Patent term extensions for pharmaceutical combinations: claims must be aligned with ARTG description
The Children’s Medical Center Corporation  APO 80
The Australian Patent Office recently refused an application for an extension of term of a pharmaceutical patent that claimed a combination of active ingredients for the treatment of cancer. This case serves as a reminder that a combination of pharmaceutical substances as separate dosage forms is ineligible for a patent term extension and that the relevant claim(s) must be aligned with the description of the goods in the ARTG.
The patent in question
The patent in issue, AU2005202596, was granted to The Children’s Medical Center Corporation on 4 February 2010 for a pharmaceutical anti-cancer combination. The patentee subsequently filed an application for a patent term extension in a submission dated 17 June 2010, which was refused at first instance by the Examiner. The matter was then set for hearing.
Requirements for grant of a patent extension
The key question before the Delegate of the Commission of Patents was whether the patent met the conditions for the grant of a patent term extension. Section 70 of the Australian Patents Act 1990 sets out several conditions that must be met before a patent term extension can be granted. The two conditions at issue in this case were:
70(2)…(a): 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;
70(3)…(a): goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods [ARTG];
The claims under consideration were directed to the pharmaceutical combination comprising thalidomide and (i) a steroid (claim 1), (ii) dexamethasone (claim 4) or (iii) prednisone and melphalan (claim 5).
Goods containing, or consisting of, the substance must be included in the ARTG: s 70(3)(a)
The Delegate, at first instance, considered whether goods containing or consisting of the pharmaceutical substance were included in the ARTG in accordance with sub-section 70(3)(a) of the Patents Act 1990.
The patentee’s application for a patent term extension relied on the inclusion in the ARTG of THALOMID, Thalidomide 50/100/150/200 mg hard capsule blister packs. THALOMID consists only of thalidomide and does not contain a steroid as required by the claims under consideration. However, the patentee argued that, for the purposes of determining whether the requirements of sub-section 70(3)(a) are met, reference should be made to the entire ARTG entry. The patentee submitted that the ARTG entry made reference to the intended use of thalidomide in combination with a steroid, as claimed, drawing the Delegate’s attention to the Product Specific Indications section in the ARTG entry, which stipulated:
Thalomid in combination with melphalan and prednisone is indicated for the treatment of patients with untreated multiple myeloma aged 65 years or over or ineligible for high dose chemotherapy. Thalomid in combination with dexamethasone is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue, for the treatment of patients with untreated multiple myeloma.
The Delegate rejected this argument, noting that the Therapeutic Goods Act draws a clear distinction between the goods and their indications, as stated by Bennett J in H. Lundbeck A/S v Alphapharm Pty Ltd  FCAFC 70 at :
The level of enquiry required by section 70(3) does not look to therapeutic effect of the pharmaceutical substance. Rather, it is a simple comparison of the pharmaceutical substance with the “ingredients” of the goods on the ARTG.
Pharmaceutical substances per se: s 70(2)(a)
Having concluded that the requirements of sub-section 70(3)(a) were not satisfied, but leaving open the possibility of having reached the wrong conclusion in this regard, the Delegate sought to determine whether at least one pharmaceutical substance per se was in substance disclosed in the complete specification and fell within the scope of at least one claim.
The Delegate agreed that at least one pharmaceutical substance per se was in substance disclosed in the complete specification. Moving on to determining whether the pharmaceutical substance per se fell within the scope of the claims, the Delegate noted the patentee’s submission that the claims under consideration were directed to a combination of thalidomide and a steroid as separate oral dosage forms, rather than to an admixture. Separate oral dosage forms were said to enable the clinician to control the possible side effects, presumably by modifying the dose of the individual components.
The definition of “pharmaceutical substance per se” has been considered by the Australian courts, most recently in H. Lundbeck A/S v Aplpharpharm Pty Ltd  FCAFC 70. It is clear from these decisions that the term is intended to mean a pharmaceutical substance that is present as a single entity; that is, without reference to anything else. Whilst the boundaries of what constitutes a single entity has been somewhat blurred in recent years, the courts have made it clear that a pharmaceutical substance per se would necessarily exclude a kit or separate dosage units, regardless of whether the separate dosage forms would be administered in combination.
Therefore, in light of the patentee’s submission that the claims were directed to separate dosage units, the Delegate concluded that the requirements of sub-section 70(2)(a) were not satisfied, reaffirming the position taken by the Australian courts on this issue.
It is interesting to note the patentee argued during the hearing that the claims are directed to separate oral dosage forms, contrary to the arguments presented throughout examination that the claims were directed to an “admixture” of thalidomide and at least one steroid in a single unit dose. This did not go unnoticed by the Delegate, who indicated that construing the claims to encompass separate dosage units was prima facie in the nature of a kit and therefore the claims of the patent may be at risk of being invalid on the basis that they define a mere collocation of known compounds.
Lessons for pharmaceutical patent owners
The Australian Patent Office’s decision reaffirms that a combination of pharmaceutical substances as separate dosage forms does not constitute a pharmaceutical substance per se for the purposes of a patent term extension, regardless of their intended use.
Furthermore, the pharmaceutical substance for which a patent term extension is being sought must be aligned with the description of the goods covered by its entry in the ARTG and one cannot rely on further information found in the ARTG entry, such as that provided by the Product Specific Indications.