Biogen Idec MA Inc. - [2014] APO 25

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Biogen Idec MA Inc. [2014] APO 25

Patent Application: 2011239311

Title:Treating neurological disorders

Patent Applicant:  Biogen Idec MA Inc.
Hearing Officer:  P M Spann, Deputy Commissioner of Patents
Decision Date:  30 April 2014 (Reasons published 15 May 2014)
Hearing Date:  30 April 2014
Catchwords:  PATENTS – examiner’s objections – whole contents novelty – whether section 24(1)(b) applies – whether relevant information made publicly available without consent – citation raised by the examiner must be disregarded.

Representation: Patent applicant: Cullens

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2011239311

Title:Treating neurological disorders

Patent Applicant: Biogen Idec MA Inc.
Date of Decision: 30 April 2014 (Reasons published 15 May 2014)
DECISION
Section 24(1)(b) applies to information disclosed in application WO 2005/080972 published on 1 September 2005 and that information is to be disregarded for the purpose of deciding whether the claimed invention is or is not novel.
REASONS FOR DECISION

This matter concerns whether information relevant to deciding that an invention is or is not novel as set out in paragraph (b)(ii) of the definition of the prior art base (‘whole contents’ novelty) is to be disregarded pursuant to section 24(1)(b) of the Act.
Background
Patent application 2011239311 was filed by Biogen Idec MA Inc. (Biogen) on 25 October 2012. It is a divisional application from application 2006214179 which was filed on 17 February 2006 under the provisions of the Patent Cooperation Treaty. That application claims priority under Article 8 of the PCT from an application filed in the US on 17 February 2005. For the purpose of this decision it is accepted that the present application is entitled to the earliest priority date of 17 November 2005.
The application was subject to examination with the examiner finding in three examination reports, inter alia, that the invention defined in all claims was not novel in light of a published patent specification WO 2005/080972 A1 (AXARON BIOSCIENCE AG) whose date of publication was 1 September 2005. While published after the earliest priority date, this specification constituted information relevant to deciding that the invention is or is not novel as set out in in paragraph (b)(ii) of the definition of the prior art base. In this regard the specification was filed for PCT application PCT/EP2005/001921 which, under section 88(1) of the Act (as it existed before 15 April 2013), must be treated for the purposes of the Act as a complete application. Most significantly, the priority date of that application, 23 February 2004, is earlier than the priority date of the present application.
As a defence to the examiner’s objection the applicant asserted that section 24(1)(b) of the Act applied such that information contained in the publication should be disregarded for the purpose of determining novelty. In support of this, the applicant’s attorneys filed an affidavit of Jennifer Zarutskie Sleczkiewicz dated 22 April 2014 setting out circumstances under which information contained in PCT/EP2005/001921 was found in German court proceedings to have been sourced from Biogen. This resulted in the equivalent European patent EP1721157 being granted in the name of both SYGNIS Bioscience GmbH & Co KG and Biogen.
Biogen’s attorneys also cited my decision in Thomson CSF v Schlumberger Holdings Limited [2001] APO 11 in support of its submissions. The examiner for her part however informed the attorneys that Australian Patent Office Manual of Practice and Procedure at part 2.4.4.6.3 states that :
Note: The grace period provisions of sec 24 are not a defence to a “whole of contents” objection in any circumstance. However, in appropriate situations, applicants may be able to overcome the objection by withdrawing their priority claim and relying on sec 24 to avoid the normal novelty objection that would then apply (see also 2.4.11.4 Publication Considerations).
In seeking to resolve the matter I obtained further oral submissions from Biogen’s attorneys on 30 April 2014. Following my decision in this matter the application was accepted on the same day.
The law
As the information in WO 2005/080972 was made publically available before 15 April 2013, the provisions of section 24 and Chapter 2 of the Patents Regulations as they applied before that date are relevant to the present matter - see section 133(4) of Schedule 6 of the Intellectual Property Laws Amendment (Raising the Bar) Act2012 and subregulation 23.26(4) Item 3 added by the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (No 1).
Subsection 24(1) at the relevant time provided:
“24 Validity not affected by certain publication or use
(1) For the purpose of deciding whether an invention is novel or involves an inventive step or an innovative step, the person making the decision must disregard:
(a) any information made publicly available, through any publication or use of the invention in the prescribed circumstances, by or with the consent of the nominated person or patentee, or the predecessor in title of the nominated person or patentee; and
(b) any information made publicly available without the consent of the nominated person or patentee, through any publication or use of the invention by another person who derived the information from the nominated person or patentee or from the predecessor in title of the nominated person or patentee;
but only if a patent application for the invention is made within the prescribed period.”
Subregulation 2.3(2) further provided:
“(2) For the purposes of subsection 24 (1) of the Act, in the case of information of the kind referred to in subsection 24 (1) (b) of the Act, the prescribed period is 12 months from the day when the information referred to in that paragraph became publicly available.”
Can subsection 24(1)(b) apply to information that is otherwise relevant under paragraph (b)(ii) of the definition of the prior art base
The operation of section 24(1)(b) in the present circumstances has not been judicially considered. My decision in Thomson CSF v Schlumberger Holdings Limited [2001] APO 11 was however made in the context of very similar circumstances and I observed that:
“Having reached this conclusion I will return to the remedy that may be available to SHL who is not so much interested in its entitlement to the present application but to establishing the validity of its own application 53305/98. It would seem that having filed its PCT application on 19 December 1997 designating Australia, SHL has filed a patent application that may satisfy the provisions of Section 24(1)(b) and Regulation 2.3(2). That is, it was an application for a standard patent filed within 12 months of the publication of the current application on 21 August 1997. Section 24 provides that any information made publicly available in those circumstance must be disregarded for deciding if an invention is novel or involves an inventive step if it was made available without the consent of the nominated person or patentee or predecessor in title. I have found, and the parties acknowledge, that the information contained in the Nessie 4 Feasibility Study was passed from Geco to TSASM. Thomson say this information was either not disclosed in its specification, is excluded from the confidentiality agreement because it was already in the public domain or, by implication, that it was excluded because it was already known to TSASM at the date of the agreement. However I have found that the feature of two independently controlled wings is disclosed in the specification and that there is no evidence to suggest that it was known publicly, or to TSASM, before 4 May 1995. Hence from my findings on the facts it may be possible to arrive at a conclusion, at least prima facie, that information was made available in the publication of the present application without the consent of Geco or SHL and in contravention of the confidentiality agreement.”
Nevertheless, the practice of the Patent Office reflected in the part of the Manual of Practice and Procedure quoted above is that subsection 24(1) cannot be a defence to a “whole contents” objection. The basis for this practice is obscure. Likely it reflects the view that the provisions of section 24, generally referred to as “grace period” provisions, are intended to remediate inadvertent publication rather than inadvertent filing. In this regard, information in an application becomes relevant for whole contents novelty purposes on the basis of the relevant priority date not the date of publication which in the patent system normally occurs 18 months from the priority date. It might also be said that, if the legislation intended to address the whole contents situation, it would do so completely. Rather, at best, it can only apply in the limited circumstance where the cited application has an earlier priority date and publication occurs within 12 months before the filing of the complete application under consideration. This however will only occur where the difference in priority dates falls within a limited range. For example, in the common case where the relevant applications both rely on a full 12 month priority period this means that subsection 24(1)(b) could only operate where there is a 6 to 18 month difference in priority dates (here it is just over 12 months). Where the application filed for subsection 24(1) does not claim priority from another application the difference in priority dates must fall within a range of 18 to 30 months. These are arbitrary periods if the intention was to avoid the prior art effect of unintended filing.
Against this are the specific terms of subsection 24(1)(b). The phase “any information made publicly available without the consent of the nominated person or patentee, through any publication or use of the invention by another person who derived the information from the nominated person or patentee …” appears to clearly apply where the consequence of filing a patent application is unavoidably publication and that the filing of the application is without consent. The legislation does not say that the person who made the information available (here the World Intellectual Property Organisation (WIPO)) must have acted improperly only that the nominated person or patentee did not consent to the information becoming available to the public and the information was derived from them. There is also no reason to assume that the person who acts to publish the information must have directly derived the information and such an interpretation would severely limit the utility of section 24.
Assuming that information in application PCT/EP2005/001921 was derived from Biogen it appears to follow that WIPO, in processing the application, derived the information from Biogen, although indirectly. Since Biogen also did not consent to the filing of the application it could be assumed that it did not consent to the publication of the application which followed duly under the requirements of the Patent Cooperation Treaty. Thus the requirements of subsection 24(1)(b) appear to be met.
French CJ, Hayne, Crennan, Bell and Gageler JJ said in Commissioner of Taxation v Consolidated Media Holdings Ltd [2012] HCA 55; (2012) 293 ALR 257 at 268-269 [39], that :
“This court has stated on many occasions that the task of statutory construction must begin with a consideration of the [statutory] text’ [Alcan (NT) Alumina Pty Ltd v Commissioner of Territory Revenue [2009] HCA 41; (2009) 239 CLR 27 at [47]]. So must the task of statutory construction end. The statutory text must be considered in its context. That context includes legislative history and extrinsic materials. Understanding context has utility if, and in so far as, it assists in fixing the meaning of the statutory text. Legislative history and extrinsic materials cannot displace the meaning of the statutory text. Nor is their examination an end in itself.” (emphasis added)
Section 24 is beneficial in nature. While there may be grounds to speculate that the whole of contents situation was not comprehended in the drafting of the provisions, there is nothing in the extrinsic material to indicate that it was intended to be excluded. The filing of an application without consent which on publication becomes prior art for the purposes of novelty determinations under the Act seems at least analogous to the mischief that the legislation is intended to address. Consequently I do not consider that section 24 can be construed in a way such that information that is relevant under paragraph (b)(ii) of the definition of the prior art base is excluded from the operation of subsection 24(1)(b), assuming the requirements of the legislation are met.
Was relevant information contained in WO 2005/080972 published without consent of the applicant?
The affidavit of Ms Sieczkiewicz addresses the circumstances of the filing of international application PCT/EP2005/001921 which was published as WO 2005/080972. She states that the international application describes the work Dr Linda Burkly an employee of Biogen and that the applicant Axaron filed the application without consent and without naming Dr Burkly as an inventor. This had been the finding in European proceedings where Biogen was added as an applicant to the European family member EP1721157
Ms Sieczkiewicz concludes by stating that it follows from the facts that the international application should not have been filed or should have named Dr Burkly as an inventor. While from the subsequent court proceedings and naming of Dr Burkly as an inventor it is apparent that at least some information contained in the application was filed and consequently published without consent, it cannot be assumed merely on this basis that information relevant to the novelty of the present claims was sourced from Dr Burkly.
The claims of the present application as amended are directed to methods of treating Parkinson’s Disease by administering an agent that blocks TWEAK/TWEAK-R interaction or activity. WO 2005/080972 discloses the use of substances to modulate or inhibit the activity of TWEAK or the TWEAK receptor for a number of conditions which are discussed in the specification. One of these is Parkinson’s Disease. In oral submissions Biogen’s patent attorneys assured me that information sourced from Dr Burkly was relevant to that disease and the novelty of the present claims.
I have also obtained a copy of the decision of the German Landgericht Mannheim (Mannheim Regional Court) referred to in Ms Sieczkiewicz’s affidavit. While I do not have access to a verified translation it appears that the decision supports Dr Burkly’s significant and central contribution to the invention disclosed in WO 2005/080972 through her collaboration with another inventor, Dr Schwaninger. On the basis of this and the submissions recieved I am prepared to accept on the balance of probabilities that information relevant to the novelty of the present claims was obtained from Biogen’s employee and published without its consent.
Conclusion
I find that section 24(1)(b) applies to information disclosed in application WO 2005/080972 published on 1 September 2005 and that information is to be disregarded for the purpose of deciding whether the claimed invention is or is not novel.
P M Spann
Deputy Commissioner of Patents