Did the Earth move for you too?
Most of the substantive Raising the Bar amendments came into force today.
Amongst other things, schedule 1 of the Raising the Bar Act introduced a raft of changes designed to raise the threshold of patentability – i.e., make it harder to get a patent.
- introducing the really diligent searcher of prior art for obviousness via changes to s 7(3) so that it will be permissible to combine any piece of prior art with common general knowledge (if the skilled addressee could reasonably be expected to combine the two), not just those elements of the prior art that the skilled addressee could be reasonably expected to have found;
- a new concept of utility based on the US approach; and
- doing away with the ’old’ fair basis requirement in s 40 as interpreted by the High Court in that Lockwood ruling.
Instead of fair basing, a patent will be required by s 40(2) to disclose:
(a) the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art; and
(aa) the best method known to the applicant of performing the invention; and …
and s 40(3) will read:
“The claim or claims must be clear and succinct and [fairly based on the matter described] supported by matter disclosed in the specification.”
Provisional specifications will have to meet the requirements set out above in s 40(2)(a) also.
This is intended to introduce into Australian law the requirements under the UK’s 1977 Act: s 72(1)(c).
The Court of Appeal provides an interesting example of how these new rules should work in it Merial ruling. Merial had (at least) 2 patents relating to its Frontline brand of flea-treatment products. One of these, the 881 patent survived the attack on sufficiency of description, but the other, the 564 patent did not.
Kitchin LJ identified the crucial difference between the 2 patents at  – :
…. This was a matter to which the judge expressly referred at :
”77. In contrast to the examples in 881, the examples of 564 simply specify different concentrations of the active ingredients. The examples do not contain any formulation details beyond saying that there should be present a crystallisation inhibitor, an organic solvent and an organic co-solvent.”
This then was the critical difference between the disclosures of the two patents. Omnipharm failed to establish that the practical guidance given by the examples of the 881 patent was not sufficient to enable the skilled team to work across the breadth of the claims. But the 564 patent claimed a combination of actives and did so without any worked examples at all. It provided no real practical assistance over and above the common general knowledge.
Kitchin LJ accepted Merial’s argument that the UK Act did not impose an obligation to include examples of the way the claimed invention worked. However, his Lordship considered that was not why the trial judge, Floyd J, upheld the attack. Rather, the description was insufficient because it did not give sufficient guidance about which ingredients to choose and in what proportions. So, Kitchin LJ explained at :
I reject these submissions. I think it is clear from  –  that the judge did not find that the absence of any detailed examples was, in itself, fatal to the sufficiency of the 564 patent. What rendered it insufficient, in his view, was the absence of proper exemplification of a formulation of the invention in the context of a specification which was generally inadequate to guide the skilled person to success and provided no real practical assistance beyond the teaching of the prior art and the common general knowledge. The specification contains no more than a very broad indication of the components of the formulation and, as the judge found, it is not a sufficient description to enable the skilled person to arrive at formulations across the breadth of the claims without undue effort.
One illustration of the problem with the 564 patent was set out earlier at :
The disclosure in relation to solvents and co-solvents is something the judge also had well in mind, as is clear from -. Here he referred to the dielectric constant ranges which the solvent and co-solvent must meet, and that the co-solvent must have a boiling point below 100°C. He also referred to the lists of suitable solvents and co-solvents. This information would not, however, be of any practical use to the formulator who, as Dr Walters explained, would have to fall back on his general knowledge of solvents and techniques for enhancing spreading and skin penetration in order to decide on the appropriate solvent system to use.
Neither the Court of Appeal nor Floyd J at first instance set out at length the legal principles underlying insufficiency for these purposes. However, Floyd J had earlier set out his understanding of ‘classical insufficiency’, Biogen insufficiency and ‘insufficiency through ambiguity’ at  –  in Zipher.
ps.: those who attended David Brennan’s talk last year will find his ‘Monash paper’ in 38(1) Monash University Law Review 78.
- Austlii doesn’t seem to have caught up with all the minutiae yet. ?
- The ‘old’ rules will continue to apply for all standard patents granted before 15 April and any pending applications for which a request for examination had been made before 15 April. (This the pre–15 April 2013 version of s 40 will break when the new rules come in.) ?
- where the words in between [ and ] are deleted by the new Act ?
- For England and Wales (of course). ?