The U.S. Supreme Court, on Monday, decisively closed the chapter on Vanda Pharmaceuticals Inc.‘s legal battle to safeguard its patents for the sleep disorder medication, Hetlioz, ending its quest for a pivotal review on patent obviousness. This denial effectively halted Vanda’s IP obviousness appeal, a crucial attempt to challenge the Federal Circuit’s approach to patent invalidity.
The Controversy Around “Reasonable Expectation of Success”
Central to Vanda’s IP appeal was the argument against the Federal Circuit’s reliance on a “reasonable expectation of success” criterion. Vanda’s contention leaned on a 2007 Supreme Court decision which emphasized a “predictable results” standard instead. This foundational disagreement underscored the pharmaceutical company’s struggle to maintain the integrity of its intellectual property amidst evolving judicial standards.
Vanda’s IP Obviousness Appeal :Impact of the Ruling on Vanda Pharmaceuticals
Vanda, a prominent player in the pharmaceutical industry, reported a significant dip in revenue from Hetlioz, with net sales plummeting from $160 million to $100.2 million in just a year, as per its latest SEC filings. The company attributed this decline to the fierce generic competition that has been exacerbated by ongoing legal setbacks.
