Major Revisions to the FDA PIV List

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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 →

Where have all the IPR’s gone?

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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 →