Evolva hits sweet spot for ‘sufficiency’ under new Act

On 15 April 2013 the ‘bar was raised’ on the Patents Act 1990.  While the law relating to sufficiency changed, there has been very little guidance as to how this change would be applied. Evolva SA [2017] APO 57 now provides some clarity as to the level of detail required in a specification.

Background

Evolva SA filed for a patent for a new way to make sugar-based sweeteners (known as mogrosides) by use of an enzyme.  The process involved contacting the starting materials with one of five specified enzymes or a polypeptide with “at least 90% sequence identity” to one of the specified enzymes, which during examination was deemed to be too broad and insufficiently supported.

This decision, which found in favour of Evolva SA, illustrates the type of information required to be disclosed to sufficiently support claims of broader scope than the illustrative examples provided.

The decision

One of the Delegate’s main considerations was whether or not a “research programme” would be required to assess whether a polypeptide, which was 90% identical to one of the specified polypeptides, would be effective in performing the invention. If so, then there would be insufficient support for the claims.

In finding for the applicant, the Delegate noted:

  • It was plausible that the invention could be worked across the full scope of the claims, in that a principle of general application was set out in the specification.
  • The claims were not unduly broad. They were not directed to every variant with 90% sequence homology, only those with a certain function (to catalyse the synthesis of mogrosides).
  • The specification also disclosed, in relation to this field of technology:
    • it is routine to sequence polypeptides to determine if it has at least 90% identity to one of the specified polypeptides;
    • it is known which changes to a polypeptide are likely to retain the desired function;
    • it is routine to produce/express and screen large numbers of polypeptides;
    • how to determine whether a candidate polypeptide has the required function; and
    • that none of this represents an undue burden, such as would require a research programme to be carried out.

Conclusions

This case highlights the need for a specification to provide enough detail about an invention for a skilled person to plausibly work the invention. For complicated technologies, consideration should be given to outlining plausible ways of working the aspects of the invention, without undue burden and across the full scope of the claims, to guard against any support objections.

Dr Leon Wong, Former POF Attorney

BSc (Hons I) PhD MIPLaw MRACI (CChem)

Leon has extensive academic and industrial experience in pharmacology and synthetic organic chemistry. Leon completed his PhD at the University of Sydney where he worked on a new synthesis for (+)-himbacine, a tetracyclic alkaloid for the treatment of Alzheimer’s disease.