FEDERAL COURT OF AUSTRALIA
Merck Sharp & Dohme Corporation v Wyeth LLC [2019] FCA 1421
File number: NSD 1381 of 2017 Judge: BURLEY J Date of judgment: 30 August 2019 Catchwords: PRACTICE AND PROCEDURE – where Notices to Produce served by each side upon the other pursuant to r 30.28 of the Federal Court Rules 2011 (Cth) – where compliance challenged by each side – applicants excused from compliance and respondent partially excused from compliance Legislation: Federal Court Rules 2011 (Cth) rr 16.01, 30.28
Patents Act 1990 (Cth)
Cases cited: AON Risk Services Australia Limited v Australian National University [2009] HCA 27; 239 CLR 175
Apotex Pty Ltd (ACN 096 916 148) v Les Laboratoires Servier [2008] FCA 1466
Construction, Forestry, Mining and Energy Union v BHP Coal Pty Ltd (No 2) [2012] FCA 707
Deep Investments Pty Ltd v Casey (No 1) [2017] FCA 1643
Tamaya Resources Limited (in liq) v Deloitte Touche Tohmatsu (A Firm) [2016] FCAFC 2; 332 ALR 199
Date of hearing: 21 August 2019 Registry: New South Wales Division: General Division National Practice Area: Intellectual Property Sub-area: Patents and Associated Statutes Category: Catchwords Number of paragraphs: 31 Counsel for the Applicants: Ms K. Howard SC with Mr D. Larish Solicitor for the Applicants: Corrs Chambers Westgarth Counsel for the Respondent: Ms C. Cochrane with Mr R. Clarke Solicitor for the Respondent: Allens ORDERS
NSD 1381 of 2017 BETWEEN: MERCK SHARP & DOHME CORPORATION
First Applicant
MERCK SHARP & DOHME (AUSTRALIA) PTY LTD
Second Applicant
AND: WYETH LLC
Respondent
AND BETWEEN: WYETH LLC
Cross-Claimant
AND: MERCK SHARP & DOHME CORPORATION
First Cross-Respondent
MERCK SHARP & DOHME (AUSTRALIA) PTY LTD
Second Cross-Respondent
JUDGE:
BURLEY J
DATE OF ORDER:
30 AUGUST 2019
THE COURT ORDERS THAT:
1.Leave is granted to the applicants to issue a Notice to Produce on the respondent, returnable at 9.30am on 11 September 2019, requiring production of the following:
(a)Any documents created on or before 13 November 2017 recording consideration of whether to, and/or the basis for the decision not to, allege infringement by the applicants in Australia of the surfactant claims;
(b)Any documents created after 13 November 2017 recording consideration of whether to seek to allege infringement by the applicants in Australia of claim 9 and/or to file the Interlocutory Application on 25 June 2019;
(c)All documents (including but not limited to file notes and memoranda) recording or evidencing:
(i)the communication between Mr Hamer and Ms Reddy referred to in paragraph 14 of the affidavit of Richard William Hamer sworn 13 August 2019 (Hamer 2);
(ii)communications between Ms Reddy and the external service provider after March 2018 in relation to the formulation of the applicants’ 15 valent vaccine (referred to in paragraph 14(c) of Hamer 2).
2.To the extent necessary, compliance pursuant to r 30.28(3) of the Federal Court Rules 2011 (Cth) is dispensed with in relation to the Notice to Produce dated 19 August 2019 issued by the applicants.
3.Compliance pursuant to r 30.28(3) of the Federal Court Rules 2011
Keep reading for free
Create a free CaseChat account to read Merck Sharp and Dohme Corporation v Wyeth LLC and more:
- Read every judgment in full
- Ask AI and get answers linked to paragraphs
- See how each paragraph was cited in later cases
- Download judgments as PDF or Word
One click creates your free account or signs you in.
By continuing you agree to the Terms and Privacy Policy.
- Case
- [2019] FCA 1421
- Decision Date
CaseChat Overview and Summary
The court found that Wyeth was not entitled to leave to amend its cross-claim to include an additional allegation of infringement. However, the court did grant Wyeth leave to issue a Notice to Produce on the respondent, requiring production of documents related to the decision-making process for the initial cross-claim and subsequent amendment. The court also exercised its discretion to excuse the respondents from complying with certain notices to produce, taking into account the need to balance the interests of both parties and the importance of the documents in question. Finally, the court ordered the respondent to pay the applicants' costs of both the respondent's interlocutory application and the applicants' interlocutory application. The outcome of this case highlights the importance of careful consideration of patent infringement claims and the need for parties to provide adequate justification for any amendments to their claims.
Orders
Orders of the court
1. Leave is granted to the applicants to issue a Notice to Produce on the respondent, returnable at 9.30am on 11 September 2019, requiring production of the following:
(a) Any documents created on or before 13 November 2017 recording consideration of whether to, and/or the basis for the decision not to, allege infringement by the applicants in Australia of the surfactant claims;
(b) Any documents created after 13 November 2017 recording consideration of whether to seek to allege infringement by the applicants in Australia of claim 9 and/or to file the Interlocutory Application on 25 June 2019;
(c) All documents (including but not limited to file notes and memoranda) recording or evidencing:
(i) the communication between Mr Hamer and Ms Reddy referred to in paragraph 14 of the affidavit of Richard William Hamer sworn 13 August 2019 (Hamer 2);
(ii) communications between Ms Reddy and the external service provider after March 2018 in relation to the formulation of the applicants’ 15 valent vaccine (referred to in paragraph 14(c) of Hamer 2).
2. To the extent necessary, compliance pursuant to r 30.28(3) of the Federal Court Rules 2011 (Cth) is dispensed with in relation to the Notice to Produce dated 19 August 2019 issued by the applicants.
3. Compliance pursuant to r 30.28(3) of the Federal Court Rules 2011 (Cth) is dispensed with in relation to the Notice to Produce issued by the respondent in an amended form and annexed to its submissions dated 20 August 2019.
4. The respondent pay the applicants’ costs of both the respondent’s interlocutory application dated 13 August 2019, and the applicants’ interlocutory application dated 20 August 2019.
Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.
Background
Background to the litigation
Full text does not contain this section.
Evidence
Evidence Before The Court
Full text does not contain this section.
Decision
Reasons for decision
Full text does not contain this section.
Ratio Decidendi
Legal Principle Established
The applicants are Merck Sharp & Dohme Corporation (Merck Corporation) and Merck Sharp & Dohme (Australia) Pty Ltd (collectively, Merck). They filed proceedings seeking the revocation of certain claims of Australian patents numbered 2006235013 and 2013206844, each of which is entitled “Multivalent pneumococcal polysaccharide-protein conjugate composition” (collectively, composition patents), and also Australian patent No. 2012216628 entitled “Novel Formulations which Stabilize and Inhibit Precipitation of Immunogenic Compositions” (container patent). Wyeth brought a cross-claim against Merck for threatened infringement of certain claims of these patents by the proposed sale in Australia of a 15-valent pneumococcal polysaccharide-protein conjugate vaccine (Merck’s proposed vaccine). The trial of the claim and the cross-claim was heard over a number of weeks in December 2018 and February 2019, and judgment is reserved. Wyeth's amendment application seeks leave to add an additional allegation, to the effect that claim 9 of the container patent will be infringed by Merck’s proposed vaccine, and leave such that following the delivery of judgment in the proceedings, the Court hear and determine all additional issues arising from the amendment. 2. THE EVIDENCE On 25 June 2019, Wyeth, which is owned by Pfizer Inc, a company within the Pfizer group of companies, filed its amendment application, together with an affidavit sworn by Richard William Hamer sworn on 23 July 2019, who is a partner of Allens and the solicitor on the record for Wyeth. Mr Hamer explains how, by the time of the trial in December 2018, Wyeth came to sue Merck for infringement of some of the claims of the container patent, but not claims 9, 10 or 11, that are for an invention for a vaccine incorporating a surfactant (surfactant claims). In summary, the affidavit addresses the following matters.(1)Since the commencement of the proceedings and until 18 February 2018, Allens was instructed in relation to the proceedings by Mr Louis Silvestri, Assistant General Counsel, and Mr Shahan Islam, Senior Corporate Counsel, from Pfizer. Mr Silvestri was, and Mr Islam continues to be in the “IP Enforcement group” at Pfizer.(2)On 13 November 2017, Wyeth filed its cross-claim alleging that Merck had threatened to infringe claims 1 – 8, 16 – 18 and 20 – 23 of the container patent. (3)Wyeth did not allege that Merck had threatened to infringe the surfactant claims, because in Mr Hamer’s opinion, there was no adequate basis to make such an allegation. He says at [17]:The state of my knowledge, the state of Pfizer’s knowledge, and the reason for my conclusion that there was no proper basis to allege that [Merck] had threatened to infringe any of the surfactant claims, is described in more detail below. (4)Mr Hamer then identifies a number of documents that he had read before 13 November 2017. These include Australian Patent No. 2011216095, published on 18 August 2011 (MSD 2011), and International Patent Publication No. WO2012/078482, published on 14 June 2012 (MSD 2012), a book entitled “Plotkin’s Vaccines” (7th ed), published in 2017, and an article published in 2011 by Skinner et al. (5)On the basis of these materials, Mr Hamer considered that he could not, consistently with his professional obligations including under r 16.01 of the Federal Court Rules 2011 (Cth) (FCR), certify that there was a proper basis upon which to allege that Merck had threatened to infringe the surfactant claims. (6)He then describes the course of requests for discovery, and admissions made by Merck that obviated the need for the provision during the course of the proceedings of any documents going to the excipients used in Merck’s proposed vaccine. (7)Mr Hamer notes that on 12 October 2018, Merck abandoned its challenge to the validity of the surfactant claims, which he considered was “not inconsistent” with his conclusion as to the absence of surfactant in Merck’s proposed vaccine.(8)After the trial, on 14 March 2019, Mr Hamer became aware of an article by Stacey et al, but he did not read it then. The article was first published online on 16 January 2019. (9)On 13 May 2019, Merck commenced proceedings NSD 774 of 2019 against Pfizer, seeking orders for the revocation of a further patent, No. 2015208821. On 12 June 2019, in the course of considering that patent, Mr Hamer read Stacey et al, which refers to a phase II clinical trial conducted by Merck prior to 7 June 2018, in which the two formulations of a 15-valent pneumococcal conjugate vaccine (PCV) containing certain CRM 197 conjugates each included a surfactant, the presence of which may be important to the immunogenicity of the PCV.(10)Mr Hamer then considered that there was a proper basis to allege that Merck proposed to make and sell a product that infringed claim 9 of the container patent. Allens wrote to the solicitors for Merck, Corrs Chambers Westgarth, seeking confirmation as to whether Merck’s proposed vaccine includes a surfactant, and undertakings not to infringe. Information and undertakings were not forthcoming, and on 25 June 2019 Wyeth filed the amendment application. (11)In the exchange of correspondence with Allens that followed, Corrs indicated that it would resist the application, and drew attention to certain documents that it contends should have alerted Wyeth to the use of a surfactant in Merck’s proposed vaccine, one of which is a document identified as the MSD Protocol which Corrs said had been published on a US government website on 16 March 2018. Page 19 of the MSD Protocol identifies the use of a surfactant within the vaccine formulations used in a study, identified as study V114-005, sponsored by Merck Corporation. Mr Hamer gives evidence that he first became aware of the MSD Protocol on 25 June 2019, and on 17 July 2019, he searched the website, and discovered that the MSD Protocol was hyperlinked to the page containing study V114-005, but that the study entry on the website does not mention the excipients used in the vaccine formulations the subject of the study.(12)Corrs also supplied Mr Hamer with a copy of a patent application referred to as the 098 application, a patent that fell within the family of MSD 2012 which Mr Hamer considered before preparing Wyeth’s cross-claim.