May 2025 - Two IP

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.

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When Life Hands You Packaging…

The Court of Appeal judgment in the case of Thatchers vs. Aldi earlier this year did not just influence wider brand protection and trade marks, it has also changed the options for protecting product packaging. Two IP patent attorney and registered designs expert Dr Neil Kilpatrick outlines the impact on packaging design.

For design attorneys, trade mark case law helps us consider how to approach the more subjective tests applied to design law, rather than the more academic tests used in patents. So, I read my colleague Rachel Havard’s review of Thatchers vs Aldi with interest (click here to read).

In brief, Thatchers held this as a Trademark:

To protect this:

Against this:

And they won. And here is where my problems began.

Conventional wisdom is that registered designs are best for protecting the look of a product. They stop copycats and give the holder extra scope for protecting the time and effort spent in making the packaging (the sleeve and the can in this case) look good.

However, I fear that if the Thatchers trade mark for its Lemon Cider had instead been a registered design, they would have been unsuccessful in stopping Aldi’s Taurus cider.

Even removing the wording, the type and layout of the lemons is different; the swirl on the Taurus is fairly striking, and the background differs.

So – file trade marks for all your important packaging launches? Probably, yes.

And stop filing registered designs? I wouldn’t go that far – they still protect different things, and unlike a trade mark, designs are not invalidated by non-use.

However, like WaterRower’s (read more here) failed attempt to assert copyright infringement for its rowing machine, companies are pushing the boundaries of IP rights between patents, designs, trade marks and copyright to best protect their products.

If you would like support in creating a strategy for your packaging (or anything else protectable by IP), please get in touch with us hello@two-ip.com, or visit our website at www.two-ip.com.

Introduction to Restrictive Covenants in Employment Contracts

One of the biggest concerns for senior patent and trade mark attorneys considering a move away from traditional practice is whether their clients can – and will – follow them.

In this practical and reassuring guide, Clare Chappell, Partner at Carbon Law Partners, demystifies restrictive covenants in employment contracts and offers clear, expert advice on how attorneys can navigate their exit without falling foul of the rules.

Introduction and summary

Restrictive covenants are clauses in an employment contract that limit an employee’s actions after they leave a company. These covenants aim to protect the employer’s legitimate business interests, including trade secrets, confidential information, client connections, and workforce stability.

Restrictions are commonly included in employment contracts, particularly for senior individuals, professionals, and client-facing roles. Restrictions can only go so far, or they won’t be enforceable – more on this below.

Sometimes, employers include unenforceably aggressive restraints in their contracts in order to intimidate employees and “lock them in” because leaving is made too hard or stressful to contemplate.

While restrictive covenants can seem daunting, remember that they are not always enforceable, and there are steps you can take to reduce the risk of aggressive action from your former employer.

About me

I am a Partner at Carbon Law Partners with over 24 years of experience in employment law. I take a pragmatic view of a situation and always try to put my clients in a better position than when they came to me for help.

My experience includes advising both employers and employees on a wide array of employment law matters. I help people navigate tricky or toxic situations, such as pregnancy/maternity issues, performance management, redundancy, and negotiated exits – and most relevant for your purposes, I help individuals who want to leave their current employment and are concerned about the scope of their restrictive covenants and the reception they will get from their employer when they raise their head above the parapet and resign.

Typical Restrictive Covenants

Non-Solicitation Covenant: Prevents a former employee from contacting the former employer’s clients or customers with the intention of soliciting their business. This usually requires a positive act of solicitation from the ex-employee, like an active approach to a client offering to work with them in your new firm, or posting on social media inviting clients to get in touch with you at your new firm.
Non-Dealing Covenant: Prevents a former employee from doing business with the former employer’s clients, regardless of who makes the first approach.
Non-Poaching Covenant: Restricts a former employee from soliciting employees of their former company to join a new business.
Non-Compete Covenant: This is the most powerful restriction, preventing an employee from joining a rival employer or starting a competing business for a specified period.
Geographical Restrictions: These limit an employee from operating within a specific area, typically defined by a radius around the former employer’s location. They are less commonly used these days.

Enforceability of Restrictive Covenants

For a restrictive covenant to be enforceable, it must protect a legitimate business interest and be no wider than reasonably necessary to protect that interest. Reasonableness is assessed at the time the contract was entered into. The courts are more likely to enforce restrictions against senior employees and those with client-facing roles, who are more likely to cause damage to the former employer’s business if they leave and are free to undertake competitive activities.

What Makes a Restrictive Covenant Unenforceable?

Overly Broad Restrictions: If a covenant is wider than necessary to protect the employer’s legitimate interests, in terms of what is prohibited and for how long after leaving, it will be void. Template clauses that are vague and wide-ranging may be deemed entirely void.
Protecting Non-Confidential Information: An employer cannot prevent an employee from using skills, experience, and know-how gained during employment, even if it benefits a competitor. There is a difference between your know-how and experience and your employer’s confidential or proprietary information.
Restraint of Trade: Covenants that are excessively restrictive and contrary to public interest, such as those limiting an employee’s ability to change jobs, (rather than “just” restricting their activities as reasonably necessary to prevent damage to the former employer’s business), may be deemed unenforceable.
Unsigned Covenants: An employer seeking to enforce restrictive covenants will be expected to show that the employee agreed to the restrictions, typically through a signed copy of the employment contract. Working under a contract without protesting about its terms can also indicate acceptance.

Impact on Professionals Working Closely with Clients

Professionals such as trade mark and patent attorneys often develop close relationships with their clients. Restrictive covenants, particularly non-solicitation and non-dealing clauses, can significantly impact their ability to continue serving these clients in a new role. Usually, restrictive covenants will state that the attorney cannot do certain things for a given period after leaving. However, as a way of reducing the chance that the restriction will be unenforceable, the contract will often provide that the former employer can give consent to the employee working with former clients. I’ll talk more below about how this can work.

For example, a non-solicitation covenant could prevent an attorney from trying to poach, or actually persuading clients of their former firm to instruct the attorney at their new firm.

Similarly, a non-dealing covenant could prevent an attorney from working with clients they served at their previous firm, even if the client actively seeks to continue the relationship. The enforceability of such a covenant hinges on whether it goes further than reasonably necessary to protect the employer’s legitimate business interests. Factors such as the extent of the personal connection between the attorney and the clients, and whether the employer can demonstrate that losing those clients would result in significant business loss, can also be relevant.

Practical Advice for Trade Mark and Patent Attorneys

Review Your Contract: Before resigning, carefully review your employment contract, specifically the sections detailing restrictive covenants, and invest in expert employment law advice to give you a sense check on the enforceability and limitations of the restrictive covenants. We will also look at provisions enabling your employer to give consent to you continuing to work with clients.
Document Your Client Relationships: Keep a record of your client relationships and the nature of your interactions. This may help demonstrate the extent to which your personal connections drive client loyalty. (This can also be a useful exercise when approaching your employer in relation to a pay rise or promotion.)
Be Mindful of Communications during your notice period: When informing clients of your departure, avoid express or implied requests to solicit their business. Simply inform them of your move without actively encouraging them to switch firms. Ideally, agree on messaging with your employer. Again, we will check the terms of the restrictive covenants to understand whether or not you are permitted to tell clients where you are moving to as distinct from that you are leaving your current firm.
Social Media Caution: Be cautious about social media announcements. A simple update to your LinkedIn profile would generally be acceptable, but avoid any language that could be interpreted as soliciting clients, especially if you’ve been advised that this would be prohibited by your restrictions. An announcement made by your new firm that you’ve joined them is more likely to be acceptable, especially if it just states that you are now with the new firm.
Seek Specialist Legal Advice: This one bears repeating: have an experienced employment lawyer review your restrictive covenants and advise on what you can and cannot do as you transition from one firm to another, and then what you can do in your new role. I have extensive experience in this area and can provide tailored advice to help you navigate these complex issues.

What is your (former) employer likely to do?

Every organisation will respond in their own way when someone resigns, or when the organisation decides they are unhappy with what the individual is doing next. As such, I can only give examples of what you might expect.

Often, you’ll receive a sternly worded letter. This might be wrapped up in an acknowledgement of your resignation – a reminder of your restrictive covenants and ongoing obligations to your current employer. Alternatively, it might be after you’ve left, containing threats of legal action such as an application for an injunction to stop you from continuing activities the organisation says are in breach of your restrictive covenants.

This can be genuinely worrying – and that’s the organisation’s aim of course. Even if they know the restrictive covenants aren’t enforceable, they want you to question your actions, feel intimidated and worried about the unknown, and facing the prospect of being taken to court.

If you don’t already have a lawyer like me on hand, it’s essential that you take urgent legal advice on this type of communication, especially if it contains threats of legal action, and more especially if it threatens an injunction. There will usually be a lot of pressure put on you including a short deadline to respond. This is not the time to ignore the matter, you need to act quickly to get advice and help to put together the best response.

In my experience, the vast majority of situations can be resolved through communication and negotiation. If the organisation thinks you’re ignoring them, that will merely raise their suspicions even more. Assuming you’ve done nothing wrong (e.g. if you’ve had legal advice that the restrictions are not enforceable, or you haven’t done the things alleged), the best strategy is to talk to them and show yourself to be the grown-up professional that you are.

As your lawyer, I can act as a buffer so you aren’t going to receive any more aggressive communications and we can discuss each step along the way to resolving things. Defending an injunction application and a further claim is incredibly costly and time-consuming. The best thing is to try to negotiate a deal so you can move forward.

What next?

With careful planning and the right guidance, you can confidently move forward in your career while minimising obstacles, stress and potential legal challenges. Seeking expert legal advice is crucial to understanding your position and developing a strategy.

It’s always better to reach an agreement before you leave about what you can do in future. That said, if your employer takes action after you’ve left, there is still plenty we can do to find a workable solution that avoids litigation.

I offer a brief free exploratory chat to get initial information on your situation, explain how I can help, and talk you through the next steps. Once you’re ready to go ahead and instruct me, we’ll agree on a scope of work and a fixed fee so that you know from the outset what you’re looking at in terms of costs.

Just get in touch at clare.chappell@carbonlawpartners.com and we’ll arrange a time to speak.

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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

Month: May 2025