Rounding Error Case Denied En Banc Rehearing

AstraZeneca AB v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2022)

The Federal Circuit has denied AstraZeneca’s petition for en banc rehearing in this scientific notation case.  I’d like to see a Supreme Court petition on scientific notation. Here is the basic setup:

  • AZ’s formulation patent includes “0.001%” PVP K25.
  • Mylan’s accused product is slightly different, but still within standard rounding error (0.0005% to 0.0014%).
  • Is it infringing?

The court found it would normally be infringing, but the patent suggests a narrower range that includes “the precise number, with only minor variation.”  Thus, the range of literal scope would be something like 0.00095 to 0.00104.  And, that narrower scope means no infringement.

6 thoughts on “Rounding Error Case Denied En Banc Rehearing

  1. 3

    There is more to this than just a simple rounding issue. There is an example in the specification that was identified as one of the worst formulations that had 0.0005% of the excipient while the good ones had 0.001% (as claimed). It clearly distinguished these two different quantities. The District Court judge construed the term 0.001% to include 0.0005% embodiment when the examples clearly distinguished them from one another.

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