Title: Methods and compositions for reducing viral genome amounts in a target cell Patent Applicant: The Board of Trustees of the Leland Stanford Junior University Date of Decision: 28 September 2012 DECISION The applicant has not demonstrated a lawful excuse in relation to notice to produce issued on 4 June 2012. I direct the applicant to produce the documents specified in the notice within one (1) month of the date of this decision with the qualifications as to confidentiality set out in the following reasons. REASONS FOR DECISION Background The current application relates to reducing viral genome amounts in a cell and more specifically to inhibiting micro-RNA (miRNA) activity in a target cell by the delivery of an inhibitory agent. Exemplified is the administration of a miR-122 inhibitory agent being an antisense oligonucleotide complementary to miR-122. The specification at page 22 sets out details of relevant oligonucleotides synthesised by Dharmacon Inc. The application was advertised accepted on 8 September 2011 and opposed by Santaris Pharma A/S (Santaris). A statement of grounds and particulars was filed 8 March 2012 and on 22 May 2012 the opponent requested the issuing of a notice to produce certain documents related to the oligonucleotides mentioned in the specification. Consequently on 4 June 2012 a notice was issued under section 210(c) by Deputy Commissioner Bokil. The applicant objected to the notice and has asserted a lawful excuse.

Santaris Pharma A/S v The Board of Trustees of the Leland Stanford Junior University [2012] APO 105 (28 September 2012)

Last Updated: 28 September 2012

IP AUSTRALIA

 

AUSTRALIAN PATENT OFFICE

 

The Board of Trustees of the Leland Stanford Junior University v Santaris Pharma A/S

[2012] APO 105

 

Patent Application: 2005240118

 

Title: Methods and compositions for reducing viral genome amounts in a target cell

 

Patent Applicant: The Board of Trustees of the Leland Stanford Junior University

 

Opponent: Santaris Pharma A/S

 

Deputy Commissioner: Philip Spann

 

Decision Date: 28 September 2012

 

Hearing Date: Hearing on written submissions

 

Catchwords: PATENTS – notice to produce – whether lawful excuse – jurisdiction – scope of notice – confidentiality – no lawful excuse demonstrated – applicant directed to comply.

 

Representation: Patent applicant: A Blattman, Patent Attorney, Spruson & Ferguson, Sydney

Opponent: G Cox, Patent Attorney, Wrays, Perth

 

IP AUSTRALIA

 

AUSTRALIAN PATENT OFFICE

 

Patent Application: 2005240118

 

Title: Methods and compositions for reducing viral genome amounts in a target cell

 

Patent Applicant: The Board of Trustees of the Leland Stanford Junior University

 

Date of Decision: 28 September 2012

DECISION

The applicant has not demonstrated a lawful excuse in relation to notice to produce issued on 4 June 2012. I direct the applicant to produce the documents specified in the notice within one (1) month of the date of this decision with the qualifications as to confidentiality set out in the following reasons.

REASONS FOR DECISION

Background

 

1. The current application relates to reducing viral genome amounts in a cell and more specifically to inhibiting micro-RNA (miRNA) activity in a target cell by the delivery of an inhibitory agent. Exemplified is the administration of a miR-122 inhibitory agent being an antisense oligonucleotide complementary to miR-122. The specification at page 22 sets out details of relevant oligonucleotides synthesised by Dharmacon Inc.
2. The application was advertised accepted on 8 September 2011 and opposed by Santaris Pharma A/S (Santaris). A statement of grounds and particulars was filed 8 March 2012 and on 22 May 2012 the opponent requested the issuing of a notice to produce certain documents related to the oligonucleotides mentioned in the specification. Consequently on 4 June 2012 a notice was issued under section 210(c) by Deputy Commissioner Bokil. The applicant objected to the notice and has asserted a lawful excuse.

Applicable Law

 

1. The power for the Commissioner to require production is provided under section 210 of the Act:

The Commissioner may, for the purposes of this Act:

(a) summon witnesses; and

(b) receive written or oral evidence on oath or affirmation; and

(c) require the production of documents or articles; and

(d) award costs against a party to proceedings before the Commissioner.

 

1. The current practice of the Commissioner in dealing with a request to issue a Notice Requiring Production is to issue the notice if and to the extent that it appears to serve a legitimate forensic purpose in the context of the opposition. Objections by the affected party are not heard before the issuance of the notice but it is expected that objections arising will be dealt with as a matter of lawful excuse for not complying with the Notice.
2. In Attorney General (Cth) v Breckler [1999] HCA 28; 197 CLR 83, the majority of the High Court noted (at [17]) that:

“The phrase “reasonable excuse” has been used in many statutes but whether an excuse answers that description depends not only on the circumstances of the particular case but also on the purpose of the provision to which the exception is provided. However, the scope of the phrase “ lawful excuse ” appears to be more limited. A trustee will have a lawful excuse for failure to comply with an order, direction or determination of the tribunal if the trustee has a reason recognised by law as sufficient justification for such failure, whether by way of answer, defence, justification or other legal right or immunity.”

 

The Notice

 

1. The documents sought by the notice of production are as follows:

“1. Copies of the laboratory notebooks documenting the embodiments of the invention described on pages 17 to 24 of the Patent Application 2005240118 or described in appendix A or B of US 60/568,358 (the priority application);

 

2. The documentation submitted to Dharmacon, Inc. prior to 3 May 2005 ordering the oligoribonucleotides used in the research described on pages 17 to 24 of the Patent Application 2005240118 or described in appendix A or B of US 60/568,358;

 

3. The documentation received from Dharmacon, Inc. prior to 3 May 2005 setting forth the specifications associated with the oligoribonucleotides set out on page 22, lines 5 to 24 of the Patent Application 2005240118; and

 

4. Documentation not already covered by items 1, 2, or 3 in your possession prior to 3 May 2005 identifying the precise chemical structure of the oligoribonucleotides identified on pages 17 to 24 of the Patent Application 2005240118 and in particular the documents that identify the specific nucleotide(s) modifications in said oligoribonucleotides, including modifications to internucleoside linkages, sugar moieties and base moieties, with particular emphasis on those sequences stipulated on page 22 at lines 5 to 24 of the Patent Application 2005240118, and the oligoribonucleotide(s) referred to as 122as20Me, 122as2Me and 2′-O-methyl antisense oligonucleotide in appendix A and/or B of US 601568,358;

 

5. Documentation not already covered by items 1, 2, 3, or 4 in your possession prior to 3 May 2005, comprising correspondence with one or more of the following individuals in the field:

a. Hutvanger G., Simard MJ., Mello CC., and/or Zamore PD.

b. Meister G., Landthaler M., Dorsett Y., and/or Tuschl T.

c. Cummins LL., Owens SR., Risen LM., Lesnik EA., Frier SM., McGee D.,

Guinosso CJ. and/or Cook PD.

d. Majlessi M., Nelson NC and/or Becker MM.

 

the documentation referring to the 2′-O-methyl modification of antisense oligoribonucleotides with particular emphasis on the specific and optimal position and number of modified nucleotide bases in the oligoribonucleotides.”

 

1. In its submissions Santaris emphasises that the notice is sought to clarify the precise chemical structure of the embodiment of the invention and that the documents specified are directly relevant to its case that the specification does not sufficiently disclose the invention including the best method for its performance. This is reflected in grounds 6 and 7 of the statement of grounds and particulars.

Objection and excuse

 

Jurisdiction

 

1. The applicant submits only that as the persons concerned are based outside of Australia and since the Patents Act applies only to Australia and its territories, the Commissioner has no power to issue a notice under section 210(c).
2. The international nature of the patent system has been formally recognised at least since the conclusion of the Paris Convention for the Protection of Industrial Property in 1883 and has been a cornerstone of patent law in Australia from that time[1]. A consequence of providing equal treatment of foreign nationals for the purpose of Article 2 and the right of priority for Article 4 of the Convention is that the Patents Act necessarily concerns itself with inventions and other acts conducted outside of the patents area by persons who may be foreign nationals. However it does so only for the determination of patent rights within Australia and the powers under the Act should be seen in that light.
3. On this basis, and while some clarification of the Commissioner’s powers under section 210 will occur on commencement of Schedule 3 of the Intellectual Property Laws Amendment (Raising the Bar) Act, I believe the applicant’s simplistic assertion should be rejected. Rather it appears to me clear that a foreign patent applicant falls within the jurisdiction of the Commissioner under the Act including section 210 and indeed numerous other provisions of the Act that require actions by applicants consequential to their application for patent rights in Australia. That a foreign applicant can be within jurisdiction for some but not all of the provisions governing the grant of patents seems to be quite anomalous and not the least where what is concerned is a provision of the Act intended to allow legitimate concerns about the validity of a patent to be examined and addressed. In any event while inherently the notice may involve information held by the applicant in a foreign jurisdiction, the action required is production in Australia for the purpose of Australian opposition proceedings.
4. I find therefore that an appropriate excuse does not lie in the notice being beyond jurisdiction.

Notice constitutes discovery and the documents are not relevant

 

1. The applicant contends that the notice constitutes de-facto discovery for the purpose of deciding the viability of oppositions in Europe (eg the opposition to EP 1747023) or for the purpose of proceedings in the US. The applicant does not provide evidence of this or, more significantly, give any reasons why the notice amounts to discovery in respect of the current proceedings or similarly why the documents sought are not relevant.
2. I rather consider the notice to be constrained specifically to documents concerned with the detail of the embodiment of the invention described and to beprima facie relevant to the ground of lack of full description including the best method known to the applicant of performing the invention that is raised in the opposition. That the document might also be relevant to foreign proceedings is beyond the point and consequently I do not find a lawful excuse arises on this basis.

Documents are confidential

 

1. The applicant asserts that the documents sought are highly commercially sensitive particularly noting that Santaris is a competitor in the field of microRNA technologies. It also refers to an absence of penalties under the Patents Act for a breach of confidence.
2. I however agree with the Deputy Commissioner in Eli Lilly & Company v Novo Nordisk A/S [1999] APO 45 that the mere fact that documents sought to be produced are confidential does not constitute a lawful excuse. Remedies for breach of confidence exist outside of patent law and means are provided within the Act by which a confidentiality regime can be established including under sub-regulation 4.3(2)(b).
3. To the extent that the applicant’s objection relates to the specific oligoribonucleotides mentioned in the specification and used by the applicant to perform the invention, that objection is without merit. The matter goes directly to the ground of objection under subsection 40(2)(a). However, if there are relevant documents that include confidential information that is not relevant to the notice then, consistent with Eli Lilly, supra, that information may be redacted, subject to any indication that relevant material has been withheld. Consequently no excuse has been identified concerning confidentiality.

The notice is onerous and oppressive

 

1. The applicant submits that a large amount of material is involved and that persons concerned are spread across several locations. The latter point appears to be largely irrelevant. As to the first, as I indicated above, I consider the notice to be constrained and consequently not onerous. Of course, complying with a notice may require effort and in some cases significantly so. However this is a matter of the reasonable expenses that the requesting party has undertaken to pay. If expenses are likely to be extensive, the applicant is entitled to ask the opponent to confirm its undertaking on the basis of an estimate of costs but, that said, I can see no reason why the present notice would be considered to involve extensive investigation. Most particularly it involves only documents in the ‘possession, custody and control’ of the applicant and, in relation to paragraph 5 of the notice, is limited to documents “referring to the 2′-O-methyl modification of antisense oligoribonucleotides”.

The notice is directed to issues relating to section 59(a) which are not pleaded

 

1. To the extent that I understand the applicant’s very brief submission, it is that the document requested may be relevant to the ground of lack of entitlement that has not been relied on in the opposition. If a document sought by production is only relevant to that ground then of course it may be found irrelevant. However, if relevant to a pleaded ground then it seems pointless to argue that it is relevant to a ground not pleaded. Consequently I do not find a lawful excuse on this basis also.

Conclusion

 

1. The applicant has not demonstrated a lawful excuse in relation to the notice issued on 4 June 2012. I will allow the applicant a further period of one month to comply at which time it may also make any request as to confidentiality that it considers appropriate and this will be considered on its merits. It may also produce documents from which confidential information not relevant to the notice is redacted.
2. If the applicant does not comply, the delegate will be entitled, in the determination of the opposition, to take that fact into consideration including in the weighing of evidence and the award of costs. There does not appear to be any costs awardable under schedule 8 in relation to the present hearing nor have submissions on costs been received. In that case I make no award of costs at this time. However the parties are entitled to make submission as to costs in this matter in the substantive determination of the opposition.

Philip Spann
Deputy Commissioner of Patents