Pharmaceutical Trademarks 2020/2021 - A Global Guide - Germany Meissner Bolte Patentanwälte Rechtsanwälte Partnerschaft mbB Oliver Nilgen, Andreas ...
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Germany
Meissner Bolte Patentanwälte Rechtsanwälte Partnerschaft mbB
Oliver Nilgen, Andreas Kabisch and Stephan Held
Pharmaceutical
Trademarks
2020/2021
A Global Guide
Germany Meissner Bolte Patentanwälte Rechtsanwälte Partnerschaft mbB Authors Oliver Nilgen, Andreas Kabisch and Stephan Held Selection, clearance and registration in black and white consisted of a number ‘4’ in On 21 February 2018 the Federal Patent two different shades of grey, placed between Court held that the registration of the mark the word elements ‘gesundheit’ (‘health’) and WUNDTHERAPIEZENTRUM, which is ‘friends’. The size was clearly distinct from composed of three simple German words that of the word elements, in which crossing (‘wund’, ‘therapie’ and ‘zentrum’) in the usual and contrasting coloured lines are perceived as linguistic and grammatically correct manner, is representing a cross because of their separation exhausted in a plainly descriptive reference to a from the vertical and horizontal lines of the therapy centre for wound treatment (Case 30 W number ‘4’ and because of their contrasting (pat) 548/18). colour in a much lighter shade of grey. The The court ruled that the difference in the graphic element of the sign is therefore colours of the letters was insufficient to confer a perceived as a whole as figure ‘4’ with the distinctive character on the mark. The internal integrated representation of a cross. capitalisation – ‘WundTherapieZentrum’ – and font was also a common means of design Confusion with INNs widely used in product advertising, and International non-proprietary names (INNs) was therefore insufficient to attribute to the are used to identify pharmaceutical substances trademark, by means of its figurative design, a or active pharmaceutical ingredients and function indicating its origin. to provide health professionals with a set In contrast, on 22 November 2018 the of international standards. The INNs are Federal Patent Court decided that the stylised assigned by the World Health Organisation trademark GESUNDHEIT4FRIENDS is eligible and can be used freely because they are in the for registration for pharmaceutical products, public domain. among other things (Case 30 W (pat) 42/16). The use of INNs has an impact on the The court found that the graphic filing of trademarks comprised of INNs when representation of the sign expressly applied for assessing the likelihood of confusion. www.WorldTrademarkReview.com Pharmaceutical Trademarks: A Global Guide 2020/2021 | 7
GERMANY MEISSNER BOLTE PATENTANWÄLTE RECHTSANWÄLTE PARTNERSCHAFT MBB
On 20 July 2018 the Federal Patent Court ‘contra’ could be protected because it was
found that a likelihood of confusion existed neither a common abbreviation nor a verifiable
between the trademark ELYSIA AL and the abbreviation of the term ‘contraceptive’,
opposing trademark ELIZA HEXAL (Case 30 the mark cited in the opposition was
W (pat) 1/16). The first element has an average ultimately limited to a combination of an
inherent distinctiveness in relation to the element ‘contra’ with the generally known
relevant goods in the present case. In particular, and widely used addition ‘gel’, which had
‘Elysia’ contains no descriptive echo of an no distinctive significance as an indication
active substance name (ie, INN) which weakens of the pharmaceutical form. Even though
the distinctive character, particularly not of the the opposing trademark as a whole could
oestrogen ethinylestradiol or estradiol normally be protected, overall it clearly had below-
present in contraceptives. To the extent that average distinctiveness.
‘Elysia’ is a female forename derived from
Greek and Roman mythology and based on the Non-traditional trademarks
ancient Greek term ‘Elysium’ meaning a ‘state Along with the introduction of the new
of perfect happiness’, it is highly unusual that it EU trademark regulation, from 1 October
would not be known either to the general public 2017 (or since 14 January 2019 in Germany)
or specialised trade. Moreover, as in the case the graphical representation requirement
of the opposing mark ELIZA, the meaning of no longer applies when submitting a
‘Elysia’ did not affect the ability of that element trademark application.
to be perceived by the relevant public as a Since that time, a number of new trademark
means of distinguishing the goods in question. types (ie, multimedia marks and motion
The further component of the mark ‘AL’ is a marks) have been filed seeking protection for
company addition of the manufacturer, which pharmaceutical preparations in Class 5. In
is recognisable in the trade. In any event, it particular, Sanofi filed a number of motion
is only the element ‘Elysia’ of the challenged marks for pharmaceuticals in Class 5.
mark which is to be taken into account and the A motion mark is a trademark consisting
opposing mark shows a clear convergence in of, or extending to, a movement or a change
the sound image. With regard to the opposing in the position of the elements of the mark.
trademark ELIZA HEXAL and the challenged A multimedia mark is a trademark consisting
trademark, there is a sufficient difference due of, or extending to, the combination of image
to the different company-related additions and sound.
‘HEXAL’ and ‘AL’, which are known to the trade, It is now possible for both trademark types to
and the differences between the components file a video file or an audiovisual file containing
‘elysia’ and ‘eliza’. the combination of image and sound.
On 4 April 2019 the Federal Patent Court So far, uncertainty exists with regard to the
decided that the trademarks CONTRACEP requirements for protection and the scope of
und CONTRAGEL are not confusingly similar protection of such trademarks since, to date,
with regard to pharmaceutical preparations there has been no opposition, cancellation or
(Case 30 W (pat) 512/17). Even if the element infringement decisions available.
Along with the introduction of the new EU
trademark regulation, the graphical representation
requirement no longer applies when submitting a
trademark application
8 | Pharmaceutical Trademarks: A Global Guide 2020/2021 www.WorldTrademarkReview.com
MEISSNER BOLTE PATENTANWÄLTE RECHTSANWÄLTE PARTNERSCHAFT MBB GERMANY
A trademark owner may oppose a modification
which involves any repackaging of a pharmaceutical
product bearing its mark, which, by its very nature,
creates real risks for the guarantee of origin of the
pharmaceutical product
However, it remains to be seen how the In Debrisoft, the German Supreme Court
applicants will accept the new possibilities. asked the ECJ whether the abovementioned
principles were to be applied without
Parallel imports and repackaging restriction to the sale of repackaged medicinal
In the European Court of Justice (ECJ) products (ie, whether the sale of repackaged
judgments of 11 July 1996 (Cases C-427/93, medicinal products cannot be prevented by the
C-429/93 and C-436/93: Bristol-Myers Squibb, trademark owner only if all five conditions are
C-427/93, C-429/93 and C-436/93), the ECJ fulfilled (6 October 2016, Case I ZR 165/15)).
issued a milestone decision regarding the The ECJ had previously decided that the
requirements of the exhaustion of rights of term ‘repackaging’ included re-labelling.
repacked pharmaceutical products. According In the present case, only an additional
to this decision, a trademark owner may oppose sticker was affixed which, in terms of content,
a modification which involves any repackaging function, size, presentation and placement,
of a pharmaceutical product bearing its mark, did not pose any risk to the guarantee of origin
which, by its very nature, creates real risks for of the manufacturer’s trademark. The mere
the guarantee of origin of the pharmaceutical affixing of such a sticker does not constitute
product, unless five conditions are met: repackaging.
• It is established that the use of the trademark Moreover, the statements made by the
rights by the trademark owner to oppose the ECJ in its judgment in Case C-642/16 (17 May
marketing of the re-labelled products under 2018), according to which the existence of
that trademark would contribute to the repackaging should depend on the specific
artificial partitioning of the markets between circumstances of the individual case, such
member states; as content, function, size, presentation and
• It is shown that the repackaging cannot placement of the sticker, contradicted its
affect the original condition of the product previous view, according to which only the
inside the packaging; dangers inherent in the changes made should
• The new packaging clearly states who be taken into account.
repackaged the product and the name of the The Federal Supreme Court has now
manufacturer; implemented the ECJ guidelines issued
• The presentation of the repackaged product following Case I ZR 165/15, Debrisoft II (11
is not such as to be liable to damage the October 2018). The ECJ decided that a
reputation of the trademark and of its owner, trademark owner cannot oppose further
thus the packaging must not be defective, of marketing of a medical product in its
poor quality or untidy; and original internal and external packaging by
• The importer gives notice to the trademark a parallel importer where the importer has
owner before the repackaged product is put affixed an additional sticker which, by virtue
on sale and, on demand, supplies it with a of its content, function, size, presentation
specimen of the repackaged product. and placement, does not pose a risk to the
www.WorldTrademarkReview.com Pharmaceutical Trademarks: A Global Guide 2020/2021 | 9GERMANY MEISSNER BOLTE PATENTANWÄLTE RECHTSANWÄLTE PARTNERSCHAFT MBB
guarantee of origin of the medical product owner’s particulars, in particular the name
bearing the trademark. of the distributor, of which the trademark
Based on the findings of the Federal is a component. It does not matter whether
Supreme Court, in Case 6 U 37/18 (7 March the importer is dependent on this PZN for
2019) the Frankfurt Higher Regional Court distribution in Germany.
decided that a trademark owner cannot, in On 20 December 2018 (Case 6 U 129/18),
principle, oppose marketing in Germany on the court found that parallel imported
grounds that the importer has affixed to the medical devices (in this case, patches) were
packaging a small sticker bearing its own offered by the trademark owner in Germany
central pharmaceutical number (PZN). That in only one package size, but the parallel
is also the case where that sticker conceals a imported product was available only in other
label on the packaging bearing the trademark package sizes.
Oliver Nilgen Andreas Kabisch
Senior associate Senior associate
o.nilgen@mb.de a.kabisch@mb.de
Oliver Nilgen obtained his law degree from Andreas Kabisch obtained his law degree from
the University of Bremen, specialising in IP the University of Würzburg, specialising in
law. He served his legal clerkship with the commercial and IP law.
Dusseldorf Regional High Court. He gained He advises and represents clients in the
experience through legal internships as field of intellectual property, developing and
assistant to one of the members of the EU implementing IP strategies by building up
Intellectual Property Office’s First Board patent, trademark and design portfolios. His
of Appeal. practice also focuses on IP rights enforcement,
Mr Nilgen has been a certified IP lawyer in particular infringement and inspection
in Meissner Bolte since 2008. His practice proceedings, as well as the drafting and
focuses on trademark and design law, negotiation of contracts.
copyright and unfair competition. He develops Mr Kabisch is a certified IP lawyer and
and manages IP portfolios and enforces and obtained an LLM in European law from the
defends IP rights, particularly in infringement University of Würzburg. He is also a trained
proceedings and border seizures. He is a business mediator.
member of the MARQUES Designs Team,
the Pharmaceutical Trademark Group
and the Intellectual Property Rights and
Copyrights Association.
10 | Pharmaceutical Trademarks: A Global Guide 2020/2021 www.WorldTrademarkReview.comMEISSNER BOLTE PATENTANWÄLTE RECHTSANWÄLTE PARTNERSCHAFT MBB GERMANY
In such situation, the parallel importer from healthcare budgets and produces
may produce new outer packaging, provided economic and social challenges to
that the specific design does not damage pharmaceutical companies.
the reputation of the trademark from the As such, the term ‘counterfeit’ is used
consumer’s point of view. In particular, such broadly, referring to medicines that are
damage to reputation cannot be seen solely deliberately produced at sub-standard
in the affixing of a sticker with a PZN of the quality, fraudulently labelled with respect to
parallel importer. their identity or origin, or otherwise tainted,
adulterated or made ineffective or harmful.
Anti-counterfeiting and enforcement Fundamentally, counterfeit medicines are
Counterfeiting in medicines is a major neither regulated nor quality controlled and
threat to public health; it diverts resources therefore should be expected to be inferior as
they move outside the safety of established,
or its representative. A power of attorney is regulated supply chains.
required, plus a document proving the capacity As from 9 February 2019, for medicinal
of the person who signed the power of attorney products subject to Directive 2011/62/EC in
to represent the applicant. conjunction with EU Commission Delegated
Regulation 2016/161 amending Directive
Protectable subject matter 2001/83/EC, a unique identifier must be
The Industrial Property Law defines an included on the packaging, as well as an anti-
‘industrial design’ as any appearance of the tempering device.
whole or a part of a product which is new and Prescription medicine products for human
has individual character resulting from the use, as well as parallel import products, may
features of, in particular, the lines, colours, be placed on the German market only if the
shapes, textures or materials of the product and outer packaging bears safety features and a
itsStephan
ornamentation.
Held device to indicate possible tampering with the
‘Product’ means any industrial or handicraft
Partner outer packaging.
item, including packaging, get-up, graphic
sh@mb.de
symbols and typefaces, but excluding Advertising
Stephan Held is a chemist and a German The requirements regarding health-related
and European patent and trademark advertising are strict. Advertising is admissible
attorney. He advises clients in all matters of only if the information that it contains is
industrial property law, particularly patent, accurate, unambiguous and clear.
trademark and design prosecution, licensing According to Section 10 of the Act on
and litigation. Advertising in the Field of Health, prescription-
Dr Held studied chemistry at the only medicinal products may be advertised
University of Munich and is active in only to doctors, dentists, veterinarians,
all fields of chemistry, life sciences, pharmacists and persons authorised to trade in
biochemistry, pharmacy and medicine. He such medicinal products.
is a member of the German and European On 27 September 2018 the Stuttgart Higher
Patent Attorneys Bar Association; the Regional Court decided (Case 2 U 41/18) that
Chamber of Patent Attorneys; the Institute the aforementioned provision is also applicable
of Professional Representatives before with respect to pharmaceutical compounding.
the European Patent Office; the German Pharmaceutical compounding is the creation
Association for the Protection of Intellectual of a particular pharmaceutical product to fit
Property; the International Federation of the unique need of a patient. In the specific
IP Attorneys; the International Association case, a pharmacist offered pharmaceutical
for the Protection of Intellectual Property; compounding on its website.
the American IP Law Association; the The court also provided some guidance
German Pharmaceutical Society; and the on the distinction between product-related
Pharmaceutical Trademarks Group. advertising which is regulated by the Act on
Advertising in the Field of Health, and general
www.WorldTrademarkReview.com Pharmaceutical Trademarks: A Global Guide 2020/2021 | 11GERMANY MEISSNER BOLTE PATENTANWÄLTE RECHTSANWÄLTE PARTNERSCHAFT MBB
The aim of the Act on Advertising in the Field of
Health is to avoid that a particular product could be
misused or used without medical supervision, in
particular where the public cannot assess the effects
and adverse reactions
corporate advertising which is not subject to cost savings. As few EU countries currently
the act. allow pharmacist substitution of biosimilars,
The aim of the Act on Advertising in the this would represent a significant change in
Field of Health is to avoid that a particular practice, particularly for Germany.
product could be misused or used without The law has still to be approved by the
medical supervision, in particular where the Federal Council and is due to enter into force
public cannot assess the effects and adverse mid-2019.
reactions. Moreover, it should avoid enabling
the addressee of the advertisement to request Online issues
the prescription of a particular medicinal On 18 January 2019 the Magdeburg District
product during visits to the doctor. Court (Case 36 O 48/18) held that a pharmacist
In contrast, corporate advertising is is allowed to sell prescription-free behind-
intended only to indirectly promote the sale of the-counter drugs via the ‘Amazon.de’
the company’s products and not to draw the trading platform.
attention of the public to certain drugs. The court ruled that although Amazon
provides customer ratings – both for the
Generic substitution medicines and the pharmacy itself – this does
In Germany, generic substitution is not not result in a violation of the regulations on
prohibited. Indeed, it is promoted in order to the advertising of medicines.
reduce costs in the healthcare system. The trading platform is different from an
Pharmacists in Germany may soon be able to online shop operated by a pharmacy owner, it
carry out automatic substitution of biosimilars. incorporates further advertising elements in
A biosimilar is a biologic-approved medical addition to the product description designed or
product that is almost an identical copy of an selected by the seller. Nevertheless, the court
original product that is manufactured by a assumed that the defendant had not violated
different company when the original product’s the regulations regulating the pharmacist’s
patent expires. Unlike with generic drugs of the advertising, because these are statements
more common small-molecule type, biologics which cannot be attributed to the defendant
generally exhibit high molecular complexity and could also be seen by the consumer. The
and may be quite sensitive to changes in the customer ratings were marked as such and were
manufacturing processes. not attributed to the seller by the internet user.
In November 2018 the Health Ministry Further, the court found that the main
introduced a draft bill on safety in the supply difference between placing an offer on the
of pharmaceuticals, which aims, among pharmacy owner’s own online shop and using
other things, to provide a legal framework the Amazon trading platform is the fact that the
for the automatic substitution of biosimilars trading platform influences the appearance and
by pharmacists in Germany. The new law presentation of the drug.
was introduced in order to increase adoption Insofar as the presentation of the drug
of biosimilars, due to the huge potential for itself is affected, the court did not consider a
12 | Pharmaceutical Trademarks: A Global Guide 2020/2021 www.WorldTrademarkReview.comMEISSNER BOLTE PATENTANWÄLTE RECHTSANWÄLTE PARTNERSCHAFT MBB GERMANY violation of legal regulations to be apparent. The seller decides on the presentation by either providing the pictures and information or by joining the presentation designed by another seller – who must also be a pharmacist. In the event of incorrect descriptions, the defendant may decide not to offer the product via Amazon. Meissner Bolte Patentanwälte Rechtsanwälte Partnerschaft mbB Widenmayerstr 47 Munich 80538 Germany Tel +49 89 212 186 0 Fax +49 89 212 186 70 Web www.mb.de www.WorldTrademarkReview.com Pharmaceutical Trademarks: A Global Guide 2020/2021 | 13
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