Patent And Trademark Office Authorization Act of 1994 Hearing Before the Subco

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Patent And Trademark Office Authorization Act of 1994 Hearing Before the Subco
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271 (e) (1) appears to exempt both A and B from infringement suit by C. The section is silent regarding any requirement that there be a nexus between the manufacturer and the user, or whether profits in sales are an issue. Accordingly, as long as the device was made, sold and used solely for purposes related to obtaining FDA approval, the patent has not been infringed.
b) If Hospital A continues to use the laser device after FDA approval, can C sue A for patent infringement?
Answer : Yes. If A
...continues to use the patented laser device after FDA approval without authorization from C, the patentee could file an action for infringement. After FDA approval, Section 271(e)(1) does not protect A from an infringement suit by C.
c) If the answer to b) is yes, and C prevails, what damages and other relief are available to C?
Answer : The court having jurisdiction in this case may grant whatever remedies for infringement are appropriate in accordance with chapter 29 of title 35, United States Code.


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