ThromboGenics NV - [2015] APO 44

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
ThromboGenics NV [2015] APO 44

Patent No.:2003300821

Title:Pharmacological vitreolysis

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

Catchwords: PATENTS – extension of term – method and 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 – requirements not met – extension application refused.

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

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent No.:2003300821

Title:Pharmacological vitreolysis

Patentee: ThromboGenics NV
Date of Decision: 4 August 2015
DECISION
The requirements of section 70 is not satisfied and pursuant to subsection 74(3) I refuse to accept the application for an extension of term.
REASONS FOR DECISION
Background

This matter concerns a request for an extension of the term of patent no. 2003300821 in the name of ThromboGenics NV (TG). The date of the patent is 5 December 2003 and accordingly the term of the patent (subject to the payment of renewal fees) will expire on 5 December 2023. An application for extension of the term of the patent under section 70 of the Act was filed on 27 January 2015.
The basis for the request for an extension of term is the inclusion in the Australian Register of Therapeutic Goods (ARTG) of JETREA ocriplasmin. This product was subject to ARTG registration commencing on 9 October 2014 (AUST R 206494) and granted to a licencee of TG, Alcon Laboratories Australia Pty Ltd. It follows from this information and the formula set out in section 77 that, if granted, the extended term of the patent would be 5 years and would expire on 5 December 2028.
Following the filing of the application, a delegate of the Commissioner reported that she considered that:
“Claims 55-58 of the present patent are Swiss claims directed to the use of TPCD, miniplasmin or microplasmin in the manufacture of a medicament for the treatment or prevention of a disorder, or a complication of a disorder, of an eye of a subject. Contrary to the submissions made in the response, these claims are not directed to a medicament or to a process for the preparation of a medicament. These claims have the additional limitation of "for the treatment or prevention of a disorder, or a complication of a disorder, of an eye of a subject". As a consequence of the Swiss-style claim drafting, this intent is not a mere suitability but an essential limitation of the claims. Therefore, a pharmaceutical substance (when produced by a process involving recombinant DNA technology) does not in substance fall within the scope of these claims.
The recent decisions ImmunoGen Inc. [2014] APO 88 and Novartis Vaccines and Diagnosis S.r.l. [2015] APO 2, were directed to processes of producing compositions. Both cases were considered to meet the requirements of…

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: ThromboGenics NV [2015] APO 44
Case: [2015] APO 44
Decision Date: 4 August 2015

CaseChat Overview and Summary

The case involves a request for an extension of the term of patent number 2003300821 held by ThromboGenics NV. The patent, which is set to expire on December 5, 2023, relates to a method of treating eye disorders using a truncated plasmin protein. The application for the extension was filed on January 27, 2015, and it was based on the inclusion of JETREA ocriplasmin in the Australian Register of Therapeutic Goods. The key issue before the court was whether the requirements of section 70 of the Patents Act for the extension of the patent term were met, specifically whether a pharmaceutical substance produced by a process involving recombinant DNA technology falls within the scope of the claims.

The court examined the nature of the claims in the patent, particularly the Swiss-style claims which are purpose-limited process claims. The court concluded that these claims are not directed to a pharmaceutical substance when produced by a process involving recombinant DNA technology, but rather to a method or process for the manufacture of a medicament limited by a specified therapeutic use. The court held that granting an extension of term on the basis of such claims would not align with the purpose of the legislation, which is to encourage the development of new processes of manufacture involving recombinant technology and not new uses of known substances.

In reaching its decision, the court referred to the legislative history and the policy underlying the extension of term provisions, which indicate that the scheme is not intended to support the development of new uses of known substances. The court also noted that the substance ocriplasmin, when produced by a recombinant process, is disclosed in the specification but does not fall within the scope of the claims as they are limited by a method of treatment. Consequently, the application for the extension of term was refused.

The final orders of the court were that the requirements of section 70 of the Patents Act were not satisfied and, pursuant to subsection 74(3), the application for an extension of term was refused.

Orders