Protecting second medical
use – opportunities and pitfalls

Author: Caroline Pallard, NLO

Innovators continue to develop drugs to further understand how to optimise the use of known drugs. The European patent system allows for protection of a known substance or composition for treating a disease in further therapy of the same disease, provided that such further therapy has not yet been published and provides new and surprising advantages to the patient.

In recent years, since Enlarged Board of Appeal Decision G02/08, the EPO has been increasingly flexible in allowing the protection of second or further medical uses of a known substance or composition. Such second or further medical use could potentially be as broad as to be related to “any specific use of such substance or composition in a therapeutic method” (Article 54(5) of the EPC 2000), provided that such use does not comprise the state of the art, thereby opening up the possibility to protect “any such specific use in a therapeutic method” where it meets all other EPC requirements. It seems to mirror the exponential development of personalised medicine, wherein specific drugs are tailored to the individual patient based on patient (genetic) context.

Use of known anti-cancer drug on new subgroup of cancer patients

This analysis is based on an EPO Board of Appeal decision (T108/09). Due to acquired resistance to a particular cancer treatment, it is common for cancer patients to first be treated with a given drug (eg, tamoxifen), then with a second drug (eg, an aromatase inhibitor) as soon as resistance to the first drug occurs, and possibly with a third drug (eg, fulvestrant) as soon as resistance to the second drug occurs. Using fulvestrant as a third line of treatment was considered a novel cancer therapy, although fulvestrant was already known as a first and second-line cancer treatment. Granted Claim 1 reads: “Use of fulvestrant in the preparation of a medicament for the treatment of a patient with breast cancer who previously has been treated with an aromatase inhibitor and tamoxifen and has failed with such previous treatment.”

Novelty

The idea behind the novelty of the third line of treatment with fulvestrant is that the tumour cells of the patient treated with the first drug and subsequently with the second drug have changed from a physiological and pathological point of view, have become more difficult to treat and are therefore no longer identical with the tumour cells of a patient treated with fulvestrant as a first or second line of treatment. This decision is in line with T19/86, wherein a new group of subjects (ie, sero-positive piglets) was vaccinated against the same disease against which a vaccination had already been disclosed for sero-negative piglets. The use of the same vaccine on a subgroup of subjects (ie, sero-positive piglets) was considered novel. The decision is also in line with T893/90, in which the use of a composition for controlling bleeding in non-haemophilic mammals was considered novel in view of the same composition for controlling bleeding in haemophilic subjects. The group of subjects served to further define the disease to be treated: bleeding in nonhaemophilic subjects compared to bleeding in haemophilic subjects.

In this new case, a new subgroup of cancer patients was identified by reference to the drugs used in the first and second lines of treatment “who previously [have] been treated with an aromatase inhibitor and tamoxifen and have failed with such previous treatment”.

Sufficiency of disclosure

It was argued that such a claim would not be sufficiently disclosed, as there would be no experimental examples in the application as filed. However, the board did not find this argument persuasive as the application as filed as a whole provided ample information as to the dose, formulation and administration mode of fulvestrant. In addition, the cancer patient in question is under strict surveillance by a physician who will decide which treatment to give, when the treatment has failed and when a new treatment must be applied. The patent therefore does not need to disclose a general method for determining failure of a treatment with an aromatase inhibitor and tamoxifen.

Inventive step

The use of fulvestrant as a third line of cancer treatment was also considered inventive in view of the use of fulvestrant as a second line of cancer treatment. It is indeed not obvious that a drug that is effective in a second line of treatment will also be effective in a third line, since tumour cells treated with two distinct cancer drugs become increasingly malignant. In addition, fulvestrant is an oestrogen, as is tamoxifen (ie, first line of treatment), and it is therefore surprising that tumour cells resistant to tamoxifen will still be responsive to fulvestrant in a third line of treatment. A skilled person would therefore not be motivated to use as a third line of treatment a drug belonging to the same class of drug (ie, oestrogen) as that used in the first line of treatment. Finally, other compounds (ie, progestin) were known that appear promising as a third line of treatment.

Tips

In such an invention (ie, a second or further medical use of a known drug), wherein a subgroup of patients is treated with a known drug, it is advisable to provide experimental data confirming that the subgroup treated has a different physiological and pathological status. For example, in T108/09, it would be interesting to demonstrate that tumour cells treated with the first and second lines of treatment are not identical with those treated only with the first line of treatment: different markers could be expressed and different behaviours could be exhibited in response to external stimuli. If such additional evidence is provided in the patent application, or possibly as post-published evidence, there will be strong arguments for getting protection for such new use of a known drug (ie, fulvestrant) as a new (ie, third line of) cancer treatment.

Comment

Although the European patent system has decided to provide more flexibility to applicants to allow the protection of a second or further medical use of a known substance or composition, applicants should be aware that such new types of invention should meet all EPC requirements. Even if novelty may be acknowledged on the balance of doubt, experimental data may be required to support the presence of an inventive step to demonstrate that a specific technical advantage is present for the new subgroup of patients treated with this known drug.

This article was first published in the 2018 edition of IAM Life Sciences.

Louboutin ‘wins’ over Van Haren?

Author: Bart ten Doeschate, NLO Shieldmark

The European Court of Justice ruling in the ‘red sole’ saga between shoe designer Louboutin and Dutch shoe store chain Van Haren has been interpreted as a Louboutin victory by the media. At a first glance, it may indeed seem like a victory for Louboutin, but it remains to be seen whether Louboutin will really benefit from this ruling in the long term.

Perhaps it is best to go back to the origins of this case: Christian Louboutin shoes are known for their red soles and feature in many films and TV series. The company registered these soles as a trademark in 2009, in the Benelux.

Position mark

Louboutin’s red sole trademark is rather unusual as it covers both colour (red) and the position of the colour (on the sole of the shoe). This is also referred to as a ‘position mark’. The jeans brand Levi’s have a similar sort of trademark for their red label on the right back pocket of their trousers. Also, Adidas has a position mark for the three diagonal stripes they place on their shoes.

Van Haren

Back to the case of the red soles. In 2012, Van Haren started selling shoes with red soles as well. This antagonised Louboutin as they believed Van Haren was infringing on the red sole trademark. Van Haren, on the other hand, did not consider the red sole trademark to be valid.

Substantial value?

The District Court of The Hague was given the difficult task of deciding whether the red sole trademark should be seen as a ‘regular’ trademark or as a 3D trademark. This was an important distinction as additional criteria needed to be satisfied for a 3D trademark, which was not the case for other types of trade marks. For instance, a 3D trademark cannot be registered if the shape “gives substantial value to the goods”. Or, in other words, a shape cannot be registered as a trademark if it enhances the attractiveness of the product, causing consumers to purchase this product. If consumers purchase Louboutin shoes for its red sole, this would imply the sole determines the attractiveness of the shoe. A trademark registration for that same sole would therefore prove to be invalid, meaning Van Haren would not be committing trademark infringement.

European Court of Justice

The District Court of The Hague struggled with the question whether the red sole should be regarded as a 3D trademark or a different type of trademark and therefore referred the case to the European Court of Justice. The European Court of Justice now ruled against the red sole trademark being classified as a 3D trademark. Consequently, the shape’s “substantial value” has become irrelevant rendering it meaningless whether or not the red sole enhances the attractiveness of the shoe. This should come as a great relief to Louboutin as it means the trademark is valid. Or so you would think.

New European legislation

This latest ruling may have little effect in reality. This is primarily due to the fact that European trademark legislation has undergone important reforms lately, ensuring the additional criteria no longer apply solely to 3D trademarks but also to other types of trademarks. Therefore, whether a trademark enhances the attractiveness of a product will continue to be relevant, not just for 3D trademarks but for other types of trademarks as well. This could negatively impact Louboutin’s red sole trademark as demonstrated by a different Louboutin case, in which the District Court of Brussels decided that the red soles do give the shoes substantial value. The District Court of The Hague hinted at a similar conclusion in its previous ruling too.

Consequently, it is debatable whether this legal battle will really end in a victory for Louboutin. Only time will tell, particularly once the courts start examining the reformed trademark legislation.

Have a break: Nestlé fails in bid for trademark protection

Author: Korstiaan Groot, NLO Shieldmark

Following many years of struggle, the Court of Justice of the European Union ruled on the validity of the KitKat bar as a three-dimensional trade mark.

A brief history:

In 2002, Nestlé filed a trade mark application for the shape of the four-fingered KitKat bar. In 2006, the trademark was registered by the EU Intellectual Property Office (EUIPO). In 2007, Mondelez, a competitor of Nestlé and the manufacturer of Milka, Oreo and Toblerone products, among other snacks, filed an application with EUIPO for a declaration of invalidity of the mark claiming it lacked inherent distinctiveness. This application was rejected in 2012. EUIPO declared that, although the mark lacked inherent distinctiveness, it had by then effectively acquired distinctive character among the EU public through use. In other words, even without packaging and the word “KitKat”, the public would identify the product as a KitKat bar by its shape.

Mondelez challenged this decision and, in 2016, the General Court annulled the EUIPO decision. While it was agreed that the shape had indeed acquired distinctiveness through use in ten EU Member States, the Court opined that EUIPO had erred in not considering four other Member States (i.e. Belgium, Ireland, Greece and Portugal). This judgment was appealed by both Nestlé and EUIPO. They both felt it was contrary to EU law and the single market principle of the EU that they were expected to demonstrate that the shape had acquired distinctiveness through use in every individual Member State.

The Court of Justice emphasized that an EU mark must acquire distinctiveness through use throughout the whole EU. As a result, it does not suffice to demonstrate that a brand has acquired distinctive character in a substantial part of the EU. Subsequently the Court declared that it is not required to provide separate evidence of acquired distinctive character in each individual Member State. The evidence may concern multiple Member States at the same time, particularly when these Member States are treated as one and the same market in terms of distribution networks and marketing strategies.

Considering this, the appeals of Nestlé and EUIPO were rejected and the Court of Justice upheld the earlier General Court ruling. The EUIPO Board of Appeal will now have to revisit whether the trade mark for the shape of the KitKat bar can be maintained. If Nestlé wants to maintain this trade mark, it will have to demonstrate that the mark has acquired distinctiveness through use in Belgium, Ireland, Greece and Portugal too. That will be no easy feat!

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