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:
Lessons
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:
- Detailed laboratory notebooks can be used to establish a finding of inventive step.
- 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.
- 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.
- A witness's use of hindsight undermines an allegation of inventive step.
- A witness's knowledge that an invention has been successful indicates the use of hindsight.
- A witness's reference to publications not available at the priority date indicates the use of hindsight.
- Knowledge of the existence of a patent dispute can cast doubt on the reliability of a witness's evidence.
- The problem and solution approach could be unfair to an inventor of a combination or a simple solution.
- 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
- Not only R&D teams, but all inventors should keep a careful developmental record in a form that can be readily reproduced.
- Where possible, witnesses should not be made aware of the patent dispute or even of the existence of a patent.
- Witnesses must be made to understand the importance of preparing their material as at the priority date, otherwise stated.
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