Aventis Pharma S.A. - [2016] APO 34

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Aventis Pharma S.A. [2016] APO 34

Patent:2005311191

Title:Antitumor combinations containing a VEGF inhibitor and 5FU or one of its derivatives

Patentee:Aventis Pharma S.A.

Delegate:  Dr B. Akhurst
Decision Date:  10 June 2016
Hearing Date:  Written submissions were filed on 13 April 2016
Catchwords:  PATENTS – s 70 application for an extension of the term of a patent – s 70(3) - whether the product-specific indications for a registered goods, or similar information in documents associated with the registration process, identifies goods included in the ARTG – application refused
Representation:  Phillips Ormonde Fitzpatrick.

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent:2005311191

Title:Antitumor combinations containing a VEGF inhibitor and 5FU or one of its derivatives

Patentees:Aventis Pharma S.A.

Date of Decision: 10 June 2016
DECISION
I refuse the application for an extension of the term of patent 2005311191.
REASONS FOR DECISION
Background

This matter relates to an application on 30 September 2013 by Aventis Pharma S.A. (the patentee), for an extension of term of patent 2005311191 under section 70 of the Patents Act 1990. The application was based on the 2 April 2013 inclusion in the Australian Register of Therapeutic Goods (the ARTG) of the pharmaceutical substance ZALTRAP® (aflibercept).
The 2005311191 patent was granted on 22 March 2012. Re-examination of the granted patent prompted amendments to the claims, which were advertised as allowed on 30 April 2015. The date of the patent is 2 December 2005 and in the normal course of events its 20 year term would expire on 2 December 2025. If an extension is granted on the basis asserted by the patentee, the term of the patent would be extended until 2 April 2028.
On 27 May 2015, the examining delegate issued a deficiency notice, advising that the application does not comply with section 70 because the ARTG-listed goods ZALTRAP® does not in substance fall within the scope of the claims of the patent specification. The delegate maintained this objection despite submissions to the contrary by the patentee, who on 9 December 2015 requested an oral hearing.
This matter was heard by way of written submissions filed on 13 April 2016, which were accompanied by an amended extension request reflecting the amended claims. An extension request based on the goods ZALTRAP® for unrelated patent 2004261165 was heard at the same time, and I have issued a separate decision in respect of that application.
The ARTG registrations
The patentee relied on two ARTG registrations with the 2 April 2013 start date. The Therapeutic Goods Administration (TGA)’s Public Summary documents establish that ARTG Entries 195234 and 195974 cover the products ZALTRAP® aflibercept in doses of 100 mg/4mL or 200 mg/8mL, respectively, as concentrated injectable solutions.
The Law
Part 3 of Chapter 6 of the Patents Act 1990 (the Act) provides a statutory framework for an extension of the term of standard patents relating to pharmaceutical substances.
Section 70 relevantly provides:
(1)The patentee of a standard patent may apply to the…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

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Details

AGLC: Aventis Pharma S.A. [2016] APO 34
Case: [2016] APO 34
Decision Date: 10 June 2016

CaseChat Overview and Summary

The Australian Patent Office rejected Aventis Pharma S.A.'s application for an extension of the term of patent 2005311191, which is titled "Antitumor combinations containing a VEGF inhibitor and 5FU or one of its derivatives". The application was based on the inclusion of ZALTRAP® (aflibercept) in the Australian Register of Therapeutic Goods (ARTG) on 2 April 2013. The key legal issue before the court was whether the product-specific indications for a pharmaceutical substance registered in the ARTG, or similar information in documents associated with the registration process, identify goods included in the ARTG for the purposes of section 70(3) of the Patents Act 1990.

The court found that while it was permissible to look beyond the TGA's Public Summary when determining as a factual matter the nature and composition of goods included in the ARTG, product-specific indications or similar information did not form part of goods included in the ARTG. The court concluded that the product-specific indications for ZALTRAP® did not identify goods included in the ARTG for the purposes of s 70(3), since ZALTRAP® does not contain 5-FU or any other additional agent specified in the patent claims. As a result, the application for an extension of the term of patent 2005311191 did not satisfy the requirements of s 70(3) and consequently it must be refused.

The final order was that the application for an extension of the term of patent 2005311191 be refused.

Orders