PanelDiscussion
Liz Cohen
Partner
Robert Watson
Partner
Cesare Galli
Senior partner
Helen Jones
Partner
Bristows LLP
Mewburn Ellis LLP
IP Law Galli
Gill Jennings & Every LLP
Nothing lasts forever
What do pharmaceutical companies do when their key patents are
about to expire? IPPro asks the experts
Pharmaceutical giants such as Merck & Co are seeing key patents in
their portfolios expire, giving rise
to generics. Their sales are taking
a hit—what can they do to prolong
their rights?
pharmaceutical companies contributes to the
delay in entry of generic medicines. As a result, the behaviour of originator pharmaceutical
companies is under even greater scrutiny from
the competition authorities than ever before,
and pharmaceutical companies will need to be
careful to ensure that they apply for and enforce
their legitimate intellectual property rights in a
manner that is compliant with both national and
Liz Cohen: The EU Commission sector inqui- EU competition law.
ry into the pharmaceutical sector resulted in a
number of findings by the commission, in which The development of safe, effective and highit suggested that certain conduct by originator quality pharmaceutical products usually in-
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volves technical advances in a number of fields,
including but not limited to the discovery and
testing of a novel active pharmaceutical ingredient (API). Patent law recognises this, and the
legislation (as interpreted by the UK courts and
the European Patent Office, or EPO) allows for
patents to a number of features of a medicinal
product, where the technical contribution of that
feature is both novel and involves an inventive
step. Patent protection is therefore available
for, among other things, APIs, combinations
of APIs, processes of manufacture, formulations and second medical uses. In the case of
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PanelDiscussion
the latter, the second medical use can include
treatment of a new indication, treatment of new
patient group or a new dosage regime.
Pharmaceutical companies should not therefore overlook patents in their portfolio that
protect aspects of a medicinal product beyond
the API, which are often the result of lengthy
and expensive research on the part of the
company. Good preparation can assist in enforcing each of these patent rights until expiry,
including applying for interim relief pending trial
where appropriate.
For existing patents, patent term extensions
(PTEs) in the form of supplementary protection certificates (SPCs) are available in the EU.
SPCs of up to five years are available, depending on the date of first marketing authorisation in
the European economic area (and a further six
month paediatric extension to the SPC is also
available). SPCs have the same effect as the
basic patent that they extend, but are limited to
the use of the active ingredient(s) that are the
subject matter of the marketing authorisation on
which the SPC is sought in medicinal products.
SPCs are only available where the “product”,
as defined in the SPC legislation (Regulation
(EC) No 469/2009) as the active ingredient or
combination of active ingredients, has not previously been the subject of an SPC and the term
of the SPC will be calculated by reference to the
first marketing authorisation in the EEA. The
first marketing authorisation had been thought
to mean the first for that API with the practical
effect that SPCs would not be available for second medical uses of that API.
However, in a notable development in 2012, the
Court of Justice of the EU (CJEU) made it clear
that SPCs are available for second medical use
patents since their term should be calculated
by reference to the first marketing authorisation
for that second medical use in the Neurim case
(Case C-130/11).
applications. This developing commercial reality increases the importance of coordination between patent and regulatory departments within
pharmaceutical companies.
enforcing the relevant rights. This is particularly
true for Italy, where not only granted patents,
but also patent applications may be enforced
in courts. Both preliminary injunction/seizures
(in urgency proceedings) and full damages/
Product-based protection can be supplement- disgorgement of profits (in cases on the merits)
ed by supporting or ancillary inventions made can be sought.
during the product development process and
throughout the product lifecycle. While such Cohen: The key driver in determining the time
developments are typically less valuable than taken to bring new medicinal products to market
rights in the product itself, they can prove ex- is the length of time required to conduct pretremely valuable in a sector that is as lucrative clinical and clinical trials and the application for
and as tightly regulated as pharmaceuticals. approval before the relevant regulatory authorExamples of such ancillary developments ity. The traditional IP attorney will have a limited
include improvements in formulations, synthetic role in this process, as it proceeds according to
methods, manufacturing processes, drug deliv- the regulatory framework.
ery devices, dosage regimes, packaging and
drug combinations.
The role of the IP attorney in the early stages of
a product’s development should therefore focus
It is essential to take a strategic approach to on working closely with the R&D department, as
patent portfolio development with a view to well as litigation specialists where appropriate,
the big picture and a willingness to diversify to determine patent filing strategies to protect as
so as to provide as many means of protection many of the technical advances that are made
as possible.
in developing a novel medicinal product or use
of an existing product. Early consideration of
Cesare Galli: In Italy, a rule introduced in Sep- the prior art with the R&D department can also
tember 2012 abolished the main problem for assist with choosing the right clinical developoriginators arising from the marketing of the ment programme and ensure that sufficient
generic drug—namely, the reduction of the drug evidence is available at the time of patent filing
redemption price by the National Health Ser- to support the claimed invention. This should
vice. It now states that drugs equivalent to those maximise the chances of obtaining valid patent
whose patent or SPC is near to expiry cannot protection of sufficiently wide scope to recoup
qualify as drugs paid by the Italian National the significant investment that will be required
Health Service before the expiry of the patent in order ultimately to bring the medicinal product
or SPC.
to market. Involving litigation specialists in these
early discussions can also assist in assessing
Apart from this provision (that is unlikely to re- whether the envisaged patent protection can be
main in force for long, as it seems to be contrary effectively enforced.
to EU law), any activity carried out by the generic drug manufacturers before the expiry of the Certain jurisdictions, such as the US, also require
patent/SPC, which are not strictly linked to the applicants for patents to disclose all relevant priobtainment of a market authorisation, may be or art that they are aware of to the national patent
prohibited and made illicit, including the market- granting office, so careful discussion and recording of the generic drug made after the expiry of keeping needs to occur to avoid subsequent
the patent/SPC, entitling the originators to ask challenges to the enforceability of patents on the
for preliminary injunctions and seizures.
grounds of non-disclosure.
The CJEU specifically referred to the need for Robert Watson: The best patents are those
the SPC system to encourage and foster inno- to true innovations. Therefore, for protection
for existing drugs to be extended, continued
vation in the pharmaceutical sector.
research into those products needs to continue
Helen Jones: In the aftermath of the recent such that innovations can be brought to the
European Commission pharmaceutical sector market. Such innovations can then be protected
inquiry, it is clear that pharma companies providing extended protection.
must avoid anti-competitive agreements and
abuse of dominance to maintain market How can IP attorneys and R&D
exclusivity. In this environment of increased departments work together better
scrutiny under competition law, the patent to get products to market quicker,
cliff presents a more significant problem, and
while pharmaceutical companies continue to so that gaps in revenue can
rely heavily on product patents, an increas- be plugged?
ing importance is placed on maximising
regulatory data exclusivity and securing Galli: A strict cooperation among patent attorSPC protection to extend exclusivity.
neys, patent lawyers and R&D departments is
necessary at every stage of the life of the patWith respect to SPCs, it is clear that these rights ent, including the drafting of the relevant applicaare becoming increasingly important, and pat- tion (and divisional ones, if it is the case). Not
ent drafting and prosecution should now take only do patent laws and regulatory rules have
place with an eye to the developing case law to be carefully considered, but also competition/
and the likely commercial need to support SPC anti-trust rules and the procedural rules aimed at
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Jones: In seeking to protect a company’s IP, it
is essential that documents are drafted well and
with the company’s commercial needs in mind.
Quick and easy passage through the patent office can prove very valuable in securing early
market exclusivity as well as maximising the
protection available under an SPC.
However, the IP attorney can also have a big
impact in the commercialisation process by
helping technical and business teams to navigate third party rights and to secure freedom to
operate. In doing so, the IP attorney can steer
licensing efforts in the most cost-effective direction and help avoid costly and disruptive product
redesigns late in the development cycle.
It is clear that a close working relationship
between business and technical teams and
the IP attorney can prove extremely valuable
for pharmaceutical companies that operate in
crowded technical fields and rely heavily on
market exclusivity.
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Watson: The main obstacles to bringing a new
drug product to market lie in the regulatory arena, and not in the IP system. Although IP protection can play a key role in protecting the huge
amount of investment that goes into bringing a
product to market, this is a supporting role to the
scientific and clinical work needed.
IP rights may also be critical when large pharmaceutical companies license in or acquire
early stage products from small research-based
companies—in such situations, the key IP work
is carried out by the small companies. Such
companies need to be well advised so that they
have adequate protection for their lead compounds, which can dovetail into the IP strategies of the large pharmaceutical companies.
Although IP will also be secondary to the science in these situations, a well thought through
IP strategy can assist in a drugs path to market,
which will inevitably involve a large pharmaceutical company with the necessary resources to
carry out the clinical studies needed.
How can in-house IP counsel forestall
competitors’ invalidity accusations?
Watson: As with all patents, they need to be
drafted well—the narrower the patent scope,
the less likely they can be attacked for invalidity.
Patents directed to novel chemical entities that
are well supported in terms of chemical scope
and contain comprehensive biological data will
fare much better than excessively broad cases
with limited biological data.
Novel chemical entity cases are likely to be
stronger than cases directed to further
medical uses, alternative forms or pharmaceutical formulations—for these types of
cases, it is even more important that the
scope of the claims is justified by experimental data supporting the innovative nature
of the development being claimed.
Jones: Competitors will always claim patents
are invalid—there is a need to clear the way,
and the expense is justified where markets are
large as in the pharmaceutical sector.
The advice to any IP attorney is the same—
build the strongest possible portfolio of patents.
The early stages of searching and drafting are
particularly important in building an appreciation of the prior art and claiming the invention
accordingly. It is essential to always claim
strategically with sufficient fall back positions
to secure commercially relevant protection,
and never put all your eggs in one basket.
There is an element of uncertainty as to the enforceability of any individual patent, but where a
patent is part of a well-constructed portfolio there
is a greater likelihood of effective exclusivity.
Cohen: A key consideration in enforcing patent
rights is an analysis of their susceptibility to revocation. Careful filing strategies are essential
to ensure that a pharmaceutical company does
not inadvertently disclose material damaging to
its subsequent patent applications, for example,
through public disclosure of the innovation by
researchers prior to filing of the patent (or priority application). In the UK, all prior public disclosures, even by the inventors, are considered
prior art when determining the validity of a patent, unless the disclosure was made in breach
of confidence.
Ultimately, there is little that patents holders can
do before revocation proceedings have concluded to prevent third parties from suggesting
that the patents are invalid. As set out above,
obtaining prior art and keeping records for the
purposes of disclosure to national patent authorities can be of assistance in defending subsequent unenforceability challenges based on
lack of disclosure.
necessary. In many cases, experimental data
showing the surprising effect of the patented invention prove to be very helpful, as secondary
indicators of inventive step.
Where do brands come in?
Jones: Brand development is a critical component of the pharmaceutical commercial development path—the most successful pharmaceutical products have all been well branded and
become instantly recognisable based on brand
names, for example, Prozac or Viagra.
Successful brand development builds a relationship with the most important of constituents—
the consumer. Commercial impact and maintenance of market share relies heavily on strong
branding, and a sufficiently strong presence can
Patents granted by the EPO already carry a help to maintain market share and pricing levels
prima facie assumption of validity due to the after patent expiry.
fairly rigorous examination procedure at the
EPO, particularly when compared to the ex- Accordingly, brand development should form
amination conducted by some national patent part of an integrated IP strategy to support
offices of member states to the European Pat- product launch, and this requires early
ent Convention (EPC).
investment just like development of a strong
patent portfolio.
Furthermore, European patents are subject to
central opposition proceedings at the EPO if any Cohen: Brand protection, whether of the regopposition is filed within a nine-month period af- istered (trademarks) or unregistered (claims
ter grant. A successful opposition will result in for passing off) variety, provides significant adrevocation of the European patent in all the EPC ditional value to medicinal products over and
countries in which protection was sought, and is above patents. However, they do not generally
final subject to an internal appeal to the Techni- protect inventions. Trademarks are not availcal Board of Appeal (TBA). On the other hand, able, for example, for shapes where that shape
an unsuccessful opposition (including appeal) is is necessary to achieve a technical result.
not final, in the sense that any party (including
the opponent) may still apply to revoke each na- Most trademarks in relation to pharmaceutitional patent deriving from the European patent cal products will constitute a word mark under
before the respective national courts.
which the product is sold. However, slogans, the
shape of goods and colours are also capable
However, a European patent that has success- of registration as trademarks. In addition to the
fully navigated an opposition, particularly an originator’s trademark for a pharmaceutical
appeal before the TBA, carries with it an even product, an international non-proprietary name
greater presumption of validity. There are many (INN) will be assigned to the API by the World
reasons to file patents through the European Health Organization (WHO) or similar national
phase rather than the national phase, the most body. Unlike trademarks, INNs can be used
obvious being the reduced costs to obtain pan- without restriction.
European protection. However, the benefit of
the presumption of validity provides additional Unlike many other industries, the regulatory
authorities strictly regulate brands that may be
incentive to pursue this route.
used to promote medicinal products. The scrutiThe UK Intellectual Property Office (IPO) will ny of the marketing authorisation application by
also issue non-binding opinions on validity if re- the national or EU regulatory authority before a
quested (only concerning novelty and inventive medicinal product can be authorised will include
step). However, these are relatively rare and it an examination of the name proposed to be givis unlikely that a patent will therefore already be en to the product. The choice of trademark must
subject to a favourable opinion from the UK IPO. be: (i) an invented name that is not liable to confusion with the INN or other common name for
Galli: Since the EPO problem and solution ap- the API, or with any other invented names used
proach is widely recognised not only before the for medicinal products; or (ii) the INN/common
EPO Board of Appeal, but also in courts (includ- name accompanied by a trademark or name of
ing the Italian courts. See for instance: Sandoz/ the proprietor. The product packaging must also
Astrazeneca Court of Trieste, Order, 29 March be approved by the regulatory authority.
2011; Pharmaland/L’Oréal, Court of Turin, Sent,
23 February 2009; and IBSA/Pfizer, Court of Trademarks do play an important role in the
Milan, Sent, 26 May 2009), a full scenario of pharmaceutical sector, in that they can provide
the real problems tackled by the researchers greater differentiation between products in the
for reaching the patented invention, and of the same class than INNs (which use a similar
obstacle and technical prejudices overcome, is stem for all compounds sharing similar and/or
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PanelDiscussion
pharmacological properties). This can be of assistance in reducing medication errors by health
practitioners, and in adverse event reporting
where different medicinal products with the
same INNs may have different adverse effect
profiles due to the choice of excipients.
and improve customer retention. Product trademarks too, especially when clearly linked to the
manufacturer’s brand, may benefit from this relationship, in such a way to prolong at least partially the possibility of leading the market even
after the expiry of patent rights. Furthermore, in
appropriate cases, they can be useful for makWith prescription-only medicines, the role of ing the parallel importers toe the line.
brands is necessarily less important when distinguishing an originator’s product from that of a Watson: In my opinion, brand awareness is
generic product with the same INN as prescrib- quite high for pharmaceuticals. Much will deing is now predominantly done by INN. Indeed, pend on the sales route, with brands playing
prescribing physicians are usually encouraged a larger role for over the counter medicines.
to prescribe by INN, and pharmacists are often Many direct consumers are distrustful of gerequired to substitute branded original products neric products, even when they have exactly
for the cheaper generic product, in the drive to the same formulation. Therefore, a well-thought
decrease costs and switch patients to cheaper through branding strategy can be valuable for
generic medicines where available.
OTC medicines. In the UK, I think that branding
is much less important for prescription mediHowever, for over-the-counter medicines, or in cines, as the choice of drug is left to qualified
countries where direct-to-consumer advertising individuals with a greater awareness of the acof prescription medicines is permitted, brands tives and formulations.
can create greater brand identity in the minds of
consumers, who are less accustomed to thinkWould trade secrets be another
ing of medicinal products by way of INN.
Trademarks do have other roles in the pharmaceutical industry, in that they can prevent
generic companies from free-riding the goodwill
generated in the medicinal product and associated advertising, ensuring that generic products
do not take unfair advantage of the reputation of
the originator and its products when the generic
product comes to market.
Furthermore, trademarks can also play a role
in the fight against counterfeit medicines, which
pose significant risk to public health, particularly where customs authorities are involved,
as these make it easy to distinguish between
genuine and counterfeit product.
Galli: Brands may be even more important than
patents, in the pharmaceutical field. Even when
drug manufacturers cannot advertise directly
their products to the consumers (like it is in Italy,
for drugs other from OTC products), the manufacturer’s general brand, if appropriately used
and advertised, may help to build confidence
option for pharmaceutical companies
over patents?
Watson: Although trade secrets can play a role
in any IP strategy, their use needs to be balanced with the inevitable public disclosures that
occur during testing, approval and sale of pharmaceutical products.
publicly available regulatory documents. There
is therefore only limited scope for use of trade
secrets by pharmaceutical companies instead
of patents, even though the period of protection
for confidential information can sometimes significantly outlast the limited patent term.
The main area in which a pharmaceutical
company might choose to protect innovations
through trade secrets is in the process of manufacture of the API, including the specific process
parameters. With traditional small chemical
compounds, there are usually many processes
of manufacture that could be developed, although it is usually worth applying for patents for
novel processes of manufacture where these
can be described at a sufficiently general level.
However, for detailed process parameters that
confer a technical advantage to the process,
such as increased yields or purity, it is often
more appropriate to protect these as trade secrets, as patent protection may be difficult to
obtain and/or easy to circumvent.
Furthermore, the modern pharmaceutical industry has made great strides since the advent
of the biotechnology age, and today’s leading
pharmaceutical products are as likely to be
biological as chemical in origin. The process
of manufacture for biological pharmaceutical
products is in most cases manifestly more complicated than that for small chemical products,
involving as it does biological systems. The
technical know-how developed in manufacturing a biological medicinal product that can satisfy the requirements of the regulatory authorities constitutes a significant proportion of the
value in such products. The detailed processes
of manufacture are therefore even more conducive to protection as trade secrets.
Cohen: In many industries, a choice lies between protecting an innovation as a trade secret
under the law of confidential information (or the
national equivalent such as unfair competition)
and applying for a patent that claims the innovation. With pharmaceutical products, however,
the product is made available to the public in
sufficient quantities so that it will usually be possible to reverse engineer most innovations that It should always be borne in mind, however,
would otherwise be protectable through confi- that a patent grants an absolute monopoly
dential information.
for the term of the patent, regardless of the
origin or nature of the process or product,
Moreover, many of the innovations, for example, whereas a claim for misuse of will need to
the APIs, combinations of API, dosage regimes establish that confidential information was
and medical uses, must clearly be stated in the used and that the information was acquired
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PanelDiscussion
in breach of confidence. Rigorous internal procedures will also be required to maintain confidentiality of trade secrets as once a disclosure
is made public, even inadvertently, it is usually
impossible to retrieve the situation. Breach of
confidential information claims are also usually
very expensive to conduct, and it is therefore
easier to maintain and assert a patent monopoly
in most cases.
real investments and the time frame for marketing drugs seem to become even more challenging and require extended patent terms for being
recovered. Also, data concerning savings for
the national health services, which may derive
from the use of more effective drugs, may be
helpful in this perspective.
Cohen: The EU SPC regime, first introduced in
1992, was extended by the introduction of paediatric extensions in 2007. Where a paediatric
investigation plan (PIP) is approved and the
studies conducted, SPCs can be extended by a
further six months. Both extensions were introduced by the EU to recognise the hurdles faced
by pharmaceutical companies as a result of the
EU’s regulatory legislative framework.
Jones: Trade secrets, or confidential information, can be very important in the pharmaceutical sector. However, reliance on them to protect
IP is not always appropriate. Pharmaceutical
companies needs to be assured that strong protection will exist for a term sufficient to recover
the vast investment made in bringing their products to market. While trade secrets are not term
limited, they are less strong and likely more dif- In the case of SPCs, the legislation is designed
to partially compensate the patent holder for the
ficult to enforce than patent rights.
significant regulatory delay in bringing a product
Trade secret protection may be appropriate to market that results in significantly reduced
where the objective is to maintain secrecy, but term of effective patent protection. The six-month
this is not likely to be the case for most phar- SPC extensions under the Paediatric Regulamaceutical products, methods or devices. The tion can be thought of as compensation for the
value in trade secrets lies in maintaining their introduction under that Regulation of compulsory
confidentiality. Should a competitor discover the additional research into the authorised medicinal
secret by legitimate means then it is free to use product in the paediatric population.
it. Accordingly, the proprietor must take steps
to maintain confidentiality. This approach might Further patent term extensions are not on the
prove useful for protection of improvements to agenda in the EU at present, although following
processes that are not subject to regulatory re- the Neurim decision, further extensions of the
SPC system may result from a broader interpreview, but such cases are not common.
tation of the SPC Regulation than from amendAdditionally, excessive reliance on trade secrets ments to the regulation itself. A number of nonmay not be in a company’s commercial best in- EU countries throughout the world have also
terest. A balance must be struck between the introduced PTEs for the pharmaceutical sector.
desire to maintain secrecy (commercial advantage) and the need to develop public trust and However, there are ongoing discussions in a
confidence (eg, regulatory approval), and open number of countries with a view to introducing
engagement with the public via the patent office a similar regime to compensate pharmaceutical
may prove a worthwhile for this reason in addi- companies for regulatory delays. For example,
the leaked contents of the Trans-Pacific Partnertion to providing robust protection.
ship (TPP) trade negotiations between a number of Pacific Rim countries suggest that patent
Galli: Even if it is hard to believe that trade seprotection measures were tabled by the US,
crets can play a really significant role in the pharincluding requirements for all countries to inmaceutical filed, since they are more relevant for
clude compensatory PTEs. These amendments
method patents than for products ones, and only
apparently faced severe opposition from some
when reverse engineering is not easily available,
other members of the TPP and were withdrawn,
we should consider the technology concerning
although it appears the issue remains live. The
specific pharmaceutical forms, where often the
TPP countries that currently do not have a PTE
know-how is much more important than the patsystem are Canada, Malaysia, Mexico, New
ents themselves, as reverse engineering may
Zealand, Peru and Vietnam, although Canada
not supply all the relevant information.
will now introduce a PTE system of up to two
years’ duration as a result of the ComprehenA case presently pending before the IP Specialsive Economic and Trade Agreement entered
ized Division of the Court of Milan deals with
into with the EU.
this issue, as it was brought in a case of stolen
know-how regarding just the formulation of con- Developments are also afoot in Australia, altrolled release drugs.
though in this case in the other direction. Aus-
What are pharmaceutical companies and their lobbyists doing
to convince legislators to extend
patent terms?
Galli: Information perhaps is the keyword in all
branches of IP law making. This is particularly
true for the pharmaceutical industry, since the
tralia’s PTE system currently extends patents by
up to five years, but the previous government
published a pharmaceutical patents review in
April 2013 that proposes either reducing the
length of extensions as across the board or ensuring that expiry is no later than the equivalent
patent/PTE/SPC expiry in major trading partners, including the US and the EU. Furthermore,
PTEs would no longer be available for patents
to methods of use and manufacture. Whether
15
the new Australian government will take forward
the recommendations in the report remains to
be seen.
Watson: The current regimes of term extensions for pharmaceutical patents appear to
be accepted in both professional and political
circles. I can’t imagine any longer term extensions being acceptable. However, there
are upcoming changes to the patent regime
in the UK, with the planned extension of the
‘Bolar’ exemptions—the extended exemptions
should make it easier to carry out clinical trials in the UK without worrying about patent
infringement issues. The UK government is
also planning to extend the exemptions to
cover the studies necessary for Health Technology Assessments. When coupled with the
recent introduction of Patent Box provisions to
the UK, it can be seen that the government is
keen for pharmaceutical companies to remain
in the UK.
Jones: Firstly, it is important to note that patent term is fixed at 20 years from first filing. Immense efforts have been made to extend this
standard globally, and it is very unlikely that any
amount of lobbying will change that. However, a
well-executed IP strategy can have the effect of
extending market exclusivity through maximisation of SPC and regulatory data protection.
Given the importance of SPCs to the pharmaceutical sector, it is worthwhile making efforts to
have the law regarding SPCs clarified. Given recent case law developments, this may be most
efficiently achieved by redrafting of the EU regulations, but whatever the mechanism, there is a
need for clarity.
Harmonisation and clarification of the law on
research use and Bolar-type exemptions from
patent infringement would also be beneficial
to pharmaceutical companies. This need
was recently acknowledged by the UK IPO,
which carried out extensive consultations and
concluded that the UK legislation required
amendment to achieve harmony with our EU
partners. Uncertainty over the scope of the
Bolar exemption remains and grows with the
imminent arrival of the Unitary Patent Court,
which will necessarily apply a standard that
is significantly different from that currently in
place in at least some major European pharmaceutical markets.
A clear understanding of reimbursement
issues in each major market is critical to
pharmaceutical companies, and this is aided
by developing a close working relationship
with those national bodies that coordinate
drug purchasing. Providing value for money
is clearly an aim of most companies, but it
is critical for the continued existence of the
pharmaceutical sector that such agencies appreciate the true cost of innovative drugs. A
healthy innovation engine is required to continue to maintain a pipeline of new medicines
to improve on existing treatments and develop
solutions to the yet unknown challenges of the
future. IPPro
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