13 The Patentability and Scope of Protection of PharmaceuticalInventions Claiming Second Medical Use – the Japanese andEuropean Approaches as Possible Paradigms for a Developing
Country like Brazil(*)
Invited Researcher : VivianeYumy Mitsuuchi Kunisawa(**)
Progress in technology in the pharmaceutical area is often achieved by the development offurther uses of an already known substance. Patent protection plays an important role by insuring
investments in Research & Development (R&D) and in clinical trials necessary for the marketingof a new drug. The Examination Guidelines of the Japanese Patent Office (JPO) of 2005 haveestablished some standards for the examination of patentability requirements of such inventions,classifying them as “inventions of products”. There are discussions about the adequacy of theprotection given to these kinds of inventions. The European Patent Office (EPO) has been
accepting them under the so-called Swiss-Type claim wording since 1985. It has also clarified thatsuch claims are towards an “effect” achieved by a substance (not to the production of a product).
This led to the interpretation that such claims afford a product-by-new-use protection. In 2004 theEPO also dealt with the admissibility of claims concerning dosage regimes. The new European
Patent Convention (EPC) 2000, in force as of December 13 of last year, introduces some changes
that might lead to different practices by the EPO in the future. The research aims at analyzing thepatterns of patentability and scope of protection of pharmaceutical inventions claiming second
medical use in Japan and in Europe. The analysis intends to be helpful in the development of theBrazilian patent system, where the situation still remains unclear.

IIntroduction

The purpose of this work is to analyze
the patterns of patentability and scope ofprotection of pharmaceutical inventions
claiming second medical use in Japan and inEurope. It takes into account the importanceof these two players in the global context andthe provisions of TRIPS Agreement, and it
analyzes elements that can be helpful indeveloping the Brazilian patent system andits boundaries.
It is first described the overall scenarioof the systems under investigation. Japan is
an example that the introduction of aneffective patent protection leads to increased
R&D activities and, thus, economic growth,
becoming one of the largest trading economy
(*)
(**)

in the world. The Japanese government
recognized the importance of improving thebusiness environment to attract investments
and developed a program to make Japan an“intellectual-property-basednation”,
byimplementing measures to promote thecreation and reinforce the patent protection
for pharmaceuticals and other arts.
For a developing country, Brazil has an
educational
systemandresearchorganization relatively able to generateinventions and to benefit from a patent
system. Brazilian universities and research
institutions are pioneers in different projects.
For example, the Empresa Brasileira dePesquisa Agropecuária (EMBRAPA), aBrazilian governmental institution, wasamong the first entities in the world toThis is a summary of the report published under the Industrial Property Research Promotion Project FY2007
entrusted by the Japan Patent Office.
Research Fellow, the Max Planck Institute for Intellectual Property, Competition and Tax Law, Munich; Attorney atLaw in Brazil●IIP Bulletin 2008106 ●

understand and reveal the genome sequenceof a living being, the bacterium Xilellafastigiosa, a pathogen that attacks citrusfruits.
The European Patent Convention (EPC)
was signed in Munich in 1973 and provides
for a centralized system for the granting ofEuropean patents. It establishes a system of34 European Contracting States withextension to four other States that recognize
the European patent. The EPO is theexecutive body of the system under the EPC
and is responsible for granting Europeanpatents for the Contracting States to the EPC.
Upon grant, a European patent has the effectof a national patent in the Contracting States
which the applicant has designated at thefiling of the application.
Then, the work describes the importanceof the development of further applications ofan already existing or known substance,
being such inventions valuable technicallyand commercially. Patent protection plays animportant role to promote the research on
further medical uses, by insuring investments
in R&D and in clinical trials necessary for thedevelopment of a new drug.
The term “first medical use” is used for a
new medicinal use of a known substance thathave not yet been used for medicinal purposes,
as opposed to “second medical use”, whichrefers to claims covering second medical
indications of know substances already usedfor medicinal purposes. In the present work,
the term “second medical use” designates not
only second but also third and further
medicinal uses of a known substance.
Grounded on the fundamental objective of
the patent system, i.e. promotion of technicaldevelopment for the benefit of the society as awhole, Japan and Europe developed one of
the most important patent systems in theworld. The analysis of the patentability
patterns and scope of protection of inventions
claiming second medical use under these twosystems may serve as guidance andcontribute to the development of a soundpatent system in Brazil.

●IIThe European System

In Europe, article 52(4) of the EPC 1973
prohibited
patentingofmethods
fortreatment of the human or animal body bysurgery or therapy and diagnostic methods
practiced on the human or animal body.
Although these subject matters may beconsideredinventions,theprovision
explicitly determined that they will not be
regarded as susceptible of industrialapplication. To support this provision is thepolicy argument that patents should not
unduly hinder the activities of physician.
Since 1985 when it decided the G1/83,G5/83 and G6/83 cases, the European PatentOffice (EPO) has been accepting the practiceof the Swiss Federal Intellectual Property
Office to protect second and subsequent
medical indications “by means of a claim
directed to the use of a substance orcomposition for the manufacture of a
medicament for a specified (new) therapeuticapplication”. It considered that, described assuch, inventions would not fall under theprohibitionofarticle
52(4),
despitecriticizing the assumption in the statutory
text that these kinds of inventions do nothave industrial applicability. The novelty
and inventive step requirements are derived
from the new and inventive use of thesubstance.
In another case, G2/88 the EPO hasclarified that “a use claim in reality defines
the use of a particular physical entity toachieve an ‘effect’, and does not define such a
use to produce a ‘product’”. From thisdecision, it can be concluded that theprotection conferred on the patentee covers
the use of a particular physical entity toachieve an effect in the sense of apurpose-related product claim, leading to a
product-by-new-use protection.
Since the G5/83 decision, the EPO has
been granting patents under Swiss-typeclaims for: i) specific group of animals orsubjects or a novel group of patients; ii)
particular mode of administration, i.e.
subcutaneous rather than intramuscular;and iii) new administration regimens, i.e.

107 ●IIP Bulletin 2008

certain dosage plan (“twice a day”) orintermittent or cyclic treatment (“on andoff”) of disease with a known drug.
On December 13, 2007, the EPC 2000
came into force, introducing some changes on
the EPC system, specially concerning
proceduralaspects.
With
regardtomodifications on substantive patent law, it
shifts the prohibition of patenting methodsof treatment from article 52(4) – whichceases to exist – to the new article 53(c).
Recognizing the criticism triggered by theEISAI decision, which considered that
second medical use inventions can beindustrial applicable, the new text simply
prohibits the granting of patents on them,but still recognizes the patentability ofproducts for use in methods of treatment.
Moreover, the new European Patent
Convention (EPC) 2000, in article 54 (5),recognizes second medical use inventions as
patentable inventions. It equates thetreatment of substances for their first andsubsequent use in a method referred to inarticle 53(c). It is expected that it would bepossible to describe a claim directed to aproduct for a specific medical use.
Because a European patent is considered
to be a “bundle of patents” to be enforced
according to the laws of the Contracting
States, it is important to analyze suchnational systems. In the present work,
United Kingdom (UK) and Germany werechosen for the analysis, with special focus onpatents on dosage regimes.
In the Bristol-Myers v. Baker Norton
case, the Court of Appeal of the United
Kingdom considered that the claim underdiscussion – consisting of a different dosage
regime – was directed to a method oftreatment of the human body andcontravened Section 4 of the UK Patents Act
1977. The Court emphasized that the newuse should be unconnected with thepreviously known uses.
In 1983, one year prior to the EPO’s
decision on G5/83 (EISAI), the German
Federal Supreme Court in the Hydropiridine
case, decided that a claim directed to the useof a known substance for the treatment of a●IIP Bulletin 2008

new disease does not contravene Section 5(2)of the German Patent Act, which corresponds
to article 52(4) of EPC 1973. The court
recognized that these inventions areindustrially applicable and established thata use claim does not need to be drafted in theSwiss-type form. With regard to dosage
regimens, in the Carvedilol II in 2006, theSupreme Court held that a therapy plan fora patient including the prescribing and theadministration of medicament is a method
excluded from patentability by article 52(4)EPC and Section 5(2) German Patent Act.

III The Japanese System
The JPO in the current Examination
Guidelines listed “methods for treatment of
the human body by surgery or therapy anddiagnostic methods practiced on the humanbody” as industrially inapplicable inventions.
Like in Europe, the policy underlying thisexclusion is to prevent patents from
hindering physicians’ activities in treatingpatients.
In order to solve the controversy andallow patents on pharmaceutical inventions
claiming second medical use, the JPO
considers them as an “invention of product”,
and, therefore, avoid them to be classified in
the category of methods for treatment.
Inventions consisting also of combination of
two or more medicines, defined by a mode of
medical treatment (dosage regimes) are also
understood as “inventions of a product”.
The Examination Guidelines establish
as admissible claims: i) “A medicine fordisease Z containing an effective componentA”; ii) “A medical composition for disease Y
containing an effective component B”; iii) “Amedicine for disease W containing effective
components C and D in combination”; and iv)“A kit for disease V comprising an injection
agent including an effective component E, anoral agent including an effective component
F, and an agent including an auxiliarycomponent G”.
Claims such “chemical compound X fortreating disease A” are not regarded as
medical use claim, but rather towards the108 ●chemical compound. The medical use
limitations
aredisregarded
in
theexamination of novelty. On the other hand,in case of first medical use inventions, theclaim can be described as “pharmaceuticalcomposition containing substance X”.
Representative embodiments or working
examples are needed to show the feasibilityof the claimed compounds to treat thediseases. The working examples required aremostly the result of the pharmacologicaltests (be it clinical, animal or in vitro), whichmust be submitted at the time of the filing of
the application, under the penalty ofrejection of the application for lack ofenablement.
Inorderto
fulfillthenovelty
requirement, the JPO established that theclaimed medical uses of the known active
ingredients should be novel over the priorart, meaning that: i) the compound shouldhave a new specific pharmacologicalproperty; and ii) the medicinal use for a
specific disease resulting from the property
should be novel. Applications would berejected on the basis of lack of novelty, incase the pharmacological effects are closelyrelated, the new claimed medical use isgeneral over the specific already known use,or the discovery of the working mechanism.
Inventions will be deemed not toaccomplishwiththeinventive
step
requirement, if the claimed new medical
uses and the prior art can be correlated witheach other in view of the mechanism of thebiological effect. With regard to combination
drugs, a new combination may involve
inventive step if such combination attains an
unexpected
remarkableeffect–theunexpected effect must be synergistic, notonly additive. Optimizing the dosing
schedule or dosage to reduce toxicity andimprove efficacy is considered by theExamination
Guidelines
aroutinedevelopment of the manufacturer of a
medicine. In such cases, the invention does
not involve inventive step, unless an
unexpected remarkable effect – to be shownby pharmacological test results – is attained.
The invention must also be towards a new●group of patients to be treated, a new dosage
form, a new strength per dosage unit or anew kit.

IV The Brazilian Situation
The current industrial property law (Law9279, of May 14, 1996) was enacted to comply
with the obligations assumed by the Brazilian
government
whensigningTRIPS.
It
establishes that inventions are patentable,
provided that they meet the requirements ofnovelty, inventive step, industrial application,
disclosure and they do not fall in thestatutory prohibitions of article 10 (subject
matter not patentable for lack of apatentability requirement) and 18 (subject
matter excluded by an express legal bar,although constituting an invention). Different
than the previous statute regulating
industrial property (Law 5772, of December
21, 1971), it does not exclude products in thepharmaceutical filed from patentable subjectmatter.
Article 10, VIII of Law 9279/96 does notconsider as inventions “operating or surgicaltechniques and therapeutic or diagnostic
methods, for use on the human or animalbody”.
The Instituto Nacional da Propriedade
Industrial (INPI) is the Brazilian Officecompetent for the examination and grantingof patents. In addition, the law requires“prior approval” by the Agência Nacional deVigilância Sanitária (ANVISA) – theregulatory agency responsible for themarketing approval of drugs – for theissuance of a patent in the pharmaceuticalarea. The “prior approval” requirement wasdefinitely introduced in article 229-C of theLaw 9279/96 on February 14, 2001 by theamending Law 10196/2001.
There is no legal guidance on therequirements for prior approval, nor any
regulation implementing article 229-C. The
ANVISA has decided on its own discretion to
re-examine the patent applications on thesame grounds already analyzed by the INPI.
The patentability requirements such asnovelty, inventive step and industrial
109 ●IIP Bulletin 2008

application are re-examined by ANVISA.
The INPI may allow patents on seconduseinventions,
includinginthepharmaceutical field, provided that suchsecond use is novel and evidence inventivestep. The current Examination Guidelines in
the Biotechnology and Pharmaceutical Field
defines what it is a second use invention.
and allow patentability of such inventions
under the Swiss-type form.
On November 26, 2003, ANVISA issued adecision about patent applications onpharmaceutical-related inventions, in which
it states that the agency will not grant priorapproval on inventions consisting of second
medical uses. It considers that patents on
second medical use inventions are harmful topublic health, to the country’s scientific andtechnological development, and that it mayhinder access to medication by thepopulation.
The conflicting understanding between
the two governmental institutions, the INPI
and ANVISA, led to the current discussions
to review the INPI’s Examination Guidelines.
To
themeetings
werepresent
representatives of the two governmental
institutions, associations from the genericindustry and the innovative industry, andpractitioners.
On December 3, 2007, the Judge of theFederal District Court of Rio de Janeiro
rendered a decision in a leading case, dealing
for the first time with the issue of second
medical use inventions. In the decision, theJudge states that new uses of pharmaceuticalproducts do not represent therapeuticmethods, and are not included among theprohibitions of article 10, VIII of Law 9279/96.
In addition, he clarifies that he does notunderstand that a Swiss-type claim to protect
a pharmaceutical second use invention should
be considered a process claim, but understandthat it should be considered as a productbound by its purpose.

Vfor a limited period provides an incentive forpeople to innovate and invest. The social
return from this incentive to innovate createdby patent possibilities is an increase in thegeneral knowledge and the creation of usefulproducts from which, ultimately, the publicbenefits.
Nevertheless,thepatentabilityofinventions in the pharmaceutical field raises
controversies, especially in the developing
countries, where pharmaceutical patents ingeneral lead to increase of prices and affectconsumer’s access to medicine. Providing
patent protection to second medical uses
would have as purpose prolonging the life ofexisting products patents, being the privilege
erroneous, because it does not cover aninvention, but rather a simple discovery.
Another argument criticizing such patents isthat they consist of methods for medical
treatment,which
areexcluded
frompatentable subject matter in some systems,
like Europe, Japan and Brazil.
Not allowing patents on second medical
uses may leads to even more damaging
effects to the Brazilian pharmaceuticalindustry, which does not have the means tofinance and perform the R&D activities andthe clinical trials needed for the developmentof new drugs containing new chemicalcompounds. In contrast, the expenses neededfor development of a drug based on new usesof known chemical compounds are much
lower, since the initial tests for proving thesafety of the substance have already beenperformed.
In light of the experience of Europe andJapan, second medical use inventions can bedistinguished from methods for medical
treatment and from mere discoveries. For
such kinds of inventions, the incentive ofpatent protection is likely to be needed toencourage innovation.

Conclusion

The basic belief governing the patent
systems is that the possibility of protection●

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110 ●