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2021 PIV Review – Market Still Correcting?

ParagraphFour.com Posted on January 11, 2022 by parryashfordJanuary 11, 2022

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 →

$28.7M Awarded to ANDA Filer

ParagraphFour.com Posted on December 8, 2021 by parryashfordDecember 17, 2021

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 →

Paragraph IV Notice – Delivered, Not Received

ParagraphFour.com Posted on November 16, 2021 by parryashfordNovember 22, 2021

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 →

Diminishing IPRs

ParagraphFour.com Posted on October 28, 2021 by parryashfordOctober 11, 2022

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 →

The Launch of Product Topic Advanced Search

ParagraphFour.com Posted on September 22, 2021 by parryashfordSeptember 22, 2021

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 →

US Supreme Court Offers “Solution” for IPR Proceedings

ParagraphFour.com Posted on June 28, 2021 by parryashfordJune 28, 2021

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 →

Navigating PIV Settlements

ParagraphFour.com Posted on May 22, 2021 by parryashfordMay 22, 2021

As mentioned in a prior blog post and The ParagraphFour Book, the Federal Trade Commission started a fresh attack on settlements in a Paragraph IV case, and the Fifth Circuit Court of Appeals was willing to oblige. Background This attack involved a settlement that used a contingent payment. As I had reported, “the FTC challenged … Continue reading →

Narrow Opening for Appeals

ParagraphFour.com Posted on April 20, 2021 by parryashfordApril 20, 2021

Court of Appeals Leaves Narrow Opening for Certain IPR Appeals Last month, the Court of Appeals for the Federal Circuit dismissed an appeal in a case involving Janssen and Mylan. Janssen had filed PIV cases against Teva and Mylan involving the 9,439,906 patent covering Invega Sustenna®(paliperidone). Mylan filed a Petition for Inter Partes Review challenging … Continue reading →

The ParagraphFour Book is Here!

ParagraphFour.com Posted on March 22, 2021 by parryashfordMay 22, 2021

The ParagraphFour Book is Here! I have compiled nearly 20 years of research Paragraph IV patent infringement cases and put it in one place — The ParagraphFour Book. The ParagraphFour Book covers the essentials of the Hatch-Waxman Act, its history since 1984, current issues and data, and much more! The book is not a boring legal … Continue reading →

2020 Annual Review – Market Correction

ParagraphFour.com Posted on January 14, 2021 by parryashfordJanuary 14, 2021

Six months ago, I posted that the First Half of 2020 showed that the PIV Market was correcting itself. The FDA PIV List showed that fewer products receiving their first PIV certifications had multiple filers. This seemed to be a natural market correction — over the past few years, the PIV Market saw several products … Continue reading →

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