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Celgene Corporation

Celgene Corporation

Case [2011] APO 37 3 June 2011

Patent Law

Pharmaceutical Patents

Extension of Patent Term

Statutory Interpretation

Intellectual Property Law

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IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Celgene Corporation [2011] APO 37

Patents:2003228508 & 2004270211

Title of 2003228508: Methods of using and compositions comprising immunomodulatory compounds for the treatment and management of myelodysplastic syndromes
Title of 2004270211: Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione

Patentee:  Celgene Corporation
Delegate:  Dr S.D.Barker
Decision Date:  3 June 2011
Hearing Date:  5 May 2011 in Canberra
Catchwords:  PATENTS – applications for extension of term of patents – whether a composition "when used" is a process or a pharmaceutical substance per se – whether pharmaceutical substance is a specific polymorph – whether “goods” in section 70(3) includes the indication of the product in the ARTG – no evidence that the goods included in the ARTG contain the specific polymorph of the claims –date of first inclusion in the ARTG considered – applications for extension of term were not made within the time specified in section 71(2) – applications refused

Representation: Patentee: Phillips Ormonde Fitzpatrick

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patents:2003228508 & 2004270211

Title of 2003228508: Methods of using and compositions comprising immunomodulatory compounds for the treatment and management of myelodysplastic syndromes
Title of 2004270211: Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione

Patentee: Celgene Corporation
Date of Decision: 3 June 2011
DECISION
The applications for extension of term were not made within the time specified in section 71(2), and there are no prospects that this can be corrected.
I refuse the applications for extension of term.
REASONS FOR DECISION

Celgene Corporation is the patentee in respect of patents 2003228508 and 2004270211. On 27 September 2010 Celgene applied for extensions of the term of both patents. The extensions are based upon the inclusion in the Australian Register of Therapeutic Goods (ARTG) of the product REVLIMID.
The Patents Act 1990 prescribes a six month period for applying for an extension of term of a patent. For the purposes of the present patents, the starting date for the six month period is the date of first inclusion of relevant goods in the ARTG. REVLIMID was first registered on the ARTG on 20 December 2007. Consequently the Commissioner advised the patentee that the applications for extension of term were made outside the six month period set by section 71(2)(b). The patentee responded by drawing attention to the fact that the Therapeutic Goods Administration (TGA) issued amended Certificates of Registration (having the same ARTG registration numbers) on 21 May 2010.
The patentee requested a hearing on whether the applications for extension of term had been made within time. The matter was heard in Canberra on 5 May 2011. The patentee was represented by David Tadgell, patent attorney of Phillips Ormonde Fitzpatrick. Richard Girards, patent counsel for Celgene, and Yeah-Sil Moon of Jones Day, also attended.
THE ARTG REGISTRATIONS
The patentee relies upon four ARTG registrations: AUST R132510, AUST R132514, AUST R132515 and AUST R132516. All registrations commenced on 20 December 2007. The product covered by AUST R132510 is described as "REVLIMID lenalidomide 5 mg capsule blister pack". The products covered by the other registrations differ only in…

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: Celgene Corporation [2011] APO 37
Case: [2011] APO 37
Decision Date: 3 June 2011

CaseChat Overview and Summary

Celgene Corporation sought an extension of the term of two patents, 2003228508 and 2004270211, under the Patents Act 1990. The patents pertain to methods of using and compositions comprising immunomodulatory compounds for treating myelodysplastic syndromes and polymorphic forms of a specific compound, respectively. The applications for extension were based on the inclusion of the product REVLIMID in the Australian Register of Therapeutic Goods (ARTG). The central legal issues revolved around the interpretation of "when used" claims, the definition of "goods" under the Patents Act, and the timing of the application for extension of term.

The court found that the "when used" claim in the '508 patent was not a claim to a pharmaceutical substance per se but rather a process claim, as the focus was on the composition used in the treatment process. Consequently, no pharmaceutical substance could be identified for the purposes of section 70, and the application for extension of term could not proceed. Regarding the '211 patent, the court determined that the pharmaceutical substance was the specific polymorph of lenalidomide, not lenalidomide itself. However, there was no evidence that the goods included in the ARTG contained the specific polymorph, rendering the application for extension of term ineffective. Additionally, the applications for extension of term were not made within the six-month period specified by section 71(2) of the Patents Act, as they were filed after the date of first inclusion of the relevant goods in the ARTG.

The delegate of the Commissioner of Patents, Dr. S.D. Barker, concluded that the applications for extension of term were not made within the time specified by section 71(2) and could not be remedied by an extension of time under section 223. As the requirements of section 71 were not satisfied, the applications were refused.

Orders