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Date Published

Under section 70(3), goods containing, or consisting of, a pharmaceutical substance must be included in the Australian Register of Therapeutic Goods (ARTG).  The issue of what are the goods included in the ARTG, and whether they contain or consist of the s70(2) substance, has been considered in several decisions, as outlined below.

​​​​​​​Merck & Co., Inc v Arrow Pharmaceuticals Limited [2002] APO 13

The nature of the ARTG and its relationship with s70(3) was discussed in detail.  The hearing officer concluded that not all of the documents held on the Therapeutic Goods Administration file for a particular pharmaceutical substance form part of the Register.

​​​​​​​Merck & Co., Inc v Arrow Pharmaceuticals Ltd [2003] FCA 1344

Wilcox J determined that a pharmaceutical substance should be considered to be included in the ARTG where it can be demonstrated that the substance is contained in a good which is included in the ARTG. The particular pharmaceutical substance need not be a named active ingredient in the ARTG, but may be an impurity present in only small amounts, e.g. a metabolite. Provided it can be established that the substance is included, then the entry can be considered to satisfy the requirements of s70(3).

​​​​​​​H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70

The subject of the patent was the (+)-enantiomer of the drug citalopram.  Pharmaceutical substances containing the racemic form of citalopram (Cipramil) were included in the ARTG.  In relation to s70(3), the Court considered the question:

“are there goods on the ARTG that contain (+)-citalopram, the (+) enantiomer?”

In addressing this issue, the Court stated:

“it is a simple comparison of the pharmaceutical substance with the “ingredients” of the goods on the ARTG.  The question is whether Cipramil contains or consists of the (+)-enantiomer molecule.  Given that the racemic mixture includes both the (-)-enantiomer and the (+)-enantiomer in equal parts, Cipramil must “contain” the (+)-enantiomer.”

Thus, inclusion of goods containing, or consisting of, a racemic mixture in the ARTG, amounts to inclusion of goods containing, or consisting of, the individual enantiomers.

​​​​​​​Celgene Corporation [2011] APO 37

The pharmaceutical substance in question was a specific crystalline form (polymorph) of lenalidomide.  In determining the goods included in the ARTG, consideration was given to the ARTG certificate.  The certificate included information regarding approval to supply the product ‘REVLIMID lenalidomide’ and ‘Product Specific Indications’ relating to the use of the drug.

It was concluded that in identifying the goods included in the ARTG, no account should be taken of any ‘indications’, i.e. the ‘goods’ for the purposes of s70(3) is the product appearing on the ARTG certificate.  As the certificate did not specify the crystal form of lenalidomide present in REVLIMID, there were no goods that contained, or consisted of, the polymorph of lenalidomide.

​​​​​​​The Children’s Medical Center Corporation [2011] APO 80

The patentee identified the pharmaceutical substance (for the purposes of s70(2)) as a combination of thalidomide and at least one steroid.  The ARTG certificate stated that the patentee had approval to supply thalidomide, whilst the ‘Product Specific Indications’ stated that the thalidomide could be used in combination with a steroid for the treatment of multiple myeloma.

Consistent with Celgene (supra), it was held that the indication provided, i.e. the use of a combination of thalidomide and a steroid, was not an element of the goods in the ARTG.  Thus, the therapeutic ‘goods’ included in the ARTG was thalidomide and not the combination.

​​​​​​​iCeutica Pty Ltd

The pharmaceutical substance for the purposes of s70(2) was characterised by a dissolution profile.  No evidence establishing that the relevant goods exhibited that profile was provided, but the attorney for the patentee stated that they were “instructed that the [pharmaceutical substance] is contained or comprised in [the goods]”.  The Deputy Commissioner concluded that this was insufficient to satisfy him, on the balance of probabilities, that the requirement of s70(3) was satisfied.​​​​​​​

Amended Reasons

Amended Reason Date Amended
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