SmithKline Beecham v. Apotex: A Conclusion?

SmithKline Beecham Corp. (SKB) v. Apotex Corp. (Fed. Cir. 2005).

Case History:

• 2003.03.03 Judge Richard Posner, sitting by designation, found the patent valid but either (i) not infringed or (ii) if infringed, the infringement excused under Posner’s newly created equitable defense.
• 2004.04.23 CAFC (RADER, J.) affirms, but on other grounds — finding that the drug (PHC hemihydrate) had been in public use during clinical trials.  Specifically, the court found that the clinical trials tested only the safety and efficacy of PHC hemihydrate as an anti-depressant and did not qualify as an experimental use. In concurrence Judge Gajarsa derided the Majority's approach, saying that it has created "unfortunate precedent that will complicate future considerations of the experimental use doctrine."
• 2005.04.08 Without opinion, en banc CAFC vacates the experimental use portion of the original panel decision.  Judge Newman’s dissent from the order declining to hear the case en banc was essentially a written as a dissent from the new panel decision issued the same day.
• 2005.04.08 The original CAFC panel issues a new opinion dropping the experimental use issue and basing the decision on “inherent anticipation.”
• 2005.06.15 CAFC denies a petition for an en banc rehearing of the new panel decision, but does not issue any opinion.

Links:

File Attachment: SKB Apotex en banc order (49 KB)

File Attachment: SKB Apotex Panel Decision (230 KB)

SKB Apotex Original Panel Decision (From Georgetown Law Center)

File Attachment: SKB Apotex District Court.pdf (2443 KB)

Discussion of the original panel opinion: Part I, Part II, Part III, and part IV.

Discussion of the en banc order and new appellate opinion: Part V, Part VI.

Howard Bashman provides an excellent commentary on the case via one of his readers.