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Justice Breyer seems to be indicating that the FDA’s interpretation of the BPCIA would be eligible for Chevron deference. And that might make sense with respect to the timing of the notice of commercial marketing. So, for example, the FDA might have some incentive in the future to say that they interpret the BPCIA to require 180 days between formal FDA approval at the expiration of the biologic exclusivity and commercial marketing.

But with respect to the civil procedure requirements—the “patent dance” aspect of the Sandoz holding, it’s not really clear what the FDA’s incentive would be or how the FDA’s authority would extend to parties’ standing before the Article III courts. It’s uncertain if the FDA has any incentive to weigh in on the patent dance, and whether they would feel confident that their interpretation of the procedural aspects of patent litigation would be entitled to deference, you know, Justice Breyer’s concurrence notwithstanding.

 

Ha Kung Wong has extensive experience litigating a wide variety of pharmaceutical cases, including those concerning biologics used to treat rheumatoid arthritis and autoimmune disorders. He also has extensive experience consulting, conducting due diligence and licensing pharmaceutical portfolios. Ha Kung has a B.S. in Biochemistry and a B.S. in Chemistry.

Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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