The U.S. CAFC ruled that the manufacture, marketing, or sale of a medical device in US market, which is used in the development of USFDA regulatory submissions, but is not part of the USFDA’s premarket approval process, is not entitled to the protection of the Hatch-Waxman Act section 271(e)(1) safe harbor provision.
The case pertains to US6785400 (Assignee: Proveris), which covers a spray data acquisition system comprising: a housing for supporting a pumping device whereby the pumping device is responsive to an applied force to generate an aerosol spray plume through an exit port thereon along a spray axis; a spray pump actuator, wherein the spray pump actuator is capable of controlling a pumping force and a duration of the aerosol spray plume of the pumping device; an illumination device for illuminating the aerosol spray plume along at least one geometric plane that intersects the aerosol spray plume; and, an imaging device for acquiring data representative of a first interaction between the illumination and the aerosol spray plume along the at least one geometric plane.
Innova manufacture Optical spray analyzer (OSA) which is used to calibrate spray based medication and the same device is used by USFDA to optimize the spray pattern of new drugs and generics. The suit was filed way back in 2005 in district court of Massachusetts, District court concluded that OSA infringe ‘400 patent and safe harbor provision are not applicable to OSA device.
The court concluded that section 271(e)(1) provides no such immunity,and Hatch Waxman act did not signify any advantage under section 271(e) to parties like Innova, whose device is not subject to USFDA premarket approval.
The CAFC further affirmed district court’s decision (Proveris Scientific Corp. v. Innovasystems: Opinion of court)
The case pertains to US6785400 (Assignee: Proveris), which covers a spray data acquisition system comprising: a housing for supporting a pumping device whereby the pumping device is responsive to an applied force to generate an aerosol spray plume through an exit port thereon along a spray axis; a spray pump actuator, wherein the spray pump actuator is capable of controlling a pumping force and a duration of the aerosol spray plume of the pumping device; an illumination device for illuminating the aerosol spray plume along at least one geometric plane that intersects the aerosol spray plume; and, an imaging device for acquiring data representative of a first interaction between the illumination and the aerosol spray plume along the at least one geometric plane.
Innova manufacture Optical spray analyzer (OSA) which is used to calibrate spray based medication and the same device is used by USFDA to optimize the spray pattern of new drugs and generics. The suit was filed way back in 2005 in district court of Massachusetts, District court concluded that OSA infringe ‘400 patent and safe harbor provision are not applicable to OSA device.
The court concluded that section 271(e)(1) provides no such immunity,and Hatch Waxman act did not signify any advantage under section 271(e) to parties like Innova, whose device is not subject to USFDA premarket approval.
The CAFC further affirmed district court’s decision (Proveris Scientific Corp. v. Innovasystems: Opinion of court)
No comments:
Post a Comment