Category Archives: FDA

Is Judge Kavenaugh an Enemy of Agency “Chevron Deference”?

Other commentators have noted that they believe that Judge Kavanaugh (“K”) does not like “Chevron deference” of the courts to the interpretation of agency regulations. I skimmed recent decisions and note, that in technical areas, the judge recognized that deference … Continue reading

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Things to be Thankful for in IP Wonderland

Apart from the carnage wrought by the ever-expanding scope of s. 101 rejections and the tightening of the written description requirement, there were still a number of events/trends in 2017 to applaud or at least to note as “worthwhile.” I … Continue reading

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Why Did the Chicken Cross the Road? To Get New Genes!

Jay Cormier has a new post on the FDA Law Blog called “Tastes Like Chicken: Second ‘BioPharm’ Animal Approved to Produce Biological to Treat Orphan Disease Includes 6th Rare Pediatric Disease Priority Review Voucher.” He writes: On December 8, 2015, … Continue reading

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FDA Publishes “Purple Book” for Biologicals/Biosimilars

In a major move to get organized for the oncoming wave of biosimilar applications, the FDA has published a “Purple Book” listing licensed (e.g., approved) biologicals and licensed interchangeable biosimilars. Rather than summarize the contents table of the book, linked … Continue reading

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