AIPPI CONGRESS
Melbourne, March 24 to 30, 2001
Workshop No. VI
PRODUCT-BY-PROCESS PATENT CLAIMS
March 29, 2001
Chairman: Roman Vuille (Switzerland)1
Speakers: Yoshiro Hashimoto (Japan)2, Randall R. Rader (USA)3,
Alexander Straus (Germany)4
Reporter: Peter Pawloy (Austria)5
Summary Report
by Peter Pawloy
By way of introduction, the term “product-by-process” patent claims describes a patent
claim in which the product is defined in terms of a process of manufacture, in contrast to a
“pure” product claim where features strictly relevant to the entity itself are claimed. Use of
“product-by-process” patent claims is made frequently in technical fields, for example in
food, where foodstuff is a quite complex material, in micromolecular chemistry, like polymer chemistry, and also very frequently in biotechnology. As confirmed by practice, these
kind of claims raise frequently problems during the patent granting procedure, as well as in
revocation or infringement cases. In many countries there is still at lot of room for interpretation, which at least means endless debates among IP lawyers or sometimes even between IP lawyers and judges. There also remains some uncertainty concerning the scope
of protection applicants are looking for. In infringement cases, for example in trials, depending on the position one is in, as plaintiff or defender, this lack of clarity, this legal uncertainty is a real concern. The following is a brief summary of the situation in Japan, the
United States of America and in Europe, i.e. before the EPO.
1
Nestec Ltd., Vevey, Switzerland
Suzuye & Suzuye, Tokyo, Japan
3
Circuit Judge, US Court of Appeal for the Federal Circuit, Washington D.C., USA
4
Becker, Kurig & Straus, Munich, Germany
2
-2-
Yoshiro Hashimoto: Product-by-Process Claims in Japan
1. SUMMARY
A "product-by-process" claim may be defined as one in which the product is defined,
at least in part, in terms of the process by which it is produced.
In Japan, a product-by-process claim is generally construed as not limited to a
product produced by the recited process but a product itself regardless of its process of
production, in prosecution of applications as well as in patent infringement litigation.
2. STATUTORY PROVISION
The Provision of the Japanese Patent Law on claims (Section 36) was amended in
1994.
Before the amendment (Section 36):
The old section 36 provided,
(4) The statements of the patent claim(s) shall comply with each of the following:
(i) the invention for which a patent is sought shall be described in the detailed explanation of the invention;
(ii) there shall be set forth, by statements separated on a claim by a claim basis, only the indispensable constituent features of the invention for which a patent is sought.
After the amendment (Section 36):
The present section 36 provides,
(5) In the patent claim(s), there shall be set forth, by statements separated on a
claim by a claim basis, all matters which the applicant considers necessary in defining the
invention for which a patent is sought.
(6) The statement of the patent claim(s) shall comply with each of the following:
(i) the invention for which a patent is sought shall be described in the detailed explanation of the invention;
(ii) the invention for which a patent is sought shall be clear;
(iii) statements set forth in the claim(s) shall be concise.
3. PRACTICE OF THE JAPANESE PATENT OFFICE
The practice of the Japanese Patent Office is governed by the Examination guide5
Sonn, Pawloy, Weinzinger & Köhler-Pavlik, Vienna, Austria
-3line established by the Japanese Patent Office.
3.1 OLD EXAMINATION GUIDELINE:
Under the old examination guideline, it was understood that under this provision requiring only the indispensable constituent features, it was also required to clearly identify
the invention by the claim statement.
The old guideline illustrated the following two cases as the type of statement disallowable in a product claim.
(i) Where, for a product claim, a technical feature is stated in terms of a process.
However, if there is no other adequate statement and the product can be specified thereby,
such a statement is allowed.
(ii) Where, for a chemical substance claim, its name or chemical structural formula is
not described. However, if it cannot be described by its name or formula, it may be described in terms of its physical or chemical characteristics. If it cannot be adequately described even by its physical or chemical characteristics, reference to the process of its
production may be allowed provided that it can be clearly specified thereby.
As seen above, under the old Law, reference to the process of production in a product claim was in principle disallowable, but in practice allowed in exceptional cases.
3.2 NEW EXAMINATION GUIDELINE:
The 1994 amendment of the Patent Law eliminated the previous provision that "only
the indispensable constituent features of the invention" be stated in a claim, and instead
introduced a new provision that "all matters that the applicant considers necessary in defining the invention" be stated in a claim.
After amendment of the Law, the Japanese Patent Office published a new examination guideline, which was rewritten and published at the beginning of this year.
New practice under the new guideline allows various ways of expressing an invention in addition to the conventional ones under the old Law.
For "an invention of a product", an applicant is allowed to describe it by means of
function, work, property, characteristics, process, use, etc., as well as by means of such
conventional expressions as combinations of components or structural limitations, so long
as the invention is clearly specified.
A patent application shall not be considered disallowable merely because a product
claim includes a reference to the process of its production.
However, it should be noted that, under Section 36(6)(ii), the claim statement of the
-4invention for which a patent is sought is required to be clear. Due consideration should be
made to both of the provisions.
The new guideline exemplifies disallowable cases where the scope of the invention
for which a patent is sought is not clear.
With respect to a product-by-process claim, it is required to be made clear what
product is imagined thereby, taking into account the claim statements and common technical knowledge as of the filing.
In a case where it is difficult to imagine what product is covered thereby, the following two requirements should be fulfilled in order that the product-by-process claim be allowed to satisfy the requirement of being clear.
(i) It can be understood that the product disclosed in the specification could not be
more clearly defined other than by reference to the process of production, and
(ii) The relation between the claimed product and the state of the art as of the filing
can be understood from a reasonable explanation, such as by showing the relation/difference through experimental examples or theoretical explanation.
Namely, a product-by-process claim is allowed when both requirements (i) and (ii)
are fulfilled. Therefore, under the new guideline too, a product-by-process claim is allowed
only in limited cases, although in principle allowable.
3.3 FINDING OF THE CLAIMED INVENTION
The new guideline explains how the examiner makes the finding of a claimed invention during examination of the application (prosecution).
The finding of a claimed invention is in principle made on the basis of the statement
of the claim.
With respect to a product-by-process claim, such a statement is to be construed as
meaning a final product itself. Namely, such a claim should be interpreted as a product finally obtained, whatever the manufacturing process stated in the claim is.
Novelty of the product, therefore, should be denied if the same product can be obtained by a process other than the claimed one, and if the product obtained by that different process is publicly known as of the filing.
The new guideline gives explanatory examples.
Example 1: "a protein which is obtained
by process P (steps P1, P2, ... and Pn)"
If the protein which is obtained by process P is identical to a publicly-known particular protein Z manufactured by process Q, that is different from process P, the novelty of
-5the claim of Example 1 is denied, regardless of whether the process P is novel or not as of
the filing.
Example 2: "A two-layered structure panel which is made by welding together an iron
sub-panel and a nickel sub-panel"
If it were assumed that the same structure as the panel made by welding could be
obtained by a process other than welding, then the novelty of the claim would be denied in
the case where it is publicly known as of the filing. Generally, however, any process other
than welding cannot produce the same structure as claimed. So, its novelty would not be
denied unless a two-layered structure panel made by means of welding is publicly known
as of the filing.
3.4 NOVELTY EXAMINATION
Novelty Examination of a product-by-process claim is also elaborated in the new
guideline as follows:
With respect to a product-by-process claim, it is generally difficult to determine the
product itself in terms of its structure. In such cases, when the examiner reasonably suspects that the claimed product would be prima facie identical to the prior art product, the
notice of rejection on the ground of the lack of novelty would be issued straightaway, without need of a strict comparison, unless no other difference is found between them.
In the Guideline, four examples where the examiner reasonably suspects prima facie identity are shown in the following:
(i) Where a prior art product is found that was made by the same production steps
from a similar starting material as the claimed invention.
(ii) Where a prior art product is found that was made by the similar production steps
from the same starting material as the claimed invention.
(iii) Where a structure of a product which is considered identical to the claimed
product is revealed, and it is found publicly known as of the filing.
(iv) Where a prior art is found that is identical or similar to the mode of carrying out
the invention described in the specification or drawings.
For these four cases, the examiner issues the notice of rejection.
Against the notice of rejection, the applicant may argue or clarify, by putting forth a
written argument or experimental results etc. Where the applicant's argument succeeds in
changing the Examiner's previous evaluation, at least to the extent that the validity of the
alleged product identity could be called into question, the rejection will be withdrawn.
Where the applicant's argument fails to change the Examiner's evaluation to that extent,
-6the Examiner will make a decision of rejection based on the previous notice.
4. COURT DECISIONS
4.1 PROSECUTION
Court decisions confirm the above practice of the Japanese Patent Office.
The Tokyo High Court stated in a case against a decision made by the trial board of
the Japanese Patent Office on February 13, 1997 as follows.
In deciding the patentability of the claimed invention, the finding of the claimed invention should be made on the basis of the statements of the claim to compare it with a
prior art. In a case where a process of production is recited in a product claim, the invention should be considered as a product finally produced regardless of its process of production, and the recited process of production should be considered only as an expedient
measure to identify the final product. Then, the claimed invention is apparently not limited
to the product obtained by the process recited in the claim.
4.2 LITIGATION
The same position is followed also in patent infringement litigations.
The Supreme Court decision of November 10, 1999 stated that in a case where, for
a product claim, a drawing method is recited to specify a shape of the product, it is a requirement that the accused product has the same shape as the shape obtained by the
said drawing method in order to be within the technical scope of the claimed invention, and
it is not a requirement that the accused product is produced by the said drawing method.
However, since the accused product was not proved to have the same shape as
that produced by the recited method, no infringement was declared.
There are many court decisions that follow the same position but no infringement
was declared. No decision has been found which held otherwise, so far as surveyed.
The Tokyo High Court decision of July 17, 1997 stated that generally, even in a
case of a product specified in terms of a process of production, when the product is patentable, it is appropriate to construe that the subject of a patent is to be a product itself,
specified in terms of the process of production in view of the protection of an invention. In
this case, there seem to be no circumstances to construe limited to a product produced by
the specified process of production. Then the human leukocyte interferon recited in the
claim should be construed as comprising not only that obtained from a human leukocyte
as a producing cell but also that obtained from other cells. It added further that such an interpretation is in agreement with a purport of the Examination Guideline of the Japanese
-7Patent Office.
However, the decision held that the accused product does not fall within the technical scope of the patented invention because of the difference of the aminosugar content
recited in the claim.
The Tokyo District Court decision of September 11, 1998 stated that generally, even
when a product is specified in terms of a process of production, and if the product is patentable, the subject of a patent is construed not necessarily as a product specified in
terms of the process of production, and also covering a identical product even if it is produced by a different process. It added further that this interpretation is in agreement with a
purport of the Examination Guideline of the Japanese Patent Office.
With respect to infringement, it is stated, in order to recognize the product identity
between an accused product and the claimed product, it is necessary either to recognize
the fact that the accused product is actually produced by the recited process, or to recognize the fact that, after revealing the structure or characteristics of the product specified by
the recited process, the accused product has the same structure or characteristics.
Finally, it held that the accused polyethylene filament does not fall within the technical scope of the patented invention because it is not considered to have the same structure or characteristics of the claimed polyethylene filament.
The Tokyo District Court decision of September 30, 1998 stated that generally, even
when a product is specified in terms of a process of production, and if the product is patentable, the subject of a patent is construed not necessarily as a product specified in
terms of the process of production, and also covering a identical product even if it is produced by a different process. It added further that this interpretation is in agreement with a
purport of the Examination Guideline of the Japanese Patent Office.
The decision held that the accused recombinant erythropoietin could not be confirmed as having the same structure or characteristics of the claimed erythropoietin specified by the recited process, and so, the accused erythropoietin is not considered falling
within the scope of the patented invention.
The Tokyo District Court decisions of September 29, 2000 (two cases) stated that
generally, in a case of a product specified in terms of process of production, since the subject of a patent is a product specified in terms of the process of production, there is no necessity to construe limiting it to the recited process.
It added further that there may be a case where the subject of the patent is limited to
the said process, if there are circumstances to construe limiting it to the recited process.
The decisions hold that, after reviewing the prosecution history, a monoclonal anti-
-8body selection step in the statement of the process is construed as specifying the particular production process to obtain the product and the accused product is not falling within
the scope of the patented invention because the production process of the accused product is not proved to meet the recited monoclonal antibody selection step.
As seen above, although a product-by-process claim is construed as not being limited to the recited process, practical difficulties are involved in establishing the infringement
when the accused product is produced by a different process from the recited process.
***
Judge Randall R. Rader: Product-by-Process Claims in the USA
When I first came on the Court of Appeals for the Federal Circuit about 10 years ago
some of the elder judges that I look upon with great reverence to this day took me aside
and they told me some of the old stories of things that had happened in the Appellant
Courts in the past to prepare the young starting judge. And one of these stories stuck with
me, has some relevance to what we talk about today. It seems that there was a panel of 3
judges and they were intent on dealing with a very difficult case and they called the counsel to the podium and said: “You may proceed counsel”, as they generally do. And, unusually, this council picks up a book, regular case book and instead of proceeding to argue the
law as you would expect, he opens the book to a certain page and starts reading, simple
basic black letter law prospects to the Court. One after the other of the three judges they
kind of look at each other what is going on, very unusual, and counsel continues, he reads
on simple principles of laws. Finally, the senior presiding judge clears his throat, leans over
the bench and says: “Counsel, you may assume we know the law.” Counsel had evidently
had prepared for that question, for immediately he looked up and said, “Your honour, I’m
only here because I made that assumption!”
Actually, that fits quite well with what our topic is today. We assume we know what
we are talking about when we say a product can be claimed by the process of making it.
We understand what we think we are talking about, and yet, when you actually examine
the implications of product-by-process claiming there are some troubling aspects, which I
would like to explore with you. After 10 years of being an appellant judge, I find it somewhat uncomfortable to discuss substantive law for fear that cases will come before me in
the future. But I have been that same 10 years a professor at the University of Virginia and
then at the George Washington and Georgetown Universities and so I find it much more
-9comfortable to explore the implications of the laws as a professor. And besides, if I turn
this into a classroom it works marvellously to my advantage, because then I get to pose
questions to you and in the end I give you the grade.
Let me then start our discussion of product-by-product claims by giving you our hypothetical case for today, students. Our hypothetical case is actually quite pertinent, because it is loosely based on a case that was tried in the United States, Scripps Clinic versus Genentech, but it is somewhat loosely patterned.
Here is our hypothetical case: I am a professor, I know that there is a great need to
treat haemophilia. Now, we have treatments for haemophilia, we have learned that you
can isolate Factor VIIIc out of plasma and that it is the coagulating agent, a protein that
acts to coagulate blood. The problem with the Factor VIIIc solution to haemophilia is that it
is very expensive to take human blood and to extract from the plasma the Factor VIIIc and
concentrate it enough to then inject it back into a haemophiliac.
I am a university professor, so in my laboratory I go to solve this problem. And I do it.
I take porcine plasma, pigs blood, and I pour it over columns of agarose beads. Those of
you who are scientists are well versed in these procedures. You pour it over the beads, the
beads separate out certain characteristics from the plasma. I poured it over different beads,
it separated out different characteristics, and eventually I achieved a product of Factor
VIIIc which I found, testing in my laboratory rats, work marvellously as a coagulant. I have
solved the problem, we can use porcine plasma to produce Factor VIIIc. Haemophilia is a
disease of the past. In my rejoicing I am, of course, visited that afternoon by the university’s patent counsel. He knocks on my door and he says, “I understand, Professor Rader,
that you have made an invention. Let’s claim it as a patent, so that our university can make
lots of money and you can be famous.” O.K., we are going to claim my invention. He starts
out by saying: “What have you done ?” and I said: “I have made Factor VIIIc out of porcine
plasma.” And he says,“Well, tell me, I am very aware of Federal Circuit Law in the United
States which tells me that even in this biotechnological inventions we are going to use
structural and characteristic claiming as the hallmark. We want to know the structure of
this thing. Write down each amino acid in this protein scheme. We want to know it with
specificity. I begin to sweat. I don’t know that. I really don’t know the structure. Moreover, if
I claim it that way I’ve got a real problem.
What’s the problem I’ve got ? Those of you, who are biotechnologists, what’s the
problem if I do learn the exact structure of this product I acquired by pouring porcine plasma over agarose beads ? Well, it is a natural product. But we have kind of gotten over that
problem in the past. We have decided that, because there is enough human intervention in
- 10 the creation of this product, it is going to suffice to be an invention made by man and so it’s
eligible for patenting. That’s not a problem. And you know what ? I can use different plasmas. But you know what ? Every time I perform this process, what do you suppose happens ? I am going to get a slightly different product. Am I not ? I’m going to get a little bit
more Factor VIIIC, 86 % pure today, 69 % tomorrow. O.K. But let’s assume that aside the
process may vary from time to time. Let’s assume I can get some specificity in my process
and could refine it so that I get exactly the same product each time I perform my process.
What would still be my problem in this field of biotechnology, claiming it by structure ? It is
a very narrow claim. If I claim it, the chains of amino acids, the biotechnologists in here, I
see Dr. Straus sitting there, he can tell you far more about this than I can. We have got this
long chain of amino acids in a protein and what do we know about this protein ? It performs a function: it coagulates blood. What is it in that long chain that performs this function ? Do we know ? Often we know a great deal. We may even know nearly everything.
We also know that you can substitute numerous and in many cases thousands of different
amino acids on different sites on that chain without affecting its function. There are interchangeable sites along that chain that I can throw in a different pairing, many different
amino acids and not affect its function at all. How am I going to claim that ? That’s tough.
I’m going to claim 1000 different claims. At each point in the chain I’m going to write the
whole definition of the chain with one amino acid substitution and then a whole other definition in the chain with a second amino acid substitution, and I’ll go through 1000 at that
one point of the chain, and then I’ll go to the next point of the chain and start over again.
Right ? Is that an efficient way to claim ? If I even know that – remember I did not know
that – I’m the Professor Rader there at the university. All I know is that I poured the porcine
plasma over the agarose beads and I got Factor VIIIc and that is going to solve the problem of haemophilia. We have got a good attorney. What’s his solution ? [From the auditorium:] A functional claim ! …. Actually, that’s not a bad idea at all. But he is not that good of
an attorney. Did you hear what he said ? Let’s have a functional claim ! And there might be
some ways in which you could claim these biotechnological inventions functionally. There
might be some problems with that, too, namely Federal Circuit Law, which says we have –
the Professor speaking – probably improperly imported chemical structure requirement in
the biotechnology and we are going to require the structure. You are probably going to
have trouble.
[From the auditorium:] The structure of the active site ! .... But this attorney is good.
He says, “I’ve got a better way to do it”. What’s he is recommending ? What’s that ? The
structure of the active site. Hire him, he is doing well!
- 11 Because this is a seminar about product-by-process claim, our attorney says, “I
know how to do it. We can claim the whole product by the process that we used. It’s perfect in this case, because then we get the claim to the product, no matter how is it made. I
think our scholar from Japan just gave as an excellent presentation of how they can and
fall under the law of most of the places in the world.
Of course, did you notice there was a key catch every place in the Japanese Law.
“As long as it’s clear what’s the product is” the Japanese Law says over and over again.
Well, we are going to claim my invention “production of Factor VIIIc out of porcine plasma
by pouring over agarose beads”. We lay out the process in some specificity. Our process
goes to the Patent Office. And the Patent Office, indeed, grants our claim and then the fun
starts. What’s the fun ? Genen Corporation, not to be confused with any other. This is my
hypothetical. It’s a corporation. This corporation does what ? It looks at the product I’ve
produced, it analyses it and reproduces it by recombinant DNA procedures. It clones it.
What does it come up with ? Same product ? Actually, under the facts of the Scripps Clinic
case, which we are borrowing from somewhat literally, Genentech cloned by a recombinant DNA process Factor VIIIc out of porcine plasma with about 99.9% purity – as you
would expect from a recombinant DNA process. They are going to produce exactly the
chain that they wish to produce and they will get exactly what they want to perform the
function, no more and no less. Something I can’t do with agarose beads, in the Scripps
Clinic case Factor VIIIc was about 60% pure.
Now, questions. We are going to gather in the university’s conference room. We are
going to discuss the implications of these facts. All of you are counsels. We have got
Genen Corp out there making factor VIIIc out of porcine plasma. Well, not really out of
porcine plasma, but they are using recombinant DNA procedures, they are taking our market away. All right ? We are the ones that went all the effort to figure out how you could
make it out of porcine plasma. And now those guys are making it cheaper, inexpensively,
in vaster quantities. They have stolen our market. What are we going to do ? First, I’m the
professor and I want to know, you guys had this brilliant idea for how I could claim my invention. You said “Let’s claim it as a product-by-process. So we claimed it as the product
of factor VIIIc made by pouring porcine plasma over agarose beads. How does that affect
the patentability of my invention ? Does the fact that we claimed it this way, does that effect at all the opportunity to acquire the patent from the Patent Office ? It’s an interesting
history here. I know, I’m the professor asking the question, but I’m also the attorney answering the question. That’s the fun thing in playing the professor, you can play any role
you want.
- 12 Here is the role I want to play now. Tell you the history a little bit. The original rule
for claiming of this type of an invention was that you had to claim it in terms of structure. In
1891 in the United States we developed an exception, called the Rule of Necessity. When
there was no other way to describe the invention, other than by the process of making it, in
1891 there were often instances when we could not discern structure, when characteristics
themselves may have been ambiguous. Therefore, when you could not describe the invention effectively any way other than by the method of making it, you could so certify and acquire a product-by-process claim. In about 1969 the Patent Office had overruled and invalidated the product-by-process claim, because the applicant could have claimed this invention according to structure, but did not and claimed it as a product-by-process claim instead, validated that claim and the predecessor to my court, the Court of Customs and Patent Appeals, overturned that decision, meaning they eliminated the Rule of Necessity.
It was no longer necessary to certify that the only reason you had claimed in form of
a product-by-process claim was because you had no other way of describing your invention. That was no longer necessary. But, in doing it, the Patent Office nonetheless said
there is a distinction between true product claims, as they were called by the Court of Customs and Patent Appeals, a true product claim being described by structure and characteristic, maybe even by function, if that could suffice. That’s a true product claim and for a
true product claim you have claimed that product, by whatever mean it is produced. That
was distinguished from a narrower product-by-process claim to a product. It’s a product
still, but in this instance you are limited to the product by the means produced. What’s the
key question in our hypothetical case ? Can we sue Genen Corp for infringement ? Can
we sue them for infringement in the United States ?
Now, I assume you have all done your homework and you know that there are two
lines of authority: There is a case in 1991 that we have been discussing roughly in this hypothetical – the Scripps Clinic versus Genentech case – and in that case the District Court
in one paragraph has set out in some details the various implications, had looked through
a variety of Supreme Court cases and prior cases of other Federal Courts in the United
States at great length in determining that a product-by-process claim was limited to the
specific process claimed. The Federal Circuit did not really rule on the issue, because it
was not before them, but they said in their lengthy opinion: In determining patentability,
that’s the Patent Office process, we construe the product as not limited by the process
stated in the claims, since the process is not a limitation.
Now, what’s the reason for that ? Why does not the Patent Office get involved in
discerning a particular process. They don’t have the administrative or experimental capa-
- 13 bility to do it. They can’t perform the process and see what product you get and then compare that to the prior art. They must assume the broadest reasonable interpretation, which
is any product by any means produced, is going to be adequate prior art against your
product-by-process claim, which is also a product claim. So, in determining patentability
before the Patent Office we are not going to hold you to the process steps stated in the
claims. Since the claims must be construed the same way for validity and for infringement,
the correct reading of product-by-process claims is that they are not limited to the product
prepared by the process set forth in the claims. That was the Scripps Clinic reasoning. The
Court of Appeals for the Federal Circuit did not do more than analysis at that point, because it was not really before them. A year later, the Court encountered another case: Atlantic Thermoplastics versus Faytex. In Atlantic Thermoplastics versus Faytex you had a
shoe invention, actually an inner sole for a shoe made out of polyurethane and elastomeric
material. The elastomeric material was lodged in the heel portion so that you had a nice
cushy shoe. But it was not claimed as a shoe inner sole product, it was claimed as a shoe
inner sole product made by the process of – and in this process where you pour out said
elastomers, you pour the urethanes around them and you come up with this inner sole.
And they wanted to have a claim to the inner sole product however it was made. The accused infringer had made it by a significantly different process, coming up with about the
same inner sole.
Now the question: Was that case going to be decided the same way as Scripps
Clinic ? You have done your homework. It was not. The reason it was not was because the
Court of Appeals for the Federal Circuit in the 1992 Atlantic Thermoplastics case came
across a significant amount of Supreme Court Precedents on that subject. Many cases
had dealt with the issue of product-by-process claims in our Supreme Court before that
and in one particular instance, a quite old case, the case is Cockran versus BASF in 1884,
the Supreme Court had decided that every patent for a product or composition of matter
must identify it, so it can be recognized aside from the description of the process for making it. Or else, nothing can be held to infringe that product patent which is not made by the
claimed process.
Now, this is exactly the opposite from Scripps Clinics. Scripps Clinics said we are
going to disregard the claimed process, as long as you have the same product. We are
going to make the test for infringement turn on the sameness of the product, regardless of
the claimed procedure. Atlantic Thermoplastics said, when the only way you have claimed
it is by the process, the only way we can identify the product is by the process. Therefore,
the process becomes what you have invented. This expressly distinguishes Scripps Clinic.
- 14 It says Scripps Clinic did not consider any of the Supreme Court Precedents which are
binding and therefore based on the Supreme Court Precedent that trumps comes ahead of
the earlier decision of the Federal Circuit, and therefore the later panel was able to reach a
different result and did. There were some strongly worded dissents, that raised the question as to whether this was proper or not and that’s the state of our law today.
You know the facts, you are the bright students, you analyse for me the merits of
Scripps Clinic versus Atlantic Thermoplastics. What are the strengths of Scripps Clinic,
what are the strengths of Atlantic Thermoplastics as a legal matter ? Just down the law as
I’ve described it up to now.
[From the auditorium:] You get a patent for what you invented ....
Interesting point. You get a patent for what you invented, nothing broader than that.
But what did you invent ? Well, the only thing you claimed was the process. But the product that you got from this process ... There is an interesting point, which I’m not sure you
are picking up on from the facts of this case as I’ve given them to you. You all are going to
flunk this class.
[From the auditorium:] What you have not claimed, you disclaimed.
That’s an interesting point. Tell me something about factor VIIIc. We finally have
found somebody who is going to pass this class. What was factor VIIIc ? A novel new invention by me? No, interestingly it was not. I did not invent factor VIIIc. It has been long in
use, as a coagulant to treat haemophiliacs. But we had always acquired it from human
plasma. What did I invent? What was just said. I invented a process for acquiring said
product from porcine plasma. So, in fact the first weakness of the Scripps Clinic Rule is
that it really has a problem in the facts of the case where it is presented. Because certainly
we would all agree and it’s the black letter law, which I’m not going to read to you from the
book, except that I did just read it to you from the book, it’s the BASF case, it’s the black
letter law that stands for the proposition. Once you have a product already in the prior art,
you cannot acquire any new rights to that by simply inventing a new process for making it.
And that was the case with Scripps Clinic. What are the others ? Since we are dealing with
the problems with Scripps Clinic, what are some other weaknesses of the Scripps Clinic
precedent ? Well this requires a bit of detail study. The BASF Supreme Court case that I
told you about actually did distinguish between patentability and infringement and had a
different rule for each. There was a different rule for patentability, which is you construe
the product as reasonably broad as you can. Why ? Because the man in the Patent Office
does not have the administrative capability to perform processes, analyse the product acquired from said process and then compare it to the prior art. They must assume that your
- 15 product is in the prior art. If they can find any product made by any process in the prior art
that anticipates or renders yours obvious. The Supreme Court had recognised that Rule
and yet at the same time applied for infringement purposes the different rule of binding you
to exactly what you have claimed. Claims have meaning.
Any other weaknesses of the Scripps Clinic ? Somebody else can get a good grade
in this class, if they really analyse, remembering a key fact, a fact that is always present:
It’s the fact that the Japanese Law keyed on. And this fact will always determine the outcome in these cases.
What is the product ? What did I get by pouring porcine plasma over agarose
beads ? I’ve got 60% pure factor VIIIc. What did Genentech produce with its recombinant
DNA process ? 98 or 99% pure. Was that the same product? Not exactly. Functionally, it
performs the same function. But is it the same product ? That’s the problem, isn’t it? Indeed, by the way in the Scripps Clinic case, do you know what happened? You American
Law Experts know what happened. It’s the one case in Federal Circuit Precedent they decided for the reverse doctrine of equivalence.
The reverse doctrine of equivalence, what’s that? You all know what that is. That’s
when something is supposedly the same but enough different in function, way and result
that we will construe it to be different, even though it is the same. Now you know why the
reverse doctrine of equivalence is as silly as it is and is not cited at all. But in this case it
was cited. And why did it have to be cited? Because they had to send the case back, to
say we are not sure if these are really the same products. They perform the same function.
So, adopting a kind of a broad functional determination of similarity of products we are going to call them the same product. But we still are not sure if they are the same product, so
we are going to send it back for further fact finding to determine whether the product is the
same.
Always this is the problem in product-by-process claiming:
Is the product identical when made by a different process? If it is, it becomes a
somewhat easier case. By the way, there is one more weakness in the Scripps Clinic argument: There was a prior Federal Circuit Case, prior to Scripps Clinic, in re Thorpe in
which the Federal Circuit had said: Product-by-process claims, of course, are limited by
their procedural process limitations. So, Scripps Clinic is not the first law on the subject
and cannot claim to be. What are the virtues of the Scripps Clinic Rule? The virtues of having the same rule for patentability as for infringement. You are supposed to chuckle, I just
gave you the answer.
But there is a virtue. Patentability is assessed by the same standard that we use to
- 16 assess infringement. And that’s generally the rule we like to follow. That is almost uniform
across patent law. You use the same assessment procedures for patentability as you do
for infringement. We’d like to be able to be consistent. The problem with consistency in this
case is that it short-circuits the process of determining whether or not the products are the
same. Which is always the key - in the light of the fact that the patent has only claimed a
process, remember. And so the patent claim itself does not help you resolve the question
of whether the products are the same. And that’s what creates the problem for you in the
first place.
There is another virtue of the Scripps Clinic Rule and that is that other nations have
tended to follow the uniform rule that patentability and infringement rules are to be the
same. However, you noticed in the Japanese presentation, just as long as it is clear that
the products are the same. That’s begging the question, because that’s the whole issue.
But now back to our meeting in the conference room to decide what we are going to
do. What are we are going to say ?
First, we are going to pitch to the District Court that, well, we have got the Scripps
Clinic Rule, right, we are going to try to get the District Court follow that. But what are we
going to say to the District Court, when he or she says “How can I identify the meets and
bounds of this Intellectual Property Right without reference to the claim? Don’t the claims
have some meaning? Isn’t the only thing that I’m legally bound to follow the claim?” What
are we going to do, when the judge says that to us? Anybody got an argument ?
Well, we are going to have trouble. We can argue as I have just mentioned that, well,
patentability, use it as covering the entire product, however it is made, as the same in any
other product patent. But that raises the questions, what is the product? Even in the case
we talked about. Genen-produced RNA product is different from the alternative product we
have made by pouring porcine plasma over agarose beads. Also we have got the problem
of the Supreme Court Precedent treating patentability different than infringement for product-by-process claims. Well, we can argue policy. We are going to argue the only way that
Genen Corp could have made their product was to step on our shoulders. They took our
product that we made by our process, the analysed it, learned the protein chain from us
and then made it by their cloning process. They owe us, we did the inventive work, we deserve some compensation, they are the bad guys, we are the inventors.
Fine. I like that argument. A very compelling argument. But we still have to convince
the District Court that Genen Corp has the same product. And the only way we can identify
the product that we have invented is pouring plasma over beads. And we really have no
claim to the factor VIIIc itself. It’s an old product.
- 17 Aah, we are beginning to realise that what we try to do with our product-by-process
claim is not going to work. We really try to get a claim to an old product. Didn’t we? And we
are not going to get away with it, I’m afraid.
Well, now is the big time. We have got the Scripps Clinic Precedent, we have got
the Atlantic Thermoplastic Precedent, the professor turns to his counsels and he says,
“What will the District Court do? What is the rule?” I ask you!
And the answer is very simple: “Go ask a judge, I’m just a professor!”
Let me just conclude here. What’s our real problem? Our real problem is: How do
we claim this kind of an invention? It really is an attractive idea to somehow get around the
problem of claiming a biotechnological invention in terms of structure and having to 5000
times replicate every known substitutable amino acid. Rather than do that wouldn’t it be
nice if we could just claim it in some broadly generic way, that would allow us to then use
the knowledge or skill in the art and say all the known substitutes for this non-functionally
important point on our structural claim should be understood to be within the bounds of our
claim? Wouldn’t that be nice?
Unfortunately, as I told you, the Federal Circuit at least has - probably improperly imported a lot of chemical standard in biotechnology law, so that we are not going to be
able to do that. We are going to have to claim structurally. Of course, there is a way we
could do it: We can claim it structurally in a few simple claims and then we can use the
doctrine of equivalence to recapture obvious substitutions.
But we just had Festo. Festo does not probably defeat that argument in most cases.
It may not defeat it in our cases. If indeed you have taken proper precautions in a way that
you claimed and you’ve claimed it structurally, you’ve claimed it by characteristics, the
doctrine of equivalence may indeed help you to recapture obvious substitutions at various
non-functionally important points of the amino acid chains. I don’t think that has been foreclosed by Festo, unless of course, you have made amendments at any point in the proceedings and if you have amended at any point of the proceedings, then you will not have
the advantage of the doctrine of equivalence.
In conclusion I like to suggest to you that the real key to this area is once again discerning whether the products indeed are identical, whether you are talking about the same
product. That kind of almost is complicated by product-by-process claiming because the
claiming techniques that you usually use to identify differences between the claimed invention and the accused become under the Scripps Clinic Rule irrelevant. They probably will
not be irrelevant in any Court wherever in the world when it comes to determining whether
- 18 the products are the same. I think the burden of proof will always in that instance lie with
the patentee.
***
Alexander Straus: Product-by-Process Claims in Europe
Obviously, there seems to be some interest on the issue of product-by-process
claims not only in Japan and in the United States but also in Europe. You know the Germans are very controlled. So I also want to address particular questions and I would like to
give you a table of contents, what I want to do today.
First, the definition we have heard. I will do it short.
Second, under which conditions will the EPO allow applicants to draft claims as a
product-by-process claim? How does the EPO assess the patentability of this sort of
claims and how does the EPO assess the scope of protection conveyed to a patentee by
this patent when he has a product-by-process claim. We have just heard from Mr. Rader
that obviously in the United States claims are assessed with respect to patentability in generic terms, however, when it comes to an infringement issue these claims are rather read
as limited by the process specified to describe the product.
Last but not least, national considerations and practical issues. Here I would like to
give some recommendations on how to deal with these sorts of claims in Europe when it
comes to opposition procedures or infringement cases on the national level.
Before I start, perhaps some words to the peculiarities of Europe as regards to the
other jurisdictions we had before. The EPO is only there to examine the applications on
formal and substantive basis. It will issue a European patent, which will then be validated
in the national countries. The most important thing for applicants to do is to pay the fees,
as a matter of course, as always. Now, on the national level these patents may be subject
to a nullity suit where the validity thereof will be assessed and also the infringement cases
are carried out on the national level. So, the EPO is subject to its own law: The European
Patent Convention, while the national courts are subject to national law. So, each applicant
or patentee has to consider that in Europe two more or less different law systems are present, namely the EPC and the different national laws in each of the contracting states. We
will see that, though both systems try to harmonise the case law, there are still some differences. In order to show you the problems associated with these sorts of claims, let me
shortly refer to the different claim categories we have.
- 19 Process claims. We define a process by the process steps. The process is covered
as a matter of course, but in Europe also the product directly obtained by the process,
meaning that we have with a process claim not only a process protection, but also a socalled product-limited-by-the-process protection. This might be similar to what Judge Rader referred to a scope of protection of a US product-by-process claim. On the other side, if
you have a pure product claim you normally describe the product by means of physical parameters, arrangements, structure, if you have a chemical compound by the chemical
structure. The scope of protection of such a claim is generic. And surely it is irrespective of
the process of manufacture, how the product has been produced.
Now, as regards a definition we have heard it by the speakers before and I can tell
you that there is no difference whatsoever with respect to Europe. Also in Europe a product-by-process claim is considered as a product claim in which the product is described by
means of its methods or process of manufacture.
The product claim cannot only be described by physical features but also by process features. This has an effect on the scope of protection, we will see later on. Now, under which circumstances does the EPO allow applicants to draft claims in this form? One
of the requirements a claim has to fulfil is laid down in Art.84 EPC, namely the claims shall
be clear and concise. Already 18 years ago in the T 15/82 (T means always a decision by
the Technical Board of Appeal) the Board had to decide whether the definition of a product
by means of its process of manufacture would effectively fulfil this requirement and it said
yes. However, such claims should be drafted only in those cases where applicant is not
able to define the entity he wants to claim by means of its composition, structure or some
other testable parameter. You will also note that the Technical Board of Appeal clearly said
“no other information in the application”, indicating that eventually applicants may start
from the very beginning with a product-by-process claim, even though he could effectively
describe a compound let’s say by a chemical formula. Now, according to the case law at
the EPO there obviously seems to be a sort of feature hierarchy:
Applicants should chose, whenever possible physical features to describe the product. If they cannot do so, then they may rely on parameters that characterise the matter by
own reliable properties, meaning properties as such: black, white, colour, etc. And only if
he cannot do so, he may rely on the process by which the product has been made. However, according to my opinion and to my experience, the EPO seems to be rather liberal in
this sense and whenever an applicant wants to draft a product-by-process claim, he is effectively allowed to do so. Let me give some examples where the EPO has allowed applicants to draft these sorts of claims. Surely, if the description by other features was not
- 20 possible. We have these old decisions.
The second example somewhat relates to the first. In this case the applicant, Merck,
has given a structural formula in the application, meaning the applicant tried to define the
compounds by means of the structural formula a precise definition. During the examination
proceedings, however, it turned out that this structural formula was wrong. According to
the specification the applicant did not have any possibility to amend the structural formula
to the correct one. According to Rule 88 EPC if applicant does not have any information
contained in the specification as originally filed, that’s it. However, in the application there
was the process for the production of this formula. And so here the Board allowed to draft
a product-by-process claim, because eventually any skilled person, third party and also of
course the patentee would arrive, when following the process, at a chemical compound
having the correct structural formula. So, product-by-process claims may also be considered as a suitable means to delimit the own invention over the prior art, namely in case
where you do not have features available in the specification to include into a claim to delimit yourself over the prior art. Here you may also use the process for producing the compound.
There is also a rather recent case; it was issued in January this year, and showed
that the EPO also allows the draft of product-by-process claims for overcoming clarity objections. The case underlying this decision was quite interesting. The applicants claimed a
chemical compound, which was described by its structural formula and said this compound
should be substantially pure. Now, the EPO as a matter of course objected to this term
and said: “This is not clear for any person skilled in the art, what this effectively means”.
So, applicants forwarded some regulations of the FDA, it was a US applicant, saying substantially pure according to FDA regulations means less than 2% impurities. In this respect
the Board said “First we do not see any indication in the specification that you might refer
to this FDA regulation and second what might apply for the United States should not always at least apply for the rest of the world, at least for Europe.“ So they did not allow an
interpretation of the “substantially pure” by this FDA regulation. However, in order to overcome this objection, applicant was allowed to describe the products by means of the process of its production, because when following the process, anyone will eventually arrive
at a compound having this low impurity level.
How does the EPO assess the patentability of such sort of claims? I have to summarise, as we have seen in the other jurisdictions in generic terms, namely the products as
such have to fulfil the requirements for patentability. They must be novel and they must be
inventive. As the Board also held in an old decision, applicant may not rely on a different
- 21 process step for delimiting his product over the prior art. But it’s really the product as such,
which must be new and inventive. Mr. Hashimoto has already said that this might cause
some problems. And it definitely does. This is just what the Guidelines say; they must be
new and inventive.
How, before the EPO can we assess whether a product is novel and inventive?
Meaning, how can we compare the subject matter, which we describe via the process of
production with the prior art, the prior products. And here I always tend to say the so-called
translation theory seems to apply. You have indicated process steps, in order to describe a
product. Now it is clear that these process steps must have an impact on the product as
such. Again, from this process steps, product features must be derived. I have here an example, in order to more clearly show that. That is a claim I drafted on short terms, directed
to a polymer obtainable by various process steps. In a first step we mix some monomers
and as a matter of course, when we set up a product analysis, when we translate the process steps into product features, we will always have monomer 1 and 2 in the product.
Second, we heat this mixture to a particular temperature. We have to ask which effect
does this have on the structure of the resulting polymer and find some feature. Again, we
add a prepolymerised compound 3 to this other mixture. Compound 3 must be a major ingredient of this polymer and perhaps there is resulting a block polymer or whatsoever. You
see, whenever you have a product-by-process claim before the EPO and you want to
compare it with the prior art, you have to translate the process steps into physical product
features. When you are able to describe the product by means of physical product features,
it is possible to compare it with prior art products.
What about the scope of protection? Now again, Judge Rader, the US say we assess the patentability of product-by-process claims in generic terms and when it comes to
the scope of protection these claims are limited to the process. This does not apply for Europe. Product-by-process claims have to be interpreted in an absolute sense, independent
of the process. The process indicated in such a product-by-process claim should rather be
considered as one example out of many processes that will eventually lead to a product to
be protected by this claim. In this case this has been confirmed. A product-by-process
claim confers absolute protection for the product. It does not matter how it is made. And
here again, the features of which are identical with those of the product resulting from the
process. Again, the translation theory comes into the game.
I would like to address one problem with the EPO which might come up later, when
applicants or patentees are going to the national phase, namely the use of the different
terms “obtained” and “obtainable”. To be strict, EPO considers both terms to designate a
- 22 true product claim. There exists a rather interesting case and it has some logic. The fact
that the term “obtained” has been changed to read “obtainable” does not at all modify the
definition of the said product, just as the process to which reference is made has clearly
stayed the same. The case underlying this decisions was an opposition and appeal in
which patentee changed the term “obtained” to “obtainable” and the Board had to decide
whether this would represent an extension of the scope of protection of the already granted patent, which is not allowed anyway at the EPO. It said it does not. Because, if we have
the product obtained by a particular process and you apply this translation theory you will
end up with a particular product description. We translate the process features into physical product features. If you exchange the term “obtained”, which was in the claim, to read
“obtainable”, you will still end up with the same product analysis with the same product
features and that’s why the Board came to the conclusion that there is no difference when
applicants use “obtained” or “obtainable”. I know another definition, which is even more
peculiar, because here the Board said, “directly obtained” is the same as “obtained” and
“obtainable”. The case here at stake was that the patentee had a process patent. Again we
had opposition and an appeal and he tried to introduce a product claim by specifying ”product directly obtained by the specific process indicated in claim 1”. Again, the
Board had to decide whether this would represent an extension of the scope of protection.
They came to the conclusion: Yes. As you might recall, the EPC and also national law provides for a product limited by the process protection via the process. If you write “process
for the production of a product”, always the product directly obtained by the specific process will be protected anyway and these were also the arguments by patentee in this respect. However, again the Board held: If you write, “product directly obtained by the specific process”, obviously when you translate the process features into physical product features, you have a change of claim categories. Now you are claiming a product and before
you had claimed a process. In this respect this had represented an extension in the scope
of protection. Now, we also see this in the Guidelines for the Examination. So, the EPO
suggests any applicant to use the terms “product X obtainable by process Y” rather than
“obtained by”, this clearly indicates, and according to my practice I also see that quite often,
that both terms are considered to be equivalent. Whether this applies also on the national
level, we will see later on.
Let me shortly summarise, what we have heard. As for the admissibility according to
the Case Law the Rule of Necessity seems to apply. Actually, if applicant wants to draft
the claims as product-by-process claims, he will be allowed to do so. Second, the products
must fulfil the requirements for patentability, since a product-by-process claim is a genuine
- 23 product claim. Since it is a genuine product claim, we also have a generic scope of protection. It’s not limited to the process. The process is just one means to describe the product.
Before the EPO “obtainable” is equivalent to “obtained” and also obviously “directly obtained.
Now, let’s go to the opinion of some national countries in Europe. I’ve chosen in this
respect Germany (I may excuse myself, I’m a German so it’s easier for me) and perhaps
some words for the UK, because the situation there seems to be a little different. Again,
the EPO only grants the patents and when the patents come on the national level they are
assessed regarding validity or in an infringement suit as if they are national patents on national law. What about the allowability of these sorts of claims?
Clearly, German courts take the same attitude as does the EPO. We have a very
old decision saying that product by process claims are allowed in case applicant may not
define the product by means of physical parameters. The court did not say “on the basis of
the information provided in the application”. Obviously, there also seems to be according
to the case law some sorts or Rule of Necessity, since applicant should rather chose the
most precise way to describe e.g. the chemical compound, in this way the structural formula. But when you really have to deal with the German Patent Office you will note that they
allow any applicant to draft a claim in the form the actually want to do it. What about the
patentability? Again, like at the EPO these claims are considered to be genuine product
claims, meaning that the products as such have to fulfil all the requirements, as if they
have been described by conventional physical features. Again, the German Federal Supreme Court here also said the method of its production, meaning the method steps as
such, cannot convey patentability to the product. If you have a product produced by a different method but the product stays the same, then you will not get a patent on this.
Prior art, how does Germany compare it? This famous “Akrylfaser”-decision. I have
tried to translate this very, very long sentence and I hope I was successful in a way. What
is important, by using parameters other than physical features, this means the process
steps here, the description of the entity is replaced by a conclusion from the process steps
to particular physical properties of the product. In short words: Also in Germany this translation theory seems to apply. You have or you should translate the process features into
physical product features and when we have these in hands, then we have a description of
the product and can compare the product with the prior art. According to my opinion there
seems to be some contradiction in the different case law involved here. Because as mentioned before, in the Trioxan-decision the Federal Supreme Court said “an applicant shall
be allowed to draft claims in product-by-process claim form if he cannot describe the prod-
- 24 uct by physical features”. Now, all of the sudden, when it comes to compare the product to
the prior art, he should eventually do so and translate the process into physical features,
meaning that you are going to describe the product again with physical features, which you
cannot do.
Scope of Protection. Again, the same applies as in Europe, namely product-byprocess claims protect a product, irrespective of its methods of production. So, again it’s a
genuine product claim, which is assessed with respect to patentability in generic terms,
and again the scope of protection is also generic in Germany.
Now, let’s come to the issue of “obtained” and “obtainable”. As mentioned before,
before the EPO these terms are considered to be equivalent. So, whenever an applicant
drafts his claim “product obtained by a particular process” and he will eventually come to
Germany and wants to enforce his patent, he might run into problems. Though there is no
definite decision about how to read “obtained” and “obtainable”, the decisions of the German Federal Supreme Court and the Civil Court in Düsseldorf rather suggest that in Germany the courts see some difference. And when you just look at the literal meaning of “obtainable” and “obtained”, you will see that “obtainable” in the word itself indicates that the
process which you use to define the product is just one example out of many others how
you can arrive at the product, whereas when you write “obtained” this might rather indicate
that exactly what you wanted to claim is the product which you obtained only by this specific method. That’s why I would suggest always, even before the EPO, to use the term
“obtainable” and never “obtained”, because there might be problems.
Summary for Germany: Although the rule of necessity seems to apply also here,
applicants may draft product-by-process claims as they like. The products must be patentable and we have a generic scope of protection. As regards the interpretation of “obtainable” and “obtained” Germany does not seem to take the same opinion as does the EPO.
Let’s shortly refer to the UK and perhaps some people here can add some valuable
information, because I have not found any relevant case law as regards product-byprocess claims in the UK which might be due to the fact that they have the so-called “concept of process claim” in a different aspect. This is more or less what we have process for
the production of a product and then you have the products directly obtained by the process protection. Here, the allowability of product-by-process claims: They are allowed as
long as the claim is clear. The patentability of these claims, however, process features
may confer novelty on such sort of claim. What applies here? The process seems to be
the major issue, applies also for the scope of protection. What we have here it’s a product
limited by the process. I think also in the UK there might come up some problems because
- 25 so many product-by-process patents come via the European route to the UK. Sooner or
later the courts there have to say what they think about these genuine product claims,
whether they are really linked or limited to the process or not.
Since I think we are all practitioners, perhaps a few words about how to deal with
this sort of claims before the EPO or before a court. If you oppose to a patent in an opposition or nullity suit, there are essentially two ways to do so: You have a claimed product and
this product claim is described via its process of production. So, first if your search was
successful and you found a document indicating the process of the production of the product, you surely can object to the process, because if the process had been disclosed it will
be clear that also the product as such cannot be novel any more. This applies only to the
question of novelty. On the other hand, if we want to object to the product, again we have
to translate the process steps into physical features. And that’s exactly the point where the
problem starts. First, which features shall we derive from the process and how many features shall we derive from the process. We had a case that went up to the German Supreme Court and we got some indications by the German Federal Patent Court at least on
this first question: Which features? Namely, the court held that at least those features,
which reflect the inventiveness of the product, should be included in such a product analysis.
Let me give you an example for this. We have the polymer obtainable by different
steps. Now, let’s assume that we have a patentee who found on the market a potentially
infringing product. The patent comprises a product-by-process claim. The patentee will, as
a matter of fact, investigate the product of the competitor and end up with the conclusion
that this product is infringing his patent. He will start a suit. First, he has to define the
scope of protection of his own claim 1. In this respect he has to derive from the process
steps product features in order to define and to say to the court: This is my product. These
are the features, the physical features that are suitable and sufficient to describe the product that I have protected through this patent. And as a matter of course, patentee will try to
include in this product analysis as few features as possible, because when he includes few
features he will most certainly always have the situation that the potentially infringing product of the competitor will also exhibit these features. However, on the other side, what the
defendant can do is say: No, I do not agree with this product analysis. In order to describe
the product in a sufficient way, we have to include more than only these 3 or 4 features into the product analysis. And we can derive out of the difference steps more features, which
have to be included into the product analysis. And all of a sudden, the defendant may
come up and say: Look, we do not have compound 4 in our polymer and so we are not go-
- 26 ing to infringe. You see, patentee will run into problems here, but also defendant, because
he cannot be 100% sure whether his product analysis is going to apply or whether this
product analysis is going to apply. On the other hand, one of the defence means in Germany, how defendants in an infringement suit may defend themselves is to start a nullity
suit, i.e. to try to invalidate the patent under discussion. And here the situation is vice versa.
Because the fewer features are required for describing the product, the higher the likelihood for the defendant to find a document that exhibits or shows all of these features.
However, most likely, defendant, since we were not able to find substantial documents,
tries to include more and more features into the product analysis and then goes to the infringement court.
You will see that product-by-process claims create a sort of uncertainty, not all for
patentee but I think above all for the competitor. Because, when he is going to develop a
new product and faces a product-by-process patent in Europe, he cannot be 100% sure
whether his new product is going to infringe – and you always have to consider that the
features are more or less the same – or not.
*****