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 →
