PTAB Declines to Institute IPR of Two Patents Challenged by The Coalition for Affordable Drugs

The Court of Federal Claims recently denied the United States’ motion to dismiss a patent infringement suit related to production of a COVID-19 vaccine. The court held that it had jurisdiction because the plaintiff filed its claim there before it filed a parallel suit in a district court and because it adequately pleaded the government’s involvement.

In a precedential and sua sponte Director Review decision, USPTO Director Squires recently vacated three related institution decisions nearly six months after institution where a district court later found the challenged claims invalid. Because the fourteen-day deadline to request Director Review of the institution decisions had passed, the Director used this opportunity to formally extend the deadline in two ways. First, he extended the fourteen-day deadline under 37 C.F.R. § 42.75(c)(1) to thirty days, which “puts requests for Director Review of decisions to institute trial on equal footing to requests for Director Review of final decisions or decisions not to institute trial.” Second, he outlined certain “exceptional circumstances” that warrant a further extension of the deadline to account for changes in the case that “surface after the deadline.” In the case at hand, the Director found the district court’s invalidity finding to be such an “exceptional circumstance” and ultimately initiated review and vacated the institution decisions on that basis.

The Supreme Court unanimously held that for a complaint of induced infringement, a patent owner must allege that the accused infringer took affirmative, not passive, steps to encourage direct infringement. Thus, where a generic drug has a skinny label, to induce infringement of the carved-out patented use of the drug, the generic company must have taken steps that were designed to cause others to perform the patented use, not just steps that could cause such conduct.

The Northern District of Illinois granted a summary judgment motion of no invalidity based on indefiniteness because the qualitative terms like “sufficiently slow” and “desired period of time” were definite when viewed in light of the surrounding claim language and specification.