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 →
In my Annual Review post earlier this year, I suggested that the PIV Market is working towards market correction. Over the past few years, many ANDA filers filed PIV certifications, and some products became “hypercompetitive” with 10 or more ANDA filers filing on Day 1. For example, the market saw 6 hypercompetitive products in 2018. … Continue reading →
Court dockets keep the documents for each case. They include the pleadings (Complaints and Answers), motions, and court decisions, among many other items. These documents are public. In theory, at least. Paragraph IV cases contain trade secrets from the brand company and the ANDA filer generic company. Because of trade secrets and other confidential information, most … Continue reading →
At ParagraphFour.com, I conduct quite a bit of original research and make it available to our subscribers. Sometimes, I place the findings in a research paper format and publish it on the site or in a journal. I recently updated some research from 2014 which looks at defenses ANDA filers raise in a PIV case. … Continue reading →
During the Covid-19 pandemic, the U.S. federal court system is functioning pretty well. Courts handling PIV cases kept busy in March. The district courts issued a Standing Order reducing their functionality (copy below). The Order stopped jury trials due to the nature of many people gathering for them (jury pools, lawyers, court personnel, etc.) The … Continue reading →
The Federal Trade Commission has resumed its attacks on PIV Settlements, claiming greater access to generic products for consumers. Considering the history and PIV data, these new and unfounded attacks likely serve to reduce the number of generics reaching the market. Supreme Court Rule of Reason The US Supreme Court issued FTC v. Actavis in … Continue reading →
