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Mathys & Squire is delighted to be ranked in the latest edition of the IAM Patent 1000: The World’s Leading Patent Professionals 2023 directory – the definitive ‘go-to’ resource for those seeking to identify world-class, private practice patent expertise. IAM undertakes exhaustive qualitative research, identifying top firms and individuals based on their depth of expertise, market presence and sophistication of work. Only those individuals who stand out for their exceptional skill sets and profound insights into patent matters feature in the IAM Patent 1000.

Aside from our firm ranking, 13 of our Mathys & Squire attorneys have been recognised as Recommended Individuals: Partners Paul Cozens, Martin MacLean, Alan MacDougall, Jane Clark, Chris Hamer, Andrew White, Dani Kramer, Anna Gregson, Craig Titmus, as well as James Pitchford. Additionally, Partners Stephen Garner, Juliet Redhouse and Michael Stott have been newly recommended in the guide.

Our attorneys have been praised as “proactive, responsive and accurate. Their communications are clear and easy to understand. The service they provide has been timely, accurate, helpful and courteous, and we have never had any issues with them. They have strong technical capabilities, and they make sure they have the right people doing the work. Their expertise, meticulous attention to detail, follow through and creativity always get positive results”. We are pleased that Mathys & Squire is recommended as “a top choice for prosecution across all manner of technical areas.”

The UK Government announced on 19 May 2023 its long-awaited national semiconductor strategy, setting out a 20-year plan to help secure and grow the UK’s world leading expertise in semiconductor technologies, whilst also strengthening resilience to supply chain disruption and protecting national security.

The national strategy recognises the importance of semiconductors to modern technologies of today and the future, and to the growth of the UK economy. The global semiconductor market, which was valued at $601.7 billion in 2022, is expected to grow by 6% to 8% a year up to 2030. The potential for growth in this industry is therefore huge and the government’s strategy is to bolster the UK’s position in the global semiconductor market by maintaining and building on its strengths.

The national strategy identifies the UK’s strategic and longstanding strengths in compound semiconductors, semiconductor chip design and intellectual property (IP), as well as world-leading research and development (R&D) supported by universities, which will play an important role in the development of new semiconductor technologies. Emphasis is placed on securing the UK an advantage in technologies such as artificial intelligence (AI), high performance computers, quantum and cyber, to drive economic growth and future discoveries.

The strategy sets out a number of ambitious initiatives to help secure and grow the UK semiconductor industry, including a commitment to invest up to £1 billion in the sector over the next 10 years, with £200 million earmarked for the 2023-2025 period. The funding aims to, among other things, help deliver a new National Semiconductor Infrastructure Initiative and a specialist incubator pilot for semiconductor startups to improve access to infrastructure and facilities, as well as boost UK commercial innovation for SMEs to help make them seem more attractive to investors, and help new products get from lab to market faster than ever.

The strategy also involves a commitment to strengthen existing collaborations with international partners, such as Japan, South Korea and the US, to help develop skills and capabilities in new areas and improve supply chain resilience. The announcement is timely and comes as other tech ‘superpowers’ including the US, China, Japan and the EU are investing heavily in maintaining their global position in the semiconductor market.

A key takeaway is that supporting further research, innovation and commercialisation in the UK semiconductor sector is central to the government’s plan for growing the industry and the economy.

Innovation naturally leads to the generation of IP, and patents are increasingly being used as an indicator of innovation activity. The UK is currently eighth globally and third in Europe for the number of semiconductor international patent families, behind Germany and France. We expect this to change in the coming years as the success of the strategy should, in part, be reflected in a rise in the number of patent filings on semiconductor technologies.

Although perhaps not as much funding as some might have hoped for, the government’s national semiconductor strategy comes as a welcome boost to the UK’s semiconductor industry.

Mathys & Squire is proud to be ranked as a leading European patent firm by the Financial Times (FT) in their 2023 report.

The annual list is based on recommendations by clients and peers, as compiled by the FT’s research partner Statista. As well as being featured as a leading patent firm, Mathys & Squire has also been recognised in five specialist areas of industrial expertise this year: ‘Biotechnology, Food & Healthcare‘, ‘Chemistry & Pharmaceuticals‘, ‘Electrical Engineering & Physics’, ‘IT & Software‘, and ‘Mechanical Engineering.’

We would like to thank all our clients and contacts who have taken the time to recommended the firm as part of the FT’s research.

To access the full report and rankings tables, please visit the FT website here.

Bioinformatics is a rapidly growing field that combines biology, computer science, and statistics to analyse biological data. The field has become increasingly important in recent years due to the explosion of data generated by advancements in high-throughput sequencing technologies.

The field has played a crucial role in advancing our understanding of genetics, genomics, and personalised medicine. However, there is a common misconception that many of the key aspects of these inventions are unpatentable such as features of genomic pipelines e.g clustering or aligning. There are of course, challenges to patenting bioinformatics methods but it can and is being done at an increasing rate.

Rise of bioinformatic-related patents

Patenting in the field of bioinformatics is not new. In fact, the first bioinformatics-related patent was filed in 1988. However, it was not until the early 2000s that the number of bioinformatics-related patents began to increase significantly. This initial increase was driven by the rapid advances in DNA sequencing technologies, which enabled researchers to generate vast amounts of genetic data. These advances led to the development of new bioinformatics tools and methods for analysing and interpreting this data.

Figure 1: Increasing global trend of bioinformatics-related patents (data acquired from IP Quants)

In recent years, the number of bioinformatics-related patents has continued to increase. According to a report by the World Intellectual Property Organization (WIPO), the number of bioinformatics-related patent applications increased by an average of 13.2% per year between 2013 and 2018 (Intellectual property protection indicators 2019). From data available since 2001, there has been a year-on-year increase in bioinformatics-related patents with a record-breaking number of patents filed in 2022 at just over 18,000 which is set to be broken again in 2023.

The increase in bioinformatics-related patents can be attributed to several factors.

  1. First, the growth of the biotechnology industry has led to increased investment in research and development. This has resulted in the development of new bioinformatics tools and methods for analysing biological data, which are often patented to protect intellectual property rights.
  2. Second, the availability of large datasets, such as those generated by the Human Genome Project, has made it possible to identify new targets for drug development and personalised medicine. These targets can be patented to protect the commercial rights of the companies that develop them.
  3. Finally, the increase in bioinformatics-related patents can also be attributed to advances in artificial intelligence and machine learning. These technologies are being used to analyse biological data and develop new algorithms for predicting disease risk, drug efficacy, and other important factors.

Growth in the bioinformatics market

The bioinformatics market is also a rapidly growing industry commercially, with a wide range of players offering products and services in the field. The global bioinformatics market in terms of revenue was estimated to be worth $10.1 billion in 2022 and is poised to reach $18.7 billion by 2027. Some of the major players in the bioinformatics market include:

To give an example, according to data acquired form IP Quants, Illumina Inc has over 470 patents relating to the bioinformatics field ranging from neural network-based pipeline to deep learning-based approaches, highlighting the diversity of technology available to patent within this field. These are just a few examples of the major players in the bioinformatics market. However, it is not only in industry where we have observed a rise in bioinformatics-related patents. There is a similar trend in academia. For example, the University of California has filed over 2000 patent application between 2002 and 2023, highlighting the academic interest in this field.

As the field continues to grow and evolve, new players are likely to emerge, offering innovative products and services to meet the growing demand for bioinformatics solutions.

Conclusions

The increase in bioinformatics-related patents reflects the growing importance of this field in advancing our understanding of genetics, genomics, and personalised medicine. As the field continues to evolve and expand, we can expect to see even more exciting developments and innovations in the future. It is important for researchers, industry professionals, and patent professionals to stay informed and engaged in this rapidly changing field.

A recent case at the European Patent Office (EPO) Boards of Appeal, T 1806/18, held a known drug dispersed in apple sauce and orally administered to treat its authorised condition could be inventive – despite such a formulation having been disclosed as being administered to healthy individuals in clinical trial documents.

Request

The Appellant-Proprietor appealed the decision of the Opposition Division (OD) to revoke the patent. Claim 1 of the main request read (in simplified form):

“A pyrimidylaminobenzamide of formula (I) … [the compound known as nilotinib] or a pharmaceutically acceptable salt thereof, for use in the treatment of chronic myeloid leukemia (CML), wherein the compound … is orally administered dispersed in apple sauce.”

Novelty

A key cited prior art document was a document from the European Medicines Agency (EMA) relating to a paediatric investigation plan (PIP) for nilotinib (document D1). D1 included three clinical study protocols: a first study in which the bioavailabilities of nilotinib capsules and dispersions in apple sauce or yoghurt were to be assessed in healthy adult volunteers, and second and third studies in which paediatric CML patients were to be administered nilotinib formulations (with no explicit mention of a dispersion in apple sauce). Whilst nilotinib was known to be effective at treating CML in adults, outcomes for none of the three trials were known by the priority date of the patent. Even though the studies were to include very young children who would not be able to swallow the capsule formulation, the Board held that “this fact does not allow concluding with certainty that this patient subset will receive the nilotinib/apple sauce formulation” (section 6.10 of the reasons), agreeing with the OD’s finding of novelty.

Inventive step

Of interest, the Board agreed with the Respondents-Opponents’ argument that the first study described in D1 was a suitable starting point for the assessment of inventive step, i.e., that this could be considered as a closest prior art disclosure despite the lack of results.

However, the Board disagreed with the Respondents’ argument that safety issues should not be considered when formulating the objective technical problem (OTP) to be solved because the reported safety issues were related to the specific use of apple sauce and not the distinguishing feature, i.e., the therapy. Instead, the Board approved of the Appellant’s reference to decision T 2506/12, which held that for a treatment to be effective, it must meet the criterion of efficacy and acceptable safety.

The Board then disagreed with the Respondents that the formulation was obvious based on D1 in light of the common general knowledge (CGK). The Board pointed to D6, that provided evidence that formulation with different foods altering the bioavailability of drugs in unpredictable ways was CGK. The Board also pointed to D58, which compared formulations of a different drug product in or with different foods, including in apple sauce, and showed there was differing drug bioavailability depending on the specific food type. D58 reports that the authors were surprised when small amounts of apple sauce caused significant delays in gastric emptying. The Board took this as further evidence of unpredictability and concluded the skilled person would not have been able to predict whether apple sauce would have any effect, and if so, how much, on the oral bioavailability of nilotinib. The Board also held that the skilled person would have been aware of other documents (e.g., D21) teaching that nilotinib can have potentially life-threatening adverse events when taken with food.

In reaching this conclusion, the Board made an interesting comment about the attitude of the skilled person when starting from D1. In particular, the Board agreed with the Respondents that “the skilled person would not have adopted a try-and-see attitude in solving the posed technical problem”, but went on to state that “this does not make the unpredictability of the food effect irrational. The fact that a clinical study is announced in a prior art disclosure does not automatically mean that its outcome was predictable and that a reasonable expectation of success had to be acknowledged.” (section 7.21 of the reasons).

The Board also dismissed the Respondents’ argument that the fact that the PIP applicant in D1 was the originator of the nilotinib capsule formulation would indicate that the applicant had a reasonable expectation of success with the claimed formulation (and that this could be inferred by the skilled person). Whilst the Board did not doubt the credibility of the content of D1, it stressed that “the respondents did not explain why the clinicians of the PIP applicant – despite being aware of the known unpredictability of the food effect of apple sauce on nilotinib – would still have had a reasonable expectation that the nilotinib/apple sauce formulation would exhibit an oral nilotinib bioavailability in healthy human adults comparable to that of the [commercial] capsule formulation” (section 7.52 of the reasons). The Board drew a distinction on the facts over decision T 239/16, which had been cited by the Respondents, on the basis that (i) the closest prior art in that case was a phase 2 clinical study; and (ii) there was no knowledge in the state of the art to diminish an expectation of success in the proposed treatment. By contrast, in the case at issue the closest prior art was a pharmacokinetic study in healthy volunteers, the result of which was unpredictable.

As there was no reasonable expectation of success based on D1 (or other documents) that the apple sauce formulation would have a comparable bioavailability to the capsule formulation, and hence be effective in treating CML, claim 1 was held inventive, overturning the OD’s decision.

Take home messages

This case further builds on established case law that the disclosure of planned clinical trials or clinical trials without published results do not mean the outcome of such trials is predictable, or that a reasonable expectation for success has to be acknowledged (see, for example, T 239/16). In this respect, it provides some comfort for patentees and innovators, although the Board does stress repeatedly that the correct approach will depend strongly on the facts of the case.

This particular case goes to show that even when a regulatory authority has approved a planned clinical trial in the intended patient group, a claim to the proposed treatment can still involve an inventive step. The case further illustrates how unpredictable effects of drug formulations can form the basis of a valid medical indication claim at the EPO.

Managing IP has released its 2023 guide of the IP STARS legal directory, which recognises the most outstanding practitioners covering several IP practice areas and more than 50 jurisdictions. Each year, the research analysts obtain information through firm submissions, client interviews, as well as online surveys, to identify the leading IP STARS.

We are delighted to announce that Partners Jane Clark, Hazel Ford and Paul Cozens have been named as ‘Patent Stars’ and Partners Gary Johnston and Margaret Arnott, as well as Of Counsel Rebecca Tew have been recognised as ‘Trade Mark Stars.’ Additionally, Partners Philippa Griffin, David Hobson and Andrew White have been featured as ‘Notable Practitioners’ in the latest guide. The 2023 Rising Star rankings are due to be released in September 2023.

The firm is also pleased to have maintained its rankings for ‘Patent prosecution’ and ‘Trade mark prosecution’ in the 2023 directory.

For more information, and to view the rankings in full, visit the IP STARS website here.

Pride Month is a time to celebrate the accomplishments, resilience, and contributions of the LGBTQIA+ community. While progress has been made towards equality and acceptance, it is important to recognise the trailblazing innovators who have left an indelible mark on the world.

From groundbreaking scientific discoveries to transformative technological advancements, LGBTQIA+ individuals have played a crucial role in shaping our society. In this article, we at Mathys & Squire celebrate the achievements of some remarkable innovators and inventors who have inspired change and left an important legacy.

Alan Turing unleashed the power of computing

Alan Turing, a gay mathematician, logician, and computer scientist, is widely regarded as the father of modern computer science. His work during World War II in cracking the German enigma code was instrumental in the allied victory. Alan’s conceptualisation of the Turing machine laid the groundwork for modern computing and artificial intelligence. Despite his brilliance, Turing faced persecution due to his sexuality, reminding us of the profound impact discrimination can have on human potential.

Lynn Conway pioneered microelectronics

Lynn Conway, a transgender woman, is an esteemed computer scientist and electrical engineer known for her invaluable work in the field of microelectronics. Her innovative research on the very large scale integration chip design revolutionised computer architecture. Conway’s work has been instrumental in enabling the development of modern computers, smartphones, and other electronic devices. She is an advocate for transgender rights and has been an inspiration to countless aspiring engineers.

Martine Rothblatt pushed the boundaries in biotechnology

Martine Rothblatt, a transgender entrepreneur, lawyer, and author, has made significant contributions to the fields of biotechnology and healthcare. As the founder of United Therapeutics, Rothblatt focused on developing treatments for pulmonary hypertension. She also spearheaded advancements in xenotransplantation, the transplantation of organs between species, with a focus on utilising pig organs to address the organ shortage crisis. Rothblatt’s work exemplifies the potential for innovation when diverse perspectives are embraced.

Benjamin Barres revolutionised neuroscience

Dr. Benjamin Barres was a transgender neurobiologist, whose innovative work contributed to our understanding of the brain and its functions. His research focused on glial cells, which were once considered passive support cells but are now known to play a critical role in brain development and function. Barres’s work challenged prevailing dogmas and opened new avenues of exploration in neuroscience. He was an outspoken advocate for gender equality in academia and worked to address the underrepresentation of women and transgender individuals in science.

Chien-Shiung Wu transformed nuclear physics

Dr. Chien-Shiung Wu, a lesbian physicist, made groundbreaking contributions in the field of nuclear physics. Known as the ‘first lady of physics’, Wu played a pivotal role in disproving the law of conservation of parity, which had been considered a fundamental law of physics. Her experiments, including one known as the Wu experiment, provided evidence for the violation of parity symmetry in weak interactions. Wu’s work fundamentally reshaped our understanding of the fundamental forces of nature. Despite facing gender and racial discrimination during her career, she persevered and left an indelible mark on the field of physics.

Sarah McBride fighting for LGBTQIA+ rights

While not an inventor in the traditional sense, Sarah McBride, a transgender activist, is an innovator in the realm of LGBTQIA+ rights and political advocacy. As the first openly transgender person to speak at a major party convention in the United States, McBride has been a prominent voice for equality and inclusion. Her work focuses on advancing legislation to protect LGBTQIA+ individuals from discrimination, and she continues to inspire others with her advocacy and commitment to social justice.

Tim Cook revolutionising the technology landscape

Tim Cook is a prominent figure in the technology industry and the CEO of Apple Inc. He succeeded Steve Jobs and has been instrumental in shaping the company’s success. Cook, who is openly gay, has been a vocal advocate for LGBTQIA+ rights and workplace inclusion. Under Cook’s leadership, Apple has continued to innovate and introduce groundbreaking products, revolutionising the technology landscape. Cook’s emphasis on user-friendly design, sustainability, and privacy has garnered praise and contributed to Apple’s continued growth and influence. His strategic vision and commitment to excellence have solidified Apple’s position as one of the world’s leading technology companies.

As we celebrate Pride Month, it is essential to recognise the invaluable work of LGBTQIA+ innovators and inventors who have reshaped the world with their brilliance and courage. From Alan Turing’s pioneering work in computing to Lynn Conway’s transformative research in microelectronics, these individuals have left a legacy that extends far beyond their respective fields. Their achievements serve as a testament to the power of diversity, inclusivity, and the limitless potential of human ingenuity. Mathys & Squire continues to honour and support LGBTQIA+ innovators as we strive for a future where everyone can thrive and contribute their unique talents to building a better world.

Today, 1 June 2023, marks the launch of the Unified Patent Court (UPC) and the Unitary Patent (UP) system after many years of preparation by the European Union and its members. As of today, the UPC has jurisdiction for patent litigation throughout the 17 member states which have ratified the Agreement on a Unified Patent Court (UPCA). From today onward, newly-granted European patents can also be brought into force as Unitary Patents, providing coverage for the 17 UPC member states through a single validation.

Any existing European Patents that have not been opted out are now automatically subject to the UPC’s jurisdiction. However, you can still choose to opt your patents out throughout the initial transitional period of at least seven years, provided that those patents are not subject to litigation at the UPC. Once opted out, patents will be subject to the jurisdiction of the competent national courts instead. Opt-outs can also be registered for pending European patent applications.

During the three-month sunrise period which ended yesterday, a total of nearly 474,000 patents and patent applications were opted out. Although precise figures are hard to calculate, it has been estimated that this represents somewhere between about 40 and 60% of all eligible patents and patent applications, with the number expected to continue to rise now that the court is open for business. It will be very interesting in the coming weeks and months to see how widely the UPC is adopted as a forum for patent litigation instead of national courts, and to see if any sectoral trends begin to emerge.

In other news which was announced at a late stage of the sunrise period, it has been confirmed that (subject to a confirmatory vote by the UPC’s Administrative Committee) Milan will host the third branch of the UPC’s Central Division, which was relocated from London due to Brexit. However, no formal announcement has yet been made as to which cases will be handled in Milan, and it seems that the Milan branch will not be opening just yet. For the time being, therefore, cases at the UPC’s Central Division will be split between Paris and Munich as we reported previously.

With our patent attorneys eligible to practice before the UPC as registered European Patent Litigators, our team at Mathys & Squire is well equipped to assist you in carving out your individual filing and litigation strategy. As we step into the unknown, we are thrilled to watch the new system change patent litigation forever, and to be part of shaping its course.

Read more about UPs, the UPC and opting out of the UPC here.

Last month, Amazon released their Brand Protection Report for 2022. Claiming to have invested over $1.2 billion and devoting 15,000 personnel to their brand protection initiatives, we look at some of the statistics and measures highlighting Amazon’s ongoing efforts to scale intellectual property (IP) protection and tackle the problem of counterfeits.

Robust proactive controls

Reportedly scanning over eight billion listings daily, Amazon states that controls such as seller verification and continuous monitoring have reduced the number of ‘bad actor’ attempts to create new selling accounts by more than 50%, year on year.

This will be reassuring for brands knowing that these measures have meant that apparently 99% of listings are proactively removed when suspected of being fraudulent, infringing or counterfeit.

Powerful tools to protect brands

Launched in 2017, Amazon’s Brand Registry provides brands with various automated protections to ensure their IP rights are protected. Amazon reports that these measures have seen a reduction of over 35% in the number of infringement notices submitted by brands compared to 2021.

Amazon also collaborates with the United States Patent and Trademark Office, working to ensure fraudulent applications and registrations are not used to enrol in its Brand Registry. They report that the partnership to date has identified and blocked over 5,000 false or abusive brands from enrolling in the Brand Registry.

Patent holders can also benefit from the Amazon Patent Evaluation Express, which allows neutral evaluation of a potentially infringing product in less time than a traditional lawsuit.

Holding bad actors to account

Amazon’s global Counterfeit Crimes Unit has reportedly succeeded in removing over six million counterfeit products from the global supply chain, claiming more than 1,300 criminals have been pursued through litigation and criminal referrals.

Protecting and educating customers

Partnerships with bodies such as the US Chamber of Commerce and the International Trademark Association show Amazon’s continued commitment to limit the reach of counterfeit goods and educate consumers.

Many brand owners will be keen to register their trade marks on the Brand Registry. Depending on the territory in which the trade mark is protected, brand owners would require either a pending application or registration in order to utilise the Brand Registry.

The Mathys & Squire team is happy to assist clients in filing trade mark applications and obtaining trade mark registrations for this purpose.

Data and commentary provided by Mathys & Squire has featured in articles by Environment Journal and The Patent Lawyer providing an update on the decline in Green Channel patent applications.

An extended version of the press release is available below.

The number of Green Channel patent applications in the UK has fallen by 47% within the last year, decreasing from 313 applications in 2021* to 166 applications in 2022*, says intellectual property law firm Mathys & Squire.

The Intellectual Property Office’s Green Channel was introduced in 2009 to encourage the development of more environmentally friendly technology by providing a quicker route for the patenting of that technology. It allows inventors of eco-friendly products to bypass the years’ long wait and obtain patents two to three times faster than they otherwise would.

The decline in the number of Green Channel applications may be because the benefits offered by the scheme aren’t enough of an incentive for smaller companies.

Posy Drywood, Partner at Mathys & Squire says that a better way of encouraging the development and patenting of green technology would be for the UK Government to pay for fees due to the Intellectual Property Office (IPO) for green patents.

Patent applications submitted through the IPO’s current Green Channel are fast-tracked through the evaluation process. However, the sooner a patent is approved, the sooner patent fees are due.

The Green Channel’s accelerated processing means that applicants have less time to gather the necessary funds, which isn’t always ideal for small businesses that may struggle to pay. In this way, speeding up the patent process could discourage small businesses from using the Green Channel.

Posy Drywood adds: “If we want to see a substantial increase in green technology created by the UK, just speeding up the patent application process is not going to cut it. Small businesses need more than that to make using the Green Channel worthwhile. As green technology is so important to the growth of the UK economy, subsidising green patent applications should be considered.”

“While fast-tracking the application process is a benefit, it also speeds up the time in which applicants have to pay their patent fees. That may be a deterrent to small businesses, especially as we enter into a period of economic uncertainty.”

“In its current state, the Green Channel isn’t working as effectively as it could do to promote more green technology. A better way to encourage greater IP production is to make patenting those products more affordable.”

*Year-end December 31