Applikon Biotechnology, Inc. v. United States

807 F. Supp. 2d 1323, 2011 CIT 154, 33 I.T.R.D. (BNA) 2355, 2011 Ct. Intl. Trade LEXIS 154, 2011 WL 6145594
CourtUnited States Court of International Trade
DecidedDecember 12, 2011
DocketConsol. 07-00364
StatusPublished
Cited by2 cases

This text of 807 F. Supp. 2d 1323 (Applikon Biotechnology, Inc. v. United States) is published on Counsel Stack Legal Research, covering United States Court of International Trade primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Applikon Biotechnology, Inc. v. United States, 807 F. Supp. 2d 1323, 2011 CIT 154, 33 I.T.R.D. (BNA) 2355, 2011 Ct. Intl. Trade LEXIS 154, 2011 WL 6145594 (cit 2011).

Opinion

OPINION

MUSGRAVE, Senior Judge:

Plaintiff Applikon Biotechnology, Inc. (“Applikon”) challenges U.S. Customs and Border Protection’s (“Customs”) classification of “BioBundle Cell Culture Bioreactor Systems” and “ez-Control Cell Culture BioBundle Bioreactor Systems” imported from the Netherlands (both referred hereafter as the Bioreactor Systems). Proper administrative protest procedure having been undertaken and all liquidated duties, taxes and fees having been paid, 1 see 19 U.S.C. §§ 1514, 1515, jurisdiction is proper pursuant to 28 U.S.C. § 1581(a).

I. Description of the Merchandise

A “bioreactor” is “a device or apparatus in which living organisms and especially] bacteria synthesize useful substances (as interferon) or break down harmful ones (as in sewage).” Merriam Webster Collegiate Dictionary (10th ed. 1996). As their names imply, Applikon’s Bioreactor Systems maintain an aseptic and homogenous environment in which to culture cells. See Def. Ex. F (Autoclavable BioBundle 3L Manual) at 3-4. The homogeneous environment is accomplished by continuous mixing or stirring of the cell culture, and mixing is routinely utilized when operating the Bioreactor System. 2 The principal *1325 function of the Bioreactor is to grow cells in an aseptic, homogeneous environment, and that homogeneous environment is maintained by the mixing function. Pl.’s Stmt, of Facts ¶¶ 16-17.

The cells are grown in the Bioreactor System for various applications in research or process development, such as for use in biopharmaceuticals, antibodies, enzymes, vaccines, antibiotics, vitamins, food additives, alcoholic beverages, biofuels, for commercial or organic waste treatment, or plant cell technology, all of which are referred to as the “cell culture process.” A typical use is in the development of bio-pharmaceuticals where the bench-size Bioreactor Systems serve as smaller research and test environments before up-scaling for production in larger bioreactors used in production. Pl.’s Stmt, of Facts ¶ 81.

In their imported condition, both of the Bioreactor Systems consist of three major components. They are the Bioreactor, the Controller, and the Actuator. In the BioBundle System the Controller and Actuator are housed in separate cabinets, and in the ez-Control System they are both housed in one cabinet. In both Bioreactor Systems the principal component, in which the cell culture process occurs, is the bioreactor vessel. This consists of a dish-bottomed glass vessel configured with a stirring mechanism that is integral to sealing the vessel in set-up and the maintenance of the aseptic environment necessary for the cell culture process. The bioreactor stirrer motor and stirrer assembly rest on the bioreactor headplate so that the stirrer assembly shaft and impeller extend into the bioreactor vessel to continuously mix the liquid cell culture at a set rate of agitation to both prevent the cells from settling on the bottom of the bioreactor vessel and to uniformly expose them to the desired environment. Pl.’s Stmt, of Facts ¶ 18. “[0]nce the vessel is sterilized, the vessel is sealed to maintain the sterile environment, and the stirrer assembly is a critical part of that sealing function.” Pi’s Reply to Defs Resp. to Pl.’s Statement of Material Facts Not in Genuine Dispute (“Pl.’s Fact Reply”) at 46.

In addition to the bioreactor (consisting of the bioreactor vessel and the mechanical bioreactor mixing equipment), both Bioreactor Systems include equipment used to control mixing and optional functions, such as control of pH, dissolved oxygen, level/anti-foam and temperature. Pl.’s Stmt, of Facts ¶ 15. These functions are configurable using a combination of eight digital and five analogue outputs, and twelve actuators incorporating various devices (pumps, valves, solenoid valves, motor speed controller, thermal mass flow controllers, rotameters, et cetera) which maintain the selected parameter set-points. The controller measures the pro *1326 cess variables and calculates corresponding controller outputs in order to keep process conditions on set point. The controller’s functions are integrated into and complete the Bioreactor System. They are operated by adjusting the controller’s setpoints for the desired parameters, switching on the “thermocirculator,” stirrer motor, acid and/or base pumps and gas flow, and when the parameters reach their desired setpoints, the bioreactor is ready for inoculation. See Def. Ex. B (Autoclavable Bioreactor User Manual) at 3-2.

Utilization of the functions for control of pH, dissolved oxygen, or temperature, is optional and dependant on the type of cell culture being grown. However, when utilizing any of these optional functions, the mixing function must still be used in order to effectively control the optional functions. Pl.’s Stmt, of Facts ¶ 33. Cells will die without mixing operations. Pl.’s Stmt, of Facts ¶ 35. The continuous mixing or stirring of the liquid cell culture ensures that all cells will have equal access to the contents of the medium in which 'they are suspended. The mixing of the medium provides the cells with proper exposure to dissolved culture medium components, dilutes harmful cell waste products, and is necessary to effectively control other parameters, such as the pH, dissolved oxygen, or temperature. Pl.’s Stmt, of Facts ¶ 34.

Mammalian cell culture, for which the Bioreactor Systems are mainly sold, requires a temperature of approximately 37 degrees Celsius (i.e., human body temperature), which is normally well above ambient room temperature. Pi’s Stmt, of Facts ¶ 37, and Def. Response thereto. The merchandise as imported includes temperature control features but does not include the electric heating blanket, which is procured separately in the U.S. by Applikon and packaged with the devices after importation. . Pl.’s Stmt, of Facts ¶ 26. The electric heating blanket is plugged into the actuator, and is not a permanent part of the Bioreactor System. Defs Resp. to Pl.’s Stmt, of Facts ¶ 38. The heating blanket function is triggered when the medium’s temperature drops by as little as 0.1 degree Celsius. Def. Ex. A at 4. The BioBundle literature describes the heating blanket “as an alternative for a thermocirculator” to maintain a desired temperature when wrapped around the bioreactor vessel containing the medium.

“For an optimum performance [sic] of any biological system, it is necessary to keep the environment of the micro-organisms at optimal conditions. Apart from temperature and medium composition, the two most important factors that effect [sic] this environment are the degree of mixing and aeration[,]” according to Applikon’s literature. See Def.- Ex. B at 2-1. Optimal temperature can be maintained by placement of the bioreactor vessel in a temperature-controlled room or an external temperature-controlled" medium (such as hot water).

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Bluebook (online)
807 F. Supp. 2d 1323, 2011 CIT 154, 33 I.T.R.D. (BNA) 2355, 2011 Ct. Intl. Trade LEXIS 154, 2011 WL 6145594, Counsel Stack Legal Research, https://law.counselstack.com/opinion/applikon-biotechnology-inc-v-united-states-cit-2011.