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

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.

The phase out of Australia’s innovation patent system caused a flurry of filing activity in 2021, so what are your options if you identify an innovation patent that affects your freedom to operate?

There was a spike in filing activity as part of the phase out of Australia’s innovation patent system, with over 2,700 innovation patents filed in August 2021 alone. With so many recently filed innovation patent cases, it is a good time to consider the available options if you identify an innovation patent that might affect your freedom to operate.

First, is there really a problem?

If you are worried about an innovation patent, it can be useful to get some early advice on the potential scope of the patent rights and, if necessary, the prospects for challenging validity. You may find that the patent claims do not cover your proposed commercial activities. Alternatively, you might get some clarity around a potential problem so that you can start developing a strategy to address it.

Tailor your strategy

If you identify a problematic innovation patent, it might be worthwhile to challenge that validity of it and we touch on some of the available options below. However, in some cases, you may prefer to negotiate with the patentee in order to reach a mutually beneficial commercial solution (e.g. licensing or assignment of the patent rights). Sometimes a validity challenge can be used strategically to encourage the patentee to come to the negotiating table, or to shift the balance in your favour during negotiations.

There is no single strategy that is appropriate in all circumstances. The best course of action for you will depend on your commercial goals and individual circumstances. The Griffith Hack team can assist you with developing a tailored strategy: feel free to contact us if you would like to discuss your options.

A granted (innovation) patent doesn’t always mean much

It is important to remember that innovation patent applications proceed to grant after only a formalities check. However, they do not become enforceable until they have completed substantive examination and been certified. If you are concerned that infringement proceedings might be commenced against you once an innovation patent has been certified, it may be beneficial to consider pre-certification options.

How likely is invalidity?

Requesting substantive examination of an innovation patent is voluntary. As a result, applicants sometimes take an “optimistic” approach to the subject matter being pursued. This may be done by some foreign applicants to take advantage of financial incentives in their country of origin. Alternatively, the underlying strategy may be for the granted (but uncertified) innovation patent to act as a deterrent to competitors, who might not go the additional step of seeking advice on whether the innovation patent is likely to stand up to scrutiny.

China’s utility model is a similar second-tier of patent protection to the innovation patent. Recent figures indicate that patent invalidation proceedings in China have been successful in a significant proportion of cases. Of the concluded invalidation proceedings for utility model patents in 2020, 39.2% of cases were invalidated entirely, 18.2% were invalidated partially, and only 42.6% of the challenged utility models were maintained.

Much is made of innovation patents being harder to invalidate due to the innovative step being a lower threshold than the inventive step requirement of standard patents. While it is true that the innovative step threshold is lower, it is not a free pass to validity. For example, it is important to bear in mind that innovation patents must meet the same validity requirements as standard patent cases for the level of disclosure in the patent specification. Recent case law indicates Australian patent specifications must now meet a higher standard, more aligned with UK and European requirements. With these recent developments in mind, it is wise not to take an innovation patent (especially an uncertified one!) on its face.

Pre-certification options

Third-Party Examination Requests

Sometimes the simplest way of dealing with a problematic case is to ask the Patent Office to look at it. Substantive examination of innovation patents is voluntary, but third parties can request that an innovation patent be examined. This can be done anonymously or by ‘strawman’. Both the third party and the patentee must pay an examination fee in relation to the third party’s examination request. If the patentee fails to pay this fee, the patent will cease. For patentees who filed an innovation patent with no real intention of having it certified, being asked to pay the examination fee may be enough to cause them to abandon the case.

Notice of Matters Affecting Validity

If you would like to enhance the likelihood of objections in examination, you can give the Patent Office a bit of help. It is possible to file a Notice of Matters Affecting Validity (NMAV). The NMAV can provide submissions (and supporting material) asserting that the claimed invention lacks novelty and/or an innovative step. The Patent Office is required to consider the NMAV when the innovation patent is examined (irrespective of who made the examination request).

You can file an NMAV at any time from when the complete specification for the patent becomes open to public inspection to immediately before the Commissioner decides to certify the patent. Again, this can be done anonymously or by ‘strawman’.

Post-certification options

After certification, a patentee can commence enforcement proceedings to assert their patent rights. Accordingly, it is important to consider the risk of the patentee commencing infringement proceedings when contemplating a post-certification challenge to the validity of an innovation. There are a number of different options available, and we recommend consulting with an IP professional to develop a strategy suited to your circumstances.

Re-examination

If the innovation patent has been examined and certified, that does not have to be the end of the matter. If you still have validity concerns, you can ask the Patent Office to re-examine the innovation patent. Again, this can be done anonymously or by ‘strawman’. Re-examination requests can address more grounds than an NMAV including written description requirements.

Re-examination can be considered a “passive” approach in that you provide information to the Patent Office and hope that they will use it wisely. If the Patent Office raises objections in the light of the re-examination request, the patentee will be given the opportunity to respond to the objections, but the party requesting re-examination does not have a formal opportunity to contest the patentee’s response. Re-examination can be a cost-effective option in circumstances where there are clear invalidity grounds.

Opposition

Alternatively, if it is strategically beneficial to take a more active approach to contesting the validity of an innovation patent, you can commence opposition proceedings before the Patent Office. In opposition proceedings, both the opponent and the patentee are given the opportunity to file evidence and make submissions in support of their respective cases. The opposition can proceed to a formal hearing, where each party can be heard and a hearing officer from the Patent Office will prepare a formal decision on the opposition. The grounds of opposition include the same grounds as re-examination.

Revocation

There is also the option of commencing revocation proceedings before the Federal Court. We do not suggest litigation lightly, but in some circumstances revocation proceedings can be the best approach. The grounds of revocation generally include the same grounds as for oppositions.

If you are dealing with nuanced technical issues or a complicated case, it may be beneficial to actively contest the validity of the innovation patent in opposition or revocation proceedings. As noted above, the best strategy will depend on the specific circumstances of any matter.

How we can help

Griffith Hack is a full-service specialist IP firm. We combine a highly experienced and technically diverse patents team with a legal team with a strong track record. At Griffith Hack, our attorneys and lawyers work together to provide you with commercially astute advice and execute a strategy tailored to your needs.

To discuss the available options, please contact a member of our team.

The draft version of legislation to strengthen the existing unfair contract term protections in the Australian Consumer Law (ACL) was recently released for public consultation, giving us a peek into what is to come. The proposed changes are significant, including potential penalties of AU$10 million, and businesses trading in Australia will likely need to review their contract terms. 

The current unfair contract term protections under the ACL have sometimes been described as a “toothless tiger”. Currently, the protections are quite limited in application and where a term is found to be an “unfair contract term”, it is simply void. Only parties who prove to a court that they have suffered loss or damage as a result of the unfair term can be compensated. No penalties currently apply.

This is set to change and businesses trading in Australia will need to prepare.

In August 2021, the Exposure Draft Legislation and accompanying Explanatory Materials were released for public consultation. The changes proposed are intended to provide fairer allocation of risk in standard form contracts and improve consumer and small business confidence when entering into such contracts. We provide a summary of the changes proposed in the Draft Legislation below.

Increased scope of application to larger businesses and no limit on contract value

The scope of application of unfair contract term laws will likely be broadened. It will continue to apply to standard form contracts which are “consumer contracts” or “small business contracts”, but those definitions would be expanded.

Currently, one of the requirements for a contract to be a “small business contract” is that at least one party to the contract is a business employing fewer than 20 persons. The Draft Legislation increases this to either 100 employees or alternatively, for the company to have an annual turnover threshold of less than $10 million.

Also, the requirement that the upfront payable price of the contract must be below a certain threshold is to be removed. This brings many more companies within the ambit of the legislation. 

We can also expect some increased clarity around the definition of a “standard form contract”. The Draft Legislation specifies that courts must not take into account opportunities to negotiate minor or insubstantial changes to the terms of the contract, opportunities to select a term from a range of options, and the extent to which parties to another separate (but perhaps similar) contract were given opportunity to negotiate its terms. This further solidifies the need to provide the other party with an effective opportunity to negotiate the contract if the unfair contract term provisions are to be avoided.

Terms declared by court to be unfair cannot be used

The Draft Legislation provides that if a term has been declared by a court to be unfair, there will be a presumption in subsequent proceedings that terms which are the same or have a substantially similar effect will also be unfair. This will require businesses to stay abreast of changes to the law in this area by actively reviewing and amending the terms in their standard form contracts in accordance with the court’s decisions.

Growing “teeth” – significant civil penalties and potential remedies

There are currently no penalties for parties using unfair contract terms in their standard form contracts. The Draft Legislation would introduce penalties not only for proposing an unfair term but also for relying on the term. Further, it creates separate contraventions for each term which is unfair. This means that a business may breach the prohibition multiple times in a single contract (and therefore, attract multiple penalties), when they propose the term and again when they rely on it.

For a company, the maximum amount of the penalty will be the greater of: AU$10 million; three (3) times the value of the benefit the company obtained from the breach of the law (if that can be determined; or, if the court cannot determine the value of that benefit, 10% of the company’s annual turnover.

The Draft Legislation also introduces some new remedies specifically for unfair contract terms. A court can now make orders to void, vary or refuse to enforce part or all of a contract if the court thinks this is appropriate to prevent or reduce loss or damage that may be caused (or to remedy loss or damage that has occurred). Unlike other orders the court can make under the ACL, there is no need to show that loss or damage has occurred, only that it may

A court can also make some new special orders on the application of the regulator, including orders injuncting the offending party from using an unfair term (or terms similar to it) in any future contracts. These orders can be made up to six (6) years after the court declares a term is unfair. This gives the regulator significant power to crack down on unfair terms on an ongoing basis.

Other proposed changes

  • It would be expressly stated that remedies for the breach of unfair contract term provisions are also available to non-parties to the contract, and regardless of their status as a consumer or small business.
  • The Draft Legislation would also clarify that if a law of the Commonwealth, State or Territory requires or reads in certain terms into a standard form consumer or small business contract, even if the law does not require or expressly permit those terms per se, it still cannot be considered an unfair contract term under the ACL.

Key takeaways for businesses

With the upcoming changes, business should prepare to review their standard form agreements (under the new definition) for use in Australia and remove or amend any unfair terms. For example, terms of sale or terms of use agreements, licensing agreements, distribution agreements, and service agreements (such as SaaS agreements), are all examples of agreements which may be considered “standard form agreements” depending on the relevant circumstances and may contain “unfair terms”.

If you’d like our assistance with conducting a review of your standard form agreements, please contact us.

Australia and the United Kingdom recently agreed to the broad terms of a Free Trade Agreement, part of which seeks to enhance design rights. As a result, Australia has (finally!) agreed in principle to join the Hague Agreement on Industrial Designs.

What is the Hague Agreement?

The Hague Agreement establishes an international system (the Hague System) administered by the World Intellectual Property Organization (WIPO) which allows designers to seek design protection in many countries at once, with fees paid in one currency, through a single international application. For those familiar with trade marks, the Hague System for Industrial Designs provides a similar procedure to the Madrid Protocol. That is, a single international application applied through WIPO enables applicants to secure rights in multiple participating countries.

How can designers benefit from the Hague System?

Centralised Management of Design Portfolios

Under the current system, Australians can apply for registered designs in Australia and overseas. However, for overseas protection, applicants need to engage in each country of interest a local agent and file a registration application through the relevant national IP administration office . Unsurprisingly, this can be an expensive endeavour, incurring costs for official fees, red tape costs at filing, translations (for non-English speaking countries) and substantive examination, all required for each country.

The Hague System enables designers to file a single design application through WIPO that can protect their designs in (currently) 92 countries simultaneously. Advantageously, this mitigates some of the costs associated with separate national filings by replacing multiple applications (and procedures and formalities) with a single application that only requires a single translation be provided with an application. This can be particularly advantageous for applicants filing designs into multiple non-English speaking countries.

There may be less of a need to involve local attorneys, but a local attorney may be required when an adverse official report issues in connection with a design in a specific country. One drawback in filing a single design application through the Hague System is that the design application may not meet the specific design registration requirements in a specific country. For example, China and the US have very particular design drawing requirements that could normally be addressed prior to filing after consultation with a local attorney.

A Single Application with Simultaneous International Design Rights

The Hague System allows designers to access some of Australia’s key international trading partners. For example, Australian designers planning to launch their designs into the global export market can utilise the Hague System to secure rights in the United States of America, United Kingdom and Canada. Additionally, designers looking to manufacture their products overseas can access design rights in Viet Nam, Japan and Korea. A full list of the contracting parties is available here.

An Option to Defer Publication

The Hague System allows applicants to defer publication of their international design applications. Advantageously, Australian designers can utilise this provision of the Hague System to keep their designs secret for up to 30-months after filing. On the international stage, this may stand as a strategic advantage for some Australian applicants. For example, registered designs can be selectively published according to e.g. a product release schedule or ‘roadmap’. In this way, an applicant can be agile with their product portfolio, publishing their registered designs when most suitable, or in alignment with a broader marketing strategy.

Term of Protection

In joining the Hague System, Australia will need to extend the term of protection from 10 years to a minimum of 15 years. Currently, in Australia, designs proceed directly to registration with only a formalities check. There is no need to undergo a substantive examination process unless the design owner wants to enforce the design. It is likely that the Australian Designs Act will be revised to not only cater for the longer term of protection, but also provide an opposition system given the increase term of protection.

Partial Designs and Graphical User Interfaces

Australian designers will also see the introduction of protection for partial designs and virtual designs in the coming years as the UK-Australia Free Trade Agreement takes shape. For those unfamiliar with partial designs and virtual designs:

a partial design registration will allow an applicant to protect a part, i.e. a ‘signature feature’ of their whole design (or product); and

a virtual design registration will allow an applicant to protect screen displays, graphical user interfaces (GUIs) and screen icons.

The Hague System includes protection for partial designs and virtual designs. IP Australia deferred introducing protection for these types of design registrations in the recent round of Design Law reforms which will come into effect in March 2022. Although not part of the current program of reforms, movement towards the Hague System will force the Australian Government to afford protection to these types of designs in order to align with other jurisdictions such as the European Union, United Kingdom and United States of America.

What can Australian Designers expect from the UK-Australia Free Trade Agreement?

As a part of the UK-Australia Free Trade Agreement, Australia has committed to make all reasonable efforts to join the UK as a member of the multilateral Hague Agreement on Industrial Designs.

While an ‘Agreement in Principle’ was announced on 15 June 2021, the Free Trade Agreement is not expected to come into effect until at least 2022, allowing for final negotiations to be made and the required legislation passed by both Australian and UK Parliaments.

In the years to come, leading to the finalisation of the Free Trade Agreement, designers can expect to see further changes to design rights in Australia. Royal assent to the current reforms to the design rights system was given on 10 September 2021 and thus will come into force on 10 March 2022 for the substantive law changes. While it is unclear how the Hague System reforms will materialise in Australia at this stage, some of the current reforms are consistent with the provisions of the Hague System. For example, the reforms introduce a 12-month grace period for design registrations in Australia which will come into effect March 2022.

The legislative and system changes associated with these reforms will benefit designers looking to maximise protection in international markets and lead Australia to the international partnership of the Hague System.

The Designs Amendment Bill 2020 has passed through Parliament ushering in a wave of reform in Australia. Jennifer Wyndham-Wheeler looks at the changes and what they mean for you. 

The Designs Amendment (Advisory Council on Intellectual Property Response) bill 2020 (‘the Designs Bill’) was passed by both houses of Federal Parliament on 30 August 2021, ushering in a wave of reform in Australia. 

Initiated by a comprehensive review in 2019, the Designs Bill enacts the following changes as recommended by the Advisory Council on Intellectual Property and public consultation:

  • A 12-month grace period. The grace period will protect designers against inadvertent self-disclosure (i.e., publication or use) prior to filing a registered design. This provides flexibility for designers starting out with new products who are unfamiliar with the design system. Designers will no longer lose the ability to register a design for a product that they have self-disclosed within the preceding year. Another benefit may be to allow designers to test products in the market before filing designs and make more informed and strategic design filing decisions.

  • Infringement exemption for prior use. Third parties who start using a design before it is published on the designs register – i.e., during the grace period – are exempt from infringement. This change balances the rights of designers with third parties. Once a design is registered and published, then third parties are considered put on notice of those exclusive rights. Prior to that it seems unfair to punish third parties who have started using an identical or similar product to the design that they may very well have created independently. The third party is able to continue using, making, importing and selling products which are identical or similar to the design.

  • Registration of designs and removal of the publication option. The registration process is now simplified and more streamlined. A request for registration of the design may be made at filing or within 6 months from filing. If a request for registration is not made within the 6-month time period, then the design will automatically proceed to registration. Once the design is registered, publication occurs within a few weeks. The option to publish the design without registering it has been removed. For overseas applicants filing design applications into Australia (i.e., up to six months after an original (Convention priority) filing), the six-month period will have already elapsed and the design will register and publish shortly after filing.

  • Relief from infringement before registration. This reform is an extension of the current innocent infringer defence which prevents third parties infringing a design that they do not know is registered.  The extension also applies the innocent infringer defence to the time period between filing and registration which as previously mentioned can be a time period of up to 6-months. This reform is consistent with the policy of balancing the rights of designers and third parties. Again, where a design is not published on the Register then the competitor could not have known about the existing exclusive rights.

  • Formal requirements. Formal requirements are directed to rules regarding drawing requirements, the specification and information that may (or may not) be included in an application, such as scandalous material. Moving the formal requirements to a non-legislative instrument allows for greater flexibility in updating these requirements with changing technology.

  • Changes to the ‘informed user’ standard. The legal standard of the ‘informed user’ is used to assess the validity (i.e., newness and distinctiveness) of registered designs and the infringement of registered designs. The primary change is that the ‘informed user’ no longer needs to be a user of the product.

Now that the Designs Bill has been passed, it will be provided to the Governor-General for Royal Assent (which typically occurs quickly). Once Royal Assent is provided, some changes including the legal standard will have immediate effect, and some changes, most notably the grace period, will commence 6 months after Royal Assent.

Of the changes to design law summarised above, the introduction of the grace period will have real tangible benefit for designers by providing flexibility for inadvertent self-disclosure. In the longer term, IP Australia intends to explore further reform measures of the design rights system to better support innovation in Australia.

How can we help

If you have any queries as to how these changes may affect your own situation, do not hesitate to get in touch with Jennifer Wyndham-Wheeler, or your usual Griffith Hack contact.