Following on from our look into the ‘enablement’ and ‘support’ requirements in Australia introduced as a result of the RTB amendments, we will next consider recent Federal court and Patent Office decisions for guidance on issues of construction and discuss the unresolved issued where further clarity is required.
Construction Matters – The Reach of ‘Comprising’
The decision of the Federal Court of Australia (Burley J) in Merck v Wyeth[1] starkly illustrates the divergence between the pre-RTB and post-RTB written description requirements. This was the first Federal Court decision contrasting the pre-RTB and post-RTB regimes
The parent patent, examined pre-RTB, survived a fair basis attack because the claim language mirrored the description. Its divisional counterpart, examined under the post-RTB standards, was held invalid on lack of support grounds: while the inclusive claim language (using ‘comprising’) covered compositions containing 13 specified Streptococcus pneumoniae serotypes plus any others, the technical contribution disclosed in the body of the specification was limited to the 13-valent composition.
Following his decision in Merck v Wyeth, Burley J adopted a similarly broad construction of the term ‘comprising’ in Cytec v Nalco Company above and consequently found the patent claims invalid for insufficiency and lack of support under the post-RTB provisions.
In contrast, in Boehringer Ingelheim v Zoetis [2], Rofe J adopted a narrower construction, holding that “comprising” did not extend to unrecited antigens, with the consequence that support and sufficiency were satisfied.
These cases highlight that the construction of even the most commonly used terms in a patent is dependent on how the invention is described in the specification, and that this can ultimately impact the assessment of support and sufficiency post-RTB.
Thus, claim construction is becoming ever more critical.
What is the Test for Plausibility?
The RTB amendments to Section 40 (3) have been interpreted, based principally on United Kingdom case law[3], to have introduced a requirement that the applicant must establish that it is ‘plausible’ that the invention can be worked across the full scope of the invention.
In BASF Corporation[4], a decision of IP Australia, the Patent Applications in dispute were directed to synergistic fungicidal or insecticidal mixtures comprising either a fungicide or insecticide selected from a particular group of fungicides or insecticides in combination with particular bacteria.
During prosecution, the Examiner was of the view that there was limited exemplification of synergy, and, in the absence of a general principle of application, the claims were not enabled across their full scope. After the claims were narrowed, the case proceeded to a Hearing.
The Delegate, in his decision, stated that while “… the specifications, given what they present as the invention, can be understood to assert that it would be expected that synergistic combinations would result… they do not provide any underpinning explanation for this assertion”.
This decision highlights that presently:
- The plausibility threshold is relatively low, although the threshold has increased beyond speculation or mere assertion. Disclosing a principal of general application or underlying mechanism that applies across the full scope of the claims provides strong basis for plausibility.
- Plausibility should be considered based on the specification at the filing date of the specification. Lack of enablement cannot be rectified by post-filed data.
- Narrowing claim scope to avoid an “undue burden of experimentation” by limiting the number of potential permutations of the invention does not necessarily remedy the issue of plausibility since these are two different arms of the enablement test.
Plausibility
The Patent Office’s decision in BASF Corporation considered the then-current standards for plausibility, based on earlier UK decisions, in light of the UK Supreme Court’s decision in Warner-Lambert v Generics[5], acknowledging that earlier UK guidance may have set the bar too low.
The Patent Office’s decision in Gary B Cox v MacroGenics[6] reiterated that plausibility is “a threshold nonetheless”.
The Federal Court has since endorsed this approach in Cytec v Nalco above and TCT v Polaris. However, just where the ‘threshold’ should be set awaits further judicial consideration.
Enablement & Support
In TCT v Polaris[7], Burley J commented as follows:
“ …[there is a] general legal principle that the extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported, or justified… This means that the definitions in the claims should essentially correspond to the scope of the invention as disclosed in the description. In other words… the claims should not extend to subject-matter which, after reading the description, would still not be at the disposal of the person skilled in the art”[8]
The language of “at the disposal of the person skilled in the art” should be understood to mean that the patent must enable the invention to be performed by such a person.
In Jusand v Rattlejack[9], Rofe J observed that one way for the claim impermissibly to exceed the technical contribution to the art is for the claim to cover ways of achieving the desired result which owe nothing to the patent or any principle that it discloses.
Conclusion
The recent decisions in the Federal Court have clarified to some extent, how the new requirements of ‘support’ and ‘enablement’ are to be interpreted. However, further judicial analysis is eagerly awaited.
Claim interpretation is now more important than ever, and the word ‘comprising’ continues to throw up serious challenges, as it has for decades.
Further, questions as to the metes and bounds of the test of ‘enablement’ in general and ‘plausibility’ in particular continue to represent a challenge to practitioners. For the present, each case will, of necessity be determined on its specific facts. Further clarification will have to await a decision of an appellate Court.
If you have further questions about enablement and support in Australian patent law, get in contact with MBIP. You can find all of our details and our online enquiry form on our contact us page.
[1] Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477
[2] Boehringer Ingelheim Animal Health USA Inc v Zoetis Services LLC [2023] FCA 1119, Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] UKSC 27.
[3] See e.g. Warner-Lambert Company LLC v Generics (UK) Ltd [2018] UKSC 56
[4] BASF Corporation [2019] APO 34.
[5] Warner-Lambert Company LLC v Generics (UK) Ltd [2018] UKSC 56
[6] Gary B Cox v MacroGenics, Inc. [2019] APO 13
[7] TCT Group Pty Ltd v Polaris IP Pty Ltd [2022] FCA 1493
[8] Fuel Oils/Exxon, (T409/91) [1994] OJ EPO 653 the EPO Boards of Appeal.
[9] Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd [2022] FCA 54
