Post TC Heartland Decision Calls Into Question Rule 12 Waiver Doctrine in Patent Cases

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.

In an ANDA litigation, the District of Delaware recently denied the plaintiffs’ motion to strike portions of the defendants’ expert reports and related deposition testimony. Although the defendants’ invalidity contentions did not state the specific theories of invalidity upon which the expert opined, the court found that none of the Pennypack factors supported excluding that expert testimony.