judit rius sanjuan juditriuskeionlineorg httpwwworangebookblogcom200808federalcircuitnarrowsthescopeofthesection271e1researchexemptionhtml case proveris scientific corp v innovasystems 20071428 fed cir 2008 35 usc 271e1 states shall act infringement make use offer sell sell within united states import united states patented invention solely uses reasonably related development submission information federal law regulates manufacture use sale drugs veterinary biological products statute passed part hatchwaxman act 1984 provides safe harbor claims patent infringement based activities related pursuit fda approval drug products example exempts anda applicants allegations patent infringement based rd done purpose establishing bioequivalence proveris scientific owns us patent 6785400 directed system apparatus characterizing aerosol sprays used drug delivery devices nasal spray pumps inhalers innova makes sells device although subject fda approval used connection fda regulatory submissions specifically device used measure physical parameters aerosol sprays used nasal drug delivery devices proveris filed suit innova alleging infringement 400 patent part defense innova invoked safe harbor provision section 271e1 innova argued allegedly infringing activities immunized device used third parties solely development submission information fda trial district court ruled matter law innova could avail section 271e1 opinion released yesterday federal circuit affirmed district court innova argued appeal entitled benefit section 271e1 offered sell device pharmaceutical companies fda device used exclusively relation applications fda approval proveris responded section 271e1 safe harbor applicable products subject patent term extensions 35 usc 156f namely drug products medical devices food additives color additives according proveris section 271e1 immunize infringement patents laboratory manufacturing equipment federal circuit framed issue whether section 271e 1 immunizes manufacture marketing sale innovas device used development fda regulatory submissions subject fda premarket approval process court concluded section 271e1 provides immunity reasoning congress intend section 271e apply parties like innova whose device subject fda premarket approval therefore faces regulatory barriers market entry upon patent expiration federal circuit explained conclusion achieves kind fit symmetry supreme court spoke eli lilly v medtronic case also dealt section 271e1 according court proveriss patented product subject required fdca approval process eligible benefit patent term extension afforded 35 usc 156f time innovas device also subject required fdca approval process need safe harbor protection afforded 35 usc 271e1 note jeff light patients patents filed amicus brief case judit rius sanjuan attorney knowledge ecology international essential information wwwkeionlineorg wwwcptechorg phone 12023322670 x18 _______________________________________________ iphealth mailing list iphealthlistsessentialorg httplistsessentialorgmailmanlistinfoiphealth thu 07 aug 2008 113042 0400 iphealth us federal circuit narrows scope patent research exemption