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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 →

IPRs Falling

ParagraphFour.com Posted on October 15, 2020 by parryashfordOctober 15, 2020

Fewer IPR Filings in 2020 As I reported in a prior post, ANDA filers are filing fewer Petitions for Inter Partes Reviews (IPRs). The most recent data for the 2020 IPR filings* add additional support. In the 2020 IPR filings, ANDA filers submitted only 15 Petitions. The IPR patent challenges are typically associated with a … Continue reading →

No Longer Competing PIV Cases

ParagraphFour.com Posted on September 23, 2020 by parryashfordSeptember 23, 2020

The Competing Cases In the last blog post, I highlighted two competing PIV cases involving the same product, patent, and legal issue. The West Virginia District Court had found claims of the patent invalid due to lack of written description. This case is currently on appeal. Meanwhile, a case in Delaware District Court had already … Continue reading →

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