The High Court has rejected a bid by biopharmaceutical company Samsung Bioepis Australia to challenge a ruling granting Pfizer preliminary discovery for a potential patent infringement case over autoimmune drug Enbrel.
SBA sought the High Court’s special leave to appeal a Full Federal Court ruling, which found Pfizer held a “reasonable belief” that SBA’s biologic drug may be infringing one or more of three manufacturing process patents.
The High Court dismissed the application with costs after hearing arguments in Melbourne on May 18.
A spokesperson for Pfizer declined to comment Monday on the decision. A SBA spokesperson did not return a request for comment.
The Full Court sided with Pfizer in a ruling on November 29, ordering SBA to grant Pfizer access to documents that could be used to build a case against SBA and its distributor Merck, Sharp & Dohme.
Overturning a March 2017 decision by Justice Stephen Burley, the Full Court found that the judge erred in considering which party’s expert evidence was more persuasive or preferable. The proper inquiry, the justices said, was whether Pfizer’s evidence was capable of providing grounds for a reasonable belief that SBA may be infringing.
Judge Burley had found that Pfizer’s expert evidence did not support a reasonable belief that SBA’s biosimilar was infringing, but amounted to “mere speculation”.
But the question was not whether the expert was right or wrong, the Full Court found, but whether Pfizer assistant general counsel believed the expert.
“The primary judge approached the matter by asking himself the wrong question. It was not a matter of which body of expert evidence to prefer; rather, it was whether Pfizer reasonably believed that it may have a right to relief,” the Full Court ruled.
“To defeat a claim for preliminary discovery it will be necessary either to show that the subjectively held belief does not exist or, if it does, that there is no reasonable basis for thinking that there may be (not is) such a case.”
Pfizer was represented at the Full Federal Court by DLA Piper.Samsung Bioepis was represented by Ashurst.
The Federal Court case is Pfizer Ireland Pharmaceutical & Ors v Samsung Bioepis Australia Pty Ltd.
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