Before proceeding it is worth noting two things. First, that my list focuses on specific and identifiable events. Second, there are a number of stories worth mentioning, but which just missed the cut for one reason or another. The two that will probably be most glaring omissions are the Federal Circuit’s decision in Vanda Pharmaceuticals v. Westward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018), and the final rules implementing the Phillips claim construction standard. With respect to Vanda, while it is a pro-patent decision, the claims found eligible are virtually indistinguishable from those held ineligible in Mayo, so it seems virtually certain a different panel of the Federal Circuit would have ruled differently. Thus, all Vanda did was seem to create uncertainty, which may be good for settlements, but likely not a repeatable decision. As for the Phillips standard, while it makes perfect sense for the PTAB to be using the same claim construction standard as used in federal district courts, many have questioned whether it will make any real difference in outcomes. Still, it is a big event and would have been 11th on my list. Had a chance to Phillips been accompanied by patent claims being presumed valid and requiring clear and convincing evidence to be declared invalid at the PTAB, that would certainly be worthy of top 10 inclusion. Alas, that would require an amendment to the statute and beyond the powers of Director Iancu. Thus, the banishment of BRI, while important, finds itself on the outside looking just in at this year’s top 10.
The appellants are appealing from a series of inter partes review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB) where the Board made the controversial decision to deny motions to dismiss the IPRs on a sovereign immunity defense raised by the St. Regis tribe. On appeal, St. Regis and Allergan asks the Federal Circuit to determine whether the PTAB erred either in holding that tribal immunity does not apply to IPR proceedings and in deciding that Allergan was the “effective patent owner,” enabling the IPRs to proceed in the St. Regis tribe’s absence even if tribal immunity applied.
The Federal Circuit issued an Order staying further proceedings at the PTAB relating to the RESTASIS patents now owned by the Saint Regis Mohawk Tribe. The stay will remain in place until at least one day after the oral argument scheduled for June 2018. The Court will consider whether the stay shall remain in effect or be lifted based on the merits of the case.
The bill has nothing to do with drugs or drug prices, how how much Missourians desire cheaper generics. The PACED Act is discriminatory, has nothing to do with lowering drug prices, and doesn’t change the fact that to date no Indian Tribe has ever asserted sovereign immunity in a patent dispute in federal court… Ironically, if the PTAB and PTAB process were seen as fair and even-handed, there would be no incentive for any company to transfer its patents to sovereign tribes or State universities in order to escape the clutches of PTAB jurisdiction. Simply stated, the problem is IPRs, not Native American Tribes or sovereign immunity.
Attorneys for the Mohawk tribe have notified the USPTO that ex parte communications between an APJ assigned to the IPRs and an APJ not assigned to the IPRs cannot possibly fall within the deliberative privilege of (b)(5), as it is commonly referred to in FOIA matters… Shore concluded his e-mail to the USPTO putting the Office on notice of impending litigation, reminding the USPTO of its obligation to retain all information and documents in anticipation of a FOIA lawsuit that would seek to compel release of documents in non-redacted form… In reviewing the March 9, 2018 document release there are several other e-mail communications that raise the specter of improper ex parte communications in violation of the APA, both relating to the Mohawk RESTASIS IPRs, as well as the IPRs where an expanded panel of the PTAB refused to recognize a sovereign immunity defense made by the State of Minnesota.