An interesting case was decided at the Federal Circuit a couple weeks ago dealing with enablement and permanent injunctive relief.

Edwards sued CoreValve for infringing its patent related to a heart valve. CoreValve argued that the patent was not enabled because at the time of filing the patent application, the heart valve had only been tested in pigs. The district court upheld the patent as being enabled.

Additionally, the district court denied a permanent injunction against CoreValve. Both parties appealed.

Regarding enablement, the Federal Circuit affirmed the district court, holding that human testing is not necessary to enable use in humans. It reasoned that when experimentation on humans is inappropriate, enablement may be met by animal tests or in vitro data.

Next, the Federal Circuit criticized the district court’s denial of a permanent injunction, stressing that a patentee’s right to exclude is fundamental. The majority even went so far as to say that, “Absent adverse equitable considerations, the winner of a judgment of validity and infringement may normally expect to regain the exclusivity that was lost with the infringement.” The Supreme Court eBay decision in 2006 held that a patentee that wins an infringement action is not automatically entitled to an injunction. As the majority opinion appears to be testing the boundaries of eBay, the majority clarified how its holding is consistent with eBay.

Judge Prost concurred, but disagreed with the majority’s standard for injunctive relief. Prost argued that creating a presumption of an injunction once the plaintiff prevails, which must then be rebutted by the defendant, is not the law according to what she considered was clear after eBay. To Judge Prost, the creation of a right to exclude is distinct from the remedies for violations of that right.

In the ongoing patent dispute between Apple and Samsung, Apple filed a “statement of recent decision” to support a permanent injunction against Samsung.

 

 

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