Patent Filings Roundup: WSOU Entity Leads Sustained Spike in District Court Filings, Sandoz Takes a Shot at Novo Nordisk’s Insulin Treatment

District court patent filings remained unusually high this week (97), with 40 Patent Trial and Appeal Board (PTAB) cases filed (one Covered Business Method, one Post Grant Review, and 38 Inter Partes Reviews). This week’s spike was driven in part by suits brought by Rothschild subsidiaries, but almost entirely (and this is true throughout this year) by the superlatively aggressive filing strategies of WSOU, who refiled or newly filed 35 suits this week in the Western District of Texas. Controlling for those 35 file/refile complaints, this week looks like a much more reasonable 65 or so new patent suits. That said, if we continue to see 100 weekly suits (or even a little less), that’s more than 4,000 projected suits in 2020. That would be below historic highs (2015 saw almost 6,000) but would be higher than the dip of the last two years, and on par with the 3,000-5,000 annual cases over that period (taking out the 2015 outlier, which seems TC Heartland–related). A few cases stand out.

Not Going to Waste My Shot: After their insulin injection Victoza® (and associated packaged injection devices) was approved by the FDA in 2010, Novo Nordisk must have thought they had a clear winner, market-wise. And they did—Victroza® has been widely prescribed and used. But reports of serious risks (read: pancreatic and thyroid cancer) associated with the incretin mimetic (a type of drug used to treat type-2 diabetes) have led to a number of class-action suits. (Having a sister with hypothyroidism and another who had and beat thyroid cancer, one can understand my sensitivities). Now their patent suite is on the verge of expiring, though it includes drug/device combinations listed in the Orange Book that extend the life of their product, prompting repeated generic challengers (signs of a healthy market for their shots).   They beat back at least Mylan and Teva, signing settlement arrangements that keep Teva, for instance, off the market until 2023. They’ve now been handed an abbreviated new drug application (ANDA) suit by Sandoz, which is seeking generic entry (or a similar sweetheart settlement.). It’s prompted at least two suits this week, the 1:20-cv-00747 in Delaware and the 3:20-cv-06842 in New Jersey on the same set; I assume at least one is a protective suit. Novo Nordisk filed against the challenger, setting up an ANDA bench trial per the Hatch-Waxman scheme in one of the two courts. (For the uninitiated, it’s common in ANDA cases for the brand to file two suits, one in their preferred forum, and one in the forum where the court is certain to have jurisdiction over the generic; it can prevent standing, forum, and do-over arguments later, but more importantly, it ensures the 30-month stay of Food and Drug Administration (FDA) approval remains in place. It’ll be an interesting one to watch, for sure, not least because it implicates the practice of patenting drug/device combinations and, if it goes to trial, will test the validity (or obviousness) of those types of evergreening strategies.

WSOU Refiles—Everything: This one is a head-scratcher. Maybe counsel revealed a gap in assignment records or a flaw in the chain of title. Maybe it was part of intimidation tactics. Maybe it was part of settlement negotiations that went south. But days after WSOU (as represented by the Etheredge Law Group, which handles almost all of Uniloc’s litigation) voluntarily dismissed their complaints prior to the defendants filing answers or any motions, they refiled—all of them (and added a few, for good measure).  WSOU has been years in the making, ranging back to 2017, and apparently Craig Etchegoyen, the founder and CEO of Uniloc, is managing part of the entity, which is seemingly related to capital funders and are in some way connected to Coast Asset Management and Juniper Capital Partners. The patents (there appear to be more than 4,000 total) come from Nokia and Alcatel-Lucent.

IP Bridge Over Troubled Waters: On March 9, the once-sovereign nation fund Godo Kaisha IP Bridge 1 (recently taken fully private) continued one of its older semiconductor campaigns, this time filing against Micron on four patents, 7,189,616; 6,747,320; 6,445,047; and 6,424,041, related to fabrication techniques for semiconductors. An earlier IPR challenge filed by Intel in 2018 was terminated due to settlement, presumably as part of a broader settlement discussion prior to any litigation; this time around, negotiations with Micron appear to have broken down, as Micron was sued in the Western District of Texas; and then quickly filed IPRs (three months later) IPR2020-01007, IPR2020-01008, IPR2020-01009, on three of the patents (including the same one Intel previously challenged) (and one would assume the fourth is either imminent, as of this writing, or subject to excellent noninfringement or 101/112 arguments elsewhere). That said, even filing those IPRs within three months of IP Bridge filing, the filings will not beat Judge Albright’s aggressive trial date schedule; the telephonic case management conference (CMC) is set for June 19, meaning that the trial schedule of 66 weeks after the CMC will put the trial, if it moves ahead as planned, at 16 months after the (rather quick) IPR filings—the final written decisions here wouldn’t come down until 18 months at the earliest. Under the PTAB’s NHK Spring decision on discretionary denials in light of trial dates, the Board will likely deny these petitions.