Effexor Patent Valid & Infringed

Case: Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2010] FCA 1211

Judge: Jagot J

In this case, a patent for a sustained release formulation of Effexor was found valid and infringed.  While a number of different aspects were covered, I found the discussions concerning inventive step most useful. I have distilled some points and lessons.  The cross examinations of the witnesses are worth reading.

Inventive step notes:

1. Detailed laboratory notebooks can be used to establish a finding of inventive step.
2. Reference to a result can define a claim.  The question is what the skilled addressee would have understood at the priority date by the reference to the result.
3. A finding that experiments performed are of a routine character that would be tried as a matter of course by the skilled addressee would support a holding of obviousness.
4. A witness's use of hindsight undermines an allegation of inventive step.
5. A witness's knowledge that an invention has been successful indicates the use of hindsight.
6. A witness's reference to publications not available at the priority date indicates the use of hindsight.
7. Knowledge of the existence of a patent dispute can cast doubt on the reliability of a witness's evidence.
8. The problem and solution approach could be unfair to an inventor of a combination or a simple solution.
9. Inventive step may be lacking if the available information at the priority date would support the existence of a motivation to prepare a formulation in question.

Lessons

1. Not only R&D teams, but all inventors should keep a careful developmental record in a form that can be readily reproduced.
2. Where possible, witnesses should not be made aware of the patent dispute or even of the existence of a patent.
3. Witnesses must be made to understand the importance of preparing their material as at the priority date, otherwise stated.