As 2022 was drawing to a close, Vanda Pharmaceuticals filed a PIV case against Teva and Apotex. Often, English football commentators will describe a foul as “cynical” when the player commits a foul intentionally or out of anger at being beaten. This is an apt way to describe this PIV case over Hetlioz®(tasimelteon) Capsules.

2022 PIV Market Review

The PIV Market in 2022 was wrapping up in a similar fashion as in the prior two years. It had a similar number of cases filed, similar number of ANDAs filed (associated with a PIV case), and PIV cases for brand products receiving their first PIV case. (See 2021 PIV Market Review.) It seemed pretty routine until Vanda filed its cynical PIV case on December 27.

Lost in December, but…

Earlier in the month, the Delaware District Court issued a ruling in the Hetlioz®(tasimelteon) Capsules case. The original cases against Teva and Apotex were filed in 2018. After trial, Vanda dismissed six patents from the case, and the Delaware Court found that Teva and Apotex either did not infringe the 4 remaining patents or that they were invalid as obvious.

When you read the Opinion, Judge Connolly made quick work of the legal arguments, and you get the feeling she was not too impressed. When concluding that the patents were obvious, she noted that there was a plethora of information available and that the elements were well-known. Vanda appealed.

The Cynical PIV Case or Clever Legal Strategy?

Two weeks after it lost, Vanda filed its new PIV case. It alleges infringement of a later-issued patent. What makes this case cynical is the fact of its timing. Of course, Vanda filed its case after losing its primary case. Moreover, both Teva and Apotex filed their PIV Notices in June and September. So, Vanda let the 45-day window pass. You rarely see this occur; an overwhelming number of brands file their PIV cases within the 45-day window.

It seems that Vanda’s legal strategy is to have the infringement case pending to put some pressure on Teva and Apotex to not market their ANDA products. Of course, they risk damages if the market their products now and later lose this new case. This is a valid legal strategy that employs the Winston Churchill attitude “Never Never Never Quit.” But at some point, is it just cynical?