Category Archives: Hatch-Waxman

Fed. Cir. in Helsinn v. Teva Declines Limiting the Requirements of the “On Sale” Bar

In Pfaff v. Wells Electronics, 525 US 55 (1988), the Supreme Court attempted to focus the factors invoking the on-sale bar of s.102, by holding that the claimed invention must both be the subject of a “commercial sale”(including offers for … Continue reading

Posted in 102 Patentability, Hatch-Waxman, Licensing, Litigation Issues | Leave a comment

AKAMAI V – “How To” Induce Infringement of a Method of Treatment Claim

I have both been busy since the holiday season and frankly, uninspired by the case law that has appeared on the scene. Who can be enraptured by the fine points of standing when we are all speculating about whether Michelle … Continue reading

Posted in Federal Court, Hatch-Waxman | Leave a comment

Vanda v. Roxane Labs. – Are Two Natural Laws Better Than One?

As you will recall, in Prometheus v. Mayo, the Supreme Court held that a claim reciting a natural law had to have other non-conventional steps to pass muster under s. 101. The natural law in Mayo was the correlation between … Continue reading

Posted in Claim Interpretation, Federal Court, Hatch-Waxman, Litigation Issues, Obviousness, Section 101 | 2 Comments

“We Don’t Need No Stinkin’ Patents” – Antibiotic and Antifungal Drugs Gain Non-Patent Exclusivity

Posted on the FDA Law Blog by Kurt Karst on June 19, 2014. After years of relative quiet, the Orange Book list of exclusivity terms has gotten quite a workout over the past year with the addition of several new terms … Continue reading

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