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Viagra is the much publicised and highly successful drug for treatment of erectile dysfunction. Eli Lilly markets a rival product called Cialis and sought revocation of claim 10 which covers the use of all compounds that have the physiological effect of preventing impotence. Viagra falls within the scope of this claim and also claim 8 of the patent which defines the use of the active ingredient in Viagra. The Federal Court’s decision at first instance allows Eli Lilly to market Cialis but Pfizer can still rely on claim 8 to prevent generic manufacturers from entering the market with generic substitutes for Viagra.
However, interest in the outcome of the appeal transcends what the Full Court has to say about obviousness and fair basis. Justice Heerey raised a few eyebrows with his finding that the date for determining sufficiency and the best method was, at the earliest, the date of grant of the patent. Before this decision, the general view was that the relevant date was the date the complete specification was filed.
The term “complete specification” is defined in the Patents Act to include the specification as amended. As the specification can be amended before the date of grant, Heerey J concluded as a “straightforward matter of statutory interpretation” that the date of grant is the earliest date for determining both sufficiency and best method. He left open the question of whether the relevant date may be as late as the date of commencement of proceedings.
Unless the Full Court overturns Justice Heerey’s decision, it appears that an applicant may delay disclosure of the best method known for performing the invention until just prior to the grant of the patent and may amend a specification which does not sufficiently describe an invention at any time before that date.
Of course, any amendment to a specification would still need to comply with the requirements of s102 of the Patents Act 1990 which restricts the types of amendments that are allowable.
The Full Court, comprising French, Lindgren and Crennan JJ, heard the appeal over four days (8 – 11 August) and its judgment is expected within a few months.
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