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Pfizer suffered a setback last week in its Australian battle to protect ENBREL (etanercept), when its preliminary discovery application against Sandoz was dismissed by Justice Burley in the Federal Court. The reasons for the dismissal are not yet public, subject to the parties seeking suppression orders over any confidential information contained in them, but are likely to be released in coming days.
ENBREL is
Pfizer's blockbuster autoimmune disorder therapy, used to treat various
chronic diseases including rheumatoid arthritis. Commercially available
in Australia since 2003, ENBREL was the only etanercept product
registered on the Australian Register of Therapeutic Goods until 2016
when Samsung Bioepis registered BRENZYS, followed by Sandoz's
registration of ERELZI in 2017.
Given ENBREL's success it is not
surprising that patents covering the product are also being litigated
elsewhere. In the United States, where Amgen holds the patent rights,
ENBREL is its top selling product. The US Federal Appeal Court recently
issued its judgment upholding the validity of the ENBREL patents and
restraining Sandoz from entering the market there. Amgen has also filed
proceedings against Samsung Bioepis in the US, where Samsung's ETICOVO
is not yet on the market pending the outcome of that litigation.
In
Australia, Pfizer launched its preliminary discovery application
against Sandoz in November 2019, after winning a similar application
against Samsung Bioepis in late 2017. In the Samsung case, Pfizer sought
discovery of documents submitted to the Therapeutic Goods
Administration in order to ascertain whether BRENZYS infringed three
patents covering methods of producing polypeptides and/or proteins in
the upstream bioprocessing phase.
The relevant Australian rules
provide that preliminary discovery can be sought before a substantive
proceeding is commenced, for discovery of documents directly relevant to
the question of whether the applicant has a right to obtain relief from
the Court. It is necessary to show that the applicant reasonably
believes that they may have a right to such relief and that, after
making reasonable inquiries, does not have sufficient information to
decide whether to start a proceeding to obtain that relief. The Court
has a discretion as to whether it makes a preliminary discovery order.
The
key issue in the Samsung case was whether Pfizer had the requisite
belief that it may have a right to obtain substantive relief; that is,
in this case, a belief that Samsung was infringing its patents. The
parties filed extensive affidavit evidence, including from experts on
this topic. Pfizer advanced six contentions which it argued supported
its reasonable belief, including the fact that BRENZYS had been
registered on the basis of its biosimilarity with ENBREL, that specific
characteristics of BRENZYS were similar to ENBREL, in particular it had
similar glycosylation profiles, and that since ENBREL fell within the
scope of the relevant patent claims, so must BRENZYS. Considering these
arguments in detail, and noting that he had not had the benefit of cross
examination of the witnesses, Justice Burley ultimately found that he
was not convinced that there was a "reasonable basis" for Pfizer's
belief of patent infringement, as opposed to a mere suspicion (see
Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017] FCA
285). However, an appeal by Pfizer to the Full Federal Court was upheld
(see Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017]
FCFCA 193). The Full Court emphasized that the inquiry was not to
determine the dispute between the experts, or who was more persuasive,
but rather whether Pfizer had a reasonable basis for a belief that it
may have a right to obtain relief. Noting the very substantial evidence
filed on the application, Allsop CJ emphasised that "these are summary
applications not mini-trials". The High Court subsequently refused
special leave for a further appeal. After the matter was remitted to the
primary judge to determine the final form of orders, those orders were
made in May 2019 and the proceeding still continues after orders were
made earlier this year for any application for further discovery to be
filed.
In light of the more generous approach to preliminary
discovery applied by the Full Court in the Samsung case, it will be
interesting to see the reasons for Justice Burley's decision in the
Sandoz case. It certainly seems plausible that another appeal to the
Full Court is on the horizon. More generally, we expect to see more
preliminary discovery applications in patent disputes in years to come,
given the increasing significance in Australia (as elsewhere) of
biosimilar patent litigation. In that sphere, patents covering
manufacturing processes are likely to assume greater importance in light
of the additional complexities at play in claiming active biological
molecules per se, and the significance of specific manufacturing
processes in the production of biologics. Given the likely lack of
available information as to a competitor's manufacturing processes,
preliminary discovery may be an essential weapon in many such cases. It
also remains to be seen whether we will see more applications to be
released from the general undertaking only to use information obtained
in an Australian proceeding for the purpose of that proceeding, in order
to allow, for example, preliminary discovery obtained in Australia at
an early stage to be used for the purpose of corresponding US
proceedings.
We look forward to providing a further update when the judgment is released in this case.
Source:www.mondaq.com
Author:Katrina Crooks
Editor:Vapor