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26: Process Patents: Burden of Proof
Article 34 Process Patents: Burden of Proof
1. For the purpose of civil proceedings in respect of the infringement of the
rights of the owner referred to in paragraph 1(b) of Article 28, if the subject
matter of a patent is a process for obtaining a product, the judicial authorities
shall have the authority to order the defendant to prove that the process to
obtain an identical product is different from the patented process. Therefore,
Members shall provide, in at least one of the following circumstances, that any
identical product when produced without the consent of the patent owner shall,
in the absence of proof to the contrary, be deemed to have been obtained by
the patented process:
(a) if the product obtained by the patented process is new;
(b) if there is a substantial likelihood that the identical product was made by the
process and the owner of the patent has been unable through reasonable efforts
to determine the process actually used. Any Member shall be free to provide that
the burden of proof indicated in paragraph 1 shall be on the alleged infringer
only if the conditions referred to in subparagraph (a) is fulfilled or only if the
condition referred to in subparagraph (b) is fulfilled.
2. In adduction of proof to the contrary, the legitimate interests of the defen-
dants in protecting their manufacturing and business secret shall be taken into
account.
1. Introduction: terminology, definition and scope
Article 34 is concerned with patents the subject matter of which is a claim or
claims to a process for the manufacture of a product, which may itself be the
subject of a patent though it does not necessarily have to be.
Article 34 reverses the procedural principle under which the person asserting
a fact must prove it. Its purpose is to meet the so called "probatio diabolica":
it is always difficult for a plaintiff owning a process patent to prove whether
or not the process used by the alleged infringer to manufacture an identical
product to the one resulting from the patented process infringes his exclusive
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right, unless the plaintiff gains access to the manufacturing process of the alleged
infringer.
967
The conditions on which the onus of proof should be reversed are as follows:
968
1. The alleged infringer's product must be identical for material purposes to the
product produced by the patented process.
2. If this is the case, Members should implement a presumption that such product
has been obtained by the patented process if –
(a) the product obtained by the patented process is new; or
(b) if there is a substantial likelihood that the identical product (new or exist-
ing) was made by such process and the owner of the patent was unable through
reasonable efforts to determine the process actually used, and the patent owner
produces evidence that he/she has used reasonable efforts to try to determine the
process used and was unable to do so.
2. History of the provision
2.1 Situation pre-TRIPS
The rule on the reversal of the burden of proof was introduced by the 1891
German patent law (Article 139). It was also incorporated in the patent laws of
Italy, Belgium and Spain. It was also included in the Community Patent Conven-
tion (Article 35), as well as in the proposed WIPO treaty for harmonization of
patent law (Article 24)
969
on terms substantially similar to the text adopted later
on under TRIPS.
2.2 Negotiating history
Negotiations on this provision were based on the proposals submitted in 1990
by the European Communities, the USA and Switzerland. Equivalents of this
provision existed in both the Brussels Draft of TRIPS and in the Anell Draft of July
23, 1990. The two conditions for the reversal of the onus probandi were similar in
both drafts, but in its final version Article 34.2 makes it clear that Members may
provide that the onus shall be on the alleged infringer if either of the conditions
is fulfilled. During the negotiations the European Commission favoured the first
condition and the United States the second.
970
2.2.1 The Anell Draft
"2.3 Reversal of Burden of Proof
2.3A.1 If the subject matter of a patent is a process for obtaining a product, the
same product when produced by any other party shall, in the absence of proof to
967
See, e.g., Miguel Vidal-Quadras Trias des Bes, Process patents on new products and reversal
of the burden of proof: factors contributing to the interpretation of its scope, European Intellectual
Property Review 2002, vol. 24, No. 5, p. 237–243 (237) [hereinafter Vidal-Quadras Trias des Bes].
968
See Gervais, p. 171.
969
See WIPO, 1991, p. 32.
970
See Gervais, p. 172.
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Process patents: burden of proof
the contrary, be deemed to have been obtained by the patented process in [at least
one of] the following situation[s]:
(a) if the product is new, [or,
(b) where the product is not new, if there is a substantial likelihood that the prod-
uct was made by the process [and the owner of the patent has been unable through
reasonable efforts to determine the process actually used].
2.3A.2 In the adduction of proof to the contrary, the legitimate interests of the
defendant in protecting his manufacturing and business secrets shall be taken
into account.
2.3B Where the subject matter of a patent is a process for obtaining a product,
whether new or old, the burden of establishing that an alleged infringing product
was made by the patented process shall always be on the person alleging such
infringement."
Alternative 2.3B, introduced by developing countries, was clearly intended to
counter the proposals for reversal of the burden of proof. But this strategy was
not successful, as is obvious from the text finally adopted.
2.2 The Brussels Draft
"Reversal of Burden of Proof
1. For the purpose of civil proceedings in respect of the infringement of the rights
of the owner referred to in Article [28](1)(b), if the subject matter of a patent is
a process for obtaining a product,
PARTIES
[shall] [may] provide in at least one
of the following circumstances that any identical product when produced by any
party not having the consent of the patent owner shall, in the absence of proof to
the contrary, be deemed to have been obtained by the patented process:
(a) if the product obtained by the patented process is new;
(b) if there is a substantial likelihood that the identical product was made by the
process and the owner of the patent has been unable through reasonable efforts
to determine the process actually used.
2. In the adduction of proof to the contrary, the legitimate interests of the de-
fendant in protecting his manufacturing and business secrets shall be taken into
account."
3. Possible interpretations
1. For the purpose of civil proceedings in respect of the infringement of the rights
of the owner referred to in paragraph 1(b) of Article 28, if the subject matter of
a patent is a process for obtaining a product, ...
The reversal of burden of proof logically applies to civil procedures only, since the
presumption of innocence generally governs in criminal cases. The subject of the
patent for the reversal to proceed should be a "patent for obtaining a process". It
is left to Members, however, to determine whether such a process should be the
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3. Possible interpretations
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sole object of the patent, or whether "hybrid" patents (including claims over both
a process and a product) should also be subject to Article 34.
This Article only applies, further, in cases where an infringement of the acts
described in Article 28.1(b) of TRIPS is alleged, that is, whenever the identical
product has been directly obtained with the patented process. It is not enough,
hence, to argue that the product is obtainable with such a process.
... the judicial authorities shall have the authority to order the defendant to prove
that the process to obtain an identical product is different from the patented
process.
Article 34.1 requires Members to empower their judicial authorities to order the
reversal of the burden of proof. It is not an operative, self-executing provision, but
requires positive action both by the Members and, in a particular case, the com-
petent judge. The defendant can be obliged to prove that the process is different
from the patented process, but cannot be obliged to prove that the process has
not been infringed. If the defendant proves that the process used by himself on
the one hand and the patented process on the other hand are different, the proof
of infringement, which would normally require the application of the "doctrine
of equivalents",
971
remains a plaintiff's burden, according to general principles of
procedural law.
972
Therefore, Members shall provide, in at least one of the following circumstances,
that any identical product when produced without the consent of the patent
owner shall, in the absence of proof to the contrary, be deemed to have been
obtained by the patented process:
Whether a product is "identical" to the product obtained by a patented process is
to be determined on the basis of its structural composition. Similarity, therefore,
is not sufficient to trigger the reversal of proof.
973
971
This doctrine provides a conceptual framework to determine if a violation of a patent exists
when there is no literal infringement of patent claims. See, e.g., Correa, 2000a, p. 85.
972
See the decision of the Barcelona Provincial Appellate Court of September 18, 2000, in
Enaaprile II, according to which the defendant's burden of proving the contrary "is confined to
disclosing the process actually used by the defendant (which would convert the proceedings into
a mere comparison of both processes) and to show that the two processes are not identical, but
not that the presumption also involves proof that the processes are not equivalent". See also the
judgment of the German Federal Court of June 25, 1976, in Alkylendiamine II, which held that a
similar rule under German law did not shift the responsibility for determining the scope of the
plaintiff's right on the defendant; but merely required the defendant to provide sufficient proof
of the process actually used in manufacturing the product. G.R.U.R 1997, p.103 (cases quoted in
Vidal-Quadras Trias des Bes, p. 240).
973
The German Federal Supreme Court in the Alkylenediamine II case clarified that the notion of
"same substance" under the old Patents Act Section 47(3) applied also when established differences
exist between two substances within the limits that technical experience shows to be attributable
to a variation of the patented process, but not the application of a different process. See Straus,
p. 820.
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Process patents: burden of proof
In addition to requiring that judges be empowered to order the reversal,
Article 34 provides for the establishment of a juris tantum presumption that the
patented process has been effectively used. This presumption admits proof to the
contrary.
As mentioned, the conditions stipulated in Article 34.1 for the reversal to proceed
constitute options for Members. They may opt for establishing one or the other,
974
at their discretion.
3.1 Article 34.1(a)
(a) if the product obtained by the patented process is new;
This condition, probably inspired by European law, requires the "newness" of the
product obtained through the protected process. In many cases, the product may
be new but not inventive and, hence, not patentable. In the case of countries that
did not grant product patent protection for pharmaceuticals or other products,
there exist many instances in which the inventor was able to patent the process,
but not the product. The rationale for this option is that when a product is new,
it is unlikely that competitors had the time to develop alternative processes to
obtain the same product. The older the product, the higher the possibility that
such alternatives have been developed.
975
For countries that opt for alternative (a), there is no obligation to order the
reversal of the burden for products which are not new.
TRIPS does not determine when a product should be considered new for the
purposes of this provision. Members enjoy considerable room for manoeuvre in
this respect. They may, for instance, establish that newness be judged:
(1) according to the novelty requirement under the patent law on the date of
the application (or the priority date). This solution is significantly advantageous
to the patent owner: though a long period may have passed between that date
and the date of infringement, the product would still be considered new for the
purposes of the burden of proof. Under this approach the attribute of new is fixed
once and forever ignoring that, as time passes, it may be reasonably presumed
that other processes to obtain the product may have been developed.
976
974
A "TRIPS-plus" solution may obviously be to order reversal of the burden of proof when any
of the conditions are met, as originally sought by the USA during TRIPS negotiations.
975
Thus, it has been noted that "it seems to be reasonable to assume that, where subsequent
processes have been described for obtaining the product resulting from the claimed patented pro-
cesses to the extent that such processes may vary to a greater or lesser extent, bring different
advantages or simply be practicable, when the patent invoked is close to expiry and alternative
processes have been described, these circumstances must be taken into account in order to under-
mine the grounds for presuming that the patented process has been used" (Vidal-Quadras Trias
des Bes, p. 242).
976
The District Court of Munich considered (as long ago as 1963) that the "new product" charac-
teristic required by the article of the Patent Law relating to the reversal of the burden of proof did
not necessarily have to be interpreted as having the same meaning as novelty for the purpose of
patentability. More recent German authors have taken the same view since such an interpretation
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3. Possible interpretations
501
Or:
(2) at the time the product is introduced into the market. If other products ob-
tained by non-infringing processes were available at that time, it would be prima
facie proven that other processes existed for obtaining the product and, therefore,
there would be no logical basis for the legal presumption to operate. This solution
was proposed in one of the texts considered in the preparatory work of the WIPO
Diplomatic Conference for the adoption of a Patent Law Treaty,
977
and has also
been suggested by some authorities in Europe.
978
3.2 Article 34.1(b)
(b) if there is a substantial likelihood that the identical product was made by the
process and the owner of the patent has been unable through reasonable efforts
to determine the process actually used. Any Member shall be free to provide that
the burden of proof indicated in paragraph 1 shall be on the alleged infringer only
if the condition referred to in subparagraph (a) is fulfilled or only if the condition
referred to in subparagraph (b) is fulfilled.
A "substantial likelihood" is more than the mere "possibility". The plaintiff must be
able to prove that, in the circumstances of the particular case, the identical prod-
uct is likely to have been obtained with his patented process. Under this option,
the plaintiff would also have to prove that he has made reasonable and unsuccess-
ful efforts to determine what process was used, for instance, by undertaking the
chemical analysis of the product, requesting information from the product man-
ufacturer (if known and different from the alleged infringer), or other measures
that the owner could undertake at a reasonable cost and within a reasonable time.
3.3 Article 34.2
2. In adduction of proof to the contrary, the legitimate interests of the defen-
dants in protecting their manufacturing and business secret shall be taken into
account.
As noted, Article 34.2 makes it clear that the obligation to reverse the burden of
proof may apply in either the circumstances specified in Article 34.1(a) or (b) set
out above. If the product has in fact been produced by a different process, the
alleged infringer will not want to disclose his process to competitors. Article 34.2
would be contrary to the purpose of the procedural rule contained in German law (Vidal-Quadras
Trias des Bes, p. 242).
977
Article 301(1)(b) of the 1987 Draft Patent Law Treaty disregarded the presumption of infringe-
ment "if, at the time of the alleged violation, an identical product emanating from a source other
than the owner of the patent and the defendant was already known in commerce in the country
in which the patent applies". See, e.g., Harold Wegner, Patent Harmonization, Sweet & Maxwell,
London 1993, p. 334.
978
See, e.g., authors quoted by Straus, p. 821.
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Process patents: burden of proof
provides that in the presentation of evidence to the contrary, the legitimate
interests of the defendants in protecting their manufacturing and business secret
shall be taken into account. Obviously, those legitimate interests include not dis-
closing the defendant's trade secrets to the other side, including technical and com-
mercial information (e.g., the source of a given intermediate used in the process).
However, the defendant will be bound to disclose the process that has actu-
ally been used in order to rebut the juris tantum presumption. Otherwise, he
will be deemed as infringing the patent. A possible strategy to protect the defen-
dant's trade secrets is for the rules of court procedure of a Member to require
the trade secrets to be disclosed only to an independent expert, who is under
an obligation of secrecy, and who will advise the court under conditions of con-
fidentiality. Another strategy which is perhaps more appropriate to adversarial
(as opposed to inquisitorial) court procedures is to require the information to
be disclosed to one member of the plaintiff's team who is similarly bound by
an obligation of secrecy. That person will communicate the information to the
plaintiff's independent lawyers (who are similarly under an obligation of confi-
dentiality), who will then advise whether the proceedings are to continue or to be
discontinued.
"Legitimate interests", as defined by the panel in Canada-Patent protection of
pharmaceutical products, must be "construed as a concept broader than legal
interests",
979
encompassing any business interest that the defendant may legit-
imately wish to protect.
4. WTO jurisprudence
There is no WTO jurisprudence on this provision. In a case settled between USA
and Argentina after consultations, the Argentine government agreed to amend its
patent law in order to comply with Article 34.1. The proposed amendment opts
for the alternative provided for under Article 34.1 (a).
980
5. Relationship with other international instruments
This provision has no counterpart in either the Paris Convention or the Euro-
pean Patent Convention, both of which leave the question of onus of proof to
national law. However, Article 35 of the Community Patent Convention provides
that
"1. If the subject-matter of a Community patent is a process for obtaining a new
product, the identical product when produced by any other party shall, in the
979
WT/DS114/R, 17 March 2000, at para 7.71.
980
With regard to the definition of "new", the proposed amendment reads as follows: "[I]t shall
be presumed that, in the absence of proof to the contrary, the product obtained by the patented
process is not new if the defendant or if an expert appointed by the court at the request of the
defendant is able to show that, at the time of the alleged infringement, there exists in the market
a non-infringing product identical to the one produced by the patented process that originated
from a source different from the right owner or the defendant". See WT/DS171/3, WT/DS196/4,
IP/D/18/Add.1, IP/D/22/Add.1 of 20 June 2002.
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7. Comments, including economic and social implications
503
absence of proof to the contrary, be deemed to have been obtained by the patented
process.
2. In the adduction of proof to the contrary, the legitimate interests of the de-
fendant in protecting his manufacturing and business secrets shall be taken into
account".
6. New developments
In implementing the rule on reversal of burden of proof mandated by TRIPS, some
countries opted for alternative (a),
981
others for alternative (b),
982
while many in-
corporated both conditions set out in Article 34.1.
983
7. Comments, including economic and social implications
Process patents are a weak form of protection, because of the difficulties involved
in proving infringement. As noted above, formerly some countries while barring
the patenting of pharmaceutical products would allow the patenting of processes.
The effect was that for practical purposes pharmaceutical products were not
fully protected, because the key feature of a pharmaceutical product is usually
its molecule, and in practice the composition of this is fairly easy to analyse,
though the same molecule must be manufactured by an alternative method in
order not to infringe the process patent. Article 34 attempts to ameliorate this
weakness by reversing the onus of proof, so that if the defendant has produced
an identical product to that produced by the process patent, the onus shifts to
the defendant to show that the product was produced without use of the process
covered by the patent. It is, of course, no defence in patent law that the defendant
independently developed the identical process. Independent creation is a defence
in copyright and trade secrets law, but a patent confers an exclusive right on the
patentee.
The reversal of the burden of proof, hence, may be of particular importance in
developing countries and economies in transition that did not recognize product
patents for pharmaceuticals or in other fields of technology prior to the imple-
mentation of TRIPS. With the universal introduction of product patent protection
for pharmaceuticals and chemical products under Article 27.1, the practical im-
portance of such principle will diminish, since infringement of product patents
would be easier to prove. However, Article 34 will provide a valuable procedural
tool to patent holders that have only been able to obtain process and not product
protection.
Those countries that opted, in implementing Article 34.1, for alternative (a)
generally aimed at excluding the application of such a rule for products already
in the market. The extent to which this will be achieved, however, would depend
981
See, e.g., Argentine patent law 24.481 (Article 88).
982
This alternative is often found, for instance, in bilateral agreements concluded between the
USA and former centrally managed economies (Straus, p. 810).
983
See, e.g., Indonesian patent law No. 14 of year 2000 (Article 119); Industrial Property Common
Regime of the Andean Community, Decision 486 (Article 240).
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Process patents: burden of proof
on the way in which the concept of "new" is defined by law and jurisprudence. If
"new" is assimilated to the "novelty" standard for patentability, and a product was
new at the time of the patent application, it would remain "new" for the purposes
of the reversal of the burden of proof until the patent expires, possibly many years
after its introduction into commerce.
