28 October 2005

Full Court Rules on Claim Construction

The Case:

On 21 October 2005, the full federal court of Australia handed down Fresenius Medical Care Australia Pty Limited v Gambro Pty Limited [2005] FCACF 220 .

This case is worthy of study by patent practitioners and patentees alike. Their honours Wilcox, Branson and Bennett JJ provide a good treatise on the construction of claims for the purposes of infringement.

Gambro is the exclusive licensee of Australian patent no. 595423. As such it had the standing to sue Fresenius for infringement, which it did. In the lower court, the judge found that Fresenius had infringed a number of the claims and that the patent was valid. This case concerns the appeal by Fresenius against this judgement. Fresenius' appeal failed.

The reasoning is turgid. However, the full court made some constructive points in connection with claim interpretation for the purposes of deciding infringement and these are discussed below.

The "Essence" of the Invention:

Fresenius objected to the manner in which the primary judge had interpreted the claims. In an apparent attempt to identify essential features of the claims, the primary judge identified some "essence" of the invention, ie " the use of dry powder in a vessel and its dissolution by the introduction of water into the vessel to produce a saturated (and so constant) concentrate fluid that was then withdrawn from the vessel and then dealt with in the customary way by the relevant machines." In order to ascertain the scope of a claim, it is neccessary to determine the essential features or integers of that claim. In support of this strategy, the primary judge cited Commonwealth Industrial Gases Ltd v MWA Holdings Pty Ltd (1970) 180 CLR, where it was held that the interpretation of the specification and claims is to be undertaken having regard to the essence of the invention. His honour decided that the essential integers of a claim are those which are necessary for "the essence of the invention". Other integers were classified as inessential and thus not influencing the scope of the claims.

Their honours held that applying such a principle on its own is erroneous. They held that the subject matter of the claims must be determined. Reference to the specification may be made to understand the context of the claim wording and thus whether or not integers were essential. In this regard, their honours concurred with Gambro in that the claims are to be read in the context of the specification not only when ambiguity exists in the claims. However, their honours did point out that doing so does not permit the adding of integers to the claims.
In Catnic Components Limited v Hill & Smith Limited [1982] RPC 183, the specification is to be read in the light of the common general knowledge before the priority date. The essential features are to be determined in the context of the then existing knowledge, as the patent is addressed to those skilled in the art. The specification serves as a tool for such persons to identify the essential features of the claims.

Functional Interpretation:

The analysis of whether or not claim 4 was infringed raised some issues worthy of discussion. The claim included the words: "a vessel containing a powder concentrate, said vessel including an inlet at the top thereof and an outlet at the bottom thereof;... ".

The "outlet" was interpreted, after consulting dictionaries, as an opening or passage by which anything is let out, including a vent or exit. Armed with this interpretation, the primary judge recognised that the Fresenius device did not have an opening at the bottom of the relevant vessel. In short, the Fresenius device is a column within a vessel. Concentrate leaves the column at the bottom of the column, which is at the bottom of the vessel. The concentrate enters a tube that conducts the concentrate to an opening at the top of the vessel. The primary judge held that the precise location of a break in the skin of the vessel is functionally immaterial. He reasoned that there was a fundamental lack of advantage of the Fresenius device over the vessel of claim 4.

In setting out the error in this approach, their honours explained that one does not investigate whether the allegedly infringing article is the same in substance and effect as the disclosures of the specification and claims. The form and wording of the claim are determinative. The primary judge impermissibly construed the claim with an eye to the allegedly infringing article.

Their honours held that when the claim is read in the light of the specification as a whole, including the figures, there can be no doubt that the outlet of the claim is an outlet both located at the bottom of the vessel and an outlet from the bottom of the vessel. By looking at the functionality of the Fresenius device, the primary judge had substituted a mechanical equivalent of an essential integer of the claim. This is not permissible for the purposes of ascertaining novelty or infringement.

For Patentees and Practitioners:

Claims should be drafted very carefully with a clear view of the features of an invention for which protection is sought. The clear meaning of the words in the claim will be taken as defining the scope of protection sought. Whether or not particular features are essential or not cannot be decided based on the functional "essence" of the invention. Rather, a reading of the specification with reference to the drawings in the shoes of the nominally skilled person is determinative of whether or not particular features are essential.

15 October 2005

Steriliser Claims Lack Fair Basis and Novelty

The Case
On 26 September 2005, the Deputy Commissioner of Patents handed down his decision in an opposition proceeding against Sheiman Ultrasonic Research Foundation Pty Limited by Novapharm Research (Australia) Pty Ltd. .
The Patent Application
Sheiman filed an international patent application on 17 February 1999, claiming priority from an Australian provisional patent application. Acceptance of the application in Australia was advertised on 31 October 2002. The matter came to a hearing on 29 August 2005. Sadly, this is an indication of the sort of time periods litigants, even in lower courts, can expect. .
The claims of the patent application included two independent claims. These were:
1. A sterilisation apparatus comprising:
an aerosol generator being adapted to generate an aerosol of a sterilising agent; and

a sterilisation chamber operatively coupled to the aerosol generator so as to receive a recirculatory flow of the aerosol, the aerosol generator being adapted to produce said recirculatory flow and the sterilisation chamber being designed to receive an article requiring sterilisation whereby in operation the recirculatory flow of the aerosol through the sterilisation chamber is effective in sterilising the article.

12. A method of sterilisation comprising the steps of:
providing a sterilisation apparatus including an aerosol generator and a sterilisation chamber operatively coupled to each other;
locating an article requiring sterilisation in the sterilisation chamber; and

providing a recirculatory flow of an aerosol of a sterilising agent through the sterilisation chamber said recirculatory flow being produced by the aerosol generator whereby in operation the recirculatory flow of the aerosol through the sterilisation chamber is effective in sterilising the article.

The Issues
Novapharm held that the claims were not fairly based on the specification and that they lacked novelty in the light of US patents. Novapharm also held that the claims lacked novelty based on Novapharm's complete application claiming priority from Novapharm's provisional patent application. Novapharm's provisional was filed after Sheiman's provisional, but before Sheiman's international application.
Fair Basis
On this issue, it became apparent that the opposition stood or fell on the basis of the interpretation of the italicised phrases highlighted in the above claims. Novapharm argued that the phrases did not give any indication as to how the aerosol generator produced the recirculatory flow. The Deputy Commissioner agreed that the phrase in claim 1 does not set out any constructional details of the aerosol generator. The Deputy held therefore that in the absence of constructional details, the aerosol generator can be taken to be a "black box" having the functional ability of producing an aerosol.
As described in the specification, the invention entails the use of an aerosol generator that does not require a fan or other such device to generate flow of the aerosol. Rather, the flow is generated by certain properties of the nebuliser used. The failure to adequately limit the claimed invention necessarily rendered claim 1 not fairly based.
For the purposes of this discussion, it is not significant that the Deputy found that claim 1 lacked novelty in the light of the US patents. However, the reasons for the Deputy finding that claim 12 and not claim 1 lacked novelty in the light of Novapharm's applications are interesting.
Sheiman's provisional made exclusive reference to the use of the device with a "detergent". On the other hand, Sheiman's complete specification makes reference to a "sterilising agent". The Deputy held that "a fair reading" of the provisional specification leads to the conclusion that the invention achieves sterilisation through the use of aerosol detergent. The Deputy was satisfied therefore that the provisional is limited to the use of detergents and that there was no real and reasonably clear disclosure of the use of sterilising agents as such.
However, the Deputy held that this did not deprive claim 1 of the priority date of the provisional because Novapharm did not point out any differences in functional requirements arising as between detergents and sterilising agents. On the other hand, the Deputy pointed out that method claim 12 expressly includes the step of providing a flow of a sterilising agent as an essential feature. Accordingly, the Deputy held that claim 12 was only entitled to the priority date of the international application and not the provisional application. As such, claim 12 was held to lack novelty as being anticipated by Novapharm's provisional patent application.
It is important for practitioners to be careful of being over-zealous when staking out the monopoly in a claim. If the claim is excessively broad, rights can be diluted or lost due to a weakening of the necessary fair basis link between the claims and the specification.
This matter also emphasises the need for provisional specifications to be drafted professionally and completely. A diligent attempt must be made to describe all possible embodiments and, where necessary, use appropriate generic structural language.