What is JCA and when is it coming?

JCA is a centralized European procedure to evaluate the clinical evidence for a product as part of the HTA process. It was formally enacted on January 12, 2022, with the pilot phase and establishment of guidance and stakeholder network being put into place over the last couple of years.

There are, however, still tenders out by the E.U. commission for provision of training of HTABs in how to manage the new process, and there have been a few delays in the overall timing of some elements of the process. JCA becomes mandatory for oncology products and ATMPs on January 12, 2025, for orphan drugs in 2028 and will become mandatory for all drugs going through the European Medicines Agency (EMA) procedure on January 13, 2030.

JCA implementation: key dates

Source: Clarivate

Four key challenges for pharmas in JCA

While the purpose of JCA is to expedite patient access to new treatments by promoting a more efficient and coordinated HTA assessment process, it brings several challenges for manufacturers.

Firstly, the JCA dossier will need to be submitted by companies at around Day 170 of the process, which is before the EMA releases the list of outstanding issues (at Day 180) and before the CHMP opinion (at Day 210). Submitting a dossier without knowing the final population will undoubtedly be challenging for manufacturers as the label (including the indication) will not be final, and may even require the re-start of JCA. In addition, there will only be 90 days between confirmation of the Population, Intervention, Comparator(s), Outcomes (PICOs) and dossier submission, leaving little time to pull together a comprehensive and high-quality evidence dossier without significant preplanning. Furthermore, the submission is likely to happen far in advance of economic discussions and pricing negotiations in individual countries, making it hard to plan strategically for optimal access and reimbursement in each country.

Secondly, the scope of the assessment is a challenge. Even with reassurances in the most recent Implementation Act, with promises of consolidated PICOs as far as possible, it is still likely that for some treatments, there is potential for many PICOs, and this may prove exceedingly difficult for the manufacturer. PICOs will potentially differ where countries consider different relevant comparators because they have different standards of care. They may also define subgroups and surrogate endpoints differently. This is likely to result in significant challenges during the PICO stage of the assessment, especially in determining a clear strategy and narrative and in generating evidence (in the format of meta-analyses, for example) in a timely manner. This is made even more challenging by the apparent lack of manufacturer involvement in this part of the process.

Thirdly, different countries may have different data requirements. Manufacturers will have to address this regardless of JCA. However, we note that JCA does not mean that countries cannot request additional data, and in some situations, it may not be the more efficient process that is promised. Indeed, compiling a dossier for JCA and then responding to requests from several countries (within a 7-to-30-day window) may increase the manufacturer’s workload in some cases.

Finally, we have worked on enough HTA submissions to know that it is not just about putting the clinical and economic data into a dossier and hoping for the best. Successful HTA submissions have a clear narrative running through background, clinical, and economic sections, which is typically the result of months of planning and strategic discussion. While some countries do already have separate clinical and economic dossiers (and even when there is a single dossier, reviewers may only focus on the sections relevant to them), it comes back to the timing -– creating that convincing narrative that runs through all sections of a submission will be made harder by the much earlier submission of the background and clinical data.

And what if it all goes wrong? JCA will not assess economics or make value judgments on behalf of individual countries, and the assessments are non-binding. However, it will amount to a relative effectiveness assessment versus comparators, which may not go in favor of the treatment being assessed. We know from experience that HTA bodies take note of assessments in other countries. Therefore, the impact of an unfavorable pan-European assessment could be huge. JCA is likely to be a challenge for manufacturers. It will impact some products in 2025, and we need to get it right. It is important to understand the benefits of JCA in order to change.

Considering the challenges, timing is going to be key to success with the JCA process.

Gaming out timing is critical to success

While submitting the JCA dossier during the EMA review process will be a challenge, it gives manufacturers an opportunity to optimize some of their processes. For example, it will encourage companies to consider involvement of market access and HEOR teams much earlier in the drug development process –- the HTA process (or at least part of it) will be conducted alongside the regulatory process in Europe, which means that, when planning for evidence generation, both processes need to be considered.

Since July 2017, EUnetHTA and the EMA have offered parallel consultations for manufacturer companies on evidence generation plans -– this is conducted prior to the pivotal trials for a new product, while phase 2 and 3 trials are still at the planning stage. The objective of these parallel consultations, or joint scientific consultations (JSCs), as they are now known, is to help generate optimal and robust evidence to satisfy both regulators and HTA bodies. It should be noted that there is a finite number of JSC slots available and there are specific eligibility criteria for JSC requests, including:

• unmet medical need for the product
• being first in class
• a large potential impact on patients, public health, or healthcare systems
• a significant cross-border dimension
• and major E.U.-wide added value or clinical research priorities

These criteria can make it difficult to secure a slot.

Even if a company does not wish to participate in a JSC, or if a treatment is not eligible for JSC, there is a compelling argument for considering HTA requirements much earlier in the drug development process. For example, with earlier HTA engagement, clinical trials and real-world studies could potentially be designed to incorporate specific comparators, endpoints, or subgroups relevant to HTA that may not have been necessary from a regulatory perspective but may satisfy regulatory needs. Of course, it may make pre-launch evidence generation planning more complex, and sometimes, it may not be feasible to incorporate all endpoints, comparators, or subgroups that may be relevant to HTA, but at the very least, it facilitates informed planning and decision making.

“We have been working with DRG/Clarivate on a high-profile orphan drug in rare diseases. We have engaged them to lead our International HTA Network to ensure that we submitted high quality HTA Dossiers in Europe.​ They have demonstrated strong organizational skills, eye for detail and ability to manage external consultancies and deal with internal stakeholders, assertively and diplomatically. “

Early planning related to the communication of treatment value will also become increasingly important with JCA. While economics will come later in the process, companies will need to develop a strategy and value narrative in preparation for JCA submission that will still be applicable during country-specific economic evaluations and pricing negotiations -– this is likely to involve early economic modelling to prepare for the economic scenarios. It will be important to consider relevant messaging for individual countries, but the narrative running through the JCA dossier must be more general global (or at least pan-European).

JCA, RWD and RWE

On a more granular level, predicting PICOs internally in order to plan for evidence generation activities will be important. The key to success with JCA will be early planning and collaboration. Companies really need to be thinking about how their various teams engage at different points in the drug development process and, particularly for market access and HEOR teams, this will need to be much earlier, when during evidence generation planning for pivotal trials.

Real-world evidence is used increasingly frequently in HTA, enabling a more robust critical assessment of technologies and can validate whether the study population and clinical context of a RCT is reflective of clinical practice. RWE offers enormous potential to inform multiple aspects of HTA, including:

• Epidemiology
• Current management
• Clinical and economic outcomes

However there remain challenges for using RWE in HTA, including skepticism about the validity of evidence and that evidence generation timing may not be synchronized with HTA and pricing bodies’ agendas.

Strong partnership among all stakeholders and pragmatic use of existing data alongside clinical evidence provided by companies are key success factors.

Case study: using RWD to inform a cost-effectiveness model to demonstrate the benefits of an inhaled antibiotic for managing a chronic pulmonary infection.

A large pharma company completed a head-to-head trial comparing their inhalation solution using a nebulizer handset with an existing treatment for a chronic pulmonary infection. In the trial, the new inhalation solution demonstrated both clinical and economic benefits compared with the existing standard of care, showing improved lung function and reduced risk of hospitalization.

The client required a model to communicate the value of the inhalation solution and nebulizer handset to national payers in order to demonstrate the cost effectiveness of their new treatment compared to standard of care for inclusion as part of their HTA submissions.

To meet these requirements, a compelling economic model was needed to evaluate the cost-effectiveness of a new inhalation solution administered via a nebulizer compared with standard of care.

Insights generated using Clarivate’s RWD ecosystem of patient-level records enabled the quantification of key areas of differentiation (improved lung function, reduced HCRU) compared with standard of care.

These insights were used inform a cost-effectiveness model to demonstrate the benefit of reduced drug, hospitalization and lung transplantation costs.

This model supported a national HTA submission, and country adaptations were created to aid the client’s local affiliates. This solution:

• Empowered our partner to demonstrate the clinical and economic value of the new inhalation solution and nebulizer system as an alternative to standard of care, in compelling format that was both robust and commercially and strategically optimal
• Provided a user-friendly and flexible cost-effectiveness analysis with scenario and sensitivity analyses to explore potential scenarios and uncertainty around key input data, and support for country adaptations of the model
• Delivered impactful messaging around the value of the product to key stakeholders

Does RWD/RWE influence HTA decisions and market access?

HTA Bodies acknowledge that RWD/RWE should become an essential component of HTA processes; their availability allows questions left open by the initial submission package to be answered.

But generating good evidence is challenging. It challenges the IT infrastructure of each health system, which in each country has its own history contingent on its welfare model, to its supply of healthcare (public or private/public mix), and to its national governance (centralization vs decentralization).

The burden of providing controlled evidence for a new treatment is borne by companies, while for RWD/RWE, it is shared between them and HTA bodies. This leads to an additional administrative burden. The time and skills needed to provide good evidence should be considered.

If you would like to discuss your 2024 plans with any of our R&D, commercialization or technology enablement teams, please connect with our experts here.

This post was written by Ruth Howells and Oliver Blandy.

Ruth Howells is Head of Health Technology Assessment (HTA) at Clarivate. Ruth is responsible for our Global HTA services and has been involved in the development and strategic direction of HTAs, contributing in-depth knowledge of procedural processes. Full bio here.

Oliver Blandy is a Senior Consultant at Clarivate. Oliver provides epidemiology and real-world data insights and solutions to meet the business needs of decision makers within the pharma and biotech industries, working across multiple therapeutic areas including cancer, infectious disease, and rare diseases.

The post Navigating Joint Clinical Assessment and the role of RWE in the new process appeared first on Clarivate.

Establishing a strategic plan for 2024 requires IP leaders to place their bets on which of these trends will most likely impact patents and trademarks this year. To help, we asked senior leaders at Clarivate who have a broad perspective on the IP landscape to provide predictions for the IP legal industry in 2024 and beyond.

Question 1: What are your predictions for the IP legal space in 2024?

“The Chinese economy’s future hinges on innovation, prompting increased investment in R&D in strategic technology areas such as AI, wireless communication, and biopharmaceuticals. To bolster this effort, China is upgrading its IP legislations, infrastructure, and related processes to enhance IP protection and enforcement. This persistent trend will put pressure on foreign organizations to reassess their China strategy.”
Vashe Kanesarajah, VP, Corporate Strategy, IP

“Leveraging IP for corporate financing is causing a transformation in the financial and legal world. Companies using their IP assets as collateral are viewed as less risky investments and become more attractive to financial institutions that fund them, particularly in a complex economic climate.

“In 2024, we will see significant growth in IP-based financing, and the IP service providers and financial institutions supporting this practice will be expected to adapt to this trend. Accurate valuation of a company’s intellectual property assets is essential for securing IP-based financing. This reinforces the need for an effective valuation strategy, reliable IP data, and efficient processes to actively protect and accurately determine the value of an IP asset. This will be a game-changer.”
Annya Dushine, Senior Director, IP Consulting

“In terms of trademark activity, 2024 is likely to be in line with volumes that we have seen in 2023, with filing activity at most trademark registers growing moderately (3-5%) and renewal volume increasing by around 5%. China has been the only major trademark register to see a significant fall in filing volume over the past 12 months (down by around 10%) and this looks likely to continue in 2024. Anyone looking to set budgets for the next year should treat 2020-2022 as outliers and consider 2024 as closer to 2018 and 2019 than recent more unpredictable years.”
Robert Reading, Director, Corporate Strategy Content, IP

“Increasing datasets and new technologies will converge in new trademark solutions that connect brand lifecycle management steps more closely. Trademark practitioners can expect to see more integrations and toolsets that combine previously separate workflows.”
Francois Neuville, Senior Vice President, Product Management, IP

If you are also interested in a pulse check of AI in IP read the special report, Redefining AI: How IP practice meets the coming wave.

Question 2: What do you think will be the biggest area of focus for the IP legal profession in 2024?

“AI is endemic now in the world of IP. Its adoption isn’t a question of ‘if’ but ‘where and how’. I expect to see a surge in new AI-enhanced solutions for IP professionals as ideas are tested in 2024. Not all will survive, and it is important for legal professionals to focus on guiding this development to make it as helpful in the practice as possible. We are in an era of large-scale change-management, and this is one area to focus on.”
Francois Neuville, Senior Vice President, Product Management, IP

“Our customers (both corporate and law firm alike) are being challenged to ‘do more with less’. They are looking at methods for standardization and automation to reduce budget and increase efficiency allowing their stakeholders to focus on higher value tasks. Although not a new focus, this year will be a pivotal point for the IP industry amid the AI discussions while many are balancing market pressure with regulatory complexity.”
Reanna Myers, Vice President, Customer Success, IP

If you are interested in reading about doing ‘more with less’ read the blog post, IP Diagnostic consulting: The key to working smarter with less.

“Leveraging the advancements of technology while also maintaining the ultimate role and value of the legal professional.“
Irmina Stroud Senior Vice President, Global Sales, IP

“Last year, the Federal Trade Commission (FTC) proposed a ban on non-compete agreements between employees and employers. A final vote will take place in April 2024 and given the clear trend of restricting or banning employee non-compete agreements, employers will need to prioritize protection of their confidential and trade secret information. It will reinforce that adequately protecting trade secrets and intellectual property requires a strategic approach that aligns business goals with employment agreements, IP protection, internal policies, as well as the need to have a clear plan of attack should trade secret or IP infringement occur.

This will also influence the start-up culture, entrepreneurship, and exchange of information among innovators, thus stimulating new ideas and technologies. Reducing the adverse consequences of a ban on non-competes will require finding the right balance between stringent IP protection and cultivating an open innovation culture. As a result, there will be a greater need for partnerships, industry standards, clear IP protection strategies, and effective policies and procedures to protect corporations.”
Annya Dushine, Senior Director, IP Consulting

“AI related commercial activity will have an impact on trademark filing volume, with applications at the USPTO that include ‘artificial intelligence’ now accounting for around 2% of applications filed each month and growing. A significant proportion of trademark applications are ‘self-filed’ without the assistance of an attorney; online AI based tools can give self-filers false confidence that they have been given reliable advice, leaving IP offices to deal with ‘hallucinations’ and invented ‘facts’ that are presented by inexperienced applicants during the registration process.”
Robert Reading, Director, Corporate Strategy Content, IP

Question 3: Aside from AI, what other trends or advancements do you see impacting the IP space in 2024?

“One, risk tolerances are shifting which impacts the IP ecosystem. Two, the speed of technology advancements continues to increase, year-over-year. This will increase the sense of urgency to realize commercial value from IP assets.”
Irmina Stroud Senior Vice President, Global Sales, IP

“With most key trademark registers now part of WIPO’s Madrid International registration system, there will be a continued shift away from filing nationally to filing via the Madrid system. Attorneys need to consider changing their focus – instead of concentrating on gaining ‘filing’ customers the growth opportunities will increasingly come from being the local problem solver – dealing with refusals and third-party actions as they arise. Attorneys who manage to change the focus of their practice may find they are moving away from filing to higher revenue/margin work.”
Robert Reading, Director, Corporate Strategy Content, IP

“New jurisdictions, such as the UPC, will result in new jurisprudence, decisions and a shift in the way IP is protected internationally. For IP professionals within the UPC, adapting strategies and approaches based on new precedent is going to be a challenge.”
Francois Neuville, Senior Vice President, Product Management, IP

Conclusion

While we will have to wait and see what 2024 brings for the IP legal industry, one thing remains true: “The only constant is change”. Contact us today, to learn how Clarivate can help your IP team plan for 2024 and into the future.

The post What’s ahead? 2024 predictions for the IP legal industry appeared first on Clarivate.

From the possibility of a recession to the swift acceleration of artificial intelligence, the past year has been one of uncertainty for the global economy. As IP legal teams strategically navigated 2023, Clarivate created resources, backed by insights from industry experts to support.

To ensure you don’t miss out, we complied the Top Five IP resources from 2023 below.

Special Report: Redefining Artificial Intelligence – How IP practice meets the coming wave

The interplay between IP, AI and the wider legal industry is complex. To get a pulse-check of the perception of AI in the IP industry, Clarivate surveyed 575 IP and research and development (R&D) professionals from law firms and corporations worldwide.

What did we learn? Rapid advancements in artificial intelligence will undoubtedly influence intellectual property law and practice, forcing IP practitioners and their technology partners to reevaluate certain assumptions in how IP is created, protected and managed. Likely, change will not come as a revolution but through a series of incremental steps.

The special report with full survey results can be found here: Redefining Artificial Intelligence. How IP practice meets the coming wave

Special Report: Innovators to Watch 2023

A true assessment of innovation goes beyond measuring accomplishments; it charts exceptional potential. This report identifies the next cohort of top global innovators. Through additional analysis built on the ongoing Top 100 Global Innovators data, focused on the fastest-rising entities, we pinpoint those potential future recipients who are poised to make it to the very top.

Innovators to Watch recognizes 36 companies that are on the path to becoming a Top 100 Global Innovator. These organizations sit within the top 250 innovators yet have never made the Top 100 before. Now, we anticipate that these organizations are within reach of Top 100 status.

The special report and complete list of Innovators to Watch 2023 can be found here: Innovators to Watch 2023.

On-demand webinar: The future of the IP legal profession: Balancing the rise of AI with human expertise

In the next three to five years, the legal space will likely look and operate differently than what intellectual property professionals experience today. The global workforce is experiencing significant shifts to keep pace with changing workplace expectations, increased retirement eligibility and evolving customer needs. Simultaneously, the artificial intelligence (AI) sector is forecasted to grow exponentially, creating new jobs that are unimaginable today.

These factors will likely result in an unavoidable reshaping of the way law firms and in-house counsels currently work. What will this mean for the future of the IP legal profession? Hear from industry experts and the Clarivate team as they discuss how IP legal teams can successfully navigate the evolving IP ecosystem through upskilling, knowledge sharing, technology adoption and process optimization.

The on-demand webinar can be found here: The future of the IP legal profession: Balancing the rise of AI with human expertise.

Case Study: A new global IP team with a tailored strategy for success

Clarivate recently helped Versuni reshape their IP legal strategy after their business was spun out from a much larger parent organization. The legal team needed help redefining their team roles, processes, technology and data to align with a new commercial business strategy and a smaller setup.

With the help of the Clarivate IP Diagnostic consulting team, Versuni implemented a tailored IP legal strategy that optimized the team structure and increased automation of existing tools to deliver rapid efficiency gains. Now, Versuni’s IP team is positioned to work in a more agile way that is both faster and more flexible.

The full case study can be found here: A new global IP team with a tailored strategy for success.

White Paper: Investing in innovative IP legal strategies during challenging times

Budgets and staffing are tight, competitive pressures are on the rise, and clients and business leaders are demanding more for less—without compromising quality.

This creates a perfect storm for corporate and law firm intellectual property (IP) teams and an opportunity to rethink how IP teams operate. Is this the right time to make strategic investments in new ways of working?

In this white paper, three IP legal experts examine how IP law firms and in-house legal teams can drive successful outcomes by investing in transformation now—and avoid playing defense later.

The white paper can be found here: Investing in innovative IP legal strategies during challenging times.

Conclusion

The continual and constant change of 2023 is expected into 2024 and beyond. It will undoubtedly influence IP law and practice, reshaping the roles of people, process, data and technology in the way IP is created, protected and managed.

To see how Clarivate can help your IP team plan for the future, contact us today.

The post Looking back on 2023: Top five resources for IP legal teams appeared first on Clarivate.

Today’s global workforce is experiencing significant, swift and continuous shifts. Customer needs are evolving. Retirement eligibility is increasing. The growth of artificial intelligence (AI) is forecasted to cause even greater changes.

These shifts are impacting the way business is done within law firms and in-house corporate legal teams. To keep pace, IP legal teams are trying to understand the downstream impact on traditional lawyering and what is needed to successfully navigate the evolving IP ecosystem into the future.

To help, Clarivate recently released two resources that explore the current state of AI in IP and the importance of embracing change to prepare for what is on the horizon:

• Webinar: The future of the IP legal profession: Balancing the rise of AI with human expertise
• Report: Redefining Artificial Intelligence. How IP practice meets the coming wave.

Changing expectations will undoubtedly influence the current norms of IP law and practice, forcing the industry to reimagine the roles of people, process, data and technology in the way IP is created, protected and managed.

What is the current state of AI in IP?

According to Forbes, AI is projected to see an annual growth rate of 37.3% from 2023 to 2030 and the AI market size is estimated to reach $407 billion by 2027.

What does that mean for the IP legal industry? The interplay between IP, AI and the wider legal industry is complex. To get a pulse-check of the perception of AI in the IP industry, Clarivate surveyed 575 IP and research and development (R&D) professionals from law firms and corporations worldwide between July 17 and August 1, 2023.

One attorney pointedly said, “Practitioners and clients need to lead the change instead of being pulled along by startups and new tech.” Clarivate found respondents were skeptical about AI deployment but keen to realize benefits. 67% of respondents were most excited about adopting AI for automating manual tasks. While 74% expressed reservations about AI, with accuracy being the top concern.

The full survey results can be found in the report: Redefining Artificial Intelligence. How IP practice meets the coming wave.

Harnessing AI technology & innovation

Advancements in AI are providing legal teams with new ways of harnessing technology to offset resource constraints. AI can help staff scale to meet growing workloads, automate routine tasks and free up time for higher value work.

• Digitalization

There is a shift toward more consolidated technology stacks to improve scalability, flexibility, and cost-effectiveness. Cloud-based solutions, such as IPFolio from Clarivate, enable IP operation management from a flexible, centralized hub.

• AI and automation

At the same time, IP professionals show growing adoption of next-generation technologies to automate repetitive tasks and focus on higher-value strategic matters. Gartner predicts that by 2024, legal departments would have automated 50% of their legal work relating to major commercial transactions.

 Read the related blog: Unlocking New Applications of AI: What IP Practitioners Need to Know Before Selecting an AI-based Solution

Preparing your people for the Great Retirement

Alongside the rise of AI, another significant event is expected to impact the legal industry. There is great anticipation around the potential effects of the sizable “Baby Boomer” generation leaving the workforce, also known as “The Great Retirement”:

• 76 million United States Baby Boomers are expected to retire by 2030
• 245 million Chinese fall into the Baby Boomer generation
• 21.3% of the EU population are Baby Boomers

As a result, prioritization is needed for knowledge transfer, supporting non-traditional and diverse candidates, and focusing resources on training, upskilling, and outsourcing. Legal teams can prepare their people though:

• Upskilling and reskilling programs

As legal functions evolve from conducting standardized legal work to digitally enhanced and impactful service delivery model, upskilling and addressing potential skill gaps is critical.

• Diversity, equity and inclusion

Organizations are shifting towards a more diverse talent base as well as implementing initiatives to foster the development of leadership skills for women in IP.

• Expanding talent pipelines by recruiting nontraditional candidates

Companies now seek candidates from nontraditional backgrounds for their valuable perspectives and experiences. Gartner also predicts that by 2024, legal departments will replace 20% of generalist lawyers with nonlawyer staff.

Leaning into data

Organizations are increasingly recognizing the value of data associated with their intangible assets. However, when using data, analytics and intelligence for efficient and informed decision making it’s important to remember not all data is worth fighting over. When it comes to AI, it can only ever be as good as the input data.

• Data driven decision making

IP portfolios are growing in volume and in strategic value. Analysis of large volumes of data can help predict what is likely to happen and promote effective decision making. While AI solutions can quickly extract deeper insights from large volumes of data, the reliability and validity of these insights depend on the types of data used.

• Data privacy and cyber security concerns

With more remote work and online deliverables, there is a higher threat to virtually held data and increased scrutiny on where said data is stored. Many organizations and their legal counsel are challenged as legal professionals deal with sensitive information, privacy and data security risks. In addition, new applications of AI could expose organizations, law firms and governments to new vulnerabilities, and these should be top of mind as IP practitioners balance the opportunities and risks.

Conclusion

As change continues to come at a faster pace, setting IP teams up for success is key to surviving the constant shifts. Responsibly leveraging AI and proactively preparing teams for change can help law firms and corporate teams stay ahead of these shifts.

Interested in learning more? Watch the on-demand webinar: The future of the IP legal profession: Balancing the rise of AI with human expertise

To see how Clarivate can help your IP team become faster, people focused, and more flexible, contact us today.

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IP legal teams continue to face a universal business challenge: how to do more with less. If this challenge is not thoughtfully addressed, it can have a negative impact on an organization’s ability to meet business requirements. Plus, it can also intensify employee burnout.

A 2022 McKinsey survey of 15,000 employees across 15 countries and various demographics found that on average one-in-four employees were experiencing symptoms of burnout. Fortunately, investments to support well-being are increasing, but how do organizations address root causes of burnout, for example doing more with less? One solution: make investments to identify efficiencies and enable teams to work smarter with less.

Working smarter with fewer resources

In the latest case study from Clarivate^TM, we explore how our IP Diagnostic consulting team collaboratively engaged with global domestic appliance business Versuni to create a tailored strategy, fine-tuning and reshaping their IP organization, including:

• Adjusting organizational requirements after becoming a new smaller company
• Aligning with the new commercial business strategy
• Addressing employee needs and concerns

“Product lines and priority deadlines keep coming, everything goes on, and all the work needs to continue. But we faced insufficient capabilities to deal with daily matters, such as the people and procedures to do the required filings or searches,” explained Birte Vanrobaeys, Head of Trademarks and Designs at Versuni.

Based on analysis of the data collected, Clarivate presented a report which proposed a range of initiatives and recommendations, structured to make both immediate and long-term changes. The Versuni team was excited at the prospect of adapting their roles and structure, honing their processes, and accelerating operations.

Understanding the changes needed

A tailored IP legal strategy starts with identifying where change is needed. To achieve an effectual outcome, careful analysis of an organization’s roles, processes, technology, and information is required. Questions to consider include:

• Are members of your IP team overburdened?
• Does your IP team need to increase operational efficiency or mitigate risk?
• Are you concerned about the quality of your patent and trademark data?
• Are you trying to reduce costs in IP protection and portfolio management?
• Do your processes support business objectives?

If this resonates, an unbiased third-party evaluation, such as an IP Diagnostic, can help identify strategies to achieve key business priorities, gauge the efficacy of the team structure and technology in place and verify whether the processes are optimal.

The benefits of unbiased evaluation 

Creating a modern and efficient IP legal team is a complex and vital undertaking. The IP Diagnostic consulting team has helped organizations successfully position themselves for the future with over 150 projects in over 15 countries.

Each IP Diagnostic is customized, focused on amplifying four key benefits:

1. Maximize the value of people
   Place the right people on the right tasks to improve productivity and adjust responsibilities to optimize workload.
2. Increase process efficiency
   Evaluate current processes for logic and consistency to uncover ways to reduce costs and boost team output.
3. Utilize the best data for key decisions
   Review the input and processing of data, analyzing where your data comes from and the quality.
4. Optimize use of IP technology tools and systems
   Assess whether existing systems are working well together and identify opportunities to meet objectives through automation.

When asked about the IP Diagnostic methodology Dries Duijnstee, Chief Legal Officer at Versuni said: “I really liked the Clarivate approach of interviewing everybody in an intensive and open way with very candid discussions about how they did their work and what was on their mind. I could see that our people enjoyed it and didn’t see it as threatening, and it also gave us a lot of insight.”

Conclusion

The case study concludes with Dries’ thoughts on the impact of the IP Diagnostic: “Clarivate came to us with a good and clear solution… As a result of the changes we’ve made, we have increased speed, solved a number of challenges, and reduced quite a lot of stress for people”.

As change continues to come at a faster pace, setting employees up for success with optimized processes, technology, and information is critical for both the business and the burnout.

Interested in learning more? Download the case study: A new global IP team with a tailored strategy for success.

To see how Clarivate can help your IP team become faster, people focused, and more flexible, contact us today.

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Budgets and staffing are tight, competitive pressures are on the rise, and clients and business leaders are demanding more for less — without compromising quality. This creates an inflection point for rethinking how corporate and law firm intellectual property (IP) legal teams operate.

The value of investing in change during challenging times has been demonstrated historically. A 2020 report by McKinsey & Company found that organizations that invested in innovation during the financial crisis of 2009 outperformed the market by 10% during the crisis and by 30% in the post-crisis years.

Now is the time to be bold

Against the backdrop of increasing demands and shrinking budgets, forward-looking IP legal teams are re-examining status quo approaches to managing IP assets.

“During a downturn and in this post-pandemic era, this is absolutely the time to be bold and invest in the future, strengthening our services to our internal and external clients,” says Tina Powers, Intellectual Property Operations Manager at Mintz.

The importance of IP is elevated during a downturn as companies seek to bolster their revenue and gain competitive advantage. David M. Weirich, Vice President & Associate General Counsel, Patents at The Procter & Gamble Company says: “It may seem counterintuitive, but a downturn is a good time to evaluate your systems and how work is done. Make changes that will help in the future, even if there is a cost now.”

Where should law firm and corporate IP leaders focus their attention and investment? The experts point to four key areas to encourage risk mitigation, agility, and morale: people, process, data and technology.

People: Investing in your teams

Knowledgeable people are a crucial resource. Making sure you are applying peoples’ skills in the most effective way is key to optimizing your investment in talent. “It’s all about having the right thing done by the right person at the right time… using their unique industry experience, talent and knowledge to serve clients,” says Robert K. Burger, Executive Director & COO at Sterne Kessler.

Third party experts like IP Services teams from Clarivate focus on utilizing specialists to decrease pressure on your internal teams, by reducing administrative burden and risk. It is important to note that the goal of these services is not to reduce in-house headcount. It is to enable and empower IP teams to focus on more strategic and value driving activities.

Process: Reduce pressure and improve output

An uncertain business environment is also a catalyst for IP departments and law firms to rethink their processes. It provides an opportunity to meet cost and staffing pressures while improving output.

“We had Clarivate take over the payment of trademark annuities, dealing with all of our agents around the world. This freed up our internal people to work on more interesting and important things. At the same time, our costs are reduced because we have the benefit of a larger organization negotiating rates” Weirich says.

He also notes the need to look at process transformation from a culture standpoint. “We got everyone thinking about simplification, encouraging them to bring ideas to the table.”

Data: Work smarter, not harder

IP management software (IPMS) and other systems are filled with data relating to IP portfolios. Optimizing and enhancing this data can help you prioritize focus and funds while enriching IP portfolios.

For example, combining portfolio data with Clarivate IP Intelligence solutions can provide clear insights to help IP legal teams:

• Accelerate critical insights with AI-powered analytics solutions combined with correlated patent, trademark, litigation, non-patent literature and firmographic data.
• Boost competitive advantage with IP intelligence you can use for a variety of high-value analyses – from evaluating IP value and risk to performing competitive intelligence.

Technology: Taking on tech

Technology plays a major role in transformation, with the experts emphasizing the importance of targeting the right opportunities for improvements.

Powers notes that connecting FoundationIP with the firm’s other software tools — such as linking docketing to billing software — yields significant improvements. “The investment we made in an IPMS, both in time and financially, has taken our technology to the next level.”

Increasing adoption and harnessing the full capabilities of existing technologies can optimize internal processes and enhance efficiency.

Conclusion

Transformation is the great unifier across IP legal teams, both law firms and corporates. It starts by carefully evaluating how your IP team is working today and identifying opportunities for new and better ways of working.

While we must always expect the unexpected, the experts agree that taking a proactive approach to transformation is a wise strategy, and we can help.

Interested in learning more? Download the report for a deep dive on this topic: Investing in innovative IP legal strategies during challenging times.

About our speakers

The IP legal experts sharing their approach to investing in innovative IP legal strategies during challenging times include:

• Robert K. Burger, Executive Director & COO at Sterne Kessler
• Tina Powers, Intellectual Property Operations Manager at Mintz
• David M. Weirich, Vice President & Associate General Counsel – Patents at The Procter & Gamble Company

The post Being bold with your IP legal investment strategy during challenging times appeared first on Clarivate.

To manage their extensive IP portfolio, Philips has a robust Intellectual Property & Standards (IP&S) organization. The organization’s IP Support group, led by Poul de Haan, handles all the administrative tasks associated with filing, prosecuting and maintaining the company’s IP rights.

Read this article for highlights of the customer story or read the full version here.

The Challenge: Growing complexity and scale

Given the sheer size and global nature of Philips’ IP portfolio, the role of De Haan’s IP Support team is complex.

“Typically Philips files about 900 new patent filings per year. Next to that Philips is also quite active in registering new design rights and trademarks. All the formalities in relation to filing and prosecution are handled by the IP Support group.” de Haan explains.

The Solution: Unified IP lifecycle management

In 2008, Philips turned to ipan, now part of Clarivate, to handle renewals. Since then, the relationship has expanded to include European Patent (EP) validations and IP recordals. In 2011, following a review of available IP management software (IPMS), Philips adopted Unycom. Unycom offers comprehensive tools for managing the entire IP lifecycle. The system provides best-practice workflows and seamless integration of internal and external stakeholders to enable efficient collaboration. Plus, it supports easy integration of incoming IP data and documents from PTOs or IP portfolio migrations.

“The combination of [IP services and software] in one company is a real benefit. Clarivate has proven to be a trustworthy and long-term partner.”

Results: More efficiency, less friction

• Time saving automation

“We have a lot of different document classifications. When uploading a document, we can specify the correct classification and Unycom automatically creates the associated task and timing within the system. That automation is a big help.”

• Seamless communication

Since the introduction of Unycom, the team uses the Unycom partner portal to streamline communicating instructions to their network of agents worldwide.

• Relief from renewals

Relying on Clarivate for renewals and annuity payments has helped De Haan’s team maintain Philips’ rights while taking a major burden off the shoulders of in-house IP support staff.

• Tackling large recordal projects

“We worked with Clarivate to get all ownership changes recorded at the various PTOs,” he says. “If we had tried to do it in-house, I don’t think we would have had the capacity to get it all done.”

• The benefit of a single partner

“The combination of [IP services and software] in one company is a real benefit. Clarivate has proven to be a trustworthy and long-term partner.”

• Streamlining patent validation

Philips also relies on Clarivate for patent validations, having established a smooth workflow integrated with their IPMS.

Read the full customer story here.

To learn more about the solutions and services in this article, please contact us.

The post How Royal Philips supports growing IP administration demands with integrated Clarivate services and technology [Customer Story] appeared first on Clarivate.

Overshooting the annual IP budget puts pressure on the company’s bottom line. Under-spending could negatively impact future budget levels. Effectively managing costs is a crucial step for strategic IP portfolio management. Without good cost control, IP leaders are not well positioned to manage higher-order priorities, like optimizing the agent network, licensing the portfolio and aligning spend with business strategy. To hit budget numbers consistently, IP leaders need the ability to predict their future IP spend accurately.

But trying to predict IP costs accurately is extremely complex. Fees vary from one jurisdiction to another and can change without warning. Gathering updated cost data is time-consuming. Making assumptions about future spending can lead to subjective guesswork.

A new forecasting solution

IP leaders need objective analysis that eliminates complexity and generates reliable budget forecasts. That capability is now available with Forecast from Clarivate.

Designed specifically for legal teams managing large IP portfolios, Forecast provides powerful IP budget forecasting and planning capabilities, seamlessly integrated with Clarivate IP Management Software (IPMS).

Forecast uses sophisticated artificial intelligence (AI) to perform predictive analyses based on portfolio trends using accurate, up-to-date cost data. It provides objective information to improve budget planning, support informed financial decisions and stay ahead of changing conditions.

Transforming budget planning

Easy and intuitive to use, Forecast transforms the IP budgeting process by enabling IP leaders to generate reliable forecasts quickly and efficiently, view costs across their portfolio, with powerful filters to zero in on critical data, and compare actuals to forecasts, helping them stay on track. Analyze data with ease using visual dashboards and custom reports. Assess different scenarios to make informed decisions with a clear understanding of their budget implications.

Forecast provides the next-generation tools IP leaders need to hit their budget consistently while dramatically improving their efficiency and speeding budget approvals.

To get the full Forecast story download our report Transforming IP budget forecasting.

Ready to sharpen your budget forecasting accuracy? To learn more about Forecast, contact Clarivate today.

The post IP cost forecasting: adding accuracy, removing guesswork [New Report] appeared first on Clarivate.

We’re incredibly excited about this next step in our union and would like to reassure our customers that we are here to support you.  While we have a new look, our commitment to you remains the same. In fact, our combined expertise, data and technologies are already helping customers make smarter and faster evidence-based decisions enabling the delivery of safe, effective, and commercially successful solutions faster. We are also taking stock of this opportunity to enhance our approach and service for a more unified and consistent brand experience for our valued customers.

How this supports our mission to help you drive innovation

Dialog’s technology and services, combined with our unrivalled access to the world’s best academic literature databases, make research more powerful and efficient. The integration with Dialog has further strengthened Clarivate as a leading global provider of information and insights that can accelerate the innovation cycle, bolstering a robust, integrated platform of life science intelligence solutions that support the entire drug development lifecycle.

As an organization centred on innovation and transformation, our products and services are imagined, created, and improved in a continuous, connected lifecycle of innovation: discover, protect, commercialize.  Our mission is to help customers solve some of the world’s most complex problems and reduce the time from idea generation to implementation. Migrating the Dialog brand to Clarivate supports our mission, enabling users to benefit from more integrated solutions and ultimately accelerates innovation and commercial efforts for customers.

Q: How this affects you, our valued customer

A: Below we’ve outlined answers to any immediate questions that may arise from this transition. Should you have further questions, please reach out to your account manager or email dialog.support@clarivate.com

Q: Is there anything I need to do as a customer in light of this transition?

A: No, we will inform customers ahead of time if any action is required on their part as we continue with the integration. We are excited to leverage our combined solutions to deliver greater value to our customers.

Q: Will my key contact change?   

A: At this time, we do not expect changes to key contacts. However, if there are changes to your key contacts, you will hear directly from your account manager or our customer support teams.

Q: How will this affect my access to products and services?   

A: Clarivate and Dialog have complementary and synergistic product portfolios that, when combined, will enable us to support the drug, device and medical technology landscape from research through to outcome. We are building a unified product strategy that will deliver innovative solutions leveraging our complete set of data and capabilities. This will be achieved via highly specialized analytics and unique expert insights. Over the coming months, you may notice changes to the names of some of the products or to their look and feel as continue to unite under a singular brand.

The post Dialog Solutions becomes Clarivate appeared first on Clarivate.

list from Clarivate.

Innovators to watch goes beyond measuring accomplishments. It identifies companies and institutions that demonstrate both exceptional potential and consistent, above-the-bar innovation excellence. These pioneers are poised to be recognized on the 2024 Top 100 Global Innovators list.

Assessing potential with three criteria

Identifying those companies and institutions on the cusp of entry involves a straightforward but powerful analysis that supplements the Top 100 Global Innovators methodology. To determine which organizations are making their way to the top, we ask three questions:

• Are they within reaching distance of the Top 100 rankings? i.e., rank inside the Top 250 in 2023.
• Are they moving quickly through the rankings? e., the organization’s average rise in ranking since 2017 is greater than its current gap to position 100.
• Are they new in the sense of not being a previous recipient of the Top 100?

The answer has to be ‘yes’ to all of the above for an organization to make the watch list.

Observations at the forefront of innovation

The world is taking shape under the influence of today’s ingenuity. Those at the forefront of the innovation ecosystem are set to be the architects of the future.

Half of those who made the list this year were new entrants, not previously included in Innovators to watch in 2022. This reflects the dynamic landscape that these innovators are operating within.

We also see diversification. A number of automotive companies continue to expand as does their global representation. Mazda, from Japan, maintains its position from the previous year and four new entrants are present in the automotive sector (Aptiv, Faurecia, Toyo Tires and Vitesco). A similar trend is seen in the semiconductor industry, which added two U.S. companies, Cirrus Logic and ON Semiconductor, to the Innovators to watch list.

Many trends observed this year reflect those found in the Top 100 Global Innovators list and continue themes from last year’s Innovators to watch. Japan remains the largest country in terms of representation with even more Japanese organizations on this year’s list, spanning multiple industries, including energy and electrical, consumer goods and food and chemicals and materials.

Clarivate is pleased to recognize the Innovators to watch 2023 – the organizations showing the fastest rise to entering the Top 100 Global Innovators list.

See who made the list.

The post Innovators to watch 2023 [REPORT] appeared first on Clarivate.