On Jun. 21, 2022, Federal Circuit on petition for rehearing vacated its prior decision, and reversed the district court’s judgment of validity.

HEC Pharm filed petition for rehearing of the decision where previously Federal Circuit affirmed the District court’s judgment that that claims 1–6 of U.S. Patent No. 9,187,405 are not invalid and that HEC infringes them. You can read the district court & federal circuit decision summary “here” & “here” respectively.

The main issue was with respect to negative limitation in claims – “absent an immediately preceding loading dose regimen”. Federal Circuit said that for negative claim limitations, like this, there is adequate written description when, for example, “the specification describes a reason to exclude the relevant [element].” A reason to exclude an element could be found in statements in the specification expressly listing the disadvantages of using that element. Another reason could be that the specification “distinguishes among” the element and alternatives to it.

The ’405 specification discloses neither the presence nor absence of a loading dose. Loading doses—whether to be used or not—are simply not discussed. Importantly, the disclosure of a daily dosage cannot amount to a disclosure that there can be no loading dose. Therefore, the district court’s finding that the no-loading-dose limitation meets the written description requirement was clearly erroneous.