Publications
European IP Bulletin, Issue 8, January -
Patents
Patents
7. Apotex Europe v SmithKline Beecham
On 5 December 2003, Pumfrey
J delivered his judgment in Apotex Europe v SmithKline Beecham [2003] EWHC
2935 (Ch), holding SmithKline’s patent invalid.
The UK patent at the heart of litigation was a process patent related to the
preparation of the therapeutic agent paroxetine hydrochloride anhydrate (PHA),
a form of paroxetine hydrochloride that, by displacing the solvent using a
displacing agent, is manufactured to be substantially free of organic
solvent. SmithKline sells the hemihydrate form of paroxetine hydrochloride
under the trade mark Seroxat, an anti-depressant drug generating 10% of its
total pharmaceutical sales.
On being sued for infringement, Apotex claimed that their process is a
substantial variant to the claimed process and hence outside the scope of
the patent. Apotex also applied for revocation of SmithKline’s patent for
lack of novelty and inventiveness and argued insufficiency in disclosure
claiming that the patent is obscure.
At initial stages of hearing, the court had granted an interlocutory
injunction preventing Apotex from selling its drug in competition with
SmithKline’s Seroxat. This injunction was upheld on appeal.
The judge proceeded with caution in interpreting what the description in
SmithKline’s patent communicated to the skilled man, a necessity for
determining the exact scope of monopoly conferred by the patent. A careful
interpretation was necessary for two reasons: first because the patent in
question, though with different claims, had already been challenged and
interpreted as to its scope in an appeal (See Smithkline Beecham v BASF [2003] EWCA Civ 872); and secondly because new amendments to the claims and
fresh evidence have been brought before the court, as compared to an earlier
case involving the same patent but different parties. (See BASF v Smithkline
Beecham [2002] EWHC 1373 (Pat))
On consideration of expert evidence, the court found that the patent deals
with the problem of how to produce PHA substantially free of organic
solvent. It formulated the test of infringement as ‘whether the displacement
step is being used to remove solvent below the level that can be normally
achieved using conventional equipment’. The court construed the word
‘displace’ literally to mean ‘displacing the unwanted solvent from the
material without replacing the solvent’ and held that the process of Apotex
did not infringe the claim, as its material steps are in the nature of
‘replacement and drying steps’ rather than a displacement step. Apotex
process did not satisfy the third limb of the Improver test and thus there
was no infringement.
On the questions of anticipation and obviousness, the court held that an
earlier Erythromycin patent makes the invention obvious, and thus the patent
is invalid and shall be revoked. However, in interpreting these questions
the court departed from the Court of Appeal in Smithkline Beecham v BASF, on
the basis of peculiar evidence and facts brought in this case.
The following principles were stated by the court:
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It is the duty of the court to give legal construction of the specification and documents independently. Once this duty is discharged, the disclosure and comparison of the specification and external document relied upon as prior art, are question of facts and a matter of evidence.
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The patent specification is to be construed and approached by the court in the same way as its notional addressee, who is the person skilled in the art and is likely to have a practical interest in the subject matter of a specification.
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The court must give regard to the evidence adduced to decide as to what the description actually conveys to the skilled man.
8. Osteoporosis Medicinal Patents
On 6 November 2003, the
Supreme Court of Judicature delivered its appeal judgment in Instituto
Gentili v Teva Pharmaceutical [2003] EWCA Civ 1545.
This was followed by the High Court of Justice judgment in Merck v
Generics [2003] EWHC 282 on 27 November 2003.
These cases are both in relation to the same type of Osteoporosis medicine.
Osteoporosis is a condition of decreased bone mass that renders bones
fragile with an increased risk of fracture. An imbalance of the natural
phenomenon governing the removal and replacement of bone could be
responsible, against which medicine such as the patented medicinal product
from Merck called Alendronate aims to treat.
In Instituto Gentili, the requirement of novelty for an invention was
addressed, especially the issue of anticipation by prior art. Novelty is one
of the main requirements for an invention to be patentable. Prior art is
destructive of novelty either by disclosing clearly the concept of the
invention or by anticipating the invention. The test for a patent to be
anticipated is whether the prior art contains a direction, while being
carried out, capable to infringe the patentee’s claims. In addressing what
is a direction, the skilled man’s thought on reading the prior art is the
same as what the prior art teaches.
In the Instituto Gentili case, appeal and possibility to amend were
rejected. Also, concerns were expressed over the role of a court of appeal,
which should only interfere with a judgment where a matter of principle is
at stake; which arguments related to the assessment of technical evidence
and their bearing on the issues that have to be decided are unlikely to
address.
In Merck, the meaning of article 69 of the Protocol on Interpretation
over the “fairness” that should be allocated to the patentee was discussed.
The court considered that the proper approach for defining infringement is
to construe the patent and its claims in the absence of the infringement,
therefore allowing an appreciation of the full breadth of the monopoly
before considering the infringement. Also, the court found that the
“fairness” of article 69 of the protocol can only be referring to protection
which the patentee intended to obtain. Such intention should be concluded
with reasonable confidence by the notional skilled reader. The case for
infringement failed.
The practice points arising from these cases are:
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Clearness of a direction from prior art may be defined as what a man skilled on the art will think after reading the prior art.
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Appeals based on the assessment of technical evidence and related judgments are unlikely to be successful.
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Fairness will not extend the scope of the patent over what is explicitly set out in the claims
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