Federal Circuit Denies En Banc Rehearing of Biosimilar Opinion in Amgen v. Sandoz

The Federal Circuit recently denied a petition for a writ of mandamus that challenged the PTO Director’s reliance on “settled expectations” to discretionarily deny two inter partes review (IPR) petitions. In so doing, the court explained that, while it was not deciding whether the Director’s use of “settled expectations” was correct, the petitioner’s arguments about what factors the Director may consider when deciding whether to institute an IPR or post-grant review (PGR) are not generally reviewable and did not provide sufficient basis for mandamus review here.

District courts are split on whether a complaint can provide the required knowledge for post-suit indirect and willful infringement in that same lawsuit. Chief Judge Connolly in the District of Delaware recently confirmed that, consistent with his prior opinions, the complaint cannot serve as the basis for knowledge for either a claim of post-suit indirect infringement or a demand for willfulness-based enhanced damages in that lawsuit.

The Federal Circuit recently held that a patentee acted as its own lexicographer to define a claim term even though it did not explicitly define the term. Rather, because the patentee consistently and clearly used two terms interchangeably to describe the same structural feature and did so in all of the embodiments in which the feature appeared, the patentee impliedly gave the term its own, unique definition.

The Federal Circuit recently held an asserted patent was not entitled to its priority date because the priority application lacked written description support for the asserted claims. In so doing, the court explained that broad disclosures that do not provide reasonably specific support for narrower claims do not meet the written description requirement. The court also considered whether the inventor’s testimony showed they possessed the full scope of the claimed genus at the priority date or whether it was more likely the inventors first became aware of the claimed embodiments from public disclosures of the accused product.