2024

Whitepaper

Patent Filing Considerations in View of Revised
EU Clinical Trials Regulation Transparency Rules

Authored by
Karen Ng, Associate, European and UK Patent Attorney, J A Kemp
James Biddlecombe, Business Transformation and CTR Lead, DLRC

© DLRC Groupjakemp.com | dlrcgroup.com

Summary
Introduction

1

Protecting information related to innovations in clinical trials

2

Patent filing strategy

4

Early patent filing strategy: before clinical trial information disclosure5

Late patent filing strategy: filing with clinical trial data

5

Combination of early and late patent filing strategy

6

Conclusion

7

Appendix

8

Meet the experts

10`© DLRC Groupjakemp.com | dlrcgroup.com

0Introduction

The transparency requirements of the EU Clinical Trials Regulation present acomplex intellectual property challenge requiring a nuanced approach to patent
protection of clinical trial-related inventions. This white paper aims to provide
some patent filing considerations and highlights the importance of engagement
and co-ordination of the legal and regulatory teams early on, and throughout thelife cycle of clinical trials, to optimise patent filing opportunities.

`© DLRC Groupjakemp.com | dlrcgroup.com

1

Protecting information related to innovations

The EMA implementing guidelines provide that Commercial

in clinical trials

Confidential Information (CCI) is to be understood as any
information:

Information related to innovations in clinical trials may form the basis of a•that is not publicly available; and•whose disclosure may undermine the legitimate economic

patentable invention. A patentable invention may relate to the drug underinterest or competitive position of the concerned entities, e.g.

investigation in the clinical trial, such as the structure, formulation or dosage of theclinical trial sponsors or marketing authorisation

drug, or method of making the drug. Alternatively, a patentable invention may

applicants/holders or service providers.

relate to the clinical trial design, such as the administration schedule,
administration route or the particular group of patients being treated.

The CTR exempts certain information from disclosure requirements, including

In the context of documents that have to be submitted to the relevant authorities
in the course of a clinical trial, information related to innovations may be present
in documents submitted as part of the clinical trial application. Examples ofsuch documents include the investigator’s brochure, the protocol and its
synopsis, informed consent form and patient documents. Once the clinical trial isapproved and underway, information related to innovations may be in the data

information related to innovations which falls under the category of Commercial
Confidential Information (CCI). CCI may include, according to EMA’s Guidance:•

Composition of excipients in the drug formulation;•

Information on the synthesis of the active substance, or manufacturing andcontrol processes of the drug;

found in the study progress reports, such as the interim report or the final report.

•

Future development plans for treatment of other indications;•

New biomarkers, novel methodologies, or innovative analytical methods;

Under the transparency requirements of the EU Clinical Trials Regulation•

Daily dose and maximum dose of drug in clinical trial.

(CTR), all clinical trials have to be registered and authorised in the Clinical Trials
Information System (CTIS) before they commence, and information related to theclinical trials has to be published throughout the course of the clinical trials at
the earliest opportunity. The rules on information that has to be published on
CTIS have been revised recently. Vital information on clinical trials will continue tobe made available to the public early in the trial life cycle. However, theamount and timing of information that is to be published as well as themechanism of protecting certain information, including information related toinnovations, are now different (see Appendix).

CCI can be redacted from documents submitted and subsequently published in CTIS
provided that this information is not already in the public domain. For somestructured data fields that are mandatory for registering a clinical trial in CTIS, theapplicant may enter ‘dummy data’ in the related fields if that information isconsidered to be CCI. For example, in the structured data fields for daily dose /maximum daily dose in CTIS, the user may enter ‘00’; grounds for which must be
clearly stated in the cover letter. However, it is likely to be difficult to omit CCI that ispart of the trial title for example. It is the responsibility of the clinical trial sponsor toprotect their commercial data and to ensure that clinical trial documents andstructured data within CTIS application form are redacted appropriately per theapplicable CTR transparency requirements.

`© DLRC Groupjakemp.com | dlrcgroup.com

2

Prior to the revised transparency rules, a deferral mechanism was available to

The key difference under the revised transparency rules is that sponsors can noprotect CCI. The deferral mechanism allowed delayed publication of certain

longer rely on delayed publication of entire documents to protect CCI. Instead,documents, e.g. trial protocol and investigator’s brochure (IB), for up to 7 years after

redaction is now the main mechanism for protecting CCI. Hence, there is now a shift

the end of the clinical trial. This deferral mechanism is no longer an option under thein the planning and management of CCI. Sponsors will have to decide what pieces

revised transparency rules (Figure 1).

of information they consider to be redactable CCI early on in the trial life cycle.
Effective implementation and management would be essential in ensuring that theHence, similar to the situation under the old transparency rules, unless sponsors

relevant information can be consistently redacted in every document that isdecided to protect CCI, that information will be published as part of the documents

submitted for publication in CTIS, and omitted from the structured data in CTIS,

and structured data in CTIS according to the revised timeline. For example,

where possible, throughout the trial life cycle, until the redaction/omission is deemed

information such as clinical trial title, drug details, dose, treatment duration andno longer necessary.

patient eligibility criteria will be published as soon as a decision on a clinical trial
application is made, with the exception of Category 1 trials in Adults only (no PIP).

Figure 1: Timeline showing evolution of publication rules under CTR`© DLRC Groupjakemp.com | dlrcgroup.com

3

application itself, for example where inventiveness is based on a surprising result

Patent filing strategy

observed in patients.

To assess the patentability of an invention claimed in a patent application, theclaimed invention is compared to information that is publicly available before thepatent application is filed, and that information is referred to as prior art. A patent
will be granted only if the claimed invention is new and inventive over the prior art(for example the claimed invention would not have been obvious, or has anadvantage that would not have been expected, from the prior art), and is sufficiently
disclosed in the patent application.

be included in the patent application (which may help to establish an inventive step),
but means there is likely to be more relevant prior art. The prior art may include theclinical trial information published according to the CTR transparency requirements,
as well as press releases, publications from parallel clinical trials in other countries,
as well as any disclosures by competitors. Moreover, the confidential manner (or lackthereof) under which a clinical trial is conducted may impact on how much clinical
trial information will become prior art.
Some prior art may be more relevant than others, depending on what distinguishes

A patent will be granted if the claimed invention is:

the invention from the prior art. For example, if the claimed invention relates to a

•

new,

•

inventive - for example, the claimed invention would not havebeen obvious, or has an advantage that would not have been
expected, from the prior art, and•Filing a patent application when results are available allows the clinical trial data to

sufficiently disclosed in the patent application - for a medical
use invention this requires information or evidence supporting
the effectiveness of the treatment.

new drug, a prior art disclosure relating to the structure of the drug would be relevant
for novelty, whilst if the claimed invention relates to a new way of using a known drug,
prior art disclosure of details and results of an earlier phase clinical trial would be
relevant.
Therefore, when considering when to file a patent application, the amount of priorart and the availability of data are important factors to consider. In any given
situation, the most appropriate filing strategy will depend on the nature of theclinical trial, what information is already in the prior art, and what aspect of theSponsors have control over what information about their clinical trial is in the priortreatment may be inventive.

art to the extent that they can protect CCI from disclosure under the CTR
transparency requirements as explained above, and choose when to file their patentapplication. However, a further consideration is whether data from the clinical trial
needs to be included in the patent application to support the patentability
requirements.
Data present in a patent application can be relied upon to establish an inventive
step and may be necessary to meet the sufficiency of disclosure requirements.
Whilst data available after the filing date of the patent application (post-publishedevidence) may also be relied upon, there are situations where data is required in the`© DLRC Groupjakemp.com | dlrcgroup.com

4Late patent filing strategy: filing with clinical trial data
An invention would likely to be more suited for a late patent filing strategy if it relies

Factors for consideration when considering patent filingon data to establish inventive step. The advantages of filing late to include morestrategy:

data in the patent application may outweigh the disadvantages of having more•

the nature of the clinical trial,prior art. Examples of inventions that fall into this category include a new•what aspect of the treatment may be inventive,

combination therapy involving known drugs that work in synergy, or a treatment•

what information is already in the prior art, andusing a known drug in a new disease indication or patient subpopulation.

•

what information relating to the invention to be claimed in apatent application will be published under CTR transparency

Sponsors wishing to protect an invention in this category may wish to wait until

requirements, when will that information be published, andclinical trial results are available for inclusion in a patent application before filing thewhether that information can be redacted or omitted in CTIS

patent application (Figure 2). In the meantime, disclosure of the information related

disclosure.

to the clinical trial should be minimised, as such disclosure may be detrimental to apatent application filed after the disclosure.

Early patent filing strategy: before clinical trial information

In particular, sponsors can make use of the mechanisms for protecting CCI fromdisclosure under the CTR transparency rules explained above. We advise thatdecisions as to what information constitutes CCI should be made early in the trial

disclosure
An invention may be more suited to an early patent filing where clinical trial results

life cycle, and this can be coupled with clear dissemination of instructions to all

are not expected to be important for establishing an inventive step.

teams involved in managing and running the clinical trial. It would also be important

For some inventions, inventive step may be established by relying on pre-clinicalinformation falling into the public domain. Furthermore, press releases andto ensure confidentiality of the trial when it is being conducted to minimise

data. Examples of this may be a new dosing schedule of a known drug based on
newly discovered properties of the drug, e.g. new pharmacokinetic andpharmacodynamic profiles. An early filing strategy may be appropriate for suchdisclosures at public meetings should be controlled. Clinical trials can take many
years to complete. Therefore, such safeguarding mechanisms would have to be put
in place early in the trial life cycle, and assessed throughout the trial cycle toinventions.

determine if any adjustments are needed.

Sponsors in this situation could minimise their own prior art by filing a patent

There may sometimes be unintentional disclosures or instances where public

application prior to any disclosure of clinical trial information relating to the claimed
invention (Figure 2). To minimise the disadvantages associated with having noclinical data in the patent application, the patent application should include preclinical data, if available, and an explanation of the mechanistic link between theclaimed invention and the treatment.

disclosure of the clinical trial information cannot be avoided. In these cases,
sponsors would have to rely on arguments during prosecution of the patentapplication to overcome any objections based on such disclosures. Appropriate
arguments would depend on the nature of the invention and the nature of thedisclosures. For example, it may be possible to argue that a disclosure is not noveltydestroying for the claimed invention because the disclosure does not allow any
conclusion to be drawn regarding the success of the claimed invention, such as the`© DLRC Groupjakemp.com | dlrcgroup.com

5success of a proposed treatment. It may also be possible to argue that a disclosure
is not prejudicial to inventive step of the claimed invention because the disclosure
would not provide any expectation of achieving the advantages demonstrated in
the patent application. However, such arguments are likely to be difficult toformulate if the disclosure is a press release published just before the filing of thepatent application describing positive data from the clinical trial, or is a clinical trial
results summary document that is made publicly available as soon as it is uploaded
to CTIS [this is applicable to all categories of clinical trials except for category 1 trials
in adults only (no PIP), see Appendix].

Combination of early and late patent filing strategy
There is no “one-size fits all” patent filing strategy. There may be instances where it
is unclear whether an early or a late filing strategy would be preferable. Somesponsors may wish to adopt both early and late filing strategies (Figure 2), and see
which works. However, depending on the timing of the filings, an earlier filed patentapplication will be published 18 months after filing and so may be prior art against
the later filing. This may be particularly problematic if the earlier filing discloses
information that is redacted from documents published in CTIS. Sponsors are
therefore advised to seek advice from their legal team before deciding on theirpatent filing strategy.

Figure 2 – Patent filing strategies visualised in relation to a typical clinical
trial application and conduct timeline`© DLRC Groupjakemp.com | dlrcgroup.com

6Conclusion
Premature publication of clinical trial information related to innovations may
jeopardise patent filing opportunities. It is therefore important to understand what
and when clinical trial information will be made publicly available under the CTR
transparency rules, and what actions can be taken by sponsors to prevent clinical
trials information related to innovations becoming prior art that may prejudicepatenting an invention. Sponsors are advised to engage with their legal andregulatory teams early on in the clinical trial life cycle to devise strategies tonavigate through the complexity of the patent system in view of the transparency
requirements of the CTR.

`© DLRC Groupjakemp.com | dlrcgroup.com

7Appendix
Timing of information that is to be published in CTIS public workspace for a clinical trial
This is not an exhaustive list of data that is to be published under the CTR revised transparency rules, rather the list of documents and data that bear direct relation to a patentfiling application strategy.

Data within the clinical trial
application

Category 1:

Category 1:

Category 2:

Category 2 and 3:

Adult only (no PIP)

Paediatrics and/or PIP

Integrated phase 1 / 2

Excluding integrated phase 1 / 2

CTIS application form
structured data fields

The first decision on the clinical(maximum daily dose, duration

30 months after the EU/EEA end of trial

trial application by a Member
State Concernedof treatment, total dose, unitsof measure)Protocol, protocol synopsis,and patient facing documents

30 months after the EU/EEA end

When the final summary of

The first decision on the clinical trial application by a Member Stateof trial

results are submitted

Concerned

Recruitment arrangements(including procedures forinclusion and copy of

The decision on the clinical trial application by the Member State

Not made public

advertisement materials)

Concerned

Subject information andInformed Consent Form
Study notifications on serious
breaches, urgent safetymeasures, unexpected events
Intermediate results`© DLRC Group

30 months after the EU/EEA endof trial

After the Member State Concerned assessment

Not made public

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Final Summary of Results andLayperson Summary of Results

30 months after the EU/EEA endof trial

As soon as these documents are submitted in CTIS

Clinical Study Report as part ofa Marketing Authorisation

As soon as this document is submitted in CTIS

Application`© DLRC Groupjakemp.com | dlrcgroup.com

9Meet the experts

Karen NgJames Biddlecombe

Associate, European and UK Patent Attorney,

Business Transformation and CTR Lead,J A Kemp

DLRC

Karen plays an active role in advising and managing patent portfolios forJames’s journey with the EU CTR started in 2017, working at the EMA in thea wide variety of clients, from startups to large multinational

CTIS business team. Over the last seven years, he supported thecorporations. In particular, she has experience of managing large,

development of the regulation and guidance, the development of CTIS,

complex portfolios of patent families, including those covering clinicaland has supported clients with CTR readiness and CTA submissions. He

candidates and platform technologies. She has expertise across a wide

has supported clients in getting them ready for the CTR Go-Live throughrange of disciplines, including cell and gene therapies, antibodies,training, redesign of operating models, and updates to processes andvaccines, biomarkers, and diagnostics. Karen is based in J A Kemp’s

procedures. More recently, he supports clients with strategic direction for

Oxford office.

trials submitted under the CTR and helps to navigate EU CTR guidelines
and ensure CTA document compliance with the regulation.

J A KempDLRC

J A Kemp is one of the largest UK and European patent and trade mark attorney

DLRC is an award-winning consultancy team of >80 highly qualified, experienced

firms, with offices in London, Paris, Oxford, Cambridge, and Munich. Their attorneys

regulatory professionals operating from our offices in the UK, Germany, and US.

draft, file and prosecute patent and trade mark applications in the UK, Europe andWith a deep commitment to excellence, we are dedicated to helping clients

internationally. The firm works for a huge variety of clients, from startups, spinouts

navigate the complex regulatory landscape of the life science industry. We develop

and SMEs through to some of the largest corporate clients and most prestigious

and execute innovative phase-appropriate regulatory strategies, providing

academic institutions in the world. J A Kemp is also renowned and respected as one

comprehensive support from early development to post-licensing activities forof the leading opposition practices in Europe and has the sector specialist attorney

medicinal products and medical devices. Our team comprises consultant experts incapabilities required to secure and protect the most complex IP portfolios.

nonclinical, CMC, clinical and MedTech from pharmaceutical, medical device andregulatory agency backgrounds. We have proudly served companies of all sizes
and backgrounds in various regulatory jurisdictions.

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Contact us

enquiries@jakemp.com

hello@dlrcgroup.com

jakemp.com

www.dlrcgroup.com

J A Kemp+44 20 3077 8600

DLRC Regulatory Consultancy
UK: +44 (0)1462 372 472
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