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Part 2: Lessons in infringement of second medical use claims in Australia

Patents

This is the second article in a two part series exploring particular issues in relation to the validity and infringement of second medical use claims in Australia with reference to two recent decisions by the Patent Office and Federal Court. Part 1, which relates to the validity of method of treatment claims with reference to the Australian Patent Office decision in Zoetis Services LLC v Boehringer Ingelheim Vetmedica GmbH [2024] APO 4 (Zoetis) can be found here.

This article considers the recent Federal Court of Australia decision in Neurim Pharmaceuticals (1991) Ltd v Generic Partners Pty Ltd (No 5) [2024] FCA 360 (Neurim). In particular, the decision by Nicholas J in Neurim provides useful guidance on the activities of generic manufacturers that may constitute direct and indirect (contributory) infringement of second medical use claims and highlights the importance of including both method of treatment and Swiss-style claims in second medical use patents to protect against different infringing activities.

Infringement of second medical use claims

Swiss-style claims

Infringement of Swiss-style claims by generic manufactures is a question of direct infringement. Direct infringement arises where a person contravenes a patentee’s exclusive right under subsection 13(1) of the Patents Act to “exploit” (e.g., make, hire, sell or dispose or import), or authorises another person to exploit the invention, subject to certain statutory exemptions.

Method of treatment claims

Infringement of method of treatment claims by generic manufacturers is typically a question of indirect (contributory) infringement. Subsection 117(1) of the Patents Act provides that “[i]f use of a product by a person would infringe a patent, the supply of that product by one person to another is an infringement of the patent by the supplier unless the supplier is the patentee or licensee of the patent”. Such use is further defined in subsection 117(2) as meaning:

  1. if the product is capable of only one reasonable use, having regard to its nature or design—that use; or
  2. if the product is not a staple commercial product—any use of the product, if the supplier had reason to believe that the person would put it to that use; or
  3. in any case—the use of the product in accordance with any instructions for the use of the product, or any inducement to use the product, given to the person by the supplier or contained in an advertisement published by or with the authority of the supplier.

It is also possible for a method of treatment claim to be directly infringed by a generic manufacturer who “authorises” (within the meaning of s 13(1)) medical practitioners to put the generic product to an infringing use. In the case of “authorisation”, the generic manufacturer need not have authority from the patentee to make such an authorisation; it is enough that they have the power to prevent the infringing conduct.[i]

While not specifically addressed in the Neurim decision or in this article, other common law concepts such as “common design” infringement may also apply to method of treatment claims.

Construction of second medical use claims

In Neurim, Nicholas J discussed the construction of method of treatment claims with reference to the High Court in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50; 253 CLR 284 and the Full Federal Court in AstraZeneca AB v Apotex Pty Ltd (2014) 226 FCR 324, which we discussed in Part 1. In relation to Swiss-style claims, Nicholas J discussed the construction adopted by the Full Federal Court in in Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2020] FCAFC 116 (Mylan), which we discussed in our previous article. Relevantly, Nicholas J stated at [155]:

… in construing both Swiss-style claims and method of treatment claims for a second medical use, it is necessary to have close regard to the purpose of the relevant treatment as specified in the claim as the specificity with which the purpose is defined may have significant implications for both validity and infringement.

Further, as noted by the Full Court in Mylan at [222]: “infringement of a Swiss type claim is concerned with what the allegedly infringing manufacturer has done, not what it intended to do”. This may be assessed with reference to a number of criteria, including the physical characteristics of the product, its packaging, labelling and Product Information (PI), its reasonably foreseeable uses, and the like.

The issues in Neurim

The patent at issue in Neurim contains Swiss style and method of treatment claims, including the following independent claims:

  1. Use of melatonin in the manufacture of a medicament for treating a patient suffering from primary insomnia characterized by non-restorative sleep and improving the restorative quality of sleep in said patient, wherein said medicament comprises also at least one pharmaceutically acceptable diluent, preservative, antioxidant, solubilizer, emulsifier, adjuvant or carrier, said medicament is a prolonged release formulation in unit dosage form and said melatonin is present in said medicament in an effective amount within the range of 0.025 to 10 mg.
  2. Method for treating a patient suffering from primary insomnia characterized by non-restorative sleep and improving the restorative quality of sleep in said patient, which comprises administering an effective amount within the range of 0.025 to 10 mg of melatonin to said patient, wherein said melatonin is administered in the form of a medicament, said medicament is a prolonged release formulation in unit dosage form, and said melatonin is the only therapeutically active agent administered according to said method.

The patent covers the Neurim Pharmaceuticals product CIRCADIN (melatonin 2 mg prolonged release tablet blister pack), which is registered on the Australian Register of Therapeutic Goods (ARTG) for “[m]onotherapy for the short term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over”. Generic Partners subsequently registered the product MELOTIN MR (melatonin 2 mg modified release tablet blister pack) on the ARTG for the same indication.

Neurim Pharmaceuticals sued Generic Partners for infringement of, inter alia, claims 1 and 4 above, and Generic Partners countersued for invalidity. Generic Partners’ invalidity challenge, which included the grounds of lack of novelty, inventive step, clarity, full description and fair basis, did not succeed and are not discussed in detail here (however, see Part 1 for our comments on the “inevitable result” aspect of the decision).

Infringement aspects of the Neurim decision

In Neurim, Nicholas J considered whether Generic Partners directly infringed the Swiss-style claims, indirectly infringed the method of treatment claims pursuant to paragraphs 117(2)(b) and (c) of the Patents Act and/or directly infringed the method of treatment claims by authorisation of an infringing use.

Direct infringement of Swiss-style claims

In relation to direct infringement of the Swiss-style claims, Nicholas J noted that while there are various uses for MELOTIN beyond those defined in the claims, the PI and approved indications (as opposed to the possible uses) of MELOTIN were of greater significance to the assessment of infringement. As the approved indication for MELOTIN was not identical to a claimed indication, and it was reasonably foreseeable that MELOTIN would mostly be used for indications outside the scope of the claims, his Honour was not satisfied that MELOTIN “is a medicament manufactured for the therapeutic purpose specified in Swiss-style claims”. Accordingly, Generic Partners’ supply of MELOTIN did not directly infringe the Swiss-style claims.

Indirect infringement of method of treatment claims

In relation to paragraph 117(2)(b), Nicholas J first considered whether melatonin is a staple commercial product, stating at [245]: “The question is not whether the product has non-infringing uses, but whether it is a staple commercial product. This involves asking whether it is a product supplied commercially for various uses”. In that regard, his Honour agreed with the patentee that melatonin was not a staple commercial product because, while melatonin may be used for a range of purposes, they are largely (if not solely) confined to the treatment of sleep disorders.

Nicholas J then turned to whether Generic Partners had a reason to believe that by supplying its MELOTIN product it would be put to an infringing use. In that regard, his Honour summarised the key principles arising from the case law at [247], including:

  1. the onus is on the patentee to show that use of the product supplied would be infringing use;
  2. it is not necessary for the patentee to identify any particular person or persons who the supplier has reason to believe will use the product in an infringing manner;
  3. paragraph 117(2)(b) may apply in circumstances where the respondent has reason to believe that a not insignificant number of clinicians will use a product to perform a method of treatment that is within the scope of a method of treatment claim;
  4. paragraph 117(2)(b) requires that the respondent have reasonable grounds to believe, at the time of supply, that the product willbe put to an infringing use (as opposed to being merely suitable for such use);
  5. The patentee must show that a not insubstantial number of persons to whom the product is supplied will use it as a method of treatment within the scope of the claims; and
  6. the extent to which the product is capable of non-infringing use, and the extent to which it is in fact used for non-infringing purposes, may be relevant to the remedies that may be granted.

In finding that Generic Partners had the requisite reason to believe that its MELOTIN product would be put to an infringing use, Nicholas J noted that although melatonin was used to treat a variety of sleep-related disorders, MELOTIN was approved by the Therapeutic Goods Administration (TGA) for the same indication as CIRCADIN. Nicholas J also considered that it should be inferred that Generic Partners was familiar with the publicly available TGA documents relating to CIRCADIN, such as the Australian Public Assessment Record (AusPAR). The evidence established that Generic Partners, with reference to the AusPAR (among other documents), would have reason to believe that a not insignificant number of psychiatrists would prescribe MELOTIN for the same indication as CIRCADIN.

In relation to paragraph 117(2)(c), Nicholas J analysed to the PI for MELOTIN, “which constitutes the relevant instruction or inducement for the purposes of s 117(2)(c)”. The relevant question was whether the PI amounts to an instruction or inducement to use MELOTIN for the specific indication recited in the method of treatment claims, namely, as a treatment for primary insomnia characterised by non-restorative sleep. As neither the PI nor the studies to which it refers makes any reference to “non-restorative sleep”, his Honour was not satisfied that the PI provided any instruction or inducement to use MELOTIN for the claimed indication.

Accordingly, Generic Partners’ supply of MELOTIN was found to indirectly the method of treatment claims pursuant to paragraph 117(2)(b), but not paragraph 117(2)(c).

Direct infringement of method of treatment claims

As to the question of whether Generic Partners authorised medical practitioners to treat patients with the claimed indication using MELOTIN, Nicholas J rejected the respondent’s proposition that there could be no authorisation of the claimed use because the PI did not provide any instruction or inducement to use MELOTIN for the claimed indication. Rather, his Honour considered the following facts to be relevant to the question of authorisation:

  1. The approved indication for MELOTIN constitutes an instruction to medical practitioners to use the product in accordance with the approved indication.
  2. The term “quality of sleep” as used in the MELOTIN PI encompasses the concepts of restorative sleep or quality of restorative sleep, as used in the claims.
  3. Generic Partners would have reason to believe MELOTIN would be prescribed by a not insignificant number of psychiatrists as a treatment for primary insomnia where the patient complained of non-restorative (or unrefreshing sleep).
  4. It was open to Generic Partners to prevent use of MELOTIN for the claimed indication, e.g., by not supplying the products at all, limiting the approved indication to exclude the patented indication, or including a statement in the PI that the products should not be used for the patented indication.

With those facts in mind, Nicholas J considered that Generic Partners’ supply of MELOTIN directly infringed the method of treatment claims insofar as it had authorised medical practitioners to treat the claimed indication in patients aged 55 and over (i.e., insofar as the claimed and approved indications overlapped). However, such authorisation did not extend to any “off-label” (non-approved) uses.

Key takeaways

The Neurim decision provides some important insights into the infringement of second medical use claims in Australia as follows.

  • While the therapeutic purpose is relevant to the assessment of both method treatment and Swiss-style claims, each claim type ultimately protects against different infringing activities.
  • Direct infringement of Swiss-style claims concerns what the medicament is actually manufactured for, which is established with reference to, inter alia, the physical characteristics of the product, its packaging, labelling and PI, and its reasonably foreseeable uses. Where the PI of an alleged infringing product does not read directly onto the claimed indication and/or it is reasonably foreseeable that it will mostly be used for other indications, it may be difficult to establish infringement.
  • Indirect infringement of method of treatment claims can be made out pursuant to paragraph 117(2)(b) where there is reason to believe that a not insignificant amount of the product will be put to an infringing use, whether or not that use is an approved indication. Assessment of reasonable belief may have regard to publicly available regulatory documents, such as the AusPAR.
  • A reasonable belief within the meaning of paragraph 117(2)(b) is also relevant to direct infringement by authorisation. However, such authorisation does not extend to “off-label” (or non-approved) indications.
  • For indirect infringement of method of treatment claims pursuant to paragraph 117(2)(c), the claimed indication must appear in (or be directly derivable from) the PI to constitute the requisite instructions or inducement.

Please contact Claire Gregg (cgregg@dcc.com) or Paul Dewar (pdewar@dcc.com) if you have any questions.

If you missed part 1 of this article, click here.

 

[i] Neurim at [300]