12Comparative Studies on Patent Systems for Protecting
High Technologies in the Advanced Medical Field

There have recently been remarkable technological innovations in the advanced medical field,
including gene therapy and regenerative medicine. It has been recognized that it is necessary to
clarify the present situation of protection of technologies in the this field in other countries andproblems which each country is addressing to protect advanced technologies, as well as to conduct
basic study on desirable systems and their operations to protect technologies in the field more
appropriately in Japan. In this study, we prepared materials that can serve as a basis for discussion
on systems to protect technologies in the field and their operations, etc. More specifically, we didresearch on how researchers and engineers expect or foresee the future trends in R&D and how they
approach to intellectual property relating to technologies in the advanced medical field, relevant
provisions in the patent laws of some countries and their operational guidelines, the background of
establishment of such provisions and guidelines, and specific operations of the patent system of eachcountry, based on the present situation of specific R&D relating to technologies in this field,.

therapy include gene transfer/expression
technology, target molecules/genes for genetherapy, target cells for gene transfer, target
diseases, technology for controlling gene
expression, technology for manipulating
genes, and experimental animals for studies
on human diseases. In addition, major
technological elements that constituteregenerative medicine include cells (ES cells,etc.),
differentiation-inducing/growth-inhibiting
mechanisms, tissue engineering, tissue
regeneration, cell therapy, technology forhandling
cells(extraction/preservation,
separation,cultivation/proliferation,transport, etc.), transplant, experimental
animals for studies on human diseases,
imaging, monitoring, and safety/quality
assessment technology.
In this study, the following surveys andresearch were conducted based on thepresent situation of specific R&D of hightechnologies in the advanced medical field, inJapan and abroad: a survey for leading
researchers and engineers in the field on how
they expect or foresee the future trends in
R&D and how they approach to intellectual
property; research on relevant provisions in
the patent law; research on other relevant

In this study, we did research on the
future trends in advanced medical care,including gene therapy and regenerative
medicine, based on the present situation of
R&D, and also surveyed basic information
with regard to the patent system of somecountries, and operations and backgrounds
thereof, as well as that with regard tosystems other than the patent system.

I

Introduction
There have recently been remarkabletechnological innovations in the fields of genetherapy and regenerative medicine. The
Institute of Intellectual Property published“Research and Study on Patent Protection for
Medical Field” in March 2001. In 2003,
Chapter
1“Industrially
Applicable
Inventions” in Part II of the Examination
Guidelines for Patent and Utility Model was
revised from the viewpoint of regenerative
medicine, etc.
In March 2006, the Japan Patent Office(JPO) published a report titled “Analysis ofFiling of Patent Applications Based on
Correlation between Trends in Articles andPatent Applications in the Advanced Medical
Field.” According to this report, major
technological elements that constitute gene
1
IIP Bulletin 2007

indicates a tendency that not many patentapplications are filed in these fields on thewhole. In Japan, the government has beendeveloping measures for R&D in theadvanced medical field, outside the patent
system, from multifaceted perspectives, andvarious laws and regulations as well as
guidelines have been put into force or madepublic. According to the survey, these laws
and regulations as well as guidelines arewidely recognized among researchers andcompanies, etc., of which, the Convention on
Biological Diversity (CBD) relating to accessto genetic resources, the Bonn Guidelines on
Access to Genetic Resources and Fair andEquitable Sharing of the Benefits Arising outof their Utilization, and the Cartagena
Protocol on Biosafety, as well as laws,
regulations
andguidelines,
etc.
for
implementation thereof in Japan arerecognized as measures oriented toward
restraining R&D as a whole. To the contrary,
reduction of fees for requesting examinationof patent applications and patent fees as wellasaccelerated
examination/appeal
proceedings systems are recognized asmeasures oriented toward promoting R&D.
In the interview survey, the respondents
were asked their opinions about the fact thatthe definition of “industrially applicableinventions” in the Examination Guidelines
for Patent and Utility Model was recently
revised to stipulate that a method for
manufacturing a medicinal product ormedical material by utilizing raw material
collected from a human being is not qualified
to be placed under the category of “methods
for treatment of the human body by surgery
or therapy and diagnostic methods practiced
on the human body,” even if the method is amethod for processing the material collectedfrom the human being based on a
presupposition that the material from ahuman being will be returned to the same
human being as part of his medical
treatment and that such a method has been
included in the subject matter of patent
protection. In response to this question, mostof the respondents positively evaluated the
expansion of the subject matter of patentprovisions;researchonthespecific
operations of the patent system in relation toadvanced medical technology; and researchon the backgrounds (discussions, etc.) of
establishment of relevant provisions inpatent law and operational guidelines for
examination in each country.

II

A Survey Concerning the Future
Trends, etc. for Leading Researchersand Engineers in the Advanced
Medical Field
In this study, an awareness survey was
conducted for individuals and companies, etc.
engaged in R&D in the advanced medical
field,
includinggenetherapyandregenerative
medicine.
That
is,
a
questionnaire survey was conducted in Japanfor researchers in the fields of gene therapy
technology and regenerative medicine
technology, and engineers and companies, etc.
engaged in these technologies, in order tounderstand the actual conditions and theirattitudes on how they regard the present
situation of R&D, what kinds of technologies
will attract their attentions in the future, andhow they approach to intellectual property.
Then, an interview survey was conducted forsome of the questionnaire respondents basedon their answers to the questionaire.
As a result of the questionnaire survey,
many respondents cited “process or means of
introducing the active ingredients of a genetherapeutic agent administered to anindividual into the target cell, etc.,” as thepresent research target in the field of genetherapy, a noticeable research target in termsof future research trends, or a category of
inventions for which they have filed patentapplications. As well, many respondents cited“process or means of differentiating, inducing,
proliferating or preserving cells,” as thepresent research target in the field of
regenerative medicine, a noticeable researchtarget in terms of future research trends, or acategory of inventions for which they have
filed patent applications. However, most
respondents have filed no more than fivepatent applications in the field of genetherapy or regenerative medicine, which
2
IIP Bulletin 2007

appeal and courts’ judgments.

protection through this time’s revision. As
the reasons, the respondents, for example,
said that the field covered by the expansion of
the subject matter of protection is the field
relating to regenerative medicine, in whichtheindustrycanparticipate,andparticipation of and support by the industry
are indispensable for the development ofadvanced medical care. On the other hand,regarding medical acts, such as a method forcollecting cells, etc. from a human being anda method for returning cells, etc. to the same
human being as part of medical treatment,
some said that the subject matter of patent
protection should be expanded to include
these medical acts while others said thatthese medical acts should be excluded fromthe subject matter of patent protection, as is.
Even the former cited the following as
conditions for expanding the subject matterof patent protection to include medical acts:(1) medical acts shall be made immune fromliability for patent infringement and (2)patent rights shall not be enforced in relation
to treatment for an incurable disease or in
the case of an emergency. Therefore, it can besaid that the respondents, including thelatter, have a common recognition of thenecessity of giving consideration in patent
practice to medical acts relating to advanced
medical care and patients who enjoy thebenefits of such medical acts. In addition, therespondents cited the following as reasons for
asserting that patent protection should be
expanded to include medial acts: (1) economic
support from companies is essential; (2) thenature of an invention in the field of
regenerative medicine using autologous cells
is often a series of processes from collecting
cells, etc. from a human being to injecting thecells, etc. into the same human being, (3)claiming a portion of the entire processcauses discrepancy between the nature ofthat invention and the claim directed to the
portion, and (4) even if a portion of the entire
process is entitled to be patented, there will
be concerns about the effectiveness of thepatent. The appropriateness of these reasonsremains to be verified, and it will become
clear through accumulation of decisions forIII

Provisions Relating to Advanced
Medical Technology in Patent Law and
Guidelines
for
Their
Specific
Operations
In this study, research was conducted onprovisions relating to advanced medical
technology in the patent law of each country(requirements for patentability, description
requirements, enablement requirement, etc.),
their
specific
operations(operationalguidelines for examination, examination
guidelines, etc.), and backgrounds forestablishment of the patent law and specificoperation guidelines thereof (discussions at
congress, the government, various bodies,and industrial parties).
The Japan Patent Act and the Ordinancefor Operation thereof do not set any
provisions specific to the technical fields
directly related to advanced medical care.
However, patent laws in the United Kingdom,
Germany and France as well as the European
Patent Convention clearly stipulate that usesof human embryos for industrial orcommercial purposes shall not be thepatentablesubject
matter.
Europeancountries have been intending to establish acommon framework for patent systems
relating to biotechnological inventions,
including uses of human embryos, throughimplementation of Directive 98/44/EC of theEuropean Parliament and of the Council of 6
July 1998 on the Legal Protection of
Biotechnological Inventions (Biotechnology
Directive) in each member country. However,there have been circumstances, problems anddiscussions unique to each country in termsofdomestic
implementationoftheBiotechnology Directive.
The examination guidelines in Japan,
the United States, France and South Korea
do not directly refer to human embryos andhuman embryonic stem cells. On the contrary,
the U.K. Examination Guidelines explicitly
exclude human embryonic stem cells thathave the potential to develop into an entire
human body and methods of producing or
culturing such cells from the patentable
3

IIP Bulletin 2007

human being will be returned to the same
human being falls under the category of
medical acts and is thus not an industriallyapplicable invention, and then cite a processof blood by dialysis as an example of suchinvention. However, the Examination
Guidelines for Medical and Health Fields ofSouth Korea stipulate that a method forprocessing blood, cells, etc. collected from ahuman being is a step that is separable fromrelevant medical acts and is thus industriallyapplicable,
and
cite
a
methodofmanufacturing recombinant human cells anda method of manufacturing artificial bone
containing
humancells,
whichareapparently intended to be used for genetherapyandregenerative
medicine,
respectively, as examples of such method.
Relationships and consistency between the
Examination Guidelines for Medical and
Health Fields and the Examination
Guidelines are not necessarily clear, andattention also must be paid to the trends offutureappealdecisionsandcourts’judgments.
As for movements relating to genetherapy, Germany and other European
countries have recently come to stipulate intheir patent laws that uses of a genedisclosed in the specification shall be
described in the claims directed to a genetic
invention. It is necessary to carefully watch
for the influence of the practice of deeming a
genetic invention as an exception to an
invention of a product and limiting the scopeof claims directed to the product by use
thereof as well as courts’ judgments.

subject matter. The present determination
standards are unique to the United Kingdom
and seem to be based on the implementationof the Biotechnology Directive. On the other
hand, it seems that as of the time of ourresearch, the implementation of the
Biotechnology Directive had yet to be directlyreflected in the examination guidelines ofFranceandGermany.
The
ChineseExamination Guidelines clearly stipulatethat no patent right may be granted for usesof human embryos for industrial orcommercial purposes as well as humanembryonic stem cells and methods for
producing them.
In Japan, a chapter titled “Industrially
Applicable Inventions” in the Examination
Guidelines for Patent and Utility Model wasrecently revised to stipulate that a method
for manufacturing a medicinal product ormedical material by utilizing raw material
collected from a human being is not qualified
to be placed under the category of “methods
for treatment of the human body by surgery
or therapy and diagnostic methods practiced
on the human body,” even if the method is amethod for processing the material collectedfrom the human being based on a
presupposition that the material from ahuman being will be returned to the same
human being as part of his medical
treatment. In contrast, the Guidelines for
Examination of the European Patent Office(EPO) stipulate that a method of treatment oftissues or fluids removed from a human bodyis excluded from the patentable subject
matter if they are returned to the same
human body, and cite a process of blood bydialysis as an example of such invention. In asimilar way, the Chinese Examination
Guidelines
stipulatethat
methods
comprising returning cells or tissues to thesame human body and a process of blood bydialysis fall under the category of methods oftreatment, and that no patent may be
granted for such processes. The Examination
Guidelines of South Korea also stipulate thata method for processing the material
collected from a human being based on a
presupposition that the material from a

IV Decisions for Appeals and Courts’
Judgments Relating to Patents
Pertaining to Advanced Medical
Inventions
In this study, courts’ judgments andappeal decisions on cases pertaining topatents in the relevant field in each country
were collected in order to analyze theexamination process in specific cases andstudy representative appeal decisions andjudgments in detail as part of research on thespecific operations of the patent system for
4

IIP Bulletin 2007

EPO and the United Kingdom, etc.,
submitted their opinions. A decision on G2/06
is expected to be rendered at the end of 2007at the earliest. On the other hand, theGerman Federal Patent Court rendered a
judgment of partial invalidation of German
Patent No. 19756864 relating to humanembryonic stem cells in December 2006. In
particular, it appears that claims pertaining
to use of human embryonic stem cells were
determined to be invalid. The said judgment
had not been made public as of February
2007, and it was not possible to review thedetails thereof. However, this judgment
attracts attention as one that may affect theoutcome of the above-mentioned case of theEnlarged Board of Appeal of the EPO(G2/06).
Some decisions and judgments were also
found in South Korea which has been making
a remarkable rise in the field of regenerative
medicine. The Supreme Court of Korea heldthat the industrial applicability requirement,
which is required for an invention pertaining
to a cell for immunotherapy under the Patent
Act, may be met even if the invention is to beindustrially reduced to practice in the future,
but that it will not be met if the invention
will become industrially applicable only after
it is technically complemented through thedevelopment of relevant technology.
In cases in the United States in which
non-obviousness was disputed, judgments
were made mainly on the procedures followedby the examiner, including motivation tocombine more than one prior art document,
unacceptable hindsight, and picking andchoosing among a number of options
disclosed by a prior art. On the other hand,appeal decisions relating to inventive step inJapan contain those on the outstanding effectargued by the appealant and the existence oftechnical difficulties at the level of the art asof the filing. The decisions of the EPO
relating to inventive step contain those onwhether or not there was an incentive toachieve the invention in terms of prior art or
the level of the art and whether or not
success of the invention could be reasonably
expected based on prior art.

inventions in the advanced medical field ineach country. As a result, about 30 cases wereextracted in which the requirements for
substantive
examination(industrial
applicability,
novelty,inventive
step,
enablement requirement, and description
requirements, etc.) have become a point ofissue on patent application claiming
advanced medical inventions.
About 30 extracted cases were classified
by the type of the disputed requirements.
Inventive step/non-obviousness has become apoint of issue in about three-fifths of all thecases extracted while eligibility for patent(industrial applicability, public order andmorality, exclusion from patentable subject
matter, utility, etc.) has become a point ofissue in about one-fifth of all the cases. In
addition, about 30 extracted cases wereclassified by the category of a patented
invention (or an invention for which an
application was filed). About half of all thecases were related to gene therapy while
about one-third were related to regenerative
medicine, of which, gene therapy-related
inventions included therapeutic genes,
vectors, antisense, combination of genes andother drugs, and gene-trapping technology,
while
regenerative
medicine-related
inventions included embryonic stem cell
cultures, hematopoietic stem cells andcompositions containing hematopoietic stem
cells, technologies for isolating, enriching or
selectively
proliferating
stem
cells,
scaffolding materials for tissue engineering,
technologies for tissue regeneration using
mesenchymal stem cells, compositions
containing cells for skin regeneration, andtechnologies for separating/culturing cells.
In Europe, there has been much debate
on whether or not inventions related toembryonic stem cells are excluded from thepatentable subject matter. With respect to adecision of the Technical Board of Appeal of
the EPO (T1374/04) over an invention of anembryonic stem cell culture, some questionsof law were referred to the Enlarged Board of
Appeal (G2/06). The Enlarged Board of
Appeal of the EPO sought public commentsfrom third parties, and the President of the5
IIP Bulletin 2007

subsequently, the Guidelines on the
Handling of Specified Embryos have been
made public. In Europe, there are regulations
at the domestic level, in addition toregulations at the European Union level
through some EU Directives and the Oviedo
Convention (Convention on Human Rights
and Biomedicine). Consequently, there aredifferences in regulations among European
countries. In the United States, there areneither laws nor regulations at the federal
level that regulate specifically research on
human embryos and human embryonic stem
cells. However, federal regulations related
thereto have been widely established, andalso, state-level laws and regulations areapplicable. In addition, R&D in the advanced
medical field is examined and supervised by
the Food and Drug Administration (FDA),
which is the regulatory authority on medical
products, etc., and the National Institutes of
Health (NIH), while research on genetransfer is examined and supervised by the
Recombinant DNA Advisory Committee(RAC) within the NIH.
Regarding pharmaceutical affairs law
and doctor law, systems (laws andregulations, guidelines, relevant authorities,etc.) to regulate clinical R&D of medical
products and equipment, such as those in theadvanced
medicalfield,
includingregenerative
medicine
using
human
embryonic stem cells and other stem cells,
have recently been newly established, or
reformed, improved or strengthened, inJapan and other countries studied. The
research provided a glimpse into the current
situation in Europe wherein the whole ofEurope has been steadily increasing theefficiency of the procedures for clinical trials
in the advanced medical field and promoting
the establishment of common procedures forthem, through implementation of EU
Directive 2001/20/EC on clinical trials and
GCP Directive 2005/28/EC in each country, as
well as through strengthening of theEuropean Medicines Agency (EMEA) and
improvement and promotion of the EMEA’s
centralized procedure for approval. In
Germany, it is not possible to select the

For the United Kingdom, France, China
and Hong Kong, however, neither decisions
nor judgments pertaining to patents directly
related to an advanced medical invention,
including gene therapy and regenerative
medicine, were detected. In addition, some
judgments relating to the enforcement of apatent right pertaining to an advanced
medical invention, including gene therapy
and regenerative medicine, were found onlyin the United States, among countries andregions subject to the research.
V

Other Relevant Provisions Relating to
R&D in the Advanced Medical Field
In this study, research was conducted onprovisions etc., relating to ethics/humanrights, pharmaceutical affairs law/doctor law,environment/genetic
resources,
R&D
subsidies, and fosterage of small and medium
sized enterprises, as well as other relevant
propulsive provisions and other relevant
restraining provisions, focusing on Europe as
a whole, countries in Europe, the UnitedStates, and countries in East Asia, with theaim of gaining an understanding ofprovisions relating to R&D in the advanced
medical field other than those under thepatent system.
In regard to ethics/human rights,
dynamic efforts have been made in Japanand other countries to develop, improve or
strengthen
theregulationsofestablishment/transfer/import and export ofhuman embryos and human embryonic stem
cells, regulations of human genome/ handlingof genetic information/genetic recombination,systems to protect test subjects in theadvanced medical field and those who
provide samples relating to advanced medicalcare (informed consent, management of
personal information, etc.), and systems to
examine, follow up and evaluate the plan,
implementation and results of research in theadvanced medical field from an ethicalviewpoint (establishment of an ethics
commission in a relevant organization, andclarification of its duties, etc.). In Japan, theAct on Regulation of Human Cloning
Techniques has come into effect, and6
IIP Bulletin 2007

manner, differences in the responses adopted
by each country are relatively noticeable. In
connection
withgenetic
resources,
procedures for revising the Patent Law are
now ongoing in China to add provisions, suchas a provision that if acquisition and use ofgenetic resources necessary to complete an
invention claimed in a patent application
violates any relevant laws and regulations in
China, a patent will not be granted for theinvention.
Regarding R&D subsidies, a frameworkadopted in the United States is distinctive.
Under the administration of the incumbent
President
Bush,
the
U.S.
FederalGovernment provides no funds (represented
by NIH Funds) to research designed to newly
establish human embryonic stem cells bydestroying human embryos and research
using
human
embryonic
stem
cells
established in said manner. However, there
are no federal-level regulations on theprovision of private funds, and provision ofstate government funds differs with respect
to each state. Although the framework ofprovision of the U.S. Federal Government’s
funds is expected to be maintained for the
meantime under the current administration,
attention has to be paid to future movements,
including the possibility that the framework
may be significantly changed in the case of achange of administration.
Regarding fosterage of small andmedium sized enterprises, the United States
has established the basis of enabling creationand fosterage of biotechnological venturecompanies in advance of other countries bypromotingtechnology
transferfromuniversities based on the Bayh-Dole Act
enacted in 1980 as well as taking othermeasures. In recent years, other countries
have been developing systems to foster small
and medium sized enterprises and venturecompanies (promotion of technology transfer,
reduction
andexemptionoftaxes,
preferential
examinationofpatentapplications, reduction and exemption of
costs necessary for filing a patent application,formation of industrial clusters).
(Senior Researcher: Toru WATANABE)

domestic procedure for approval that is
implemented by the German national
authorities, for medical products derived
from biotechnology, and the EMEA’s
centralized procedure for approval is the only
way to approval. In the United States, theregulatory authorities for medical products
and equipment are centralized in the FDA.
Also in the United Kingdom, such authorities
have just been centralized in the Medicinesand Healthcare Products Regulatory Agency(MHRA).
While
clinicaltrialsandpermission/approval for medical products
and equipment are examined and supervised
in a centralized manner through said
regulatory authorities in the United States
and the United Kingdom, clinical trials under
the Pharmaceutical Affairs Act and clinical
trials led by doctors coexist in Japan. In
addition, the International Conference on
Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human
Use (ICH) plays an important role instandardizing the quality of clinical trials at
the international level. Development ofsystems is ongoing in reference to the ICH
guidelines in China and other countries, aswell as in Japan. In terms of measures thatcan promote clinical trials in the advanced
medical field, various measures taken by the
FDA (micro-dose study, Phase 1 GMP, etc.)
attract attention.
Regardingtheenvironment/genetic
resources, it is possible to see the present
situation where the above-mentioned CBD,in particular, the Cartagena Protocol on
Biosafety under the CBD, plays an importantrole in Japan and other countries. For
example, Japan, South Korea and so on haveenforced laws and made guidelines toimplement the Catagena Protocol to the
public. In relation to the CBD, the Bonn
Guidelines on Access to Genetic Resources
and Fair and Equitable Sharing of the
Benefits Arising out of their Utilization havebeen published. Then, China is going onstrengthening measures to prevent its own
genetic resources from running off to outside
the country. On the other hand, the UnitedStates has not ratified the CBD. In this7
IIP Bulletin 2007