Mathys & Squire Associate Alexander Robinson and Partner Stephen Garner explore some of the regulatory issues in the life sciences and pharmaceutical sectors that are likely to be affected by Brexit.
The UK’s withdrawal from the European Union presents legal and administrative challenges on an unprecedented scale, and will have a significant impact on anyone carrying out business at a pan-European or global level. This is especially true for companies in the life sciences and pharmaceutical sectors, which operate within a highly-regulated environment and which currently rely on a high degree of harmonisation between the UK and other EU countries.
Deal or no deal?
At the time of writing, the UK Government has failed to gain the approval of the House of Commons for the Withdrawal Agreement (WA) which has been negotiated with the EU. While further attempts to obtain Parliamentary approval for the current WA or a different agreement cannot be ruled out, the prospect of the UK leaving the EU without a deal should not be discounted either.
In the event that the WA does pass Parliament, the UK will leave the EU on Exit Day (currently set as October 31 2019) but will immediately enter a two-year standstill transition period during which the UK will remain subject to most EU law and the jurisdiction of the CJEU, essentially as though it were still an EU member. The regulatory landscape will therefore remain unchanged for most purposes during this period, subject to some exceptions mentioned below. The future relationship between the UK and the EU will then be subject to further negotiations during the transition period. It is unknown what the UK’s objectives might be in such negotiations.
In the event that the WA does not pass Parliament, the UK could – whether by design or by accident – end up leaving the EU without any agreements in place regarding transitional or future arrangements. In this no-deal scenario, the UK’s formal links with the EU’s legal and regulatory framework would be severed overnight. However, Parliament has passed legislation which will, in effect, transpose all existing EU legislation into domestic legislation on Exit Day, even in a no-deal situation. The legal and regulatory landscape within the UK would then mirror the existing EU provisions, subject to any necessary amendments (e.g. to replace references to European regulatory bodies with references to their UK counterparts). However, in the absence of any formal agreements with the EU, some UK-EU asymmetries would inevitably arise.
Marketing Authorisations (MAs) for medicinal products
MAs for medicinal products are currently granted both by the European Medicines Agency (EMA) and by domestic regulators in individual EU Member States, such as the UK’s Medicines and Healthcare products Regulatory Authority (MHRA).
Certain types of product, including new active substances indicated for the treatment of AIDS, cancer, and neurodegenerative disorders, as well as orphan medicinal products and certain types of biotechnological products, must be authorised by the EMA via the Centralised Procedure, in which the EMA carries out the necessary regulatory assessments in consultation with national regulators. An MA granted by the EMA is then valid for all EU and EEA Member States.
For other products there is a choice between the use of the Centralised Procedure or the Mutual Recognition or Decentralised Procedures. In these latter two procedures, one EU Member State is nominated as the Reference Member State (RMS) which performs regulatory assessments while the other designated Member States will then each grant their own national MA, subject to the grant of a national MA by the RMS.
MAs if the Withdrawal Agreement is approved
If the UK leaves the EU under the terms of the WA, it will remain in the current regulatory system (including the Centralised, Decentralised and Mutual Recognition authorisation routes) during the transition period. Any MA granted in the UK or in any EU Member State via the Decentralised or Mutual Recognition routes prior to the end of the transition period will continue to be valid after the transition period, and any MA granted via the Centralised Procedure will continue to be valid in both the UK and EU after the transition period (subject to conversion of the Centralised MA into a UK MA, in common with the no-deal scenario discussed below).
An important exception to note is that the UK will not be able to act as the RMS for applications made via the Decentralised or Mutual Recognition Procedures during the transition period. It is uncertain how MA applications designating the UK as RMS will be handled in the EU if these are still pending upon entry into the transition period.
Applicants should therefore consider whether to nominate an RMS other than the UK, even in the case of MA applications filed before Exit Day, if it is likely that the application will still be pending at the start of the transition period. It may also be worthwhile attempting to accelerate any pending MA applications which designate the UK as RMS to try to ensure that these are finalised prior to Exit Day (see UK government guidance).
The fate of applications which remain pending at the end of the transition period, whether filed via the Centralised, Decentralised or Mutual Recognition route, remains to be determined in future negotiations. However, it seems probable that the UK will treat these at least in line with the corresponding no-deal provisions.
MAs in a no-deal scenario
In a no-deal scenario, it will be necessary to apply separately for MAs in the UK and in the EU. EU MA holders and applicants must be based in the EU or EEA, and therefore the ownership of any granted or pending MAs covering EU countries will need to be transferred to an EEA-based entity prior to Exit Day (see the EMA’s recent Q&A document and “Notice to Stakeholders”).
The MHRA will replace the EMA as the regulator for all types of medicinal product in the UK. Any MA granted in the UK via the Decentralised or Mutual Recognition Procedures prior to Exit Day will remain in force. The UK is currently legislating for transitional provisions which will convert MAs granted via the Centralised Procedure into UK MAs on Exit Day; holders of Centralised MAs will also be able to opt out of such conversion during a limited period. The MHRA intends to write to MA holders setting out the conversion and opt-out procedures in further detail ahead of Exit Day.
Where MA applications are still pending on Exit Day in a no-deal scenario, the approach taken by the MHRA will depend on the stage of assessment which has been reached. In short, it currently appears that the MHRA intends to follow or take into account any opinions or decisions which may have been reached as part of the assessment procedure. However, in some circumstances the MHRA may need to perform a fully independent assessment and may also diverge from the decisions of the relevant EU bodies (e.g. by granting a UK MA where the corresponding MA within the EU has been refused).
If a Centralised MA application is still pending at Exit Day, applicants will in most cases need to submit supporting data to the MHRA (e.g. data corresponding to the dossier held by the EMA) to support conversion of the application into a corresponding UK MA application (see MHRA guidance note).
One notable feature of the no-deal preparations is that the MHRA intends to introduce several new fast-track routes of assessment in the UK for certain types of product such as new active substances and biological and/or biosimilar active agents. A “rolling review” procedure has also been proposed for new active substances, which intends to provide ongoing feedback to avoid certain regulatory barriers to the grant of an MA during research and development. Details of these new routes are still under development.
Despite the new fast-track routes which are proposed, the increased workload for the MHRA in a no-deal situation is likely to lead to slower authorisation overall, while the loss of the MHRA’s capabilities from the European regulatory framework could also lead to delays in the corresponding European authorisation procedures.
Supplementary Protection Certificates (SPCs)
At present it appears that the EU Regulations concerning SPCs will be transposed directly into domestic law on Exit Day, meaning that SPCs will continue to be available in the UK via essentially the same system as at present whether or not a deal is agreed.
In a no-deal situation, some discrepancies between the UK and EU SPC regimes would arise nevertheless. For example, the duration of an SPC is calculated based on the date of the first MA to place the authorised product on the market in the EU or EEA, and this provision will be retained in the UK. Where the earliest MA in respect of a product is an EU or EEA authorisation, both the UK SPC and any corresponding EU SPCs will therefore have the same term. By contrast, however, where the earliest MA is a UK authorisation, the UK SPC will have a shorter term than any corresponding EU SPCs, as EU Member States will not take account of the UK authorisation in the absence of a reciprocal agreement.
After Brexit, and in the absence of any deal to the contrary, courts in the UK will not be bound by the case law of the CJEU. The UK Supreme Court will be the final arbiter on SPC matters, and will be permitted to diverge from past CJEU decisions if it sees fit. The perceived deficiencies in the SPC Regulations have given rise to a large body of references to the CJEU in recent years, and the resulting CJEU decisions have been criticised for a lack of clarity.
Brexit may therefore provide an opportunity for the Supreme Court to diverge from the CJEU’s interpretation of the SPC legislation, for example with regard to determining whether a product is “protected by” a basic patent, or in deciding whether to allow SPCs for medical devices. It is too early to say how far the UK may seek to diverge from the EU, although the Swiss SPC system may provide an interesting precedent for SPC legislation and jurisprudence outside the EEA.
Regulatory data protection
The grant of an MA provides a period of eight years of data protection, preventing MA applications for generic versions of authorised products from relying on the data submitted in support of the earlier MA. A further two years of market exclusivity (extendable by one year in some circumstances) are also provided, barring entry of generics onto the market.
The UK intends to retain these provisions after Brexit, with the data and marketing exclusivity periods being calculated based on whichever is the earlier of a UK or EU MA. As with SPCs, this would create a discrepancy between the exclusivity periods available in the UK and EU in a no-deal situation as EU states would not take account of an earlier UK MA.
The UK government intends to review the Regulatory Data Protection provisions within two years of Brexit to ensure that the UK remains competitive, and therefore changes to these provisions cannot be ruled out. However, it is too early to say what alterations, if any, might be made.
Conclusion
MAs, SPCs and regulatory data protection are among the key regulatory matters which life sciences IP practitioners and their clients will be concerned about due to Brexit. Other issues to consider include orphan designations, parallel imports, the conduct of clinical trials, and pharmacovigilance. In many cases, the relevant legislation preparing the UK for life after Brexit is still in draft form, and MHRA guidelines are still being developed. Companies in the life sciences and pharmaceutical sectors, and IP practitioners, should therefore keep a close eye on any further announcements as Brexit approaches.
This article was first published in Managing Intellectual Property Magazine’s IP Stars in June 2019.
Interest in cell-cultured meat has been steadily gaining momentum since the first laboratory-grown burger was unveiled in 2013 by scientists from Maastricht University in the Netherlands.
In general, the process for producing cell-cultured meat requires a few ‘satellite’ cells, which can be obtained from a muscle sample taken from a living animal. These cells can then be transferred to a bioreactor containing a scaffold upon which the cells can attach and grow in a nutrient-rich (and preferably animal-free) medium. The scaffold provides structural support for the cells and promotes muscle fusion, creating ‘strips’ of muscle fibres. The fibres can be mechanically stretched to increase size and protein content and the resulting tissue is harvested and processed into a boneless meat product.
A significant amount of research relating to cell-cultured meat has focused on the formation of processed meat (such as hamburgers and meatballs) and formulation of an economical manufacturing process. In order to effectively scale up production, a suitable scaffold (which is cost effective and preferably edible) to support the growing cells is required. To date, progress in manufacturing such products is advancing beyond all expectations, and slaughter-free meat could be in our shopping trollies sooner than expected. For example, JUST Inc (with laboratories in San Francisco) aims to sell its first cell-cultured meat products this year, whilst Mosa Meat and US-based Memphis Meats aim to have their products on supermarket shelves by 2021.
This focus on producing processed cell-cultured meat is due, at least in part, to the complexity of unprocessed meat, which includes bone, blood vessels and connective tissues, making this structure difficult to replicate. An appropriate scaffold that aids cell alignment will be required to develop unprocessed cell-cultured meat. A significant amount of research and ‘out of the box’ thinking will be needed before we can expect to enjoy a cell-cultured steak or rack of lamb.
In the race to provide a suitable solution to this problem, varied approaches have been taken by companies and research groups within this sector and some are seeking patent protection for new inventions. Some examples of scaffolds being trialled for forming either processed or unprocessed meat are discussed below.
Starch fibre mats
Researchers from Pennsylvania State University and the University of Alabama have collaborated to produce a method of forming edible starch fibre mats using a cost effective wet-electrospinning technique. Starch has the benefit of being one of the least expensive natural fibres.
The wet-electrospinning technique typically comprises a polymer solution, a syringe with a metal needle, a coagulation bath and a grounded collector. The polymers required to form the scaffold are first dissolved in a solution, which is placed inside the syringe and subsequently forced through the needle at a constant flow rate. At the same time a high voltage is applied to the solution. The electric charge draws and stretches the jet of the polymer solution as it is directed to a coagulation bath containing ethanol and water, which precipitates the polymer fibres from solution. The resulting polymer fibres are collected on a rotating drum submerged in the coagulation bath. The thin starch fibres provide a high surface area scaffold upon which cells can adhere and grow to form a structured meat product.
The electrical field that forms between the nozzle and a rotating collection drum draws the starch into long threads.
In a study recently published in Food Hydrocolloids, the researchers built an inexpensive electrospinning device partially using the children’s toy, Lego® to form the rotating drum collector (shown in Figure 1).
The research found that the formation of suitable starch fibres was dependent on the speed of the rotating drum and the amount of ethanol in the electrospinning bath used to collect the fibres.
Figure 1 – ‘Aligned wet-electrospun starch fibre mats’
Porous protein scaffold
Israeli company, Aleph Farms, announced that it had produced the first prototype of a cell-cultured steak in December 2018, with thin strips of steak costing around $50 to produce. The company admits that the size and flavour of the steak requires some further research before the product is ready for commercialisation. It has collaborated with the Technion – Israel Institute of Technology, Haifa, to develop the manufacturing method, which includes a bio-engineering platform and innovative approaches to an animal-free growth medium to nourish the cells.
Aleph Farms is reported to use a combination of six technologies, which provide a more economical manufacturing method.
These techniques include innovative approaches relating to an animal-free growth medium to nourish the cells, and bioreactors (the tanks in which the tissue grows). Little information on the specifics of these technologies seems to be publically available.
However, a recent patent application by Technion Research & Development Foundation Ltd published in January 2019 (WO 2019/016795), discloses a method of forming cell-cultured meat on a porous scaffold. The method comprises the steps of incubating a three-dimensional porous scaffold formed from a textured protein, such as a soy protein, and a plurality of cell types including myoblasts (muscle cells) and at least one extra cellular matrix (ECM)- secreting cell type.
The ECM-secreting cells may be adipocytes (fat cells), fibroblasts (which produce the structural framework of animal tissues), progenitor cells (satellite cells), or endothelial cells (cells which line the interior surface of vessels). Once the porous scaffold has been incubated with the different cells, they are allowed to expand on the scaffold. Muscle cell fibres are then formed through the fusion of myoblasts into multi-nucleated fibres (myotubes).
Grass as a scaffold
A research group at the University of Bath in the Department of Chemical Engineering has come up with an alternative method to formulating a suitable scaffold for cell-cultured meat. Dr Marianne Ellis, working with a multidisciplinary team with expertise in biochemical engineering, biology and biomaterials, has focused on scaling-up the manufacturing process of cultured meat.
The researchers used stem cells extracted from an animal, which are fed a mixture of glucose, vitamins, minerals and amino acids. The cells are then transferred to a bioreactor containing grass as a scaffold, on which they can attach and grow. To date, the team has used rodent cells to test the effectiveness of this scaffold, as they are cheaper and easier to use compared to stem cells extracted from cows or pigs, for example.
At the present time, it is unclear whether a grass scaffold would be suitable for producing the complex structure of unprocessed meat. This would require a system containing multiple cell types growing in an organised manner and a structure that will need a replicated blood vessel network. A more simplistic and near-term goal is to produce a muscle protein ingredient based on muscle cells alone.
Decellularised spinach leaves
A method that uses decellularised spinach leaves (i.e. spinach leaves in which the cellular material has been removed) to produce a scaffold for tissue engineering has been developed by Glenn R. Gaudette, a professor of Biomedical Engineering at Worcester Polytechnic Institute in Massachusetts.
A patent detailing the decellularisation method (WO 2017/160862) was published in September 2017. This work is based on the similarities in the vascular structure of plant and animal tissues (Figure 2).
Figure 2 – Crossing kingdoms: using decellularised plants as perfusable tissue engineering scaffolds
The method first decellularises spinach leaves by applying a solution containing 10% sodium dodecyl sulphate (SDS) in deionised water for five days. After this, a clearing solution (0.1% TritonX100, 10% sodium chlorite in deionised water) was applied to the leaves for two days. The resultant leaves were colourless and translucent, forming an acellular scaffold consisting of extracellular matrix (ECM), preserving an intact vascular network (Figure 3).
Gaudette, is collaborating with Dr Marianne Ellis of the University of Bath to assess the potential of this technique to develop muscle cells from the stem cells of a cow. If successful, spinach leaves could provide a low cost and edible scaffold for producing more complex meat structures.
Figure 3 – A cellular scaffold consisting of extracellular matrix
Conclusions
Cell-cultured meat has the potential to reduce the amount of land, water and antibiotics required for traditional farming practices. This field is moving rapidly with some processed cultured meat products already poised to enter the marketplace. Unprocessed meat products represent a more elusive target, but research is underway to develop scaffolds that allow the formation of the characteristic texture of a T-bone steak.
This article was first published in The Journal of the Institute of Food Science & Technology in May 2019.
Mathys & Squire is thrilled to be once again a recommended firm in the latest edition of IAM Patent 1000. Four of our partners were this year singled out as recommended individuals in the firm – Chris Hamer, Craig Titmus and Martin MacLean.
The IAM Patent 1000 features 48 country-specific chapters analysing local patent professional services markets and detailing the firms and individuals identified as leaders in their respective fields. The tables and accompanying detailed editorial reflect the depth of expertise, market presence and levels of work on which firms are typically instructed. The publication therefore serves as a one-stop reference source for anyone seeking patent services.
Will you be attending the 2019 AIPPI World Congress? If so, Mathys & Squire would like to invite you to join us for drinks with a view at our London office in The Shard to celebrate!
AIPPI is the world’s leading international organisation dedicated to the development and improvement of laws for the protection of intellectual property. Based in Switzerland, the organisation has over 9,000 members representing 125 countries and its World Congress meeting open to all members is held annually. The 2019 Congress takes place at the Queen Elizabeth II Centre and Central Hall Westminster from 15-18th September.
To mark the start of the London Congress, Mathys & Squire’s event will take place on Sunday, September 15th 2019, where you can expect cocktails, canapés, live music, stunning panoramic views of the City and the chance to meet other AIPPI members.
For more information and to RSVP, click here or contact [email protected].
*N.B. This event is for international delegates only and not UK IP firms or law firms. For more information about this, please contact the Mathys & Squire Marketing team here.
Mathys & Squire will once again be sponsoring and exhibiting at the flagship event for London Tech Week, TechXLR8, which brings together seven of the biggest technology conferences with over 15,000 attendees, 300 exhibitors and 600 speakers.
From 12th-13th June at the ExCeL Centre, London, our team of patent, trade mark and design experts will be based in the Startup Elevate hub at stand S104 ready to discuss all intellectual property related matters including protection, strategy and valuation for startup businesses.
Managing Associate Andrew White will be a judge at the ‘Pitch off’ session on Security and Connectivity from 14:20 – 15:20 on 13th June.
For further details and a copy of the full agenda, click here.
Mathys & Squire LLP has promoted Hazel Ford and Posy Drywood to the partnership. The firm now has 27 partners and 10 offices across the UK and Europe.
Hazel Ford has nearly 20 years’ experience in the patent profession and joined Mathys & Squire from the London office of a leading US IP law firm. She advises clients on all aspects of patent strategy, and handles patent prosecution, EPO opposition and appeal proceedings. She specialises in biotechnology and pharmaceuticals including antibodies, vaccines, genes and proteins, drug formulations and diagnostics. Hazel has a PhD from the University of Cambridge and is qualified as a Chartered and European Patent Attorney and a Patent Attorney Litigator.
Posy joined the chemistry group at Mathys & Squire in 2009. She drafts and prosecutes patent applications for her clients, as well as managing global portfolios on their behalf. Posy is experienced in opposition and appeal proceedings before the European Patent Office, and has coordinated the filing and prosecution of Supplementary Protection Certificates across Europe. As part of the chemistry group, Posy is particularly familiar with inventions in the fields of pharmaceuticals, oil and gas, batteries and green technology. Her clients range from large multi-national companies to SMEs and universities. Posy has a master’s degree in natural sciences, specialising in chemistry, from the University of Cambridge.
Commenting on the firm’s new promotions, partner Chris Hamer said: “We are delighted that Posy and Hazel are joining the partnership to augment our high-level skills in their specialist chemistry and biology sectors and to service our clients across these global industries. It has been a very successful year for Mathys & Squire and these promotions highlight the firm’s continued growth and strength in the marketplace, as well as our dedication to nurturing and progressing talented individuals in the business. We wish them the best of luck in their careers as partners in Mathys & Squire!”
For small companies in the medtech space, the most usual exit is to be acquired by a larger corporation. Having seen this process from both sides, through advising a vast number of startups and multi-nationals, I cannot overemphasize how important spending a small amount of time in order to look ahead and get the intellectual property (IP) strategy right at the outset can make a big difference both to the likelihood of a successful acquisition and the sale price.
Following are some top tips on what medtech businesses should do in order to help protect their IP and avoid risks to their inventions.
Think about IP from the outset and start protecting it early on.
If you are successful with your product, potential larger acquirers will want to know:
(a) is it protected, or can it be copied; and
(b) is it free to use or does it infringe someone?
You cannot patent an invention once it has been disclosed publicly, whether in a press release or to potential investors unless those investors are under a non-disclosure agreement (NDA). You should be aware even of teasers which may not go into full detail but make it public enough to render a later patent application obvious. Therefore, it is important that you apply for patent protection prior to disclosing the technical details of your technology. Be wary of including too much speculative information early on as you may reduce the chances of protecting future advances, which could be considered obvious if you hint towards them in earlier applications.
Check that you can show you own the IP.
This is particularly important when you have research and development collaborations or where tech comes from university research/work with healthcare providers. The default in the UK is that the right to patents or designs is owned by the employer of the inventor(s) or designer(s), although this can be altered by agreement. Make sure it is clear from the outset who will own the IP from any collaborations and ensure this is clearly reflected in the IP clauses in the agreement.
Some universities have standard procedures for transferring or licensing the IP, whilst it is harder at others. Ensure you know the terms of your contract and your options before entering into any discussions about who owns the IP and how to transfer it out, if necessary.
Know what IP your competitors have and make a plan for dealing with it.
Third-party IP rights can block you from getting your product to market, lead to potentially lengthy and uncertain litigation, costly settlements or simply make you less attractive to investors. There is a delicate balance as an almost limitless amount of money could be spent searching for and analysing third parties’ IP, whereas doing nothing may result in being surprised by something that really should have been identified before and may have been a simple work-around or might have been effectively neutralised, had it been identified earlier.
Consider third-party observations or oppositions (in Europe) which are much cheaper than litigation or Inter Partes Review (in the US) to help prevent competitors getting IP that may be an issue. Gaining protection which may interfere with competitors’ commercial activities, even if such IP does not directly cover your own, may improve your negotiating position and provide a disincentive for competitors to assert their own IP against you.
Tie in your IP strategy closely to your funding and business plan.
It is not essential to apply for worldwide protection for everything from day one. Work out what you need to protect early on – the key concept is anything you have to disclose publicly to obtain funding – and file a national application with little or no official fees. Defer costs by filing an International PCT application a year later, which puts off the decision on which countries you eventually want to pursue protection in for two and a half years after the initial filing. Include several concepts in one application; you are likely to get an objection that the application relates to multiple inventions but can file divisional or continuation applications later to protect separate concepts, reducing the initial cost of official fees and prosecution.
It is normally quicker and easier to obtain protection for narrower concepts, so if there is a difficult battle and funds are tight, one strategy is to focus on getting something useful protected early on, while ensuring you have basis to protect the broader idea in a divisional or continuation later when you hopefully have more funding. Investors often want to know you have registered IP and showing a few early grants for patents that read directly onto your products can be very helpful.
Aim to achieve good protection in key territories rather than weaker protection everywhere.
Think about the key markets for yourself and your competitors; where your competitors are based and manufacture; and where – normally as a last resort – you would litigate if needed. It would be very unusual to fight litigation in every possible market. The US, Europe – particularly Germany and the UK – and, increasingly China, are normally key territories. But this very much depends on the marketplace and your commercial strategy.
Beware that IP protection differs throughout the world. For example, there are restrictions on patenting medical methods of treatment or diagnosis in Europe. Although, the devices can be protected as can related methods, as long as they do not involve the actual treatment or diagnosis. Taking a strategic view early on may give you better outcomes.
Don’t overlook registered designs and trade mark protection.
Registered designs are relatively cheap; a few hundred to a few thousand pounds, and fairly quick; a few weeks to a few months to obtain as they do not require substantive examination prior to grant. Designs cover products which are novel in appearance (i.e. design), rather than technical innovations.
If you have spent time and money getting your product to look right, whether a web/app interface or a hand-held device, then it is normally worthwhile to obtain registered design protection. If you are successful, your brand may become your biggest asset so set your brand strategy early and don’t do things to weaken it.
Finally – a little good strategic advice early is generally much cheaper and more valuable than scrabbling to resolve problems after they have become serious enough to get your attention.
This article was first published in Medtech Insight in May 2019.
In an episode of CUTalks, Mathys & Squire Partners James Pitchford and Craig Titmus speak to Cambridge University Technology and Enterprise Club (CUTEC) hosts about the secrets of good IP management for founders and business owners.
The podcast covers a range of IP management topics, including types of IP; advice about timing; costs associated with IP for international reach; and examples of tech-based scenarios with IP advice.
To listen to the full podcast, please click here.
On 27th March 2019, the IP Tribunal of the Chinese Supreme People’s Court (the CSPC IP Tribunal) handed down its first judgment of an appeal case since its establishment on 1st January 2019: Xiamen Lucas Auto Parts Co., Ltd. (China, hereinafter “Lucas”), Xiamen FuKe Auto Parts Co. Ltd. (China, hereinafter “FuKe”) v. Valeo Systèmes d’Essuyage (France, hereinafter “Valeo”).
Summary
The CSPC IP tribunal, in its very first judgment, explored the relationship between interim judgment and temporary injunction when they coexisted in a trial. The CSPC judges also discussed claim construction and gave guidelines on the criteria on assessing functional and “means-plus-function” features in its role as a national appeal court.
Background
Valeo is a French supplier of car wipers and sued Lucas, FuKe and Chen Shaoqiang to the Shanghai IP Court for infringing its Chinese patent ZL200610160549.2 (Wiper connector of motor vehicle and the corresponding connecting device) by manufacturing and selling three models of car wipers. The Shanghai IP Court acknowledged the infringement and issued an interim judgment on 22nd January 2019, ordering Lucas and FuKe to immediately stop infringing Valeo’s patent rights. Then Lucas and FuKe filed an appeal to the new CSPC IP tribunal.
The appeal
The CSPC IP tribunal accepted the appeal case on 15th February 2019 and held the public hearing on 27th March 2019. The panel of five judges maintained the interim judgment of the Shanghai IP Court and the judgment was pronounced in court.
Fig.1 and Fig.3 of Valeo’s Chinese patent ZL200610160549.2
Claim construction
The first core issue discussed in court was whether the alleged infringing products would fall within the scope of claim 1 of Valeo’s patent. In particular, three technical features of claim 1 were analysed by the CSPC judges:
1) Claim 1 recites “a connector (42) of a wiper for securing a connection and articulation between a wiper arm (22) and a component (40) of a wiper blade (24)” (feature 1). Lucas and FuKe claimed that the wiper arm and a component of wiper blade of the alleged infringing products were not directly connected and articulated as recited in claim 1. The CSPC judges disagreed with them and stated that claims and terminologies should be interpreted, from a skilled person’s point of view, based on claims in combination with the description and drawings and cannot be interpreted in isolation, because according to Article 59 of Patent Law of the People’s Republic of China “For the patent right of an invention or a utility model, the scope of protection shall be confined to what is claimed, and the written description and the drawings attached may be used to explain what is claimed”. Firstly, feature 1 itself didn’t exclude indirect connection of the wiper arm and wiper blade, and secondly, paragraphs [0043] and [0044] of the specification and Figs. 1 and 3 show that the wiper arm and the connector were connected, and the connector and a component of the wiper blade were articulated, therefore the connector secured the connection and articulation of the wiper arm and a component of the wiper blade, which means that skilled person would understand that feature 1 didn’t require direct contact of the wiper arm and a component of a wiper blade. Therefore, feature 1 could read onto the alleged infringing products.
2) Whether the alleged infringing products include feature 2 “at least one elastically deformable member (60) – the member (60) locking the connector (42) at an embedded position at the front end (32) of the wiper arm (22)”. Lucas and FuKe argued that the elastic member of the alleged infringing products can only “fix” rather than “lock” the connector. Again, the judges restated that the skilled person reading the original disclosure (the description, claims and drawings), would understand that “locking” in claim 1 does not mean tight “locking” but only “fixing” or “locking to a certain extent” in the context that Valeo’s patent aimed to address a technical problem of accidental disengagement of the connector. The three alleged infringing products all comprise elastic members which are configured to fix the connector or lock the connector to a certain extent at an embedded position at the front end of the wiper arm. Feature 2 thus could also read onto the alleged infringing products.
3) Whether feature 3 “in the closed position, the safety fastener (74) extends toward the locking member (60) for preventing elastic deformation of the locking member (60) and locking the connector (42)” was a “”means-plus-function” feature or not. The CSPC judges overruled the Shanghai IP court’s interpretation of feature 3 as a means-plus-function feature and investigated the boundary of identifying a functional feature. According to Articles 8 of CSPC’s Interpretation (II) of Several Issues concerning the Application of Law in the Patent Infringement Dispute Cases, that if a certain technical feature has defined or implied specific structures, components, steps, conditions or the relationships of a technical solution, even if the technical feature also defines its function or effect, in principle it is not a means-plus-function feature.
In the present case, the judges clarified that feature 3 described the position relationship between the safety fastener and the locking member and also implied a special structure – “the safety fastener extends toward the locking member”. Therefore, feature 3 further contributed position and structural limitations (also seen at paragraphs [0056] of the description) and thus is not to be interpreted as a means-plus-function feature, and its positional, structural and functional limitations should all be considered when the features are compared for infringement analysis.
The judges then found that three models of car wipers had equivalent positional/structural/functional features as feature 3, and again feature 3 could also read onto the alleged infringing car wipers.
In conclusion, the three alleged infringing products therefore fell within the scope of claims 1 of Valeo’s patent.
The interim judgment and the temporary injunction
The second core issue was how to deal with the temporary injunction request in the second instance.
In the first instance, Valeo requested a temporary injunction to stop the defendants from continuing alleged infringing activities. However, the appeal was filed shortly after Shanghai IP Court issued the interim judgment, leaving the temporary injunction request undealt with.
In the second instance, the temporary injunction request was transferred to the CSPC IP tribunal. When dealing with the temporary injunction request in light of the first-instance interim judgment, the CSPC judges applied a special test to see if there would be any urgent damage made to Valeo and if yes, whether the CSPC IP tribunal would be able to make a final decision when the temporary injunction was being processed. In this case, the evidence submitted by Valeo was not sufficient to approve the urgency of damage, and in view of the fact that the judgment was pronounced in court, Valeo’s temporary injunction request was therefore not supported by the CSPC IP tribunal.
An “Innovative” hearing
The CSPC IP tribunal’s first public hearing emphasises the concept of “protecting innovations in an innovative way”:
1) As mentioned at the beginning of this article, this is the first judgment of the CSPC IP tribunal, which was established to handle appeals decided by Chinese Intermediate People’s courts or IP Courts in invention patent cases as well as other highly technical IP cases. Such a national appeal court will unify the criteria of IP trials, help prevent inconsistency of legal application and improve the quality and efficiency of trials.
2) The CSPC IP tribunal, for the first time, explores the relationship between the interim judgment system and the temporary injunction system, and clarifies the conditions when the two systems coexist.
3) The CSPC IP tribunal closed the whole case within an impressive 50 days, from case acceptance to decision delivery. The speedy second-instance decision enabled Shanghai IP court, which made the interim judgment to simplify a complicated first-instance trial, to continue the rest of the trial in good time.
4) The judgment of the CSPC IP tribunal explained in detail the rules for identifying a functional feature and a means-plus-function feature, which is particularly relevant because means-plus-function features are typically interpreted quite narrowly. This decision, encouragingly, interprets the feature of the locking member in a manner such that it is not restrictively interpreted as a means-plus-function feature, perhaps opening the way to more functional claim language being interpreted in such a way in China.
5) Various different forms of technical support were used during the hearing. For example, Augmented Reality (AR) technology was used to display evidence, speech recognition was used to generate transcripts, and a QR code was provided for downloading the decision.
Continuing…
On 23rd, April 2019, the CSPC IP tribunal’s held a public hearing of the first administrative case: appellant Baidu, Inc., Sogou, Inc. and the appellee State Intellectual Property Office Patent Re-examination Board. Due to the complexity of the case, the court did not pronounce a judgment in court. However, we will continue to watch this case and future decisions made by the CSPC IP tribunal.
Mathys & Squire and Food Tech Matters will be co-hosting a VIP pre-launch party to Food Tech Matters 2019.
Food Tech Matters is a meet-up between the best food tech startups from all over the globe, corporates, accelerators and leading food tech investors who attend not only to hear about the latest food tech trends and developments from the experts, but to forge strategic partnerships to accelerate these breakthrough technologies. The event will be held from 25th – 26th June 2019 at The Crystal, London.
As the official IP partner, Mathys & Squire will co-host the VIP pre-launch party at our London office in The Shard. Below are the details:
When: Tuesday, June 18th 2019
Time: 18:00 – 21:00
Where: Mathys & Squire, The Shard, 32 London Bridge Street, SE1 9SG
*Please remember to bring photo ID to enter The Shard
If you’re interested in attending the event, please email the Mathys & Squire Marketing Team by Friday, June 14th 2019.
