Pfizer has lost a bid in the Federal Court of Australia to access Samsung Bioepis’ confidential material about how it produces its biosimilar BRENZYS (etanercept).
BRENZYS was approved by the Australian Therapeutic Goods Administration (TGA) in July 2016 and was listed on the publicly-subsidized Pharmaceutical Benefits Scheme (PBS) on April 1, 2017. PBS listing of BRENZYS will trigger a statutory price reduction of 16% in the publicly-subsidized price paid for Pfizer’s ENBREL.
In the court proceeding Pfizer sought an order for preliminary discovery of confidential documents Samsung Bioepis lodged with the TGA in order to determine whether to commence proceedings against Samsung Bioepis for patent infringement. Specifically, Pfizer suspected that the process by which the BRENZYS products are made (BRENZYS Process) might infringe one or more of its patents, but required more information in relation to the BRENZYS Process in order to ascertain whether it infringes the claims of the three patents identified.
The order for preliminary discovery was sought pursuant to Rule 7.23 of the Federal Court Rules 2011 (Cth), which is in the following terms:
- A prospective applicant may apply to the Court for an order under subrule (2) if the prospective applicant:
(a) Reasonably believes that the prospective applicant may have the right to obtain relief in the Court from a prospective respondent whose description has been ascertained; and
(b) After making reasonable inquiries, does not have sufficient information to decide whether to start a proceeding in the Court to obtain that relief; and
(c) Reasonably believes that:
i. The prospective respondent has or is likely to have or has had or is likely to have had in the prospective respondent’s control documents directly relevant to the question whether the prospective applicant has a right to obtain the relief; and
ii. Inspection of the documents by the prospective applicant would assist in making the decision.
2. If the Court is satisfied about matters mentioned in subrule (1), the Court may order the prospective respondent to give discovery to the prospective applicant of the documents of the kind mentioned in subparagraph (1)(c)(i).
The central issue in this case was whether Pfizer had a reasonable belief, considered objectively, that it may have the right to obtain relief for patent infringement from Samsung Bioepis. Pfizer relied on six contentions, considered cumulatively, in order to establish the requisite belief that would entitle it to obtain preliminary discovery. Burley J stated that “the high point of Pfizer’s application involves a cascading series of inferences” and summarized as follows:
The chain of reasoning is, first, that the BRENZYS product has a peculiar level of similarity to the Pfizer product, a fact that can be inferred from the contents of the Cho article and the similarity between glycosylation profiles. Secondly, that the similarity between products enables the inference that the process to make each is similar. Thirdly that the Pfizer Process falls within the claims of the patents in issue. Fourthly, that because the Pfizer Process falls within the claims, the BRENZYS Process may likewise fall within the claims.
Burley J found that the mere fact that BRENZYS and ENBREL are biosimilar does not inform the question of what process is used to make either product. Notwithstanding the evidence of Pfizer’s in-house expert, Dr Neysi Ibarra, that the process falls within the claims, Burley J found that it did not provide a reasonable basis for Pfizer’s ‘belief’ in patent infringement by Samsung Bioepis, as opposed to mere suspicion. Critically, Dr Ibarra failed to give evidence of her observations, the source of her knowledge or any other evidence that went toward the manner in which she assessed that the process by which ENBREL is made as falling within the claims and thus the evidence did not rise above mere speculation.
Further, even if Pfizer had established the requisite belief, his honour would have exercised the judicial discretion conferred by rule 7.32(2) against granting the preliminary discovery order sought as Pfizer had not placed “before the Court all evidence already available to it relevant to the sufficiency of the information it possess to enable a decision to be made whether to commence a proceeding”.
Pfizer’s application was dismissed with costs. It can appeal, but has not yet done so.
It will be interesting to see the next steps Pfizer takes in this matter. It would face procedural difficulties if it sought to make a fresh application for preliminary discovery, but it is also now on record as saying it does not have enough information to make a decision as to whether or not to commence proceedings. It is possible that Pfizer will, in any subsequent patent infringement proceedings, seek to rely on section 121A of the Patents Act 1990 (Cth) (broadly equivalent to 35 U.S.C. § 295) in order to put the onus on Samsung Bioepis to establish that BRENZYS is not made by a process falling within the claims of the patents. However, due to the particular wording of section 121A, this could be argued to constitute an admission that ENBREL and BRENZYS are identical products, something we assume Pfizer would seek to avoid.
In any event, this is an important practical decision and we see several clear takeaway points:
- Preliminary discovery applications, which are likely to be required in order to enforce process claims relating to biologics, will require extensive and detailed evidence in support and are not a forgone conclusion.
- Market developments require a prompt response. Pfizer, for whatever reason, did not progress this matter expeditiously (see paragraphs - of the judgment). As a result, the possibility of obtaining an interlocutory (preliminary) injunction, and avoiding the statutory 16% price-drop, has passed.
- Expert evidence is key. Pfizer’s application essentially failed due to deficiencies in the expert evidence of Dr Ibarra.
You can read the full judgment here.
If you think you might need to enforce a process patent against a manufacturer of a biosimilar, it’s essential you seek strategic advice before doing so. As the Pfizer v Samsung Bioepis case demonstrates, the issues are complex and could have significant ramifications if not carefully considered.