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Article 3d of the SPC-regulation, read in conjunction with Article 1b, must be interpreted as meaning that the marketing authorisation for a new formulation of an old active ingredient cannot be regarded as being the first marketing authorisation for that product, when the active ingredient has already been the subject of a marketing authorisation.

The European Court of Justice (CJEU) handed down its ruling today in the case C-443/17 between Abraxis Bioscience LLC and the Comptroller General of Patents. The reference for a preliminary ruling came from the UK High Court of Justice, where Abraxis sought annulment of the Comptroller’s decision to reject the SPC application for a combination of substances containing the active ingredient paclitaxel in the form of nanoparticle bound to albumin (nab-paclitaxel).

Already before Abraxane (the market name of the medicinal product containing nab-paclitaxel), was put on the market, paclitaxel was marketed for use in eliminating cancer cells. Nab-paclitaxel is a new formulation of paclitaxel, marketed also for use in cancer treatment. Nab-paclitaxel is protected by that basic patent relied upon for the SPC application, but the protection conferred by that patent does not extend to paclitaxel as such.

The preliminary ruling concerned the understanding of Article 3d of the Regulation (EC) 469/2009 (the SPC Regulation), namely if the marketing authorisation for nab-paclitaxel was to be considered as the first authorisation to place the product on the market as a medicinal product.

The national court had asked the CJEU to clarify the scope of the earlier Neurimjudgement (C-130/11), which sets out that the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product, if such application is within the limits of the protection conferred by the basic patent. Specifically, the national court asked if the points of principle in Neurim apply also to new formulations of the product, and not only to new therapeutic uses.

The CJEU answered this in the negative. Firstly, the CJEU refers to the narrow and strict interpretation of ‘product’, and reminds us that a carrier which does not have any therapeutic effects of its own cannot be regarded as being an active ingredient within the meaning of Article 1(b). Consequently, the Court says, a new formulation of an old active ingredient, which, such as nab-paclitaxel, consists of that active ingredient and a carrier which has no therapeutic effect on its own linked together in the form of nanoparticles, cannot be regarded as being a product distinct from the product consisting solely of that active ingredient even if such a formulation allows that active ingredient to exercise its therapeutic effect with increased efficacy.

A literal interpretation of Article 3d presupposes that “the first marketing authorisation for the product” is the first for a medicinal product incorporating the active ingredient or the combination of active ingredients at issue. Therefore, only the authorisation in respect of the first medicinal product placed on the market, consisting of the product concerned, may be regarded as the first marketing authorisation within the meaning of Article 3d.

So, how does that fair with the Neurim teaching?

That is maybe not so clearly spelled out by the CJEU. Rather, the Court focuses on what the Neurim judgement does notsay. In summary, the Court says that Articles 3 and 4 of the SPC-Regulation must be interpreted as meaning that, in a situation such as that in the case which gave rise to that judgment, the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the SPC application.

However, the Court did not, in that judgment, cast doubt on the narrow interpretation of the notion of ‘product’.  Moreover, it should be noted that the exception to the narrow interpretation of Article 3d as held in the Neurim judgment, does not, in any event, refer to cases of a new formulation of the product at issue. That exception cannot, therefore, in any event, be relied on in the case of a marketing authorisation granted for a new formulation of an active ingredient which has already been the subject of a marketing authorisation, even if the marketing authorisation for that new formulation was the first to come within the scope of the basic patent relied on in support of the SPC application.

The Advocate General had suggested that the Neurim teaching should be limited to the situation where the one marketing authorisation was granted for veterinary use, and the other for human use. The CJEU does not specifically address this, but one may note that the Court has included a reference to one of the marketing authorisations being for a veterinary medicinal product and the other having a different application.

In conclusion, the CJEU has succeeded only in clarifying that the Neurim judgement is an exception to the narrow interpretation of Article 3d. The exact scope of that interpretation, other than that it is not applicable to new formulations of previously authorised products, is still not specified. Again, it is difficult to see a clear path of the guidance from the CJEU, and it remains to be seen if this is only an isolated ruling within the SPC regime, to set boundaries for our understanding of the Neurim judgement, or if it is a swing of the pendulum in the direction preached by the Advocate General.

If you have any questions on the prosecution of supplementary protection certificates, please feel free to reach out to Louise Jonshammar using louise.jonshammar@awa.com

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Louise Jonshammar takes a closer look at the final mandate surrounding export waivers for European Supplementary Protection Certificates, what it means for applicants and holders and the importance of monitoring once the Regulation comes into effect

Supplementary Protection Certificates (SPC) offer patent owners an extension of up to five years of the basic patent’s protection period in order to compensate for the time needed to complete marketing procedures, which can take an extended period of time and during this time the owner cannot commercially exploit the active ingredient.

The export waiver was originally announced in late 2015 as part of the European Commission’s Single Market Strategy. This initiative proposes to introduce an exception to let EU firms manufacture certain pharmaceuticals for export to non-EU markets during the term of the SPC. In terms of the Strategy, it is a targeted recalibration of certain aspects of patent and SPC protection.

Essentially, the European Commission understands that the current SPC system puts makers of generics and biosimilars established in the Union at a significant competitive disadvantage compared with makers based in third countries (outside of the EU). It further assumes that without any intervention, the viability of makers of generics and biosimilars established in the Union could be under threat, with consequences for the Union’s pharmaceutical industrial base as a whole.

Since 2015, several studies and public consultations have been conducted that generally support the waiver and in May 2018, the European Commission announced a legislative proposal to introduce an export manufacturing waiver into Regulation (EC) No. 469/2009. On January 16, 2019, the Council of the European Union published its final mandate for negotiations with the European Parliament. There were several changes between the Proposal in May 2018 and the January 2019 Mandate, this article considers the waiver in its current format as set out in the Mandate.

Waiver Application

The Mandate covers two general categories for application: (i) all SPCs applied for after the waiver enters into force and (ii) from July 1, 2022, all SPCs (including granted and pending SPCs at the date the waiver enters into force) that come into effect after the waiver enters into force.

The following diagram is based on the comments and proposal from the Legal Affairs Committee (JURI) that was submitted on November 22, 2018. It has been updated to reflect the July 1, 2022 entry into force, and captures the scope of application as set out in the Mandate:


For Category (ii) the waiver applies to all SPCs that enter into force after the legislation is passed. This means the waiver shall ultimately apply to all SPCs that enter into force after the legislation is passed and which are enforceable on or after July 1, 2022. The waiver also covers certain SPCs that have been applied for and/or granted before the legislation is passed. Some SPCs might come into force without being subject to a waiver, but subsequently become subject to the waiver on July 1, 2022. Consequently, only SPCs for which the term expires prior to July 1, 2022 will be entirely unaffected.

Waiver Safeguards

The Mandate puts forth several safeguards to ensure SPC holders are notified and that the export waiver operates within the permissible scope of the Regulation. Notice is to be given no less than three months prior to conducting activities directly to the SPC holder and the local IP authority (who will be responsible for publishing the notice).

The information on the notice is limited to what is necessary and appropriate for the SPC holder to assess whether the rights conferred by the certificate are being respected.  The notice should not include confidential or commercially sensitive information and there is no obligation to list the date on the notice for when activities may commence. This means the SPC holder will only know that this is at least three months away.


The Mandate sets out the application of an EU Export Logo (see image to the right taken from the Mandate). This logo is to be affixed to the outer packaging and where feasible the immediate packaging.

Guidance

It is possible the amendment to the SPC Regulation will be achieved by May 2019. Turning to the UK, if it is not passed by March 29, 2019 and a Withdrawal Agreement is not in place it is uncertain if this legislation will apply to the UK. It remains to be seen what affect this will have on the UK and until clarity around Brexit ensues it is difficult to make any assertions.

It is worth noting that the waiver only exempts the exclusive rights of the SPC. If the SPC basic patent is a product patent, but there is also a later process patent providing some protection for the medicinal product, generics or biosimilars may be hindered by such patent. Thus, overlapping protection may become even more useful in the future.

It may also help to monitor the generics market entry and to follow the supply chains. The manufacturer shall apply due diligence and is responsible for informing persons within the supply chain that the medicinal product is covered by the waiver and intended for the exclusive purpose of export. If the manufacturer does not meet the information responsibility, the exception does not apply, and the production instead entails infringement.

In particular, monitoring is recommended because if SPCs are in place in other jurisdictions, then the generics or biosimilars being made in the EU cannot be exported to that jurisdiction. If the medicinal product is exported to such a jurisdiction, this will be in breach of the waiver requirements and not only constitutes infringement in that jurisdiction but also in the EU country where they were produced.

If you have any questions on the waiver or SPCs, please feel free to reach out to Louise Jonshammar using louise.jonshammar@awa.com

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In October 2018, UK luxury goods brand Dunhill announced that it had won a trademark battle against Chinese menswear brand Danhouli. The Foshan Intermediate People’s Court in Guangdong Province awarded Dunhill Rmb10 million (approximately $1.5 million) in an infringement case involving its well-known mark.

The court also determined that Danhouli was guilty of unfair competition practices and found the individual in charge of the Chinese company personally liable for infringement.

Media channels around the world called it a landmark win for trademark litigation in China. There is no doubt that this is a win for Dunhill and that the damages awarded are signicant. However, before conclusions can be drawn as to whether this is truly a landmark case, some of the details leading to the judgment must be considered.

The adverse party selected a similar-sounding name – Danhouli – and replicated the elongated vertical lines and lower-case lettering of the Dunhill logo – essentially creating a copycat brand identity (see comparison below).

Both Dunhill and Danhouli had registered trademarks in China. Below are application records for Danhuoli filed by the defendants.

Meanwhile, Dunhill filed a trademark application for the word mark below in connection with clothes and fashion items in Class 25 in 1982, which was granted in 1983 and remains valid.

A subsequent registration included the stylised mark below, which was filed in 1996, registered in 1997 and remains valid.

From 2002 to 2007, Dunhill further filed applications for the following series marks in Class 25:

Dunhill also has prior registrations for series marks in Classes 18, 24, 26 and 35. All of these registrations were granted many years before Danhouli’s applications in such classes.

Danhouli operates more than 200 franchise stores across 61 Chinese cities and generates annual revenues of Rmb100 million (approximately $14.7 million).

This has been a long battle for Dunhill – its win here did not happen quickly and would have been part of a major effort on its part against the infringing party.

One of the determining factors in this case was Dunhill’s early registrations on all fronts. Without this it is possible that the case could have gone another way.

This case serves as an important reminder to trademark owners to remain vigilant in this market – early registration is essential as China is a first-to-file regime.

Danhouli had been operational for years by the time the case was heard by the Intermediate People’s Court in Foshan. Not only was it operational – it was incredibly successful – with close to $15 million in annual revenue.

The infringing mark was incredibly similar to Dunhill’s and in many jurisdictions this case could have been an easy and early victory. In China, enforcement of trademark rights is a long process. In practice, judges are reluctant to find trademark infringement unless marks are identical.

The amount awarded ($1.5 million) is definitely the exception rather than the rule. It is rare to see damages this high and until it becomes commonplace trademark owners cannot expect this kind of award.

China is a challenging jurisdiction from an IP perspective. Even though the landscape is changing and the business community has felt an increase in enforcement and witnessed positive legislative changes, it is important for IP owners to remain vigilant.

This is especially true for trademark owners, as the market is so crowded. The China Trademark Office received a record breaking 5.748 million applications in 2017. Not only is this the highest number of applications from a single country in the world but the pace shows no sign of slowing down as that number is up 55.7% year on year.

This article first appeared on WTR Daily, part of World Trademark Review, in January 2019. For further information, please go to www.worldtrademarkreview.com.

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Joacim Lydén and Simon Markström share their insights from CES 2019 on the latest technologies being developed and the challenges that still remain

CES or the Consumer Electronics Show in Las Vegas is the world’s largest trade show, attracting over 4,400 exhibitors from all over the world and has a total attendance of 182,000 people. The trade show encompasses consumer electronics in the broadest sense – from light bulbs to helicopter drones – everything is on display.

The most impressive part of CES 2019 was the large automotive section. Autonomous vehicles, transportation pods, electrical trucks and passenger drones were extensively displayed. Innovation in this sphere not only stems from companies rooted in the automotive industry, but also from companies with completely different technology backgrounds.

Automotive giants like Audi, BMW and Mercedes displayed their vision for the future of transportation alongside tech companies like Google and Baidu. There were also joint initiatives like the Kenworth Toyota fuel cell tuck and start-ups like K-Byte or Swedish Einride.

From discussions with these companies it became clear that despite the multiplying research resources available in this field, challenges still remain. Fully autonomous vehicles that can handle all types of weather and traffic are still a long way down the road. One of the remaining challenges is the transfer and management of vast amounts of data. This data is needed to make accurate predictions about the erratic behaviour from human drivers that autonomous vehicles share the road with. The solution to the data challenge lies in increased access and validation of data, new wireless technologies like 5G, and both local and remote processing of data with the use of neural networks. Aside from technical challenges, many view the alignment of regulations, formulating standards and raising consumer confidence equally difficult obstacles.

Voice controlled assistants like Siri, Alexa and Google were given vast marketing space throughout CES. Companies from all areas of technology displayed products and services with the tech giant’s assistants deeply integrated into its functionality. Without even opening your eyes: you may brew your coffee, get your floor vacuumed, learn to play the piano or get a status update from your company’s ERP-system on today’s profit level.

Artificial Intelligence (AI) was the buzz word throughout CES and it was used most frequently to refer to a concept similar to Kaizen in operations, instead of a single technology. It is a way of thinking in terms of automated improvement and updates. AI is gradually becoming part of all technology as systems and products are being designed to engage in constant self-learning.

The development of autonomous vehicles, voice-controlled assistants and the implementation of AI all share a common feature – they require and generate data on a level that is hard to grasp. It is also becoming clear that the data itself is a valuable asset for making the technology work, for example avoiding collisions or providing users with answers to requests. To benefit from the vast amounts of data, AI needs human intelligence to validate and tag the contents which gradually adapts the perception of the AI in-line with human perception. This ultimately makes the AI understand human behaviour and communication.

One example many are familiar with is the reCAPTCHA validation tools, where users are required to choose pictures of road signs or store fronts in order to validate that they are not a computer. These processes are in fact a way of mass-crowd generating validated data for autonomous driving. While you are establishing to the security system that you are not a computer, you are also assisting  computers in learning to perceive the images in the same way humans do. Odds are that we will see increasing creativity in the ways of collecting human input on data contents, especially as the amount of data collection increases.

Another trend at CES was strategic partnerships allowing commercialisation by crossbreeding different technology fields. The need for collaboration is partially driven by the increasing specialisation required to develop the best technology but crossbreeding also enables win-win situations where synergies arise that would otherwise not be achieved.

A key tool in achieving effective collaborations is working with intellectual property managers to capture, define and package knowledge into transferrable business objects.

Crossbreeding between parties with known brands combines loyal customer bases as well as the products, resulting in a better outcome than what would have been possible by only one of the parties. A key tool in achieving effective collaborations is working with intellectual property managers to capture, define and package knowledge into transferrable business objects. This includes ownership of the copyright protected data sets generated by users and often owned by the major service providers.

The future will undoubtedly bring many new technologies, with products and services constantly being launched and intimate collaborations between different companies. Humans and machines will most certainly play a central part.

If you have any questions or thoughts on these trends, wish to hear more about our trend scouting or how to safeguard intellectual property during collaborations, please do not hesitate to contact us.

Joacim Lydén, Partner, European Patent and Design Attorney, joacim.lyden@awa.com

Simon Markström, Partner, European Patent Attorney, simon.markstrom@awa.com

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On 7 November 2018 the Riksdag (supreme decision-making body of Sweden) voted in favour of modernising and simplifying the Trademarks Act. The changes came into effect on 1 January 2019.

The motivation behind the amendments is to align Swedish trademark law more closely with that of other EU member states and is based on the EU Directive (2015/2436).

The changes are also closely connected to EU Trademark Regulation (2017/1001), taking into account the Court of Justice’s interpretations of EU trademark law.

Highlights

The updated Trademarks Act stipulates that a filing date will be assigned to all applications (previously there were no such requirements as long as what has been submitted to the office could be interpreted as an application).

The condition that marks must be presented by graphic means has been removed and the requirements for presenting trademarks are now technology neutral. This means that all clearly representable signs will be eligible, as long as the authority and the public can plainly understand the protection being applied for or granted. This makes it easier to register sound marks, and for the first time motion trademarks can be registered.

The amendment states that counterfeit goods in transit passing through Swedish customs will be presumed to be infringing trademark rights. The authorities can seize the goods (without considering the owner’s objection), but they cannot destroy them.

If a trademark owner claims infringement before the court, the legal owner of the goods must bear the burden of proving that the goods are not counterfeit. It must prove that the goods were destined for another country and are considered non-infringing goods in that destination country.

In terms of opposition proceedings, changes to the law include a two-month cooling-off period in which either party can request and provide a timeframe to facilitate negotiations between themselves during an opposition.

Requirements on genuine use have tightened under the amendments. If the counterparty (in both cancellation and infringement proceedings) objects on the grounds that the older mark (more than five years old and registered) is not being used, the owner of the older mark must prove genuine use to claim, use or invoke that prior right against the other mark. However, the courts and authorities will not assume genuine use. Proving genuine use means providing evidence that the mark was used within five years of the initiation of court proceedings.

This requirement places a heavier burden on trademark owners to prove genuine use while easing the burden on the objecting party during cancellation and infringement proceedings.

Company names

A new law on company names will enter into force at the same time as the amended Trademarks Act. A key point is that a trademark owner may hinder the registration for a company name (for that trademark) and vice versa. This applies regardless of whether the business uses the name in question as a mark for goods and/or services. Because of this, the rules with regard to crossover protection have been heavily criticised. Objections were raised during a review of the Trademarks Act, and lawmakers did not take the opportunity to adjust this point.

A Swedish trademark can be partially revoked while a company name cannot. A company name can only be revoked in its entirety, resulting in the requirement of use being lower for company names than for trademarks.

In certain situations, it is more difficult to revoke a company name based on non-use than a trademark. In other words, the requirement of use can be bypassed by taking advantage of this crossover protection.

A change in the law would have opened up cases for partial invalidity of a company name (for part of its business activities), which lawmakers sought to avoid because it would cause issues with regard to the scope of protection for a partially valid company name.

The government has commented on the increasingly important role of trademarks in company development, both in Sweden and globally, and observes that for Swedish companies to be able to compete in the best possible way, the rules need to be simple, predictable and neutral.

This article first appeared on WTR Daily, part of World Trademark Review, in December 2018. For further information, please go to www.worldtrademarkreview.com.

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Sweden, Denmark and China succeed in Latest WTR 1000 Rankings

The 2019 Edition of World Trademark Review 1000 – The World’s Leading Trademark Professionals has been published.

 

Now in its ninth year, the WTR 1000 shines a spotlight on the firms and individuals that are deemed outstanding in this critical area of practice. The WTR 1000 remains the only standalone publication to recommend individual practitioners and their firms exclusively in the trademark field and identifies the leading players in 70 key jurisdictions globally.

In Sweden, AWA tops the prosecution and strategy ranking in the gold banding and for enforcement and litigation is listed in the silver banding. For the first time, Kristian Martinsson joins Magnus Hallin in the prosecution and strategy listing for leading individuals.

In Denmark, Anette Rasmussen has moved up into the silver banding as a leading individual for enforcement and litigation. Claus Marcussen joins Anette as a leading individual for prosecution and strategy. The firm maintains its silver banding rank for Denmark overall.

AWA Asia maintains its status as a leading foreign firm in China with Ai-Leen Lim ranked as a highly recommended individual.

The 2019 Edition of the WTR 1000 will be released to the public in January. For more information on the WTR 1000 – please click here.

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Danish Anette Rasmussen balances her job as a Partner, Attorney at Law and Team Manager at AWA Law with a six-year commitment to ECTA. Starting out as Second Vice-Present two years ago, she is now the current First Vice-President of the association. In June 2020, she will become the president

Tell us a bit about yourself.

Anette Rasmussen: I am a lawyer admitted to the bar and I was just recently allowed to represent clients before the High Courts in Denmark. While I practice the same law as traditional lawyers within IP, I also have the ‘nerdy’ specialist trademark background. I started out my career working in the Norwegian Patent Office where I learned some real nitty-gritty trademark stuff and I’ve been working in the IP industry for more than 20 years now.

What do you do at AWA?

Since 2010, I am the team manager for the legal team in Copenhagen. We are eleven people in the team now, so I try to help develop them, our department, and the services we offer. About half of my working hours are spent on direct client contact. I have both larger and smaller, Danish and foreign clients. I really enjoy the variation of different tasks, people and how close you get to the client. I also like long-term relationships. I started working for IPB [Danish IP firm which was merged with AWA in 2009, Ed.] 18 years ago and acquired some clients that I still work with today. For me, it’s great to have this continuity. You get to know the client well which enables you to service them on a different level. I know competing IP firms are trying to woo them every other week, but they remain loyal to us because of our well-established relationship and the fact that we deliver each time on all parameters. I see that as a true success factor.

What I really like about working at AWA is that if you perform well and show interest in the company, you get the freedom to do additional things – like ECTA. While ECTA is in the interest of AWA, it also requires a real effort. You must want to do it.

Some of my colleagues at competing law firms are not allowed to be active in organisations like ECTA as it requires time and effort – even though it would benefit the company in the longer run. But when working at AWA, you can do it.

I also appreciate the fact that, while lawyers at many traditional law firms work 12 hour days, at AWA it is possible to maintain a personal life.

How did you get involved with ECTA? 

A close colleague of mine was a member of the law committee back in 2003, and I joined her for a conference in Salzburg, Austria. I found it quite interesting so when my colleague couldn’t attend the committee meetings a few years later, I went in her place and since 2005 have been an active committee member within ECTA.

What is the aim of ECTA?

ECTA is an organisation mainly consisting of attorneys within trademark, design, copyright, and internet related topics  as well as anti-counterfeiting. We work to improve and influence European legislation and practice.

We do so by having regular meetings with the European Commission and we meet several times a year with different sectors of the commission. It is our business to keep au fait with upcoming legislations. As they request our opinion on these matters, we produce opinion papers and try to influence the legislation that way.

We meet with authorities like EUIPO (European Intellectual Property Organisation) and WIPO (World Intellectual Property Organisation) to raise questions on the behalf of our members. ECTA has about 1500 members and many of them are active in committees, assisting or producing papers and attending meetings. We have about 300 committee members in total, and the council consists of about 70 members.

At ECTA, we meet twice a year for a larger annual meeting and a by-invitation-only autumn meeting. The latest autumn meeting was just held in Geneva, Switzerland. Beside these two meetings, the management of ECTA meets in person at least three times a year.

It’s quite a legal substance heavy organisation. Because we are lawyers used to represent both pros and cons, we know the importance of proper legislation. The authorities are very happy to talk to us as we comment on how the legislation is written and should be. We don’t have opinions on party political wishes to a certain legislation, though we generally aim at assisting businesses. In that aspect, we are not a political organisation.

For example, the [European] commission recently contacted us to help them with the IP situation regarding Brexit. I think it’s quite fun as it requires me to really be on top of what is going on. It’s inspirational and you get to share opinions with knowledgeable colleagues.

What has you work for ECTA entailed so far and what will you do going forward?

As the Second Vice-President, which I was for two years, I was coordinating all the committee activities. It means you are there to push the agendas and projects, so that the committees produce position papers and keep their deadlines. I was also pushing the position papers to the council, as they must approve them. You are very much on the substance of matters and must know things by detail.

Since June of this year, I am the First Vice-Present. This work entails being responsible for the annual conference programme. I have drafted the programme for next year’s conference which will be held in Edinburgh, Scotland. I have found speakers and I will coordinate things with them shortly. It is usually about 700-900 people attending the conference so it’s quite a big event.

In addition, the council agreed to introduce a new IT system last year and that is a task I am heading. I’ve been working for over a year to look at the back office functions in the ECTA secretariat and understand them properly, so we can streamline our processes and modernise the organisation. We are also working on a new website design and I have been preparing the structure for that as well as many small details connected with the operation of such a site. We want a platform where the committee members can work directly together in a document. This project has taken much of my time, but I aim to get it finished by the end of the year/January 2019.

In June 2020, the annual conference will be held here in Copenhagen and I will become President of ECTA at that conference. I look forward to that as I won’t have to travel for that conference at least! As President, you are very much involved in everything and you travel frequently to attend official meetings.

Being active in ECTA is a lot of work, but you get to know many interesting people. I find it very rewarding.

Is the job different from what you originally thought?

Even though I had been active in ECTA for several years and I knew what I was getting myself into, I must confess I was overwhelmed by the amount of work involved. I received huge amount of emails every day, which is also why I wanted to improve the IT situation.

You get a good view of your colleagues though; how they react, respond, and think on political and substance matters. A few can continue to push a matter even if the subject is long dead. You get a good overview over their competence, which is key for sussing out whether you want to send over a client to them in the future.

Being active at ECTA has helped my work at AWA. I know where to send work and I receive a lot work from the network. It’s a good opportunity to talk to people in an informal way and see how they handle the more difficult topics.

Do you have any goals set for your Vice Presidency?

It’s mainly for the Presidency you set your goals (which are announced publicly and you are held accountable for meeting them at the end of your term), but I can say I wouldn’t have accepted the invitation to join the ECTA Management if I didn’t believe I could put my footprint on some topics. I don’t do it for the titles, I do it for changing things and making an impact – for both ECTA and AWA.

When I was supervising the committees, I tried to push some of my political views on how the law should be and why. On some aspects I have been successful in doing this. E.g. I wrote parts that have been used for the implementing regulation on trademarks, i.e. how the text is. It is satisfactory to see how it has made a difference.

How is your work at ECTA and AWA entwined?

I gain so much knowledge from ECTA that I can implement in my work at AWA. I know where legislation will move on some points, which gives us [at AWA, Ed.] an advantage to amend the advice we give to clients.

I get input and feedback regarding existing and potential new partners from my colleagues at ECTA. It is very useful.

And as I mentioned, I get many new clients from the ECTA network.

What is ECTA currently working towards?

We are working to support a solution regarding Brexit. On internet issues, we have the new legislation on data protection. When you do a WHOIS search for the owner of a certain domain name, you cannot see the details. This means that infringers are difficult to find out. In some countries, you have to go through a court proceeding just to find out who the person is behind the domain name and before that proceeding is over, the domain will have changed to a new owner. The law is currently benefiting infringers and not trademark owners. We are actively trying to get a different rule set so that this information will be visible. But it is a struggle also with the reform of the .eu coming up. We have commented and assisted with various topics on copyright law and will aid with the upcoming reform of the design regulation. Our work is very much law oriented and, since it is law we use in our everyday work, it is very useful knowledge to possess.

What challenges is ECTA facing at the moment?

Brexit! ECTA is based in the UK but we are planning to transfer our formal seat to Brussels. Our organisation mirrors the European Parliament in numbers of members of the governing body, the Council. The big countries like the UK and Germany have four representatives in ECTA’s council, whereas Denmark and Sweden have two each. This means that after Brexit, we must decide how to deal with the UK members. They can continue being ordinary members of ECTA, but how about being Council members? This is one of the issues we are currently discussing.

Since we are such a big group of people from different countries and cultures in the ECTA Council, it can be hard to agree on things sometimes. We have really wild discussions on some topics. What you see on TV with the European Parliament is also real in smaller formats. So yes, it can be difficult to navigate, but it’s also interesting and good fun. You learn from the experience.

What advice would you give somebody interested in joining ECTA?

Show commitment. The more effort you put in, the more you get out. Join committees, attend meetings and be ready to invest time – some of your spare time as well. In 2019, it is election year for the committees and you can apply to join on ECTA’s website.

I would like to encourage IP professionals to be active within organisations and associations like ECTA. It is important to have a voice in how the law looks like – and use it.

In addition, clients appreciate that you listen to their concerns as companies and that you are active in the IP political field to try to change things for them. I get very positive feedback from my clients regarding this, so I think it’s brilliant that AWA is willing to take on the role as a big player in the IP field and allow us to do it.

ECTA (European Communities Trade Mark Association)

For more information on ECTA, please visit their website.

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Based in Martinez, California (US), ExThera Medical (ExThera) has developed a state-of-the-art device that filters harmful bacteria and viruses from patients’ blood in a dialysis-like circuit. This device, named Seraph, is proving to be a promising alternative for treating drug-resistant bloodstream diseases, which remain a significant health concern worldwide

A serious blood problem

Bacterial bloodstream infections are one of the top causes of death in North America and Europe, with an up to 677,000 cases estimated annually in North America and up to 1,200,000 cases in Europe. For some bloodstream diseases the mortality rate is as high as 50 percent.

In a report published earlier this year, the World Health Organisation (WHO) revealed that they had encountered high levels of antibiotic resistance to a number of serious bacterial infections across the world. The antibiotic resistance is present in both high- and low-income countries.

One factor driving antibiotic resistance is the overuse of antibiotics. A study at Bristol University found children with urinary tract infections more than 13 times as likely to have contracted drug-resistant strains if they had been given antibiotics in the previous six months.

Each of these credible, third-party reports tell a similar story: drug-resistant diseases pose a serious threat to global health. “There have been cases in China, Europe, and the United states where people have been infected by bacteria which has been resistant to all drugs,” said Dr. Keith McCrea, Chief Science Officer and Vice President of Research and Development at ExThera. “The doctors simply have little options to treat these infections effectively.”

Seraph® 100

ExThera wants to address the growing health problem of drug-resistant disease with a new and different treatment solution. The Seraph® Microbind® Affinity Blood Filter (Seraph 100), which is not currently approved for clinical use, uses a groundbreaking technology to capture and remove bacteria, viruses, toxins and pro-inflammatory cytokines from the blood.

“By quickly removing the circulating levels of pathogens and toxins in the blood, Seraph 100 should make a significant impact on drug-resistant infections along with hard-to-treat bacteremia and viremia,” says Dr. McCrea.

Since ExThera was founded in 2007 under a joint venture with a technology company at the Karolinska Institute (Stockholm), the company has focused entirely on developing the Seraph technology. They were first to report on a device-based method for removing bacteria from infected blood.

Seraph works as a filter for harmful pathogens and substances in the bloodstream. The patient’s blood flows through the device, passing over proprietary microspheres coated with molecular receptor sites. These receptor sites (on permanently-bound heparin) mimic the receptors found on human cells inside our blood vessels, which are what pathogens target when they invade the body. Confusing the biomimetic receptor sites with their human equivalents, the pathogens get captured and absorbed onto the Seraph surface, and thereby removed from the bloodstream.

The blood is continuously recycled back into the patient’s bloodstream with the blood cells still intact.

“The Seraph has been designed to be easily adapted into the clinical environment,” said Dr. McCrea. “Nephrologists were the first to use Seraph in our European clinical trial.”

There is a huge potential that Seraph will have a positive impact on many patients.
-Keith McCrea, Chief Science Officer and Vice President of Research and Development, ExThera Medical
At risk

Immunocompromised patients, such as children and the elderly, are a special target patient group for ExThera. Pediatric patients with hepatitis delta virus are faced with a 75 percent increase in mortality rate in comparison to an adult patient with the same disease. Seraph may be an alternative or complement to the toxic drugs doctors must use to treat these immunocompromised patients.

“For most pathogens, doctors still have effective antibiotics that they can use,” said Dr. McCrea. “There is usually more than one drug for treating a disease – however the toxicity issue is always a concern and release of fragments of dying bacteria may contribute to disease severity.”

“The WHO, US CDC, and European CDC all agree that we are in the post-antibiotic era, and alternative treatment options must be developed.”

There are other potential indications that may also be helped by the Seraph. Cancer mediators may also be effectively removed from circulation, to be confirmed in studies using Seraph.

“There is a huge potential that Seraph will have a positive impact on many patients,” said Dr. McCrea.

“Cancer is definitely an opportunity for us, as are chronic inflammatory diseases Bloodstream infections and sepsis are the near-term focus though.”

Trials

In their preclinical studies, ExThera scientists have found that the concentration of Carbapenem Resistant Enterobacteriaceae (CRE) bacteria in blood can be reduced by up to 99 percent in a single pass when circulating contaminated blood through the Seraph. With source control of the infection, a four-hour treatment having the blood continuously recirculating through the device could result in a >99.9 percent reduction in the concentration of bacteria in the patients’ bloodstream.

Bob Ward, CEO of ExThera, presented the results of a new prospective, non-randomized clinical trial of the safety and performance of the Seraph in early September.

“These findings from the Seraph 100 trial support our belief that the Seraph filter has the potential to change the landscape for treating bloodstream infections, impacting a significant unmet need for new treatment options,” said Ward.

In the study, patients on renal replacement therapy who developed bacteremia had the Seraph filter included in their dialysis treatment for only four hours, with regular measurement of the reduction of bacteria. This was followed by a 14-day monitoring of the patients.

All initial results indicate that the Seraph 100 was safe and effective, in addition to being compatible with commonly-used dialysis equipment and procedures. In patients with measurable bacteremia who were not responding to antibiotics, Seraph100 helped decrease the bacteria significantly. Vital signs, including heart rate and blood pressure, were all stable during the study.

“We are excited that we have completed our first clinical study in Europe and expect to publish our results soon,” said Dr. McCrea. “This will be the first time that a device has been used to treat bloodstream bacterial infections. After we obtain CE mark and FDA approval for Seraph 100, doctors will have another tool to treat infections beyond antibiotics alone.”

Intellectual Property

AWA has been ExThera’s IP partner for all European matters since the company was founded. Senior European Patent Attorney Torbjörn Presland is based at AWA’s Stockholm office and handles their European patents.

“The assignments from ExThera provide challenging work in view of the European exclusion from patentability of methods for medical treatment,” said Torbjörn.

Having their IP in check is an obvious choice for ExThera.

“Investors must see a strong patent portfolio before they are willing to invest in a small company like ExThera,” said Dr. McCrea. “Without patent protection, other companies could copy Seraph 100 without all of the significant development and regulatory costs associated with pioneering technology.”

As for the future of Seraph and ExThera, Dr. McCrea is optimistic.

“We will continue to create technology which can meet medical needs,” Dr. McCrea affirmed. “I believe Seraph 100 will make a real difference in combating drug resistance and difficult to treat infections. We hope to be on the market in Europe in Q2 2019, and are currently discussing our clinical trials with the FDA for US approval.”

ExThera Medical

For more information on ExThera Medical, please visit their website.

For their European IP matters, ExThera Medical is consulted by Torbjörn Presland at AWA’s Stockholm office.

The post ExThera Medical: Drug resistance appeared first on AWA Point.

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Blockchain has lately risen in popularity with uses such as the cryptocurrency Bitcoin, and new applications are implemented or suggested almost daily. As an emerging technology with the possibility to validate, preserve and track digital data, and to provide a platform for low cost and transparent for transactions on a global scale, it has the possibility to revolutionise sharing of digital assets. So what are the implications for the management of intellectual property?

The current IP registration framework

As the trade market becomes more and more global, the market for registration of IP assets is growing as well. Last year, USPTO received a record amount of new trademark registrations, adding up to more than 440,000. The IP industry landscape relies on third party authenticators for trademarks and patents, all of them created in the pre-digital age, with registration authorities spread across the world. Entering a new record into the system, such as registering a patent or a trademark, involves a costly screening process by a legal framework, which must be repeated for every country or region where the registration of ownership is to take effect. Even global initiatives using international agreements have not managed to achieve more than a common framework for application with some common attributes, but with limited legal effect. In other areas, in particular copyright for digital assets, registration is difficult or non-existent.

A better solution?

The situation is very similar in the financial world. A flora of local registries in the form of private banks and loan institutes manages local assets globally with the help of standards in the form of currencies and exchange rates. Despite this established legacy, Bitcoin has in a few years managed to establish itself as a new global currency, managed with a public registry and based on open source code. Would the same be possible to achieve in the realm of IP?

Information Age states that the development of blockchain for IP management use will be more challenging than for the financial industries, since proven methods of verification exist. However, Bitcoin was able to disrupt large parts of the financial market despite the fact that national and international methods for financial verification were in place. The key was the development of a system from the bottom up.

What is blockchain?

A distributed ledger technology is a concept where a database, or ledger, is kept in multiple copies on a peer-to-peer network. Each computer holding a copy forms a node in the network and updates itself in relation to the others. When a new record is added to the ledger, it needs to be verified against all the other nodes, which makes it very hard to falsify data, as there is no central data store. Blockchain is perhaps the most commonly known form of distributed ledger technology. It has been named blockchain because each record of the ledger is called a block, and they are connected in a chain to form the ledger. Each block holds both a cryptographic key as identification, and another key, identifying the previous block in the chain. If data is changed within a block, the key is changed accordingly, and when compared to the other members of the chain, the block will no longer fit and be rejected by the ledger. In this fashion, new data can easily be added to old data by the formation of a new block, but it is very hard to change existing data blocks. Bitcoin is probably the most famous form of a distributed ledger, but it was actually not invented there, but was first used for the creation of digital timestamps. Watch this short movie for a quick understanding of blockchain technology.

Benefits of Distributed Ledger Technologies

The most important benefits of distributed ledger technologies are:

– Oversight is crowdsourced and the need for a central authority is removed. This will effectively remove large costs and delays related to bureaucracy;

– Security is improved with an increasing number of users. For a hacker attack on the system to succeed, it must hit (almost) all nodes simultaneously, and this will be much more difficult, the larger the ledger is;

– Providing a time stamp. In most countries, the rights to an invention belong initially to the first person to file a patent application (“first-to-file system”). This means that the application date is very important in the patent process. In this context, the blockchain’s ability to create an immutable date of creation is an appealing trait;

– Providing a record of transactions. The chain is updated with each transaction, so users can see the chronological activity for that particular blockchain, effectively creating a chain of custody for each IP;

– Lower administrational cost. When a new user enters a public blockchain network, that user becomes both the client and the governor. Instead of setting up a central bank or governing body, effectively introducing both bureaucracy and cost to the administration, blockchain gives each user the power to communicate on equal footing, as each node is part of the ecosystem.

Blockchain use in IP

The technology of blockchain became famous with the use of Bitcoins, but its usefulness far outweighs that of a simple digital currency. Applications range from finance, merchandise distribution management, and the sharing economy. Though the source code for Bitcoin is open source, patents are emerging for blockchain-related solutions, and the blockchain technology has triggered the filing of numerous patent applications for related technologies in recent year across a broad spectrum of industries. A worldwide search on Espacenet for patents titled “blockchain” will result in 17 hits for 2016. Two years later, 2018, the number is 672. Commercial solutions have not been far behind. A week ago, SONY announced the development of a rights management system for digital content, based on the blockchain technology. They are far from first to market. Estonian company Agrello is working of creating an application for legally binding smart contracts. Bernstein is offers blockchain based solutions for intellectual property management. Everledger has used blockchain to create a database of diamonds, to ensure that they are not being used to fund conflicts. Blockai (or Binded) registers work of art, creates a timestamp and serves as a proof of copyright. Several other companies have created a business model around IP rights; Stampery, Signatura, bitcoin.com, Proof of Existence, Copyrobo, Vaultitude and Blocknotary. A number of open source or semi-open source initiative have also been launched, such as IP-Chain by Unity Labs, Openchain and Hyperledger by Linux Foundation. Generally, a registration of an IP to a distributed ledger will not necessarily mean it has to be made public. The registration can be kept private using encryption, the uploaded document or resource will remain confidential, but the registration will establish the possession of it at a specific time, and guarantee that it has not been tampered with. Even though the digitisation of copyrighted sound or text is nothing new, the ability to prove authorship of a modified copy can be difficult. Blockchain technology has the potential to create a digital footprint of the work which would allow for better control of the use, while at the same time making the work publicly accessible. TaTaTu has launched a blockchain-based video platform, Ujo a corresponding for music and this year we saw the first blockchain-powered Music Festival.

An IP registry revolution?

However, the use of distributed ledgers is for sure here to stay. As with many emerging technologies, blockchain has attracted various opportunists, and as the number of applications increase, an increasing number of governmental agencies are getting involved. The European Union Intellectual Property Office (EUIPO) are looking into the capabilities, the EU Commission has plans for a blockchain observatory and the US Chamber of Digital Commerce has recently launched the Blockchain Intellectual Property Council (BIPC) with the aim to combat blockchain patent trolling. Global standards have been discussed by various organisations.

The advocates of blockchain often express a desire for a method to connect registries across the world through a single distributed ledger – the ultimate database. However, the reality is far from that simple. Successful management of IP rights using blockchain requires an agreed upon and internationally supported platform. In this way, the blockchain as technology presents no differences from current systems. Technical means to connect registries exist today. The problem is as always rather the issue of aligning national and regional judicial frameworks and traditions. To such issues, no technology will ever be able to provide the magic solution. Distributed technologies are a great tool for democratic grassroots movements, not necessarily the best tool for corporations attempting to commercialise on distributed ledger technologies. The lesson is – don’t attempt using blockchain if you already have another technology doing the same thing, unless you see a way of reducing the cost of operation. Despite the increasing use and value of Bitcoin, it has not, and will not replace the need for established financial institutions in the banking system. Rather, the systems coexist, complementing each other. Most likely, the case will be the same in the world of IP.

What is your view on IP rights, open source, copyrights and human rights? Please get in touch on alm@awa.com

The post How blockchain can change how we view IP rights appeared first on AWA Point.

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The legal situation in the US concerning client-attorney privilege for patent attorneys has seen some development in recent years. But, especially for non-US patent attorneys, the situation is still uncertain. A recent order of the US International Trade Commission (ITC), 3Shape, confirms the uncertainty concerning foreign patent attorneys.

Federal Circuit decision Queen’s of 2016 introduced for the first time on a federal level an evidentiary privilege for US patent agents. The privilege applies to patent office proceedings only and so not, for example, to infringement or validity opinions.

In Queen’s, the Federal Circuit recommended that clear statutory provisions concerning patent agent privilege be established, and the Patent Trial and Appeal Board (PTAB) in 2017 did establish such new provisions. These provisions introduced an evidentiary privilege in proceedings before the PTAB which, in accordance with Queen’s, apply to patent office proceedings only. The provisions apply explicitly also to foreign “authorized” patent agents, i.e. persons authorized to practice patent law before a foreign patent office. Foreign law concerning client-attorney privilege is irrelevant.

In contrast to Queen’s, in the case in re silver, of February 2018, the Texas Supreme Court held that a US patent agent complies with the state’s definition of “a lawyer”. Therefore, a patent agent’s client could invoke a client-attorney privilege of the patent agent similar to that of lawyers, i.e. which was not limited to patent office proceedings. In re Silver only applies to the State of Texas. However, 37 other states have adopted the same or a similar rule of evidence, and at least these other states may reach a similar result as the Texas Supreme Court in similar cases1.

The mentioned ITC order 3Shape was granted in a case involving Danish company 3Shape. The order granted a motion to compel production of an unredacted copy of a document relating toa competitor patent analysis produced by a European patent attorney (EPA), i.e. a foreign authorized patent attorney, who was based in Denmark. The order was not appealed.

In the ITC order, the ITC denied 3Shape’s attempt to invoke evidentiary privilege for the competitor patent analysis of the EPA. Worth noting, the order was granted subsequent to an amendment of the Danish procedural act which entered into force on July 1st, 2018 and which introduced an evidentiary privilege in Denmark with respect to EPAs similar to that applying to Danish lawyers (“advokater”).

The ITC order referred to Queen’s to establish that the evidentiary privilege of US patent agents applies to patent office proceedings only. Since the question at hand related to a competitor patent analysis, US patent agent evidentiary privilege would not apply. Since the EPA was to be considered “a patent agent”, i.e. not “an attorney licensed to practice law”, Danish law concerning the EPA was considered irrelevant and was not considered.

In view of these cases, it especially remains a question to which extent US courts will respect foreign law in cases where a foreign patent attorney’s client attempts to invoke client-attorney privilege in other matters than patent office proceedings.

Neither Queen’s nor in re Silver concern non-US patent attorneys or agents, but some earlier US district court precedents did apply foreign law and, thereby, recognized client-attorney privilege concerning foreign patent attorneys.

For a number of years there has been a global interest in establishing a clearly defined client-attorney confidentiality between patent attorneys and their clients. Clients should be able to discuss confidential, privileged legal issues with their local authorized patent attorney without fear of such discussions being used against them in legal proceedings before any court.

In line with this, both Queen’s and in re Silver recognized that clients have a reasonable expectation that communications with their patent agent relating to a patent matter will be subject to privilege.

In Denmark, for example, the evidentiary privilege concerning EPAs is not limited to patent office proceedings, and in view of this it seems more than reasonable that clients should be able to trust US courts to respect Danish law in this respect. It is the opinion of the undersigned author that client-attorney privilege concerning foreign patent attorneys ought to be respected by US courts in the same manner as it would be by a foreign court under the law in the relevant jurisdiction.

Hopefully, the current uncertainties will be resolved soon so that foreign clients can rest assured that confidential, privileged matters shared with their local patent attorney will not be subject to discovery in a US court. Until then, non-US patent attorneys should continue to be careful and exert suitable precautions when advising clients if there is a risk an attorney opinion is or can become of relevance in US court proceedings and, especially, in matters not concerning patent office proceedings.

On a final note, if US courts in future cases should not consider foreign law concerning the extent of EPA client-attorney privilege, e.g. as in the above ITC order, it seems entry into force of the Unified Patent Court Agreement (UPCA) may change this.

The UPCA aims to establish a unified patent court covering 25 European countries and is expected to enter into force within a few years. The Articles of the UPCA and the associated Rules of Procedure include provisions which establish a broadly scoped client-attorney privilege for EPAs and other patent attorneys and is not restricted to patent office proceedings. Furthermore, EPAs holding the co-called UPC Litigation Certificate will be able to practice law before the court, without the involvement of a lawyer.

After entry into force of the UPCA it seems that EPAs holding the Litigation Certificate could, therefore, reasonably be equated to US lawyers regarding to which extent an evidentiary privilege applies.

Mikkel Roed Trier

Partner, European patent attorney

President ADIPA (Association of Danish Intellectual Property Attorneys)

1 Article “Privilege”, McAnaulty, Winkler, July/August 2018, https://www.finnegan.com/en/insights/privilege.html

The post Client-attorney privilege for non-US attorneys: Can clients trust that privileged communications with their patent attorneys will not be disclosed in US courts? appeared first on AWA Point.

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