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

The Southern District of Florida recently dismissed a complaint without prejudice because the allegations used a form of “shotgun pleading.” The court explained that a shotgun pleading includes those where every count incorporates every preceding paragraph into each cause of action, and that dismissal of such pleadings was required under Eleventh Circuit precedent.

The Federal Circuit recently addressed whether the PTO must conduct notice‑and‑comment rulemaking before issuing instructions that guide how the Board should exercise discretion at the institution stage of IPRs. The court held that no such rulemaking is required. Instructions to the Board regarding its use of the Director’s delegated discretionary authority not to institute review are merely general statements of policy exempt from notice-and-comment rulemaking.  

The District Court for the District of Delaware recently invalidated claims directed to a panoramic objective lens for lack of enablement, holding the claims impermissibly recited a single element in means‑plus‑function form. Under § 112, ¶ 6, “[a]n element in a claim for a combination may be expressed as a means or step for performing a specified function….” By its plain terms, the statute permits means‑plus‑function claiming only in the context of a “combination.” In other words, a claim may not consist solely of a single means‑plus‑function element. Claims drafted as a single means are invalid for lack of enablement as a matter of law.

In an ANDA litigation, the District of Delaware recently denied the defendants’ motion to compel the production of correspondence between the plaintiffs’ testifying expert and a third-party analyst who had performed experiments and provided data used by the testifying expert. The court found that the scope of material sought by the motion was overbroad and disproportionate to the needs of the case.