Welcome to Shelston IP’s wrap-up of the most notable patent law decisions in Australia and New Zealand delivered during 2020 – a remarkable year indeed. The High Court delivered its first decision in a patent case since 2015, and there was an interesting spread of Full Federal Court, Federal Court, Australian Patent Office and Intellectual Property Office of New Zealand decisions relating to issues of patent validity, infringement and amendment as well as procedural issues.

Read our full report

  • The High Court of Australia has endorsed the doctrine of exhaustion in favour of the longstanding doctrine of implied licence with respect to patented products in Australia, but made clear the critical question remains whether the modifications made to a product in each case are properly characterised as permissible repair or impermissible re-making (Calidad v Seiko Epson).
  • An enlarged Full Federal Court has confirmed that a protocol for a clinical trial that is publicly available can be novelty-defeating, provided the information disclosed is sufficiently specific and complete to disclose the invention that is later claimed. The Full Court has also provided important guidance on the nature and scope of Swiss-style claims, and the circumstances under which such claims may be infringed (Mylan v Sun).
  • The Full Court of the Federal Court has found that a computer-implemented method that linked website users to online advertising was not a manner of manufacture and therefore not patentable subject matter (Commissioner of Patents v Rokt). In separate decisions, a computer-implemented method relating to “sandboxing” (Facebook) and an invention relating to the hardware and software components of an electronic gaming machine (Aristocrat v Commissioner of Patents) were held to be patent-eligible subject matter, while a modified roulette table was found not to be patent-eligible (Crown).
  • The Full Court of the Federal Court has confirmed that section 105(1A) of the Patents Act 1990 (Cth), introduced by the Raising the Bar reforms, confers on the Federal Court the power to direct amendments to patent applications during the course of an appeal hearing (Meat and Livestock Australia v Branhaven).
  • In the long-running patent dispute relating to Lundbeck’s antidepressant, Lexapro (escitalopram), the Full Court of the Federal Court overturned a decision that had found Sandoz liable for patent infringement during the extended term of a patent after it was restored, and awarded damages. Lundbeck has recently been granted special leave to appeal to the High Court of Australia, which for the third time will hear an appeal regarding an aspect of this long-running litigation (Sandoz v Lundbeck).
  • The Federal Court provided its first detailed analysis of the Raising the Bar reforms to Australian patent law concerning sufficiency and support. A subsequent judgment on final relief, delivered in November 2020, highlights the challenges facing a defendant who seeks to resist final injunctive relief on public interest grounds (Merck Sharp & Dohme v Wyeth). Those sufficiency and support requirements, as well as best method, were also considered in detail by the Australian Patent Office (University of British Columbia, Gliknik v CSL).
  • In an unprecedented decision, the Federal Court of Australia has considered and dismissed a claim by the Commonwealth Government for compensation from sponsors of innovator pharmaceutical products, pursuant to undertakings as to damages given in exchange for an interlocutory (preliminary) injunction restraining the launch of the first generic product (Commonwealth v Sanofi).
  • A party which gave undertakings not to launch an allegedly infringing biosimilar without first giving notice successfully resisted an application for preliminary discovery (Pfizer v Sandoz). Conversely preliminary discovery was granted against a former employee, but limited in scope due to the prevailing financial circumstances (Sovereign v Steynberg).
  • Extension of term applications were refused for pharmaceutical patents (Pharma Mar, Ono).
  • An opposition to an Australian patent application based solely on a challenge to entitlement was successful (Liquid Time v Smartpak).
  • The Federal Court considered the applicability of the Crown use defence to infringement, and the effect of prior disclosures by the Crown on validity (Axent v Compusign).
  • The nature and detail of disclosures in prior art and the common general knowledge proved determinative of the validity in decisions concerning a combination pharmaceutical product (Boehringer v Intervet) and a parking management system (Vehicle Monitoring Systems v SARB).
  • The construction of claims in the context of the entire specification proved determinative of issues of infringement and validity in several decisions (Caffitaly v One Collective, Nufarm v Dow, CQMS v ESCO).
  • The Intellectual Property Office of New Zealand has delivered decisions demonstrating the difficulty of opposing an application under the “old” 1953 Act (Lonza v Koppers), the high burden for computer-implemented methods (Thomson Reuters) and the more onerous support requirements under the “new” 2013 Act (Taiho Pharmaceutical).

As we continue into 2021 (and away from 2020), we hope this review provides a practical and comprehensive resource. Please do not hesitate to take the opportunity to contact our authors, all subject-matter experts in their respective fields, for advice on the issues raised by these important decisions.

Authored by Duncan Longstaff and Dr Roshan Evans

5 min read

The America’s Cup (the “Auld Mug”) is the world’s oldest sailing trophy and enjoys a storied history of fierce competition – both on and off the water.  Whereas legal drama throughout the years was previously restricted to claims of sabotage, subterfuge, cheating or some far-fetched interpretations of the “rules”, the upcoming 2021 event has thrown up yet another reason to get off the water and into the courtroom – allegations of patent infringement.

Background

The 36th edition of the America’s Cup is scheduled to be held in Auckland, New Zealand, between 6 and 21 March 2021.  It pits the holders, Emirates Team New Zealand (ETNZ), up against the winner of a challenger series to be contested between Luna Rossa (Italy), Ineos Team UK and American Magic.  The concept of the challengers sailing off before matching up against the holder is nothing new.  However, what is unique to this event is the category of yacht in which the event will be contested – the new “AC75” (America’s Cup 75 class) is a 75-foot (23 metre) hydrofoil monohull vessel.  To the layperson, it’s a regular yacht that “flies” just above the waterline.

Again, the concept of a flying (or more correctly, “foiling”) yacht is nothing new.  For example, the 34th (2013) and 35th (2017) editions (held in San Francisco and Bermuda, respectively) used a class of foiling catamarans (double-hulled yachts), which, when conditions and crew-work were optimised, was able to get up on its foils (i.e., lift the hulls out of the water), thereby minimising drag and increasing speed.  The ultimate goal, of course, was to complete the entire course on foils, which was referred to as a “dry lap”.  Foiling catamarans certainly provided for spectacular racing over the two events.

Following the narrowest of misses in 2013, the 2017 event was won by ETNZ.  In accordance with the “rules” of the event, ETNZ not only got to host the next edition, but also had the authority to decide upon the class of boat in which the event would be contested.  Following lengthy consideration (much of which was centred upon conditions likely on the Hauraki Gulf where the 2021 event would be contested), ETNZ opted for a new class of boat – the AC75 foiling monohulls.

What’s a “foil”?

As shown on the official America’s Cup website, the hull of the AC75 lacks the traditional centred keel, but instead has a retractable “foil” on either side. When one of the foils is engaged with the water, and provided sufficient speed is reached, it acts in combination with the rear rudder foil to force/lift the hull out of the water, which in turn imparts the speed advantages mentioned above.  In operation, the leeward (on the side opposite to which the wind is coming from) foil is engaged with the water whilst the windward foil is retracted or held out of the water.

Shown below is an example of ETNZ’s test boat “Te Aihe” (a 50-foot scaled-down version of the AC75) foiling successfully during testing.

Despite the conceptual imagery linked above, all four syndicates are employing similar, although subtly different, foil designs.

So, what’s the patent problem?

Manoel Chaves, a Brazilian naval architect and boatbuilder, is the patentee in respect of New Zealand patent 740860, dated 31 October 2016.  NZ’860 is a granted patent derived from PCT/BR2016/050275 via WO 2017/083947.  It is entitled “Sail boat propulsion and stabilisation system and device”, which is more specifically characterised by IPONZ as a “Sail boat hydrofoil with pair of wings on opposite hull sides with downward keel and outstanding lift wing, with pivoting of keels and wings independently”.

According to media reports, Mr Chaves believes the canting foil system used in the AC75 boats is covered by NZ’860.  Mr Chaves’ representatives are understood to have contacted ETNZ in this regard.  However, the same article quotes ETNZ as having already denied patent infringement as of July 2020.

What does NZ 740860 describe and claim?

Figure 1 of NZ 740860 appears to illustrate, broadly, a hydrofoiling system arguably similar to those found on the AC75 yachts:

As we know, “similar” is a subjective term. That said, claim 1 of NZ 740860 is reasonably wordy, and construing it would no doubt account for several days’ court time should the matter ever proceed to trial:

  1. A system for propelling and stabilizing a sail boat, comprising a control panel, standard or electronic stabilization, actuated by a battery connected to a hydraulic aggregate that is connected to directional valves and solenoids through which each device of a pair of devices for propelling and stabilizing the sail boat is independently actuated respectively to larboard and starboard, and each device is provided with a wing keel, a counterweight or “lift” wing joined by a bulb, a cylindrical actuator of the counterweight or “lift” wing, a rotary hydraulic actuator for hoisting the assembly, an articulation shaft, which runs in the direction of the counterweight or “lift” wing and transverse to the keel, and a tilting shaft for the assembly, which is coupled to the boat broadside or to a mounting base provided for the boat broadside of already existing boats, beside sensors of the angle of attack of the counterweight or “lift” wing.

The dependent claims (claim 2, in particular) are even longer.  According to the above-linked media, ETNZ’s July 2020 response to Mr Chaves was that NZ’860 defines features not found on the AC75 yachts.  Quite what those features may be based upon my “elementary” understanding of the foiling system used on the AC75s and chemist’s understanding of claim 1, is uncertain.

Legal permutations

As noted above, all three challengers (Luna Rossa, Ineos Team UK and American Magic) are employing hydrofoils broadly similar, albeit subtly different to ETNZ.  If ETNZ is held to infringe, then does it necessarily follow that the three challengers are infringing also?  Alternatively, as the entity that created the new AC75 class, does ETNZ bear any responsibility for the challengers infringing?  Of course, until such time as the matter is formally contested in a New Zealand court, these questions are all strictly hypothetical.

A continuing history of more fun off the water than on it

In my time following the America’s Cup, which dates back to 1983, when Australia II defeated Dennis Conner’s Liberty, the event has been beset with a series of courtroom battles that, depending on one’s perspective, either amplify or detract from the drama on the racecourse.  From Australia’s winged keel (1983), to New Zealand’s “plastic fantastic” fibreglass boats (1987), to New Zealand’s “big boat” challenge (1988), to all the legal jostling regarding the citizenship rule, the use of technology, where the event should be staged when the Cup was held by landlocked Switzerland, etc., this has always been more than just a yacht race.

Watch this space.  The America’s Cup equals high stakes and big money. Whilst not your traditional battlefield for a patent dispute, it does have almost every other ingredient.

Authored by Gareth Dixon, PhD

2 min read

To celebrate International Women in Engineering day (23 June 2020), Shelston IP would like to highlight our outstanding female patent attorneys and patent engineers qualified in this field.

With 30 years of experience in the patent profession, Caroline Bommer is the female engineer that we aspire to be. She provides a wonderful example of the possibilities for our young female attorneys and is appreciated by all of her clients, particularly in her effective communication and her ability to understand their business strategies. Caroline’s mechanical engineering expertise is also extensive, including practical knowledge acquired prior to joining the patent profession in the industries of building, transport, aerospace, and defence. She has a keen interest in green technologies, with many years of personal involvement in solar car racing. Ask her to take you for a spin!

Tam Huynh works in the fields of electrical engineering and information technology patents. Growing up, Tam would find any excuse to integrate electronics into her arts and crafts projects. This included raiding her Dad’s electronics kit to make LED greeting cards for her family. She went on to study Computer Engineering at University and undertook a project exploring the use of solar power technologies and their application with mobile devices. Tam now assists with the ongoing management of patent portfolios in a range of fields, including electrical power systems, information and software systems, mining and automation, and medical devices. Tam also holds a Bachelor of Commerce degree and her accounting background adds additional depth to her handling of financial-system related inventions.

With childhood memories of jumping off a red billy cart and yelling “Newton’s third law”, Allira Hudson-Gofers brings her enjoyment of physics and engineering into her role as the head of Shelston IP’s Engineering and ICT Patents Group. Allira studied both mechatronics and biomedical engineering at University, going on to develop particular expertise in research, product development, regulatory affairs, and intellectual property in the medical technology space. She now applies this expertise, together with her recent MBA studies, to help her clients protect and commercialise their innovations.  

Connie Land had her interest in the human body and medical devices sparked in high school, which lead her to pursue a degree in Biomedical Engineering. Connie started her career with hands-on experience maintaining, repairing, and programming medical devices.  Last year, after discovering that the role of a patent attorney was a career option for engineering graduates, she hung up her tools and joined Shelston IP as a Patent Engineer. Connie now works with medical devices in a different capacity and uses her passion and knowledge of medical devices and technology to help her clients navigate the path to obtaining patent and design protection. She is currently studying a Masters in Intellectual Property and is looking forward to becoming a registered patent attorney in Australia and New Zealand. 

Authored by Allira Hudson-Gofers, Caroline Bommer, Tam Huynh and Connie Land

1 min read

Welcome to Shelston’s wrap-up of the most notable patent decisions in Australia and New Zealand delivered during 2019. It was a busy year for patent jurisprudence with some interesting themes emerging – in particular, it has been a banner year for decisions on the “manner of manufacture” requirement for patentable subject matter.

Read our full report

  • An expanded Full Federal Court clarified the “manner of manufacture” test for computer-implemented methods to be patentable (Encompass), a topic that was also central to several other Federal Court (TettmanRepipeWatson) and Patent Office (Apple) decisions.
  • There were also important “manner of manufacture” decisions in the life sciences space, with single judges finding both a diagnostic method involving a process of detecting genetic material (Sequenom) and use of genetic information to infer traits (Meat & Livestock Australia) to be patentable subject matter.
  • The Full Court confirmed there is no doctrine of patent exhaustion in Australia, the critical distinction being between repairs permitted by implied or express licence terms brought home to the purchaser of a product, and the impermissible re-making of the product beyond the scope of any licence (Calidad (No. 1)).
  • The Full Court confirmed that a permanent injunction framed in general form by reference to the claims of an infringed patent is generally appropriate and may be ordered in addition to a specific injunction describing products or conduct found to infringe (Calidad No. 2).
  • The Full Court overturned an award of additional damages for flagrant patent infringement on the basis that the infringer had believed, on objectively reasonable grounds, that its conduct did not infringe the patent (Oxworks).
  • The tide continued to turn against pharmaceutical patentees being granted interlocutory injunctions (MylanSanofi-Aventis).
  • Patentees learned some harsh lessons as the Full Court dismissed infringement claims based on the construction of the terms “contains” (construed exhaustively in Nichia) and “recognise” (construed broadly in Davies).
  • There were several applications by patentees to amend patent claims and specifications after commencing infringement proceedings (Meat & Livestock AustraliaNeurimBlueScope), with mixed success.
  • Consideration was given in the Patent Office to Australia’s “raised bar” requirements for support and sufficiency (Gary CoxUniversal Polymers).
  • Both clinical trial patient consent forms (InterPharma) and academic conference posters (Regeneron) were considered prior art documents in life sciences cases.
  • There were further decisions regarding families of patents that have been litigated for a decade or more (GlobaltechSNF).
  • There were also decisions regarding the admissibility of “WayBackMachine” evidence (Dyno Nobel), summary dismissal of an infringement case (Pilkin), a successful application for preliminary discovery (MMD), a failed cross-claim for unjustified threats (Liberation), a failed attempt to withdraw admissions relating to infringement (Juno), a “strawman” opponent to a patent application having to pay security for costs in an appeal despite winning the opposition (Toolgen) and a party commencing infringement proceedings despite not being a proper exclusive licensee having to pay indemnity costs (Vald).
  • Two recent decisions issued by the Intellectual Property Office of New Zealand provide new hope that, in certain circumstances, it may be possible to obtain an extension of time to file a divisional patent application (PrimapakMagic Leap).

As 2020 gets underway, we hope this provides a useful and practical resource and, of course, please do not hesitate to take the opportunity to contact our authors, all subject-matter experts in their respective fields, for advice on the issues raised by these important decisions.

Authored by Dr Roshan Evans, Duncan Longstaff and Onur Saygin

It seems the abolition of Australia’s second-tier patent system, the innovation patent, (as detrimental as this will be for Australian business) could be considered a high-profile distraction to divert attention away from new laws that will potentially render patents claiming chemical compounds, with reference to a structural formula, vulnerable to invalidation.

This issue relates to new laws that apply to Section 40(3A) of the Patents Act 1990, which was originally introduced in 2013 to remove the use of claims that refer to examples in a specification, i.e. omnibus claims. At that time, Section 40(3A) recited that “the claim or claims must not rely on references to descriptions or drawings unless absolutely necessary to define the invention”. More recently, the Intellectual Property Bill (Productivity Commission Response part 1 and other Measures) Bill 2018, expanded the scope of Section 40(3A) to cover claims referring to “drawings, graphics or photographs”.

Relevantly, Section 40(3A) does not refers to “parts” of the specification – it simply refers generally to “descriptions, drawings, graphics and photographs”. Thus, current Section 40(3A) appears to go beyond its initial purpose of removing the use of omnibus claims and potentially renders claims that include drawings, graphics and photographs unacceptable. This arguably includes frequently used chemical claims that refer to a structural formula as a graphic representation of the molecular structure of a chemical compound, or an X-ray diffraction pattern, i.e. drawings or graphics.

Currently, Section 40(3A) can only be considered during examination and, in our experience, the Patent Office is only enforcing it against claims that refer to parts of the specification. However, when the Intellectual Property Bill (Productivity Commission Response part 2 and other Measures) Bill 2019 comes into force, most likely at the end of November 2019, Section 40(3A) will become a ground for re-examination, opposition and revocation.

At the very least the new laws, as they relate to Section 40(3A), introduce considerable uncertainty as it is not clear how they will be interpreted judicially. The explanatory memorandum to the Bill is not helpful because it only considers Section 40(3A) as covering omnibus claims. Moreover, as there is a reasonable argument that reference to a structural formula in a claim is not absolutely necessary to define the invention because compounds can be defined by chemical names, future patentees of chemical compounds have a right to feel nervous. For this reason, it may be prudent for applicants of chemical compound applications to cover their most commercially relevant embodiments in independent claims that define a chemical compound by its IUPAC name, in addition to relying on claims that define a structural formula. Notwithstanding, that a claim that refers to a chemical structure is more succinct than one that refers to a long and potentially unclear chemical name.

Shelston IP will, of course, continue to monitor the introduction of the new laws and provide necessary updates.

Authored by Gareth Dixon, PhD

In July 1969 the United States of America put two men on the moon. Years later in 2011, the then Prime Minister of Australia, Julia Gillard, stood before US Congress and recalled the same moon-landing memory and with acquiescence wept that “Americans could do anything!” Today, the US seems to have entered, what was once described in an episode of Seinfeld as, “Bizzaro world” – Donald Trump is in the White house and, even more astonishingly, researchers are unable to protect what have been described judicially as “truly meritorious” and “ground breaking” innovations in the diagnostics and personal medicine space. Today it is Australia that reigns supreme over the US, as the Federal Court in Sequenom, Inc. v Ariosa Diagnostics, Inc. [2019] FCA 1011 (27 June 2019) confirmed that a non-invasive method of detecting fetal characteristics and abnormalities is patent eligible subject matter in Australia!

The set up

The inventors of the patent-in-suit, Australian Patent No 727919, in the name of Sequenom, Inc., discovered that the cell-free fractions of a pregnant woman’s blood contain surprisingly large amounts of cell-free fetal DNA (cffDNA). Traditionally, this portion of the plasma or serum was discarded as medical waste. This pioneering discovery led to the development of the claimed non-invasive method to determine fetal characteristics and abnormalities, such as Down syndrome. Ariosa Diagnostics Inc, who sought to revoke Sequenom’s Patent, conducts and licenses others to conduct a non-invasive prenatal diagnosis test, marketed under the name “Harmony”, which Sequenom claims infringes their patent.

The significance of the Australian Sequenom decision has been fuelled by the corresponding US case where the claims of the Sequenom’s patent were found to be patent ineligible because they were held to be directed to naturally-occurring matter. The ensuing detrimental impact on US diagnostics industry has subsequently resulted in a proposal for changes to the patentable subject matter legislation, which is currently being considered by US congress.

Issues and findings

Under Australian law, patent eligibility is guided by the principles of the High Court’s decision in National Research Development Corporation v Commissioner of Patents(‘NRDC’) [1959] HCA 67. In that landmark decision, it was held that subject matter was considered patent eligible if it was “an artificially created state of affairs” having “economic significance”.

Ariosa’s case relied heavily on the approach that proved successful in the US, namely that the claims cover a mere discovery, that being the presence of cffDNA, which can be detected in the plasma or serum of pregnant women, and that the end result of each claim is not an artificially created state of affairs. Ariosa further submitted that the claims involve nothing more than the use of well-known techniques to detect cffDNA in maternal blood.

Ariosa also suggested that the Court should follow the US position, which they suggested was in harmony with the Australian Myriad decision. Judge Beach’s response was an emphatic, “I hardly think so”. In fact, in considering the Australian High Court Myriad decision, Beach J emphasised the difference between the gene product claims considered in Myriad and the method defined in the claims of Sequenom’s patent. In particular, he stated that “in nature, the presence of cffDNA in the maternal blood has not and cannot be detected without human action. Accordingly, unlike the claims considered in Myriad, the invention claimed adds to human knowledge and involves the suggestion of an act to be done which results in a new result, or a new process”.

The Court also agreed with Sequenom that the substance of the claimed method is distinct to simply the identification of a natural phenomenon, namely the presence of cffDNA in maternal blood. This, the Judge said, is made clear by the patent specification, which explains that the invention offers a new approach for non-invasive prenatal diagnosis, which only occurs through human intervention and provides a significant advantage over existing fetal DNA detection methods, thus producing a result possessing economic utility.

Consistency with foreign law

Given the intense spotlight that has illuminated patentability issues in the US for diagnostic methods in recent times, the consistency of the Australian decision and the corresponding UK proceedings between Ariosa and Sequenom (Illumina, Inc v Premaitha Health Plc[2017] EWHC 2930), will likely go unnoticed. Those, however, looking for controversy in the conflicting Australian/US findings should look no further than Judge Beach’s swatting away of the issue by stating that the conclusion reached in the US decision is problematic because of the US Court’s dissection of the claims into their constituent parts, which is contrary to Australia’s NRDC and Myriad decisions, – end of story.

Conclusions

This decision, and the recent decision in Meat & Livestock Australia Limited v Cargill, Inc [2018] FCA 51, make it clear that claims directed to practical applications of naturally-occurring phenomena, including gene sequences, used in methods of diagnosis and prognosis are patent eligible subject matter in Australia. This will come as a welcome relief to the diagnostics and personal medicine industry and can be considered as “one small step” forward for Australian patent law but also, hopefully, “one giant leap” that influences beneficial change to the patent eligibility laws in the US.

Shelston IP congratulates its valued client Finisar Australia on being the recipient of the Prime Minister’s Prize for Innovation. The team at Finisar, which included Dr Simon Poole, Mr Andrew Bartos, Dr Glenn Baxter and Dr Steven Frisken, were awarded the prize at a ceremony on 17 October 2018 for their development of wavelength selective optical switches in the early 2000s. The switches use a dispersive prism to separate different colours of light and a liquid crystal on silicon chip to switch the different colours between optical fibres. The optical switches are now in use across the globe and have helped to increase the capacity and reliability of communications networks.

Shelston IP is proud to have assisted Finisar with the protection of their IP around the wavelength selective switch technology and many other inventions.

Authored by Peter Treloar

The purposes of the claims of a patent are to define the metes and bounds of an invention, and to place the public on notice of what constitutes an infringement. Generally speaking, the requirements for patent claims are that they must:

  • define the matter for which protection is sought, preferably in terms of the “technical features of the invention”,
  • be clear and concise/succinct, and
  • supported by matter disclosed in the specification, and enabled across their full scope.

There are arguably only 2 basic types of patent claim:

  1. claims to a physical entity (e.g., compound, product, apparatus) and,
  2. claims to an activity (e.g., process, use).

For many inventions, claims in more than one category are needed for full protection. In the field of chemical sciences (meaning chemical compositions such as those arising in the fields of chemistry, materials science, petrochemicals, pharmaceuticals, and biotechnology), to properly protect the invention a patent may protect any one or more of the following subject matter:

  • a compound, which may be defined as a class of compounds, as a specific compound, or group of specific compounds,
  • a composition containing the compound,
  • an article made from, or containing the compound,
  • a process for preparing the compound (and the compound when prepared by the process),
  • a composition when used in a particular manner or under some defined circumstances (generally understood as a pseudo method claim),
  • a compound for treating a medical condition,
  • a method of using a compound for a specific purpose (e.g., for curing a polymer composition), or for treating a medical condition (a method of treatment claim), and
  • the use of a compound in the manufacture of a medicament for treating a medical condition (known as “Swiss style” claims).

Another common claim type is a claim to a kit, which either comprises a novel component (compound or composition), or is constructed to ensure that the kit components are applied simultaneously/sequentially to produce a new product or synergistic affect, or the kit limited to use in a novel and inventive method.

In the field of biotechnology, patentable subject matter includes isolated naturally-occurring micro-organisms, peptides, or proteins, and (under some limited circumstances) gene sequences. Patent claims can therefore be directed to one or more of these categories, too. For protein-type inventions claims can be directed to a nucleic acid encoding the protein, a vector containing the nucleic acid, and a host cell comprising the nucleic acid or vector.

Depending on the circumstances, there are a myriad of other claim types that can be pursued. For example, claims to a precursor or an intermediate (e.g., such as a pre-polymer) may be appropriate. In another example, claims could be directed to a solution that has some specific use. For example, a copper electroplating solution that comprises a solution of copper sulfate, sulphuric acid, and wherein the pH has been adjusted to a specific range.

In another example, the invention may lie in methods of identifying compounds that achieve a certain technical effect (e.g., A binding assay for detecting one or more specific analyte(s) in a sample), or may lie in the particular spatial configuration of entities of a mixture (e.g., one entity may be an immediate release phase and the other entity may be a prolonged release phase).

Closing comments

In the field of chemical sciences (e.g., chemistry, materials science, petrochemicals, pharmaceuticals, biotechnology, etc) to protect an invention one or more different types of patent claims may be required.  The choice of claim types depends on the invention at hand, under what circumstances there may be infringement, who may license the patent, and should ultimately align with the applicant’s commercial objectives.

Outlined in this article is a summary of the main types of claims that are pursued when drafting a patent application in the chemical sciences field. It is impossible to foreshadow all the types of patent claims that may be pursued, and thus when an idea is an important commercial asset, it is wise to engage a qualified patent attorney to assist in the generation of relevant intellectual property rights that suitably protect that commercial asset. At Shelston IP, we have a number of highly experienced attorneys who can assist in navigating these complexities.

The content of this article is general in nature and must not be relied on in lieu of advice from a qualified professional in respect of your particular circumstances.

Authored by Michael Christie, PhD

The Australian Government has announced an independent review of the Defence Trade Controls Act 2012. Local inventors (and indeed, patent attorneys) may think “so what? Unless I’m looking to patent a weapon, how is this remotely relevant to me?” Well, if your invention falls into what’s termed the “dual use” category – inventions having potential downstream military application (remembering it is the Government that decides this – not you, and not us), then please read on…

Review of the Defence Trade Controls Act 2012

The Government has announced the appointment of Dr Vivienne Thom AM to conduct an independent review of the Defence Trade Controls Act 2012 (“the DTC Act”), which will be guided by the Terms of Reference.  The review is largely to determine if the DTC Act is meeting its purpose.  Submissions are due by 31 May 2018.

Insofar as the DTC Act relates to locally-originating patent applications, Shelston IP has been fully compliant since the 2015 amendments (prescribing criminal sanctions for breaches) took effect.  Our local clients have benefitted from such compliance on our part.  On this basis, there’s possibly not a great deal that our clients may wish to feed back to the Government by way of submission.  However, the review does place this little-known piece of legislation squarely in the public eye and provides an opportunity to issue a reminder as to the scope and significance of the DTC Act.

The 2015 amendments – criminal sanctions for non-compliance

The Defence Trade Controls Amendment Act 2015 entered into Australian federal law on 16 May 2015.  The (criminal) sanctions for non-compliance took effect from 2 April 2016.  In regulating the extent to which one can communicate new technologies overseas – and in providing criminal sanctions for non-compliance, the legislation stands to impact significantly upon the day-to-day activities of Australian patent attorneys – and their clients.

The DTC Act regulates the overseas supply and publication of Defence and Strategic Goods List (DSGL) technologies and the brokering of DSGL goods and technology.

Shelston IP actually worked closely with the Defence Export Controls Office (DECO) throughout the 2015 public consultation process, and as a consequence, our internal systems are fully compliant with the restrictions imposed.  In short, when dealing with Shelston IP, local clients can rest assured that we fully understand the situation and will have taken the necessary steps to minimise any risks to the parties involved.

Criminalising non-compliance

As patent attorneys, the communication and publication of “technology” is a staple of our everyday work.  Often, such communications are sent offshore.  Other times, we communicate new technology in the form of patent specifications to our local clients, who in turn, send these documents overseas.  Depending on the nature of the “technology”, the DTC Act stands to criminalise such activities.

Because the offence provisions for supplying and publishing DSGL technology and for brokering DSGL goods and technology took effect from 2 April 2016, individuals and organisations are required to seek permits for any otherwise-offending activities.

Why have export controls in the first place?

The DTC Act is a little-known document having significant, wide-reaching consequences.  Australia’s export control system aims to stop goods and technology that can be used in military applications from being transferred to individuals, states or groups of proliferation concern.  As a member of various international export control regimes, Australia is part of a global effort to regulate the export of items of concern, many of which have potential terrorism or weapons of mass destruction applications.

Australia already regulates the physical export of certain military and dual‐use items under Regulation 13E of the Customs (Prohibited Exports) Regulations 1958.  However, the DTC Act is Australia’s means of closing any gaps that have appeared in the interim (as required by the Wassenaar Arrangement, to which Australia is a signatory).

Accordingly, the DTC Act regulates three main activities:

  • The intangible supply (transmission by non‐physical means, such as e-mail) of controlled technology from a person in Australia to a person outside of Australia;
  • Publishing controlled military technology; and
  • Brokering (akin to enabling another to communicate overseas) controlled military goods or technology.

How do I know if my technology is covered under the DTC Act?

The DTC Act applies to different stakeholders, depending on whether their activities involve military or “dual‐use” items listed in the DSGL.  The DSGL, accessible here, is a 350-page legislative instrument defining as “dual use” a broad range of otherwise fairly benign-sounding technologies.  As such, potentially one could assume a technology was exempt on the basis that it had no immediately or apparent primary military end use.  It is important to note that secondary or incidental military applications may suffice, hence the term “dual use” technologies.

International export control regimes are generally conscious of their impact upon people’s day-to-day activities, and so the controls are designed to only capture what is considered necessary.  For example, the DSGL lists computers that are specifically designed to operate below ‐45 °C or above 85 °C.  The DTC Act controls only apply to the technology which is necessary for the computer to operate at these extreme temperatures.  Technology that does not influence the computer’s ability to function at these temperatures is not controlled.  Using the above example, an Australian inventor who has created such technology for the primary purpose of, say, exploring the surface of Mars, would need to be acutely aware of the restrictions imposed by the DTC Act – as would his/her patent attorneys.

Non-compliance is a criminal offence

As mentioned, the offence provisions specified in the DTC Act came into force from 2 April 2016.  Although the sanctions for non-compliance are criminal in nature, this should be tempered with the knowledge that being hit with the full extent of the sanctions (10 years’ imprisonment) would require prosecutors to prove the requisite levels of intent, knowledge, recklessness and negligence.  The operation of the Criminal Code Act 1995 means that a person who mistakenly supplies, publishes or brokers controlled technology contrary to the DTC Act after diligently following institutional compliance processes would be unlikely to be prosecuted, much less to the full extent of the law.  The Code applies general principles of criminal responsibility to Commonwealth offences; in particular, the knowledge requirement is akin to having received fair warning.

If the goods or technology at issue are listed in the DSGL, a permit or approval may be required from DECO.  The qualifier “may” is dependent upon:

  • The activity being undertaken (“supply”, “brokering”, or “publication”); and
  • Whether it is a military or a “dual‐use” DSGL technology; and
  • Whether an exemption applies (such as “basic scientific research” or material that has been lawfully placed into the public domain).

As readers will appreciate, a simple “yes/no” answer as to whether a permit is likely to be required is necessarily dependent upon the unique circumstances that each scenario presents.

Patent-specific exemptions

As mentioned, a staple of our day-to-day activities as patent attorneys is the exchange of information relating to “technology”.  We communicate technology internally, domestically and internationally on a daily basis – and our clients do the same.  It is useful, therefore, to understand the activities that will be exempted under the DSGL regulations.

Firstly, the “pre-publication” exemption amounts to recognition, on DECO’s part, that they cannot regulate the publication of information.  As such, the communication of information contained in a patent document that will later be published (e.g., a draft convention application or a draft PCT application) appears to fit comfortably within the definition of “pre-publication”.  On the other hand, provisional patent applications do not appear to fit within this category – and as such, another exemption must be invoked.

To this end, the “patent application exemption” covers activities “directly related to seeking a patent”:

This exemption applies to the supply of DSGL technology where it is done for the purpose of “seeking a patent” in Australia or overseas. “Seeking a patent” includes lodging a patent application and the supply of DSGL technology to a person or organisation (e.g., a Patent Office, patent attorney, research collaborator or a patent review panel) that is directly associated with the lodging (or potential lodging) of a patent application, or as a result of the patent examination process.

Supply for a purpose that is not directly related to seeking a patent will require a permit (unless other exemptions apply). This includes supply of DSGL technology to a research collaborator located overseas before a decision is made to seek a patent. Once a provisional patent application is filed, any supplies of DSGL technology to further develop an invention prior to preparing/submitting a complete patent application will require a permit. Supplies of DSGL technology to locate investors and determine overseas markets (including forwarding a recently-filed provisional application) will require a permit.

The process of publishing a patent (or an unsuccessful application) into the public domain is covered by this exemption. Until such time as that information exists in the public domain, it is still controlled and would require a permit to be supplied if it is not for the purpose of “seeking a patent” and no other exemptions applied.

As such, DECO would appear to have intentionally extricated the acts of overseas communication for the purposes of preparing a patent application (exempt) and communication with a view to ancillary business activities such as seeking investor funding (not exempt).

We will keep abreast of any changes to, or unusual interpretations of this new exemption.  As it is, it is clearly important to the manner in which we – and our clients go about our everyday professional activities.

Shelston IP’s proactive approach to the DTC Act restrictions

At Shelston IP, being aware of the potential impact of the DTC Act, we closely monitored progress throughout the public consultation process (dating back to 2014).  We have liaised with DECO on a regular basis and have developed an internal best practice guide.  Adherence to such best practice will protect not only our interests, but also those of our clients.  This, in turn, means that clients dealing in controlled or dual-use technologies can be assured that their interests are in safe hands.

Based on our experience and understanding, compliance with the DTC Act can be as easy as following a few simple rules.  In some instances, a deeper consideration of the specific circumstances and legislative requirements will be necessary.  Those concerned about their own internal procedures under the DTC Act are invited to make contact with their Shelston IP patent attorney.

Authored by Gareth Dixon, PhD

Shelston IP wishes to congratulate Professor Hala Zreiqat from Sydney University, who has recently been named NSW Premier’s Woman of the Year.  She is currently Professor of Biomedical Engineering, where she founded the Tissue Engineering and Biomaterials Research Unit in 2006.

Shelston IP has been providing IP-related services to Sydney University for many years, and has been involved in drafting and prosecution the majority of the patent applications naming Professor Zreiqat as an inventor. The innovative technologies developed by Professor Zreiqat and her teams relate to biocompatible ceramic materials and uses in applications such as bone regeneration, for improving the stability of implantable medical devices, and as synthetic implantable scaffolds. The particular biocompatible ceramic materials covered by her patent applications include materials such as Baghdadite, Strontium-doped Hardystonite, and 2-phase materials comprising metal oxide doped Hardystonites.

Shelston IP is proud to be associated with Sydney University and eminent scientists such as Professor Zreiqat.

Authored by Gareth Dixon, PhD and Serena White, DPhil