The Full Court of the Federal Court of Australia has delivered a significant victory for generic pharmaceutical companies, unanimously overturning two Bayer follow-on patents for rivaroxaban (Xarelto) in a decision that clarifies the obviousness standard for pharmaceutical patents and opens Australia's lucrative anticoagulant market to generic competition.
On October 23, 2024, the three-judge panel ruled that Bayer's formulation patent (AU 2004305226) and dosage regimen patent (AU 2006208613) for rivaroxaban were obvious in light of an earlier compound patent that disclosed the drug. The decision in Sandoz AG v Bayer Intellectual Property GmbH [2024] FCAFC 135 represents a major recalibration of how Australian courts assess inventive step in follow-on pharmaceutical patents.
Market Impact and Commercial Significance
Rivaroxaban stands as one of Australia's most commercially significant pharmaceuticals, ranking as the 13th most prescribed active ingredient in 2023 and generating over $4 billion in global sales for Bayer. The compound patent for rivaroxaban expired in November 2023, but Bayer had sought to maintain market exclusivity through two follow-on patents covering specific formulation and dosing aspects.
The Therapeutic Goods Administration has already approved 158 rivaroxaban products, with 149 being generic formulations. Following the Full Court's decision, Teva and Alphapharm have obtained Pharmaceutical Benefits Scheme listing for generic rivaroxaban products, with additional competitors expected to move swiftly to launch their products.
Redefining the Obviousness Standard
The Full Court's decision fundamentally reshapes how Australian courts evaluate inventive step in pharmaceutical development. At first instance, Justice Rofe had found the patents valid, accepting that while a skilled team would select rivaroxaban as a lead candidate from Bayer's compound patent, the inherent risks and uncertainties in drug development created sufficient barriers to render the follow-on inventions non-obvious.
The primary judge had relied on literature estimates showing only 10% of drug candidates successfully proceed from pre-clinical testing to product approval, concluding that these risks precluded the requisite expectation of success for an obviousness finding.
The Full Court rejected this approach, establishing several key principles that will guide future pharmaceutical patent disputes:
Routine Nature of Drug Development
The appellate court held that "carrying out clinical trials and other tests in order to obtain further data is routine work" in pharmaceutical development. The court emphasized that while multiple steps in drug development may lead to failure, "that risk is common to the field and establishes the baseline or context for the inventive step inquiry; it should not be determinative of the outcome."
Expectation of Success Standard
The Full Court clarified that the relevant expectation must be measured against the ordinary level of expectation and risk inherent in routine work in the pharmaceutical field. The test requires only that the skilled person expect the steps "may well work," not that they would definitively succeed.
The court found it implicit that selecting a drug as a lead candidate carries with it an expectation of success, noting that "the skilled person would not proceed into pre-clinical and clinical tests if they did not have a sufficient expectation of success."
Evidence Requirements
Critically, the Full Court noted there was no evidence that any particular problems would arise during pre-clinical and clinical trials that would require inventive skill to overcome. The court found no evidence that the claimed wet granulation formulation into rapid release tablets or the once-daily dosage regimen would not have been identified during conventional pharmaceutical development work.
Ascertainment Under Pre-Raising the Bar Law
The decision also clarifies the "ascertainment" requirement under the pre-Raising the Bar version of Australia's Patents Act. The primary judge had found that Bayer's compound patent could not serve as prior art because Sandoz had not adequately demonstrated that a skilled person would have discovered it through reasonable searches.
The Full Court overturned this finding, establishing that the ascertainment standard requires only proof of "a reasonable expectation that the skilled person would" discover the document "on the balance of probabilities." The court rejected requirements for evidence that the skilled person would "prefer, prioritise or select" one piece of prior art over others, calling such an approach an "artificial ex post facto literature search."
Implications for Patent Strategy
The decision carries significant implications for both originator and generic pharmaceutical companies. For originators, the ruling emphasizes that follow-on patents must involve genuine inventive work beyond routine pharmaceutical development activities. The court's analysis suggests that formulation and dosage optimization work that follows predictable pathways may struggle to meet the inventive step threshold.
Generic companies will likely view the decision as lowering barriers to patent challenges, particularly for follow-on patents that claim routine pharmaceutical development outcomes. The clarified ascertainment standard also reduces evidentiary burdens for establishing prior art under pre-Raising the Bar patents.
Broader Legal Precedent
The Full Court's reasoning extends beyond rivaroxaban to establish principles applicable across pharmaceutical patent disputes. The decision's emphasis on routine pharmaceutical development work as insufficient for inventive step may influence how courts evaluate other follow-on patents covering formulations, dosing regimens, and manufacturing processes.
The ruling also demonstrates Australian courts' willingness to scrutinize pharmaceutical patents that appear to extend market exclusivity through incremental innovations rather than genuine technical advances.
Next Steps and Market Entry
Bayer may seek special leave to appeal to the High Court of Australia, though the unanimous Full Court decision and clear legal reasoning may limit prospects for further review. In the interim, generic competitors are positioned to rapidly enter the Australian rivaroxaban market, potentially driving significant price competition in this high-value therapeutic area.
The decision represents a watershed moment for Australian pharmaceutical patent law, establishing clearer boundaries around what constitutes inventive pharmaceutical development and potentially accelerating generic market entry across multiple therapeutic areas where similar follow-on patent strategies have been employed.
