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 →
This past Saturday, Senator Orrin Hatch passed away at the age of 88. His 42 year tenure in the U.S. Senate was the longest of any Republican. He, along with Congressman Henry Waxman (D), authored what became to be known as the Hatch-Waxman Act. He died in his home in Utah. Humble Roots and Senate … Continue reading →
The Court of Appeals for the Federal Circuit in Washington hears all PIV cases. It recently issued an Opinion “In re: Violation of the Revised Protocols for In-Person Arguments and Related Order.” Apparently, some lawyers who appear before the Court of Appeals like to bend a few rules. But this time, two of them got … Continue reading →
A Modest Request Back on November 23, 2005, Camargo Pharmaceutical Services filed a Citizen Petition with the FDA (2005P-0329). Camargo asked FDA to approve an ANDA filing for a proposed new product: meloxicam orally disintegrating tablets, 7.5mg and 15mg. This type of request, or suitability petition, is common. Citing an approved product (Mobic®(meloxicam) tablets), the … Continue reading →
