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The Trump Organisation owns a lot of domain names – around 3,000, for everything from <TrumpOnTheRocks.com> to <TrumpRussia.com>.  Unfortunately for the President, this impressive portfolio doesn’t include <TrumpHotels.org>.

Golf enthusiasts, honeymooners and high-powered executives wanting to stay at one of Trump’s 11 hotels will not find what they are looking for at <TrumpHotels.org>.  The website features images of America’s immigrant detention camps, including photos of children in cages.  A section titled “Thoughts From Our Manager” includes the President’s rant about Mexicans being “rapists” and a quote espousing the benefits of an authoritarian government.

The domain name was registered by Loren Collins, a self-described “libertarian/conservative” lawyer, who does not like President Trump’s federal immigration policies.  The website states that is it intended solely for “entertainment, satirical, and political commentary purposes” and emphasises that the site has no connection with President Trump or his actual hotel business.  It denies any claim of intellectual property infringement.

The Trump Organisation’s team of lawyers is no doubt clambering to get Mr Collins’ website taken down.  And they are no strangers to WIPO’s Uniform Domain Name Dispute Resolution Policy.

In this post we examine the current state of the WIPO domain name dispute rules in the context of satire and fair use and consider what issues may arise for <TrumpHotels.org>.

A UDRP refresher

WIPO’s Uniform Domain Name Dispute Resolution (UDRP) Policy governs certain disputes regarding ownership and use of generic top level domains and some country code top level domains.  A person can initiate an administrative proceeding by submitting a complaint.   Paragraph 4(a) of the Policy outlines the elements that must be made out for a complaint to be successful:

  • the domain name is identical or confusingly similar to a trademark or service mark in which the complainant has rights; and
  • the domain name holder has no rights or legitimate interests in respect of the domain name; and
  • the domain name has been registered and is being used in bad faith.
Identical or confusingly similar

The Trump Organisation has rights in the TRUMP HOTELS trade mark.  One of Trump’s companies applied for registration of the mark on 7 May 2018.  The mark has been approved for publication, but has not yet published for opposition.  It is clear that the <TrumpHotels.org> domain name is identical to the TRUMP HOTELS mark. (Panels disregard domain name suffixes like “.org” when comparing domain names to trade marks).

Rights or legitimate interests

Mr Trump’s lawyers would argue that Mr Collins has no rights or legitimate interests in respect of the domain name.  Mr Collins would likely seek to rebut this by claiming fair use.

Paragraph 4(c)(iii) of the Policy states that a respondent can demonstrate rights or legitimate interests to a domain name if they are “making a legitimate noncommercial or fair use of the domain name, without intent for commercial gain to misleadingly divert consumers or to tarnish the trademark or service mark at issue”.

The factors that a Panel will consider in establishing “noncommerical or fair use” are set out below.

The nature of the domain name

The situation here is different from the “sucks” cases, where it is clear from the domain name that the website is a criticism or parody site (for example, <bewareoftitangarages.com>).

Panels have expressed conflicting views where a domain name is identical to a trade mark and the website at the domain name is a criticism or parody site.[1]

The dominant view is that a right to criticise does not extend to registering or using a domain name that would otherwise be considered identical or confusingly similar to a Complainant’s trademark.

Another view has been adopted in some cases involving parties exclusively from the United States.  Applying US First Amendment principles, Panels have found that even if a domain name is identical to a trade mark, if that domain name is being used for a bona fide noncommercial criticism site this may support a legitimate interest.  This position was helpfully summarised by the Panel in WIPO Case No. D2014-1821, as follows:

US jurisprudence recognizes a qualified free speech right to display a trademark in connection with genuine criticism, even in the context of a domain name identical or confusingly similar to a trademark, where there is not a commercial motivation or indicia of bad faith, such as an attempt to create a likelihood of confusion on the associated website.

While the dominant view favours the President (and his team of lawyers), a Panel may be inclined to favour the second (First Amendment) approach, given that both parties are from the US.

Circumstances beyond the domain name itself

A Panel may consider the context in which the website exists by considering circumstances beyond the domain name itself.  These circumstances may include whether the respondent reasonably believes use of the trade mark in the disputed domain name (whether referential, or for praise or criticism) to be truthful and well-founded, and whether it is clear to visitors of the respondent’s website that the website is not operated by the trade mark owner. In this case, the website <TrumpHotels.org> carries a clear disclaimer.

Commercial activity

After weighing up the above, Panels will consider whether the website at the domain name is being used for commercial gain (for example, by providing goods or services for sale or displaying pay-per-click links).  In Mr Collins’ favour, the website at <TrumpHotels.org> is clearly not intended for commercial gain.

Trump and the UDRP

Mr Trump has had his fair share of domain name disputes. Many have tried (and failed) to make use of TRUMP marks in their domain names.[2]

In Donald J. Trump v Britt Reeves, a complaint was filed by Mr Trump requesting the transfer of the domain name <trumppalace.com>. Mr Trump had registered the TRUMP PALACE mark in 2004. The Respondent was using the <trumppalace.com> domain name to re-direct users to their real estate website. In its decision, the Panel noted that the domain name was identical to the TRUMP PALACE mark. However, unlike the website at <TrumpHotels.org>, the website did not use satire.  The Panel found that the Respondent had used the domain name as a marketing lure by taking advantage of the Complainant’s famous marks, thereby satisfying the bad faith requirement.  This resulted in a finding of bad faith and the domain name was transferred to future leader of the free world.

The case of Donald J. Trump v Web-adviso provides yet another distinction to the <TrumpHotels.org> situation. This case concerned four disputed domain names that used the TRUMP mark (eg <trumpindia.com> and <trumpmumbai.com>).  The Respondent claimed that the sites were used for satire purposes and even included a disclaimer stating that they were parody and news and information websites. The Panel was not satisfied that this was true. The sites have since been taken down, but in its decision the Panel stated that “[a]ll of the video ‘parodies’ posted at Respondent’s websites were originally created by third-parties and posted at www.youtube.com”. The Respondent was described as a frequent cyber-squatter, having been found liable of cybersquatting by courts in the United States. The Panel decided in favour of Mr Trump and ordered that the disputed domain names be transferred to Mr Trump’s ever-growing domain name portfolio.

Will the “Trump” card be played?

As far we are aware – and we checked his recent Twitter posts – the President has not taken any action in relation to the <TrumpHotels.org> domain name.  However, the website has remained in the spotlight.  Last week, Twitter users reported they were unable to post about <TrumpHotels.org> website and the associated #trumphotels hashtag. According to one article, users reported that their tweets were being marked as ‘suspicious’, ‘spam’, or ‘malicious’, and were prevented from posting about the site.[3]

We are sure that there will be plenty more IP-related tussles between the President and his vocal critics.  We are keeping an eye on @POTUS for updates, so watch this space.

This article was prepared by Rebecca Slater and Kai Nash.

[1] See WIPO’s Overview of WIPO Panel Views on Selected UDRP Questions, Third Edition (“WIPO Jurisprudential Overview 3.0”) available at <http://www.wipo.int/amc/en/domains/search/overview3.0/#item24>.

[2] Fun fact: Back in 2015, before President Trump had begun “Making America Great Again”, our own John Swinson (with his WIPO panellist hat on) decided in Mr Trump’s favour in relation to the domain name <TrumpCard.com> available at <http://www.wipo.int/amc/en/domains/decisions/text/2015/d2015-0077.html&gt;.

[3] See ‘Twitter prohibits users from sharing links to fake Trump hotel website’ by Luke Barnes available at <https://thinkprogress.org/twitter-prohibits-users-from-posting-links-to-trumphotelorg-96998a76b0b4/>.

The post Domain name disputes: Will the President play his trump card again? appeared first on IP Whiteboard | King & Wood Mallesons.

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The United States Government, acting through the United States Postal Service (USPS) has been ordered to pay US $3.5 million for copyright infringement after accidentally using a replica Statue of Liberty on its 2011 Forever Stamp.  The creator of the replica sculpture, Robert S. Davidson, brought a claim against the United States for infringing his copyright over the original and protected work.  Mr Davidson has described his work to the media as a sexier version of the original Statue of Liberty. It’s a costly mistake for the USPS which has many wondering how the blunder occurred in the first place.

Background

In the mid-1990s Mr Davidson won the tender to create the ‘Lady Liberty’ statue in front of the New York-New York Hotel in Las Vegas. Throughout his passionate testimony, Mr Davidson described his desire to make the final product ‘a little more modern’ and ‘feminine’ than the original, drawing on a photo of his late mother-in-law for inspiration and making facial features softer and more well-defined.  Mr Davidson said his replica was more appropriate for Las Vegas.

In 2008, the USPS sought to update the image on its ‘Forever Stamp’ – the workhorse of the US postal system, which remain valid forever, even if the rate of postage rises. The photograph of Mr Davidson’s replica was chosen to feature on the stamp, having been presented to USPS by a contractor as a photo of the original statue. USPS paid $1,500 to Getty Images for a three-year nonexclusive licence for the photograph and proceeded with production.

In 2011, after distribution had already started, USPS found out that the image on the stamp was Mr Davidson’s work and not an image of the original Statue of Liberty as first thought. Nevertheless, with billions already printed at a significant cost, the USPS decided to continue distributing the Lady Liberty stamp without revision.

After his wife saw the stamp at her local post office, Mr Davidson filed an application for copyright registration. Once his copyright was issued in 2013, he brought proceedings against the government for infringing his copyright over his original and protected work. In its defence, the government sought to rely on non-originality, fair use, and a statutory exemption for pictorial representations of architecture.

Decision

In its judgment, the Court focused on three issues:

  1. whether Mr Davidson’s replica statue can be considered ‘original’ such that it can be the subject of copyright;
  2. whether a defence of ‘fair use’ applies; and
  3. how the damages, if any, should be calculated.

There was no dispute about whether the defendant used an image of the replica statue without permission. Despite holding a licence for the photograph itself, the Court held that USPS had no rights to the substance of the image.

Can a replica be ‘original work’?

The Court emphasised that the fundamental principle of copyright is originality, but that originality requires only a ‘minimal degree of creativity’.[1] This is an ‘extremely low’ standard,[2] which only requires the plaintiff to show the independent creation of some ‘original elements’.[3] It follows, therefore, that a work of art does not need to be entirely original for it to be copyrightable.

In this case, the Court was satisfied that Mr Davidson’s statue was sufficiently different to the original Statue of Liberty and able to be subject to copyright. In particular, they agreed with Mr Davidson’s testimony that the facial features of the replica statue evoked a more ‘feminine appeal’, noting the decision in Eden Toys, Inc. v Florelee Undergarment Co[4] which found that minor changes to an illustration of Paddington Bear were non-trivial, as they gave the bear a ‘different, cleaner look.’

Does the defence of Fair Use apply?

The United States Copyright Act provides that, in certain limited circumstances, copying protected material may be characterised as ‘fair use’ and therefore not amount to an infringement. Generally, fair use will apply in circumstances where the copyrighted material has been used for educational or non-commercial purposes, or for a ‘transformative’ purpose to create something new.

In this case the Court determined that fair use could not be established. In particular, they focused on the fact that the photo on the stamps was of the face of the statue—the most distinctive and original part. In its defence, the government sought to argue that the photo was not used for a commercial purpose (despite being sold as stamps) and caused no harm to Mr Davidson’s business. However, the Court rejected this proposition. USPS printed billions of copies of Mr Davidson’s statue and sold them to the public, collecting over $4 billion in revenue. Notwithstanding that the overall profits were low, and that USPS operates at a loss, Mr Davidson was entitled to some form of damages.

Damages

In determining the sum of damages owed to Mr Davidson, the Court considered a range of expert submissions—including opinions about industry standards for art licenses and royalties calculations, the market conditions at the time of production, and USPS’s standard approaches to both acquiring artwork and licensing its own intellectual property.  The Court was then left to craft a remedy that reflects fair market value of a non-exclusive licence in 2010, the time at which the licence agreement should have been negotiated.

The bulk of the argument centred on whether Mr Davidson was entitled to a running royalty over the entire production (upwards of four billion stamps) or only over the stamps that resulted in a profit for USPS. Although the Forever Stamp is redeemable at any date in the future, USPS estimates that a certain portion of stamps sold are subject to ‘breakage or retention’ and represent a pure profit.

Ultimately, the Court accepted that granting Mr Davidson a running royalty over billions of stamps would have made no economic sense in the context of licensing negotiations. Furthermore, Mr Davidson would have been in no position to demand such a royalty if he was approached at the time. As such, Mr Davidson was only entitled to the standard $5,000 non-exclusive licensing fee that USPS generally pays in respect of the whole stamp production.

However, the Court considered that stamps that were retained by the buyer, or were lost or destroyed, should be treated as distinct from the production run as a whole. According to USPS, the breakage and retention rate represented roughly 3.24 percent of stamps sold during the time. When applied to the total revenue collected from the Lady Liberty stamp, this amounted to slightly more than $70 million in profit to USPS. Having determined from expert opinions that an average running royalty was around 5 percent, the Court was prepared to grant Mr Davidson a running royalty over the sales of profit-earning stamps, being US $3.5 million.

Some might say Mr Davidson’s sculpture has received the ultimate stamp of approval.

A copy of the judgment can be found at https://ecf.cofc.uscourts.gov/cgi-bin/show_public_doc?2013cv0942-136-0.  Thanks to our winter clerk Rohan McPhee for his assistance with this article.

[1] Davidson v The United States (Fed Cl, No 13-942C, 29 Jun 2018) 17.

[2] Feist Publ’ns, Inc. v Rural Tel. Serv. Co, 499 US 340, 345 (1991).

[3] Davidson v The United States (Fed Cl, No 13-942C, 29 Jun 2018) 17.

[4] 697 F.2d 27, 34-35 (2nd Cir, 1982).

The post ‘Sexy’ stamp leaves United States Postal Service blushing   appeared first on IP Whiteboard | King & Wood Mallesons.

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We can all be guilty of promising more than we can deliver – but for a patentee, that can be fatal for the validity of your patent.  Under Australian patent law, inventions must be ‘useful’ in order to be patentable, and one of the complex elements of this requirement is whether any promises made with respect to the invention in the specification are satisfied.  If you promise more than your invention can deliver, your invention will be found inutile. But how is the ‘promise’ of an invention to be characterised – and what if your patent specification makes many promises?

The Full Court of the Federal Court of Australia (FCAFC) recently confirmed the applicability of the ‘Promise Doctrine’ under Australian patent law – particularly as it applies to patents that disclose ‘composite’ promises.  In its decision in ESCO Corporation v Ronneby Road Pty Ltd, the FCAFC.  held that the invention as claimed in each and every claim of a patent must achieve the promise set out in the specification – including ‘composite’ promises that may comprise multiple features or parts.

The ‘Promise Doctrine’

The requirement that an invention should be useful before it can support the grant of letters patent predates the Statute of Monopolies and, along with novelty, is one of the earliest requirements of patent validity. [1]

Over time, courts have developed several rules for assessing the utility of an invention. One of these rules requires that an applicant or patentee delivers on any promise for the invention which was made in the specification.  This rule is sometimes referred to as the ‘Promise Doctrine’.

The Doctrine finds its roots in the “False Promise Doctrine” from the United Kingdom,  which developed in the early part of the 20th Century when the grant of a patent resulted from the Crown exercising its own discretionary power. There was a presumption that the Crown granted patents on the entirety of the disclosure in the application being true.[2]

Although the requirement that a patentable invention should be useful is now a specific statutory requirement,[3] the application of the Promise Doctrine as an element of the utility requirement, continues to persist in Australia. The approach taken by the FCAFC in this case  is notably in contrast to the position in jurisdictions such as Canada, where the Supreme Court of Canada, in the recent decision of AstraZeneca Canada Inc v Apotex Inc (2017) SCC 36, declared that the promise doctrine is no longer good law as it undermines the interpretation of utility under Canadian patent law.

This case – Application of the Promise Doctrine and the question of composite promises

The patent application in this matter concerned an invention that “pertains to a wear assembly for securing a wear member to excavating equipment”.  The invention was described in the abstract of the patent as:

A wear assembly for excavating equipment which includes a wear member and a base each with upper and lower stabilising surfaces that are offset and at overlapping depths to reduce the overall depth of the assembly while maintaining high strength and a stable coupling. The nose and socket each includes a generally triangular-shaped front stabilising end to provide a highly stable front connection between the nose and wear member for both vertical and side loading. The lock is movable between hold and release positions to accommodate replacing the wear member when needed, and secured to the wear member for shipping and storage purposes.

Relevantly, paragraph 6 in the “Summary of the Invention” section, stated:

The present invention pertains to an improved wear assembly for securing wear members to excavating equipment for enhanced stability, strength, durability, penetration, safety and ease of replacement. (emphasis added)

Ronneby (who sought to challenge the validity of the patent application) argued that the promise of the invention, being “the consideration for the grant of the monopoly”, lies in attaining, in each of the claims of the patent, each and every one of the features said to produce the improved or enhanced wear assembly.  That is, every claim of the patent application should provide a wear assembly that has enhanced:

  • stability, and
  • strength, and
  • durability, and
  • penetration, and
  • safety, and
  • ease of replacement.

A failure of any claim to achieve all of these promises, Ronneby argued, would render that claim invalid.

But what was the promise?

The Federal Court at first instance declared Esco’s patent invalid for lack of utility,[4] finding that although a number of the claims delivered one or more of the promised advantages, none delivered on all six of the promises.

The FCAFC took the view that where a composite promise has been made with respect to an invention,  a failure to attain any one of the elements of that composite promise in any claim will render that claim inutile.  However, the FCAFC found that on a proper construction of the Esco’s patent application, the promise of the Esco invention as claimed was not that it would achieve each of the enhanced features identified in paragraph 6 of the ‘Summary of the Invention’.

It was noted that the standard or ‘orthodox’ approach in applying the Promise Doctrine is to look first to the body of the specification to determine what the promise(s) of the invention are, and then turning to the claims to see whether those promise(s) have been attained.  However, the FCAFC considered that in cases like Esco where the claims are variously directed to different aspects of the invention, including the different enhanced features identified in paragraph 6 of the specification, a ‘heterodox’ approach is more apt.  This involves looking at the body of the specification and then at the claims and then back at the specification. Regardless of which approach is used, it was the FCAFC’s view that the construction of the specification (when read as a whole) should not produce discontinuity or asymmetry.

Going forward

While it has been suggested that Australian courts should follow their Canadian brethren by abandoning the Promise Doctrine, the FCAFC’s decision in this case shows that, at least for now,  it remains a key element in assessing whether an invention has met the statutory “usefulness” threshold.  Whether the orthodox or ‘heterdox’ approach to patent construction is adopted, the conclusions reached by the FCAFC in this case highlights the importance of ensuring that care is taken when describing outcomes said to be achievable by the invention as claimed.

The author wishes to thank Sally Knowles-Jackson and Veg Tran for their assistance in the preparation of this article.

[1] McEniery, Ben, ‘Patent Eligibility and Physicality in the Early History of Patent Law and Practice’ (2016) 38(2) UALR 175, 181.

[2] 2017 SCC 36 [AstraZeneca] at paras 34, 35.

[3] Section 18(1)(c) of the Patents Act 1990 (Cth) for standard patents and section 18(1A)(c) for innovation patents.  As in the case of the Patents Act, 1952 (Cth), lack of utility was not a ground for pre-grant opposition. Lack of utility was introduced as a ground for pre-grant opposition by the US Free Trade Agreement Implementation Act 2004 (Cth). Following the passage of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012, it has also become a ground for re-examination.

[4] ESCO Corporation v Ronneby Road Pty Ltd [2018] FCAFC 46.

The post Promises, promises: Full Federal Court of Australia finds invention useful in ESCO Corporation v Ronneby Road appeared first on IP Whiteboard | King & Wood Mallesons.

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The Intellectual Property Laws Amendment (Productivity Commission Response Part 1 and Other Measures) Bill 2018 seeks to introduce yet further changes aimed at improving Australia’s intellectual property laws.  The proposed amendments to the Plant Breeder’s Rights Act, 1994 cover many key aspects of Australia’s plant breeders’ rights regime and are expected to have a significant impact on the agricultural sector.  For interested readers, we have prepared this AgThinking article.

The post Australian Plant Breeders’ Rights to be significantly strengthened appeared first on IP Whiteboard | King & Wood Mallesons.

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As we wrap up our week of insights on the biotech industry and coverage of #Bio2018, what is clear is that for many biotech innovations, the story is just beginning. From landmark developments in genetic engineering techniques, the integration of AI and digital technologies into health care products and services and the increasing investment in genomics based medicine, perhaps the words of BIO president and CEO, Jim Greenwood, best captures the future of this industry: “My friends, this is the power of biotechnology”.

For those interested readers, the following articles are also available on IP Whiteboard:

We hope you will continue to follow our blog and LinkedIn posts as we continue to report on key biotech trends and issues.

#Bio2018: Our “live” report from Anna Feros

For those readers following our program on IP Whiteboard.  Part 1 of our #BIO2018 update focussed on sessions and industry updates.  This Part 2 will focus on the other benefits of BIO – partnering and partying (aka networking).

BIO’s popularity has not waned.  This year, it officially broke the Guinness World Records title for the Largest Business Partnering Event (yes, that is a thing).  Partnering is a major reason why people come to BIO.  Partnering is literally getting down to business with companies signing up to pitch ideas, products and services and companies signing up to be pitched at.  The most obvious ‘pitchees’ are big pharma, who are very popular with full partnering meeting diaries but are also very keen to hear from smaller companies with licensing opportunities to help big pharma build their pipeline.  My vendor contacts tell me that partnering has become more aggressive in that many companies actively screen out vendors from partnering – which is a disappointing development as a good service provider can be worth their weight in gold.

Before the partying, a little on some of Wednesday’s sessions.  The keynote plenary session included the CEO of Alnylam Pharmaceuticals who touched on how there had never been a more favourable regulatory environment for drug development with a choice of truncated pathways to approval and how “real palpable innovation ultimately means real patient impact”.  The CEO of Alkermes spoke about the patient perspective being enormously important and this led nicely into a discussion about the very topical opioid crisis being the “public health crisis of our time” and that medicines alone are not sufficient to fix the crisis – comprehensive support and the understanding of the patient’s and their family’s point of view is vital.  The director, Rob Reiner, was then introduced and after a highlights reel of his works, we moved on to discuss the very real impact of prescription drug addiction and his son.  Out of this experience, he and his son, Charlie, worked together to make the film “King Charlie” which is an honest look at addiction, the lucrative industry of unregulated rehab, and discrimination regarding substance abuse disorders.

The super session on precision medicine focussed on the possibilities of patient electronic records, “real world data” and AI.  Real world data is the data currently held but in general, most of it is not particularly usable so there is a need to determine what data to collect and how to better collect it.  The promise of electronic patient records is also problematic as much of it is unstructured and many physicians still work in a world of handwritten notes with test results simply included in a patient file with no comprehensive analysis.  Therefore, the challenge is how to take that data and raise it to the level of quality of patient data that results from clinical studies so it is reliable and of real value.  If we can get it right, the real world data can be used as an evidence base to feed into real world care and ultimately the hope is to have “synthetic control arms” in clinical trials which will greatly reduce the cost of studies.  This is where the potential of AI comes into play but at the moment, it is still very much in the realms of potential.

Lastly, although many are dubious about the term “networking”, it is a mainstay of industry conferences and BIO is no exception.  BIO presents an opportunity to catch-up with interstate and international clients and contacts who all converge for a few days in the one city with the primary intention of having meetings.  In addition, although it sounds counterintuitive, the best networking is often done with your home crowd as you are all in the one place at the same time with no distractions so everyone is more convivial and willing to catch-up over drinks.  Just the act of hanging out at the Australia pavilion (thank you #AusBiotech) and having chats with those there in between sessions and other meetings, provides many opportunities that cannot be planned but have borne fruit.  In fact, it is this informal networking that is far more effective than the large formal events but then who is going to turn down some international disco with Diana Ross?

Thank you Bio2018 for another great event.  We’re already looking forward to BIO2019!

The post #BIO2018: Gene therapy, AI in healthcare, precision medicine and Diana Ross – The power of biotechnology appeared first on IP Whiteboard | King & Wood Mallesons.

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Continuing our series on biotechnology for #Bio2018, this post looks at the development of new gene editing and genetic engineering techniques – a key trend shaping the biotechnology industry.  

New genome editing techniques, such as CRISPR/Cas9, have made editing genomic material cheap, efficient and accessible.  These new techniques have opened up a plethora of opportunities for scientific progress previously considered decades away.  For governments around the world, however, novel genome editing techniques present a regulatory challenge – governments must consider whether frameworks designed for traditional genetic engineering techniques remain suited to address newer techniques like CRISPR/Cas9, zinc finger nucleases (ZFNs) and transcription activator-like effector nucleases (TALENs).

Australia’s current regulatory system for gene technology comprises a patchwork of organisations administering an assortment of national regulations, guidelines and principles.  As shown in the diagram below, this system provides mixed coverage depending on the end-use of the genetically modified material and the development stage of the application. Questions remain however and the application of laws regulating genetically modified organisms (GMOs) and genetically modified foods (GM foods) produced by, or involving, genome editing are uncertain.  For example, are organisms modified by CRISPR/Cas9 ‘genetically modified organisms’ within the meaning of the legislation?  This arguably depends on whether the edit to an organism’s genome introduces new genetic material or simply involves the deletion of a mutation.

The Australian Government is proactively considering these uncertainties and the suitability of existing regulatory systems as they relate to new genome editing techniques.  In particular:

  • Australia’s chief gene technology regulator, the Office of the Gene Technology Regulator (OGTR), has initiated a technical review of genome editing techniques. Submissions on proposed amendments to the Gene Technology Regulations closed in February 2018 and the OGTR is now considering the issues raised in submissions and formulating draft amendments.  More information on the reforms, as well as an exposure draft of the proposed amendments, can be found here.
  • Food Standards Australia New Zealand (FSANZ), the statutory authority responsible for developing food standards in Australia, is evaluating the suitability of the Food Standards Code to appropriately regulate foods derived from new breeding techniques. FSANZ released a consultation paper in February 2018 and a preliminary report will be published in July 2018.  For more on these reforms, you can read about them here.

We will be watching developments in these areas with interest!

The post ‘Thought’ piece: Gene editing and genetic engineering techniques appeared first on IP Whiteboard | King & Wood Mallesons.

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Couldn’t make it to #Bio2018? This week, Anna Feros reports on her insights from the BIO International Convention in Boston, hosted by the Biotechnology Innovation Organization (BIO), which represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations. 

The first full day at BIO2018 kicked off with an inspirational keynote session led by BIO president, Jim Greenwood, who raised his key theme of inclusion by way of the “BioDiversity Initiative” to drive diversity at the executive level in the industry and “truly embrace meritocracy”.  He then also touched on some of the hot biotech topics of gene editing in terms of CAS and CRISPR and the new applications to not only turn genes off and on but to “dial them up or down” and how this can be applied to many sectors including being viewed as an extension of traditional breeding of livestock.

Turning to introducing the first gene editing patient survivor who was greeted with a standing ovation, Greenwood focused in on transitioning the clinical approach from patients as subjects to “partners as partners” in the development of new treatments. Then to sprinkle some celebrity dust, Robin Roberts from ABC’s Good Morning America inspired the audience with her story of not only surviving cancer but then going to survive MDS (myelodysplasia) and profusely thanking the biotech community for the gift of stem cell technology without which she believes she would not have survived.

With 16 tracks of sessions plus super sessions and keynotes, there is even more to choose from at BIO this year.  The tracks embrace everything from digital health, IP, translational research, biofuels and renewables, opioids, regulatory, corporate best practices though to personalised medicine and diagnostics.  Where to start?

The vaccines supersession produced invaluable insights from its panel of big pharma and smaller biotechs emphasising the value proposition and working with public health organisations.  Also stressing how vaccines are often the unsung heroes as they work away to protect people in the background. Many issues abound including lifecycle management and the continuing hunt for a universal flu vaccine.  Mixed in with emerging infectious diseases and outbreaks such as Ebola and Zika, management of vaccine development and manufacturing levels has many issues including the continuing debate about what sort of model is best placed to access innovation.  Debating how to deal with public malcontent and fear of vaccines was also touched upon with a plug for the way the Australian government stood firm on the HPV vaccine representing a stable position of “science backed by government”.

Another supersession on deal trends in the last 10 years picked up the usual themes of the continuing no.1 popularity on immune-oncology with the microbiome and CAR-T also trending highly.  Small molecules and humanised antibodies are now considered to be on the wane as low hanging fruit that has largely been picked. Interestingly it was speculated that 2018-2019 may match the highpoint of dealmaking done in  2015.  In music to industry ears, apparently M&A is up, VC fundraising is at unprecedented levels in terms of the size of funds all raising the query are we in a golden era of biotech?  Apparently money is pouring into the industry also with China endorsing the trend with a clear intention to be a big player in the pharma market.  Early-stage in-bound deals are getting harder though but the “IP sweet spot” is after proof of concept.  Encouragingly for the Australian biotech industry both AbbVie and Genentech singled out Australian research as a pipeline source that is much overlooked and that they should be encouraging players to not forget about looking outside the US for partners.

And so with the myriad of today’s evening networking events completed (for most of us at any rate), we now look forward to kicking off Wednesday’s sessions with  a keynote session with the director, Rob Reiner and the chemistry of addiction.  BIO knows how to draw a global crowd and this year is no exception … the closing event tomorrow is to be headlined by Diana Ross.  Perhaps the industry really is entering a golden era …

Stay tuned for Anna Feros’ updates as #BIO2018 continues!

The post #BIO2018: KWM report from the Bio 2018 Convention (Part 1) appeared first on IP Whiteboard | King & Wood Mallesons.

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As keepers of the world’s ‘big data’, many of the major tech companies  are naturally well placed to turn to the data-hungry development of artificial intelligence, or AI.  And while AI is a hot topic in almost every industry, its presence and potential application in healthcare is exploding.

AI – what is it exactly?

In the simplest sense, AI is a computer system that can reason and perform a task in a human-like way.  This can mean computer systems that are able to learn, communicate, make decisions and solve complex problems on their own.

Traditionally, AI’s application in medicine has been limited to the use of algorithms to analyse data and suggest diagnoses or recommend treatments.  An example is the treatment of cancer.  By feeding patient data into algorithms, a computer can review treatment alternatives and recommend a combination of chemotherapy drugs for a particular patient.

But these algorithms have, until recently, required intensive human effort to define and label data before subjecting it to analysis – necessarily, therefore exposing it to at least some level of human bias and error.

A more advanced step in the AI chain is “machine learning” – a type of computer data analysis that finds patterns in data and, in doing so, learns from the experience.  Machine learning is, in other words, a kind of “smart” algorithm.  It mimics the way the human brain processes data through probabilistic analyses.

Another form of AI is “deep learning”, a variant of machine learning which simulates neural “layers” that can each be trained to identify and integrate visual, aural and other variants to generate an outcome.  The layers of software neurons each learn patterns in different features, like colour and shape.  This enables deep learning systems to solve problems of far greater complexity than other forms of machine learning.

The promises and challenges of AI in medicine

AI has the potential to contribute to the diagnosis, treatment and prevention of disease, and provide more targeted healthcare to more people at lower cost.  Through the use of predictive analytics, AI has potential applications across almost every facet of healthcare, spanning from administrative through to clinical contexts.

One example of an application of deep learning comes from experimentation with algorithms that scan the retina to assess blood pressure and risk for heart attack or stroke.  The research, conducted by Google and its life sciences subsidiary Verily, relies on the fact that diseases like diabetes and high blood pressure can cause visible changes in the retina.  The research involved scanning hundreds of thousands of patients’ eyes and embedding this data into the algorithms for review.  The deep learning systems then established and learned patterns that reveal signs of pathology.  The potential for this technology in risk prediction is, demonstrably, enormous.

AI might also have a role to play on the hardware side of healthcare through applications like robot-assisted surgery – another project Verily is undertaking in partnership with Johnson & Johnson.

But AI still has vulnerabilities.  One weakness, in particular with deep learning systems, is a cultural one.  Computer-based diagnostic tools, for instance, analyse data and produce predictions based on a series of algorithms – but do not provide the patient with how or why the conclusion was reached.  Widespread implementation is dependent on significant demand and an enormous level of patient trust as well as an acceptance by clinicians and patients of digital monitoring and treatments.

Where does this leave pharmaceutical companies?

It’s clear that the development of AI applications in healthcare is changing the landscape of the healthcare industry, shifting dominance from traditional healthcare providers to big tech firms.  This trend is a result of the fact that giving computers enough understanding of the world to do useful things requires quantities of data, processing power and computing infrastructure that only big tech has the means to mobilise and develop.

But AI in health does present opportunities for collaboration between tech and pharmaceutical companies.  One example is in the field of digital therapeutics – or ‘digiceuticals’ – essentially, apps that are subject to regulatory approval processes and prescribed by doctors.  Take diabetes, for instance.  Diabetes digiceuticals essentially monitor markers through sensors or through user input, collate this information, and use it to more effectively manage the disease.  The development of these apps is dominated by tech startups and they are being developed to treat a range of conditions such as addiction, depression and schizophrenia.

AI applications can also be adapted to meet pharmaceutical companies’ research needs, increasing efficiency and automation to drive R&D.  Pharmaceutical companies have been partnering with AI-driven startups to apply AI to drug discovery by synthesising vast amounts of data relating to, for instance, toxicity, absorption, metabolism and excretion, to find promising drug candidates and even repurpose existing drugs to other indications.

What’s next

Stakeholders have been trumpeting the potential of AI to reinvent healthcare for decades.  It seems we are finally at the point where AI can start to make good on promises to provide wider access to better health outcomes at lower cost.  Some applications of AI, such as in the field of drug discovery, might take years to have a tangible effect on the industry.  Others, like digiceuticals, are already empowering patients and changing the model of disease diagnostics and management.

Despite its challenges, AI projects are driving change in the healthcare industry.  Industry players, healthcare providers, and patients – take note!

The post How AI is shaping healthcare appeared first on IP Whiteboard | King & Wood Mallesons.

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For those readers interested in the issues surrounding competitive moves by pharmaceutical companies in the scenario where a key patent comes to an end, we report on the recent decision of the Full Federal Court in the ACCC v Pfizer matter here: ACCC v Pfizer – KWM News & Insights

The post The final word and ‘smoking gun’ documents – ACCC v Pfizer appeared first on IP Whiteboard | King & Wood Mallesons.

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15 years has passed since the Human Genome Project, involving the identification and mapping of all the genes of the human genome, was declared complete. Work on the project (which formally started in 1990 and spanned 15 years) involved international collaboration between scores of scientific researchers and funding of ~US$3 billion. As one of the world’s greatest collective scientific endeavours, the successful unravelling of the human DNA sequence has paved the way for vast developments in biotechnology innovation and opportunities for advancements in a wide range of fields, from food and agriculture and animal husbandry through to high value human therapeutics.

Biological and molecular medicine has emerged as one of the most anticipated applications of the DNA sequence, with biopharmaceuticals (or biologics) based on recombinant DNA technology and pharmacogenomics-led drug therapy widely capturing the interests of the biotech and healthcare industries.

Using drugs that are gene based or extracted from biological materials, or based on an individual’s unique genome, offers the promise of targeted treatment for illness and disease that is more precise, potentially more effective and with fewer side effects than traditional pharmaceuticals.

But will these biotech advancements fulfil their promise?

Annual global sales of biopharmaceutical medicines are now worth over US$200 billion and represent 20% of the total pharmaceutical market.

Pharmacogenetics, the study of single genes that have major effects on the action of particular drugs has been a recognised science since the 1950s. Pharmacogenomics subsequently developed as a related discipline through realisation that the controls of most drug responses are multi-factorial. However, the growth of pharmacogenomics has really only been made possible recently with advancements in methods that allow the study of multiple genes or gene patterns, such as high throughput sequencing technologies.

Through a deeper understanding of the influence of genetic variation on drug response and the accumulation of knowledge of an individual patient’s genotype, the promise of pharmacogenomics-led drug therapy is that the administration of drugs and other therapies may be made more precise and personalised and could even allow for preventative treatment through predictive prescribing.

However, despite the promise that biologics (particularly those based on gene, cell or tissue engineering) hold for providing a novel range of biological medical products and solutions to problems associated with the delivery of effective and less invasive therapeutics, the roadmap for biopharma and genomic medicine companies hoping to secure a piece of this burgeoning market involves many structural, legal, regulatory and ethical challenges.

So what are the issues that the industry will have to face in 2018 (and beyond)?

Biopharmaceuticals

Pharmacogenomics-led drug therapy

 

 

 

The post Is the cure in your DNA? – The rise of biopharmaceuticals and pharmacogenomics-led therapy appeared first on IP Whiteboard | King & Wood Mallesons.

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