the United States for purposes of § 271(g) where “the patented process [was] not used in the actual synthesis of the drug product,” the court reiterated that the word “made” in 271(g) equates to “manufacture.”

Momenta’s assertions that the FDA’s GMP regulations define “‘[m]anufacture’ and ‘[p]rocessing’ of drug products as including ‘testing[] and quality control of drug products,’” were rejected by the court emphasizing that such definition applies to 21 C.F.R. § 210.3(b)(12)12 and not § 271(g).

Regarding Amphastar’s infringement under § 271(g), based on the holding that the accused products were not “made by” the patented process, the court did “not reach the question of whether that subsection applies if the patented process is practiced domestically rather than abroad.”13

The court’s decision seems to have relied on the claim term “analyzing” which appears in the preamble. A claim preamble typically will not be seen as limiting unless it “breathes life and meaning into the claim.”14 Further, the preamble can be limiting when elements in the preamble serve as an antecedent basis for limitations in the claim body.15 In this instance, the court did not address the issue whether the claim preamble was a limitation.

The fact that the decision, in part, relied on the basis that the claims are directed to “method for analyzing” invites exploring into whether the court would:

a. come to the same conclusion in a situation involving a claim directed to “a method comprising…[with a step of analyzing a product sample as the last step]” instead of “a method for analyzing, comprising …”?
b. determine that “a method comprising…[with a step of analyzing a product sample as the last step],” falls within the meaning of § 271(g) in circumstances similar to the Momenta v. Teva scenario?

Under both scenarios, whether the court would come to the same conclusion would rest on various factors, including whether the claim also includes traditional manufacturing steps. It is thus possible that the scope of such claim will not be limited to “a method for analyzing…” The court may reason that such claim relates to both a method of manufacturing the product and a method of quality control release testing.

Similarly, under scenario (b), because the scope of a claim directed to “a method comprising…” would not be limited to “a method for analyzing…”, the court may more readily find that this claim falls within the meaning of § 271(g).

Focusing solely on claim interpretation, it would be interesting to see what the court would decide when confronted with a claim that is directed to (i) a method for analyzing X, comprising steps that include manufacturing X with the last step as analyzing X, as compared to a claim directed to (ii) a method, comprising steps that include manufacturing X with the last step as analyzing X.

1 Momenta Pharma., Inc. v. Teva Pharma. USA Inc., Nos. 2014-1274, -1277, -1276, and -1278 (Fed. Cir. Nov. 10, 2015).
2 Section 271(g) provides that “[w]hoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent. In an action for infringement of a process patent, no remedy may be granted for infringement on account of the noncommercial use or retail sale of a product unless there is no adequate remedy under this title for infringement on account of the importation or other use, offer to sell, or sale of that product. A product which is made by a patented process will, for purposes of this title, not be considered to be so made after—
(1) it is materially changed by subsequent processes; or
(2) it becomes a trivial and nonessential component of another product.”

3 Momenta Pharma., Inc. at 4.
4 Id. at 5.
5 Id. at 4.
6 Id. at 5.
7 Id. at 11.
8 Momenta argued that (i) “made” means “manufactured,” and (ii) its patented method is “a crucial interim step used directly in the manufacture of [Teva’s] product[s],” asserting that its “method is used [by Teva] to select and separate batches of intermediate drug substance that conform to USP requirements for enoxaparin from batches that do not,” and that selected batches are then “further process[ed].”
9 Id. at 9.
10 Id. at 8-9.
11 Bayer AG v. Housey Pharm., Inc., 340 F.3d 1367, 1373 (Fed. Cir. 2003).
12 Momenta Pharma., Inc. at 11. “§ 210.3 explicitly states that its definitions apply when the terms are used in parts 210, 211, 225, and 226 of Chapter 1 of Title 21 (“Food and Drugs”).
13 Id. at 12.
14 In re Wertheim, 541 F.2d 257 (CCPA 1976).
15 Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332 (Fed. Cir. 2003).