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Replies to post #193730 on Biotech Values
U.S. Solicitor General recently sided with NVS/MNTA by asserting that Amphastar’s (and Teva’s) invoking the Safe Harbor in their defense was inappropriate
Accepting defendants’ contrary arguments would transform section 271(e)(1) into a royalty-free, open-ended statutory license for the use of patented inventions in commercial drug manufacturing. That result cannot plausibly be attributed to congressional design.
Defendants’ proposed interpretation of section 271(e)(1) would radically alter the balance that Congress struck by immunizing routine, ongoing commercial activity from patent infringement claims by competitors. FDA requires drug manufacturers to maintain records of numerous steps of the drug-manufacturing process. See 21 C.F.R. § 211.180(a)-(c). Indeed, Congress has authorized the FDA to inspect all records relating to whether adulterated, misbranded, or otherwise unauthorized prescription drugs “have been or are being manufactured, processed, packed, transported, or held” in violation of the FDCA. 21 U.S.C. § 374(a)(1)(B). An interpretation of section 271(e)(1) that encompassed the routine generation and recording of information in drug manufacturing—even limited, as defendants contend here, to tests designed to confirm the identity, strength, quality, or purity of a drug product’s active Case: 14-1274 Document: 89 Page: 18 Filed: 07/13/2015
12 ingredients—would therefore immunize a broad range of commercial activity from infringement claims. Moreover, as Judge Dyk observed at oral argument, because a generic manufacturer is required to document on an ongoing basis that it is adhering to the manufacturing and control processes proposed in its ANDA, endorsing defendants’ arguments would have the peculiar “boot-strapping” effect of allowing generic drug makers to grant themselves royalty-free licenses simply by proposing in their ANDAs to employ the patented inventions.
Momenta is mistaken, however, in relying on the term “solely” in seeking reversal of the district court’s decision. See, e.g., Momenta Opening Br. (Nos. 14-1274, 14-1277) 46-48; Momenta Opening Br. (Nos. 14-1276, 14-1278) 45-48. Section 271(e)(1) provides that it shall not be an act of infringement to make, use, or sell a patented invention “solely for uses reasonably related to the development and submission of information” under a federal law that regulates drugs.
08/09/15 7:16 PM
AI
