Bayer Pharma Aktiengesellschaft [2022] APO

In recent times, the Australian Patent Office and the Federal Court of Australia (FCA) have had a series of cases dealing with patent term extension (PTE) in which consideration of the term “earliest first regulatory approval date” was key. We have commented on these cases previously (Ono Pharmaceutical Co., Ltd. et al [2020] APO 43 (Ono 1); Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643 (Ono 2); Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2021] FCA 947 (MSD)).

On 7 February 2022, the Australian Patent Office published its decision Bayer Pharma Aktiengesellschaft [2022] APO 7 (Bayer), again considering “earliest first regulatory approval date”. This term is central to the calculation of PTE in Australia, which also requires that at least 5 years have elapsed between grant of the patent for which PTE is requested and first regulatory approval for the pharmaceutical substance upon which the PTE request is based. Issues have arisen where a patent covers more than one pharmaceutical substance with regulatory approval, i.e. listed in the Australian Register of Therapeutic Goods (ARTG). In these circumstances, the pharmaceutical substances may be listed in the ARTG by a third party as well as by the patentee.

Bayer fell in the latter group, because the patent in question covered two of the patentee’s products, each listed on the ARTG, each having a first regulatory approval date. The question then was which of the first regulatory approval dates was the earliest first regulatory approval date, the answer to which would dictate whether PTE would be granted. If the earliest first regulatory approval date was that of the pharmaceutical substance first listed in the ARTG, 5 years would not have elapsed between grant of the patent and first regulatory approval. If the earliest first regulatory approval date was that of the pharmaceutical substance second listed in the ARTG, more than 5 years would have elapsed between grant of the patent and first regulatory approval.

At the time of requesting PTE, the Commissioner of Patents was satisfied that the earliest first regulatory approval date was that of the pharmaceutical substance second listed in the ARTG, i.e. the pharmaceutical substance upon which the PTE was requested. Subsequently, a third party challenged the PTE by asserting that the patent register had an incorrect expiration date, beyond the true date of expiration. Bayer deals with the request for rectification of the register to void the PTE.

The patentee’s arguments in Bayer were akin to the FCA’s reasoning in Ono 2, which aligned with the Commissioner’s grant of PTE in the first instance based on the earliest first regulatory approval date was that of the pharmaceutical substance second listed in the ARTG.

As we noted at the time, our view was Ono 2 simplified PTE requests for patentees and provided a degree of certainty by allowing a patentee to ignore third party pharmaceutical substances listed in the ARTG. However, issues regarding a patent covering two or more pharmaceutical substances listed in the ARTG by the patentee remained.

As noted by the Delegate of the Commissioner of Patents at [26], Bayer was heard before MSD was decided and published. The FCA distinguished the facts in MSD from the facts in Ono 2, and the Delegate in Bayer has followed MSD. In short, in Bayer the Delegate held that where two pharmaceutical substances are covered by the same patent and both are listed in the ARTG by the patentee (or with the patentee’s approval), the earliest first regulatory approval date will be that of the pharmaceutical substance first listed in the ARTG. In many cases, including Bayer, this means that the patent in question will not be granted PTE (or according to the legislation, will be PTE-eligible, but will be granted PTE of zero days).

This continues to be a developing area with judgment reserved by the Full Court of the Federal Court of Australia in appeals of both Ono 2 and MSD. It is also possible that the decision in Bayer will be appealed.

In any event, as we have recommended, during patent prosecution, careful consideration should be given to the likelihood of listing in the ARTG more than one pharmaceutical substance that will fall within the scope of the claims of a patent granted on the application. If the likelihood is high, each pharmaceutical substance to be listed in the ARTG should be covered in a separate divisional application to maximise the chance of obtaining PTE for at least some of the patents. Alternatively, it should also be possible to have granted claims covering more than one pharmaceutical substance, and keep a divisional application pending. Because non-broadening amendments may be made after grant, when there is some certainty about what pharmaceutical substances will be listed in the ARTG, the granted patent could be narrowed to one pharmaceutical substance, and the divisional claims redrafted to cover the second pharmaceutical substance.

For more information on PTEs, please contact Dr Malcolm Lyons.

A recent Australian Patent Office decision, Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd,[1] has resulted in the grant of an extension of time to allow the owner of an accepted patent application to take advantage of the 12 month ‘grace period’. In certain circumstances, the ‘grace period’ is available to Australian patent applicants wanting to avoid a novelty destroying self-disclosure.

Neurim (the Applicant) had been alerted to an unauthorised disclosure but failed to communicate this information to the relevant person within the company. However, despite this fact, Neurim convinced the Delegate of the Commissioner that this failure was a genuine error on their part, with the belief that they did inform that relevant person or at least should have done so, weighing heavily into the favourable decision. The net result is that an initial failure to file a patent application in time to take advantage of the grace period has been rectified through an eight-month extension. The decision has significant consequences for the validity of the patent application in question, as the self-disclosure can no longer form part of the prior art base for the assessment of novelty and inventive step.

The decision has highlighted that the extension of time provisions available to Australian patent applicants with respect to the grace period can be lenient and flexible in nature.

Grace Periods & Extensions of Time

Information made publicly available before the filing date of a patent application (i.e. prior art) can be lethal to the validity of a patent application or granted patent. This is because, for an invention to qualify as a patentable invention, among other requirements, it must be novel and have an inventive step (be non-obvious) over the prior art base.

Section 24(1) of the Patents Act 1990 (Cth) (‘the Act’), provides a 12 month ‘grace period’ which allows any information made publicly available, with or without the consent of the applicant, the patentee, or the inventor, within 12 months before the effective filing date of a complete application, to be disregarded from the prior art base for assessment of novelty and inventive step.

Further, section 223(2) of the Act, also permits the extension of deadlines to a ‘person concerned’ (for example, an applicant or patent owner) to do certain acts (e.g. payment of fees, or filing a divisional patent application), but only if that person can demonstrate that an ‘error or omission’ has occurred, or when circumstances beyond a person’s control have prevented the person from performing the relevant act prior to the deadline. In addition to the decision in Ashmont Holdings Limited v American Home Products and Nature Vet Pty Limited,[2] the Australian Patent Office has previously reinforced that filing a patent application is a ‘relevant act’ suitable for the grant of an extension of time under s 223(2), as was shown in Mark Johnson v Paul Weingarth, Spiro Rokos and Paul Scully-Power.[3]

However, although it is technically possible to obtain an extension of the grace period beyond 12 months in situations when an error or omission, or circumstances beyond a person’s control, have led to certain information becoming publicly available, the Australian Patent Office’s 21 January 2020 decision in Amicus Therapeutics, Inc.[4] reminds us that the general extension of time provision of the Act (that is, s 223(2)(a)) does not apply to fix every error or omission.

The Background & Evidence

Neurim filed the application under consideration, AU2016426598 (the “Application”), relating to Melatonin mini-tablets and a method of manufacturing the same, on 26 April 2018 (from PCT/IB2016/057190), in the name of Neurim Pharmaceuticals Pty Ltd (the “Applicant”). The Application has an effective filing date of 29 November 2016 (PCT filing date), and an earliest priority date of 31 October 2016.

Prior to filing their patent application, Neurim had entered into a confidential agreement with the Centre for Human Drug Research (CDHR), relating to a pharmacokinetic study of the prototype product of the future patent application (a new age appropriate formulation of Circadin). Without Neurim’s consent, CDHR electronically published a thesis on 15 April 2015 (over 19 months before the PCT filing date), which unknowingly disclosed the study as Chapter 8. The chapter was meant to be embargoed, but this was not relevant to the facts of the case at hand.

The Vice President of Clinical and Regulatory Affairs at Neurim was made aware of the publication and undertook to have the situation immediately corrected. The CDHR subsequently redacted the chapter from the thesis, but this redaction was not sufficient to put a stop to the ongoing availability of unredacted copies of the thesis in electronic form.

The employee of Neurim, who was not involved in managing the company’s intellectual property, failed to communicate the knowledge of the disclosure to the Vice President of Drug Discovery and Development, the individual at Neurim who was responsible for and had experience regarding intellectual property.

After the Application was accepted, Generic Partners Pty Ltd filed a notice of opposition to the grant of the application under s 59 of the Act, citing a chapter of the published thesis as a key part of the prior art basis for the opposition.

Neurim filed a request for an extension of time under s 223(2)(a) and s 223(2)(b) to rely upon the grace period under s 24, seeking to remove the chapter of the thesis from the prior art base.

Once the request for the extension of time was deemed allowable by the Delegate of the Commissioner, Generic Partners opposed the grant of the extension, which brings us to the current decision.

The Decision

In the Opposition to the extension of time, and in addition to numerous other objections put forth by the Opponent, Generic Partners Pty Ltd mainly asserted that:

  • the alleged act is not a relevant act for the purposes of s 223(2)(a); and
  • the error as asserted is not established by the evidence.

In the Delegate’s view, it was considered that filing a complete application within twelve months of an unauthorised disclosure of the information to claim the benefit of the grace period pursuant to s 24(1)(b) comprises a relevant act for the purposes of s 223(2)(a), for which the time to perform the act may be extended. This was in accordance with Amicus.

All of the Opponent’s assertions were rejected, with the Delegate forming the view that the omission or error was one which deviated from Neurim’s usual practices of clearly relaying important information about products under development between Neurim’s teams. The evidence put forth by Neurim was enough to establish that the employee in question had an awareness that they should bring things like the publication of a thesis to the attention of the relevant people and would ordinarily do so.

It was concluded that on balance, the failure of the employee of Neurim to communicate the publication of the thesis to the relevant person was in fact causative with respect to the failure to file the Application in time to claim the benefit of the grace period, and thus was a causative error for the purposes of s 223.

The Delegate was satisfied that a proper case has been made out and exercised their discretion to grant the extension in favour of the applicant, despite the public interest being against the exercise of the discretion, although the interests of the parties were seen to be equally balanced. Importantly, the Delegate noted that it was not a “…matter of simply calculating how many considerations necessarily fall one way or the other, but understanding the material import of each consideration to whether the discretion should be exercised or not”.

Take Home Points

It is possible to extend the grace period under s 223 of the Act if the failure to file a complete patent application in Australia in time was due to a genuine an error or omission.

The error in question was determined to be the failure of one person to communicate the known disclosure of an invention to the relevant person.

This decision emphasizes that ‘errors or omissions’ can assume a wide variety of forms, and further reinforces the commonly held belief that the provisions available to Australian patent applicants with respect to extensions of time can be quite generous.

We expect that we have not heard the last of this decision, as the Opponent, Generic Partners, is likely to appeal the decision by the deadline of 4 February 2022. If you have any questions regarding this case or topic or would like to know more about the options available to you or your clients regarding extensions of time, please get in touch with our team.


[1] Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd [2022] APO 2

[2] Ashmont Holdings Limited v American Home Products and Nature Vet Pty Limited [2002] APO 24

[3] Mark Johnson v Paul Weingarth, Spiro Rokos and Paul Scully-Power [2020] APO 32

[4] Amicus Therapeutics, Inc. [2020] APO 4

Griffith Hack principal and practice group leader of the firm’s law team Derek Baigent has been recognised as one of Australia’s leaders in intellectual property in The Legal 500 Asia-Pacific guide for 2022.

Derek received the prestigious ranking of Leading Individual, an honour he has received every year since 2019.

Griffith Hack was also recognised as a leading intellectual property firm in Australia, maintaining its Band Two ranking for the second year running. Griffith Hack is the only specialist IP services firm to be ranked in either Band One or Two, demonstrating the firm’s capacity to rival larger international firms in technical capability and engagement management.

Full rankings can be found here.

Melbourne-based patent attorney Ben Dziekan has been named co-winner of the Institute of Patent and Trade Mark Attorneys of Australia’s (IPTA) prestigious Edwards Waters Prize for 2021.

The award is presented to the best performing Patent Attorney in their first year of practice, in recognition of both professional (post registration) performance as well as academic performance during the Masters of IP.

Speaking on the announcement, Griffith Hack managing director Aaron LePoidevin said, “This award is tremendous recognition of Ben’s committed and professional approach to his clients, and the technical and commercial acumen he demonstrates in all matters he works on. On behalf of everyone at Griffith Hack, we congratulate Ben on this well deserved honour.”

Ben, together with co-recipient Samuel Elnajar, will formally receive the award at the 2022 IPTA Annual Conference, where Ben is scheduled to speak on the state of play of Sports and Esports IP in Australia.

Ray Tettman and Sarah Cox will be attending the Victorian Cleantech Cluster event in Melbourne on December 9. 2021.

In preparation for the event, we have prepared some insights on the funding the sectors of renewable energy, recycling, biofuels and green chemistry receive in Victoria and Australia, as well as the level of patent registrations across these sectors in Australia in comparison to the top five countries internationally.

To download your copy, please click the button below.

Australia’s pre‑grant opposition proceedings are playing a more significant role in the strategies of patentees and challengers. 

However, facing a patent opposition in Australia is a new experience for many patent owners. So, what should a patent owner do when faced with an opposition in Australia?

Time is on your side, but don’t sit around

As a patent applicant, time is on your side at the start of the patent opposition procedure. Work on the overall defence plan should commence promptly. Early decisions can be crucial to success, and early mistakes could end up being fatal. Accordingly, long-term planning ought to be done sooner rather than later.  In the past, patent opposition proceedings in Australia often became protracted due to generous provisions relating to extensions of time for lodging evidence. This is no longer the case.

Evidentiary time periods are still extendable, but the regulations relating to extensions of time for evidentiary periods are now reasonably onerous and strictly applied by IP Australia. Unless a party can show that they acted promptly and diligently and made all reasonable efforts to file the evidence in time, an extension will not be granted. In situations where, for example, a party wishes to provide experimental evidence to support their case, such studies may need to be set up early on in the proceedings.

What does an Australian patent opposition involve?

Patent oppositions are conducted before the Australian Patent Office (IP Australia). Any person can oppose the grant of a patent on a patent application by filing a notice of opposition (a simple one-page form) within three months of publication of acceptance of the patent application. Straw man oppositions, where the opposition is filed in the name of a third party (usually a patent attorney firm), are also possible.

After filing the notice of opposition, the opponent has three months to file a statement setting out the grounds and particulars of the opposition, together with a copy of any documents referred to in the statement. The grounds for opposition include:

  • non-entitlement;
  • the invention is not a patentable invention (including not patentable subject matter, lack of novelty or inventive step, in-utility, prior secret use); and/or
  • the specification does not comply with the written description requirements section 40(2) or 40(3) of the Patents Act 1990 (Cth).

Both parties are given the opportunity to file evidence. The evidence in patent oppositions is filed in the form of declarations. In a typical opposition the evidence will include declarations by one or more experts. 

Once all the evidence has been filed, the opposition is then set down for a hearing. Submissions may be made at the hearing in person, by video-conference or in writing. The hearing officer usually takes about three to six months to issue a written decision. The decision in an opposition can also be appealed as of right to the Federal Court of Australia.

Develop a strategy early

Initially patent owners should conduct a cost-benefit analysis, e.g. evaluating the value of the patent versus the cost of fighting the opposition, in view of the likelihood of success. In doing so, it is important to bear in mind that the fact an opposition has been filed strongly indicates that it is at least commercially important to the opponent to try and ‘clear the path’.

If defence is warranted, it is critical to identify potential experts that might assist with providing evidence at an early stage. Obviously, any expert must have the relevant expertise, but they also need to be available to assist, both logistically and in terms of potential conflicts. In highly specialised technical areas the number of potential experts can be small, and it can be a race to secure the best options.

Whilst the case against the patent application cannot be fully understood until the evidentiary rounds are complete, we recommend conducting an analysis of the opposition at an early stage once the Opponent’s Statement of Grounds and Particulars is received, and then updating that analysis on receipt of the evidence. This early review includes understanding the commercial position, considering the patent specification and prior art, and reviewing prosecution history in Australia and other major countries. The analysis can assist with identifying suitable experts, understanding which topics are important to address in the evidence, and highlighting possible amendments that may strengthen the patent application.

Patent applications under opposition can be amended as of right at any time, even after a written decision has issued. The procedure takes time, however, as the amendments need to be advertised for two months and can delay the proceedings. If amendments might be required or desirable, it is important to consider the best timing for making those amendments.

Consider your options for new representation

Opposition practice is a specialised area of Australian patent law, particularly with regard to areas such as preparation of expert evidence, hearing preparation, dealing with procedural aspects and extending into commercial aspects such as settlement negotiations and licensing.

Not all Australian patent attorneys handle patent oppositions regularly and even some that do simply default to a ‘wait and see’ approach when acting for patent applicants. Sometimes that is the right approach, but not always. If your Australian patent attorneys are not proactively engaging with you on these issues, then it is worth considering whether they are the right team for your matter.

How we can help

Griffith Hack’s experts have extensive experience in handling Australian patent oppositions. Our combined patent attorney and legal team provides integrated scientific and legal expertise, together with strategic, commercially-relevant insight, and has a proven track record in delivering results.

To discuss patent oppositions further with a member of our team, click on their profiles on this page.

Despite not being specifically excluded under s18 of the Australian Patents Act, technology utilising embryonic stem cells (ESCs) is not able to be patented in Australia.

With the technology forming a critical pillar of regenerative medicine and therefore having the potential to help realise treatments for some of the world’s most wicked diseases, and since Australia has such a strong reputation for cutting edge biological invention, why is this so?

The story of modern regenerative medicine begins in 1998, in the laboratories of Jamie Thompson at the University of Wisconsin. Working on rhesus monkeys, Thompson’s group showed for the first time that you could program ESCs to differentiate into pluripotent cells.

This gave rise to one of the key pillars of regenerative medicine – the ability to replenish cells in degenerative disorders. The breakthrough also brought with it a small, but growing minority who began to voice more loudly their objections to such use. Primarily, these objections arose from the need to use spare embryos donated from couples undergoing IVF.

These ethical and political concerns intertwined with the patentability of ESCs in Australia in an unexpected way.

The legislative framework

In Australia, section 18(2) of the Patents Act specifically excludes the patentability of ‘humans and biological processes for their generation’. The amendment was introduced during the Patents Bill 1990 by conservative catholic senator, Brian Harradine, almost as an after-thought.

In the second reading of the Bill, the Hon Simon Crean, the Minister for Science and Technology was sufficiently concerned by the absence of comment from the Opposition to voice his opinion. Stating that ‘flexibility was needed’, Mr Crean pointed out numerous scientific advances that were not anticipated by the preceding Patent Acts and suggested that the amendment should not be viewed as restricting patentability. Yet the repercussions of the hurried exclusion, incorporating concerns along the political, theological and ethical spectrum, while not explicitly defining what constitutes a ‘human being’, are felt even today, over 20 years later.

Why Australian patent applications are rejected

A quick review of recent patent applications claiming methods or uses of ESCs reveals numerous applications that have lapsed due to failure to gain acceptance. This is because, based on a 2004 decision of the Commissioner of Patents , they automatically trigger a s18(2) exclusion from patentability on the basis that an ESC can only be created in a process that involves the establishment of human life via a fertilized ovum, no matter how early. A review of these objections reveals that the IP Australia takes a hardline stance on patents directed to the utilisation or generation of ESCs, regardless of whether embryos are created, destroyed or arise from surplus Assisted Reproductive Technology embryos.

Yet given that the initial consternation arising from Senator Harradine’s conservatism was an objection to the potential destruction of embryos, and with the passage of time, it is interesting to reflect on whether or not such a hardline stance would hold up in a challenge to the Commissioner of Patents refusal to progress patent applications directed to ESCs.

A 2016 challenge did marginally move the goalposts: if the patent claims relate to parthenotes and parthenogenesis, IP Australia considers them no longer to fall under the umbrella exclusion of s 18(2). Parthenogenesis, in which researchers use chemicals to induce the egg to begin developing as if it had been fertilized. The egg—called a parthenote—behaves just like an embryo in the early stages of division. However, because it contains no genetic material from a father, it cannot develop into a viable fetus. This result was achieved by the patent applicant taking the issue to a hearing – a high stakes step which might have resulted in more weight to the Commissioner’s decision to reject applications under s18(2) rather than a relaxation of the position.

Time for a more modern approach?

In 2001, President George W Bush introduced restrictions on federal funding for research involving embryonic stem cells. This meant that projects that did not utilize already derived stem cell lines would not be eligible for funding. In a move meant to circumvent these restrictions, California voters in 2004 voted 59% in favour of the establishment of the California Institute for Regenerative Medicine (CIRM), a $3 billion dollar stem cell research agency. Unlike Australia, politicians struck while the stem cell iron was hot, and built on the optimism generated by early stem cell research. Fast forward to 2021 and California is now an international hub for regenerative medicine. The majority of CIRM’s research grants have been awarded to universities like Stanford, USC and UCLA, where researchers have made significant advances in stem cell research.

It has been over 20 years since the modern regenerative medicine story started, and ESC research is moving into clinical phases all over the world, including in Australia. Research has progressed from merely identifying these cells,[5] to now knowing how to replicate the intrinsic cues to trigger the differentiation of ESCs to beating heart cells.[6] Perhaps it is time to again revisit the exclusion from a legal and judicial perspective. Drawing inspiration from the words of Bruce Lehman, the former Commissioner of the USPTO, we are not patenting life – we are patenting technology.

If you would like to discuss the patentability generally in stem cells, or have a more specific query about embryonic stem cell technology, contact us.


[1] C Limon, ‘Human beings as non-patentable inventions’ in Yoriko Otomo and Edward Mussawir (eds), ‘Law and the Question of the Animal: A Critical Jurisprudence’, 57.

[2] Commonwealth, Parliamentary Debates, Senate, 16 October 1990, 2954 (Simon Crean, Minister for Science and Technology).

[3] Fertilitescentrum AB and Luminis Pty Ltd. (2004) (APO 19)

[4] International Stem Cell Corporation [2016] APO 52

[5] Martin, G. R. Proc. Natl Acad. Sci. USA 78, 7634–7638 (1981) and Evans, M. J. & Kaufman, M. H. Nature 292, 154–156 (1981).

[6] Murray, C. E. & Keller, G. Cell 132, 661–680 (2008).

There is increasing awareness (in part due to COVID-19) that mental ill-health can affect anyone under certain circumstances, and that mental ill-health can be prevalent in society. 

Within this context, it may be an opportune time to analyse promising and/or effective therapies that have not yet entered mainstream therapy for mental ill-health, likely because of regulatory impediments. One such class of therapy would be psychedelic therapy.

On 25 August 2021, Mind Medicine Australia (MMA) released a media alert urgently calling for the Australian Federal and State governments to enable psychedelic-assisted therapies to be used to treat severely ill patients who desperately need safe and effective treatments. MMA noted that current treatments achieve remission rates for depression of around 30-35% and for PTSD only around 5%. In contrast, MMA noted that psychedelic-assisted therapy with psilocybin and 3,4-methylenedioxymethamphetamine (MDMA) achieved remission rates for depression and PTSD of between 60 and 80% after just 2 to 3 treatments in combination with a short course of psychotherapy. In Australia, psilocybin and MDMA are classified by the Therapeutic Goods Administration (TGA) in Schedule 9 as Prohibited Substances.

Despite this contrast in therapeutic efficacy, MMA highlighted what it referred to as an absurd situation preventing such therapy. Specifically, psychiatrists in Australia can obtain approval from the TGA to use substances such as these in medically-controlled environments as part of psychotherapy, but are unable to do so because the States and Territories of Australia (except Victoria) do not have a permit system allowing access to Schedule 9 substances.

In July 2020, MMA applied to have certain psychedelics reclassified from Schedule 9 to Schedule 8 as Controlled Drugs. In a further media release dated 1 October 2021, MMA announced that the TGA had moved one step closer to rescheduling MDMA and psilocybin in Australia upon release of the TGA’s Independent Expert Panel on MDMA and psilocybin on 30 September 2021. The Panel searched for randomised controlled trials (RCTs) of MDMA and psilocybin with either inactive or active controls, reviewed the outcomes, and conducted a meta-analysis on the studies. The Panel demonstrated statistically significant differences of the two psychedelic agents between both inactive and active treatments and noted that both agents were well-tolerated. The Panel concluded that:

…MDMA and psilocybin may show promise in highly selected populations but only where these medicines are administered in closely clinically supervised settings and with intensive professional support.

The Panel’s report will be considered by the Advisory Committee of Medicines Scheduling (ACMS) on 3 November 2021, with a final decision anticipated to be published the first week of December 2021.

If psychedelics are to achieve their promise in treating mental ill-health, what tools are available to promote and reward innovation and commercialisation in bringing improved therapies to market? With this question in mind, we address below two aspects of registrable intellectual property (IP), patents and plant breeder rights (PBRs), that could contribute to advancing psychedelic therapies.

Patents

According to the Poisons Standard June 2021 (a legislative instrument made under the Therapeutic Goods Act 1989), Schedule 9 is described as (emphasis added):

Prohibited Substance – Substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities.

Schedule 9 contains substances that should be available only for teaching, training, medical or scientific research including clinical trials conducted with the approval of Commonwealth and/or State and Territory health authorities. Although appearing as a Schedule in this Standard, the method by which it is implemented in the States and Territories may vary.

Section 50(1)(a) of the Patents Act 1990 (Cth) provides that (emphasis added):

The Commissioner may refuse to accept a request and specification relating to a standard patent, or to grant a standard patent for an invention the use of which would be contrary to law.

Accordingly, by use of discretionary rather than mandatory language, and despite Schedule 9 being for “Prohibited Substances”, neither the Patents Act 1990 nor the Poisons Standard June 2021 appear to prohibit patenting a Schedule 9 psychedelic.

Having said that, MDMA was developed by Merck in 1912 and psilocybin was isolated from the mushroom Psilocybe mexicana in 1959, so clearly, these psychedelics are not new, and therefore cannot be afforded patent protection, because they lack novelty. However, patent protection would be available for new and non-obvious:

  • derivatives with improved characteristics
  • genetically modified organisms producing a psychedelic or derivative
  • processes for production, isolation and/or formulation
  • combination formulations
  • treatment indications
  • patient sub-groups
  • methods for identifying patients amenable to treatment
  • dosage regimens
  • administration devices

In other words, despite some psychedelics with therapeutic benefits being known, there remains ample scope to develop patent coverage to promote commercialisation of psychedelic therapies.

Plant breeder/variety rights

In addition to the potential for obtaining patent coverage for genetically modified organisms producing a psychedelic or derivative, it would also be possible to obtain PBR if the genetically modified organism was a new variety of plant, fungus or alga (but not a bacterium, bacteroid, mycoplasma, virus, viroid or bacteriophage).

Further, PBR may be granted in addition to a patent. The terms of each form of IP may run concurrently, but conceivably, a new plant variety could be generated and covered by PBR after filing a patent application or even after grant of a patent to which the new variety relates. This could extend IP coverage related to a psychedelic or derivative beyond that of a patent. Notably, and in contrast to patents, PBRs run from the date of grant rather than the date of filing. For most plants, the term is 20 years, but for trees and some vines, the term is 25 years. As such, a PBR could extend considerably beyond a patent for related plant technology.

Other IP

Although we have discussed patents and PBRs, other forms of registrable IP such as trade marks (protecting a badge of origin) and designs (protecting visual appearance) may also be important for promoting commercialisation and bringing psychedelic therapies to market.

How we can help

At Griffith Hack, we are client-centric. We reduce complexity in and maximise the impact of your IP to target commercial results for you. We are experts in all areas of IP. In particular, we have extensive experience in managing IP protection for Scheduled substances such as opioids and cannabis extracts. Together, our technically diverse patents, trade marks and legal teams can assist you with protecting and commercialising innovative psychedelic therapies as the regulatory framework develops. So please contact us if you wish to explore IP strategies for psychedelic therapies.

Welcome to the first article in our five-part Spotlight Series on one of the most exciting frontiers of scientific research and innovation, regenerative medicine.

Throughout this series, we will find out more about what regenerative medicine encompasses, its historical origins, recent advances in the lab and the clinic, the current standard of care, and look over the horizon to what the future holds for the sector.

What is regenerative medicine?

Regenerative medicine refers to the field of study harnessing the body’s innate ability to repair, restore or establish normal function due to damage or impairment, whether through birth, disease, trauma or aging. The appeal of regenerative medicine lies in the potential to utilise normal repair mechanisms within our body to restore function to a damaged organ, or to treat previously incurable diseases such as cancer.

“Regenerative medicine is the process of creating living, functional tissues to repair or replace tissue or organ function lost due to age, disease, damage, or congenital defects. This field holds the promise of regenerating damaged tissues and organs in the body by stimulating previously irreparable organs to heal themselves. Regenerative medicine also empowers scientists to grow tissues and organs in the laboratory and safely implant them when the body cannot heal itself.”

The National Institutes of Health (NIH) in 2006

Stem cell therapies are the most well-known arm of regenerative medicine, however the field also includes other cell therapies (such as CAR T cell therapies), genetic therapies, nanotechnology and biomedical engineering, and reprogramming of cells and tissue.

Experts in the field come from a plethora of backgrounds and expertise. Biomedical engineers and computer scientists might come together on how to generate 3D-printed biologically compatible scaffolds to be implanted into a site of injury, in order to promote formation of new tissue and cell regeneration. Clinicians and stem cell scientists could collaborate on an autologous stem cell therapy, from isolating appropriate adult stem cells from an individual, treating or activating the stem cells in the laboratory and re-injecting the stem cells to the same individual at a site of injury to repair damage. Developmental biologists are working on how to reprogram embryonic stem cells to grow tissues and organs in the lab, and provide an avenue for thousands of people waiting on an organ transplant list.

The future is bright

Regenerative medicine has truly come to the forefront in the last decade. Perhaps the superstar of the sector is chimeric antigen receptor (CAR) T-cell therapy, including Kymriah ® for treating leukemia (by Novartis) and Yescarta ® for treating lymphoma (by Gilead Sciences), both of which received FDA Approval in the U.S.A. in 2017. CAR T-cell therapies isolate T cells (a type of immune cell) from a patient suffering from cancer, genetically edit these T cells in the lab so that the T cells express a CAR, and transplant the edited CAR T-cells back into the patient. The T cells now express CARs, which are cell surface receptors that target cancer cells, thereby bringing the CAR-T cell into contact with the cancer cells so that the CAR-T cells can kill the cancer cells. CAR-T cell therapies have taken the biotechnology industry by storm, resulting in a number of large mergers and acquisitions of regenerative medicine companies, and an increasingly competitive and dense patent landscape.

On the other hand, relatively established cell therapies such as bone marrow transplantation have matured and is expected to be a US$15 billion market by 2027. The surge is thought to be driven by the growing prevalence of cancer and anemia patients, who have compromised bone marrow and require transplanted stem cells to repair and replace the injured cells.

The regenerative medicine sector globally is projected to develop into a US$120 billion market by 2035 (UK Cell and Gene Therapy Catapult, AusBiotech 2018 report). A recent draft strategic roadmap released by a consortium of leading companies in the regenerative medicine landscape in Australia suggests that proper investment and development of our manufacturing capabilities would translate to at least AUD$6 billion in revenue and 6,000 new jobs for Australia in the same timeframe.

Australia remains one of the leaders in basic research for the regenerative medicine sector, ranking 10th in the world for publications (2nd when adjusted on a per capita basis). Proper buy-in and investment from industry and the government at this key turning point would lead to a significant boost to the Australian regenerative medicine ecosystem, as well as early access to ground-breaking therapies for patients.

In the next part of the series, we discuss the historical origins of regenerative medicine.

From 12 April 2021, new rules governing the eligibility of registering .au domain names come into effect. The primary changes affect domain name holders who rely on an Australian trade mark as the basis of their eligibility to hold an .au domain name. 

Key aspects of the new rules and how they may apply to your brand, are outlined below. 

Relying on trade marks to meet “Australian presence” requirements

To register an .au domain name, it is necessary to have an “Australian presence”, which can be satisfied by meeting various criteria including:

  • being an Australian company;
  • trading under a registered business name;
  • owning an Australian trade mark registration or an application for a trade mark which has a “close and substantial” connection to the domain name. Reliance on an Australian trade mark registration or application is particularly common for overseas rights holders using .au domain names. 

The new rules governing .au domain name eligibility require domain names be an “exact match” to the holder’s trade mark. The domain name must include all the words which comprise your trade mark, in the order they appear in your trade mark. However, not all trade mark elements have to be included in the domain name, specifically:

  • Domain Name System (DNS) identifiers such as com.au;
  • punctuation marks, such as exclamation points or apostrophes;
  • articles such as “a”, “and” or “the”;
  • ampersands.

As an example of how strict the new “exact match” requirements are, a party holding the trade mark registration for GRIFFITH HACK could rely on the trade mark registration as a basis for registering the domain name griffithhack.com.au, but not as a basis for registering domain names such as griffithhacklaw.com.au or gh.com.au.

One further rule change of specific interest to overseas rights holders relying on an Australian trade mark registration or application as a basis for holding a .au domain name, is that companies can now hold .au domain names on behalf of another company in their corporate group, as long as they meet the Australian presence requirement.

When the new eligibility rules come into effect on 12 April 2021, they will apply to all .au domain names registered or renewed after this date.  We recommend that .au domain name holders review their .au domain names to ensure they will meet the new eligibility requirements. It may be necessary to take actions such as filing new trade mark applications that are “exact matches” for your .au domain names or transferring your .au domain names to your Australian businesses or subsidiaries to ensure your .au domain names remain valid.