Source: https://www.bioloquitur.com/momenta-v-teva-effective-claiming-of-methods-of-testing-drug-products/
Timestamp: 2019-04-22 01:39:53+00:00

Document:
2. Amphastar’s use of Momenta’s patented method is not protected by the 35 U.S.C. § 271(e)(1) safe harbor.
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).
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.
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).
3 Momenta Pharma., Inc. at 4.
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”).
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).

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