Category: Patents

EPO vs UPC: Why diverging standards on patentability of Amgen’s PCSK9 Therapy could signal strategic crossroads for Biotech Innovators

A tale of two tribunals is unfolding over Amgen’s European patent for antibody PCSK9 inhibitors. Two IP patent attorney Sheena Linehan unpicks the potentially profound consequences for life science innovators navigating the evolving European patent landscape.

When the Unified Patent Court (UPC) opened on 1 June 2023, it was quickly tested with a high-profile case: Sanofi launched a revocation action against Amgen’s European patent EP 3 666 797 B1, which covers antibody PCSK9 inhibitor therapies, including the blockbuster Repatha^®. In a decision issued on 16 July 2024 (UPC CFI 1/2023), the UPC revoked the patent for lack of inventive step. The court held that development of antibody therapies targeting PCSK9 was an obvious next step based on prior art.

Yet, in stark contrast, the European Patent Office (EPO) has upheld the same patent in first instance opposition proceedings in light of the same prior art document. The EPO’s Opposition Division found that, while the prior art pointed to PCSK9 as a promising target for development of antibodies, there was a lack of a “reasonable expectation of success” regarding the therapeutic efficacy of antibody PSCK9 inhibitors—a critical factor in establishing inventive step under EPO standards.

This divergence is more than legal nuance. It goes to the heart of biotech innovation, where therapeutic development is uncertain, high-cost, and fraught with clinical risk.

A Divergence in Legal Reasoning

At issue is how to assess inventive step of a new biologic therapy when the prior art already validates the biological target. The UPC adopted a pragmatic view: if a skilled team is motivated to take the next logical step in developing the prior art, and does not foresee any particular difficulties in doing so, the claim lacks inventive step. The court did not require evidence that the skilled team would have a “reasonable expectation of success” in achieving a therapeutic effect in light of the prior art.

By contrast, the EPO emphasized the unpredictability of therapeutic outcomes in complex biological systems. It underscored that lack of direct evidence in the prior art for therapeutic efficacy meant that a skilled team could not have reasonably expected success—making the invention non-obvious under EPO jurisprudence.

The EPO also referenced EPO Enlarged Board of Appeal decision G2/21, which requires “plausibility” of therapeutic effect in patent applications for medical use claims. It concluded that if the prior art wouldn’t meet that standard, it can’t support a reasonable expectation of success either.

Why This Matters for Biotech and Biopharma Innovators

For life science companies, this difference isn’t academic. Development of therapeutics, including antibodies, is notoriously risky, with a roughly 90% failure rate from clinical candidate to approved drug. Around 40–50% of failures stem from lack of clinical efficacy, which reflects a failure in target validation.

If courts downplay this uncertainty and adopt an “obvious next step” standard, they risk undermining broad patent protection for first-in-class therapies—those built on unproven biology and bold clinical hypotheses.

The UPC’s stance could make room in the marketplace for second-in-class therapies — providing greater choice for patients — but it carries the risk of disincentivising innovation.

Strategic Choices in the European Patent System

The UPC and EPO are independent bodies. The EPO grants European patents, and patent owners can choose to validate their European patents nationally or as Unitary Patents which have unitary effect in participating EU member states. The EPO also provides a central post-grant opposition mechanism. Patent owners can opt out EPO-granted patents which have been validated as national patents from the UPC’s jurisdiction, at least during a seven year transitional period. The UPC rules on infringement and validity of Unitary Patents, and nationally validated patents which have not been opted out.

Amgen’s case puts the spotlight on a critical strategic decision: Should biotech innovators rely on the UPC, or stick with traditional national validation routes and courts? The answer may increasingly depend on how courts assess “inventive step” in complex therapeutic areas.

Notably, Amgen is also asserting its patent in a separate UPC infringement action against Sanofi and Regeneron, in respect of Praluent^®, a structurally distinct but functionally similar antibody which they developed independently. The stakes are high—not just for the parties, but for the system’s coherence.

Global Trends and the Innovation Climate

Amgen’s broad antibody PCSK9 inhibitor claims have faced hurdles elsewhere. Corresponding patents in the U.S. and Japan were also invalidated, albeit for different reasons. The global trend suggests increasing scrutiny of broad antibody claims that are defined functionally rather than structurally.

This raises a broader policy question: Are innovators being fairly rewarded for high-risk, early-stage biologics development—or only for de-risked, follow-on products?

Key Takeaways for Life Sciences Companies

EPO upheld Amgen’s patent, recognising the uncertainty and lack of a “reasonable expectation of success” from the prior art.
UPC revoked the same patent, seeing the claimed invention as the next logical and routine step.
Diverging approaches to inventive step create legal uncertainty and strategic complexity for innovators.
Appeals pending in both venues will be closely watched—and could reshape European patent strategy for biologics.

Looking Ahead: Strategic Considerations for Biotech IP Teams

Until these appeals are resolved, life science companies should:

Closely evaluate patenting strategies for functionally defined biologics and therapeutic uses.
Consider opting out of the UPC for foundational or early-stage assets where clinical uncertainty is high, and a broad claim scope is desired.
Strengthen EPO applications with data supporting plausible therapeutic effects, in order to support second medical use claim format.

Our patent and trade mark attorneys can help you work out what you should be doing to protect your IP and then help you do it. To get in touch, click here or email us at hello@two-ip.com.

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Sources

UPC Decision

EPO Decision

Approval success rates of drug candidates based on target, action, modality, application, and their combinations – PMC

Why 90% of clinical drug development fails and how to improve it? – PMC

UPC affirms second medical use patent in Sanofi v Amgen antibody therapeutics ruling

Following recent judgment from Europe’s newest patent litigation forum in the case of Sanofi & Regeneron v Amgen, Two IP patent attorney Sheena Linehan looks at the implications of the ruling for protecting and enforcing patents covering new medical uses of known therapeutics.

The Unified Patent Court (UPC), operational since 2023, is already shaping up to be a powerful venue for life sciences litigation in Europe. With its ability to issue EU-wide injunctions and invalidate patents centrally, it’s no surprise that innovators are paying close attention.

In a pivotal early decision UPC CFI 505/2024 the Court of First Instance addressed the validity and infringement of a second medical use patent EP3536712 held by Regeneron and exclusively licensed to Sanofi. The decision affirms the potential value of such patents, which cover new medical uses of known therapeutics, and provides guidance for what factors must be taken into account in deciding whether infringement has taken place.

The patent at issue

Regeneron’s patent covers antibody PCSK9 inhibitors for use in reducing lipoprotein(a) levels in a defined patient group with (or at risk of) cardiovascular disease and having elevated lipoprotein(a) levels. The alleged infringement is Amgen’s Repatha^® antibody PCSK9 inhibitor which is approved for lowering LDL-C (low-density lipoprotein cholesterol) in cardiovascular disease.

Validity: strong endorsement of second medical use claims

The UPC upheld the validity of Regeneron’s patent, which has broad protection for antibody PCSK9 inhibitor therapeutics, albeit in the context that the therapeutic is limited by reference to a specified medical use. More generally, the court affirmed the potential patentability of claims covering a known therapeutic agent for a further medical use in:

treating a new indication, or
addressing a new patient group, even if the broader disease area overlaps with existing uses.

The court found the claims both novel and inventive, ruling it was not obvious before the filing of the patent that PCSK9 inhibitors could decrease elevated lipoprotein(a) levels. Furthermore, a skilled person would not have been motivated to pursue this use based on the prior art.

Infringement: no direct hit for Regeneron

Although Amgen’s Repatha^® antibody would fall within the broad functional language of Claim 1 as “an antibody or antigen-binding fragment thereof that specifically binds PCSK9”, the court found Amgen’s product not to infringe Regeneron’s patent.

The court held that “for a finding of infringement of a second medical use claim, the alleged infringer must offer or place the medical product on the market in such a way that it leads or may lead to the claimed therapeutic use of which the alleged infringer knows or reasonably should have known that it does”. In finding non-infringement, the court focussed on the indication defined in the summary of product characteristics (SmPC) of the Repatha^® marketing authorisation, but held more generally that the package insert and SmPC, although important, are not always the only decisive factor. As the Repatha^® SmPC does not specify reducing lipoprotein(a) in the context of the indication, the court looked at evidence of off-label prescribing, but found that such use had not been made out.

The court noted that the fact that the effect of Repatha^® in reducing LDL-C may have the bonus effect of reducing lipoprotein(a) levels is not relevant to infringement.

However, the court signalled that infringement analysis goes beyond the label, allowing for real-world factors like physician practice and marketing intent, an approach that patentees will welcome.

What comes next?

The UPC’s first major decision on second medical use patents sets a practical tone — strong on validity, nuanced on infringement. It’s a positive sign for innovators navigating the evolving European patent landscape.

Stakeholders should watch closely for a potential appeal to the UPC Court of Appeal, which could shape binding precedent on second medical use claims across the EU. Given harmonisation in Europe, the decision may also influence UK courts.

Antibody patent standards: an evolving landscape

Interestingly, Regeneron’s patent claims the PCSK9 inhibitor broadly as “an antibody or antigen-binding fragment thereof that specifically binds PCSK9”, but this broad functional definition did not attract scrutiny in the present case. Given the newness of the UPC, its approach to functionally defined antibodies is still being developed. Last year in its first ever patent revocation UPC CFI 1/2023, the UPC revoked Amgen’s functionally defined antibody patent for lack of inventive step, finding it obvious to develop antibody inhibitors of PCSK9 in light of the prior art which disclosed PCSK9 as a potential target for treatment of hypercholesterolemia.

Whilst functionally defined antibodies may be acceptable in European patent claims, the US approach usually requires antibodies to be defined structurally, which is the case for the granted counterpart US patents corresponding to EP3536712. In landmark US litigation, Amgen’s functionally defined antibody patents were revoked by the Supreme Court in 2023 for lack of enablement, as covering far more species of antibody than actually described, and failing to teach how other such antibodies across the broadly defined class may be obtained.

The evolving landscape of European antibody patentability and differences of approach with respect to the US requires a nuanced approach to IP strategy and patent drafting.

How valuable is a second medical use patent directed to a new patient group?

A patient with a cardiovascular disease may have elevated lipoprotein(a) and elevated LDL-C, and both may have the potential to be reduced by antibody PCSK9 inhibitor therapy. Given the overlap in potential market segment (cardiovascular disease) and the non-infringement finding, the question of the value of Regeneron’s second medical use patent arises.

Regeneron’s patent does not prevent Amgen from marketing Repatha^® for its authorised indication, but it would restrain a label extension for Repatha^®to cover reducing elevated lipoprotein(a). In addition, Regeneron’s patent would provide protection if Sanofi were to seek a label extension for its own antibody PCSK9 inhibitor Praluent^® to cover reducing elevated lipoprotein(a) in the patient group defined in the patent claims.

Hence, there is potential value in a second medical use patent directed to a new patient group, even if a case for infringement has not been made out, and the market segment is overlapping with the established use of a competitor therapeutic.

In addition, given the potential challenges in securing broad protection for antibody therapeutics per se, the patenting of a new and inventive medical use may provide a means to avoid being required to limit patent claims by reference to particular antibody structures.

Key takeaways:

UPC confirms second medical use patents are valid tools for life sciences innovation.
Infringement depends on how a product is marketed and prescribed — not just what’s on the label.
European vs US patent claim strategies for antibodies are diverging — plan accordingly.

Read the full court decision here.

Our patent and trade mark attorneys can help you work out what you should be doing to protect your IP and then help you do it. To get in touch, click here or email us at hello@two-ip.com.

Found this information useful? Click here to sign up for our monthly Two Insights newsletter.

Missed your chance of a free IP Clinic session at CWX Expo? It’s not too late…

Two IP were thrilled to attend the CWX Expo, an exciting showcase of the innovation in the creative and immersive technology sector within the West Midlands region.

If you missed your chance to book a free IP Clinic session at the event, don’t worry there is still time to book a free discovery call with our expert patent, design and trade mark attorneys.

Need advice on patents?

Need advice on designs?

Need advice on trade marks?

Meet our attorneys

Dr Anna Molony

Anna is a UK & European Patent Attorney with over 20 years experience in private practice, plus experience as in-house patent counsel for a fast-growing University spin-out.

She works with a wide range of technology driven companies ensuring their R&D and investment is fully protected, so it can be commercialised to best effect.

Neil is a European and UK Patent Attorney, who specialises in IP strategy, patents, registered designs, copyright and early-stage litigation.

Neil enjoys working with individuals and SMEs, learning about their businesses, and advising how best to leverage their IP.

Dr Neil Kilpatrick

Rachel Havard

Rachel is a UK Chartered Trade Mark Attorney, qualified since 2000, with more than 25 years spent in private practice.

She devises and implements appropriate strategies for protection and enforcement of trade marks in the UK, Europe and internationally, with a good eye for commercially sensible resolutions to legal problems. 

Alternatively, you can contact us here or email us at hello@two-ip.com

Don’t Develop Blind: How to use IP to power new product success

Intellectual Property (IP) can kill or boost new product development success – it just depends how you use it.

At each stage of the new product/service development process, from ideation and prototyping to development and launch, IP plays a critical supporting role.

Here’s what using IP optimally during product/service development looks like:

Ideation

Use Intellectual Property (IP) searches to:
- Understand what IP rights exist in the technology/product area
- Identify gaps in technology or the market
- Identify IP trends in the technology or the market
Use existing IP rights:
- As inspiration
- As a kicking off point
- To identify problems with existing technology or services that you could solve

Prototyping

As you solve problems and generate prototypes, identify any new ways you are developing to solve a problem – this might be protectable Intellectual Property (IP)

Analysis

Does the prototype product/process or service fit with your business strategy?
Does the prototype product/process or service fit with your IP strategy?
What IP rights (patents, trade marks, registered designs) do your competitors have in this space? Are any of these a problem for you?
Carry out initial patent and registered design freedom to operate (FTO) searching to find any third-party IP rights that might stop you from launching this new product/process.

Development

Make sure you own the IP in the product/process or service you are developing:
- If the development is being done by employees, the company that employs them will own the IP
- If you are using external supplier/contractors, check your agreements to make sure you will own any IP (inventions, designs, copyright) arising from the work they are doing for you – just because you are paying for the work does not mean you will own the IP.
- Require external suppliers/contractors to assign any IP (inventions, designs, copyright) arising from the work to you
Protect the IP:
- File patent applications as soon as how the product or process works is finalised
- File registered design applications as soon as final product designs are agreed
If you are launching under a new brand/trade mark:
- Shortlist 3 or 4 potential new names
- Do trade mark clearance searching for each shortlisted name and only pick one that you are free to use

Launch

Mark the product, any packaging and literature with patent application, registered design and registered trade mark numbers – this puts potential competitors ‘on notice’ that you have IP rights covering the product, process or service
Double check that the patent, registered design and trade mark applications you have filed actually cover the final product or service to be launched – late developments can mean they no longer cover the final product, process or service

Integrating intellectual property into the new product development process, ensures that development time and effort is well spent, and the vision behind each innovation is protected. This, in turn, not only safeguards the product or service but also ensures brand integrity and future success.

At Two IP we’re experts in intellectual property. If you’d like our help with using IP to support your new product or service development, you can send us an email to hello@two-ip.com.

Navigating the complexities of patenting AI inventions

AI innovation is moving fast—but can the patent system keep up? Drafting patents for AI systems isn’t just about protecting technology; it’s about bridging the gap between coders, technical experts, and legal frameworks.

With evolving regulations and the challenge of defining inventorship, securing strong IP protection requires careful strategy. Two IP patent attorney and AI expert Dr Coreena Brinck shares what you need to know.

Drafting patents for AI systems presents a complex array of challenges, particularly when it comes to inventions involving inventor teams who may be experts in different disciplines.

AI inventions can often be a result of collaborative efforts between coders, technical specialists in various areas, for example, medicine, and commercial managers, each with their own understanding of what the invention is, and possibly each having their own technical language to describe what may be the same thing in practice.

On top of this, are the various ways that code can be generated for any computer-implemented invention these days. For example, many coders and programmers rely on libraries of code snippets or pre-existing code modules and computer models to build their own platforms and systems and some also use generative AI applications to automatically generate source and/or executable programs using prompts (an example here being Claude, also available as a mobile phone app). This can lead to a lack of awareness over implementation and may bring additional challenges and complexity not just from describing how to implement an invention but also when it comes to identifying who exactly made various inventive contributions. The later is essential not just as the fundamental right to a granted patent rests with the inventor(s) unless assigned away, for example, to their employer, but also as only humans can currently have such ownership rights and this means non-human inventors are not allowed by patent offices.

Patenting complex technology accordingly means professional help may be crucial for success. Not only can a patent attorney help assess whether an invention is eligible for patent protection, but they can also determine who should be named as an inventor in view of their contribution to the invention. A patent attorney can also keep track of your patent application as it progresses which may include revisiting the question of inventorship as the inventors listed in the initial patent claims may differ from those who are ultimately listed in the granted claims, making the process even more fluid and challenging.

The issue of AI-assisted inventorship is further complicated as different patent offices have different guidelines and regulations. As of February 2025, the European Patent Office (EPO) does not allow non-human inventors to be named on patent applications. This rule means that AI systems, while they may play a significant role in the invention, cannot be listed as inventors, even though they may arguably have contributed to generating part or all of the inventive idea.

In patent drafting, a key challenge for protecting inventions involving applied AI, where a known AI model is used in a new way for a particular application, may be simply identifying what AI model(s) can be used in the invention and how their features and characteristics, including how the AI system is trained and functions operationally, contributes to a technical effect. The inventors may not have thought of their invention in this manner and it can be perplexing for them to understand what information they may need to share with their patent attorney so that the patent specification includes sufficient information to “teach” how their invention can be implemented by others skilled in that technical field.

Assessing what is sufficient information is not straight forward and can be particularly challenging for core-AI inventions. In some situations, during the training stage, details such as the volume, source, and cleaning/pre-processing of training data may need to be provided. What counts as “trained” and when the training process should stop may be other important factors to describe for some models. The weight learning algorithm of the ANN and initialization methods may need to be explained for some core models and it may be that a training method contributes to a different technical effect from that provided by the trained ANN model. The various possible training methods may also need to be described, and whether one or more different types of training are possible. For example, training may be supervised, unsupervised, on-going or continuous, in some situations.

If the training is on-going, it is crucial to describe what this means, as well as how errors are measured ongoingly and how this can impacts the performance of the model.

The operational stage of the AI system may be the core commercial proposition that the applicant wants to protect from its competitors. In this case, how the trained AI system is being used should be explained, and a causal link provided including any post-processing of its output so that the AI system as claimed provides a patentable technical effect.

Finally, given the ongoing evolution of AI technology and regulatory frameworks, considerations like the EU AI Act are become increasingly important. Inventors and patent professionals must navigate the fine line between patenting the AI system, protecting trade secrets, and utilizing open-source and defensive publications to safeguard innovations without over-disclosing sensitive details.

Ultimately, patent drafting in the AI space requires clear communication among diverse stakeholders with varying levels of expertise, clear and consistent language to be used in documentation of both the technical and operational stages, and some understanding of the AI regulatory landscape is also helpful. Successfully balancing technical disclosure, confidentiality, and patentability is what makes AI patent drafting a particularly complex and evolving field – as well as why I so enjoy working in this area.

If you are seeking guidance on protecting your AI inventions, you can contact Coreena via our website here or email us at hello@two-ip.com

Innovation saves lives – but only if we protect it

During the COVID-19 crisis, we saw a spike in vaccine patent applications – but why does that matter? Because intellectual property rights (IPR) aren’t just legal protections; they’re the foundation of life-saving innovation. Without them, groundbreaking research wouldn’t have scaled into global solutions.

Curious about why IPRs matter to biotech and life sciences innovators, and how their use played out in the COVID-19 pandemic and beyond? Two IP patent attorney Sheena Linehan explains more.

In the realm of biotech and life sciences, the ‘Why’ of protecting intellectual property (IP) is deeply connected to the mission to advance human health. Safeguarding IP is essential for fostering innovation, allowing groundbreaking medical discoveries to be developed and scaled to address pressing health challenges.

Why protecting Intellectual Property matters

The primary purpose of intellectual property rights (IPR) in this sector is to incentivise the development of new medical solutions. The process of creating vaccines, therapies, and medical technologies demands significant investment in research and development. By securing IP, organisations can protect their innovations from unauthorised use, allowing them to recoup investments and fund further research. This protection is crucial for translating scientific discoveries into accessible health solutions that benefit society at large.

Securing patents and other IP rights allows organizations to:

✅ Secure investment for R&D and clinical trials

✅ Form strategic partnerships for clinical development and large-scale manufacturing

✅ Enter new markets and foster global accessibility through licensing and collaborations

The COVID-19 pandemic highlighted a critical role for IP in public health. The University of Oxford developed a candidate COVID-19 vaccine ChAdOx1 and secured its IP. To ensure widespread access, they licensed this IP to AstraZeneca, which carried out clinical trials and franchised production to global partners, facilitating mass production and distribution. AstraZeneca notably partnered with the Serum Institute of India (SII), which alone manufactured over a billion doses. This collaboration was pivotal in delivering vaccines to low- and middle-income countries, demonstrating how strategic IP management can serve the public interest.

How IPR fuels ongoing innovation

The benefits of IP protection don’t end with one breakthrough. Following the success of the COVID-19 vaccine partnership, SII has pledged £50 million for a vaccines research facility at Oxford University, and has partnered with the University in development of the R21/Matrix-M malaria vaccine, which it will manufacture on a large scale.

Companies like Moderna and BioNTech, pioneers of mRNA vaccine technology, utilised their IP to rapidly develop COVID-19 vaccines, primarily for high-income countries. Post-pandemic, they are exploring the application of mRNA technology to cancer vaccines, showcasing how robust IP portfolios can drive ongoing innovation to address various health issues.

What are Intellectual Property Rights?

Intellectual Property Rights are legal protections granted to creators and innovators. In the biotech and life sciences sectors, these typically include:

Patents: Protect new inventions, such as novel biologics and their medical uses, and medical devices, for a limited period of up to 20 years.
Trade Secrets & Confidential Information: Protect proprietary formulae, research data, and manufacturing processes etc.
Trademarks: Safeguard brand names and logos, ensuring market identity.
Designs: Protect the unique appearance or design of a product, such as a medical device, for a limited period of up to 25 years.

These rights ensure that innovators can control the use of their creations, providing a framework to monetise their inventions and fund further research.

Impact of IPR on health

Owning IPRs significantly influences the ability of biotech and life sciences companies to address health challenges. The COVID-19 pandemic led to a substantial increase in vaccine patent applications, reflecting a surge in innovation aimed at combating the virus. This surge was driven by the need to develop effective vaccines rapidly, highlighting how IP protection can stimulate the creation of solutions to global health crises.

Moreover, strategic IP management facilitated collaborations that were essential for large-scale vaccine production and distribution. The partnership between AstraZeneca and SII, underpinned by IP licensing agreements, enabled the delivery of vaccines to numerous countries, exemplifying how IP can be leveraged to enhance global health outcomes.

In essence, for biotech and life sciences companies, the belief encapsulated in obtaining IPR is that innovation is a catalyst for improving health. Protecting IP not only rewards innovators but also ensures that their innovations can be developed, scaled, and distributed to address critical health challenges, ultimately serving the greater good.

Biotech Leaders – Protect your innovations

Biotech and life sciences companies must take action to protect their IP. Without it, groundbreaking research can be copied, funding becomes harder to secure, and the path to global impact becomes uncertain.

Our patent and trade mark attorneys can help you work out what you should be doing and then help you do it. To get in touch, click here or email us at hello@two-ip.com.

💡Found this information useful? Click here to sign up for our monthly Two Insights newsletter.

Sources:

astrazeneca.com

£50m funding for Poonawalla Vaccines Research Building at Oxford University | University of Oxford

Oxford R21/Matrix-M™ malaria vaccine receives WHO recommendation for use paving the way for global roll-out | University of Oxford

Merck and Moderna’s mRNA cancer vaccine aces its first efficacy trial | pharmaphorum

Promising lung cancer vaccine trial starts in UK – BBC News

The 3 most important things for optimizing working between patent in-house counsel and private practice attorneys

Two IP founder and director Anna Molony was recently invited to speak at the CTC Legal Media Winter IP Conference. Here, Anna shares the key takeaways from the discussion on the day for those unable to attend the event.

As part of the panel at the CTC Legal Winter IP Conference session “Maximizing synergy: nurturing dynamic partnerships between in-house counsel and private practice” I shared some of the things I’ve learnt from being in-house counsel and from working with in-house counsel clients as an attorney in private practice.

For those who didn’t make it to the Conference, here are

The 3 most important things I’ve learned about optimizing working between patent in-house counsel and private practice attorneys:

Private practice attorneys – sometimes you really do need to have a serious level of expertise in the technology to protect it properly
In-house counsel – don’t underestimate the value of giving the private practice attorney you’re instructing the business context of the invention
In-house counsel – be really clear about how you want the private practice attorneys you’re instructing to do the work you give them

So, how come I know about this?

Well, I’ve been on both sides of the in-house counsel/private practice relationship.

For a couple of years, I was in-house counsel at a high-tech, spin-out called Indigo Photonics. Indigo made optical fibre sensors and I lead the IP function internally, with external support from a private practice firm who did the filings and so on. During my time at Indigo I learnt about how R&D teams work and how to work with them, and I learnt about where IP sits within an early stage, VC funded business and I learnt a lot about what an in-house attorney needs from their private practice outside counsel.

As an attorney in private practice, I have worked closely with a number of corporate in-house IP teams, mainly with their patent departments. Each relationship is different in terms of the work that I do and how I do it. For one client, we are that outside resource that does the filings and so on, for another I have been drafting patent applications for nearly 20 years, and for a third I work 1 day per week for them, as a fully integrated part of their patent team.

I’ve learnt a lot about that relationship from working with each of those clients.

Let’s take a look in a bit more detail at those 3 most important things for optimizing working between patent in-house counsel and private practice:

The problems that can arise if the private practice attorney doesn’t understand the client’s technology properly

As patent attorneys, we are great at getting our heads around a wide range of technologies and understanding them to a level that is “good enough” for us to be able to advise our clients. But, for clients who are leading the way in their technical fields, having a “good enough” understanding of the technology sometimes just isn’t, well, good enough. Expertise is needed.

I’ve seen enough poorly drafted patent applications in my areas of expertise (optical comms, optical fibre, lasers, photonics) over the years to know the problems that not properly understanding the client’s technology can cause. This is how it sometimes goes: I read the patent claims and I think “Hmmm”, and then I read the description, particularly the bits that have clearly been pasted in from the invention disclosure, and I think “Double hmmm. I can see what the invention is but that’s not really what the claims are covering”.

I have, in those circumstances, then had to draft an exam response – it’s not straightforward, overcoming the Examiner’s objections while at the same time trying to redraft the claims to cover the invention properly. I’ve also had to handle exam reports where the patent office Examiner hasn’t properly understood the invention. Both can cause serious limitations to the scope of the patent you can get and therefore on the commercial value of the patent.

In some areas of technology, if you don’t have a depth of understanding of the technology, you simply can’t describe it, and define the claims, properly. And, if the examiner doesn’t understand the technology, how can you explain where they’ve gone wrong if you don’t understand it fully yourself?

So, my first lesson to share would be this: in-house counsel, make sure that your outside private practice attorneys have the necessary level of expertise to fully understand your technology; and private practice attorneys, don’t take on work that you’re not technically qualified to cope with.

The value of in-house counsel giving private practice attorneys the business context of the invention

The amount of information about an invention that you receive from a client can massively impact the quality of the work that you can do.

At one extreme, I’ve prepared exam responses where all I’ve had is the published application, the exam report, the prior art, and instructions to prepare a response that overcomes the objections. Now, I can absolutely do that. But without any access to the inventor or any information about which features of the invention are commercially important, my response may not actually result in commercially useful protection.

At the other extreme, one of my clients gives me access to a brilliant internal document that they have for each patent family. It’s a narrative of where the invention came from, what the commercially important features are, what’s happened during the prosecution of each application in the patent family, and notes from the inventors and in-house counsel. It is a fantastic source of context and supporting information for me when I’m preparing an exam response or considering whether we need a divisional application to protect any other features. I can highly recommend writing this type of document, the time spent is well worth the effort.

The value of in-house counsel being really clear about how they want the outside counsel to do the work.

As in-house counsel, how tightly do you want to control how the private practice attorney that you’re instructing does the work you give them. What drafting style should they use? Is there an in-house style or are you happy to let them draft in their own way?

I’ve got a lot of experience of drafting applications using a template and very detailed drafting style guidelines from the client. But I also have clients whose in-house counsel are happy for me to draft in whatever style I think best, on the basis that I know as much about the technology as they do. Both have their merits and their disadvantages.

The first approach can result in a very highly controlled patent portfolio but it requires a significant amount of input from in-house counsel. And not every qualified attorney will be happy having their work scrutinized on a regular basis. I’m used to it and I’m pretty comfortable with it because I think there’s always something new to be learned.

The second approach, letting people work in their own way, will probably be more comfortable for most private practice attorneys. And I think drafting can be easier to do if you’re not trying to squeeze it in to someone else’s preferred approach. However, it may mean that your patent portfolio is less consistent and, possibly, of more variable quality.

European Patent News – No legal basis to require patent applicants to amend European Patent application description to conform with allowed claims

Another European Patent Office (EPO) Boards of Appeal decision has been issued on 4th October stating that there is no legal basis to require amendment of a patent application description to bring it into conformity with the allowed claims. We take a look at what it means for European patent applicants.

In T 0056/21 (Adaptation of the description/HOFFMANN-LA ROCHE), the EPO Board of Appeal has held that there is no legal basis to require adaptation of the description to conform with the allowed set of claims in a European patent application. The decision summary states that: “In examination of a patent application, neither Article 84 nor Rules 42, 43 and 48 EPC provide a legal basis for requiring that the description be adapted to match allowable claims of more limited subject-matter”.

European patent applications are regularly required to amend the description in this way and patent attorneys are universally opposed to it, for several reasons. Most important of which is that the content of a patent application amended in this way can adversely affect the scope of related patents in other jurisdictions. This is because the EPO requires that any embodiment that is not, in its opinion, covered by the allowed claims is specifically identified as not being an embodiment of the invention – not something you really want on public record in the event of future patent litigation in, for example, the US.

In this particular case, the EPO Examining Division objected that the description contained “SPECIFIC EMBODIMENTS”, which contained claim-like clauses”. Claim-like clauses usually consist of an earlier set of claims, for example, from a priority founding application or a parent application of the application in question. Patent attorneys include them so that the entire content of the priority founding or parent application is contained within the application being examined, in case amendment back to earlier claims becomes necessary or the applicant wants to file a divisional application to a different set of claims.

The examining division held that these “claim-like” clauses made the application unclear as to the actual scope of protection as defined by the claims, contrary to the requirements of Art. 84 EPC and these claim-like clauses had to be removed according to the EPO Guidelines.

The Board of Appeal disagreed, stating that there is no legal basis to require the application to be amended in this way.

As more of these decisions keep appearing, European Patent Attorneys keep hoping that the EPO will see the error of its way and remove the requirement from the Guidelines for Examination for amendment of the description to conform with allowed claims. Unfortunately however, the Board of Appeal in this case also stated that it is “not concerned with the correctness of the Guidelines for Examination and, even less, with a possible need for their correction.”

The Board also stated that “To the extent that the Board’s interpretation of the European Patent Convention differs from an interpretation that may follow from the Guidelines for Examination, the Board’s reasons for the divergence should be readily understood [the reasons for the decision]. However, such reasons do not oblige the President of the Office to “correct” the Guidelines for Examination under Article 10(2)(a) EPC. Indeed, the Board’s decision has a binding effect only on the examining division that issued the decision under appeal (Article 111(2) EPC).”

So, once again, we await a decision from the Enlarged Board of Appeal to, hopefully, get rid of this ridiculous requirement that the EPO brought in when it amended the Guidelines for Examination.

You can read the full decision here: https://www.epo.org/en/boards-of-appeal/decisions/t210056eu1

A time for designs?

In today’s fast-paced business landscape, intellectual property (IP) protection is crucial for safeguarding innovation and securing investment. In this article Two IP patent attorney Neil Kilpatrick explores the growing importance of design rights and highlights how businesses can leverage design protection to deter copycats and maintain a competitive edge.

If Dragon’s Den has given the UK public anything, it is the awareness that IP is crucial for securing investment and protecting businesses. Almost every enquiry I receive, from clients new and returning, focus on whether, and how, their latest innovation can be patented.

But in reality, not all products are new and inventive enough to meet the patent threshold. Other innovations, such as software or artistic creations are excluded from patent protection. Even for the best inventions, the patent process is a multi-year journey, with an often uncertain path towards protection. And of course if the idea has already been disclosed then a patent can be dead on arrival.

Fast fashion, or first follower?

Patents don’t suit all businesses. Whilst a patent covering product fundamentals is still the best way to secure market share, product innovation has become more and more focussed on the yearly update, the killer new feature, the brand refresh. IP filings are reflecting this trend. Patent filings are broadly flat over the past few years, whilst registered design filings are up 1154.9% between 2015 and 2023.¹

Design, prepare, protect

Designs protect how a product looks. They are the perfect tool to deter and stop pure copycat competitors. Being a valid and issued IP right, they are a powerful tool for IP takedown action on the key online marketplaces.

The design system is flexible and made with business in mind. For the UK (and the US and Europe at least), designs can be filed up to 6 months after being disclosed. The process itself is also fairly straightforward and quick compared to patents. Produce the required formal drawings, submit the request and pay the (reasonable) official fee, address any formal objections, and receive an issued certificate. Timescales of weeks (c.f. years for patents) from start to finish provide quick business certainty.

Practical Tips

Up, down, left, right, top, bottom, and perspective. These are the standard typical views needed for a successful design filing. Consistency is key here – there can be no ambiguity between what is shown in one view and visible in another. Accordingly, the best design drawings are generated straight from the CAD file, albeit for designs we want technical line drawings. A technical draughtsman and attorney input here pays dividend in the long term.

The next question is what to show, what to emphasise, and what to omit. Is a particular colour key? Or are we interested in the colour contrast? Omitting all colour is broadest, but a blank box is not likely to be valid. Similarly, features can be emphasised or ignored by using dashed or dotted lines to disclaim elements.

Multiplicity

All the questions above give many branching options for what a design is focussed on protecting. Each design is a compromise between breadth and validity, and can’t do everything all at once. The design system knows this and has been set-up to encourage multiple design filings made together by tailoring the fee structure in this way. One design can emphasise features on the front of a design, a second features on the back, a third the overall shape or colour, etc. By building a thicket of protection around your core product you stop not just full copycats, but also companies who “take inspiration” from your ideas.

Enforcement

With your registered design you can now use it to protect your commercial advantage. Designs are powerful tools because they shift the onus for proving copying to the defendant. “Prove you didn’t copy my registered design” is a much harder question for a competitor to answer than any broad accusation that they did copy. Also, being a registered right, they are easy to use for online-marketplace takedowns, which are a powerful tool for quickly blocking the sales of competitors.

1. https://www.gov.uk/government/statistics/facts-and-figures-patents-trade-marks-designs-and-hearings-2023

If you would like further advice or support, please get in touch via our website here or email us at hello@two-ip.com.

WIPO releases new Guide to Trade Secrets and Innovation

You are probably familiar with patents, trade marks, designs and copyright as types of intellectual property – but do you know about trade secrets?

Trade secrets are valuable confidential information and can help you gain (and keep) your competitive edge over the rest of the market. The World Intellectual Property Office (WIPO) has just released a new Guide to Trade Secrets – here’s our overview of what’s in it (and why you should take a look at trade secrets in your business).

The strategic role of trade secrets in the innovation ecosystem and the world economy

Trade secrets should foster fair competition, enhance the efficiency of the innovation ecosystem and facilitate generation of commercially valuable information.

What is a “trade secret”?

A great example is the Coca-Cola recipe, which has been kept secret since 1891 (the Guide lists lots of different types of information that might be protected as trade secrets)

How to keep your trade secrets, well, secret. And how to manage them.

You need to protect your trade secrets against theft and leakage, and contamination with third parties’ trade secrets. Strategic exploitation of your trade secrets and their valuation can help you build value in your business.

Enforcement action you can take if someone steals your trade secret.

You can take litigious or non-litigious action when a trade secret has been misappropriated. Injunctions and monetary remedies can be available through the Courts.

Who owns trade secrets that arise during collaborative innovation?

It is important to set out in any collaboration or join venture agreement who will own all foreground IP rights, i.e. those that are created through the collaboration. This should include trade secrets as well as patents and know-how. Particularly if you are collaborating with a University.

Digital trade secrets – what are they and how can you identify them?

Trade secrets can also exist in digital objects. Similarly to digital copyright, timestamping and digital signatures are useful for identifying digital trade secrets as yours, so you can prove ownership, or copying, in the future.

You can read the WIPO Guide here: https://www.wipo.int/web-publications/wipo-guide-to-trade-secrets-and-innovation/en/index.html

If you would like further advice or support, please get in touch via our website here or email us at hello@two-ip.com