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.

As foreshadowed in our recent article on Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643 (Ono), the Federal Court of Australia has issued Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2021] FCA 947 (MSD), a further decision regarding patent term extension (PTE).

Whereas Ono considered PTE in the context of a pharmaceutical substance listed on the Australian Register of Therapeutic Goods (ARTG) by a third party prior to the patentee’s ARTG listing, MSD relates to PTE in the context of a patent that covers two or more pharmaceutical substances listed on the ARTG by the patentee or a related entity.

MSD had two pharmaceutical substances listed on the ARTG, both covered by claims of the one patent. Based on the pharmaceutical substance first listed on the ARTG, the patent was ineligible for PTE, because 5 years had not elapsed between the effective filing date of the patent and listing of the first pharmaceutical substance on the ARTG. However, based on the second pharmaceutical substance with the later listing on the ARTG, the patent was granted PTE, because greater than 5 years had elapsed between the effective filing date of the patent and that listing on the ARTG.

Merck Sharp & Dohme Corp. (MSD) initiated proceedings against Sandoz Pty Ltd (Sandoz) alleging threatened infringement during the PTE period. In response, Sandoz cross-claimed that the PTE based on the second pharmaceutical substance was erroneous and sought rectification of the patent register to indicate that the patent expired 20 years after its effective filing date.

MSD proposed a construction on the calculation of the extension of term with reference to Ono, effectively by replacing recitation of “s70(2)” in s77 with “s70(3)”. At [49], Jagot J noted that “MSD relies heavily on Ono at [118] and [144].” However, Jagot J was not swayed, not least in noting at [53] that:

All of the above paragraphs from Ono [relevant to MSD’s construction] are obiter dicta. The ratio of the case is confined to the answer Beach J gave to the issue of construction with which he was dealing, namely, as identified at [27]:

…whether an application for an extension must be filed within 6 months of the first inclusion in the ARTG of goods containing or consisting of any pharmaceutical substance falling with the claims of the patent:

  1. where the goods were those of the patentee (the applicants’ position); or
  2. irrespective of whether the goods were those of the patentee, that is, they could be the goods of a third party that had nothing to do with the patentee and, moreover, might be a competitor (the Commissioner’s position).

In short, Jagot J held that recitation of “earliest” in s77 relating to calculation of PTE duration meant exactly what is said. Therefore, the duration of PTE was to be calculated using the date of listing the pharmaceutical substance listed first on the ARTG, not the pharmaceutical substance listed second (or subsequently) on the ARTG. It followed that the term of the patent should not have been extended, or technically, the PTE should have been calculated as zero days.

Consequently, it remains best practice to pursue each pharmaceutical substance likely to be listed on the ARTG in a separate divisional application.

For more information, please contact Malcolm Lyons.

With Australia’s innovation patent system set to end later this month, pre-grant opposition proceedings will likely play a significant role in the strategies of challengers going forward – and owners will want to be prepared. Gavin AdkinsDr Toby Thompson and Amanda Stark discuss. 

Australia’s innovation patent system is ending soon. As a result, Australia’s pre‑grant opposition proceedings will likely play a more significant role in the strategies of patentees and challengers in the future.

Innovation patents are subject to a different ‘post-grant’ opposition procedure to standard patents that is stayed by the commencement of court proceedings. As a result, divisional innovation patents are sometimes used as a litigation tool in order to, among other things, short circuit the enforcement delay associated with the pre‑grant opposition procedure for standard patents. As the innovation patent system is phased out, this tactic will fall away.

Australia’s pre-grant patent opposition procedure is long-standing but has undergone some important changes in recent years that will become critical in the future.  These changes include higher requirements for several grounds of opposition, resulting in a less pro-patentee opposition regime than was previously the case.   

Lower burden of proof

Previously, in order to succeed in opposing grant of an Australian patent it was necessary for an opponent to establish that the patent, if granted, would be clearly invalid.

Now an opponent need only satisfy the Hearing Officer on the balance of probabilities that a ground of opposition to the grant of the standard patent is made out.

Stronger grounds for opposition

In respect of standard patent applications which are filed on or after 15 April 2013, or for which examination is requested after this date, there are four substantive changes that strengthen the grounds for challenging validity:

1. Broader prior art base for inventive step (obviousness)

Firstly, the background “common general knowledge” is no longer confined to that which existed in the art in Australia. In practice, this removes the need to use local Australian experts or otherwise prepare evidence in order to establish that the relevant art is ‘international’ in nature.

Secondly, in order for prior art to be eligible for assessing inventive step it is no longer necessary to establish that it must be “information that a skilled person […] could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood, regarded as relevant”. This removes another evidentiary obligation from an opponent and broadens the prior art base substantially.

2. US utility requirement

An express utility requirement was inserted to align with the US position such that “a specific, substantial and credible use for the invention (so far as claimed) is disclosed in the complete specification”. This is in addition to the pre-existing requirement for the invention itself to be useful.

3. UK/European enablement and support requirements

The disclosure requirement for complete applications has been amended to conform substantially to the corresponding UK provision, such that the complete specification must “disclose the invention in a manner which is clear enough and complete enough for an invention to be performed by a person skilled in the relevant art”.

Further, the ‘old test’ for fair basis has been replaced with a requirement based on UK/European law that that the claims are “supported by” the description. The ‘old test’ for fair basis was essentially limited to a textual comparison between the claims and the body of the specification or priority document that did not involve any inquiry into ‘technical contribution to the art’.

4. Tighter restrictions on amendments

While not a ground for invalidity, patent applicants are not allowed to add matter that goes beyond the disclosure contained in the specification at its filing date, except to correct a clerical error or obvious mistake.

Strict time-frames for evidence

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.

The procedure from filing the Notice of Opposition to the issuance of a written decision on validity can now be completed within about 18 months, although extensions of time (where allowed), amendments and procedural disputes can extend this time-frame.

Use all available options

It is currently still possible to file new applications for innovation patents in Australia, until 25 August 2021. Even after that date, it will still be possible to file applications for innovations which are divisionals of existing applications filed before that date.  As a result, if your invention is of significant commercial value and is likely to be commercialised in the short to medium term, an 8-year term innovation patent may still be a useful option.

How we can help

Facing a pre-grant opposition in Australian is often a new experience for many patent owners, and opponents also.  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 such as amendment requests and extensions, and extending into commercial aspects such as settlement negotiations and licensing.

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 below. 

AusBiotech has released a draft strategic roadmap for a new regenerative medicine Catalyst, and is now seeking sector feedback from those interested in the future of regenerative medicine in Australia.

On 29 July 2021, AusBiotech released for comment a draft roadmap for Australian regenerative medicine (RM), with the aim of developing strategic goals, objectives and priority actions for a national RM sector ‘catalyst” collaboration body, the Catalyst Body.

We welcome the impetus of the seven consortium members of the Regenerative Medicine Catalyst Project in seeking to advance the development and earlier access to ground-breaking regenerative medicine therapies for Australian patients.

The draft roadmap states:

“Our vision is that Australian patients have access to world-class regenerative medicine therapies sustained by a thriving Australian RM industry. 

Our mission is to create an end-to-end world-class value chain that can discover, develop, and distribute regenerative medicine, while creating jobs, commercialising research, and exporting Australian therapies to the world.

An excellent summary of the strategic plan is provided in Figure 1 on page 8 of the draft roadmap, outlining priority actions to build stakeholder engagement and encourage investment within the sector, establish forward-looking regulatory pathways, and develop the requisite manufacturing capability needed to accelerate growth in regenerative medicine therapies.

The underlying theme of the draft roadmap is that the vision and mission will only be achieved through collaboration, with a call for greater coordination and cooperation concluding the draft roadmap.

The Australian RM sector is invited to comment on the draft roadmap by Friday, 13 August 2021 by providing feedback to Camille Shanahan, National Projects Manager – Regenerative Medicine.

We look forward the RM sector’s input on this important initiative.

Malcolm Lyons looks at the recent Federal Court decision in Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643 which has provided long needed clarity on requests for patent term extension.

In a readily digested, well written decision dated 11 June 2021, Beach J of the Federal Court of Australia has provided long needed clarity on requests for patent term extension (PTE). In particular, Beach J has provided a logically consistent interpretation of the statutory term “earliest first regulatory approval date”, which had caused difficulty for many patentees.

As made clear in the decision, PTE aims to provide an effective patent life for a patent covering a new and inventive pharmaceutical substance by compensating for the delay between grant of the patent and regulatory approval when the patent may be exploited. In Australia, regulatory approval is listing of the pharmaceutical substance on the Australian Register of Therapeutic Goods (ARTG).

The decision was a Judicial Review of an earlier decision of a Delegate of the Commissioner of Patents refusing PTE of a patent based on nivolumab marketed as OPDIVO. Based on an earlier decision of the Federal Court of Australia, Pfizer Corporation v Commissioner of Patents (No 2) (2006) 69 IPR 525 (Pfizer), the Delegate had interpreted “earliest first regulatory approval date” as applying to a pharmaceutical substance listed on the ARTG by any party, irrespective of whether the pharmaceutical substance was that of the patentee or a competitor. In this instance, the Delegate found that the earliest first regulatory approval date was that of pembrolizumab marketed as KEYTRUDA by another party.

In contrast, Beach J held that the PTE legislative provisions required beneficial and remedial construction. In doing so, Beach J was able to distinguish Pfizer. Reasons that were persuasive included:

  • determining whether a competitor product falls within the claims of a patent (to determine its first regulatory approval date is the “earliest”) may require information which can only be provided by the competitor if the Court were to order discovery of relevant documents, which is a non-trivial task to say the least
  • products may be removed from the ARTG in certain circumstances, including upon request by the sponsor, and therefore the ARTG is not necessarily a complete database of all the possible “first regulatory approval dates” in existence.

Beach J concluded that the construction advanced by the Delegate and maintained upon judicial review resulted in manifest absurdity or unreasonableness. Consequently, the appeal was allowed, and the PTE was granted based on nivolumab / OPDIVO.

It will be interesting to see if the Commissioner of Patents appeals this decision to the Full Court of the Federal Court of Australia. If so, leave to appeal must be sought by 25 June 2021. However, given Beach J’s grounds for distinguishing Pfizer, this seems unlikely. In which case it will be interesting to see also if patentees seek reconsideration of PTEs refused by the Commissioner of Patents on the basis of Pfizer.

Although this decision has simplified PTE requests for patentees and provided a degree of certainty by allowing a patentee to ignore third party pharmaceutical substances listed on the ARTG, there remain issues regarding a patent covering two or more pharmaceutical substances listed on the ARTG by the patentee. At [174] to [178], Beach J explained that a patentee will not be permitted to wait and elect to apply for PTE based on a good that may be second, third, or last on the ARTG, nor to pick and choose which of its products to nominate as the pharmaceutical substance for the purposes of requesting PTE. In these circumstances, the latest ARTG listing would provide the greatest PTE. Consequently, it remains best practice to pursue multiple pharmaceutical substances likely to be listed on the ARTG in separate divisional applications.

For more information, please contact Malcolm Lyons

Griffith Hack is proud to formally announce the elevation of two high-achievers to the position of Principal, effective as of 1 January 2021.

Patent Attorneys Dr Malcolm Lyons and Georgina Higinbotham have been key contributors to Griffith Hack since joining as trainee patent attorneys.

Managing Director Aaron LePoidevin said that the elevations recognise Malcolm and Georgina’s contribution to delivering great outcomes for Griffith Hack’s clients and developing many of the firm’s young attorneys. 

“It’s fantastic recognition of their client centric approach and the value delivered to clients in Australia and globally. It’s great to see the firm cultivate the IP industry’s future talent. I look forward to supporting Malcolm and Georgina’s continued success with the firm” 

Georgina Higinbotham – Patent Attorney (Sydney) 

A former US patent agent, Georgina has expertise in medical devices including implantable devices and materials and mechanical devices, processing and packaging systems, reactor technology, mechanical devices, energy storage, building products and building and mining equipment. With more than 15 years’ experience working on mechanical devices and a background in physical and analytical chemistry, Georgina has developed a strong capability in medical systems and devices, chemical engineering systems, and systems that require both pharmaceutical or chemical aspects alongside mechanical devices or assemblies.

 “I first qualified and worked as a patent agent in the United States, then moved home to Australia to continue my career. I’ve never regretted the decision to work in IP. It’s a rare job that teaches so much every day. Patent attorneys stand at the crossroads of law, science and business, and no two clients are the same.

For me, the highlight of my job is developing an understanding of not just innovative technologies but also the businesses and people that create them. From the beginning, I was impressed by the thoughtful leaders of Griffith Hack and I am proud that I can step up to lead our team with them.” – Georgina Higinbotham

Dr Malcolm Lyons – Patent Attorney (Melbourne) 

Malcolm trained in chemistry and biochemistry, and now specialises in biotechnology and genomics. He has post-doctoral and industry experience in medical research into various aspects of human health and disease during which he was awarded several prestigious fellowships and published his research regularly. His work extends across the IP lifecycle from analysis of invention disclosures and drafting through prosecution to post-grant enforcement strategy. Malcolm has expertise in patent term extensions for pharmaceutical patents, and discretionary extensions of time.

“After 13.5 years, I’ve now been in the patent profession for about twice as long as I was in research at the lab bench – I guess time flies when you’re having fun! It seems like there’s always something new to learn or a new way to look at something with patents and IP. Whenever I can, I look to our up and coming attorneys to prompt me to keep that fresh approach. I hope that never changes.

With that in mind, it makes sense that relationships are key to this profession. So as a principal, I look forward to a more significant mentoring role for our attorneys within Griffith Hack, and outside Griffith Hack, I aim to spread Griffith Hack’s reach to new clients and strengthen relationships with existing clients.” – Dr Malcolm Lyons

Approximately 90% of new pharmaceutical substances in phase I clinical trials do not gain marketing approval. 

The market entry cost for those that do is estimated to be between US $1-3 billion. A patentee gains no or little return on this investment until marketing approval is achieved, and delays reduce the effective patent term.

It is easy to see why patent term extension (PTE) is so important to companies developing and commercialising new pharmaceutical substances. The recent decision of a Delegate of the Commissioner of Patents, Ono Pharmaceutical Co., Ltd. et al [2020] APO 43 (Ono, available here), concerns PTE.

PTEs: what and why? 

In Australia, PTEs aim to compensate a patentee for the delay between filing a patent application covering a pharmaceutical substance and receiving regulatory approval for marketing that pharmaceutical substance, i.e. when the pharmaceutical substance is included on the Australian Register of Therapeutic Goods (ARTG). PTE aims to provide an effective patent term that is approximately in line with that available in other fields of technology. In Australia, an effective patent term is estimated to be 15 years. PTE achieves this by extending the patent term by up to 5 years, thereby improving the return on investment. Importantly, as the delegate notes in Ono, PTEs are intended to encourage the development of new pharmaceutical substances. 

Ono is not new law. Instead, Ono confirms precedent set by G. D. Searle [2008] APO 31 (Searle), an earlier decision by a Delegate of the Commissioner of Patents, and is consistent with Pfizer Corp v Commissioner of Patents (No 2) [2006] FCA 1176 (Pfizer). Ono and Searle considered a single patent covering two pharmaceutical substances, each falling within the scope of the claims but each having a different ARTG inclusion date, and which was the correct date for calculating PTE. Because the two pharmaceutical substances are covered by the same patent, the patent application filing date is the same. However, the ARTG inclusion dates were different. Therefore, the PTE calculated based on the later ARTG inclusion date would provide a longer patent term, which would be to Ono’s benefit.

Broader is not always better 

In refusing the PTE request, at [45], the delegate concluded that:

As such, the application for an extension of term does not comply with requirements as the extension request, relying as it does on [the later regulatory approval], has not been made on the basis of the good on the ARTG with the first regulatory approval date…that falls within the scope of claim 3 of the patent…

In other words, the PTE must be requested and calculated based on the earliest pharmaceutical substance included on the ARTG and falling within the scope of the claims. Ono’s PTE application based on the pharmaceutical substance with the later ARTG inclusion date was refused because it did not satisfy this requirement.

Although not the focus of this article, it is important to note, as the delegate did at [31]-[33], that the PTE scheme makes no distinction as to the owner or sponsor of a pharmaceutical substance with the earliest inclusion on the ARTG. The earliest inclusion on the ARTG falling within the scope of the claims of the patent may be that of the patentee or of a third party.

Many patentees (and their patent attorneys) may have found Ono’s argument attractive. However, Ono’s arguments focussed on PTE policy in relation to the patentee, whereas the delegate viewed the balance of PTE policy between public and patentee benefits. Accordingly, the delegate focussed on PTE policy applying to new pharmaceutical substances being made to the public, irrespective of their source, while the narrower version proposed by Ono focussed on new pharmaceutical substances made by the patentee.

It is worth noting that the patent in question is a divisional patent. Its parent patent had PTE granted, because its claims only covered one pharmaceutical substance. Accordingly, the patentee has obtained some compensation for the delay in bringing its pharmaceutical substance to market.

Ono has appealed the delegate’s decision to the Federal Court of Australia to be heard by Beach J, and it will be interesting to see how the court interprets this aspect of PTE legislation. However, given the existing guidance of Pfizer, it seems unlikely that the appeal will succeed.

Key considerations 

Ono reinforces several principles patentees should take into account when seeking patent coverage for pharmaceutical substances, including:

  • PTE should be considered during examination, and certainly before the deadline for filing a divisional application
  • advise your patent attorney as soon as possible when a patent covers a commercial embodiment of a pharmaceutical substance
  • claim separate commercial embodiments of the patentee’s pharmaceutical substance in separate divisional applications
  • where claims capture a third party, potentially competitor, commercial embodiment of a pharmaceutical substance, be aware that any PTE will be calculated from the earliest marketing approval date irrespective of the owner/sponsor
    • if unintentional, it may be possible to narrow the scope of the claims
    • if intentional, accept that any PTE may be shorter than that based on a claim covering only the patentee’s commercial embodiment of a pharmaceutical substance
  • if possible, keep a divisional application pending