Cold Comfort: AFT’s Cold and Flu Combination Medicine Patent Applications Found Obvious

AFT Pharmaceuticals Limited [2024] APO 41 (8 October 2024)

Highlight

In October 2024, Delegate C. Mitchell of the Australian Patent Office upheld a decision to reject AFT Pharmaceuticals’ (AFT) drug combination patent applications – AU2022201576 (’576) and its divisional child AU2023222825 (‘825) – for lack of inventive step.

The claimed inventions proposed combining:

• paracetamol and ibuprofen (both oral analgesics); and
• xylometazoline (a nasal decongestant spray)

for the treatment of common colds.

History & Key Issues

The claims in the ‘576 application included Swiss-type claims and method of treatment claims reciting existing treatment regimens and routes of administration.  Dependent claims further defined specific dosages, formulations and treatment results.

During prosecution of the ’576 application, AFT failed to overcome the Examiner’s objection that the claimed invention related to mere aggregates of known components which lacked any inventive contribution.

The Examiner reasoned that:

(i) multi-ingredient treatments for cold and flu were well-established before the priority date, with the prior art supporting this position;

(ii) combining well-known cold/flu medications, such as those claimed in the ‘576 application, lacked an inventive step as it was routine practice in the field to administer these medications to treat a common cold, with the combination treatment being common general knowledge (CGK);

(iii) the drugs were administered at known dosages, via conventional routes of administration, and at different times of the day according to each drug’s standard treatment regimen; and

(iv) AFT failed to demonstrate any surprising or synergistic effect from the combined treatment.

AFT requested a hearing on the ‘576 application, and at the same time filed the ’825 application as a divisional from the ’576 application.  The ‘825 application, however, suffered from the same issues as its parent application.  As a result, both applications were considered at the hearing which AFT had requested for the ‘576 application.

At the hearing, AFT argued that:

(i) the prior art did not explicitly suggest the claimed combination or specific dosage regimen;

(ii) side effect concerns from treatment with xylometazoline, such as the “3-day rebound problem” with decongestants would lead a skilled person away from this formulation; and

(iii) secondary evidence, such as improved clinical efficacy and patient convenience, supported the invention’s non-obviousness.

Consideration

Skilled Person and Common General Knowledge

The Delegate uncontroversially determined that the person skilled in the art was likely to be a pharmaceutical scientist who was skilled in formulating a variety of drug formulations, potentially working with pharmacists and clinicians.

The Delegate made a number of findings on the CGK at the relevant priority date.  In particular, the Delegate considered that the evidence showed that:

• Cold and flu treatments were well-established, with both analgesics and decongestants being routinely used in combination.
• Analgesics had long been accepted for their ability to relieve cold and flu symptoms by inhibiting inflammatory processes, with both paracetamol and ibuprofen recognised as safe and effective treatments.
• The CGK around decongestants was well-developed, with documented understanding since the 1980’s about their effects and side effects depending on individual factors and duration of use.

The Delegate also noted that the patent specification lacked commonly known information on multi-ingredient combinations of cold and flu drugs.  For example, it did not refer to common over-the-counter multi-active combination medicaments, such as paracetamol and pseudoephedrine, that had been used for over 60 years as cold and flu treatments.

Inventive Step

The Delegate found that each of the claimed active ingredients, when considered individually, was defined in commonly known dosage formulations.  This raised the question of whether the skilled person would, as a matter of course, prepare a medication combining these known actives in their known dosage formulations for treating cold and flu.  The Delegate concluded they would, noting that analgesics were commonly used together and that it was routine to recommend that nasal decongestants be used with analgesics for cold and flu treatment.

The Delegate also considered the CGK in combination with prior art ‘D1’ (a 2020 edition of a resource by the Institute for Quality and Efficiency in Health Care, summarising key health information from Germany’s national health information portal).  The Delegate noted that, although D1 did not specifically mention xylometazoline, the CGK clearly indicated xylometazoline was an often-recommended decongestant for cold and flu treatment.  The Delegate concluded that D1, together with the CGK, clearly taught the provision of sprayable xylometazoline with oral ibuprofen or paracetamol as a medication for cold and flu treatment.

Secondary Evidence

The Delegate was also unpersuaded by AFT’s secondary evidence, including arguments about improved clinical efficacy and concerns about the “3-day rebound problem” with decongestants.  The Delegate concluded that the supposed improved clinical efficacy would have been achieved given the skilled person would have inevitably arrived at taking the active ingredients together to independently relieve cold and flu symptoms.  Regarding the “3-day rebound problem”, the Delegate gave this little weight as the claimed invention did not specify a duration of treatment, nor was it mentioned in the patent specifications.

Outcome

The Delegate agreed with the Examiner and concluded that the claims merely aggregated known components without offering an inventive contribution.

The Delegate commented that he did not see a path forward for AFT to amend the claims to overcome the objections and so both applications were refused.

Implications

This decision reinforces the standard of inventiveness set by the “Raising the Bar” Patents Act, which exists to ensure that the Australian patent system rewards genuine innovation.  Where a combination patent is directed to existing treatments, a surprising or synergistic effect must be demonstrated to meet the required level of inventiveness.

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