29 November 2024

Is It Time to Talk (Again) About Reforming Australia’s ‘Best Method’ Requirement?

It's cool to be vaccinated, even if you're a pig!The recent Full Federal Court decision in Zoetis Services LLC v Boehringer Ingelheim Animal Health USA Inc [2024] FCAFC 145 has highlighted fundamental flaws in the Australian patent law’s ‘best method’ requirement.  While the court's application of existing principles appears sound, the resulting analysis reveals that the requirement is not only arbitrary in its operation, but potentially counterproductive to innovation.

The Australian Patents Act 1990 sets out requirements for patent specifications in section 40.  These include that the specification must: disclose the invention in a manner clear enough and complete enough for the invention to be performed by a person skilled in the relevant art (the enablement requirement);  disclose the best method known to the applicant of performing the invention (the best method requirement);  and that the claims must be supported by matter disclosed in the specification (the support requirement).  While failure to satisfy enablement or support might affect only certain claims, failure to disclose the best method is fatal to the entire patent.  It is, in effect, a ‘nuclear’ ground of invalidity that cannot be remedied by amendment or partial revocation.

The Zoetis case concerned three patent applications for pig vaccines that were found invalid for failing to disclose the best method of performing the inventions.  While the applications disclosed ranges of antigen concentrations that would work, they did not reveal the specific concentrations used in Zoetis's successful experimental vaccines.  The court’s analysis of why this was fatal to the applications exposes deep problems with the requirement itself.

28 November 2024

Hindsight by Stealth? Pre-RtB ‘Ascertainment’ After Sandoz v Bayer

Looking for documentsA recent Full Court decision suggests that demonstrating prior art could be ‘reasonably expected to be ascertained’ under the pre-Raising the Bar (RtB) law may be considerably easier than previously thought.  But has the pendulum swung too far?  In relaxing the evidentiary requirements for establishing that prior art information would have been found by the skilled person, the Full Court may have undermined a safeguard against hindsight analysis that was inherent in the prior law.

In Sandoz AG v Bayer Intellectual Property GmbH [2024] FCAFC 135, the Full Court has taken a markedly different approach to prior art ‘ascertainment’ than the primary judge (Rofe J in Sandoz AG v Bayer Intellectual Property GmbH [2023] FCA 1321).  While acknowledging that whether prior art ‘could be reasonably expected to have been ascertained’ is a question of fact, the Court has effectively lowered the bar for the evidence required to establish this factual foundation.  This raises a question of whether the practical difference between the old and new law is as great as previously assumed.

The primary judge took what might be called a ‘real world’ approach to ascertainment.  Her Honour wanted to see evidence of the complete search process that would have been undertaken by the skilled person, without knowledge of the target document.  This included evidence of searches across multiple databases using various relevant search terms, and – critically – how the skilled person would have identified the relevant document from among all the search results that would have been generated.

The Full Court rejected this approach as too demanding.  Instead, the Court held that once it is established that a document would have been found in a relevant database search, it is not to the point that additional searches might have been performed or that other documents might also have been found.

This might seem like a practical approach – after all, if a document exists in a database that would have been searched, using search terms that would have been used, isn't that enough to show it could have been found?  But this reasoning potentially introduces precisely the kind of hindsight analysis that the ‘ascertainment’ requirement was – arguably – meant to guard against.

27 November 2024

Full Court Delivers Hot N Cold Comfort in Katy Perry Trade Mark Battle

Two rightsWhile this blog normally focuses on patent matters, occasionally a case comes along that warrants stepping outside my usual lane.  The Full Court of the Federal Court’s decision in Killer Queen LLC v Taylor [2024] FCAFC 149, delivered last week, is one such case.  After all, it’s not every day that an Australian small business owner finds herself locked in a trade mark dispute with an international pop superstar over their shared name.

The case is a sobering reminder that sometimes you can wake up to find that your own name has effectively been monopolised by someone more famous – even if you got there first. It's enough to make you want to Roar in frustration!


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