AbbVie Biotechnology Ltd - [2015] APO 45

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
AbbVie Biotechnology Ltd [2015] APO 45

Patent No.:2012261708, 2013203420, 2013257402

Title:Human antibodies that bind human TNFalpha

Patentee:  AbbVie Biotechnology Ltd
Hearing Officer:  P M Spann, Deputy Commissioner of Patents
Decision Date:  4 August 2015
Hearing Date:  12 June 2015 Melbourne; supplementary written submissions completed 17 July 2015

Catchwords: PATENTS – extensions of term – Swiss claims – whether a pharmaceutical substance, when produced by a process that involves the use of recombinant DNA technology, falls within the scope of the claims – first inclusion in the ARTG of goods that contain or consist of the substance – whether application made in time – extension application refused.

Representation:  Mr B Caine, QC
Mr M Caine, patent attorney,
  Dr S Khosa,
  Davies Collison Cave

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent No’s.: 2012261708, 2013203420, 2013257402

Title:Human antibodies that bind human TNFalpha

Patentee: AbbVie Biotechnology Ltd
Date of Decision: 4 August 2015
DECISION
The requirements of section 70 and 71 are not satisfied and pursuant to subsection 74(3) I refuse to accept the applications for extensions of term.
REASONS FOR DECISION
Background

This matter concerns applications for extensions of the term of patent numbers 2012261708 (‘708), 2013203420 (‘420) and 2013257402 (‘402) all in the name of AbbVie Biotechnology Ltd (AbbVie). Patent ‘402 is a divisional of patent ‘420 which is a divisional of patent ‘708. These patents are in a larger chain of divisional patents including 2009202707 (’707), 2006241387, 2004202769, 775499 and 722077 (‘077). ‘077 and ‘707 have already been granted an extension of term on the basis of the listing of HUMIRA adalimumab on the Australian Register of Therapeutic Goods (ARTG) with the extended terms expiring on 10 December 2018.
It follows that all 3 of the present patents are related. The date of the patents is 10 February 1997 and the maximum 20-year term will therefore expire on 10 February 2017. The applications for extensions of term were all made on 3 October 2014 and, if granted on the basis asserted by the patentee, the extended terms of the patents will expire on 10 August 2021 (‘402) and 10 February 2022 (‘420 and ‘708).
The grounds for the extension applications are various inclusions in the ARTG for HUMIRA adalimumab, differing relevantly in the product specific indications. For present purposes it is sufficient to say that HUMIRA was subject to the first inclusion on the ARTG on 10 December 2003 with indications for Rheumatoid Arthritis. Subsequent inclusions added indications for other conditions being Ankylosing Spondylitis (10 August 2006), Crohn’s Disease (29 June 2007) and Ulcerative Colitis (23 July 2013). The present patents include claims of the “Swiss” type characterised by manufacture of a medicament for use in the treatment of the latter three conditions.
The examiner has objected that, as the Swiss claims are purpose limited, they are not directed to substances when produced by a process that involves the use of recombinant DNA technology. She has also objected that the applications do not correctly identify the first…

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: AbbVie Biotechnology Ltd [2015] APO 45
Case: [2015] APO 45
Decision Date: 4 August 2015

CaseChat Overview and Summary

AbbVie Biotechnology Ltd sought an extension of the term of their patents related to human antibodies that bind human TNFalpha. The patents in question were numbers 2012261708, 2013203420, and 2013257402, all of which were due to expire in February 2017. The application for an extension was made on 3 October 2014, seeking an extension until 10 August 2021 for one patent and until 10 February 2022 for the other two patents. The basis for the extension application was the inclusion of HUMIRA adalimumab on the Australian Register of Therapeutic Goods (ARTG) for various indications.

The legal issues before the court were whether the pharmaceutical substance, when produced by a process involving recombinant DNA technology, fell within the scope of the claims and whether the applications correctly identified the first regulatory approval date for the relevant substance. The court needed to determine if the claims were properly directed to the substance in question and whether the applications met the statutory requirements for an extension of patent term.

The court found that the claims were not directed to the substance when produced by a process involving recombinant DNA technology. The court held that the reference to a substance produced by recombinant technology meant the substance itself, not characterized by its therapeutic use or other features. The claims, being Swiss claims, were characterized by therapeutic use and thus did not meet the statutory requirement for an extension of term. The court also concluded that the applications did not correctly identify the first regulatory approval date for the substance. Consequently, the court refused the application for an extension of term.

In conclusion, the court refused the applications for extensions of term as the requirements of sections 70 and 71 of the Patents Act were not satisfied. The court held that the claims were not directed to the substance produced by recombinant DNA technology and that the applications did not correctly identify the first regulatory approval date. The patents in question will expire on their original dates.

Orders