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 →
A recent U.S. Supreme Court decision brought an end to legal strategy involving Allergan and its product Restasis®(cyclosporine). The strategy appears to have been borne out of the frustration that pharmaceutical competition can bring and leaves us with a perception that is not so positive, to put it mildly. Like most industries, the pharmaceutical business … Continue reading →
September 2019 marks an important moment for ParagraphFour.com with the re-launch of its new website. The revision to the site is a bit bittersweet. It’s joyous and exciting to refresh the look, feel and navigation of the site as well as take advantage of the enhanced features a new database can bring. But it is … Continue reading →
On June 18, 2019, FDA posted its PIV List with some major revisions and additional data fields. Over the past 20 years, FDA has maintained the same format with basic information including the drug name (generic and branded trade name), dosage form, and strength. If memory serves me well, around 2004, it added the Date … Continue reading →
The first 6 years of IPR filings ended September 30, 2018. After the USPTO implemented the IPR process, it took a couple of years before ANDA filers started adopting petitions for Inter Partes Review, an alternative forum to litigating a Hatch-Waxman PIV case in district court. In 2013, only 10 petitions were filed on patents … Continue reading →
