A curious PIV case surfaced at the end of October involving Lonsurf®(trifluridine and tipiracil) Tablets and its 9,943,537 patent. It reminds us of some similar behavior of Bristol-Myers from 20+ years ago which brought an aggressive response from the US Federal Trade Commission.

On October 20, 2023, Taiho filed a PIV case against ANDA filer Aurobindo (Eugia) over the ‘537 patent. On its face, there is nothing unusual about this case, as Taiho filed it in response to PIV Notice letter of an Orange Book patent. But when you dig through the Complaint, another story appears.

A pending court decision, then a late-listing

The October case was a secondary case against Aurobindo. Taiho had filed its primary, or lead case, against Aurbindo back in December of 2019 over four patents. The parties whittled down the dispute to one patent by the time it completed trial in March of 2023. While the Court decision was pending (that is, had yet to be decided), Taiho listed the ‘537 patent in the Orange Book on August 7, 2023. (One week after listing the patent, the Delaware District Court ruled in its favor in the primary PIV case.)

Of course, there is nothing unusual about listing a patent in the Orange Book. However, Taiho “late-listed” this patent. The USPTO issued this patent five years prior in April of 2018. Often, the USPTO grants a new patent to a brand company while a PIV case is pending over the associated product. Typically, the brand company immediately lists in the Orange Book and files a secondary PIV case typically within days or months after the listing or issuance. In spite of the patent being 5 years old, Taiho described its listing as being “timely submitted.”

Echoes of Bristol-Myers Squibb

If you have been watching the PIV Market over the past 25 years, this Complaint reminds you of the activities of BMS back in the late 1990’s. It adopted a practice which – while technically sound – pushed the boundaries of PIV rules. While its PIV cases were pending, BMS sought new patents to list them in the Orange Book and then to argue that the new patent renewed the 30-month stay. The FTC aggressively stopped this strategy, and the rules have changed to prevent renewal of 30-month stays with the filing and listing of new patents. This story is fully detailed in The ParagraphFour Book.

Clever Strategy or ill-intent?

Of course, I have no way of knowing the intention of Taiho in late-listing its patent. However, the timing is suspect. Listing a 5-year old patent while the lead case is pending a decision? Hmmm…