The
case concerned a long-running dispute between pharmaceutical giants
Synthon BV and SmithKline Beecham (now known as GlaxoSmithKline)
over the validity of a patent for an ingredient in the popular
antidepressant drug Seroxat.
Both firms discovered the substance at about the same time, and
in June 1997 Synthon filed an international application under the
Patent Application Treaty for a patent covering the compound. This
was not published until December 1998.
In the meantime, SmithKline Beecham sought a UK patent for the
substance, filing an initial paper with the Patent Office in
October 1998 and filing the application itself in April 1999. The
UK patent was published in May 2000.
Synthon sought to revoke SmithKline Beecham’s patent, arguing
that it did not cover an invention that was new, and was therefore
unpatentable.
Synthon won its case in December 2002, despite a set back for
the firm when two chemists who had been instructed to make the
compound following the details outlined in Synthon’s application,
could not make the experiment work until they worked round the
prescribed method using their own expertise.
SmithKline Beecham appealed, and in June 2003 the Court of
Appeal reversed the lower court ruling, finding in favour of
SmithKline Beecham. Synthon appealed to the House of Lords, which
last week, in a unanimous ruling, found in favour of Synthon and
revoked the SmithKline Beecham patent.
Lord Hoffman, giving the opinion of the five-panel court, set
out the process by which Synthon had to prove its case.
Firstly, in a “disclosure” stage, Synthon had to show that its
application had disclosed the invention that had later been
patented by SmithKline Beecham.
In effect, said Lord Hoffman, this means that the “matter relied
upon as prior art must disclose subject matter which, if performed,
would necessarily result in an infringement of the patent.”
This applies whether or not the person infringing the patent is
actually aware that he is infringing the patent. According to Lord
Hoffman:
“It follows that, whether or not it would be
apparent to anyone at the time, whenever subject-matter described
in the prior disclosure is capable of being performed and is such
that, if performed, it must result in the patent being infringed,
the disclosure condition is satisfied. The flag has been planted,
even though the author or maker of the prior art was not aware that
he was doing so.”
Secondly, Synthon had to show that “an ordinary skilled man
would be able to perform the disclosed invention if he attempted to
do so by using the disclosed matter and common general knowledge”.
The judge called this stage “enablement”.
Both concepts are distinct from each other – as is the role of
the ordinary skilled man when considering each concept, said Lord
Hoffman.
“In the case of disclosure, when the matter relied upon as prior
art consists (as in this case) of a written description, the
skilled person is taken to be trying to understand what the author
of the description meant. His common general knowledge forms the
background to an exercise in construction,” he explained.
“But once the meanings of the prior disclosure and the patent
have been determined, the disclosure is either of an invention
which, if performed, would infringe the patent, or it is not. The
person skilled in the art has no further part to play,” added the
judge.
Looking at enablement, Lord Hoffman found that the question is
“no longer what the skilled person would think the disclosure meant
but whether he would be able to work the invention which the court
has held it to disclose”.
In this case, he said, Synthon’s application did disclose an
invention that, if performed, would infringe on the SmithKline
Beecham patent. The existence of the compound was clearly disclosed
on the application.
The judge then had to decide whether the disclosure would have
enabled a person skilled in the art to create the compound. He
concluded:
“Synthon, as I have said, got off to a bad
start by specifying, in their main example, a solvent which proved
unsuitable for crystallisation. Nevertheless, the judge found that
the skilled man would have tried some other solvent from the range
mentioned in the application or forming part of his common general
knowledge and would have been able to make PMS crystals [the
compound under dispute] within a reasonable time. This is a finding
of fact by a very experienced judge with which an appellate court
should be reluctant to interfere”.
