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 →
In 2019, the PIV Market has perhaps entered a “market correction” as analysts like to say about the stock market. The PIV Market saw a downturn in PIV cases and ANDAs filed, dropping 13% from the prior year. Here are the highlights: Fewer Cases in 2019 Here’s the graph over the past decade of PIV … Continue reading →
In response to the efforts of Purdue Pharma to settle and resolve its litigation, I started a blog post considering the behavior of Purdue. Part I covered citizens petitions and Part II covered Paragraph IV patent cases. Both establish that, in spite of the fact of the well-known risks of addiction of its product, Purdue … Continue reading →
In response to the efforts of Purdue Pharma to settle and resolve its litigation, I started a blog post considering the behavior of Purdue. Part I covered citizens petitions. Petitions filed with FDA provide insight into the story and establish that: (1) the risk of oxycodone addiction and abuse was well-known by the early 2000’s … Continue reading →
In early September, news reports surfaced regarding a $10-12 Billion settlement Purdue Pharma LP proposed to reduce its liability and to end the thousands of lawsuits filed against it.1 The primary driver of the lawsuits has been dozens of states claiming that they have been damaged by the additional cost of medical care to treat … Continue reading →
