Date of
Judgment: June 5, 2015
Issuing
Authority: Supreme Court
Level of
the Issuing Authority: Final Instance
Type of
Procedure: Judicial (Civin( �b>
Subject
Matter: Patent (Inventions)
Main
text of the judgment (decision):
1.The
judgment in prior instance is quashed.
2.The case is remanded to the Intellectual
Property High Court.
Reasons:
Concerning Reasons I, II, IV, and V for
petition for acceptance of final appeal argued by the appeal counsel, UETANI
Kiyoshi, et al.
1. In this case, the appellant of final appeal, who holds a patent right for an
invention of a product based on a claim which recites the manufacturing process
of the product, generally referred to as a "product-by-process
claim," alleges that the medicine manufactured and sold by the appellee of
final appeal infringes the appellant's patent right, and seeks an injunction
against the appellee to stop it from manufacturing and selling the medicine in
question and demands the disposal of the same. The appellee contends, inter
alia, that the appellee’s medicine does not fall within the technical scope of
the invention covered by the appellant’s patent. The point at issue in this
case is how to determine the technical scope of the patented invention in the
case where a claim of a patent for an invention of a product recites the
manufacturing process of the product.
2. The outline of the facts determined by the court of prior instance is as
follows.
(1) The patent in question
The appellant holds a patent for an invention titled "pravastatin sodium
substantially free of pravastatin lactone and epipravastatin, and compositions
containing the same" (Patent No. 3737801; the number of claims: 9;
hereinafter referred to as the "Patent").
(2) The invention in question
Claim 1 of the Patent (hereinafter referred to as the "Claim") is as
described below (hereinafter the invention described in the Claim is referred
to as the "Invention").
"Pravastatin sodium prepared by a process comprising the steps of:
(a) forming an enriched organic solution of pravastatin;
(b) precipitating pravastatin as its ammonium salt;
(c) purifying the ammonium salt by recrystallization;
(d) transposing the ammonium salt to pravastatin sodium; and
(e) isolating pravastatin sodium,
and containing less than 0.5 wt% of pravastatin lactone and less than 0.2 wt%
of epiprava."
(3) The appellee's product
A. The appellee manufactures and sells medicine named pravastatin Na tablets,
10mg, "KH" (former name: pravastatin Na tablets, 10mg,
"Merck"; hereinafter referred to as the "appellee's
product").
B. The appellee's product contains pravastatin sodium that contains less than
0.5 wt% of pravastatin lactone and less than 0.2 wt% of epiprava. The
manufacturing process of the appellee's product does not contain, at least, the
step of "a) forming an enriched organic solution of pravastatin,"
which is stated in the Claim.
3. The court of prior instance dismissed the appellant's claim, holding as
follows.
(1) When a claim of a patent for an invention of a product recites the
manufacturing process of the product, the technical scope of the invention
should be determined as being limited to products manufactured by the
manufacturing process recited in the claim, except when there are circumstances
where it was impossible or difficult to directly define the product subject to
the invention by means of its structure or characteristics at the time of the
filing of the application.
(2) Since such circumstances mentioned in (1) above cannot be found with regard
to the Invention, the technical scope of the Invention should be determined as
being limited to products manufactured by the manufacturing process recited in
the Claim. The manufacturing process of the appellee's product does not
contain, at least, the step of "a) forming an enriched organic solution of
pravastatin," which is stated in the Claim, and hence the appellee's
product does not fall within the technical scope of the Invention.
4. However, we cannot affirm the criterion mentioned in 3.(1) above, which was
presented by the court of prior instance, and then, we also cannot affirm the
determination mentioned in 3.(2) above, which was made by the court of prior
instance based on that criterion. The reasons for this conclusion are as
follows.
(1) The recitation of a claim attached to a patent application plays a role of
the basis for determining the technical scope of a patented invention (Article
70, paragraph (1) of the Patent Act), and also for identifying the gist of the
invention claimed in a patent application, which serves as the premise for
examining the requirements of patentability prescribed in Article 29 of said
Act (see 1987 (Gyo-Tsu) No. 3, judgment of the Second Petty Bench of the
Supreme Court of March 8, 1991, Minshu Vol. 45, No. 3, at 123). A patent is to
be granted for an invention of a product, an invention of a process or an
invention of a process of producing a product. If a patent has been granted for
an invention of a product, a patent right relating to that patent is effective
against any products that have the same structure, characteristics, etc. as
those of the product subject to the invention, irrespective of the
manufacturing processes of these products.
Consequently, it is appropriate to construe that even when a claim of a patent
for an invention of a product recites the manufacturing process of the product,
the technical scope of the patented invention should be determined as being
limited to products that have the same structure, characteristics, etc. as
those of the product manufactured by the manufacturing process recited in the
claim.
(2) Under Article 36, paragraph (6), item (ii) of the Patent Act, the
recitation of a claim must meet the requirement that the claimed invention is
clear. The patent system is designed to grant a patent right, which is an
exclusive right, to a person who has disclosed his or her invention, thereby
protecting the invention for the interest of the patentee, while enabling a
third party to understand the content of the patented invention, with the
ultimate purpose of promoting the utilization of inventions to encourage
inventions, and thereby contributing to the development of industry (see
Article 1 of the Patent Act). The provisions of Article 36, paragraph (6), item
(ii) of said Act can be understood as requiring clarity of the claimed
invention because of such purpose of the patent system. From this viewpoint, in
cases where a claim of a patent for an invention of a product recites the
manufacturing process of the product, without exception, if the technical scope
of the patented invention is determined on the assumption that a patent right
relating to that patent is effective against any products that have the same
structure, characteristics, etc. as those of the product manufactured by the
manufacturing process recited in the claim, this could be unfairly prejudicial
to the interest of a third party and would be problematic. More specifically,
when a claim of a patent for an invention of a product recites the
manufacturing process of the product, it is generally unclear what structure or
characteristics of the product are represented by the manufacturing process, or
whether the technical scope of the patented invention is limited to products
manufactured by the manufacturing process, although the subject matter of the
invention is the product, and this would prevent those who read the recitation
of the claim, etc. from clearly understanding the content of the invention and
make it impossible for them to predict the scope of the exclusive right to be
conferred to the patentee, leading to an inappropriate situation.
On the other hand, in a claim of a patent for an invention of a product, the
applicant is usually supposed to directly define the product by clearly
reciting its structure or characteristics. However, there may be cases where,
depending on the specific content, nature, etc. of the invention, it is
technically impossible to analyze the structure or characteristics of the
product at the time of the filing of the application, or where it is utterly
impractical to require the applicant to define the product in such manner
because, in light of the nature of a patent application that needs to be
handled speedily, etc., the work to define the product could require excessive
economic costs and time. Assuming so, it is inappropriate to prohibit reciting
the manufacturing process of a product in a claim of a patent for an invention
of a product in any case, but rather it must be said that if there are such
circumstances as mentioned above, it would not be unfairly prejudicial to the
interest of a third party to determine the technical scope of the patented
invention as referring to products that have the same structure,
characteristics, etc. as those of the product manufactured by the manufacturing
process recited in the claim.
According to the above, it is appropriate to construe that when a claim of a
patent for an invention of a product recites the manufacturing process of the
product, the recitation of the claim should be held to meet the requirement
that the claimed invention is clear as prescribed in Article 36, paragraph (6),
item (ii) of the Patent Act, only if there are circumstances where it was
impossible or utterly impractical to directly define the product subject to the
invention by means of its structure or characteristics at the time of the
filing of the application.
5. Contrary to this conclusion, the court of prior instance determined that
when a claim of a patent for an invention of a product recites the
manufacturing process of the product, the technical scope of the patented
invention should be determined as being limited to products manufactured by the
manufacturing process recited in the claim, while generally permitting a claim
in this form. This determination involves violation of laws and regulations
that apparently affects the judgment. The appeal counsel's arguments are
well-grounded, and the judgment in prior instance should inevitably be quashed.
We remand the case to the court of prior instance to have it determine the
technical scope of the Invention in the manner as instructed in this judgment,
and further examine issues including whether or not the recitation of the Claim
meets the requirement that the claimed invention is clear and therefore it is
acceptable based on the assumption that there are such circumstances as
mentioned in 4.(2) above.
Therefore, the judgment has been rendered in the form of the main text by the
unanimous consent of the Justices. There are a concurring opinion by Justice
CHIBA Katsumi, and an opinion by Justice YAMAMOTO Tsuneyuki.
The concurring opinion by Justice CHIBA Katsumi is as follows.
In addition to the majority opinion, I would like to give my opinion as follows
with regard to how to grasp a claim that is generally referred to as a
"product-by-process claim."
1. First, I understand the basic framework for the construction and handling of
a product-by-process claim as follows.
(1) The amendment to the Patent Act in 2004 introduced a new clause as Article
104-3, which allows a defense of invalidity of a patent to be raised in an
infringement suit. As a result, the issue of identifying the gist of the
invention as the premise for determining whether the defense of invalidity
under said Article is established (whether the invention has novelty and an
inventive step) and the issue of determining the technical scope of the
patented invention as the cause of action in an infringement suit are addressed
in the same litigation proceedings. In that case, since it is unreasonable if
these issues are addressed within different basic frameworks for the
construction and handling of a product-by-process claim, a uniform framework
should be applied. This is what is to be expected under the Japanese patent law
system, and on the premise of this view, the majority opinion examines the case
according to the product identity theory).
(2) Meanwhile, in the United States, as a framework for the construction and
handling of a product-by-process claim, the part reciting a process in the
claim is not considered to be a particular problem in the patent examination,
and an application with such a claim is accepted according to the product
identity theory as long as the scope of the patent is not unclear. However, at
the stage of determining the existence or absence of patent infringement, it
has been an issue whether or not such part reciting a process should be
regarded as a factor for limiting the claim. As is well known, the United
States Court of Appeals for the Federal Circuit (CAFC) presented inconsistent
views, i.e. a view that rejected the limitation in Scripps Clinic &
Research Foundation v. Genentech, Inc., 927 F.2d 1565 (Fed. Cir.1991), and a
view that supported the limitation in Atlantic Thermoplastics Co. v. Faytex
Corp., 970 F.2d 834 (Fed.Cir.1992). Then, in its en banc decision in Abbott
Labs. v. Sandoz, Inc., 566 F.3d 1282 (Fed. Cir. 2009), the CAFC finally adopted
the latter view, and decided that the scope of a right based on a
product-by-process claim is limited to products manufactured by the
manufacturing process recited in the claim. This means that in an infringement
suit, the CAFC will not adopt the view that a product-by-process claim should
be construed according to the product identity theory broadly, without being
limited by the manufacturing process recited in the claim. Regarding this last
mentioned case (=566 F.3d 1282)], the Supreme Court of the United States denied
certiorari, and the CAFC decision became final and binding.
(3) Thus, in the United States, as a framework for the construction and
handling of a product-by-process claim, the existence of such circumstances as
pointed out in the majority court, i.e., it was impossible or utterly
impractical to directly define the product subject to the invention by means of
its structure or characteristics at the time of the filing of the application
(hereinafter such circumstances are referred to as "impossible or
impractical circumstances"), is not strictly required, and the gist of the
invention is identified according to the product identity theory. However, when
infringement is claimed, that is, when the technical scope of the patented
invention needs to be determined, the gist of the invention is construed
strictly in the end, being limited to the manufacturing process recited in the
claim. In the present case, since this court adopts a uniform framework for
determination to be applied to both stages of identifying the gist of the
invention and examining whether the allegedly infringing product falls within
the technical scope of the patented invention, the outcome would inevitably be
different in some aspects from the operation of the patent system in the United
States. Having said that, looking at the operation in the United States as
described above, when infringement is claimed, the entire scope of a
product-by-process claim would end up being limited to the manufacturing
process recited therein, in which case the significance of admitting the
concept of a product-by-process claim as a patent for an invention of a product
would be greatly undermined, ending up having to admit a double standard.
Hence, as long as the United States maintains such operation, harmonization
with the operations in Japan and European countries under different law systems
will never be achieved.
(In Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (2014), which
was concluded on June 2, 2014, the Supreme Court of the United States revoked
the CAFC judgment and remanded the case, holding as follows: with regard to the
definiteness of a claim, which is one of the descriptive requirements of a
claim, although the CAFC determined that a claim should be judged to be
indefinite only when it is not amenable to construction or when the claim is
insolubly ambiguous, a claim should be judged to be indefinite if, when read in
light of the specification and prosecution history, it fails to inform, with
reasonable certainty, those skilled in the art about the scope of the
invention, and in this respect, the CAFC's determination would diminish the
definiteness requirement’s public-notice function. This decision by the Supreme
Court is worthy of note in that it shows the court's attitude of strictly
requiring a high level of definiteness.)
2. Next, I would point out the following with regard to the JPO's current
criteria for examination of a product-by-process claim.
(1) According to the JPO's Examination Guidelines for Patent and Utility Model
(Part I, Chapter 1, 2.2.2.4(2), Part II, Chapter 2, 1.5.2(3)), the JPO still
examines a product-by-process claim according to the product identity theory,
in a manner as outlined below.
The product subject to the invention may be defined by the manufacturing
process thereof when there are circumstances where it is impossible or difficult
to directly define the constitution of the invention by means of its
properties, etc. (e.g. structure, etc.) independently of the manufacturing
process, or it is inappropriate to do so for some reasons (for example, when
defining the product in such manner would not be impossible or difficult but
would increase the degree of difficulty in understanding) (such circumstances
are hereinafter referred to as "impossible, difficult or inappropriate
circumstances"). When a part of a claim is written to define the product
by means of the manufacturing process, such claim is construed as referring to
the product itself that is finally obtained.
If a claim contains expressions intended to define the product by means of the
manufacturing process, in the examination on the clarity of the claim (Article
36, paragraph (6), item (ii) of the Patent Act) before examining the novelty
and involvement of an inventive step in the invention according to the product
identity theory, the JPO rarely conducts substantive examination as to whether
or not there are any such impossible, difficult or inappropriate circumstances
as mentioned above because the applicant has filed the application with a claim
in said form in the first place on the grounds of the existence of such circumstances.
If the applicant files an application with a claim in said form, the JPO finds
the existence of any impossible, difficult or inappropriate circumstances by
making reference to what is recited in the claim, and regards the claim as a
product-by-process claim and examines whether the product itself has novelty
and an inventive step according to the product identity theory.
(2) However, when an application is filed for a patent for an invention of a
product, the subject matter should in principle be directly defined by means of
the structure or characteristics of the product itself as recited in a claim.
If the scope of the subject matter to be defined by means of the manufacturing
process of the product is determined too broadly, the scope of the right to be
conferred by a patent would be expanded to cover any products that have the
same structure, characteristics, etc. as those of the product manufactured by
the manufacturing process recited in the claim, which could impede fair
competition and be unfairly prejudicial to the interest of a third party as
pointed out in the majority opinion. To avoid such a situation, a
product-by-process claim should be permitted only exceptionally, and strict
consideration should be made as to whether or not there are circumstances due
to which a product-by-process claim should be permitted. The examination of
such a claim should be handled virtually in line with such consideration.
3. According to the view explained above, I would examine the details of
exceptional circumstances due to which a product-by-process claim should be
permitted.
(1) In the present case, this court (majority opinion) states that such
circumstances can be found if "there are circumstances where it is
impossible or utterly impractical" to define the product subject to the
invention, and the details of these circumstances are explained in the majority
opinion. The term "impossible" referred to therein means the case
where it is impossible mainly from a technical perspective for a person
ordinarily skilled in the art at the time of the filing of the application to
define the product subject to the invention by analyzing its structure or
characteristics (the term "characteristics" as used here means
characteristics that are appropriate and significant in distinguishing the
product in question from other products in the course of determining the
novelty and involvement of an inventive step in the invention). The term
"utterly impractical" referred to in the majority opinion assumes the
case where, rather than from a technical perspective, the work to define the
product could force a person ordinarily skilled in the art at the time of the
filing of the application to spend time and costs to an extent that is
impractical in terms of profitability and therefore it would be too cruel to
require such person to perform such work while trying to obtain a patent in the
face of the rapid advancement of technology and fierce competition on a global
scale. Although the meaning of the latter term is not firmly established, the
guideline for considering what case would actually fall under the meaning of
the latter term will be made clear as court cases addressing this issue are
accumulated in the future.
(2) The third criterion adopted in the JPO's current examination practice,
i.e., "where it is inappropriate," covers too broad a range because
it relies too much on an aspect of value judgment and its substance is unclear.
Furthermore, even when it is not so difficult to define the product by means of
its structure, etc., this criterion could lead to allowing the applicant to
recite the manufacturing process in the claim merely for the purpose of making
it easier to understand the constitution of the invention. At any rate,
applying this criterion could result in the outcome being inconsistent with the
purpose of admitting the concept of a product-by-process claim, and therefore
it cannot be held to be reasonable.
If the applicant intends to make it easier to understand the constitution of
the invention, it would be sufficient to describe the manufacturing process in
the "detailed explanation of the invention," rather than reciting it
in a claim, and the applicant should take this approach.
4. I would comment on the patent practice in the future and the conventional handling
of a product-by-process claim.
(1) Conventionally, in the examination of a product-by-process claim at the
time of the filing of an application, the JPO has permitted the application
with such claim by loosely applying the requirement of impossible, difficult or
inappropriate circumstances, without conducting substantive examination on this
point. In the future, on the contrary, if a claim recites the manufacturing
process, the JPO is expected in the examination process to first confirm that
the application contains a product-by-process claim, and then request the
applicant to allege and prove that there are impossible or impractical
circumstances, and if the applicant fails to submit sufficient allegation and
proof on this point, the JPO is to issue a decision to refuse the application.
If the applicant wishes to avoid the refusal, the applicant would need to apply
for a patent for the same invention as an invention of a process for producing
a product as well (Article 2, paragraph (3), item (iii) of the Patent Act).
(2) In this respect, according to the criterion presented in the judgment of
the Grand Panel of the Intellectual Property High Court, which is the court of
prior instance of the present case, it is assumed that the JPO, in its
examination practice, does not reject a product-by-process claim by reason of
the failure to meet the clarity requirement irrespective of whether or not
there were circumstances where it was impossible or difficult at the time of
the filing of the application to directly define the scope of the invention of
the product by means of the structure, etc. of the product (hereinafter
referred to as "impossible or difficult circumstances"), and based on
this assumption, the JPO adopts the approach that categorizes a product-by-process
claim into two types, in that, both when identifying the gist of the invention
and when determining the technical scope of the patented invention, the JPO in
principle follows the manufacturing process limitation theory by regarding the
claim as a pseudo product-by-process claim, whereas the JPO follows the product
identity theory if the claim is a genuine product-by-process claim for which
impossible or difficult circumstances exist. This approach, in light of the
spirit of Article 1, etc. of the Patent Act, permits a claim that defines a
product by means of its manufacturing process, and treats such claim as not
violating Article 36, paragraph (6), item (ii) of said Act. It can be described
as representing the JPO's view reached through its elaborate efforts to pursue
a realistic way of handling a product-by-process claim in accordance with both
the principle of said Act and the JPO's examination practice.
However, this view is somewhat inconsistent with the precedents of this court
in which the court seems to have adopted the product identity theory to
construe a product-by-process claim (1997 (Gyo-Tsu) No. 120, judgment of the
Third Petty Bench of the Supreme Court of September 9, 1997, not officially
published, 1997 (Gyo-Tsu) No. 121, judgment of the Third Petty Bench of the
Supreme Court of September 9, 1997, not officially published, 1998 (O) No.
1579, judgment of the Third Petty Bench of the Supreme Court of November 10,
1998, not officially published). Furthermore, while whether the product-by-process
claim in question is a genuine or pseudo one remains unclear until the court
presents its view on this point, the scope of the claim would greatly differ
depending on this distinction and might disagree with what the applicant
intended. The scope of a right to be conferred by a patent would also greatly
differ depending on whether the invention is defined by a genuine or pseudo
product-by-process claim, but this point remains unclear, making it difficult
for a third party to predict the scope of the right appropriately. This problem
is ultimately attributed to the scope of the patent being unclear and
unspecific, which should be held to be in violation of Article 36, paragraph
(5), and paragraph (6), item (ii), etc. of the Patent Act. Moreover, according
to the JPO's view, it would be necessary in the examination practice to make a
clear distinction as to whether the product-by-process claim is a genuine or
pseudo one before permitting the patent application because the scope of the
claim, etc. could differ depending on this distinction. As a result, the JPO
would have to be very careful in carrying out the examination and hence would
have to bear a greater burden, and this would be highly likely to cause delay
in examination.
(3) In light of the abovementioned problems posed by the court of prior
instance, the majority opinion presents a view that will help establish the
examination practice in which the JPO will strictly consider whether there are
circumstances where a product-by-process claim should be permitted, while
taking into account the principal purpose of the concept of this type of claim,
and will advise the applicant to apply for a patent for an invention of a
process for producing a product if the application with a product-by-process
claim is likely to be refused due to the absence of such circumstances. This
will change the conventional examination practice in that the JPO will be
expected to substantively examine the requirement for permitting a
product-by-process claim as a patent for substance. However, the applicant
would doubt how common it has been to apply for a patent with a
product-by-process claim rather than an ordinary patent with regard to an
invention of a product even when the product can be defined by means of its structure
(when impossible or impractical circumstances do not exist), and if it is truly
"impossible" or "utterly impractical" to define the product
by means of its structure, etc., the applicant would not find a great burden in
alleging and proving this point (for example, in the field of life science, a
claim which recites a cell, etc. created by a new genetic engineering technique
would not be rejected on the grounds of the absence of circumstances where it
is impossible or utterly impractical to define such a cell, etc. by its
structure, etc. at the time of the filing of the application). In the
examination process, since there is a limit due to the nature of the task to
the applicant's potential to prove the existence of such circumstances
voluntarily and strictly, the JPO will not be able to strictly require the
applicant to do so and would be very likely to find the existence of such
circumstances unless there is a reasonable doubt. In this meaning, it is very
likely that the applicant would not have to worry so much.
(4) Next, it is also expected that requests for invalidation trials will be
filed or the defense of invalidity will be raised in infringement suits in
relation to patents with product-by-process claims that have already been
granted and registered without, in principle, going through the test in terms
of the existence of impossible or impractical circumstances in the examination
process. However, if the applicants of these patents were unable to establish
the existence of impossible or impractical circumstances at the time of the
filing of the applications (which means that the applicants easily chose to
file product-by-process claims in which the products were defined by the
manufacturing processes although the products could have been defined by their
structure, etc.), it is inevitable that their patents would later be
invalidated. However, this situation results from the conventional examination
practice in which the JPO has loosely examined and permitted product-by-process
claims, and it is not attributable to the applicants alone. To avoid such a
situation, procedures such as a request for correction (Article 134-2 of the
Patent Act) in a patent invalidation trial and a request for a trial for
correction (Article 126 of said Act) may be helpful. How these procedures will
actually be handled is an issue to be addressed in the future.
The opinion by Justice YAMAMOTO Tsuneyuki is as follows.
I agree with the decision to remand the case to the court of prior instance,
for reasons different from those given in the majority opinion. I would explain
the reasons in the sections below.
1. In view of the background for the amendment to the Patent Act in 1994, a
patent applicant is considered to be basically free to choose what to recite in
a claim. Article 36, paragraph (5), item (ii) of the Patent Act prior to said
amendment provided that a claim should recite "only such matters that are
essential to the constitution of the invention for which a patent is
sought." However, the Industrial Property Council explained this issue in
its report as follows: "(1) Necessity to permit a function or process
claim…basically, in the case of an invention of a 'product,' 'matters that are
essential to the constitution of the invention' are required to be expressed in
the form of a 'product,' and a function and process are not considered as
matters that are essential to the constitution of the invention. Accordingly,
the following approaches of reciting a function or process in a claim are not
permitted: [i] where the matters recited in a claim consist of a single
technical means, and the technical means is recited in the form of a function
or process; and [ii] where a claim relates to an invention of a product, and a
technical means incorporated therein is recited in the form of a process.
However, as a result of greater emphasis being placed on technologies for
intangible infrastructure along with the development of information-related
technologies (electronics, communication, information technologies), etc., it
is more often the case that inventions of devices developed in these fields can
be expressed more appropriately by defining the relevant device by means of its
function or operating method, rather than by reciting the physical structure of
the device or the specific means incorporated therein as matters that are
essential to the constitution of the relevant invention. (2) Necessity to
respect what is recited in a claim…the applicant should take responsibility for
deciding what to claim for a patent. Therefore, it is inappropriate for the
examiner to direct the applicant to modify the scope of a claim as long as the
claimed invention is described in the detailed explanation of the invention in
a manner to enable a person ordinarily skilled in the art to easily work the
invention, and the invention meets the requirements of patentability including
novelty and involvement of an inventive step…However, due to the provisions
requiring a claim to "recite only such matters that are essential to the
constitution of the invention" remaining in the existing law, when a
notice of reasons for refusal is issued with respect to such a claim reciting a
function or process as mentioned above, the applicant would have to revise the
claim in the form of a generic concept (function or process) and recite a more
limited, specific means, which would result in forcing the applicant to limit
the claim…" (the Council's report of September 1994, from pages 23 to 24).
Thus, the Industrial Property Council declared that the applicant should take
responsibility for deciding what to claim. In order to make this point clear,
Article 36, paragraph (5) of the Patent Act was amended in full, with the term
"only" deleted from the phrase "only such matters that are
essential…," thereby respecting what is recited in a claim as expressed by
the applicant of his or her own will. The reasons for this amendment are
naturally true not only with a function claim but also with a claim that is
designed to define a product by means of its manufacturing process (generally
referred to as a "product-by-process claim"). I understand that this
patent practice follows the trend of international harmonization of patent
systems and basically conforms to the practices at the major patent offices in
the world.
2. What patent practice is acceptable on a global scale? I would explain this
point based on my understanding, taking the patent practice in Japan as an
example.
As a result of the abovementioned amendment to the Patent Act, the patent
practice at the JPO has changed so that an examiner will not refuse an
application by reason of the failure to conform to the provisions of the
amended clause, based on the idea that it is inappropriate for an examiner to
examine whether all the matters necessary for defining an invention are recited
in a claim, against the will of the applicant who drafted the claim at his or
her own discretion. Accordingly, under the existing system of the Patent Act,
it is up to the applicant to choose a function claim, product-by-process claim
or whatever form of claim to define the invention for which a patent is sought,
whereas the invention defined by such claim will not be patented if it falls
under any of the items of Article 49 of the Patent Act (reasons for refusal),
and even where it is patented, the patent will be invalidated if it falls under
any of the items of Article 123 of said Act (grounds for invalidation).
Consequently, according to the purpose of the legal amendment in 1994, it seems
to me that the JPO has been very careful about refusing an application or
invalidating a patent by assessing what is recited in a product-by-process
claim to be unclear on the grounds of, in a sense, procedural matters---whether
the claim in question meets the formal definition of a product-by-process claim,
or what kind of product-by-process claim it is---, insomuch as the applicant
him/herself chose this type of claim. I consider that this practice at the JPO
reflects correct interpretation and application of law.
To my understanding, according to the JPO's Examination Guidelines, an
application with a product-by-process claim may be refused in the following two
cases.
Case 1 is that a product-by-process claim fails to meet the clarity requirement
and is rejected due to violation of Article 36, paragraph (6), item (ii) of
said Act (referred to in Article 49, item (iv) and Article 123, item (iv) of
said Act) (Examination Guidelines, Part I, Chapter 1, page 15, [2] Typical
examples where the claimed invention is considered to be unclear). More
specifically, an application with a product-by-process claim may be refused if
[i] the claimed invention is unclear because the manufacturing process (e.g.
starting material, manufacturing steps) recited in the claim cannot be
understood, or [ii] the claimed invention is unclear because the
characteristics of the product (e.g. structure and nature) recited in the claim
cannot be understood (for example, when the description includes only
process-related characteristics (e.g. high yield or efficiency in manufacturing
can be achieved by the manufacturing process in question)). In these cases, it
cannot be said that the invention of a product is defined by a
product-by-process claim. In other cases, as long as the invention of a product
is defined by a product-by-process claim, the examiner permits the claim as-is
and then examines the requirements of patentability such as novelty and
involvement of an inventive step. This practice applies even when part of what
is recited in a product-by-process claim is unnecessary. I understand that it
is common practice on a global scale.
Case 2 is that a product-by-process claim fails to meet the novelty requirement
and is rejected due to violation of Article 29, paragraph (1), item (iii) of
said Act (Examination Guidelines, Part II, Chapter 2, page 8). In this case
(where it is clear that the invention claimed in a patent application is a
product because it is recited in a product-by-process claim which is composed
in the form of a noun that refers to a "product"), what is recited in
the claim is construed as referring to the product itself that is finally
obtained. Accordingly, the novelty of the claimed invention is denied when the
same product can be manufactured by any manufacturing processes other than the
one recited in the claim and this product is publicly known.
In brief, in Case 1 [i], an application with a product-by-process claim is
refused if the invention is unclear because the matters necessary for defining
the invention cannot be understood from what is recited in the claim, as in the
case of other forms of claim. In Case 1 [ii], an application with a
product-by-process claim is refused if the invention is unclear when viewed as
an invention of a product because the claim only recites process-related
characteristics, such as high yield or efficiency in manufacturing achieved by
the process in question, and the characteristics of the product in question are
unclear (which means that the invention should have been claimed as an
invention of a process). In Case 2, an application with a product-by-process
claim is refused due to lack of novelty and an inventive step because the
product itself is publicly known or can be easily invented from publicly known
art.
As explained above, although the applicant is free to choose what to recite in
a claim, an application with a product-by-process claim that should have been
refused is eventually refused through the necessary and sufficient application
of the clarity and novelty requirements. If such a claim is patented by
mistake, the patent will be invalidated under the same criteria as those
described above. I consider that the same should be applied to the cases under
Article 104-3 of said Act.
3. However, the majority opinion in this judgment could result in fundamentally
undermining the abovementioned interpretation of the Patent Act and patent
practice. I would have no particular objection if it is in the right direction,
but to me, it does not at all seem to be right. The majority opinion (4.(2))
explains that a product-by-process claim regarding an invention of a product
must be clearly written, in reference to the purpose of Article 1 of the Patent
Act and the provisions of Article 36, paragraph (6), item (ii) of said Act.
This is right as a general theory. However, it is often the case that an
invention of a product cannot be clearly recited in a claim other than a
product-by-process claim. In particular, in the case of an invention of a
product that has novelty, it would be very easy to understand the invention if
the applicant describes the process by which the product is made. However, if
the applicant tries to describe the product by means of its structure or
characteristics, the description would, no doubt, need to be expressed with
complicated concepts and terms. In that case, the applicant would have to spend
unnecessary time and cost and would miss the chance to file an application at
the right time, and what is more, such description would rather be hard to
understand not only for the examiner but also for a person ordinarily skilled
in the art, which is contrary to the clarity requirement. For example, with
regard to an invention relating to a new cell in the field of life science, if
this invention is described by a product-by-process claim in such a manner as
"a cell produced by a certain method of injecting a certain gene into a
certain cell," the description of the claim would be very easy to
understand for a person ordinarily skilled in the art. If, to the contrary, the
cell produced by such process is required to be described based on its
structure or characteristics, although it may not be completely impossible to
do so by spending considerable cost and time, the description of the claim
regarding the cell that has been finally elaborated through such effort might in
most cases be dry-as-dust, pointless and incomprehensible to anyone. It is easy
to imagine that an application with such a claim will be refused due to the
failure to meet the clarity requirement. Such a consequence goes further away
from the ideal of the Patent Act, i.e., the achievement of harmonization
between protection of inventions and public use thereof.
On this point, the majority opinion states, "there may be cases where … it
is technically impossible to analyze the structure or characteristics of the
product at the time of the filing of the application, or where it is utterly
impractical to require the applicant to define the product in such manner
because, in light of the nature of a patent application that needs to be
handled speedily, etc., the work to define the product could require excessive
economic costs and time," thus it appears to intend to permit a
product-by-process claim although in an extremely limited manner. However, it
concludes, "the claim should be held to meet the requirement that the
claimed invention is clear as prescribed in Article 36, paragraph (6), item
(ii) of the Patent Act only if there are circumstances where it was impossible
or it was utterly impractical to directly specify the product subject to the
invention by means of its structure or characteristics at the time of the
filing of the application." If this interpretation applies, there would be
almost no chance for a product-by-process claim to be permitted.
This issue reminds me of recent important inventions in the field of life
science, which relate to stem cells produced by new genetic engineering
techniques. In most cases, when a patent application is filed for such an
invention by claiming it as an invention of a product, the claim would be in
the form of a product-by-process claim. Then, according to the majority opinion
mentioned above, the applicant, when drafting a claim, would first need to
consider if it is possible to directly define the product by means of its
structure or characteristics, for fear that the application or patent with that
claim would be refused or invalidated just because the claim is in the form of
a product-by-process claim. However, it is not at all easy for the applicant to
perform the work to define the product and prove the fact as required according
to the criterion presented by the majority opinion, that is, "there are
circumstances where it was impossible or it was utterly impractical to directly
define the product subject to the invention by means of its structure or characteristics
at the time of the filing of the application" (hereinafter referred to as
the "criterion of impossible or impractical circumstances"). It seems
to be rather unrealistic just to imagine such work or proof, but there is no
evidence, either, that it is impossible to do so. Meanwhile, while taking much
time to do such a thing, the applicant would lag behind in fierce global
competition with other applicants under the first-to-file principle, so the
applicant would feel pressed to file a patent application. Presumably, the
applicant in such a situation would take the decision to file an application
with a product-by-process claim because of being unable to express the product
by means of its structure or characteristics, although he or she is not firmly
confident whether or not such decision was right. Then, in the examination or
trial procedure, the application or patent with a product-by-process claim
would be tested as to whether it should be refused or invalidated by reason of
the failure to conform to the criterion of impossible or impractical
circumstances. However, since this criterion of impossible or impractical
circumstances is too ambiguous and vague to grasp, it seems to me to be very
difficult to interpret and apply the criterion in a stable and uniform manner.
Moreover, seeing that matters such as how an assessment as to circumstances
where "it was impossible or utterly impractical" would be made by
whom and by what criteria have not been clearly indicated at all, I would say
that the concept of circumstances where "it was impossible or utterly
impractical" is almost equal to referring to circumstances where it was
"impossible." I am concerned that, as a result, most patent
applications claiming inventions of products with product-by-process claims
would be refused by reason of the failure to meet the clarity requirement. This
could bring about what is called the chilling effect, driving all
product-by-process claims out of Japanese patent applications even when these
claims are truly necessary, and impeding protection of inventions. I am also
concerned that since the failure to conform to the criterion of impossible or
impractical circumstances could be the ground for invalidating the existing
patents, the validity of a number of patents with product-by-process claims
that have already been granted would be challenged more frequently in
litigation. When these patents were granted, there was no room for the
applicants to be conscious of the criterion of impossible or impractical
circumstances. Such background should be taken into careful consideration in
such litigation.
4. It is true that the perspective of preventing the interest of a third party
from being unfairly prejudiced is as important as the perspective of protecting
inventions, as pointed out in the majority opinion. The essential nature of
patents can be described as residing in balance between these two perspectives.
However, there is the risk that the application of the criterion of impossible
or impractical circumstances presented in the majority opinion would lead to
the complete failure to achieve the protection of inventions, which is what I
am most concerned about.
In the current patent practice, when each claim in a patent application is
composed in the form of a noun that refers to a "product" rather than
a "process," it is clear that protection by a patent for an invention
of a product is sought even if the relevant claim is a product-by-process
claim. Then, the application is eventually refused if the product finally
obtained by the process recited in the claim is found to lack novelty and an
inventive step, that is, it is a publicly known product. Accordingly, a third
party would have to pay attention only to patent applications that claim new
products, in which case the third party's burden of caution would be mitigated
to a considerable degree. In other words, in cases such as where a person
ordinarily skilled in the art would have been unable to assume the specific
product manufactured by the manufacturing process recited in the claim even by
taking into consideration the common general technical knowledge available at
the time of the filing of the application, it would suffice to treat this as
the premise for determining the novelty and involvement of an inventive step in
the claimed invention. Contrary to this, according to the majority opinion,
when a claim is composed in the form of a product-by-process claim that fails
to meet the criterion of impossible or impractical circumstances, the
application or patent with such claim would be refused or invalidated without
exception on the grounds of the failure to meet the clarity requirement because
of this claim form. I consider that this consequence is far outside the range
of the conventional interpretation of Article 36, paragraph (6), item (ii) of
the Patent Act and it obviously constitutes misinterpretation of law.
5. Conventionally, the issue of identifying the gist of the invention and the
issue of determining the technical scope of the patented invention were
addressed separately, the former by the JPO and the latter by the court. Since
these issues, when brought to litigation, were dealt with in separate cases, I
presume that it did not appear to be so strange even if these cases ended up
with inconsistent conclusions. However, as a result of the introduction of
Article 104-3 to the Patent Act through the amendment in 2004, it has become
possible to raise the defense of invalidity of a patent in the litigation
proceedings in which patent infringement is claimed. Accordingly, it has come
to be considered to be unreasonable for the same claim to be construed
differently, and the double standard that previously existed is now being
eliminated. This is the right direction. The "gist of the invention"
involved in determining patentability and the "technical scope of the
patented invention" involved in determining infringement must be
consistent with each other as claim construction.
Having said that, if the "technical scope of the patented invention"
is assumed as the first place to start, and in the stage of identifying the
"gist of the invention," emphasis is placed on a sort of a procedural
issue, i.e. whether the claimed invention meets the criterion of impossible or
impractical circumstances, and a patent is refused from the beginning by
applying the clarity requirement, such practice has gone too far as claim
construction. In light of the purpose of the amendment to the Patent Act in
1994, if the claimed invention can be defined based on the content of a claim
that the patent applicant has chosen him/herself, a patent should be granted as
long as the invention has novelty and an inventive step. This is irrelevant to
whether a product-by-process claim is contained in a patent application. This
is the stage of identifying the gist of the invention.
In such case, a question may be raised as to the interpretation of Article 70
of the Patent Act in connection with the handling of a product-by-process
claim. In this respect, I consider that the manufacturing process recited in a
claim of a patent for an invention of a product (a claim composed in the form
of a noun that refers to a "product") should be construed as being
recited with a view to defining the product itself that is made by the
manufacturing process, rather than as being recited to limit the scope of the
patent by means of the manufacturing process. Such claim construction is made
on the basis of the wording of the claim. In other words, when the
manufacturing process is recited in a claim of a patent for an invention of a product,
this fact can be construed as the applicant's intention to seek protection for
the invention of the product itself, and such manner of construction should be
the principle.
Next, with regard to a product-by-process claim, it is necessary to admit that
there may be exceptional cases where the issue of determining the technical
scope of the patented invention cannot be considered in the same manner as
considering the issue of identifying the gist of the invention addressed in
response to the defense of the invalidity of the patent. Claim construction
performed by the court in an infringement suit is intended for the purpose of
determining the scope of legal protection of a patent right already granted. On
the other hand, claim construction performed by the JPO in the examination and
trial procedures is intended for the purpose of assessing whether or not to
grant a patent for the claimed invention (in the examination procedure) or
assessing whether or not a patent already granted should have been granted at
all (in the trial procedure). Thus, purposes are different between claim
construction by the court and that by the JPO, and it may be inevitable that
the court and the JPO reach different constructions. In this sense, a
product-by-process claim should be regarded as an exceptional case where the
technical scope of the patented invention determined in an infringement suit
may be inconsistent with the gist of the invention identified by the JPO. This
view could lead to the consequence that for some product-by-process claims, the
technical scope of the patented invention determined by the court, within which
a patent may be enforced, is narrower than the gist of the invention identified
by the JPO. However, this results from the applicant having chosen a
product-by-process claim, and hence it is an inevitable consequence. Therefore,
as is currently done in some actual cases, a reasonable conclusion may be drawn
by construing the technical scope of the patented invention, which is based on
a patent for an invention of a product expressed in the form of a
product-by-process claim, as being substantially limited to the manufacturing
process, by applying the doctrines of claim construction already established,
such as the doctrine of estoppel and the doctrine of intentional exclusion.
6. The court of prior instance determined that when a claim of a patent for an
invention of a product is expressed as a product-by-process claim, the
technical scope of the patented invention should in principle be determined as being
limited to products manufactured by the manufacturing process recited in the
claim, while generally permitting a claim in this form. However, although a
product-by-process claim may be generally permitted, the criterion of
impossible or difficult circumstances, which is applied to distinguish cases
where this claim form is permitted from those where it is not permitted, is
extremely ambiguous and is subject to the same criticism as that of the
criterion of impossible or impractical circumstances presented in the majority
opinion.
In addition, the court of prior instance held that if this claim form is not
permitted, the technical scope of the patented invention should be determined
as being limited to products manufactured by the manufacturing process recited
in the claim. In this respect, as pointed out in the majority opinion, I
consider that when a claim of a patent for an invention of a product recites
the manufacturing process of the product, the technical scope of the patented
invention should be determined as referring to products that have the same
structure, characteristics, etc. as those of the product manufactured by the
manufacturing process recited in the claim.
The Invention based on the Patent held by the appellant relates to a product expressed
by a product-by-process claim (pravastatin sodium that contains less than 0.5
wt% of pravastatin lactone and less than 0.2 wt% of epiprava). On the other
hand, the appellee's product has been found to contain pravastatin sodium that
contains less than 0.5 wt% of pravastatin lactone and less than 0.2 wt% of
epiprava. Thus, as long as the Patent remains valid, the appellee's product
would be held to fall within the technical scope of the patented invention in
question, but this is yet to be proved to be true. Therefore, I agree to remand
the case to the court of prior instance, for the purpose of having it examine
that point as well as issues including whether it is possible to construe the
technical scope of the patented invention in question in a limited manner in
light of the prosecution history of the patent application concerned.
(This translation is
provisional and subject to revision.)