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 →
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 →
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! 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 →
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 →
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 →
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 →
The competing PIV cases Last December, a PIV case involving several ANDA filers concluded its trial in Delaware involving Tecfidera®(dimethyl fumarate). A few months later in West Virginia, a trial in a PIV case involving the product’s 8,399,514 patent concluded against Mylan. Both cases involved the same product, same patent, and same defense – lack … Continue reading →
