Source: http://thespcblog.blogspot.com/2015/
Timestamp: 2017-04-25 08:27:54
Document Index: 533890746

Matched Legal Cases: ['CJEU ', 'Art\n68', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ']

Pharmaq v Intervet - an English language version of the decision has arrived The SPC blog is grateful to the attorneys at Thommessen in Norway for providing
an unofficial English language translation here (and
also on the blog resources page) of the Oslo District Court’s Judgement of 25
August 2015 in the Pharmaq and Intervet matter. A summary of the Judgement, reproduced below, is authored by
the advocates Eirik W. Raanes, Camilla Vislie and Magnus Hauge Greaker at
Thommessen who represent Intervet Internatinal B.V. in the proceedings. Thanks
International BV: Oslo District Court’s Judgment 25 August 2015
Oslo District Court has
delivered a Judgement in the case between Pharmaq AS and Intervet International
BV, where the EFTA Court delivered its Advisory Opinion on 9 April 2015 (Case E 16/13 Pharmaq
v Intervet International BV). The case inter alia
concerns the validity and scope of protection of Intervet’s Norwegian SPC
protecting the active ingredient in Intervet’s vaccine against Pancreas Disease
in salmon. In Oslo District Court’s
Judgment 25 August 2015, Pharmaq’s claims for invalidity and non-infringement
of the SPC on the basis of Article 2, 3 and 4 of the SPC Regulation, were
Pharmaq has appealed the
Judgement, and the hearing at Court of Appeal is preliminary scheduled to take
place in the late autumn of 2016.
Before Oslo District
Court, Pharmaq challenged the validity of Intervet’s SPC on the basis of
Article 2, 3 and 4 of the SPC Regulation. Pharmaq also submitted an alternative
claim for non-infringement on the basis of Article 4 of the SPC Regulation.
Article 2 of the SPC
validity challenge under Article 2 Pharmaq submitted that Intervet’s vaccine
was placed on the market prior to being granted a market authorisation in
accordance with Directive 2001/82/EC. In support of this challenge Pharmaq
invoked that Intervet between 2003 and 2011 had delivered its vaccine to fish
farmers in Norway and Ireland under Special Approval Exemptions and AR16
A provisional MA was
granted for the vaccine in the UK in 2005. An ordinary MA was granted for the
vaccine in Norway in 2011. Pharmaq submitted that the UK PMA from 2005 could
not be considered to be a marketing authorisation within the meaning of Article
2 of the SPC Regulation, which would have the consequence that Intervet’s
supply of the vaccine under Special Approval Exemptions and AR16 licenses
subsequent to the grant of the UK PMA would be relevant for the assessment
under Article 2 of the SPC Regulation.
started by concluding that the UK PMA was the first MA granted within the EEA
area for the purpose of Article 2 of the SPC. This had the consequence that
only events that took place prior to 6 May 2005 (the date the UK PMA was
granted) was relevant for the assessment of whether the vaccine was placed on
the market within the meaning of Article 2 of the SPC Regulation.
Further, Oslo District
Court held that it is only authorisations granting full market access that
entail that a product has been “placed on the market” within the meaning of
Article 2 of the SPC Regulation. According to Oslo District Court, this
interpretation of Article 2 was supported by the wording of the SPC Regulation,
the purpose of the SPC Regulation and the system which it is a part. The Court
referred to that the objective of the SPC Regulation is to compensate the
patent holder for the time that has passed between the filing of the patent
application and the completion of the regulatory process for obtaining a
marketing authorisation, i.e. in other words the SPC Regulation is intended to
compensate for lack of full market access. The Court went on pointing out that
the term “placed on the market”, or similar, in the SPC Regulation is only used
in connection with marketing authorisations pursuant to Directive 2001/82
(Veterinary Medicinal Products Directive) and that under the Veterinary
Medicinal Products Directive it is only marketing authorisations that allow for
a product to be “placed on the market”.
CJEU’s Judgement in the Cases C-195/09 Synthon and C-427/09 Generics,
that Pharmaq had relied on, Oslo District Court noted that those cases
concerned products that had been granted full market access and consequently
were not comparable with the case at hand.
Pharmaq also submitted
that the Special Approval Exemptions and AR16 licenses only could be considered
as permissions that did not allow for “placing on the market” if they were
granted on the basis of national rules that implement Article 8 of the Veterinary
Medicinal Products Directive correctly. The Court, however, rejected this
argument and held that the relevant question rather was whether the Special
Approval Exemptions and AR16 licenses in legal terms conferred a market access
that corresponds with the rights a market authorisation affords. Oslo District
Court noted that the Advisory Opinion of the EFTA Court must be interpreted in
the light of other sources of EU/EEA law and must be understood such that the
relationship between the Special Approval Exemptions/AR16 licenses and the
Veterinary Medicinal Products Directive was not decisive.
found that strong policy concerns supported its interpretation of Article 2 of
the SPC Regulation. In the Court’s view it would counteract supplies under
limited authorisations according to Articles 7 to 11 of the Veterinary
Medicinal Products Directive if such authorisations were to disqualify the
product from SPC protection. This consideration also indicated that it should
not be of significance whether a limited authorisation is granted within the
framework of the Veterinary Medicinal Products Directive, because it is not
possible for manufacturers to know whether the authorities have complied with
assessment of the Special Approval Exemptions and AR16 licenses, Oslo District
Court found that there were decisive differences between the market access
under a marketing authorisation and the market access on the basis of the
Special Approval Exemptions/AR16 licenses. The Court inter alia pointed out
that the Special Approval Exemptions/AR16 licenses only could be granted in
special situations and at the authorities’ discretion, and that the permissions
were limited both with respect to volume and time. In the Court’s view there
are thus significant qualitative and quantitative differences between Special
Approval Exemptions/AR16 licenses and marketing authorisations, since the
latter gives the holder an unlimited right to market and sell the product,
subject to the restrictions that apply generally to medicinal products. Based on this the Court
concluded, noting that it had not been in doubt, that the authorisations prior
to 6 May 2005, could not entail that the product had been “placed on the
market” within the meaning of Article 2 of the SPC Regulation.
Pharmaq submitted that
the Special Approval Exemptions in any event amounted to marketing
authorisations within the meaning of Article 3 of the SPC Regulation, and that
Intervet’s SPC therefore was granted in breach of Article 3(d) and 7(1) of the
SPC Regulation.
rejected this submission, noting inter alia that a marketing authorisation
within the meaning of Article 3 of The SPC Regulation must, as in other
provisions of the Regulation, be understood as a marketing authorisation
granted in accordance with Veterinary Medicinal Products Directive, and that
the Special Approval Exemptions were not such authorisations.
In Intervet’s marketing
authorisation the active ingredient in the vaccine was identified as
“Inactivated Salmon Pancreatic Disease Virus Strain F93-125”. The product
description of Intervet’s SPC comprised: “Salmonid pancreatic disease virus that, when
injected intraperitoneally at a titre of 103.5 TCID50 into Atlantic salmon
post-smolts held in sea water at 14°C causes the fish to develop symptoms of
pancreatic disease, wherein
a) said virus is the virus strain as deposited at ECACC under
Deposit number V94090731 or closely related strains which share similar
genotypic and/or phenotypic characteristics to said deposited virus strain and
b) said virus reacts serologically with convalescent anti-FPDV
antiserum or antiserum raised against the deposited virus strain V94090731 and
the SPC was granted in breach of Article 4 of the SPC Regulation, since this
provision required that the SPC should be confined to the strain identified in
the marketing authorisation. In the alternative Pharmaq submitted that the SPC
did not cover their virus strain (ALV 405).
On this topic Oslo
District Court split into a majority, consisting of the legal judge and one
expert lay judge, and a minority, consisting of one expert lay judge.
The majority held that the SPC was not granted in
breach of Article 4 of the SPC Regulation and that a vaccine based on Pharmaq’s
virus strain would infringe the SPC.
The majority referred to
the opinion of the Advocate General in case C-392/97 Farmitalia,
where the Advocate General emphasized that the meaning of the term “product” in
the SPC Regulation could not be determined based only on textual grounds. The
majority found it difficult to determine the meaning of the product definition
without also considering the purpose of the SPC Regulation, because a literal
interpretation based on the marketing authorisation would, for a vaccine that
is based on inactivated whole-virus particles, imply that it would be possible
for a competitor to make a new vaccine based on a different isolate of an
identical or similar virus, without infringing the SPC. In the majority’s view
this seemed to give an unreasonable result.
The majority went on by
ascertaining that case law provided support for a purpose oriented
interpretation. The Court inter alia referred to case C-392/97 Farmitalia and
the EFTA Court’s Advisory opinion.
On this backdrop the
majority concluded that Article 4 of the SPC Regulation permits that a SPC
covers other strains than identified in the marketing authorisation, provided
that the other strain can be said to constitute the same active ingredient with
a similar prophylactic effect as the strain identified in the marketing
criterion the majority continued with a comparison of Intervet’s and Pharmaq’s
virus strains. Based on a comprehensive material, inter alia studies, submitted
by the Parties, the majority concluded that the differences between the virus
strains F93-125 and ALV 405 are insignificant and that they thus must be
considered to be the same active ingredient. Further, the majority concluded
that both strains may be used in the same prophylactic field. Thus, it was held
that the SPC was valid and that Pharmaq’s virus strain was covered by the SPC’s
scope of protection. The minority interpreted Article 4 of the SPC
Regulation such that the product description of the SPC must be confined to the
strain that is identified in the marketing authorisation, and thus held that
the SPC granted to Intervet is invalid. Posted by
In the Eurovision contest of CJEU SPC referrals it is maximum points to Estonia for the referral that is C-572/15, on the topic of Article 21 of Regulation 469/2009. The two referred questions are below, with Q1 on the topic of the transitional provisions and Q2 raising the interesting issue of possible incompatibility with EU law in the event that Q1 is answered in the affirmative.... The following
questions have been referred for a preliminary ruling:
Must Article 21(2) of Regulation No 469/2009 of the European
Parliament and of the Council of 6 May 2009 concerning the supplementary
protection certificate for medicinal products (codified version) be
interpreted as shortening the duration of a supplementary protection
certificate issued in a Member State which was issued under national law
before the accession of the State in question to the European Union and
whose duration in relation to an active substance, as stated in the
supplementary protection certificate, would be longer than 15 years from
the time when the first marketing authorisation in the Union was granted
for a medicinal product consisting of the active substance or containing it?
If the answer to the first question is in the affirmative, is Article
21(2) of Regulation No 469/2009 of the European Parliament and of the
Council of 6 May 2009 concerning the supplementary protection certificate
for medicinal products (codified version) compatible with European Union
law, in particular the general principles of European Union law on the
protection of acquired rights, the principle of the prohibition of
retroactive effect of law, and the Charter of Fundamental Rights of the
If you have any thoughts, the UKIPO has set a deadline of 22 December 2015 to send them in to policy@ipo.gov.uk. Posted by
Little did I realise, when we started The SPC Blog back in
June 2008, that I would be saying goodbye to a thriving weblog with an email
subscription list of nearly 2,100 – a blog that has also attracted well in
excess of 800,000 pageviews and which has supported highly popular annual
seminars in which people from all sectors of the pharma and agrochemical patent
term extension world have gathered to share their thoughts, their experiences
and, all too often, their frustration with the rulings of the Court of Justice
Anyway, it is with a feeling of great happiness that The SPC
Blog has been so popular – and so useful – that I take my leave of it and step
down as I take the retirement route. Do please continue to give the blog your every support and
help to keep it as the valuable resource which it has become!
In the context of product patents directed to ingredients of pharmaceutical products, "elements examined for authorization relevant to substantial identicalness as a pharmaceutical product" are components, quantity, administration, dosage amount, effect and efficacy. Administration and dosage amount of the previously authorized pharmaceutical product are "... intravenous drip infusion of 5mg/kg (body weight) per dose or 10mg/kg (body weight) per dose ... administration interval is 2-week or longer ...", while those of the newly authorized pharmaceutical product are "... intravenous drip infusion of 7.5mg/kg (body weight) per dose ... administration interval is 3-week or longer ...". Further, production and sales of the subject pharmaceutical product for a combination therapy of XELOX therapy and bevacizumab therapy newly became available by such new authorization. Based on the facts described above, it is not established that the prior authorization encompasses the new authorization in terms of an authorization for production and sales of a pharmaceutical product. Therefore, the decision of appeal board of the JPO is not legitimate, and the IPHC Grand Panel decision is approved.
Further, in our previous post, it was mentioned that "If the patentee may wish to obtain a PTE corresponding to a dependent claim in the future, it is recommended to file a divisional application to establish a patent specifically directed to the invention of the dependent claim, describing the invention as an independent claim". Under the new examination guidelines, PTE may become available without filing such divisional applications.
Here's a guest post from Dr Seigen Tsukuda (Ohno & Partners, Japan, right) on patent term extensions in that important jurisdiction. Our thanks go both to Dr Tsukuda and to Darren Smyth (EIP)) for procuring it on our behalf and giving it the benefit of his editorial scrutiny. Introduction Patent
systems differ from nation to nation, and the practice relating to patent term
extension (PTE) shows an extreme example of such variation. The Japanese PTE system is quite distinct
from those of Europe and United States. Significant
features of the present Japanese PTE procedure are as follows.
(1) Although it is required that an authorized
pharmaceutical product falls within the scope of a claim of the patent, it is
NOT required that the claim recites (specifies) any active ingredient. Thus, patents relating to drug delivery
systems (DDS), for example, can be extended in principle. (2) Multiple extensions are available for a
single patent (but the term of extension may not exceed 5 years). (3) Multiple patents belonging to the same
patentee can be extended based on a single authorization. The
idiosyncrasy of the Japanese system has increased even further recently. In order to elucidate the current situation, let
us look briefly into the Patent Act provisions and the history of Japanese PTE
practice. Relevant provisions of
Japanese Patent Act Article
67 paragraph 2 provides conditions for PTE, mentioning "Where there is
a period during which the patented invention is unable to be worked because
... disposition [authorization] ... is necessary to obtain for the working of
the patented invention, the duration of the patent right may be extended ...,
by a period not exceeding 5 years." Art
68-2 provides effects of PTE, i.e. "Where the duration of a patent right is
extended ..., such patent right shall not be effective against any act other
than the working of the patented invention for the product which was the
subject of the disposition [authorization] ... which constituted the reason for
the registration of extension (where the specific usage of the product
is prescribed by the disposition [authorization], the product used for that
usage)." [Japanese Patent Act]
PTE examination practice at
JPO until 2011 Conventionally,
the JPO assumed that "product" and "usage" recited in
Article 68-2 should be interpreted as "active ingredient(s)" and
"effect and efficacy" respectively. Based on this assumption, the JPO further interpreted Article 67
paragraph 2 as meaning that a PTE can only be based on an authorization that is
"new" in terms of a combination of "active ingredient(s)"
and "effect and efficacy". For
example, let us assume a case where an authorization is obtained for a pharmaceutical
product using a new DDS technology, and the DDS technology is protected by a
patent. In this case, according to the
JPO practice, the patent could NOT be extended so long as there is a previous
authorization corresponding to a pharmaceutical product whose active ingredient,
effect and efficacy are the same for those of the newly authorized pharmaceutical
product. It is not relevant whether the
previously authorized pharmaceutical product falls within or outside the claims
of the subject patent (situation was similar to MIT case [C-431/04]). According
to Article 67 paragraph 2, a PTE may be allowed "when there is a period
during which the patented invention is unable to be worked". Under the Japanese Pharmaceutical Affairs
Act, it is not permitted to market a pharmaceutical product of new formulation
or new dosage until a new corresponding authorization is obtained, even if a previously
authorized pharmaceutical product contained the same active ingredient and was authorized
for the same effect and efficacy. It
could thus be argued that there is "a period during which the patented
invention is unable to be worked". Accordingly,
since late 1990s, new-drug developers have been struggling in courts arguing that
the above JPO's practice is not legitimate. Supreme Court decision in
April 2011 Finally,
on 28 April 2011, the Supreme Court gave a decision determining that the above
JPO practice is not legitimate [H21(Gyo-hi)326: Takeda v Commissioner of Patents]. According to the decision, an application for a PTE cannot be rejected
based on a previous authorization if a pharmaceutical product authorized by the
previous authorization does not fall within the scope of any of the claims of
the subject patent for which PTE is applied. The decision opened a door for PTE of a patent protecting a new
formulation, such as DDS drugs. [H21(Gyo-hi)326] Revised examination guidelines
in December 2011 Forced
by the Supreme Court decision, the JPO revised its examination guidelines for PTE
in December 2011. The revised guidelines
are fairly complicated, but could be summarized as follows. An application for a PTE based on a new
authorization for a new pharmaceutical product cannot be rejected if an old pharmaceutical
product authorized by a previous authorization falls outside the scope of all
of the claims of the subject patent. On
the other hand, if the old pharmaceutical product falls within the scope of a broadest
claim of the subject patent, the application for PTE must be rejected so long
as the old and new pharmaceutical products do not differ in term of the elements
described in the broadest claim of the subject patent. For
example, assume a case in which a new pharmaceutical product is a new
formulation including active ingredient A and excipient polymers B and C2, where
the old pharmaceutical product was a formulation including active ingredient A
and excipient polymers B and C1. In this
case, a PTE will not be allowed if an independent claim of the subject patent
simply recites active ingredient A, or a combination of active ingredient A and
excipient polymer B. On the other hand, a
PTE may be allowed if the independent claim of the subject patent recites a
combination of active ingredient A and excipient C (C1 and C2 are examples of
C). There
remained a question of whether such revised guidelines (to refuse a PTE if the
independent claim only recites active ingredient A, or a combination of active
ingredient A and excipient polymer B) are in accordance with Article 67
paragraph 2, because marketing of the new pharmaceutical product (A+B+C2) is
not allowed under authorization for the old pharmaceutical product (A+B+C1). It may be possible to argue that "there
is a period during which the patented invention is unable to be worked" in
respect of the pharmaceutical product (A+B+C2) until a new authorization is
obtained for the new pharmaceutical product (A+B+C2), even though the patented
invention was able to be worked in respect of the old pharmaceutical product
(A+B+C1). New-drug developers again
fought in courts questioning whether JPO's revised practice is legitimate or
not. [Revised Guidelines] Intellectual Property High
Court (IPHC) Grand Panel decision in May 2014 On
30 May 2014, the Grand Panel of IPHC rendered a decision determining that the
revised examination guidelines are not legitimate [2013(Gyo-Ke)10195: Genentech v Commissioner of Patents]. According to the decision, if an
authorization is new in terms of a combination of components (not only active
ingredients), quantity, administration, dosage amount, effect and efficacy, the
application for a PTE shall not be refused based on a prior authorization. This means that a PTE may be allowed based on
any substantially new authorization, so long as the subject patent covers the
newly authorized pharmaceutical product. The
decision also mentioned in obiter dictum
that, during the extended period, the patent will cover only a drug within both
the scope of claim of the patent and the scope of the authorized pharmaceutical
product in respect of “components (not only active ingredients),
administration, dosage amount, effect and efficacy”, and equivalents or
substantially identical products thereof. Since the PTE system was established in 1988 in Japan, there has been no
legal precedent determined in ratio
decidendi what is the claim scope of an extended patent. [2013(Gyo-Ke)10195] Practical suggestions As
mentioned above, under the current examination guidelines, a PTE is allowed on a
patent-by-patent basis, and examination will be performed based on the broadest
claim of a patent. In a case where a
prior authorized pharmaceutical product falls within the broadest claim and there
is a reason for rejection with respect to the broadest claim, a PTE is not
allowed even if the old pharmaceutical product falls outside a narrower
dependent claim (and the new pharmaceutical product falls within the dependent
claim). However, if a divisional
application including the dependent claim is filed to separate the claim from
the independent broadest claim of the parent, and a secondary patent is
obtained, a PTE may be allowed for such secondary patent under the current
examination guidelines, based on the authorization for the new pharmaceutical
product. If the patentee may wish to
obtain a PTE corresponding to a dependent claim in the future, it is
recommended to file a divisional application to establish a patent specifically
directed to the invention of the dependent claim, describing the invention as
an independent claim. It
should also be kept in mind that the current examination guidelines have been disapproved
by the Grand Panel decision and the situation is quite unstable. The JPO appealed against the Grand Panel
decision, and the case is still pending at the Supreme Court. It is expected that a decision will be given
within a few years. The JPO's practice
has not substantially been changed since December 2011, but it is quite
possible the guidelines will be revised again after a new Supreme Court
decision. If the Supreme Court affirms the
Grand Panel decision, then a PTE will become more easily allowed, but the scope
of protection provided by an extended patent will become more restricted. In 2011, the Supreme Court decision stopped
all PTE examination at the JPO until the examination guidelines were revised
and fixed. It is therefore recommended
that, whenever a new pharmaceutical product is authorized in Japan, an application
for a PTE shall be considered for any patent covering the new pharmaceutical
product, even if the PTE might appear unallowable based on the present
guidelines. Posted by
It is no secret that our good friend Mike Snodin (Park Grove IP) has taken a keen interest in the Seattle Genetics reference to the Court of Justice of the European Union (Case C-471/14), so no readers of this weblog will be surprised that he has some further thoughts about this ruling which he is happy to share with us. As Mike explains: I have a particular reason to welcome the judgement in Seattle Genetics. This is because it validates an argument that I first proposed in an article published in Scrip Regulatory Affairs in October 2011 (discussed on the SPC Blog here), namely that the duration of SPC protection should (where relevant) be calculated upon the basis of the notification date of a "centralised" Marketing Authorisation -- and not the (earlier) date of the European Commission's decision to issue the MA.
It is gratifying that the CJEU has validated another novel concept that I devised (the first being zero / negative term SPCs -– see this RAJ Pharma article from July 2007 and this SPC Blog post from 2011). However, it is disappointing to note that the CJEU's judgement in Seattle Genetics solely addresses the issue of SPC duration but does not comment upon the interpretation of other provisions of the SPC legislation that also rely upon the precise date ascribed to a MA.With this in mind, I have published an article that, while noting the additional duration that should be awarded to certain SPCs (perhaps up to about 40% of all SPC applications for medicinal products), also discusses some potentially broader implications with respect to:- the deadline for filing some SPCs;- determining the date of certain national MAs; and- determining the MA date for the purposes of Articles 3(b) and 3(d) (which are two of the four key provisions that determine entitlement to SPC protection). Finally, the article mentions the battles that companies may face when trying to persuade certain national patent offices and courts to correct (by lengthening) the duration of SPCs already granted -- and points to a recent decision (discussed on the SPC Blog here) that may help to win those battles. My latest article may be viewed by clicking here. With two validated concepts under my belt, I am now keen to complete my hat-trick. Indeed, there may already be an opportunity for this. This is because another concept that I proposed (again relating to SPC duration, but this time based upon the Euratom treaty), although rejected by the UK IPO in the Genzyme case, would appear to be eminently arguable in the light of the CJEU’s decision in Merck Canada (C-555/13, see this Scrip Regulatory Affairs article from June 2014, as discussed on the SPC Blog here). However, with only one additional day at stake for less than half of all SPCs in a handful of countries, I doubt that there will be sufficient commercial incentive for any applicant to vigorously pursue the relevant arguments. Having said that, this is one occasion on which I would be delighted to be proved wrong!
correction of duration of granted SPCs,
deadline for filing SPC applications,
The Pharmaq v Intervet case [the EFTA Court ruling, here, discussed on this weblog here] considers, in the context of a salmon virus vaccine, the important issues of what types of marketing authorisations count for the purposes of determining whether a supplementary protection certificate (SPC) is available and what its duration is, and whether an SPC based on a particular authorised biological product can validly extend protection to an authorised variant of that product. Possible implications with respect to SPCs for human biological medicines are also discussed. This is followed by a case analysis by Katie Hutchinson and Laura Reynolds (Bristows), "CJEU rules again on combination SPCs - Actavis v Boehringer". Explains the journal: This comment considers the latest judgment from the CJEU on combination SPCs. It summarises earlier cases from the court in order to build up a picture of the position the CJEU is now taking. Further details of the journal can be accessed here.
BioSLR,
SPC based on process claim,
Rosuvastatin: is it a “pharmaceutically acceptable salt”? On 15 July 2015 the District Court for The Hague handed down its decision in Resolution Chemicals v Shionogi and AstraZeneca. This case turned on the validity and scope of protection of Shionogi’s SPC -- in particular, was Resolution Chemicals’ proposed zinc salt of rosuvastatin a “pharmaceutically acceptable salt” as claimed in the basic patent and which would infringe the SPC? The District Court granted a declaration of non-infringement. Jan Pot and Mark van Gardingen (both of Brinkhof, which acted for Resolution Chemicals) know how interesting this decision is for our readers and therefore have kindly let us have both the authentic Dutch text of the judgment and an English translation. Their summary of the decision -- without any commentary -- appears below.
pharmaceutically acceptable salt,
Matthew RoylePartnerTaylor Wessing (United Kingdom)
The Italian Court completely rejected this point by affirming the following: “the overcoming of those obstacles and the identification of the pharmacokinetics data concerning quetiapine – the latter was not yet marketed at the priority date of the patent – implied an activity, which can be qualified as a mere routine activity for the expert of the field, consisting of clinical trials. The statement of the Court Technical Expert who affirmed that those barriers would have discouraged the expert of the field, who could have reached the invention but would have not found a stimulus to do that, is not shareable. After all, the same Court Technical Expert affirmed that the expert of the field could have identified such elements through clinic research and that the long analysis which were necessary may also be qualified as routine ones in the pharmaceutical field, in the sense that they have in any case to be carried out but require the use of a great number of employees and resources as well as a substantial economic disbursement. Moreover, the necessity to make use of employees and resources and the costs of the analysis is an element which is not enough to state the inventive step of the patented technical solution because the expert of the field was not required to carry out any inventive activity but instead merely usual clinic research and tests” (see lines 276, ff. of the English translation).