As of 1 April 2017, Samsung Bioepis' Brenzys, a biosimilar to Pfizer's Enbrel (active ingredient etanercept), will join the very short list of "a-flagged" biosimilars listed on the Australian Government's Pharmaceutical Benefits Scheme (PBS). Pharmacists can substitute a prescribed biologic with an "a-flagged" biosimilar at the pharmacy level (ie. at dispensing).
The listing of Brenzys on the PBS coincided with the decision of the Federal Court of Australia to refuse an application by Pfizer for discovery before action of documents pertaining to the process of manufacture of Brenzys by Samsung Bioepis.
The launch and PBS listing of Brenzys, without an interlocutory injunction application from Pfizer, and the failed application for discovery shows that the pathway to restraining the launch of a biosimilar may be more difficult than in the small molecule market.
In the landscape of the Australian government's express commitment to increasing awareness of biosimilars(in which it has promised an investment of AUD20 million over 3 years), Brenzys' unimpeded PBS listing is an encouraging development in the biologic/biosimilar landscape.
Federal Court action - background
Pfizer sought discovery in the Federal Court of Australia of confidential documents that Samsung Bioepis had lodged with the Therapeutic Goods Administration in support of its PBS application
According to Pfizer, it needed these documents to decide whether to bring proceedings against Samsung Bioepis for patent infringement under 3 method of manufacture patents in relation to Enbrel.
Pfizer also sought an order that if Samsung Bioepis did not have the requested documents in its possession custody or power, that it take reasonable steps to obtain them for disclosure.
The main issue before the Court was whether Pfizer had the required subjective and objective reasonable belief that it might have a cause of action as required by the Federal Court Rules.
Pfizer relied on six contentions in its submissions and argued that when considered cumulatively, they would satisfy the "reasonable belief" threshold.
Pfizer’s principal argument was that because Brenzys is a biosimilar of Enbrel it must have been made using the patented methods, given in particular, the fact that characteristics of biologics are very sensitive to the process by which they are created. In support of its argument, Pfizer relied on evidence that the glycolisation profiles of Brenzys and Enbrel are very similar.
Burley J concluded, however, that although the end products are biosimilar this does not necessary mean that the method is similar.
Similarly, Pfizer contended that his Honour should infer that Brenzys' manufacturing process is similar to the Enbrel manufacturing process, and since Enbrel process falls within the relevant claims of Pfizer's patents, that it may be inferred that so too did the Brenzys process. Burley J rejected this reasoning.
Pfizer also submitted that since Samsung Bioepis did not deny in correspondence or in the course of proceedings that the Brenzys manufacturing process involved the patented method the Court should draw an inference that this was the case. Burley J noted that the inference was available to Pfizer, nevertheless it would be inappropriate to draw the inference in the present case.
Overall, Burley J ruled that when taken together, Pfizer’s contentions supporting its "belief" did not satisfy the threshold for “reasonable belief”. Therefore, Pfizer's application for discovery was refused.
His Honour went further and found that even if Pfizer satisfied the “reasonable belief” threshold, in the circumstances he would have exercised the judicial discretion against granting the preliminary discovery order conferred in FCR 2.23(2).
Lessons from the case?
The failure of Pfizer to obtain an order for preliminary discovery demonstrates that a patentee of a process for the manufacture a biologic will need something more concrete than the fact that the biosimilar has the same characteristics as the biologic to ground a reasonable belief of a patent infringement claim.
Having failed in this application, it is difficult to see how Pfizer will be able to gather such information to found any patent infringement claim in Australia (if grounds for such an application exist).
There is a procedure available whereby a patentee issues infringement proceedings and establishes that it is very likely that the patented process has been used, then the onus of proof is reversed so that the alleged infringer must prove that it is not using the process. However, given the finding in the case, Pfizer's evidence would not have met this hurdle.
The case demonstrates the difficulty for patentees trying to establish infringement of process claims, in the absence of cooperation by production of documents by the alleged infringer. Patentees will need to consider very carefully how they formulate and evidence their belief in the use of the patented process before seeking discovery in such circumstances.