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 … Continue reading →
We can’t let January go by without some personal fanfare. ParagraphFour.com has reached the 20 year mark! “Just put up a website.” The ParagraphFour.com journey started in the summer of 2003 when I had the idea to start researching PIV cases. At the time, legal cases were all over the place and hard to access. … Continue reading →
This year’s Annual Review made me reflect on the Paragraph IV Market over the past years. We have reached a new plateau which indicates that the terrain is a bit rocky at this point for anyone participating. Consistently Fewer ANDA Filings The high-point of the PIV Market was 2015 which saw a record number of … Continue reading →
On November 7, 2023, the Federal Trade Commission issued a Press Release targeting more than 100 patents currently listed in the Orange Book. The Press Release elevates its position that certain device-related patents are not appropriate for listing and demands their removal. 10 Companies Notified, Sort-of Over the past couple of months, FTC has notified … Continue reading →
Like a salmon at the end of a buffet, decades-long PIV litigation over Latisse®(bimatoprost) Topical Solution came to a hard ending. PIV Litigation since 2010 Back in 2010, several generic companies showed an interest in the eyelash growth product Latisse®(bimatoprost). Allergan subsequently filed nearly 20 PIV cases against five ANDA filers. The Court of Appeals … Continue reading →
On July 14, 2023, Gilead filed two PIV cases in Delaware which were similar, yet curiously different. They both involve its $2B product Genvoya®(elvitegravir, cobicistat, emtricitabine, tenofovir) Tablets and one ANDA filed (ANDA 218575). The First Complaint Gilead filed its first Complaint against two defendants Apotex and MSN Laboratories over the 10,039,718 patent (# 1:2023cv00774). … Continue reading →
Earlier this month, Vanda submitted a Citizen Petition asking FDA to revoke the approval of Teva’s ANDA product for Hetlioz®(tasimelteon) Capsules, the sleep disorder drug. Vanda also asks FDA to remove the Teva product from the market. This Petition comes after Vanda lost its PIV case in December which case is pending appeal. (Citizen Petition: … Continue reading →
As 2022 was drawing to a close, Vanda Pharmaceuticals filed a PIV case against Teva and Apotex. Often, English football commentators will describe a foul as “cynical” when the player commits a foul intentionally or out of anger at being beaten. This is an apt way to describe this PIV case over Hetlioz®(tasimelteon) Capsules. 2022 … Continue reading →
At the end of October, the PIV Market saw a rather curious case emerge. Abbvie filed a PIV case against 9 ANDA filers in defense of Orilissa®(elagolix). All 9 filers filed their ANDAs on the NCE-1 date and are thus “first filers.” Does this case signal that the PIV Market has lost its steam, interest … Continue reading →
The past 12 months have provided more data since my prior post Diminishing IPRs. In that post, I had suggested that IPRs would become more targeted over certain patents and products. 2022 data support this opinion. Handful of IPRs filed in 2022 In 2022, there were 11 IPRs filed involving PIV products.* While this is … Continue reading →
