Indirect Infringement - Silvia Vitro 2018

27-2-2018
INDIRECT INFRINGEMENT
by SILVIA VITRO’
Court of Turin, Italy
BASIC CONCEPT
• There is indirect infringement when the patented
product or process is not exploited directly by the
third party, which, however, provides other subjects
with the means necessary for the implementation of
the patented invention.
• Therefore, there is contributory infringement when
lawful behaviours (such as the supply of products or
instruments not covered by patent) are univocally
destined to implement the patented invention, or in
any case when the author of the contribution to the
counterfeiting is aware that the final destination of
the supplied means is suitable for reproducing the
object of the patent claim
Union-IP Roundtable 2018 1

27-2-2018
BASIC CONCEPT
• In practice, to illustrate, indirect infringement occurs:
• • In the case of production and marketing of spare
parts (not protected by patent), but intended to
operate within a patented mechanism or process;
• • In the case of inventions of new use of a known
compound. If the compound can have two different
uses and only one is patented, then the manufacture
and sale of the compound are lawful (since potentially
intended for use not patented) and counterfeiting
exists only with reference to the second use (patented)
and to the purchaser who uses it for commercial
reasons (and not for personal use) and to the seller
aware of this illegal destination.
BASIC CONCEPT
• We can have, for example, indirect
infringement in the mechanical sector when
there is supply of unpatented parts of
machines which, taken together, are however
protected by a patent.
• Similarly, in the chemical sector the realization
and supply of the c.d. "Intermediate", not
patented, but used by third parties to produce
a patented pharmaceutical invention
•

27-2-2018
RULES AND REGULATIONS

• The indirect infringement is now regulated in
Italy by paragraphs 2bis, 2ter, 2quater of art.
66 of the CPI (Italian Code of Industrial
Property), as introduced by the law of
"Ratification and execution of the Agreement
on a unified patent court" of November 3,
2016, no. 214, effective from 25 November
2016.

• ART. 66 CPI:
• 1. The patent rights for an industrial invention consist of the
exclusive right to implement the invention and profit from
the same in the territory of the Country, within the limits
and at the conditions established by this Code.
• 2. In particular, the patent grants the owner the following
exclusive rights:
• a) if the object of the patent is a product, the right to
prohibit third parties, subject to the consent of the owner,
from producing, using, putting on the market, selling or
importing the product in question for such purposes;
• b) where the patent is on a process, the right to prohibit
third parties, subject to the consent of the owner, from
applying the process, and to use, put on the market, sell or
import the product directly obtained by the process in
question for such purposes.

27-2-2018
• 2-bis. The patent confers on its owner also the

exclusive rights to prohibit third parties, subject to
the consent of the owner, from supplying or
offering to supply subjects other than those
entitled to the use of the patented invention with
means, relating to an indispensable element of
that invention and necessary for its
implementation in the territory of a Country in
which it is protected, if the third party has
knowledge of the suitability and intended use of
such means to implement the invention or is able
to have it with reasonable care."
• 2-ter. Paragraph 2-bis does not apply when the

means are constituted by products that are
currently on the market, unless the third party
induces the person to whom they are supplied to
perform the acts prohibited under paragraph 2.
• 2-quater. For the purposes of paragraph 2-bis the
subjects performing the acts referred to in Article
68, paragraph 1 are not considered subject
entitled to the use of the patented invention".

27-2-2018

• Before the introduction of these rules, i.e. before
November 2016, there was no specific regulation of
indirect infringement in Italy (unlike other foreign
jurisdictions, such as the American one, in which it was
expressly regulated).
• However, the academic jurisprudence and case law
had repeatedly dealt with indirect infringement,
identifying its legal base in a series of rules of the
Industrial Property Code (Legislative Decree 10.2.2005,
No. 30), which appear to presuppose it:
• Art. 66 - Patent rights
• Art. 67 - Patent of a process
• Art. 124 - Corrective measures and civil sanctions
• Art. 129 - Description and seizure
• Art. 66: Patent rights

• 1. The patent rights for an industrial invention
consist of the exclusive right to implement
the invention and profit from the same in the
territory of the Country, within the limits and
at the conditions established by this Code.

27-2-2018
• Art. 67 - Patent of a process

• 3. When the owner of a patent concerning a
new industrial method or process provides to
others the means intended solely to
implement the object of the patent, it is
assumed that he has also given a license to
make use of that method or process, provided
that agreements to the contrary do not exist
• Article 124 - Corrective measures and civil

sanctions
• 4. By the judgment that determines the
infringement of industrial property rights, it may
be ordered that the items produced, imported or
sold infringing the right and the specific means
that univocally serve to produce them or to
carry out the protected method or process, be
assigned to the ownership of the owner of the
right, without prejudice to the right to
compensation for damages

27-2-2018
• Art. 129 - Description and seizure

• 1. The owner of an industrial property right may
request the description or seizure, and also the
seizure conditional on the description, of some or
all of the items constituting an infringement of
that right, as well as of the means used for their
production and of the elements of proof
concerning the reported infringement and its
entity. The measures necessary to guarantee the
safeguarding of confidential information shall be
adopted
• From the rules indicated it is deduced

that the exclusive patent includes and
therefore reserves the owner of the
patent also the preparation and supply
of means that are uniquely intended for
the implementation of the invention.

27-2-2018
ACADEMIC JURISPRUDENCE
• Professors have held that the supply to the third

counterfeiter (indirect counterfeiting or
contributory infringement) of components
(mechanical or chemical) not patented but
essential to the realization of the finished
product (patented machine or compound)
constitutes counterfeiting only if the supplier is
aware of the univocal destination of the single
pieces to the patent infringement.
•
Professors have therefore identified, as
requirements for the existence of indirect
infringement:
ACADEMIC JURISPRUDENCE
• - the essentiality of the component supplied

to the realization of the finished product;
- the awareness of the supplier of the
destination of the individual pieces to the
infringement of the patent.
• There has been no uniformity of theories
regarding the destination of the component
to the realization of the finished product, in
the sense that it must be unequivocal or not

27-2-2018
CASE LAW
• Judges generally think that there were two requirements for

ascertaining indirect infringement:
• - objective requirement
• - subjective requirement
• Indirect infringement requires the presence:

• of a material element, that is the production of an element absolutely
necessary for the realization of the object infringing the patent by a
third party,
• of the subjective element of awareness, for the producer and seller of
such material component, of the unambiguous destination of the
component supplied to the patent infringement.
This awareness can be real (if indeed the destination is univocal) or
presumed (if the destination is not unique, but the supplier knows or
presumes that the component will be included in a finished product or
in a process that violates the patent).
CASE LAW
• Therefore, with regard to the subjective element, the

assessment of indirect infringement did not present
particular problems in the event that the indirect
infringer realizes and provides means that could only
be used in an infringing manner.
• Where, on the other hand, there was also the
possibility of lawful use of the means, the only
available ruling by the Court of Cassation on this point
referred to the awareness that the means were
intended for infringement, awareness also found in the
case in which the infringing use it could be presumed
using ordinary care, so as to eliminate the necessity of
a real intentionality for the supplier of the means

27-2-2018
CASE LAW
• 1)Subjective Element
•
• Awareness of the "unique destination" of the
component to the insertion in the product or infringing
process
• Cass. 24/11/1956, n. 3387, Roncuzzi v Pasté:
• "It constitutes an infringement of the patent for
industrial invention the manufacture and trade of parts
of the patented machine, even if not patentable or
falling into the public domain, if the manufacture and
sale are made with reference to the
patented product, and if said parts are uniquely
destined to be used in the infringement of the patent. "
CASE LAW
• Court of Appeal of Milan (23/6/1992)

• "A responsibility of the manufacturer for
contribution to the infringement made by users
who make use of means produced by him to
violate another's patent, necessarily presupposes
that they do not have any other legitimate
possibility of use or, if they can be used for other
results, they are realized with reference to the
patented invention and with univocal and
intentional destination to its implementation

27-2-2018
CASE LAW
• Cass. 1/11/1994, n. 9410,

• "The supplier of the drawings of the system has been held
responsible for the implementation of the offense if he has
the awareness of their destination at the perpetration of
the offense".
•
• Cass. 12/6/1996 n. 5406- Sidermes-
• "Anyone who puts on the market products or instruments
suitable to be used to implement a method by others
patented, but also capable to be objectively non-conflicting
with the scope of patent protection, does not contribute in
the infringement eventually made by the purchasers of
such products or instruments, if the awareness that he has
of the illicit use by the buyers themselves is not
demonstrated ".
CASE LAW
• Court of first Instance of Rome 4/5/2006:

• "Where a patent claims a panel of concrete characterized by the
presence, inside, of metal flanges to increase its resistance and
provided with holes at a certain distance to improve the anchorage to
concrete, production and marketing in the various possible forms only
of the flanges (not covered by patent protection), accompanied by the
subjective element of the supplier's awareness that the buyer will
insert them into concrete panels according to the teaching of the
patent, constitutes an indirect infringement.
• In particular, indirect infringement can be seen all the times in which
not the whole product is produced, but a component, not patented
and specifically intended to produce a product directly in contrast with
the invention, so that the component is essential to realize the
patented invention.
• And the shape of the components as to the patented panel profile and
the presence of holes in the flanges suitable for the best placement in
the panels, allowed the supplier to understand that the production of
those components was intended for inclusion in infringing products " .

27-2-2018
CASE LAW
• Court of first instance of Cuneo (3/5/2008)

• "It does not constitute counterfeiting, even indirect, of a patent, the
supply of components of a product that, although they can be used for the
realization of a product operating according to the teachings of an earlier
patent, are not uniquely prepared and intended for violation of the
property rights of others ".
•
• Court of first instance of Venice 29/10/2008
• "There is contributory infringement when the person charged with
infringement does not directly produce the good that is the object of a
patent, but however realizes a different good, whose specific functionality
is to realize the product object of the patent. In the present case, actually,
the machinery produced by the
defendant is not directly covered by industrial property rights, but was
made in such a way as to be immediately functional to the product
(scaffolding tables) object of the patent owned by the plaintiff”
CASE LAW
• The subjective element may also consist of culpable

negligence, where the means provided are not
unequivocally destined to illicit use, but the supplier
should have, with the ordinary care, realize that the
use in that case would have been illicit.
• Court of first instance of Milan 16/5/2011- EC&C
Technologies/Siirtec Nigi-:
• "Contributory infringement: it appears to be
undisputed that the ammonia production plant,
supplied by Siirtec Nigi s.p.a. to ENEL for the
Torrevaldaliga thermal power plant, it is applied to the
treatment of the nitrogen oxides present in the
combustion fumes according to the SCR method, i.e.
exactly for the purposes pursued by the EC & C patent.

27-2-2018
CASE LAW
• Beyond the intentionality in the contribution to the

illicit meant as an awareness to operate to make
infringement possible by the third party, an attitude of
culpable negligence may also be relevant, where illicit
use became particularly evident on the basis of specific
circumstances in fact.
• The awareness that the process would have been used
in the Enel plant emerges from the documentation
produced (news taken from the Siirtec Nigi website,
with which announcement was made of the supply of
the plant to the Enel plant for treating the fumes of
boilers; document about the use of the plant for the
treatment of nitrogen oxides and therefore for
purposes corresponding to those of the patent )".
CASE LAW
• Or the subjective element may even consist in the

induction, by the supplier, to make illicit use of
the supplied means.
• Court of first instance of Milan 25/6/2010 –
Dimetomorf-:
• “It is an indirect counterfeiting of a patent to
disseminate promotional and advertising material
in which a product containing Dimetomorf (not
covered by patent and suitable for not illegal
uses) is offered with the invitation to use it
always with copper or Folpet, where such
combinations are covered by patent rights ".

27-2-2018
CASE LAW
• Court of first instance of Milan 24/4/2014:

• "The Court of Milan stated that there is a
contribution to infringement even if the product
can have multiple uses and only one of the
multiple uses can be considered infringing, but
not the others. In this case there is a contribution
to infringement if there has been an inducement
to infringement by the manufacturer towards the
customers, inviting them to use the product in
the manner protected by the patent ".
•
CASE LAW
• Court of first instance of Genova 4/7/2016 – Eurosider/Carservice-:

• "The plaintiff is the owner of a patent concerning a spray painting method
in nitrogen, the counterpart supplies appliances (a nitrogen generator and
a heater) which are not covered by patent, but can be used to carry out
the mentioned spray painting.
• The liability of the seller can be affirmed if it is proved his awareness of
the use to which the tools supplied were intended.
• The burden of this proof hangs over the plaintiff and concerns the use of
the tools to carry out spray painting with nitrogen propellant and not also
the illicit nature of such use, ie the fact that the method was covered by a
patent (actually patent protection operates regardless of the actual
knowledge of third parties even in the case of indirect counterfeiting).
• The proof is reached because the supplier has not been able to explain
what alternative use he thought his customers could have of those
devices. Furthermore, these devices were advertised as tools suitable for
spray painting ".
•

27-2-2018
CASE LAW
• 2) Objective Element
• Requirement for the configurability of indirect infringement is the
essential nature of the component supplied to the finished product
• Cass. 19/10/2006 n. 22495
• It is an infringement of the patent for an industrial invention also to
produce and market only the components of a patented machine, if these
are unequivocally destined to be part of said machinery, with the
clarification that for infringement in such hypothesis it is necessary that
the components of the machinery reproduced and marketed are those in
which the inventive value of the patent is essentially expressed (In this
case the SC has therefore confirmed the existence of infringement in the
production and marketing of particular discs, constituting the
characterizing part - "the core" - of the invention of a more complex
machinery, by others patented, and intended to be sold as spare parts of
that machinery)”.
CASE LAW
• Court of first instance of Rome 13/3/2006 –

Peka/Siderplast-:
• "These are devices intended to be installed on
corner furniture.
There is indirect infringement when only a part of
the patented invention is realized, which is
essential for its execution and is intended
exclusively or at least unequivocally to realizing
infringement.
• The defendant did not even indicate a possible
different use of those devices ".
•

27-2-2018
CASE LAW
• Court of first instance of Turin 13/5/2012 and 15/6/2012 – Nespresso

Italiana/Casa del Caffè Vergnano:
• "Also commit infringement those who only produce one component of a more
complex patented device on condition, however, that the destination is
unequivocal (in the sense that its use necessarily coincides with the infringement
of the right) so that to have indirect infringement it is necessary that the
reproduction falls on the elements that realize the patented teaching. The concept
of indirect infringement can not be further extended to the paradoxical
consequence to charge with infringement the manufacturer and supplier of
absolutely banal elements of common use”.
• This is the case of the combination of a capsule of ingredients and a beverage
machine, where the shape of the capsule is not patended, while the infringement
of another's patent would be where the capsule is suitable for being inserted and
coupled to the extraction and infusion devices (these are patented).
• In reality there is no direct infringement by anyone, because the inclusion of the
capsule in the machine is carried out by private consumers after the purchase of
the machine (therefore after the exhaustion of patent rights).
• Nor there would be any indirect infringement, because it has not been
demonstrated that the capsules at issue are uniquely destined for the machines of
the Nestlè group, appearing also compatible with machines of other companies.
CASE LAW
• According to some rulings, it does not seem

necessary to verify in practice a direct
infringement below, that is, the creation of a
product suitable for the implementation of a
patent by itself consitutes indirect
infringement, without being necessary to
consider it illegal, that the third buyer actually
makes direct infringement

27-2-2018
CASE LAW
• Court of first instance of Turin 10/11/2004- Peri/Faresin-:

• "Case of the telescopic prop, fitted on the external surface of the inner
tube with a measuring scale. The object of the invention is to protect the
measuring scale on the inner tube as much as possible from damage. "The
solution consists in the fact that it" is arranged, as a measuring tape, in a
groove on the inner tube ", with a series of further advantages, among
which its quick and easy replaceability in case of damage or wear or where
it is necessary to use different units of measurement.
• The defendant part produces props equipped with the groove and
intended to accommodate the measurement scale. Thus, Faresin
supports, even without a measuring tape, provide means specifically and
exclusively intended to implement the invention and therefore infringe the
Peri patent according to the principles of the c.d. "indirect infringement",
since it is a product suitable to be used to implement a patented method
and such as to involve the responsibility of its manufacturer at least for
contribution in infringement.
• It is irrelevant that there may not be evidence of the concrete inclusion of
the scale by users ".
CASE LAW
• Court of first instance of Bologna 3/3/2006:

• "Indirect infringement involves an anticipated
protection threshold as to the real infringing
activity: the supply or offer of assets singularly
not protected by the claims implies a form of
violation of the rights of the owner already in
itself perfect, ie independently of the fact that
then a direct infringement of the patent is
carried out by the third buyer ".

27-2-2018
CASE LAW
• Court of first instance of Milan 5/3/2015 – Gima-Ima/Cama-:

• "The invention concerns the gripping head for a robot that can be
used in a machine for packaging articles by alternating an upright
article with an article overturned by 180 °, in order to gain space
and optimize the use of space inside the boxes .
• The Gima machine applies the aforementioned method and acts on
upright and overturned coffee capsules. The Gima defense states
that patent infringement should be ruled out, since the machines
were never activated in Italy but only in the U.S.A. or in Canada,
where patents do not extend their effect. This finding, however,
does not appear to be conclusive, since the creation of a product
suitable for the implementation of patent of process constitutes by
itself a infringement (i.e. indirect infringement or contributory
infringement) of the latter ".
CASE LAW
• Place of commission of the tort

• "There is infringement in the case of an intermediation
activity, carried out in Italy, with regard to a patented
active pharmaceutical ingredient, which however did
not even pass through Italy, being made in a country
where the patent did not exist and from there
delivered to another country where the patent did not
exist, considering that the economic outcome of the
operation would take place in Italy: and this according
to the rule for which the exclusive patent gives its
owner not only the right to "implement the invention",
but also to "profit from it in the territory of the state".

27-2-2018
CASE LAW
• The decision has been criticized, considering

that "the behavior of those operating in the
territory of the State to favor the placing on a
foreign market of goods coming from another
foreign market can be considered prohibited
only in the presence of a commercial passage
in Italy", obviously related to the infringing
product and not to one of its legal
components.
CASE LAW
• Court of first instance of Bologna 3/3/2006:

• "In the present case, it appears that the use of
the spare at issue took place abroad, in Thailand,
that is, outside the scope of protection of the
patent (European patent), since, although it was
actually manufactured in the territory of Italian
state, it is then marketed abroad, in Thailand. In
this regard, it must be assumed that the
commercialization (occurred abroad) is more
significant than production ".

27-2-2018
THE NEW ARTICLE 66 CPI
• THE NEW ARTICLE 66 CPI

•
• The statutory law n. 214 of 3/11/2016,
ratifying the UPC Agreement, introduced in
art. 66 CPI three new paragraphs. The first is
as follows:
• 2-bis. The patent confers on its owner also the

exclusive rights to prohibit third parties, subject
to the consent of the owner, from supplying or
offering to supply subjects other than those
entitled to the use of the patented invention
with means, relating to an indispensable
element of that invention and necessary for its
implementation in the territory of a Country in
which it is protected, if the third party has
knowledge of the suitability and intended use of
such means to implement the invention or is
able to have it with reasonable care.

27-2-2018
• The corresponding art. 26 of the Unified Patent System

Agreement, Brussels 19/2/2013 (and which is similar to
Article 26 of the Luxembourg Convention of
15/12/1975) states:
• “A patent shall confer on its proprietor the right to
prevent any third party not having the proprietor’s
consent from supplying or offering to supply, within
the territory of the Contracting Member States in
which that patent has effect, any person other than a
party entitled to exploit the patented invention, with
means, relating to an essential element of that
invention, for putting it into effect therein, when the
third party knows, or should have known, that those
means are suitable and intended for putting that
invention into effect”.
• Means, relating to an indispensable element

of that invention and necessary for its
implementation
•
• Means:
• this expression appears to be attributable not
only to devices, but more generally to phases
of the invention, whereby the contribution to
counterfeiting can refer both to a product
patent and to a process patent.

27-2-2018
• In accordance with the art. 124, 4 ° co., CPI (referred to

by the preparatory works of law 214/2016), according
to which: “By the judgment that determines the
infringement of industrial property rights, it may be
ordered that the items produced, imported or sold
infringing the right and the specific means that
univocally serve to produce them or to carry out the
protected method or process, be assigned to the
ownership of the owner of the right, without prejudice
to the right to compensation for damages”
• And on the other hand, even if the leading case of the
Italian case law (Cass. 5406/1996 Sidermes) concerned
a patent of process, subsequent judgments also
examined product patents.
• Indispensable element of the invention and

necessary for its implementation
• There is, therefore, no longer the reference
(previously elaborated by most of the judges) to
unequivocally destined means to infringement.
• It therefore seems possible to interpret it, even if
it is a matter of means capable of non- infringing
uses, where the supplier is aware (or should be
using ordinary care) that they will be destined to
infringement, he will be responsible for indirect
infringement.

27-2-2018
• The modification of the art. 66 therefore confers

a wider protection to the patent holder, allowing
him to block the third party that produces an
indispensable element for the invention even if
not univocally intended for the implementation
of the patent (as already admitted by a part of
the previous judgments).
• An indispensable and necessary element for the
implementation of the invention (or, as in Article
26 of the UPC Agreement, an essential element)
is not any element of the patent claims, but that
which carries out the patented teaching
• In agreement are the judicial precedents:

• "The components of the machinery reproduced and
marketed are those in which the inventive value of the
patent is essentially expressed”
• .Court of first instance of Turin 13/5/2012:
• "In order to have indirect counterfeiting it is necessary that
the reproduction falls on the elements that realize the
patented teaching. The concept of indirect infringement
can not be further extended to reach the paradoxical
consequence of considering even the manufacturer and
supplier of absolutely banal elements of common use (such
as screws or other very common mechanical components)
".
•

27-2-2018
• The third party must have knowledge of the

suitability and intended use of such means to
implement the invention or be able to have it
with reasonable care.
•
• The subjective element consists in the knowledge
or presumption of knowledge of the destination
of the means for carrying out the invention.
• The expression "ordinary care" seems to be
interpretable in a very broad sense, extended to
several sectors and sources of information. The
degree of diligence required can be discussed.
• Territory:
• The Italian legislator used an expression different
from that of art. 26 UPC Agreement ("territory of
a State to which the invention is protected",
rather than "territory of one of the Contracting
Member States in which the invention takes
effect") and furthermore in the Italian rule the
reference to the territory has been moved to the
ending (i.e. with reference to the carrying out of
the implementation of the patent and not with
reference to the supply of the means).

27-2-2018
• It could be interpreted as follows:

• -in art. 26 it is forbidden to provide, within the territory
of one of the Contracting Member States, the means
for the implementation of the invention in the territory
itself ("therein");
• -in art. 66, co. 2 bis, CPI, may appear to be prohibited
the activity of the supplier even if carried out in
another country (EU or non-EU), provided that the
invention is implemented in any country (EU or non-
EU) where the invention is protected.
• This could include the case in which the act of
providing the means and that of implementing the
invention take place in different jurisdictions.
• It seems more appropriate the interpretation,

more in accordance with the art. 26 of the UPC
Agreement, according to which the contribution
of the supplier who has taken place in Italy with
reference to an invention protected in Italy, may
be taken into consideration, as the
implementation of the invention may also take
place in the territory of another State, EU or extra
EU, in which the invention is also protected.
• Even in this way, however, the protection seems
to be wider than that established by judgments
preceding the enactment of the new statutes.

27-2-2018
• 2-ter. Paragraph 2-bis does not apply when

the means are constituted by products that
are currently on the market, unless the third
party induces the person to whom they are
supplied to perform the acts prohibited under
paragraph 2.
• Means constituted by products that are currently on the

market
•
• It can not simply be a question of means freely available on
the market because capable of legitimate uses.
• Actually, the preceding paragraph 2 bis already includes
this category, requiring only indispensable and necessary
means for the implementation of the invention and not
also that these are univocally intended for implementation.
Furthermore, if paragraph 2 bis refers only to means whose
use is unequivocally infringing, it would be superfluous to
require that the supplier be aware of the destination of the
means.

27-2-2018
• Therefore, paragraph 2 ter ("products currently on the

market") refers to a narrower category.
•
• Article 26 of the UPC Agreement states: “Paragraph 1 shall
not apply when the means are staple commercial products,
except where the third party induces the person supplied to
perform any of the acts prohibited by Article 25”.
• “Staple commercial products” is an expression that refers to
consumer goods, real commodities or raw materials, used
in everyday life, freely obtainable on the market and
susceptible of several uses and applications in the technical
fields.
• In these cases, paragraph 2 ter provides that the supplier of
the means is responsible for indirect infringement only
where it induces the infringing use.
• 2-quater For the purposes of paragraph 2-bis the

subjects performing the acts referred to in
Article 68, paragraph 1 are not considered
subject entitled to the use of the patented
invention".
•
• Article 26 of the UPC Agreement states: “Persons
performing the acts referred to in Article 27(a) to
(e) shall not be considered to be parties entitled
to exploit the invention within the meaning of
paragraph 1”.

27-2-2018
• Art. 68, co. 1, CPI (Limitations on patent rights):

• 1. Whatever the object of the invention may be, the
exclusive authority attributed by patent rights does not
extend to the following:
• a) actions carried out in the private sphere and for non-
commercial purposes, or as experimentation;
• b) studies and trials aimed at obtaining a marketing
authorization for a drug, including in foreign countries, and
the resulting practical requirements including the
preparation and utilization of the pharmacologically active
raw materials strictly necessary for the same;
• c) the infrequent preparation of unit doses of drugs in
pharmacies on prescription, and the drugs thus prepared,
provided that active principles produced industrially are not
utilized.
• Article 68.1 IPC, provides some exemptions

from patent infringement, namely for: private
and non-commercial use;
• research and experimental use;
• acts for obtaining the marketing authorization
from the relevant Medicines Authorities (the
so-called "Bolar exception"); and
• the extemporaneous preparation of
medicines.

27-2-2018
• Therefore, the notion of "subject not entitled

to the implementation of the invention" does
not coincide with that of " infringer", since
they may also be subjects not authorized to
implement the invention, but which are not
punishable according to the aforementioned
limitations
• But the behavior of the "contributory"

infringer remains illicit even when the
conduct of the receiver of the contribution is
not punishable.
• Therefore, in order to deem indirect
infringement illegal, performing a downstream
infringement act is not necessary, because the
person acting “downstream” could be not
punishable, without excluding the illegitimacy
of the conduct of the supplier of "upstream"
means.

27-2-2018
• These observations are relevant for two issues

debated at the European level:
•
-The limits of the lawfulness of the conduct of
those who supply the substances necessary
for carrying out the activity of the
experimenter or of the genericist, where the
suppliers operate in a structured and large-
scale manner, rather than producing small
quantities of the product specifically at the
request of the experimenters;
• - The issue of 3D printing, today often easily

feasible even at the "private" level: if the
printing done by a private individual of an
element protected by a patent is in itself not
punishable, in the absence of a commercial
destination, such is not the supply of means
intended to carry out the invention, and in
particular the supply of the file containing the
instructions to the printer directed to the
realization of the specific infringing element.

27-2-2018
CASE LAW subsequent to the introduction of

the new regulation pursuant to art. 66 CPI
• Court of first instance of Milan 10/9/2017 –

Fresenius Kabi Oncology/Eli Lilly&Company-:
• The plaintiff asked the assessment that the
antitumor drug that it intended to put on the
market - Pemetrexed Fresenius Kabi- did not
constitute infringement of the Italian portion of
the patent EP1313508, owned by the defendant
• PEMETREXED FRESENIUS was a generic medicine
of Alimta, marketed by ELI LYLLI CO since 2004.
The latter was a specific salt of pemetrexed,
pemetrexed disodium, whose active ingredient,
pemetrexed, had anti-tumor therapeutic
properties.

• ELI LILLY CO had brought multiple disputes in foreign
countries against pharmaceutical companies that had
introduced, or were about to place on the market,
products containing pemetrexed salts different from
pemetrexed disodium.
• The expert, after an in-depth analysis, said that the
pemetrexed diacid in association with tromethamine,
components characterizing the product FRESENIUS,
cannot be considered an obvious technical substitution
equivalent to what is the subject of EP'508, considering
the 'patent teaching, strictly limited to the use of
pemetrexed disodium in association with vitamin B12
always in antitumour treatment. "

27-2-2018

• The defendant also deduced in the answer the
existence of an indirect infringement because
PEMETREXED FRESENIUS would provide the
means relating to an element indispensable for
the invention and necessary for its
implementation, means represented, according
to the resistant, by the pemetrexed Anions,
obtained by dissolving in the glucose solution,
being, vice versa, irrelevant that the mean was
constituted by pemetrexed diacid instead of
pemetrexed disodium

• Statutory law 214/2016 amended the art. 66
of the c.p.i., introducing the paragraph 2-bis.
The statute substantially incorporates the
conclusions reached by judges on the subject
of indirect infringement, requiring, for the
purpose of recognition of indirect
infringement, on the one hand, the supply to
third parties of means relating to an essential
element of the invention and, on the other ,
the awareness of the third of the destination
of these means to implement the invention.

27-2-2018

• The expert also excluded indirect infringement, observing,
in short:
-with regard to the means relating to an essential element
of the invention, that it cannot be identified in the
pemetrexed anion since the invention is limited to "the use
of sodium pemetrexed", which is a different active principle
from that used by Fresenius product;
• - as regards the solution in which to reconstitute and dilute
the two products, in the description and in the examples of
the patent only a saline solution (i.e. a 10 aqueous 0.9%
sodium chloride solution) is indicated and no mention is
made regarding a possible reconstitution and dilution in
other infusion fluids. The Fresenius Product provides
exclusively the reconstitution and dilution in 5% glucose
solution, which is a chemically different, and not
equivalent, liquid from the saline solution.

• At the same time, this issue, concerning a Swiss-type
second medical use claim (related to Pemetrexed
disodium), has been discussed in other European
countries:
-In Germany, the Regional Court of Düsseldorf held
that the use of Pemetrexed dipotassium instead of
Pemetrexed disodium constituted an infringement
under the doctrine of equivalence, but then the Higher
Regional Court of Düsseldorf held that the patent was
neither infringed under direct infringement, nor under
the doctrine of equivalence. On further appeal, the
Federal Court of Justice has set aside the decision of
the Higher Regional Court and remitted the case back
to the Higher Regional Court for reconsideration.

27-2-2018

• In the United Kingdom, in July 2017 the Supreme Court
overturned the decision of the court of first instance,
considering that the infringement of the European patent
exist;
• -Also the District Court of The Hague stated, in October
2017, that generic products of Pemetrexed diacids of Teva
and Fresebnius Kabi violate the patent of Eli Lilly (which
concerns the use of Pemetrexed disodium in combination
with vitamin B12 for the treatment of some types of lung
cancer), thinking that the essence of the invention is
reducing the side effects caused by Pemetrexed, due to the
addition of vitamin B12, while the form (salty or acidic) in
which the product is placed on the market (diacid instead
of disodium) is not important.
•

• Court of first instance of Milan 21/12/2015:

• Order by which the court decides to ask the opinion of an expert:
• After taking note of some results of the urgent description (eg: "In
consideration of the above, assuming that it is effectively
demonstrated that the Da Kong machine is similar to the Da Kong
patent and / or the Tellaroli declaration, the machine da Kong is
able to implement the method of claim 1, whereby it interferes with
it in a contributory way - "contributory infringement" -), the judge
has asked the opinion of an expert, requesting to ascertain, inter
alia, the nature and characteristics of the technical contribution that
Sunrise has offered to the construction of the equipment of the
resistant (having the plaintiff claimed in the hearing the hypothesis
of the "contributory infringement");

27-2-2018
CONCLUSIONS
•
It is believed that the entry into force of the
UPC will increase the cases of indirect
infringement, both because (as in Italy with
the legislative novelty described above) the
indirect infringement has been better
delineated, both because a decision of the
Unitary Court can bring clarity and avoid
conflicting decisions of the Member States.

Indirect Infringement - Silvia Vitro 2018

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Indirect Infringement - Silvia Vitro 2018

Uploaded by

Copyright:

Available Formats

27-2-2018

Union-IP Roundtable 2018 1

Union-IP Roundtable 2018 2

RULES AND REGULATIONS

RULES AND REGULATIONS

Union-IP Roundtable 2018 3

RULES AND REGULATIONS

• 2-bis. The patent confers on its owner also the

RULES AND REGULATIONS

• 2-ter. Paragraph 2-bis does not apply when the

Union-IP Roundtable 2018 4

RULES AND REGULATIONS

RULES AND REGULATIONS

• Art. 66: Patent rights

Union-IP Roundtable 2018 5

RULES AND REGULATIONS

• Art. 67 - Patent of a process

RULES AND REGULATIONS

• Article 124 - Corrective measures and civil

Union-IP Roundtable 2018 6

RULES AND REGULATIONS

• Art. 129 - Description and seizure

RULES AND REGULATIONS

• From the rules indicated it is deduced

Union-IP Roundtable 2018 7

• Professors have held that the supply to the third

• - the essentiality of the component supplied

Union-IP Roundtable 2018 8

• Judges generally think that there were two requirements for

• Indirect infringement requires the presence:

• Therefore, with regard to the subjective element, the

Union-IP Roundtable 2018 9

• Court of Appeal of Milan (23/6/1992)

Union-IP Roundtable 2018 10

• Cass. 1/11/1994, n. 9410,

• Court of first Instance of Rome 4/5/2006:

Union-IP Roundtable 2018 11

• Court of first instance of Cuneo (3/5/2008)

• The subjective element may also consist of culpable

Union-IP Roundtable 2018 12

• Beyond the intentionality in the contribution to the

• Or the subjective element may even consist in the

Union-IP Roundtable 2018 13

• Court of first instance of Milan 24/4/2014:

• Court of first instance of Genova 4/7/2016 – Eurosider/Carservice-:

Union-IP Roundtable 2018 14

• Court of first instance of Rome 13/3/2006 –

Union-IP Roundtable 2018 15

• Court of first instance of Turin 13/5/2012 and 15/6/2012 – Nespresso

• According to some rulings, it does not seem

Union-IP Roundtable 2018 16

• Court of first instance of Turin 10/11/2004- Peri/Faresin-:

• Court of first instance of Bologna 3/3/2006:

Union-IP Roundtable 2018 17

• Court of first instance of Milan 5/3/2015 – Gima-Ima/Cama-:

• Place of commission of the tort

Union-IP Roundtable 2018 18

• The decision has been criticized, considering

• Court of first instance of Bologna 3/3/2006:

Union-IP Roundtable 2018 19

THE NEW ARTICLE 66 CPI

• THE NEW ARTICLE 66 CPI

THE NEW ARTICLE 66 CPI

• 2-bis. The patent confers on its owner also the