French
Court of Appeals upholds
human growth hormon patent
On 30 May 1997, the Court
of Appeals of Paris has issued a major decision in a genetic engineering patent
case, upholding a GENENTECH French patent (n° 80 14108,
equivalents : US 5 424 199, EP 22 242,
UK 2 121 048).
As it is the first decision in
this field of the Court of Appeals of Paris - which decides a vast
majority of patent cases in France - it deserves a particular attention.
The case was brought in first
instance by a GENENTECH's competitor, LILLY FRANCE, which submitted that claims
10 and 17 to 20 of French patent n° 80 14108 were invalid.
In a judgement issued on
21 January 1993, the Court of First Instance of Paris held that patent was
invalid because it was not capable of industrial application and because the
disclosure was non enabling.
This judgement is completely
reversed by the Court of Appeals which found the patent valid and struck out
LILLY's claims.
The Court of Appeals of Paris
reaches therefore the same conclusion as the Board of Appeals of the European
Patent Office (T 0 347 187) which found the corresponding
EP 22 242 valid in all respects.
Claim 10 of the French patent
n° 80 14108, the key issue, was drafted as follows :
" A replicable bacterial plasmid capable, in a
transformant bacterium, of expressing human growth hormone unaccompanied by
extraneous conjugated protein."
It was under attack on four
grounds :
- industrial application impossible,
- non enabling disclosure,
- lack of novelty,
- obviousness.
Overturning the first
judgement, the Court dismissed LILLY's first ground of attack (invention not
susceptible of industrial application) based on the contention that claim 10
was merely describing a result, not means for achieving it.
It held that "in this
very domain where there is a direct link between structure and function",
the claim of a replicable bacterial plasmid was not for a result but for a
function, since the patent specified that the claimed plasmid was capable of
expressing human growth hormone (because it includes a gene coding for this
polypeptid) unaccompanied by extraneous conjugated protein.
As to sufficiency of
disclosure, the Court of Appeals also reversed the decision of first instance.
It stated that "claims
covering an invention which opens a completely new domain may be drafted in
more general terms than those for an invention which merely brings new features
in a well known technical domain."
In view of this general
statement, the Court found that specification and drawings provided those
skilled in the art with all necessary technical information, thereby meeting
the legal requirement of enabling disclosure.
LILLY's attack for lack of
novelty - which the Court of first instance had not considered in view of
its decision of nullity on other grounds - is also rejected.
The Court of Appeals found
that the two pieces of prior art invoked did not anticipate GENENTECH patent
claim.
STANFORD patent
EP 0 009 930 is not considered because it merely mentions
process for obtaining growth hormone without disclosing any DNA sequence coding
for human growth hormone.
GENENTECH prior patent
UK 2 007 676, referred to by the Court as the Regulon
patent, is also considered as unable do destroy GENENTECH patent
FR 80 14108, because it discloses, in a general manner, a basic
process for obtaining bacterian plasmids allowing in turn obtention of
heterolog proteins.
The Court found that it did
not provide those skilled in the art with the main characteristics of a
specific plasmid for obtaining human growth hormone.
The Court of Appeals also
dismissed LILLY's claim of obviousness.
After in depth examination of
various pieces of prior art, it found that "several major prejudices,
difficult to override, existed against the patented process".
Claims 17 to 20 of French
patent 80 14108, which relate to process for obtaining the plasmid subject
matter of claim 10 are also held valid for similar reasons.
French Courts arrive in the
field of genetic engineering patents a little while after the Courts of some
other countries.
However the reported judgement
shows that this first case was fully mastered.
Pierre VÉRON
LAMY, VÉRON, RIBEYRE
PARIS