Preliminary Discovery

Noel Kim 03 Sep 2018

Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017] FCAFC 193.

Summary:

Prior to filing a patent infringement lawsuit, Pfizer, the patentee, applied for a ‘preliminary discovery’ order against Samsung Bioepis, a suspected infringer of the patent, to submit a specific document.
2016, first trial (Federal Court of Australia): Pfizer’s did not meet the requirements of the preliminary discovery application: Pfizer lost, Bioepis wins.
2017, second trial (Full Federal Court of Australia): Preliminary discovery requirements were not about the objective facts of evidence submitted (expert’s findings) but rather whether Pfizer’s assertion was rational. Pfizer met the requirements; Pfizer wins, Bioepis loses – an order was made for Bioepis to provide documents requested by Pfizer.
March 2018, third trial (High Court): Bioepis’ requested special leave was denied: Final – Pfizer wins, Bioepis loses.
From the Patentee’s perspective, proactive use of the preliminary discovery order (you can receive information from the other side in advance and decide whether or not to proceed with a lawsuit if you are unsure on whether the other side is violating through the use of the patent).

“Between war and war”. This famous phrase from the book “The Art of War” means that if you know the situation you are in well, you can fight a hundred times and not be at risk. It is a word that can be applied in a situation where there is an opponent should that be at war, a negotiation, sports game or gambling. The same applies for court proceedings where if you know more about the information or evidence the other side has, you can file a lawsuit more confidently and if you believe the situation will not be in your favour, you can find out whether there is another viable solution.

A discovery regime is to offer evidences each party has upon requests by the other party in pre-trials, and it is very useful to determine whether to continue litigations after looking at each other’s evidence and also to prevent in advance from encountering unpredictable evidences (“surprise”) later on in trials by ascertaining the other party’s strengths and weaknesses prior to hearings and trials. Of course, on special occasions such as in privileged documents due to lawyer-client relationships, a party can reject a request from the other party to offer an evidence; however, the court can generally intervene in if a party does not submit to the other party’s reasonable requests.

Thanks to a discovery regime, many litigation cases are often terminated early upon settlements between parties in the middle of litigations. Interchanging and examining each other’s evidence helps a party to understand the other party’s strengths and weaknesses, and it may be more beneficial to each other in a long run to compromise each other rather than going all the way in litigations while paying a great sum of money.

In Australia, a common law country, this discovery regime takes huge part in civil proceedings. According to the rule 7.23 of the Federal Court Rules 2011, there is a regime called a preliminary discovery, which enables each party to obtain evidences from the other party upon request to the court even prior to submitting complaints.

As this preliminary discovery clause is conservatively and sparingly used, it has been difficult for parties to get such order. Even prior to litigations, it is unlikely for a party to unreluctantly offer any information or document which is sensitive to the other party (confidential sales/operative information). Since such request is oftentimes triggered among competitors in the same industry, respondents actively try to defend themselves. Reversely, for the applicants who urge such requests, they may get themselves into trouble by recklessly initiating a litigation based on a conviction without a material evidence. Even so without a litigation, it may not be satisfying for a party to observe the competitor’s gradual encroachment into a common-share market. Especially in pharmaceutics- related patent litigations like the case below, the other party’s information obtained prior to a trial would be a valuable information in determining whether to proceed to litigations further, since a manufacturing process is often not overtly displayed.

The case to be introduced below is a litigation after a long period of appeals and cross-appeals, between the Pfizer Ireland Pharmaceuticals Ltd and the Samsung Bioepis AU Pty ltd, which ended up being a precedent concerning a preliminary discovery by the Australian Federal Court.

Facts Overview

Specialized in biomedicals, the Samsung Bioepis Ltd, which was co-founded by the Samsung biologics Ltd, a subsidiary of the Samsung Group, and the Biozen Ltd from the United States, is primarily in charge of developing biosimilars. In turn, these biosimilars are produced by its parent company, the Samsung biologics.

In 2016, the Bioepis Ltd was successful in getting an approval of two biologics consisting of Etanercept in the name of BREZNYS by the Australian Register of Therapeutic Goods (TGA). These products are known to be affiliated with one of the Disease Modifying Anti-Rheumatic Drugs (DMARD) commercially sold as ENBREL, whose patent is beheld by the Pfizer Ltd. Approved by the U.S. Food and Drug Administration (FDA), the Pfizer Ltd’s ENBREL is a very first DMARD, leading a global DMARD market up until now.

Although having a doubt as to a possible infringement of its own company’s patent right by the TGA-approved BREZNYS products, the Pfizer Ltd did not have any affirmative evidence to be submitted in a patent litigation. The Pfizer Ltd contemplated that had it obtained a document as to the Bioepis’s manufacturing process submitted to be authorized by the TGA, it could have determined a prospect of the litigation as to an infringement of its own patent more meticulously.

Thereafter, as the Pfizer Ltd submitted an application for a pre-trial discovery order to a court pursuant to rule 7.23 of the Federal Court Rules 2011, and the Bioepis Ltd rejected the discovery request, the federal court handed down a judgment as to the trial provided below.

Federal Court of Australia’s decision

According to the rule 7.23 of the Federal Court Rules 2011, a prospective applicant may apply to the court for an order if the prospective applicant reasonably believes that he or she may have the right to obtain relief in the court from a prospective respondent, does not have sufficient information to decide whether to start a proceeding in the court to obtain that relief despite making reasonable inquiries, reasonably believes that 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 inspection of the documents by the prospective applicant would assist in making the decision.

The Pfizer Ltd’s head of manufacturing process technology, Dr Ibarra informed Mr Silvestri, who is a chief in-house council, of the company’s patent information and an expert opinion with respect to the product’s manufacturing process. Following the Dr Ibarra’s opinion, the Pfizer Ltd alleged in the court that it is highly probable that the Bioepis’s product, BREZNYS, infringed its patent right.

Against this, Professor Gary on behalf of the Bioepis submitted an expert opinion denying the Pfizer Ltd’s allegation that the counterpart’s evidence is not sufficient for them to form a reasonable belief that its product, BREZNYS, has infringed the Pfizer Ltd’s patent right.

A federal court judge, Burely J stood on the side of the Bioepis, determining that the expert opinion submitted by the Pfizer Ltd alone is not sufficient enough for it to form a reasonable belief that the Bioepis’s product infringed its patent right, and such belief is no more than a mere suspicion. Furthermore, Burely J added that the mere fact that the BREZNYS and the ENBREL are both biosimilar products does not mean that their manufacturing process are alike.

An Appeal in the Full Federal Court of Australia- different opinion as to a “reasonable belief”

Upon an appeal by the Pifzer Ltd, all three judges from the Full Federal Court of Australia upheld the appeal, determining that the federal court made a mistake in its judgment.

The full federal court of Australia emphasized that a determination with respect to the rule 7.23 is not a mini-trial dealing with the infringement issue, and the purpose of a pre-trial discovery is to reduce the costs to be incurred in the court proceeding and by right support the applicant’s determination. That is, judging factual correctness of each party’s expert opinion as to the possibility of patent infringement in an adversarial manner is not a point at issue, rather its more of reasonableness of the Pfizer Ltd’s belief.

In conclusion, the Pfizer Ltd won whereas the Bioepis Ltd lost, and the full federal court ordered the Bioepis Ltd to disclose the documents requested by the Pfizer Ltd.

An Application for special leave to the High Court

In May 2018, the Bioepis Ltd applied for a special leave to the High Court in order to appeal the Full Federal Court’s decision. Hight Court Judges, Nettle J and Gordon J rejected a special leave and affirmed the Full Federal Court’s decision. Overall, the Pifzer Ltd won and the Bioepis Ltd lost.

Implication

This final decision lays out the conversion from the court’s conventional proclivity to requiring subjective determination as to facts in patent infringement cases to objective yet reasonable determination. That is, there is an unanimous decision in the court that an applicant fulfills the requirements of the rule 7.23 as long as he or she forms a objective and reasonable belief, which resonates the interpretation of ordinary meaning of the terms in the rule 7.23.

Such decision is a good news to patent holders unlike to latecomers in the market. It has become highly likely for patent holders to obtain their opponent’s evidence without burdening themselves to initiate litigations if they utilize a “pre-trial discovery” scheme wisely in circumstances where there are doubts as to possible patent infringements. Also, prior to initiating litigations, they would be able to negotiate with their opponents based on evidences that they obtained through a pre-trial discovery.

In a state-of-the-art biomedical technology, telecommunication, and software-related patent arena, it has become more difficult to discern and reason a manufacturing process or structural analysis using advanced technology such as reverse engineering. Therefore, given such circumstances, Australia’s “pre-trial discovery” regime has become a strong weapon.

On the other hand, for prospective respondents against a pre-trial discovery request, they have to allege neither their opponents’ belief are objective nor subjective evidence as to such belief is sufficient. It would be hard for them to ward off the opponent’s spear just by contending a factual correctness based on the evidence provided by the prospective applicants.

Key Contacts

Noel Kim

Consultant

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Is it possible for an AI (Artificial Intelligence) to be an inventor?

Is it possible for an AI (Artificial Intelligence) to be an inventor? - Thaler v Commissioner of Patents [2021] FCA 879 Summary: ● Dr Stephen Thaler (Thaler) filed an Australian patent application for an invention that was created autonomously by an AI system called ‘DABUS’. ● IP Australia rejected the patent application, determining that only a human can be named as an inventor for an Australian patent. ● Thaler successfully appealed to the Federal Court, which ruled that an AI could be appointed as an inventor for the purpose of the Patents Act 1990 (Cth) (Act). In recent years, the topic of whether AI can be an inventor has been at the forefront of patent laws in numerous countries. Defining the term ‘AI-generated invention’ has triggered a heated discussion over the future of patent law and policy. While it is widely agreed that such discoveries contradict the concept of human inventorship, it is unclear to what extent topics regarding ‘non-human’ creativity are justified. This raises the question of how AI may autonomously create innovations and how AI-generated ideas differ from AI-assisted ideas. The Australian Federal Court recently handed down the world’s first judgment in Thaler v Commissioner of Patents [2021] FCA 879, acknowledging AI as an inventor under Australian patent law with the broad interpretation of s15(1) of the Act. This advances our understanding of who can be the owner of the ‘solutions’ made accessible by these new technologies and how to utilise artificial intelligence to promote economic wellbeing through technological innovation. Background Thaler filed Australian Patent Application No. 2019363177 for ‘Food Container and Devices and Methods for Attracting Enhanced Attention’ on 17 September 2019 by the national entry of the corresponding PCT application. Thaler created The Device for Autonomous Bootstrapping of Unified Sentience (DABUS) to devise, on its own accord, novel ideas such as enhanced storage beverage containers and ‘neural flame’ for search-and-rescue operations. Equivalent patent applications have also been filed in 16 countries including Canada, China, Germany, India, Israel, South Africa, the UK, South Korea and the US. However, the European Patent Office refused to examine Thaler’s patent application on 21 December 2019, citing a failure to comply with their requirement that “an inventor designated in the application must be a human being, not a machine.” Based on the ideology that only natural individuals can be inventors, most countries, including the US, the UK and South Korea, have rejected Thaler’s patent application. So far, the South African Patents Office has only accepted the application but bear in mind that there was no substantive examination prior to this grant in South Africa, Australia is the first jurisdiction to permit a patent invented by a robot creator. IP Australia’s decision The Deputy Commissioner of Patents determined that Thaler’s application did not satisfy the requirements under s15 of the Act since the ordinary meaning of the word “inventor,” as defined by numerous dictionaries, is essentially human (natural or legal). The Deputy Commissioner asserted that the Patent Regulations 1991 (Cth) (Regulations) imply that the term ‘inventor’ refers to a person and that s15(1) of the Act, which specifies who is eligible for a patent, also stipulates that the inventor must be a human. Further, an AI system cannot have a beneficial interest or title in the property, so an AI’s invention cannot be assigned. Consequently, the Deputy Commissioner rejected Thaler’s patent application since it failed to designate a human inventor. Thaler applied for a judicial review to the Federal Court of Australia. Federal Court of Australia’s decision The appeal was heard by Justice Beach, who overturned the Deputy Commissioner’s decisions on 30 July 2021. Justice Beach noted that neither the Act nor the Regulations explicitly define the term ‘inventor’. The term ‘inventor’ is a noun that acts as an ‘agent,’ which can be a person or a thing. Therefore, claiming that a non-human/non-person cannot be an inventor is a fallacy. Henceforth, DABUS can be referred to as an ‘inventor’ as it satisfies the agent noun component. Justice Beach queried, ‘If the output of an artificial intelligence system is said to be the invention, who is the inventor? And if a human is required, who? The programmer? The owner? The operator? The trainer? The person who provided input data? All of the above? None of the above?’ In this regard, the Court acknowledged that Thaler owned DABUS’ source code (as the copyright owner of the source code) and the computer on which it was administered. Based on the concept of ‘deriving a title’ extending to assignments and title transfers, Thaler was found to have absolute ownership and control of the computer on which the program runs (i.e. DABUS). His Honour reached his conclusion based on a combination of legislative interpretation and policy considerations. Justice Beach believes that the term ‘inventor’ should not be interpreted narrowly since doing so would hinder innovation not just in the field of computer science but in all other scientific areas that may benefit from the output of an artificial intelligence’s system. Similarly, His Honour emphasised the fundamental significance of giving effect to the Act’s objective unless its terms or context requires the statutory definition. Justice Beach added that computer inventorship facilitates and incentivises computer scientists to develop novel inventions, resulting in new scientific advantages. So unlike the copyright law which mandates a human author, the Act does not exclude non-human inventors. Implications Justice Beach posited in this case that “We are both created and create. Why cannot our own creations also create?” This significant judgment implies that applications claiming AI as their inventor will no longer be denied on the grounds of failing to name a human inventor. Subsequently, some critics have voiced concerns that granting patent protection to AI-generated inventions may increase the threshold of originality of ‘person skilled in the art,’ making it more challenging for human inventors to obtain patent rights. Furthermore, allowing AI to be an inventor may encourage humans to create AI systems that undertake innovative activities on behalf of humans. It is worth considering whether this serves the Act’s objective of ‘providing a patent system in Australia that promotes economic wellbeing through technological innovation and the transfer and dissemination of technology’ (s2A of the Act). On the other hand, those who favour patent rights for AI-generated ideas believe that the decision will encourage more creation and publication of AI-based breakthroughs. Especially because many pharmaceutical and computer science enterprises and other scientific areas may greatly benefit from an AI system’s output. IP Australia announced on 30 August 2021 that the Commissioner of Patents has decided to appeal the Federal Court’s decision. So stay tuned for more exciting news. Written by Noel Kim (Partner) & Lisa Kwak (Paralegal) Written on 10/09/2021 Disclaimer: The contents of this publication are general in nature and do not constitute legal advice. The information may have been obtained from external sources and we do not guarantee the accuracy or currency of the information at the date of publication or in the future. Please obtain legal advice specific to your circumstances before taking any action on matters discussed in this publication.

IP Australia Fee Changes from 1 October 2020

IP Australia’s 2019-2020 fee review has resulted in changes to various official fees within the Australian Government Charging Framework. The aim of the changes is to ensure the recovery of fees from the administration of intellectual property rights systems. The changes are effective 1 October 2020. The key changes are summarised as follows. Trade marks Standard Trade mark applications are subject to fee increases depending on the type of application. Applicants filing a new non-pick list application using the preferred filing method will be charged $400 for a standard trade mark application and $550 for series trade mark application, both of which are increased by $70 from the old fees. Non-pick list applications are those with classifications that are not from a collection of pre-approved goods and services created by IP Australia. A new single fee of $400 for all hearing requests will be introduced. The single fee applies notwithstanding the type of hearing. Each day of the hearing will also attract fees ranging from $400 to $800 per day, depending on how the hearing is conducted (e.g. by written submissions or in-person). This fee will be offset by the hearing request fee. Patents The changes to the patent fee structure will be three-tiered. Firstly, new excess claim fees have been introduced for the following categories: Standard Patents: 21 to 30 claims $125 Standard Patents: 31+ claims $250 Secondly, renewal/maintenance fees for patents exceeding 5 years will increase significantly, particularly for extended pharmaceutical patents. Standard Patent Renewal/Maintenance Fee Old fee New fee 5th Anniversary $300 $315 6th Anniversary $300 $335 7th Anniversary $300 $360 8th Anniversary $300 $390 9th Anniversary $300 $425 10th Anniversary $550 $490 11th Anniversary $550 $585 12th Anniversary $550 $710 13th Anniversary $550 $865 14th Anniversary Renewal $550 $1050 15th Anniversary Renewal $1250 $1280 16th Anniversary Renewal $1250 $1555 17th Anniversary Renewal $1250 $1875 18th Anniversary Renewal $1250 $2240 19th Anniversary Renewal $1250 $2650 Pharmaceutical Patent Renewal/Maintenance Fee Old fee New fee 20th Anniversary $2550 $4000 21st Anniversary $2550 $5000 22nd Anniversary $2550 $6000 23rd Anniversary $2550 $7000 24th Anniversary $2550 $8000 Finally, and on a brighter note, preliminary search & opinion fees will be reduced significantly from $2,200 to $950. Designs Both application and renewal fees will increase for registered design applications. A new design application which is not submitted via preferred means will cost applicants $450 (previous fee $350). Subsequent designs within the same application will also attract a new fee. Preferred Methods If applicants use filing methods other than IP Australia’s preferred method, higher fees will be attracted. The obvious aim is to incentivise online filing methods for efficiency purposes. It is also to encourage users to make use of trade mark pick lists. Finally, applicants should expect further changes in relation to awards of cost in opposition and non-use removal proceedings. The changes will be released once relevant stakeholder submissions and additional consultations have been assessed. A full list of the fee changes can be viewed on IP Australia’s website. For any enquiries, please contact us at ip@hhlaw.com.au.