In the field of intellectual property, the interplay between trade marks and patent claims is very rarely discussed, given the distinct scope of protection provided by each. In Australia and New Zealand, patent examiners tend to raise an immediate clarity objection when a trade mark finds its way into a claim. This concern arises from the fact that a trade mark is an identifier of origin, and products bearing them can undergo variations across jurisdictions and time frames. This makes the intended scope of the claim unclear in many situations. Consequently, Australian and New Zealand examiners commonly raise objections based on clarity when trade marks feature in patent claims during the examination process.

When it comes to pharmaceutical substances, an attractive strategy often emerges, being to replace brand names with generic ones, specifically the International Non-Proprietary Name (INN). This swap generally traverses the clarity objection due to the chemical-composition specific nature of the INN or generic name. However, in certain scenarios where an INN or generic name isn’t applicable, alternative amendment tactics may become necessary.

The recent decision handed down by the Australian Patent Office in MGP Ingredients, Inc v Manildra Milling Corporation [2023] APO 32 (“Alcalase”) shines a spotlight on a novel proposition: there are circumstances where a trade mark can exist within a patent claim framework. To unlock this possibility, an applicant needs to furnish unequivocal evidence that an expert or person skilled in the art would understand the product’s attributes, its enduring stability, and the absence of foreseeable changes down the line.

Picture a patent claim outlining a method for crafting gluten-free starch. Within this matrix, a proprietary enzyme named Alcalase® steps into the spotlight. This enzyme, a proteolytic wonder, emerges as a novel and inventive component of the gluten-free starch, whilst still being offered by reputable suppliers in reliable and regular supply for general and sometimes related uses.

The core legal principle here isn’t novel and has been considered in past cases like Flexible Steel Lacing Company v Beltreco Ltd [2000] FCA 890. This principle emphasises that precision in definitions isn’t the be-all and end-all. Rather, a claim should resonate practically and make sense in a real-world context.

The verdict in the Alcalase® case highlights the power of evidence. Manildra Milling effectively demonstrated that the term “Alcalase®” consistently referred to a singular product. This expert-provided proof fortified the integrity and clarity of their claim, ultimately leading to a favourable outcome.

The hearing officer ruled that the claims did not lack clarity, and had support within the specification. The Alcalase® case highlights that when drafting a patent specification, any reference to a trade mark component should be well defined within the specification to specifically disclose the details of the product as someone skilled in the art would understand or appreciate such that it is well described, clear and unambiguous. This is vital in the case where the applicant may be forced to amend the specification to remove the trade mark as a result of ambiguity, and replace it with the common generic name or other descriptive identifier.