Duncan Longstaff has been named as one of Managing Intellectual Property Rising Stars for 2018.

This year’s publication is based on the information obtained during the research period for the 2018 edition of IP STARS (September 2017 to February 2018). Rising stars typically have less than 10 years post-qualification experience but individuals with over 10 years of experience may also be considered.

This is well deserved. Duncan’s hard work and dedication to his client’s has been recognised.

Congratulations Duncan!

The notion of what constitutes “best practice” when it comes to prosecuting New Zealand patent applications over the past 4-5 years has changed almost as often as Australia has changed Prime Minister.  Over this period, we’ve found that at least one of legislation (Act and Regulations), precedent law, Patent Office throughputs, examination protocols and international/bilateral obligations has remained somewhat fluid – and with it, the challenge for patent prosecutors to strike an appropriate balance between cost, scope and expediency has remained an imperfect science.  In this article, we play some of these factors (as they currently stand) off against each other – and come up with some ideas as to how attorneys and applicants alike can effectively manage the prosecution of New Zealand patent applications so that the facility to file a divisional application is not compromised.

Brief history

As readers will know, New Zealand patent law has recently changed; on 14 September 2014, the Patents Act 1953 (the “old Act”) was replaced by the Patents Act 2013 (the “new Act”).  On the one hand, this creates a binary old Act/new Act distinction – and as we will see, best practice differs appreciably depending upon which legislation governs any particular New Zealand application.  However, as we will also see, life under the new Act is itself divisible into distinct pockets of time, each of which has caused our coveted “best practice” to fluctuate somewhat.

Life under the Patents Act 1953

Prosecuting applications under the old Act was (as remains, for any old Act divisional applications still pending) a fairly easy gig.  Automatic examination, local novelty, no consideration of inventive step, fairly gentle written description requirements, no time limit on filing a divisional (other than it must be filed pre-acceptance of its immediate parent) and relatively slow Patent Office throughputs meant that somewhat broad New Zealand patents could generally be obtained with a relative minimum of time, hassle and expense.  Often (albeit with a few notable exceptions relating to patentable subject matter), IPONZ was effectively only rubber-stamping what had gone before it in IP Australia, the EPO, USPTO or wherever.  Under the old Act, New Zealand was very much a follow-on jurisdiction.

Critically though – at least within the context of this article – “best practice” essentially took care of itself.  As IPONZ throughputs were relatively slow (certainly, much slower than those of IP Australia for counterpart AU/NZ cases), and because divisional applications could be “daisy-chained” indefinitely, applicants faced little by way of time pressure.  It was all biased a little too heavily in favour of the applicant and New Zealand’s patent landscape was becoming encumbered with thickets of overly broad (and possibly invalid, remembering that inventive step wasn’t examined, but was a ground for opposition and revocation) patents, granted principally to foreigners, at relatively minimal expense.  Many, including the Government, felt that change was overdue.

The Patents Act 2013 – Early days

Applications filed in IPONZ on or after 14 September 2014 are subject to law and practice governed by the new Act (divisional applications filed from old Act cases notwithstanding).  Generalising slightly – and with a few notable exceptions, new Act law and practice at the time of commencement was closely akin to life under Australia’s Raising the Bar reforms of 2013.  To some extent, this was a natural consequence of the now-abandoned Single Application Process and Single Examination Process initiatives that took place between IP Australia and IPONZ.  Examination was now commenced by way of formal request, inventive step was examined, heightened support and written description standards applied, and Patent Office turnarounds were published, somewhat aspirationally, on the IPONZ website.  In a nutshell, New Zealand practice was now going to be quicker, stricter – and as a consequence, more labour-intensive and ultimately more expensive.

Under the new Act, divisional applications still had to be filed pre-acceptance.  However, in addition, a new 5-year statutory bar on requesting examination was introduced (which, due to the speed at which IPONZ was now operating, was unlikely to be a problem – more on that, below).

As with the old Act, best practice under the new Act was effectively self-governing: IPONZ dictated the speed at which an application progressed through examination – and so long as a divisional was filed before acceptance of its immediate parent, the 5-year statutory bar was unlikely to raise its head for at least one further generation of application.

The new Act effectively represented a 180-degree change in best practice – from slow, broad and cheap to fast, narrow(er) and more labour-intensive.  However, the principal take-home has already been alluded to above: best practice under both the old Act and during the early days of the new Act was effectively self-governing.  If an applicant did what IPONZ told them to do, when they told them to do it, their interests would be effectively preserved; attorneys didn’t need to exercise a great deal of imagination in terms of how best to manage timelines (including the 5-year statutory bar) during the early days of the new Act.

The Patents Act 2013 – Latter days

Around mid-2016, things began to change again – for a variety of reasons, IPONZ started to fall behind and application pendency began to increase as a result.  Now, if this were Australia (and assuming the applicant didn’t have cause for wanting to expedite prosecution), it wouldn’t necessarily represent a problem – but remember that with New Zealand’s new Act came the 5-year statutory bar on requesting examination.  The kicker, here, being that the 5 years commenced at the filing date of the application (or antedated filing date – generally the PCT filing date of its eldest parent application in the case of divisional applications).  As IPONZ throughputs continued to slow, readers will appreciate that the action of requesting examination began to converge for both parent and any divisional applications.  This really now sets the cat amongst the pigeons…

During the early days of the new Act, a direction to request examination would generally issue around 7 months from the date of national phase entry.  First exam reports issued fairly quickly – around 3-4 months later, setting in place a 12-month acceptance deadline.  Adding everything up, the final acceptance deadline for a New Zealand national phase entry would generally fall around 40-45 months from its filing date, i.e., well within the 5-year/60-month statutory bar for not only filing, but also requesting examination of any subsequent divisional application/s.  In other words, an applicant knew where they stood (relative to whether or not they needed to file a divisional application) comfortably within the deadline for doing so.  Remember also, that the quoted 40-45 months is an “outside” timeframe also – for applications prosecuted actively (part of the reason for IPONZ’ new response deadline), further time could be saved – perhaps even enough to allow a full prosecution cycle for a first-generation divisional application before any decision on a second-generation divisional needed to be made.

Fast forward to today.  The backlog at IPONZ is now so deep that directions to request examination are no longer issuing at all; it’s all now on an applicant’s attorney to keep them apprised of the 5-year deadline and what is required of them within this period.  Here’s an everyday example of “passive” attorney work (let’s call it “worst” practice): An applicant, in the absence of a direction, instructs its attorney to request examination shortly before the 5-year deadline; an examination report issues 6 months later raising a unity of invention objection that would otherwise be addressed by filing a divisional application.  Oops…  Alternatively, if an obviousness (or any other) objection cannot be overcome within the 12-month acceptance deadline, the facility to maintain pendency via a divisional application is again extinguished.  In such circumstances, an applicant really does rely on its NZ attorney to have its back and come up with something a little more constructive than a passive prosecution strategy.

Note, however, that any delay at IPONZ’ end is not with respect to the time taken to produce a first examination report; in fact, they remain fairly quick in this regard.  Timeframes published on the IPONZ website range from 3 months (mechanical) to 6.5 months (biotech); this is considerably faster than the Australian Patent Office, which presently generates first reports in around 12-14 months across all technology spheres.  Any delay, as such, relates strictly to the absence of examination directions – and this is where “the problem” lies.

The problem, summarised

In the absence of proactive case management by an its attorney, time can be a New Zealand patent applicant’s worst enemy.  If the applicant finds itself backed into a corner from which the only escape is a divisional application, they had better hope that the 5-year statutory bar has not yet passed.  As readers will appreciate, slower, stricter examination in IPONZ only serves to heighten this possibility – and with it, the imperative that attorneys are proactive in managing the deadline.

The solution

Short of legislative reform to allow New Zealand law and practice to live together, there appears no “perfect” solution to this problem.  The only way to effectively tackle the 5-year statutory bar is for an attorney to be both vigilant and proactive in managing it.  If IPONZ isn’t going to issue a direction requiring an applicant to request examination, then this responsibility effectively now vests in the attorney – and internally, at our firm, we have adopted this practice.

As such, the required action is clear: encourage the applicant to request examination as soon as possible upon NZ national phase entry.  This maximises the chances that an applicant will have, at least, a first examination report prior to expiry of the statutory bar – and as such, will have at least a pointer as to where they may stand in relation to a potential divisional application.

However, what is the perfect number?  When should attorneys be reaching out to clients encouraging them to request examination?  Of course, there is no right or wrong answer to this question – only a very general “the sooner, the better”.  We’ve heard 3 years suggested recently (i.e., about 18 months post national phase entry) – and on the face of it, this seems as good as any other suggestion.  It allows an applicant a period of financial recovery following national phase entry (remembering that national phase entry day is the most expensive time a patentee will face), and means that an examination report will issue in good time, setting the acceptance deadline (and with it, the first deadline for filing a divisional) comfortably before the 5-year

We have attempted to show this in the timeline above.  However, it will be appreciated that with the time increment between requesting examination and acceptance relatively consistent (depending upon technology) at around 15-18 months, the sooner examination is requested on a “parent” application, the more time is available for prosecuting a first-generation divisional prior to expiry of the statutory bar.  In fact, if an applicant requests voluntary examination upon entering the NZ national phase, there is sufficient time (without rushing unduly) to begin prosecuting a second-generation divisional prior to expiry of the statutory barIn the appreciably-rare cases where more than two divisional are required, the applicant of course has the option of filing several at once (it doesn’t need to be one at a time).  The take-home is that despite its apparent rigidity, New Zealand practice is flexible enough to accommodate any number of prosecution strategies.  It simply requires proactive case management on the part of the attorney responsible.

Other measures to help manage the 5-year statutory bar

Whereas current IPONZ throughputs and the 5-year statutory bar may be, in practice, somewhat incompatible, there are some other measures available to an attorney that may help mitigate the risk that an applicant misses the deadline.

Firstly, an attorney should review any international phase prosecution history for potential unity of invention issues.  In this respect, New Zealand law is that same as that expressed under PCT Rule 13.2; if it is foreshadowed during international phase, there’s a good chance it will be raised during examination in IPONZ – all the more reason to request early examination and find out for sure.

Secondly, an attorney should make use of the comprehensive online file wrapper facilities at either the USPTO or EPO.  The majority of New Zealand patent applications are PCT national phase entries from US or EP first filings.  Often, by the time the New Zealand national phase is entered, the precursor application will already be well advanced in its jurisdiction of origin.  Is there anything in the recent file history that would suggest prosecution before IPONZ may be problematic?  Patentable subject matter, strong obviousness citations, restriction requirements – any one of these would give an applicant cause to keep a close eye on the 5-year statutory bar.

Is the 5-year statutory bar here to stay?

Although it is possible that next year’s Patents Omnibus Bill may provide applicants with some relief from the 5-year absolute bar restriction, this is probably unlikely in practice.  Rather, we believe that IPONZ will maintain its current position that management of the deadline is an applicant’s responsibility (of course, via its attorney).  The reason we expect the status quo to be maintained reflects what has been a palpable shift in focus from the somewhat applicant-friendly old Act to the more third party-centric new Act – in other words, the New Zealand Government considers it in the public interest that an applicant’s position is established as quickly as possible so that third parties are not encumbered by the eternal pendency of divisional-upon-divisional-upon-divisional (i.e., daisy chaining).  All things considered, this position is unlikely to change (although we’d be very happy to be proved wrong here).

Any reasons why early examination might not be “best” practice?

Perhaps the most significant downside to early examination is that post-acceptance amendments in New Zealand are fairly heavily restricted.  Aside from correcting obvious mistakes, an applicant can generally only amend down (i.e., narrow) an accepted claim – you can’t broaden, and you can’t move sideways should a killer piece of prior art emerge after an application has been accepted.

Although readers will appreciate that this is, of itself, a good reason to delay, rather than expedite examination in New Zealand, it should be tempered by the observations that: a) international phase searching is generally fairly comprehensive; b) IPONZ only rarely uncovers new prior art itself; and c) with the majority of New Zealand applications coming by way of the US or Europe, additional high-quality searching will usually have been completed well before the counterpart New Zealand case is due for acceptance – even if examination is brought forward, as suggested.

Are there any other aspects of NZ divisional practice requiring proactive management?

Unfortunately, yes.  Self-collision is the big one.  Although it’s outside the scope of this article, we’ve written previously on the subject of poisonous priority.  Popular opinion seems to be that if the Patents Omnibus Bill is going to correct any aspect of NZ divisional practice, it’s probably going to be this, rather than the 5-year statutory bar.

(Don’t) fear the walking dead

For completeness, another aspect of current NZ divisional practice that may/should be cleared up by the Patents Omnibus Bill is the concept of the “zombie” divisional.  This occurs where a divisional is filed outside the 5-year statutory bar.  The Patents Regulations 2014 don’t actually prevent filing outside of the deadline; they only prevent the act of requesting examination.  As such, current NZ practice provides for zombie divisionals, which are filed validly, but cannot ever be examined and won’t ever have any legal effect; they just roam the patent landscape in a permanent state of undead.  This is probably a loophole worth closing in the upcoming legislation.

Conclusion – what is current New Zealand “best practice”?

With so many moving pieces to consider, the notion of “best” practice is perhaps a little subjective.  Rather, let’s only make the claim that we’re suggesting “good” practice.  To this end, even though such pieces will probably never synchronise, a proactive attorney can effectively manage the 5-year absolute bar for requesting examination and with it, mitigate any attendant risks by:

  • Reviewing international phase/EPO/USPTO prosecution histories shortly (g., 2-3 months) following NZ national phase entry.
  • Incorporating any potential issues that may give an applicant cause to want/need to file a divisional into early advice following NZ national phase entry.
  • Assuming it is in their best interests, counsel the applicant to request examination sooner, rather than later.
  • Proactively managing IPONZ’ new response deadline (this action is largely self-regulating; IPONZ sets the deadline and attorneys/applicants need to comply).
  • Avoiding, to the extent possible, applications going down to the wire in terms of the 12-month acceptance deadline. Rather, address the Examiner’s objections as soon as possible and if necessary or advisable, maintain the postponement of acceptance.
  • Maintaining postponement of acceptance until such time as the applicant has made an informed decision regarding a divisional (remembering that acceptance of a NZ application triggers an unextendible bar on filing a divisional from it).
  • Being cognisant of the restrictions on post-acceptance amendments under New Zealand practice – what are the chances of close prior art surfacing after the case has been accepted?
  • Whilst juggling each of these six balls, keep the closest eye on the 5-year statutory bar deadline – and remember it’s not just for filing a (or all) divisional application/s – it’s for requesting examination.

To conclude, if there’s one thing to take away from this article, it’s that these considerations are perfectly manageable – both individually and in sum.  However, it requires an attorney who is in sync with the requirements and their limitations working in combination with an applicant who is prepared to prioritise – at least during the initial stages, a filing in what is likely one of the smaller jurisdictions in which they have elected to file.  Whereas our personal preference is to request examination at the time of entering the NZ national phase, this must be offset against incurring further costs that can always be deferred.  As always, it’s a case-by-case, client-by-client proposition – but it is eminently manageable.

The Australian medical cannabis industry is growing rapidly, and cannabis-related businesses are starting to look to intellectual property rights to secure a competitive advantage. This article discusses the history of medicinal cannabis, the Australian market and the types of IP that can be utilised.

Medicinal cannabis – an evolving story

Cannabis has been cultivated for thousands of years to produce fibre and for various medicinal uses.  Records of its use date back as far as 2737 BC, when Emperor Shen Neng of China was said to have used it for the treatment of various medical conditions, and by the mid-19th Century, cannabis plant extracts were mentioned in the British and US Pharmacopoeia.  Later on, fears in relation to the wanton use of the plant as a recreational drug led to strict laws being implemented against its use.

In recent years however, international sentiment has been rapidly changing as strong evidence of the medical efficacy of chemical compounds extracted from the plant has been accumulating.  As a result, many major jurisdictions including the USA, Germany, the UK, Canada, Turkey and Australia have broadly legislated in favour of legalising cannabis for various medical purposes.

Cannabis extracts are now widely recognised for their potential in the treatment of chronic pain, Crohn’s disease, sickness related to cancer medication, spasticity related to multiple sclerosis, Alzheimer’s disease and many other conditions.  The plant contains over 400 unique chemical compounds, many of which are known to interact with specific receptors in the human body.  Of these compounds, tetrahydrocannabinol (THC) and Cannabidiol (CBD) are currently of most interest to researchers.

In much of Europe, Mexico and North America, two drugs containing synthetic THC, Dronabinol (Solvay Pharmaceuticals) and Nabilone (Valeant Pharmaceuticals International), are currently approved for medical use as anti-emetics.  Dronabinol and Nabilone also ease chronic pain and have been used to increase appetite in patients suffering from AIDS.

The Multiple Sclerosis drug Nabiximols (GW Pharmaceuticals) has also been made available on prescription in several major jurisdictions.  Nabiximols is formulated from purely non- synthetic plant- derived cannabinoids, and is the first such medicine to receive regulatory approval.

In light of the rapid global legislative and regulatory changes, the outlook for the market potential of medicinal cannabis is vast, with many analysts expecting the global medicinal cannabis market to reach $55.8 billion by 2025.  The global hemp fibre market for clothing and cosmetic products, which analysts expect will rise to $10.6 billion by 2025, should also not be forgotten.

The largest player in the sector is currently Canada, with an industry worth over $6.2 billion.  However, the United States is expected to be the world’s most lucrative market going forwards, and acceptance of medical cannabis in Europe is also growing rapidly.

Against this kind of background, it is easy to see that investment in this field is set to grow exponentially in the coming years.

Australia set to become a major player

In 2017, the Federal Government of Australia allowed the import and sale of medicinal cannabis products.  Today, the Australian medical cannabis industry is worth around $18 million, and as of early 2018, there were 19 companies listed on the ASX involved in the field.  However, many experts predict that the industry will explode into a multi-billion-dollar market over the next 10 years, especially since the Government has recently made clear its plans to make Australia a major player in the medicinal cannabis export market.

Although it is still a complicated procedure in Australia to obtain a licence to grow and export cannabis-related products, this looks set to change in line with the sentiment of other leading markets.  Australia would also face challenges in relation to export distance and logistics, but has world class facilities for the production and testing of medicinal cannabis that should ensure its potential is not overlooked by investors.  Indeed, Australia is positioning itself to be to be an exporter of premium grade product to overcome these issues, mirroring its position in other sectors such as the wine industry.

Intellectual property rights available for cannabis

In Australia, cannabis-related products and the plants they are obtained from are eligible for protection by a range of IP rights.  In particular, both patents and plant breeder’s rights may be held simultaneously for cannabis plants when the requirements discussed below are met.

Plant patents

Under Australian law, subject matter relating to plants is eligible for patent protection, only if it provides a practical solution to a technical problem and meets the usual patentability requirements.  To be eligible, the subject matter must be novel and involve an inventive step, and must have involved the technical intervention of a person in its development.  The specification must enable a person skilled in the art to reproduce the subject matter, which may require the deposit of plant reproductive material at a recognised depositary prior to filing the application.

Providing the above requirements are met, Australian patent legislation provides exclusive rights for up to 20 years from the application filing date in relation to plants per se or any part thereof, including reproductive material, genetic material, seeds, cells, or harvested material.  Products derived from a qualifying plant including oils, fruits and pharmaceutical compounds are also eligible for protection as are methods and uses involving plant-based subject matter, such as breeding methods, tissue culture or transgenic methods and plants produced therefrom.

Plant Breeder’s Rights

Plant Breeder’s Rights (PBR) are also available for plant varieties in Australia, providing that the application is filed within 12 months of any commercial exploitation in Australia, or within four years (for most varieties; six years for trees or vines) of commercial exploitation overseas.  Thus, PBR protection may still be available for a plant variety following commercial exploitation.

To be eligible for protection, a new plant variety must be distinct from other known varieties by at least one or more characteristics.  These characteristics must be uniform across a tested batch of the variety and must be stable over multiple generations.  In order to establish distinctiveness, uniformity and stability (DUS), it is necessary to engage the services of an accredited “Qualified Person”, who is an expert in testing new plant varieties and can certify DUS before the Plant Breeder’s Rights Office.  Shelston IP has in-house Qualified Persons who can assist you with any aspect of a PBR application.

Australian plant breeder’s rights legislation provides exclusive rights over the production or reproduction, sale, conditioning for sale, importation or exportation of propagating material of the protected variety.  In certain circumstances, harvested material and essentially derived varieties may also be covered under the Act.

Importantly, plant breeder’s rights offer a longer term of protection than patent rights.  PBR protection essentially begins at formal acceptance of the application when provisional protection is provided, and extends for 20 years for most plant varieties from the date of grant (not filing) of the PBR.  Again, trees and vines are treated differently, and are eligible for up to 25 years of protection from the date of grant.

Finally, Australian plant breeder’s rights legislation also provides protection for the name of a protected variety for the life the PBR registration.

Contrary to Law

Until recently, it was difficult to obtain patent protection for subject matter relating to cannabis plants, since under the Patents Act 1990, a patent may not be granted for subject matter that would be contrary to law.  However, due to the recent changes to the law relating to the use of medicinal cannabis in Australia, patents relating to cannabis-related subject matter may now be granted since it can be argued that there is a legal use for the invention.  In relation to plant breeder’s rights, there are no barriers under PBR legislation preventing protection for cannabis plant varieties.  However, the requirement to prove DUS through field trial data would require obtaining a special license under the Narcotic Drugs Amendment Act 2016 if the field trials are held in Australia.

How we can help

Businesses seeking to capitalise on the booming cannabis market in Australia currently need to negotiate complex legislative and regulatory hurdles before they can establish their business, whether it be in relation to import and export of cannabis related products or production on site.  During this process, appropriate management of your intellectual property is crucial for your success.  At Shelston IP, our Agribusiness team includes patent attorneys with industry experience in Agribiotech and plant-based patents, trade mark attorneys, design right attorneys, litigators and PBR Qualified Persons, and is uniquely positioned to offer strategic advice help you achieve your business goals.

Shelston IP is helping agriculture and food businesses, farmers, plant breeders and research organisations to unlock the value of their innovations and find opportunities in the growing Agribusiness space.  Our clients include some of the world’s largest providers of agricultural and food products, specialist agricultural biotech companies, grain handlers, plant breeders, seed producers, chemical suppliers, and government-owned research organisations.

If you have any questions or require advice in relation to any aspect of your intellectual property, do not hesitate to contact us.

Recently we reported on the Government’s plans to abolish Australia’s second tier patent system, the innovation patent.

The decision to abolish the innovation patent system appears to have been made without due consideration being given to the views of Australian small and medium sized business owners, the main users of the innovation patent.

For past year, the Institute of Patent and Trademark Attorneys of Australia (IPTA) has been liaising with many Australian businesses and the consistent message from this work is that the innovation patent system represents an important tool for: protecting inventions; attracting investment funds; and ensuring inventions come to market for the benefit of the Australian public.

IPTA has produced the following video in which Australian business owners present their independent views about the innovation patent and the ramifications should it be abolished.

Clearly, the proposed abolition of the innovation patent system will have detrimental results for Australian business owners and their ability to innovate. For this reason, the Government must reconsider its decision to abolish the innovation patent.

The UK Supreme Court has handed down its judgement in Warner-Lambert v Generics & Anr [2018] UKSC 56 in which the issue of plausibility was considered in-depth. The Supreme Court unanimously held that broad medical treatment claims were invalid, with the majority finding that the requirement of plausibility is not a low, threshold test. This approach is somewhat at odds with that adopted by the Australian Patent Office in Evolva SA [2017] APO 57, which relied upon earlier UK case law.

Background

The UK Supreme Court recently delivered their decision on a long-running dispute between Pfizer (parent company of Warner-Lambert) and Generics (UK) Ltd (trading as Mylan) and Actavis Group. The dispute concerned the validity and infringement of Warner-Lambert’s patent which covered “second medical use” (Swiss-style claim) protection of the drug, pregabalin. Claim 1 and dependent claims 2 and 3 were principally relevant and are as follows:

  1. Use of (S)-3-(aminomethyl)-5-methylhexanoic acid or a pharmaceutically acceptable salt thereof for the preparation of a pharmaceutical composition for treating pain.
  2. Use according to Claim 1 wherein the pain is inflammatory pain.
  3. Use according to Claim 1 wherein the pain is neuropathic pain.

The patentability requirement of sufficiency (and the related concepts of enablement and plausibility) ensures that the monopoly granted by a patent extends only to that which could reasonably be said to be disclosed in the patent specification and no further. The sufficiency requirement is found in section 14(3) of the UK Patents Act 1977 which states “[t]he specification of an application shall disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art.” A patent may be revoked on the grounds that the invention is insufficiently disclosed under section 72(1)(c).

Actavis marketed a pregabalin generic under the brand name “Lecaent”. In 2014, Actavis and Mylan separately sought revocation of Warner-Lambert’s patent on the grounds of insufficiency. Warner-Lambert commenced infringement proceedings against Actavis later in the same year. Arnold J of the High Court held claims 1 and 3 to be insufficient and that even if the claims are valid, they are deemed not infringed. It was further ruled that a post-trial amendment lodged by Warner-Lambert to limit the claims to valid subject matter would amount to an abuse of process and was thus rejected. Warner-Lambert’s appeal in 2015 was unsuccessful as, broadly, the Court of Appeal upheld the decision of the High Court.

The judgement of the Supreme Court was handed down on 14 November 2018 for which inter alia issues of insufficiency and infringement of Swiss-style claims were considered. Here, we will discuss the ruling on plausibility in detail.

The Supreme Court’s Decision

The Supreme Court unanimously agreed that it was implausible that pregabalin would be effective at treating any type of pain (claim 1) and all neuropathic pain (claim 3) including peripheral and central pain.

However, the Lords were split on their views of what the appropriate test for plausibility should be. The majority of the Supreme Court (Lord Sumption, Lord Reed and Lord Briggs) disagreed with the Court of Appeal’s statement that:

The EPO and domestic cases do, however, indicate that the requirement of plausibility is a low, threshold test. It is designed to prohibit speculative claiming, which would otherwise allow the armchair inventor a monopoly over a field of endeavour to which he has made no contribution. It is not designed to prohibit patents for good faith predictions which have some, albeit manifestly incomplete, basis. Such claims may turn out to be insufficient nonetheless if the prediction turns out to be untrue. A patent which accurately predicts that an invention will work is, however, not likely to be revoked on the ground that the prediction was based on the slimmest of evidence. Thus, the claims will easily be seen not to be speculative where the inventor provides a reasonably credible theory as to why the invention will or might work. The same is true where the data in the specification is such that the reader is encouraged to try the invention”.

Turning to some of the observations of the majority of the Supreme Court, it was stated by Lord Sumption:

Without some disclosure of how or why the known product can be expected to work in the new application, it would be possible to patent the manufacture of known compounds for the purpose of treating every conceivably relevant condition without having invented anything at all, in the hope that trial and error might in due course show that the product was efficacious in treating at least some of them…[t]he patentee must disclose some reason for regarding this assertion as “plausible”. (emphasis added); and

“The Court of Appeal’s statement of the effect of the plausibility test has already been quoted (para 20 above). They considered that the threshold was not only low, but that the test could be satisfied by a “prediction … based on the slimmest of evidence” or one based on material which was “manifestly incomplete”. Consistently with that approach, they considered (paras 40, 130) that the Board’s observations in SALK laid down no general principle. I respectfully disagree. The principle is that the specification must disclose some reason for supposing that the implied assertion of efficacy in the claim is true. Plausibility is not a distinct condition of validity with a life of its own, but a standard against which that must be demonstrated. Its adoption is a mitigation of the principle in favour of patentability. It reflects the practical difficulty of demonstrating therapeutic efficacy to any higher standard at the stage when the patent application must in practice be made. The test is relatively undemanding. But it cannot be deprived of all meaning or reduced, as Floyd LJ’s statement does, to little more than a test of good faith. Indeed, if the threshold were as low as he suggests, it would be unlikely to serve even the limited purpose that he assigns to it of barring speculative or armchair claims.” (emphasis added)

Applying the test for plausibility as Lord Sumption had described it, the majority were not satisfied that efficacy in peripheral neuropathic pain was plausible. Notably, Lord Sumption said:

“The question, it must be remembered, is not whether it is plausible but whether the specification discloses something that would make it so in the eyes of the skilled person.”

In contrast, the minority of the Supreme Court (Lord Hodge, with whom Lord Mance agreed) thought Lord Sumption has set the standard for plausibility too high. Lord Hodge said, “I do not interpret those principles as requiring the patentee to demonstrate within its patent a prima facie case of therapeutic efficacy”.

As explained by Lord Hodge:

“Adopting the lower standard of plausibility which the recent decisions support, I am inclined to think that Arnold J, who heard and analysed the expert evidence on this matter, including that of Professor Woolf, Dr Scadding and Professor Wood, did not err in his evaluation of that evidence when he concluded that Warner-Lambert had done just enough to satisfy the plausibility test in relation to peripheral neuropathic pain. The result of the rat paw formalin test demonstrated that pregabalin reduced inflammatory pain at phase 2. There was expert evidence which treated as credible the suggestion that the efficacy of pregabalin in reducing pain which that test revealed would not be confined to inflammatory pain and that the medication would also be effective in relation to peripheral neuropathic pain. As Arnold J stated (para 351), it was common general knowledge that central sensitisation was involved (at least as an amplifying mechanism) both in relation to inflammatory pain and in relation to peripheral neuropathic pain and that it played a role in the rat paw formalin test. The patent had not demonstrated that pregabalin had an effect on central sensitisation and a prima facie case had not been made out. But the plausibility test does not require that standard.” (emphasis added)

Nevertheless, Lords Hodge and Mance agreed with the majority that claim 3 did not satisfy the standard for plausibility in respect of the central neuropathic pain.

Implications for Australia

In Australia, since 15 April 2013 (Raising the Bar Amendment) a specification must disclose the invention in a clear enough and complete enough manner to enable performance by a person skilled in the relevant art (section 40(2)(a)).

According to the Explanatory Memorandum to the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (Cth), the purpose of the change of law was to require enablement across the full width of the claims, while adopting language that is consistent with that used in other jurisdictions. The wording in section 40(2)(a) is similar to section 14(3) of the UK patents legislation and Article 83 of the European Patent Convention.  The intention is that paragraph 40(2)(a) be given, as close as is practicable, the same effect as the corresponding provisions of UK legislation and the European Patent Convention.

Although it is clear that Australian courts are not bound to follow UK or European legal precedent, the courts often seek guidance from the approach used and case law from UK and Europe. Since Parliament has explicitly indicated that the new enablement requirement is intended to align with UK law, it seems even more likely that the Australian Courts will consider UK case law on this topic carefully. While there have not been any Court decisions on the new enablement requirement in Australia yet, the Patent Office recently issued a decision in Evolva SA [2017] APO 57 (the Evolva decision) which considered the importance of plausibility and whether an invention would work across the scope of the claim.  In this regard, the Evolva decision agreed with the Court of Appeal’s interpretation that the requirement of plausibility is a low threshold test and may be based on the slimmest of evidence. The Evolva decision further drew reasoning from another UK decision (HGS v Eli Lilly & Co [2011] UKSC 51) where Lord Neuberger stated that in some cases a “reasonably creditable” claimed use or “educated guess” can suffice.

As noted above, the majority in the Supreme Court disagreed with the principle that plausibility is a “low, threshold test”.  Given the precedent established by the Australian Patent Office in following earlier UK law for plausibility and the statements to this effect in the Explanatory Memorandum, we would anticipate that an Australian court would carefully consider the Supreme Court’s decision, despite the Lords being split on the relevant test for plausibility.

This article was recently re-published in Practical Law Australia, by Thomson Reuters Legal. A copy of the re-published article can be found here.

Australia’s second-tier innovation patent system is presently on death row. With all appeal avenues seemingly now exhausted, we ask the question – albeit somewhat academically, as to whether it necessarily has to die – or whether it could be rehabilitated. In other words, whether the punishment fits the crime…

Introduction

Around 15 months ago, the Australian Federal Government released its response to the Productivity Commission’s inquiry into intellectual property arrangements in Australia. One of the headline features of the response was that the Government had agreed to phase out the innovation patent system. Whereas there appears to be a general acceptance throughout Australia’s IP community that the innovation patent system may be somewhat imperfect, it did not necessarily follow that it was failing to meet its stated objectives – namely, to foster innovation amongst local SMEs. This article considers whether the Government may have over-reached in recommending a complete culling – could it be rehabilitated, or is euthanasia the only real option? If the latter holds true, patentees may wish to give some advance thought to availing of the innovation patent facility while it still exists.

What’s happened over the past 15 months?

Champions of the innovation patent system have continued lobbying away in the background – and on occasion, the foreground. Throughout July-August 2018, IP Australia sought public comment on the Exposure Draft of the Intellectual Property Laws Amendment Bill (Productivity Commission Response Part 2 and Other Measures) Bill 2018. Among other measures, the draft legislation contained provisions to phase out the innovation patent system once and for all.

Six non-confidential submissions relating to the innovation patent system were received during the consultation process. In late October, IP Australia then published its response. It was noted that the “majority of the submissions did not comment on the drafting of the legislation, but expressed their continued opposition to the decision to abolish the innovation patent system”. In response, IP Australia noted that “the decision to abolish the innovation patent system was taken by the Government, and that this consultation was directed towards the implementation of that decision. No significant new evidence on the value of the innovation patent system was presented by the submissions that had not already been considered by the Productivity Commission and the Government in reaching that decision”. In other words, advocates of the innovation patent system had chosen the wrong forum in which to attempt re-opening the debate.

As we understand things, the Government remains keen to introduce the Bill before the end of the year. Parliament’s final session for 2018 concludes on 6 December – and the small window available therefore stands as a test of its resolve to achieve a quick kill.

Innovation patents 101

From its introduction in 2001, the “innovation patent” has been held up as a symbol of the Australian Government’s commitment to encouraging small to medium enterprises (SMEs).

The innovation patent is Australia’s second-tier patent system. Novelty, written description and industrial applicability criteria are the same as for the first-tier “standard” patent system. However, in exchange for offering the public only an “innovative step” (a pseudo-novelty test requiring differences amounting to a “substantial contribution to the working of the invention”), a patentee is afforded only an 8-year term as opposed to the standard 20 years.

Proponents of the innovation patent system note that not all inventions are of the “Eureka” quantum leap variety befitting a standard patent. Rather, many are iterative – making slow but steady advances on what came before it. The argument is that such iterative advances may be “obvious” for the purposes of a standard patent, but still invite substantial RD&E expenditure on a patentee’s part – and so why shouldn’t the patentee be compensated with some measure of monopoly right?

Innovation patents are “granted” upon filing (a potential problem in itself, as we will see below), but are not enforceable at law until such time as they have been “certified” (i.e., examined). However, once certified, the enforcement remedies available to a patentee are the same as those for a standard patent. Thus, innovation patents – particularly innovation patents divided out from standard patent “parents”, can be effective “litigation weapons” because the low innovative step threshold makes them somewhat difficult to revoke in a counter-claim for invalidity (and suing against a divisional innovation patent will not expose the parent standard patent to a revocation cross-claim). Thus, innovation patents provide a legitimate strategic tool for those looking to enforce their Australian patent rights.

So, what’s the problem?

The perceived “problem” with the innovation patent is three-fold. Firstly, there has been a perception that local SMEs were not making use of the innovation patent system (and even if they were, they were not deriving tangible benefits from it). Secondly, that the “granted upon filing” status rendered the system susceptible to abuses such as foreign applicants potentially being able to claim Government subsidies in their country of origin for obtaining a “granted” patent. Thirdly, there has been a perception that the threshold test for innovative step (essentially a pseudo-novelty test, as noted above) was too low and that this, in turn, may give rise to a proliferation of difficult-to-revoke certified innovation patents that were enforceable at law. Ultimately, it was the first perceived problem that has been considered terminal.

Problem 1: Local SMEs are not making use of the system

This appears to be the primary justification for abolishing the innovation patent system. A 2014 review conducted by ACIP (the Advisory Council on Intellectual Property) had recommended – somewhat surprisingly at the time, that the innovation patent system be abolished. Following a protracted review process stretching back to 2011, ACIP eventually concluded by way of economic modelling that the innovation patent system was not meeting its stated objectives. Such objectives, of course, were to stimulate innovation in Australian SMEs by providing easier, quicker and cheaper patent rights as well as an avenue to protect their lower level inventions – a patent system aimed at “backyard inventors”.

Objectively, it appears that the data presented in the economic report may have been open to a number of interpretations, and that disproportionate weight may have been attributed to certain factors. For example, the fact that there are a relatively high proportion of self-filed innovation patent applications cloud the data relating to the calculated total regulatory cost of the system and the assessment of commercial success of innovation patent filing entities. This obviously has an effect on the concluded net economic impact, which appears to have been a major factor influencing the stand taken by ACIP. Notwithstanding, the Productivity Commission and the Australian Government have subsequently backed this position, which in turn, effectively sounds the death knell for the innovation patent system.

Problem 2: A “granted” patent for a wheel

An example of the shortcomings of the “granted upon filing” status was highlighted by way of innovation patent 2001100012, which was “granted” for a “circular transportation facilitation device” – a wheel. The facility to obtain a granted innovation patent for a wheel suggests that all is not well with the present system. Obvious “fixes” involve reverting to the “filed” status ascribed to a standard patent before such time as it has passed through examination, and/or requiring that every innovation patent application is to be examined within, say, 2-3 years of its filing date (at present, examination/certification is merely optional subject to the limitations in enforceability as mentioned above). Adopting either or both of these two very obvious solutions would ensure that a) nefarious claiming of Government subsidies would be reduced or eradicated; and that b) patents for wheels and the like will not clog the register of patents for the entirety of their 8-year term.

Problem 3: The innovative step threshold

As noted above, the test for innovative step is essentially one of pseudo-novelty; this dates back to the decision of the Full Federal Court in Dura-Post (Australia) Pty Ltd v Delnorth Pty Ltd [2009] FCAFC 81 (30 June 2009) and requires an advance over the prior art that amounts to “a substantial contribution to the working of the invention”. It is generally accepted that this test represents a very low bar and that the quid pro quo offered by the Government of an 8-year monopoly period invites something more on the part of innovation patent applicants.

In this respect, timing is everything. Indeed, Recommendation 7.2 of the Government response to the Productivity Commission supported the notion that in respect of standard patents, the inventive step threshold was too low also. The current primary test for inventive step is fundamentally whether the skilled person faced with the same problem would have taken, as a matter of routine, whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not (Wellcome Foundation (1981) 148 CLR 262 at 286). Along with sub-tests such as the requirement for a “mere scintilla” of inventiveness, the Government agreed that retaining these tests did not, in fact, “raise the bar” as was the intent of the recent 2012 reforms (see, our previous article on this topic). The Government recommended adopting the “problem/solution” or “obvious to try” approaches of the European Patent Office, which would be expected to provide a higher inventive step standard across the board. Draft legislative amendments have followed.

What then, to do with “directly led as a matter of routine” and/or “a mere scintilla”? Couldn’t these become the new examination standards for an innovative step?

It is worth noting at this juncture that the “real” issue arguably concerns innovation patents in the “borderline patentable” category. Given the low innovative step threshold for patentability, these are hard to ignore and require that a commercial entity expends time and funds obtaining a FTO opinion and/or requesting examination/certification in order to be assured that they may safely carry out their intended activities.

Thus, it appears that two relatively simple “fixes” could address two of the headline deficiencies of the innovation patent system.

Notwithstanding, the (broken) innovation patent system is not meeting its stated objectives

In recommending the innovation patent system be abolished, the Government had merely assumed the position of both the Productivity Commission and ACIP before it. Both had opined that the innovation patent system (as it stood) was unlikely to provide net benefits to the Australian community or to the SMEs who are the intended beneficiaries of the system. The Productivity Commission found that the majority of SMEs who use the innovation patent system do not obtain value from it and that the system imposes significant costs on third parties looking to navigate around thickets of low-level patents.

The Government noted that the innovation patent system was established with the express objective of stimulating innovation amongst Australian SMEs. Rather than “fix” the innovation patent system, the Government was of the opinion that more targeted assistance may better assist SMEs, while avoiding the broader costs imposed by the innovation patent system. Along with initiatives to support SMEs introduced through the National Innovation and Science Agenda (NISA) and existing programs such as the R&D Tax incentive, the Government noted that it had already implemented a number of measures to support SMEs such as the IP Toolkit for Collaboration, Source IP, the Patent Analytics Hub and grants and advisory services for businesses in certain industry sectors looking to leverage their IP. Moreover, IP Australia has recently established a new IP Counsellor to China, is trialling patent analytics services and is raising education and awareness of IP issues with local start-ups.

But could a “fixed” innovation patent system meet its stated objectives?

Arguably so. A “fixed” innovation patent system could very easily address problems 2 (“granted” upon filing) and 3 (the innovative step threshold). However, problem 1 (lack of buy-in from SMEs) appears to run much deeper and invites a paradigm shift on Australia’s part in recognising that “innovation” is an aspiration rather than a dirty word.

Notwithstanding, the question is merely academic because the abolition of the innovation patents system now seems inevitable based upon the Government’s response to the debate surrounding it.

Is abolition widely supported throughout the profession?

The Institute of Patent and Trade Mark Attorneys of Australia (IPTA) is the peak professional body charged with representing the views of our local profession. IPTA has assumed a position diametrically opposed to that adopted initially by ACIP, and now supported by both the Productivity Commission and the Government:

IPTA remains of the view that the innovation patent system remains an appropriate means to stimulate innovation by Australian small to medium business enterprises and that it is an appropriate means for protecting lower level inventions that may not be entitled to standard patent protection. IPTA also believes that the innovation patent system also continues to serve the function of providing a fast route to a granted and certified patent which can be used in enforcement action in a similar manner to the former petty patent.

Although IPTA’s position was made public long before the economic modelling that ultimately shaped ACIP’s stance (and more latterly, that of the Productivity Commission and Government), there appears little evidence that the views of the wider profession have changed significantly in the interim. Anecdotally, we understand that there remains strong support for the innovation patent system within Australia’s patent attorney profession as a whole.

Has little brother taught big brother anything?

As readers will know, New Zealand has a short and fairly unspectacular history when it comes to second-tier patents regimes. Although the draft legislation for an “advancement patent” was tabled back in April 2018, it took only four months to be voted down in New Zealand’s Parliament.

As it happens, New Zealand’s draft legislation claimed to borrow heavily from the Australian experience. An “advancement step” (being based upon the Danish standard preferred by ACIP and of a higher standard than Australia’s pseudo-novelty “innovative step”), a compulsory request for examination (no more innovation patents clogging up the register for their full term when the patentee has no intent to examine or enforce them), no “granted” status upon filing, and a 10-year term in exchange for providing the public with an “advancement step” – in a nutshell, the draft NZ legislation purported to correct everything that is perceived to be wrong (at least at the legislative level) with Australia’s innovation patent system.

And what did we learn from this? Precisely nothing. As mentioned, the draft legislation was voted down following its first reading in New Zealand’s Parliament. However, voting was conducted along party lines – not on merit. As such, the advancement patent could conceivably reappear with the next change of government (i.e., when the party proposing the advancement patent next has a majority in the house).

Next steps

As noted, the Government has now proposed legislative amendments to the Patents Act 1990 to abolish the innovation patent system, with appropriate transitional provisions to maintain existing rights. The Government has announced that it will continue to explore more direct mechanisms to better assist SMEs to understand and leverage their IP and access affordable enforcement.

Proposed transitional provisions for abolishing the innovation patent

The Intellectual Property Laws Amendment Bill (Productivity Commission Response Part 2 and Other Measures) Bill 2018 proposes the following measures for abolishing the innovation patent system:

  1. The legislation is passed into law on “date-X”; it takes effect from “date-Y”, which is 12 months from date-X.
  2. At any time prior to date-Y (i.e., between now and date-X, and then between dates X and Y), new innovation patent applications can be filed. In other words, nothing changes until the legislation takes effect on date-Y.
  3. As of date-Y, no new innovation patent applications can be validly granted. However, an existing standard patent application (i.e., having a filing date prior to date-Y) can still be converted into an innovation patent, or can have a divisional innovation patent filed from it. With innovation patents having an 8-year term, it will be appreciated that under the proposed system, all innovation patents will have expired by “date-Z” (effectively, date-Y+8).

The proposed transitional arrangements also give rise to another interesting consequence: added matter restrictions. An Innovation patent claim having a priority date on or after date-X cannot be validly certified. This guards against effective US C-I-P practice such that a claim reliant on added subject matter may not be entitled to its original priority date; if its revised priority date falls after date-X, the claim cannot be certified following examination and is thereby not enforceable at law.

Commentary – Let the punishment fit the crime

I’ve always been a proponent of the innovation patent system. In fact, I’ve spent a sizeable chunk of the past 15 years trying to drum up interest amongst my clientele (and that of our firm) in the strategic use of the innovation patent system. Little by little we’ve made inroads, to the extent that several clients – both local and foreign – are making legitimate and effective use of the system. To see it abolished now would effectively undo a lot of what we’ve all worked for.

Nobody’s pretending that the innovation patent system is perfect. The very first paragraph of this article admits as much. However, abolishing it seems unnecessarily harsh – a bit like imposing the death penalty for jaywalking. From a personal standpoint, one can’t help but think there has got to be a better way.

Shelston IP will keep readers informed as to progress. In the meantime, patent Applicants may wish to give advance consideration to availing of the Australian innovation patent system while it still exists.

We handle the intellectual property (IP) portfolios for a diverse range of clients, many of whom are large multinationals. Their IP portfolios typically include all forms of registrable rights – patents, trademarks and designs. We also often find that certain clients have many IP service providers, each of which handle one or more of those registrable rights. Such a fractured vendor landscape can arise due to a variety of factors, such as historical reasons. For example, different IP Managers within the organisation have had different preferences for IP services providers and have spread the work around over time, or there may have even been an internal policy in this regard. Sometimes, a parent company may acquire smaller entities and will transfer any IP into the parent’s name, but will retain management of the IP with the existing service provider. This may be for perceived convenience, or simply due to a perceived cost for transfer of the portfolio. Whatever the reason, there are disadvantages to having the IP handled by plurality of service providers.

By reviewing the IP portfolios of the most successful organisations it is clear that industry best practice is to have the IP handled by a very limited number of service providers, and preferably consolidated to a single provider.

Industry best practice

There are many advantages of having your IP handled under one roof by a single dedicated IP team. For example, to enable the attorneys handling the IP to better understand:

  • the client’s commercial objectives,
  • the client’s existing technology, the technology currently under development, and what technology may be required in the future,
  • the client’s main competitors and their technologies, and
  • to gain a better understanding of the industry in general, including the common technical knowledge.

An understanding of the commercial objectives is important, as these objectives should frame the IP being developed now and into the future, and will assist the attorney to more comprehensively protect and enforce the IP. Consolidation of IP with a single service provider enables the attorneys to become more embedded in the organisation and fosters a more collaborative working relationship with the key people in the organisation (researchers, inventors, business development managers, etc). It can also be important to understand the client’s key competitor(s) and its technologies for freedom to operate issues and to assist the organisation in its decisions to attack its competitors’ IP.  All these factors lead to:

  • greater proactive and strategic management of the client’s IP (rather than a reactive approach to IP issues as they arise);
  • increased efficiencies in dealing with IP matters;
  • a service provider enabled to add real value to the organisation, and
  • cost benefits.

Furthermore, there are synergies which come about from this approach.  As attorneys/lawyers become more embedded in an organisation they are better able to brainstorm technical solutions with R&D personnel and to assist them to understand the commerciality of the solutions they develop to real-world problems. Additionally, the improved collaboration which is possible between attorneys and R&D staff can lead to more robust patent specifications being drafted, thereby improving the strength of the IP, reducing the ability of infringers to work around the IP, and increasing the prospects of surviving a validity attack. It also leads to the attorneys having a better understanding of the key prior art in the field, and the common ‘terms of art’.  The organisation can also benefit in other ways. For example, many in-house IP teams are relatively small and there can sometimes be a high turnover of attorneys. Utilising a single service provider supports portfolio knowledge and corporate memory.

Conclusions and summary

There are many advantages to an organisation having its IP handled by a single service provider, and is a ‘best practice’ approach to strategic IP portfolio management.

Shelston IP is well placed to assist with management and consolidation of your IP portfolio to achieve your commercial objectives.

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.

The UK is scheduled to leave the EU in March 2019. In the event of the UK leaving the EU without a deal being reached, the UK Government has provided some guidance on how trade mark rights will be affected.

EU Trade Mark Registrations

For existing national EU trade mark registrations, the UK Government has confirmed that it will automatically provide an equivalent UK registration. Owners will be informed of the new UK registration, but will be given the opportunity to opt out. At this stage, it is unclear whether there will be costs payable.

In order to provide continued protection in the UK for trade marks protected through Madrid and Hague systems designating the EU, the UK Government is proposing to work directly with the World Intellectual Property Organization (WIPO).

EU Trade Mark Applications

For national EU trade mark applications which are still pending on the day of the UK’s exit from the EU, trade mark owners can apply to file a corresponding UK application within 9 months from the exit date. During this process, the date of the EU application will be retained for priority purposes. Additional UK application costs will be payable.

The UK Government is also proposing to discuss “practical solutions” for pending EU designations filed through Madrid and Hague systems with the WIPO.

Recommendation for Proposed New EU and UK trade mark applications

Assuming no objections are filed during examination, and no oppositions are filed by third parties, the current national EU trade mark registration process usually takes approximately 4.5 months to complete.

If you are considering obtaining trade mark protection in both the EU and UK, you may wish to consider filing a national EU application (not via the Madrid process) as soon as possible.[1] As noted above, if no objections are raised or oppositions are filed, EU trade marks filed now are likely to be registered before 29 March 2019.

The main benefit of filing a national EU application now is that extra costs for separate UK protection (assuming the EU trade mark is registered before the UK’s exit) may be avoided (although this is not confirmed at this stage).

If trade mark protection is required in the UK on a more urgent basis, it may be preferable to file separate applications in the EU and UK simultaneously, since the timeframe for obtaining automatic equivalent UK registrations from EU registrations, and the costs involved, are uncertain at this time.

*The UK Government’s guidance notes can be located at: https://www.gov.uk/government/publications/trade-marks-and-designs-if-theres-no-brexit-deal/trade-marks-and-designs-if-theres-no-brexit-deal

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.

A new database has been launched with the principal purpose of providing easily accessible and understandable information about the patent status of a specific medicine in a particular country, by identifying key patents related to the medicine worldwide.

This database is meant to have all this information in a single place, and to complement other patent databases including commercial products, national patent offices and WIPO’s PatentScope.

It is called Pat-INFORMED, or more fully, the Patent Information Initiative for Medicines.

Establishing the patent status of medicines can be a difficult task.  The Orange Book has been providing the relevant information for many years but only contains US patent numbers. Pat‑INFORMED aims to provide similar information on a worldwide basis.

It currently contains information on 160 products in six therapeutic areas plus additional products on the World Health Organization Essential Medicines List. There are over 14,000 patents from over 600 patent families at this time.

The six therapeutic areas are HIV/ AIDS, cardiovascular disease, diabetes, hepatitis C, oncology and respiratory conditions.

Pat-INFORMED is a collaboration between WIPOIFPMA and 20 pharmaceutical companies, namely Abbvie, Astellas, Bristol-Myers Squibb, Daiichi-Sankyo, Eisai, Gilead Sciences, GSK, Ipsen, Johnson & Johnson, Leo Pharma, Lilly, Merck, MSD, Novartis, Novo Nordisk, Pfizer, Roche, Shionogi, Takeda and UCB.

This is undoubtedly a valuable addition to the Orange Book but as a patent information professional with many years of searching pharmaceuticals notched on my belt, it is clear that Pat-INFORMED is not without its shortcomings.

It is limited to granted patents. Pending applications are not listed, for the reason that pending applications can be refused, amended or abandoned, where they may no longer be applicable to a pharmaceutical product. To be fair the Orange Book is the same. These databases are to start you off in the right direction, but patents are not listed if they are solely directed to metabolites, intermediates, packaging or methods of manufacture. The problem is there are many more patent applications, and granted patents for that matter, that will be relevant to the drug you are interested in, and these are not discoverable here.

Some shortcomings are listed in Pat-INFORMED’s terms and conditions of use.

Any participant who lists patents or provides information or other services does so on a purely voluntary basis. This can be contrasted with the Orange Book, where providing patent information is mandatory. Pat-INFORMED is already limited to just twenty participants and their patents. Many drug names do not appear. Hopefully this picks up and we see more pharmaceutical companies adding information.

The next issue is twofold. The terms state that “Once fully populated, information in the database will be updated at least annually”. Firstly, it points to the fact that the database is essentially incomplete, or a work in progress. There’s no indication as to when it will be complete. Secondly, it won’t be updated very often, which can lead to out of date information being relied upon. Commercial patent database providers and many national patent offices update their information daily, or at the very worst, weekly.

There are some challenges to searching for pharmaceuticals, and this database touches on one of those in particular. Pat-INFORMED relies on the International Nonproprietary Name (INN) or ‘generic’ name of the drug as the basis of the search. This is deliberate. It is relying upon participating pharmaceutical companies to provide patent information that might otherwise be undiscoverable by someone searching for an INN in PatentScope, for example.

Generic or brand names are not likely to appear in patent specifications early in the lifecycle of a particular drug, typically because the INN is approved some years after the first, or ‘molecule’ patent.

The language of the INNs and medical sector is different to the language of patents, which describe drugs in different ways or with different names.

It is therefore difficult to identify relevant patent applications filed before the INN is approved through a search using the common, generic name.

A variety of sources of information is required to bridge the information gap between the molecule patent of a pharmaceutical and the recommendation of its INN.

Some of the pieces of information are non patent, such as the chemical name, the manufacturer’s code name and the drug type.

For example, the drug Brexpiprazole, approved in the United States in 2015, was originally filed as a patent application in 2006 and obtained its recommended INN in 2012,        and is known by its chemical name (7-{4-[4-(1-benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one), its manufacturer’s code (OPC-34712) and the drug type (antipsychotic/antischizophrenic).

Two of these pieces of information should be enough to identify the molecule patent as US7888362 as its chemical name appears in claim 7 and the drug type appears in the preamble. The third piece of information has been used in eleven patent families to identify the drug as being of interest, with some prior to the INN being proposed.

Other sources of information are relevant to a patent search. These include the IPC (International Patent Classification), or more recently, the CPC (Cooperative Patent Classification), and citation searching.

The patent classes that a drug such as Brexpiprazole is placed into are very straightforward. The compound class (C07D409) focuses on the benzothiophene ring and what is attached to it; the active ingredient class (A61K31) considers the piperazine ring as the primary ring; and the indications class (A61P25) relates to disorders of the nervous system and specifically mentions antipsychotics and schizophrenia. It is unlikely that a patent application relating to Brexpiprazole will not be placed in the correct patent class.

There are also other patent classes that may be of interest that relate to the pharmaceutical form or the inactive ingredients making up the form.

There are a number of searching techniques available that use these patent classes either alone, together or in combination with other pieces of information such as keywords and relevant parties (especially the manufacturer) that enable a searcher to locate relevant patent families filed between the filing date of the molecule patent and a time when the INN is in common use.

It is also worth remembering just because there is an INN, and it is in common use, that patent applicants will use it. There is no requirement to do so. For instance, use of the generic name ‘Brexpiprazole’ peaks in 2016, some four years after the INN was approved. Some advantage can be sought by not using the INN and instead referring to the chemical name, the manufacturer’s code or sometimes “the compound of Formula I” in order to disguise the application to avoid early discovery of a competitor’s intentions.

A further method of discovering patent applications filed before the INN is approved is citation searching. A patent application filed today may cite some related, earlier filed patents in the preamble, so while those earlier patents may not mention the INN, the later patents make the link.

Here’s a line from the preamble of a patent application filed in 2016, clearly referencing an application that could not have mentioned the INN.

WO 2006/112464 A1 discloses brexpiprazole and its use for the treatment of schizophrenia…

Citations can not only be found in the preamble but also on the front page and in the search report.

Pat-INFORMED has the potential to reduce the amount of searching required when establishing the patent position around specific medicines. However, it should be regarded as a first step for the global health community and pharmaceutical procurement agencies, rather than a complete source of information, particularly given the consequences of missing a critical pharmaceutical patent.