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 →
PIV cases can get complicated. But sometimes, lawyers can make things even more so. Three weeks before trial in the Aptiom(eslicarbazepine), the Delaware District Court ordered the parties: “ORAL ORDER: WHEREAS, the parties filed the proposed pretrial order … Plaintiffs’ assertion of 15 claims across eight patents at this juncture makes clear that Plaintiffs have … Continue reading →
Once or twice a month, FDA issues a PIV List providing information for newly-filed, first-filed ANDAs. The June 13 List was rather remarkable – it contained 9 products, 8 of which represented ANDAs filed in April. This PIV activity has not been seen since 2014. Does the June 13 FDA List mark a turn in … Continue reading →
