IP SPOTLIGHT MARCH 2020

THE AUSTRALIAN PATENT OFFICE MAKES CLEAR THAT PRODUCTS WITH TWO PHYSICALLY SEPARATED PARTS ARE NOT ELIGIBLE FOR PHARMACEUTICAL PATENT TERM EXTENSIONS.

SEPARATELY STORED COMPONENTS ARE NOT PHARMACEUTICAL SUBSTANCES PER SE However, despite the Delegate’s above accepted positions, the Delegate concluded that the pharmaceutical substance per se was not the reconstituted solution. The Delegate concluded that a pharmaceutical substance per se as stated in the PTE legislation must be an “an integrated dosage form” and cannot be in the form of physically separated components, or “a “deconstructed” formulation intended for later reconstitution” (which she characterised as a kit). To support this finding, the Delegate referred to a number of Federal Court decisions and in particular relied on Celgene Corporation [2011] APO 37, 93 IPR 309 ( Celgene ). This somewhat facile citation of the Celgene decision bears further examination. In the cited passage of Celgene, the patentee relied on a claim for a drug “when used” to treat a specific indication as the “pharmaceutical substance per se” . The patentee in Celgene pointed to indications listed in the Product Information leaflet (PI) for which the drug was administered. The Delegate, in that case, said that he was unable to look to the indications of the goods in the PI in order to ascertain what the actual goods were. In our respectful view, the delegate’s finding in Celgene is divorced from looking at what substance is actually administered to the patient by reference to its ARTG public summary document. Indeed in the Decision, the Delegate went on to cite Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, 81 IPR 228 at [239] where Her Honour said: The level of enquiry required by s 70(3) … is a simple comparison of the pharmaceutical substance with the ‘ingredients’ of the goods on the ARTG. Curiously, had the Delegate taken that approach it would seem logical that the ingredients of the administered dosage form of the goods be ascertained by reading the ARTG public summary document. Nevertheless, the Delegate for the Decision concluded that this approach is impermissible because the definition of “directions for use” in the Therapeutic Goods Act 1989 ( TG Act) includes “appropriate doses of the goods” and “the method of administration or use of the goods” , albeit that that definition does not actually include ‘dosage form’ , which is used as a separate term in the TG Act.

active ingredient plitidepsin in powder form, and (2) a vial containing a solution for reconstituting the plitidepsin powder. The invention of AU 754073 lies in the particular combination of reconstitution solvents, which allow the preparation of a stable aqueous solution. The reconstituted solution is not stable, and so must be reconstituted only shortly before administration to the patient. Importantly, the claims of the patent and the description describe and define both the reconstituted solution and the component parts of the solution. The ARTG documentation notes that the reconstituted solution is the composition that is ultimately administered to the patient and is, therefore, the composition that was ultimately approved. As we describe in further detail below, these important points were not accepted by the Delegate as supporting the extension application. WHAT I N SUBSTANCE FALLS WI TH I N THE SCOPE OF THE CLA IMS? As noted above, one of the first conditions that must be met before a PTE is granted is that the claimed pharmaceutical substance must be “be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification”.

Claim 1 of AU 754073 reads:

This note provides a brief summary on the recent decision of a Delegate of the Commissioner of Patents reported as Pharma Mar S.A. [2020] APO 8. Wrays acted for the applicant. BACKGROUND Pharmaceutical patent term extensions (PTE) are available to patentees in Australia where a patentee has been delayed in bringing a pharmaceutical substance to market. This may happen through delays caused by Australia’s rigorous clinical trial process, which must be navigated before marketing approval for a pharmaceutical substance is acquired. Australia’s PTE patent legislation thus compensates patentees for marketing approval delays, providing them with an effective patent term similar to patent terms observed for other technologies outside the pharma industry. A PTE may be achieved for up to five (5) years, on top of the 20-year regular patent term.

A PTE will be granted if the following conditions, amongst others, are satisfied:

1. A pharmaceutical composition of a didemnin compound, comprising firstly a lyophilised didemnin preparation including water-soluble material and secondly a reconstitution solution of mixed solvents.

– – one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification (s70(2)(a) Patents Act 1990). – – goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods (s70(3)(a) Patents Act 1990). These conditions were considered in the recent decision of a Delegate of the Commissioner of Patents, Pharma Mar S.A . [2020] APO 8 (the Decision ). THE PHARMA MAR S . A . [2020] APO 8 DECI S ION Pharma Mar S.A. applied for PTE for Australian patent 754073 on the basis of a listing on the Australian Register of Therapeutic Goods ( ARTG ) of the product APLIDIN, which is indicated for the treatment of multiple myeloma. APLIDIN is sold as two separately stored components: (1) a vial of the

Plitidepsin is a didemnin compound.

In the decision, the Delegate accepted that claim 1 covers: (1) a kit comprising two vials, wherein the first vial contains plitidepsin and a second vial containing a reconstitution solution; and can also cover (2) the reconstituted solution (that is plitidepsin already reconstituted and ready for administration to the patient). The Delegate also acknowledged that the ARTG documentation for APLIDIN made clear that the product that was listed on the ARTG was both the separately stored components and also the reconstituted solution. The Delegate also acknowledged that the product that was ultimately administered to the patient was the reconstituted solution and not the separately stored components.

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