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European
Patent Convention. Art. 69 - “In vitro detection of HIV infection” |
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Patent claim for a method for the in vitro detection
of viral infection due to LAV (HIV) covered only a method using the probes
mentioned in the patent claim, namely probes containing DNA sequences
characterized by their restriction sites and the fact that they correspond to
a deposited clone; the claim thus did not cover any method for the in vitro
detection of HIV in which a DNA probe hybridizes with viral RNA. |
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The action for infringement of the method
claim was dismissed because the plaintiff did not show evidence of the
alleged infringement. The action for contributory infringement of a
patent claim covering purified RNA was dismissed because the diagnostic kits
containing a purification step, supplied by the defendant, did not relate to
an essential element of the patent claim. |
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Decision of the Paris District Court (Tribunal de Grande
Instance) |
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Facts: The
French research organization, Insti- Most of
the claims of this patent had been amended before the EPO, during examination
or opposition proceedings, particularly in light of European patent
No. 0 173 529 filed by the NIH on August 19, 1985 under
the priority of the US patent application of August 22, 1984, published
on March 5, 1986, and thus relevant for novelty considerations only. Chiron
Blood Testing SAS and Chiron Healthcare Ireland Ltd were offering for sale
diagnostic kits for the detection of HIV in blood samples. Institut
Pasteur argued that these companies directly infringed claim 8 of its
patent and indirectly infringed (i.e. contributory infringement) claim 11. It
initiated proceedings by summons served on 25 July, 2005, just three months
before the expiry of its patent, and requested payment of an account on damages
of €8 000 000. Claims 1–6
of patent No. 0 178 978 relate to cloned DNA which contains a
DNA corresponding to the HIV retroviral genome contained in a deposited clone
and characterized by its size, or to cloned DNA fragments of the same
deposited DNA, characterized by their size and restriction sites. Claim 7
covers a probe for the in vitro detection of viral infection by HIV, which
consists of a DNA according to any of claims 1–6. Claim 8
covers a method for the in vitro
detection of viral infection due to the LAV virus which comprises contacting
a biological sample originating from a person to be diagnosed for LAV
infection and containing RNA, in a form suitable for hybridization, with the
probe of claim 7 under hybridizing conditions and detecting the
hybridized probe. fragments
of claims 1–6 and claimed, on the contrary, that the probes used in
their detection kit differ from those referred to in claim 8. Chiron
argued that the marketing of the detection kits could not have amounted to
contributory infringement of claim 11 since the means supplied did not
relate to an essential element of this claim. Findings: The
Court reviewed: - the scope of claims 8 and 11
of EP No. 0 178 978; and - the alleged infringement of those
claims. While
assessing the scope of claim 8, the Court studied the prior art relied
on by Chiron. Scope of claim 8 The
Court began by quoting Art. 69 EPC. It then
decided that claim 8 could only be construed so as to cover a method for
the in vitro detection of HIV using the probes of claim 7, namely a
probe consisting of cloned DNA fragments of claims 1–6 defined by their
restriction sites and the fact that they correspond to the retroviral genome
of LAV contained in the deposited clone. The
Court based such construction on: the
language of claim 8 and the patent description which does not relate to
a general means consisting of hybridizing DNA probes with viral RNA, but
which relates to specific probes consisting of given DNA fragments; the
prior art which already disclosed a general method for the detection of HIV
consisting of hybridizing DNA probes with viral RNA. The
reference to the wording of the claim and to the patent description is, in
our view, a correct application of |
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No. 0 178 978
on September 17, 1985, under British priority of September 19, 1984
for “cloned DNA sequences, hybridisable with genomic RNA of Arguments of the parties The
plaintiff, Institut Pasteur, alleged that claim 8 of its patent covers a
general method for the in vitro detection of HIV, i.e. any method enabling
the detection of AIDS, characterized by the hybridization of DNA probes with
viral RNA. It
therefore claimed that the marketing of Chiron’s detection kit infringed
claim 8 of its patent, either literally or by way of equivalence. Institut
Pasteur further claimed that claim 11 covers any purified RNA sequence
of HIV, whatever its size and irrespective whether it corresponds to the cDNA
of the deposited clone. It thus
argued that Chiron indirectly infringed claim 11 of its patent by
supplying the means relating to an essential element of that claim. The defendants, Chiron, argued to the contrary that claims 8 and 11 could not be construed broadly. Specifically, Chiron argued that: - claim 8 relates to a specific method using the probes of claim 7, namely probes consisting of cloned DNA fragments of claims 1–6; - claim 11 covers the specific isolated RNA sequence corresponding to the cDNA of the deposited clone. Chiron
further submitted that, should the patent be construed differently,
claims 8 and 11 would be invalid in view of the prior art. Chiron requested the Court to dismiss
Institut Pasteur’s action for infringement of claim 8 on the ground that
the plaintiff did not demonstrate that the detection kit in question would
use the probe of claim 7 consisting of cloned DNA This first finding provided sufficient
grounds for the Court’s decision. But the
Court clearly wanted to emphasize the difficult position in which the
plaintiff found itself, namely that a broad construction of its patent would
entail its invalidity in view of the prior art. Scope of claim 11 The
reasoning followed by the Court in relation to claim 11 was similar. The
Court decided that claim 11 should be construed so as to cover only the
claimed purified RNA characterized by its size and the fact that it
corresponds to the complementary cDNA contained in the deposited clone. The
Court based such construction on the fact that the purified RNA of the LAV
virus was known from the prior art. Although
prior art must not be taken into consideration in claim construction, the
Court was correct in deciding that the scope of a claim cannot extend beyond
the literal wording of that claim when a broader scope would entail the
nullity of the claim. Non-infringement of claim 8 The
Court dismissed Institut Pasteur’s claim for infringement of claim 8 on
the ground that the plaintiff did not demonstrate that the probes used in the
kits in question would, in fact, contain the DNA fragments of claims 1–6
of its patent. The
Court noted that Institut Pasteur had not challenged Chiron’s argument that
their probes are different from those described in the patent. In this
respect, the Court also noted Chir-on’s argument that the detection kits
contained 3 oligonucleotides likely to be considered as probes (capture
oligonucleotides, amplification primers and la- |
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ging,
nor whether all or any of those oligonucleotides would reproduce the
characteristics of claim 8 as it has been construed. Although
the Court could have ended its judgment at this stage, it went on to add that
Chiron had demonstrated that their probes differed from the patented ones. Non-infringement of claim 11 The
Court relied on two findings to dismiss Institut Pasteur’s argument that the
Chiron companies had indirectly infringed claim 11 of the patent. First,
the Court of Paris noted that contributory infringement only applies when the
means supplied relate to an essential element of the invention i.e. when it
is one of the claimed characteristics. It thus
dismissed the plaintiff’s action on the ground that claim 11 does not
cover a process comprising a purification step, but instead a product, namely
purified RNA. The
Court held that the kit for capturing viral RNA is not an essential element
of claim 11. Secondly,
the Court held that Institut Pasteur had not proven that the RNA captured by
the device would be RNA covered by claim 11 and that Institut |
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Pasteur
had not rebutted Chiron’s submission that the isolated RNA would have a much
longer size than that claimed. Comment: Despite
the complex technology at stake, the Court issued a well reasoned and comprehensible
decision. The
Court found at least two grounds on which to base its rejection of each of
the plaintiff’s arguments. And in
doing so, the Court relied on ordinary rules of patent construction (Art. 69
European Convention) and on the ordinary rules governing the assessment of
the scope of the patent in view of the prior art. It recalled that the
plaintiff has the burden of proving an alleged infringement. This
decision, the first ever issued by a French Court addressing infringement of
a patent on molecular biology, shows that general concepts of patent law,
when properly applied, provide appropriate tools for deciding complex cases
involving new technology.
* The
authors represented Chiron in this matter |
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