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 →
Steady Decline of PIV Cases Continues In last year’s 2020 Annual Review – Market Correction, I noted that there was a decline in PIV cases from previous years. While a decline, the numbers were never to their lowest point. It seemed that the PIV Market was returning to its normal patterns before the large number … Continue reading →
Court Awards Damages After At-risk Launches The Delaware District Court recently issued an award of $28.7M to Piramal, an ANDA filer over Sensipar®(cinacalcet). Back in 2018, Amgen filed a PIV case against Teva, Piramal, and Cipla. Before trial, Cipla settled. The Court concluded that neither Teva nor Piramal infringed one of the Sensipar patents. The … Continue reading →
Nexus Files ANDA over Minocin®(minocycline) Last year, Nexus filed an ANDA over Minocin and sent its PIV Notice to the patent holder Melinta Therapeutics. Nexus sent its Notice via FedEx to the Melinta corporate address. FedEx delivered it on December 8, 2020. Office Closed Due to Covid-19, the Melinta office was closed on December 8, … Continue reading →
IPRs Have Nearly Disappeared Inter Partes Review Proceedings associated with Paragraph IV cases have nearly disappeared. This graph says it all: From a high number of filings (130) in 2015, to only 1 filed in 2021, ANDA filers have nearly abandoned the IPR petition. While ANDA filers may have considered the IPR petition as a … Continue reading →
We are proud to announce the official Launch of the Product Topic Advanced Search . New Addition to ParagraphFour.com Since its inception, we have updated and modified ParagraphFour.com to ensure that subscribers can find what they need quickly and easily. The site has nearly 20 years of research in its database. The data include nearly … Continue reading →
Supreme Court Issues Opinion Affecting Inter Partes Reviews On June 21, 2021, the US Supreme Court issued its Opinion in United States v. Arthrex. This case involved the question of whether the IPR law (Leahy-Smith America Invents Act) violates the constitution. The Supreme Court agreed that it does. Background Back in 2019, the Court of Appeals … Continue reading →
