Sanofi v Amgen Inc - [2018] APO 3

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Sanofi v Amgen Inc. [2018] APO 3

Patent Applications: 2013203677
2013203748
2013203685
2013203689
2013203751

Title:Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) [each application has the same title]

Patent Applicant:  Amgen Inc.
Opponent:  Sanofi
Hearing Officer:  Dr S.D. Barker – Deputy Commissioner of Patents
Decision Date:  11 January 2018
Hearing Date:  9 January 2018, in Canberra

Catchwords: PATENTS – section 210 – request for production of documents – whether the documents are likely to be of substantial relevance to the matter – request refused

Representation: Patent attorneys for the applicant: Gary Cox and Dr Linda Kennaugh of Wrays
Counsel for the opponent: David Shavin QC
Legal representatives for the opponent: Lisa Taliadoros and Anthony Muratore of Jones Day

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Applications: 2013203677
2013203748
2013203685
2013203689
2013203751

Title:Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) [each application has the same title]

Patent Applicant: Amgen Inc.
Date of Decision: 11 January 2018
DECISION
I refuse the request for the Commissioner to order production of documents under section 210.
REASONS FOR DECISION

This matter concerns requests by Sanofi for orders under section 210 of the Patents Act 1990 (the Act) for the production of documents for the purpose of five oppositions under section 59.
Background
Patent application 2008288791 was filed in the name of Amgen Inc. (Amgen) on 22 August 2008, and has now proceeded to grant. Five divisional applications were filed on 11 April 2013: 2013203677, 2013203748, 2013203685, 2013203689 and 2013203751 (the present applications). The present applications were accepted and grant of each application has been opposed by Sanofi. Evidence in answer has been completed in each opposition.
As part of the evidence in answer of each opposition, evidence was provided by Professor Petsko. Professor Petsko's evidence included a consideration of the crystal structure of various products identified as PCSK9/31H4, PCSK9/21812/31H4,PCSK9/8A3, PCSK9/11F1, PCSK9/1A12, PCSK9/25G4 and PCSK9/EGFa. This task involved the use of computer files (known as .pdb files) using the PyMOL program. Professor Petsko declared that Amgen provided him with copies of the .pdb files. Professor Petsko's evidence included copies of the information in the .pdb files in the form of .txt files in PDF format.[1]
[1] The PyMOL program is an X-ray crystallography data imaging program. PyMOL uses atomic coordinates data in a file that has the extension .pdb. Amgen has stated in correspondence dated 13 November 2017 that the .txt files provided by Professor Petsko can be converted to .pdb files that can be used by the PyMOL program by changing the file extension from .txt to .pdb.
Prior to filing Professor Petsko's evidence Amgen had sought a direction from the Commissioner that it be allowed to file .pdb files and that those files be treated as confidential. The Commissioner declined to provide the direction.
On 3 November 2017 Sanofi requested that the Commissioner issue a notice to Amgen to produce the .pdb files used by Professor Petsko. A Senior Examiner at IP Australia informed the parties that she was not satisfied that there was any basis for requiring production, noting that "it would appear that production would substantially replicate information already in evidence and in the possession of the Opponent".[2]
[2] Correspondence dated 9 November 2017.
In essence, Sanofi's argument for a notice to produce is that they have a concern that there is a material difference between the .txt file in evidence and the .pdb file given to Professor Petsko.
Amgen has subsequently provided to the Commissioner a copy of a set of .pdb files on a thumb drive, and the Commissioner has made those files available to Sanofi. Despite this, Sanofi has maintained its request for a notice to produce the .pdb files. I heard Sanofi in relation to the request on 9 January 2018. Amgen appeared by telephone.
The law
Section 210 of the Act provides:
210 Commissioner's powers
Commissioner's powers
(1) 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.
Exercise of power to summon witnesses
(2) The Commissioner must not summon a witness under paragraph (1)(a) unless:
(a) the Commissioner is satisfied, on the balance of probabilities, of the following matters:
(i) the witness has a substantial interest in the proceedings before the Commissioner;
(ii) the witness is likely to provide oral evidence of substantial relevance to a matter before the Commissioner;
(iii) receiving oral evidence from the witness is necessary or desirable in all the circumstances; and
(b) the Commissioner notifies the witness of the actions the Commissioner may take under section 210A if the witness fails or refuses to comply with the summons.
(3) The Commissioner may summon a witness under paragraph (1)(a) whether the witness is in or out of the patent area.
Exercise of power to require production of document or article
(4) The Commissioner must not require a person to produce a document or article under paragraph (1)(c) unless:
(a) the Commissioner is satisfied, on the balance of probabilities, of the following matters:
(i) the person has a substantial interest in the proceedings before the Commissioner;
(ii) the document or article is likely to be of substantial relevance to a matter before the Commissioner; and
(b) the Commissioner notifies the person of the actions the Commissioner may take under section 210A if the person fails or refuses to comply with the requirement.
(5) The Commissioner may require a person to produce a document or article under paragraph (1)(c) whether the person is in or out of the patent area.
Exercise of powers in relation to bodies corporate
(6) The Commissioner's powers in subsection (1) to make a requirement of a person extend, if the person is a body corporate, to making that requirement of any person who is an officer, agent or employee of the body corporate.
These provisions apply to the exercise of the Commissioner's powers on or after the commencement of Schedule 3 of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Raising the Bar Act), that is, 15 April 2013. Relevantly the changes brought about at that time were the insertion of subsections (2) to (6). The effect of these changes was discussed by the Deputy Commissioner in Domino's Pizza Enterprises Limited v Precision Tracking Pty Ltd (Domino's):[3]
"in my view 'substantial relevance' means more than just 'substantive relevance' or 'not of limited relevance' as suggested by Mr Cordiner. It must be something that is likely to be, if not determinative, highly significant in the determination of a relevant issue in dispute in the proceedings."[4]
[3] [2016] APO 13.
[4] Domino's at [31].
The Deputy Commissioner drew a distinction between production under the Act and discovery:
"It follows that section 210 as amended is unlike the scheme for discovery and production in other jurisdictions. It is not to be invoked by one party as a general means of exploring the other party’s case and particularly is not to be used in a fishing expedition or a hunt for a 'smoking gun'. Usually it will be necessary to identify a real and specific factual issue in dispute, not merely speculation that production or summons might reveal such a matter and a plausible basis for concluding that the order will in some way be likely to provide substantial assistance in resolving the matter. Otherwise the Commissioner cannot be satisfied on the balance of probabilities that what is sought is 'likely to be of substantial relevance'."[5]
[5] Domino's at [32].
The Deputy Commissioner also pointed out that the power is discretionary:
"The power exercised by the Commissioner is discretionary and must only be exercised after considering the respective interests involved and the purpose of the legislation. Some relevant factors will include fairness to the respective parties, whether any order made would be onerous, delay in the resolution of the proceedings and in the granting of the patent, the correctness of the determination of the proceedings and the efficiency of IP Australia in administering the process."[6]
[6] Domino's at [33].
At the hearing Mr Shavin submitted that "substantial relevance" should be understood as relevant to a substantial issue in the opposition, and the focus of attention is on whether the issue is sufficiently substantial rather than whether the document is of sufficient relevance. I do not agree. The Explanatory Memorandum, as quoted by the Deputy Commissioner in Domino's,[7] makes it clear that a high threshold applies, and it is the degree of relevance that must be considered. I adopt the reasoning and conclusions of the Deputy Commissioner in Domino's in relation to the operation of section 210.
[7] Domino's at [26].
Consideration
Amgen is the applicant, and clearly has a substantial interest in the proceedings. The only question is whether the .pdb files are likely to be of substantial relevance.
I accept that the parties have different views on whether the specifications disclose any antibodies that bind to particular residues of PCSK9, and thus whether the specifications comply with section 40. I also accept that the evidence of Professor Petsko and the information in the .pdb files used by him are relevant to this ground of opposition. Professor Petsko's evidence included copies of the .pdb files as .txt files in PDF format.
Sanofi put forward several arguments in support of a notice.[8] First, Sanofi argued that they have the right to consider the exact material that Amgen relies upon in the opposition rather than a copy of that material. I do not agree. Oppositions proceed on the basis of declarants providing a copy of material that they refer to – whether that is books, journal articles or computer files. It is only where a party can demonstrate a substantial relevance that a notice to produce the original will be issued.
[8] Correspondence dated 3 November 2017.
Sanofi's main argument is that there could be a material difference between the .pdb files and the .txt files. This argument is based on several inferences. Sanofi sought to draw an inference from Amgen's behaviour in asking to file the .pdb files as confidential material, and then filing a .txt copy instead. It is relevant to note that the Commissioner had advised the parties that she was not satisfied that the requested course of action was appropriate. In these circumstances is not clear that an inference adverse to Amgen should be drawn. Sanofi also posed the rhetorical question – if the .pdb files used by Professor Petsko are the same as the .txt files, why hasn't Amgen simply provided the .pdb files to Sanofi? There are many answers to this question, and I do not find any assistance in asking it.
Finally, Sanofi consider that the language used by Professor Petsko indicates that it is possible that the .txt copy may not contain everything that was included in the .pdb files. The key passage of Professor Petsko's evidence is as follows:
"Amgen provided me with a copy of the .pdb file for this crystal structure. Annexed hereto and marked GAP-19 is a .txt file, in PDF format of the information that Amgen provided to me. The .pdb file, which is produced at the end of the refinement process, contains the same coordinates as found in Table 35.1 of the Amgen applications, and it provides the R-value and R-free metrics for this structure."[9]
[9] Professor Petsko's evidence at [175]. Similar statements are made at paragraphs [199], [223], [231], [240], [253] and [274] in relation to other files.
Sanofi submitted that this is ambiguous and open to a number of interpretations, including that the .txt file contains only some of the information in the .pdb files. This conclusion relies upon interpreting the "information" contained in the .txt file as different to the "data" in the original .pdb file, and "a .txt file … of the information" as including the possibility that "the information" can be "some of the information". I do not agree. The plain meaning of Professor Petsko's words is that the .txt file contains the information in the .pdb file (and not merely a subset of the information). There is no reasonable inference that the .txt file is materially different to the .pdb file.
In earlier correspondence from Sanofi they advanced a different argument that the .txt files are different to the .pdb files:
"a very real concern that there is some material difference in information as between the PDB Files provided to Professor Petsko and the .txt files (or PDF copies thereof) provided to the Opponent. Indeed, an inference to this effect can be properly be drawn from the following circumstances:
(a) In paragraph 175 of the Petsko Declaration, Professor Petsko expressly attests to the fact that the '.pdb file' which the Applicant provided to him for the 'PCSK9/31H4' crystal structure 'contains the same coordinates as found in Table 35.1 of the Amgen Applications' (emphasis added).
The Opponent of course does not have the PDB Files. However, despite the statement in paragraph 175 of the Petsko Declaration, what is apparent from the annexed marked up copy of Annexure GAP-19 (which is said to correspond to the .txt file for the 'PCSK9/31H4' crystal structure provided by the Opponent) is that this document differs from Table 35.1 of the Amgen Applications, including in relation to the 'coordinates' (as shown in yellow highlighting).
On this basis, it appears that 'information' in the .txt tiles is not the same as the information in the PDB Files."[10]
[10] Correspondence dated 16 November 2017.
The difference between the .txt file and Table 35.1 relates to coordinates for co‑crystallised water molecules that are present within the crystal structure (and some "REMARK" information). The coordinates of the water molecules are given in the .txt file, but are not included in Table 35.1. I accept that the .txt file contains information in addition to that in Table 35.1, but that does not suggest that the .txt files are different to the .pdb files used by Professor Petsko. There is no reasonable inference that can be drawn from this.
I am not satisfied that Sanofi has demonstrated a reasonable basis to believe that there is (or that there could be) a material difference between the .pdb files used by Professor Petsko and the .txt files.
Sanofi also suggested that they would be denied natural justice if they did not have access to the very .pdb files used by Professor Petsko.[11] Based on my conclusion that there is no reasonable basis to believe that there is a material difference between the .pdb files and the .txt files, it follows that nothing has been withheld from Sanofi and there is no denial of natural justice.
[11] Correspondence dated 3 November 2017.
I am not satisfied that there is a substantial relevance in producing the .pdb files.
Conclusion
I will not issue a notice to produce.
Dr S.D. Barker
Deputy Commissioner of Patents