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It was announced last week that total venture capital (VC) funding for London’s tech companies rose by an unprecedented 87% last year to reach $9.7bn, over double that raised in Berlin and triple that raised in Paris. 

The UK is now the fastest growing tech ecosystem in Europe, and the UK tech sector recently overtook the US for foreign investment per capita. The surge was primarily fuelled by investments in fin-tech, AI and clean energy, all areas in which the Mathys & Squire team has significant expertise and where we are seeing increasing numbers of patent applications being filed by clients.

In such fast-growing sectors, establishing a carefully thought out and commercially sensitive intellectual property (IP) strategy is key. Not only will this avoid costly mistakes occurring down the line (often only being spotted at the 11th hour before a deal or investment is about to go through), but an effective IP strategy should add value to the business and help drive revenue – whether it be through locking in supply chains or keeping competitors ‘off the grass’.

The team at Mathys & Squire has years of real-world, commercial experience in creating such IP strategies and can really help to increase the growth and value of such businesses by making their IP work harder for them.

Contact us to find out how we can help you to maximise the value of your business’ IP.

An extended version of this article, with advice for early-stage startups, was published in Startups Magazine in February 2020.

At a packed hearing in Munich, Board 3.3.8 in five-member form upheld the decision of the Opposition Division revoking EP-B-2771468 – an important CRISPR patent belonging to the Broad Institute, MIT and Harvard – for lack of novelty over intervening art due to loss of priority. The appeal in case T 844/18 was of significance not only to the CRISPR community, but also to users of the European patent system more generally due to the questions of law it raised. 

The case turned on the issue of legal entitlement to priority. The PCT request for the application from which the patent derived had not included all of the applicants for the US provisional applications from which priority was claimed, or their successors in title. The proprietors argued that this did not matter, for three innovative reasons, any of which would, if accepted, mark a radical shift in European practice. 

Firstly, the proprietors argued that the EPO is not empowered to assess legal entitlement to priority, in the same way that the EPO cannot determine entitlement disputes. 

A second line of argument, which only became relevant if the first did not succeed, was that the EPO was wrong to assess legal entitlement to priority on the basis of the ‘all applicants’ approach, according to which all of the applicants named on a priority application, or their successors in title, must be named on the later European filing in order to introduce priority rights.  The proprietors argued that the approach limited access to international protection and was therefore contrary to the object and purpose of the Paris Convention. They advocated an approach requiring only one applicant / successor in title in common.

A third line of argument, which only became relevant if the second did not succeed, was that the EPO should determine the person who ‘duly filed’ a priority application under the national law of the state in which the priority application was filed. According to the proprietors, the omitted applicants were not, under US law, persons who had duly filed the provisional applications with respect to the subject matter claimed in the PCT application, or successors in title thereto, because they had not contributed to that subject matter or derived rights from an inventor who had contributed to that subject matter.

The opponents, one of which was represented by James Wilding and Alex Elder of Mathys & Squire, argued that EPO practice in assessing legal entitlement to priority aligns with the object and purpose of the Paris Convention, finds support in the wording of the legislation and in the established case law, and should therefore continue. 

Events took an interesting turn at the start of day three of the hearing when, having heard the parties on only the second argument, the Board indicated that it was minded to seek guidance by referring questions to the Enlarged Board of Appeal in relation to all three arguments. The opponents protested that they should be heard on the first and third arguments before a decision to refer was taken, and so the hearing continued with a discussion of the remaining arguments. 

After hearing the parties, the Board concluded on the fourth day that it could decide the case without the need for a referral. The Board went on to reject all three of the proprietors’ arguments. In upholding the decision of the first instance, the Board opted to follow established EPO practice. Whilst that did not work to the proprietors’ advantage, it does help maintain certainty within the European patent system.

In this article for Business & Innovation Magazine, we talk to TBAT Innovation about R&D Tax Credits.

Research & Development (R&D) Tax Credits are a UK tax incentive, designed to encourage investment in R&D, which enable businesses to reduce their tax bill, or claim payable cash credits as a proportion of their R&D expenditure.

R&D Tax Credits can be a hugely effective way to inject additional finance into a business, and in recent years, there has been a steady increase in the number of businesses claiming them. However, there is still a large proportion not taking advantage of the scheme and for those that are, they may not be claiming all they’re entitled to, as qualifying R&D is potentially being overlooked.

Business Development Manager, Vincent Seddon, from TBAT Innovation, who provides business support for SMEs and, in particular, R&D advice nationwide, tells me: “There seems to be a lack of understanding in relation to what R&D means when it comes to making R&D Tax Relief claims, and consequently, what can and cannot be claimed.”

He goes on: “It can be difficult to navigate areas of the HMRC guidelines, and it’s important for an R&D Tax Consultant to take the time to fully consider and understand your business’s technical projects to identify all eligible activities. In many cases, making an R&D Tax Credit claim is left to the company’s accountancy firm, but do they have the experience, the time and the technical expertise to build a robust and maximised claim on your behalf?”

Some of the definitions below can be a little ambiguous, but if you and your business have said ‘yes’ to any of them, then you may be able to claim back some of your R&D spend.

To make a claim for R&D Tax Credits, your business must have done the following:

Your project may result in a new process, product or service, or improve on an existing one.

To make an R&D Tax Relief claim, it’s important to invest time gathering relevant information in relation to your spend, as this can have an impact on the claim value. It is also crucial to include technical reports to demonstrate that R&D has been completed, focusing on the technical uncertainty faced.

Vincent goes on to explain, “It’s a long process to follow and can be quite time consuming if it’s done in-house. Important elements can be perceived not to be R&D, and potentially be omitted, or even worse, overlooked. Using a specialist R&D Tax Credit consultant can help avoid this from happening and serve as a fresh pair of eyes overseeing the claim.”

When working with businesses, it is always a sensible approach to ensure that there is a robust IP strategy in place which takes R&D into account. Quite often R&D is focused on crowded technical areas and it is important to work with an IP firm to help you uncover any prior art or patents from other businesses where R&D efforts may provide limited scope.

At Mathys & Squire, we work directly with R&D teams and technical directors, and can provide advice such as patent searching and identification of any prior art which could be used to help companies ensure they do not embark or invest time in developing new technologies which may, or may not be eligible for R&D claims.

In summary, if you are not claiming R&D Tax Credits, or are claiming, but are unsure whether you are including all your eligible spend, get in touch with an R&D Tax Relief expert.

This article was first published in Business & Innovation Magazine in January 2020.

In this article for Open Access Government, Laura Clews, managing associate at Mathys & Squire, analyses the protection for innovative new products in the medical cannabis & CBD sector.

In recent years, ongoing medical research into the use of CBD (cannabidiol, a non-psychoactive compound found in the flower of the cannabis plant), for the treatment of conditions, such as epilepsy, stress, arthritis and Alzheimer’s disease, has become more widely publicised. This has, at least partly, contributed to the notable change in consumer perception of CBD and CBD-based products. Consumers have become more aware of the potential health benefits associated with CBD-based products and the distinction between CBD and other cannabis extracts, such as THC (tetrahydrocannabinol), which induce a ‘high’ upon consumption and so the demand for CBD-based products continues to rise.

It has been predicted that the value of the global legal cannabis market is expected to reach $66.3 billion by the end of 2025 (reported by Grand View Research, Inc.) and so it is no surprise that medical manufacturing companies have committed more funding into the research of new CBD-based drugs. In addition, the relaxation of legislation surrounding the use of CBD-based products in many countries has surely incentivised further research and innovation in this field.

Successful companies know that in order to secure a competitive advantage in rapidly developing markets, early protection of intellectual property (IP) rights is essential. However, as this market is fairly new, there is still some uncertainty as to how different patent systems across the world will approach the assessment of, for example, novelty and inventive step for CBD-based products, extraction methods and their uses.

Is it possible to obtain patent protection for a naturally occurring compound?

Although it is not possible to protect a CBD compound per se, given that this compound occurs in nature, it is still possible to protect CBD-based products. For example, companies may be able to obtain valuable protection in the form of:

Also, at least under European practice, if a naturally occurring compound can be shown to have a specific technical effect, this compound may be patentable for particular use as a result of that effect. For example, the use of CBD or a medicament comprising CBD in the treatment of new diseases/ailments.

As with all patent applications, the applicant would still need to demonstrate that the claimed invention is novel and inventive in view of the prior art, as well as being industrially applicable.

As cannabis-based products were, until recently, illegal in most countries, there appear to be far fewer publicly available disclosures on methods of producing cannabis-/CBD-based products, compared to other types of medicinal compounds or food and drink products, enabling those quickest off the mark to obtain broad protection. However, as cannabis has been used for thousands of years in medicine and textiles, the validity of the broadest patent claims on file may be uncertain in view of this prior use.

The validity of broad CBD-based claims has recently been assessed in the US. On 30 July 2018, United Cannabis filed an action against Pure Hemp Collective LLC in Colorado, alleging that products made by the Collective fell within claims 10, 12, 14, 20 to 22, 25, 27, 28, 31 and 33 of their U.S. Patent US 9, 730,911. As an example, Claim 10 of this patent states:

“A liquid cannabinoid formulation, wherein at least 95% of the total cannabinoids is cannabidiol (CBD)”.

In response, Pure Hemp filed an Early Motion for Partial Summary Judgment, arguing that the asserted claims of U.S. Patent No. 9,730,911 were invalid.

The arguments presented by United Cannabis as to the validity of the claims were based on two main points, (i) the liquid formulation itself, was purported as being novel; and (ii) alleged “markedly different physiological characteristics” of the liquid. However, the court was able to form a decision based on the first point alone.

In the decision by Judge Martinez, it was set out that: “Pure Hemp has failed to establish beyond genuine dispute that a liquefied version of cannabinoids and related chemicals at the concentrations specified in the 911 Patent is anything like a natural phenomenon. It may be true, as Pure Hemp insists, that cannabinoids in nature can take the form of a resin; that a resin can be highly viscous; that a highly viscous substance may at times be considered a liquid; and therefore it is logically possible that cannabinoids in nature might appear in a form that could, in some sense, be deemed a “liquid.”…Even accepting as much, the 911 Patent specifies threshold concentrations of cannabinoids and related chemicals. Pure Hemp nowhere claims that these precise concentrations, or anything close to them, occur in liquid form in nature.”

Whilst this case provides some certainty on patentable subject-matter in the US, it is not clear that the same approach would be followed in other countries. Indeed, under European practice, a known compound is not considered novel purely on the basis of the compound being provided in a purified form, as long as the degree of purity can be achieved by conventional means. In this way, the above claim may not be considered novel over any previous methods of extracting CBD (regardless of how effective these methods are).

Path to selling CBD-based medicine

Although the use of cannabis-based products for medical purposes is legal in many US states, to date, the US Food and Drug Administration (FDA) has only approved one CBD-based drug, Epidiolex, for treating a rare, severe form of epilepsy. It has been reported that further drugs have not yet been approved due to the limited information available about CBD, including about its effects on the body.

Similarly, in the UK only two CBD-based drugs have been awarded approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) – Epidiolex and Sativex (which is a mouth spray that contains a mixture of THC and CBD for treating muscle stiffness and spasms in patients with multiple sclerosis).

The House of Commons Health and Social Care Committee published a report on 18 June 2019 – “Drugs policy: medicinal cannabis – Sixteenth Report of Session 2017-19” discussing that whilst medicinal cannabis was changed from Schedule 1 to Schedule 2 of the Misuse of Drugs Regulation 2001 in November 2018, allowing specialist doctors to prescribe it and for products to be available for further research to be conducted, the committee believes that further robust clinical trials are necessary in order to test the efficacy and safety of such medical products before the approval of further drugs can be granted.

This article was first published in Open Access Government in January 2020.

In this article for AgFunderNews, Mathys & Squire partner Michael Stott highlights the importance of food and drink companies protecting their intellectual property in order to prevent competitors from exploiting their innovations.

The food and drink sector is the largest manufacturing sector in the UK — larger than the automotive and aerospace sectors combined. It is home to significant innovation, with companies looking to develop new consumer products and striving to keep up with consumer trends, all while ensuring compliance with evolving industry regulation and keeping pace with commitments to improve green credentials. Protecting the intellectual property (IP) resulting from this research and development can help companies to maintain their competitive advantage by preventing others from exploiting the fruits of their labour. However, the full potential of IP is not always harnessed in the food and drink sector. This article is intended to demystify IP in the food and drink industry and shed light on the full extent of the opportunities available to companies to protect and benefit from their IP, with a particular focus on the role patent protection can play.

Research commissioned by the Food and Drink Federation (FDF) in 2018 to identify both the opportunities available to manufacturers and the barriers to growth found that almost nine in 10 (89%) of food and drink manufacturers in the UK were involved in new product development and that nearly half (46%) of respondents have an on-going collaboration with higher education or research initiatives. Clearly, there is a significant focus within the industry on research and development and a consequence of that is the generation of different forms of protectable IP rights that are of varying value to innovative companies, examples of which include:

Patents – these provide protection for products (including food, drink, packaging and machinery), processes (such as recipes or production methods), and uses of products. Granted patent rights provide the patent holder with a temporary monopoly that means that no one can work the invention covered by the patent (for example, make or use a patented product or operate a patented process) without the patent holder’s permission while the patent is in force.

Trade secrets – these can endure indefinitely if the invention remains a secret (which has worked well for Coca-Cola’s original drink formula). However, they provide no protection if another company independently develops the same product or process, or if they successfully reverse engineer a product.

Registered designs – these provide protection for aesthetic aspects of products, such as packaging or aesthetically-pleasing food products. Some protection is also available for designs which have not been registered (unregistered designs).

Trade marks – these identify a product as being from a particular company and include logos (for example, KitKat’s “have a break…”) as well as branding.

Copyright – this comes into existence automatically and protects only against copying of literary, dramatic, musical or artistic works (e.g. artwork on product packaging or the written form of a recipe).

As is evident to many, trademarks and branding play a vital role in distinguishing products and services in the food and drink sector and it is therefore no surprise that these IP rights are often the initial focus of food and drink businesses. However, the possibility of patent protection should also be an early consideration for innovative companies for much the same reasons as it is, for instance, in the pharmaceutical and automotive industries. Patents can provide the means to ring-fence an area of innovation so that it cannot be exploited by competitors so as to help reinforce a dominant market position.

Trade secrets, or confidential know-how, have been relied upon historically by the food and drink industry to a varying extent to maintain competitive advantage, typically beyond the maximum lifetime of patent protection (20 years). However, trade secrets are only useful to the extent that it remains possible for the know-how to remain secret, and it remains difficult for other parties to replicate the know-how by, for instance, reverse engineering a product. Trade secrets are therefore not always the most appropriate way to protect innovation, particularly as advances in chemical analysis can make reverse engineering more achievable than it has been previously.

Patent protection represents an alternative form of IP protection that, despite not providing indefinite protection that is potentially possible with trade secrets, has a number of benefits to innovator companies. Not only do patents offer a monopoly right, they are assets that can be used to add value to a business that can be attractive to investors and they can be sold or licenced as with other forms of property. Products covered by granted patent rights can also benefit from corporation tax relief, such as the ‘Patent Box’ in the UK. Granted patent rights can also be a useful marketing tool – a stamp of approval that a new product is innovative and unique.

With all the potential benefits offered by patent protection in the food and drink sector, there still can be misconceptions surrounding exactly what forms of innovation may be eligible for patent protection, and it may come as a surprise to some companies that their innovations could be patent protected. In order to be granted a patent, an invention must be new and represent a non-obvious solution to a technical problem. Although the features of an invention which define a contribution over what was previously known must have technical character, an invention does not have to be complex or necessarily the result of ground-breaking or expensive research to be patentable. Some very familiar food products have been the subject of patent protection, including for example rice cakes (EP1025764), granola bars (US 4,451,488), new orange juice formulations (WO 2004/060083), veggie burgers (EP3125699) and even a fast setting donut glaze (EP2101595).

One more common misconception is that recipes (i.e. product preparation processes) cannot be patented. They can. So long as they fulfil the basic requirements set out above. For instance, a recipe for a new fish and chip batter was found to be patentable on that basis that it reduces oil uptake during the frying process (GB2543623). A new bread recipe was found to be patentable for giving improved textural properties (GB2545647). A recipe for an “egg gel” composition was considered patentable on the basis that it confers the organoleptic properties of fresh egg, whilst providing an extended shelf life to confectionary compared to normal egg-containing products (GB2565178). A recipe for preparing oat milk having improved soluble oat protein content was also found to be patentable (EP2953482). Numerous examples of patented recipes exist.

Innovative companies should also remember that process know-how can be just as patent-eligible as the new products they produce, which can open up different opportunities for potential revenue growth. A new feature of a food manufacture process, for instance, might allow a food product to be made with a desirable texture which obviates the need for certain additives to be used or for certain customer cooking steps (e.g. oil frying) to be implemented. For example, a process for preparing low-fat oven-fries involving a super-heated steam treatment step which confers a texture of normal “French fries” without oil frying at home was found to be patentable (US7560128).  Process patents can be particularly useful for innovative companies to licence their technology and open up additional revenue streams and can be particularly useful in supplementing product patents in a company’s portfolio.

According to the FDF, 96% of food and drink manufacturing businesses in the UK are small to medium-sized enterprises. It is these smaller companies that may be less familiar with the patenting process and the benefits to their businesses, yet which are actively innovating and potentially overlooking opportunities to exploit the IP that is being generated. Although the costs of obtaining granted patents are not insignificant, these may seem trivial when weighed against the potential value addition to a business, opportunity to obtain a monopoly in the market place, ability to generate revenue through licencing and opportunity to benefit from corporation tax relief associated with the sales of patented products.

This article was first published on AgFunderNews in December 2019.

T 0318/14 concerns an appeal based on an Examining Division’s decision to reject EP 2429542 on the basis of double patenting.  EP ‘542 has identical claims to, and claims priority from, granted patent EP 2251021. The Board of Appeal in T 0318/14 affirmed that while there is no statutory basis for a double patenting rejection under the European Patent Convention, that Enlarged Board of Appeal decisions G 1/05 and G 1/06 set out the principles for such a rejection on the basis that an applicant has “no legitimate interest in proceedings leading to the grant of a second patent for the same subject-matter if he already possesses one granted patent therefor.” 

Moreover, while G 1/05 and G 1/06 related to divisional applications claiming the same subject-matter, the Board considered that the principles should not be restricted to such situations. Thus, an interesting question arising in T 0318/14 is: ‘does an additional 12 months of patent term enjoyed by applicant for EP ‘542 versus EP ‘021 constitute a “legitimate interest”?’ Indeed, in decision T 1423/07, the Board held that a legitimate interest did exist in a scenario where there were different applicants for the priority document and later European application claiming the same subject-matter. 

Nevertheless, the case law in this area is divergent, thus a referral to the Enlarged Board of Appeal was considered appropriate. The questions referred seek to establish:

Needless to say, having answers to each of the referred questions will improve legal certainty in this somewhat grey area of European patent law.

Mathys & Squire has been recognised by JUVE Patent in its inaugural UK rankings. The guide brings together UK patent practices, solicitors and barristers, who, according to the in-depth research carried out by an independent team of journalists, have a leading reputation in the UK patent law market.

Ranked in the category of patent filing, Mathys & Squire has been specifically noted for its expertise in the fields of pharma and biotechnology; medical technology; chemistry; digital communication and computer technology; electronics; and mechanics, process and mechanical engineering.

Partners Chris Hamer and Jane Clark have been individually recommended for their expertise in chemistry and digital communication and computer technology / mechanics, process and mechanical engineering respectively.

For more information and to see the JUVE Patent UK rankings 2020 in full, please click here.

Many companies within the food and drink industry are searching for the most effective ways to reformulate their products in response to consumer demands for healthier consumables, along with the new sugar reduction guidelines which were published by Public Health England (PHE).

The required overhaul for many companies to meet these reduced sugar or sugar-free targets means that significant research and innovation continues within this sector.

Two companies working towards this end are Cadbury and Nestlé, who both launched healthier chocolate bars in 2019.

Cadbury reformulated the recipe of its classic Dairy Milk chocolate for the first time in 114 years, reducing the sugar content by 30% without including any artificial sweeteners, colours or preservatives. Reportedly, it took a team of 20 scientists, nutritionists and chocolatiers three years of research and testing to produce this new treat. Mondelez International, (parent company of Cadbury) has announced that the new recipe will remain a trade secret, however, it has been suggested that the reduction in sugar has been made possible by the inclusion of a plant-based fibre to provide a similar taste and texture to the traditional Dairy Milk chocolate.

Nestlé announced that it has been able to produce new chocolate bars containing no added sugar by including a natural sweetener based on mucilage (the white pulp surrounding a cocoa bean), a component which is typically discarded in traditional chocolate-making processes.

Nestlé has also launched a new KITKAT containing the “Cacao Fruit Chocolate” in Japan and is now looking to expand this latest creation across the globe in 2020.

An excerpt of this article (below) was published in the December 2019 issue of Food Manufacture.

Generics and innovator sources from the pharma industry explain why documents from US and UK trade discussions do not point to the US trying to extend pharmaceutical patents

Pharma insiders from generics and innovator companies tell Patent Strategy that contrary to what Labour Party leader Jeremy Corbyn interpreted from the 450 pages of trade talk negotiations, the UK and Europe have longer patent monopoly rights for medicine than most of the world.

Last week, Corbyn accused the government of negotiating with US trade representatives to lengthen UK drug patents in a post-Brexit trade deal. The Labour Party leader said the trade documents give undeniable proof that the NHS will be “up for sale” after Brexit because prolonging patents will give US pharma drug companies extended market exclusivity in the UK.

“Longer patents can only mean one thing: more expensive drugs. Lives will be put at risk as a result of this,” said Corbyn.

He also said the trade talks give further credence to his accusations that the NHS is not safe in Conservative Party leader Boris Johnson’s hands, and that discussion to extend patent rights is proof the NHS is “on the table” in negotiations with the US if Johnson wins.

While lengthening patents would indeed lead to delayed market entry for generics companies and result in higher drug prices, a pharmaceutical industry source says that Corbyn doesn’t understand that patents do not control costs, and that drug prices are set by the National Institute for Healthcare and Excellence (NICE).

“There are two distinct issues here; one is the NICE side and one is the IP side. NICE is a price regulator and is separate from patents. NICE decides drug prices,” he says.

“The documents go back to 2016 and are a record of four or five meetings that really are the US side asking the UK to tell them about the SPC system, regulatory data system and patent system.”

He says a closer reading of the documents reveals that the IP discussions were simple exchanges of information between the two sides, with the US asking for more information about the EU SPC system.

The head of IP for a global generics company in Switzerland agrees and adds the documents show nothing more than a standard discussion between two countries in the first steps of a trade deal.

“We know the US has a different system and this shouldn’t be seen as the fault of pharma people. Some people are making it sound like this is big bad pharma doing something nefarious.

“It is most likely the US trade reps were putting forward their position on patent rights and patent law that don’t exist in the UK, but that is what the US would do in trade talks with any country,” he says.

Patent term length is controlled by the European Patent Convention and is similar to the rights granted by the US Code. For the UK to lengthen patents after Brexit, the government would have to change the current EU SPC system that grants extensions for some inventions that face regulatory approval before market entry.

But Martin MacLean, partner at Mathys & Squire in London, points out that the SPC framework is longer than the US patent term extension regime. “The EU SPC regulations goes up to 15 years, the US goes up to 14 years, so I do not see on what basis Corbyn is saying the US is trying to get the UK to extend patents.

“Both of us have patent extensions, we both have the same principle and the US gives a shorter maximum term, so I just don’t see how even if we were to accept the US system if would mean longer exclusivity on the UK market.”

The general counsel at a UK generics company says he believes Corbyn’s accusations that IP discussions are proof this government is willing to sell of the NHS to US companies are nothing more than political fear-mongering.

He says: “This is a cheap political move by Corbyn and bares no relation to reality. It is an extraordinary suggestion that the UK would change the patent system. Western Europe has on average patent rights that extend longer than anywhere in the world so it is the most favourable part of the world for originator companies.

“I find it an incredible suggestion that the UK would negotiate with the US to become the most favourable place for big pharma by maintaining monopolies longer and keep access to medicines from the population longer,” he says.

MacLean adds that one area of agreement between the two countries was the UK’s membership of the UPC, and that any modifications to the current patent system would jeopardise the possibility of the UK becoming or remaining a member. “The US stakeholders were in favour of the UK being part of that, and anybody worth their salt in Europe would also want to be part of that system,” he says.

“But changing our patent system would be madness, absolute madness. I don’t say impossible, but it would be crazy.”

Grace periods and data

One part of the trade talks that Corbyn did not highlight was the discussion about data protection rights for innovative drugs. The pharma industry insider explains the US has five years of data protection for simple molecules and 12 for biologics, while the UK has 10 years for both large and small molecules.

Data protection is important for innovator drug companies to protect their inventions in the rare circumstances that their patents are found invalid. But the pharma insider says that even though he believes trade talks focused heavily on data exclusivity rights, he doesn’t believe many molecules would be affected by changing the system. 

“In principle, if we introduced a US style system for biologics, we’d gain a little but then lose for small molecules. Data protection is your backup in case you lose your patent, but most of the time you don’t need to rely on it because you have a valid patent,” he says.

The head of IP in Switzerland tells Patent Strategy that he doesn’t believe data exclusivity rights are a deal breaker for the US, especially since these rights are controlled by the EPC and not the UK.

“My sense is that talks about this are all standard posturing that the trade representative would take when they are kicking off trade talks with any country and that doesn’t mean the UK would accept any proposals.

“In the replacement for the North American Free Trade Agreement, Mexico did not accept the 12 years data exclusivity or patent term extension, and neither did Canada,” he says.

The trade documents do show that US trade representatives pushed for the 12-month application grace period for inventors who reveal parts of their discovery before filing a patent. This is a unique feature of US IP law and is not found in the EPC.

“There are many industries here in the UK that would see the grace period as a benefit, but any discussion about that would have to take place at the EPO,” says the head of IP.

Even if the US argued heavily for the UK to adopt a grace period for disclosure of inventions, MacLean believes that alone would not be enough for the UK to abandon the EPC.

“These documents are a very healthy discussion between two parties who want to get a deal done,” he says.

“It is madness to say this points to the NHS being up for sale because whatever rules the US pharma companies have to play by the UK companies would as well. I just don’t get it. This whole thing is a storm in a teacup.”

Hopefully, the storms won’t involve any more egregious misunderstandings about IP.

This article was first published on Patent Strategy in December 2019.

In this article for Intellectual Property Magazine, Mathys & Squire associate Max Thoma comments on Shnuggle’s suit against US rival Munchkin.

The Intellectual Property Enterprise Court (IPEC) has sided against UK baby product maker Shnuggle, in a high-profile design case.

IPEC dismissed Shnuggle’s suit against US rival Munchkin on 22 November, after it found it had made an error in preparing its initial application.

Shnuggle reportedly filed simple computer-generated images rather than properly prepared line drawings, which in turn made it difficult to enforce its design rights against Munchkin.

The error saw its later filed design invalidated in the case, due to the earlier error.

Mathys & Squire’s Max Thoma suggested Shnuggle “could have been in a stronger position had they filed a more considered initial registered design application based on properly prepared drawings, rather than simply filing CAD images of an early version”.

He said the ruling “seems to indicate that the differences between [Munchkin’s] Sit & Soak product and the Shnuggle designs would have in any case been too great for a registered design infringement claim to succeed.”

Thoma continued, “In legal terms, this case provides some clarification on the amendment made to the law on unregistered design right by the Intellectual Property Act 2014, in that the judge ruled that a “part of an article” which can benefit from design right does not necessarily have to be a separate component.

“Despite Shnuggle showing that part of their design had been copied, they failed at the final hurdle to show unregistered design infringement as the judge ruled that not all of the part had been copied,” he concluded.

Background

Shnuggle filed suit with the High Court against rival Munchkin in September, asserting it copied two registered Community designs.

The company sought an injunction, claiming the US competitor intends to import and sell in the UK and EU its Sit & Soak (S&S) baby bath.

“The shape of the S&S is the same or substantially the same as the shape of each of the Shnuggle designs,” the litigation stated.


This article was first published in Intellectual Property Magazine in November 2019.