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« BIO Says CBO Estimate of Follow-on Biologics Savings Is Based on "Troubling Assumption" | Main | Biotech/Pharma Lobbying Scoreboard - Third Quarter Update - Part II »

December 30, 2008

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Comments

Kevin,

A very interesting insight on how the Federal Circuit may be trying to avoid further review by SCOTUS. It is very consistent with what I was told about understanding the various standards for appellate review, and how you frame issues depending upon whether you want a "tough" standard to overcome or an "easy" standard to overcome. "Abuse of discretion" is at the "tough" end of the scale, followed by "clearly erroneous" (for review of factual errors). So it makes sense that the Federal Circuit here wasn't going to reverse the grant of permanent injunction unless there was something grossly wrong (or there was error in the legal standard applied). Conversely, when the appellate advocate wants to make it easier to reverse the district court, that's when they seek to characterize the issue as being a "question of law" and thus subject to "de novo" review (at the "easiest" end of the appellate review scale).

Unfortunately, the Federal Circuit hasn't always been consistent on applying the appellate standards for review. This is particularly true in the "written description" area for biotech which is characterized by the Federal Circuit as a question of fact (suggesting a "clearly erroneous" standard should be applied), but the reality is that the Federal Circuit reviews this issue as if it is was a "question of law" (applying a "de novo" standard). The Eli Lilly v. Univ. of California case is a good example of the Federal Circuit applying this "schizophrentic" standard to the "written description" requirement.

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