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European IP Bulletin, Issue 20, March - Patents
Patents
7. Mayne Pharma V Pharmacia Italia
On the 17 February 2005, the Court of Appeal gave its
judgment in Mayne Pharma PTY Ltd v Pharmacia Italia SPA,
[2005] EWCA Civ 137.
In May 2004, Mayne Pharma commenced proceedings for a
declaration of non-infringement of Pharmacia’s UK patent, which
was followed by a counterclaim for infringement. The judgment at
first instance, given in November 2004, found that there was no
infringement. That decision was appealed.
The case was one of the first (and the first in the Court of
Appeal) to consider the issue of construction of patent claims
following the House of Lords’ judgment in Kirin Amgen v
Transkaryotic Therapies [2004] UKHL 46 (“Amgen”) in October
2004. Notably, it was agreed between the parties, consistent
with Amgen, that the “protocol questions” set out in Improver
would not assist in the construction of the patent. In this
particular case, this meant considering how a claim requiring
the absence of a particular step should be interpreted.
The invention related to a solution incorporating a widely used
anti-tumour agent, Epirubicin hydrochloride. In prior art
systems, it was conventional for Epirubicin hydrochloride to be
supplied in ampoules in lyophilised (freeze dried) form which
were subsequently made up into an injectable solution
immediately prior to use. This was due to the instability of the
drug in solution, but the process carried the serious danger of
accidental contact for the healthcare professionals at the time
of making up the solution. The invention provided a stable
solution, which avoided any process of reconstitution and
associated dangers.
The dispute centred on the interpretation of the first claim:
“An injectable, ready-to-use, sterile […] solution which has not
been reconstituted from a lyophilisate…”. The Mayne Pharma
product was a ready-to-use solution which was prepared using
material that had, as part of its history in the preceding
steps, been subject to lyophilisation. Thus, was the use of a
lyophilisate in an earlier stage of preparation was sufficient
to take Mayne Pharma’s product outside the scope of the claim?
Mayne Pharma relied on a subsequent process claim setting out
that the formation of the solution should be with a
non-lyophilised material, followed by some additional steps.
Lord Justice Jacob, referring to the principles of construction
contained in article 69 of the European Patent Convention, held
that the skilled person would understand that the invention was
concerned with how to achieve a stable, ready to use solution
that could do away with the previously essential step of
lyophilisation. He would know that the solution, in accordance
with the invention, had not been made by reconstitution at all
(whether using a lyophilisate or not). Thus, the Mayne Pharma
product fell within the claim when construed in a manner
consistent with the inventor's purpose as disclosed in his
specification. Lord Justice Jacob rejected the subsequent
process claim argument as there was no nexus between the scope
of the two claims that would suggest that the product claim was
necessarily as narrow as the process claim. Pharmacia Italia’s
appeal was allowed.
This case is particularly significant from a practitioner’s
point of view as it proceeded by agreement under the streamlined
procedure of the Patents Court to provide both a first instance
judgment and an appeal judgment in the space of nine months. The
fact that the only substantive dispute was one of construction
meant that the case was particularly suitable for this
procedure, in which there is limited provision for disclosure,
expert evidence and cross examination. Given the comments of
some of the judiciary in recent cases relating to the high cost
and delays associated with patent litigation, it is likely that
more and more cases are likely to follow this type of
streamlined procedure.
8. Obvious to Try? Think Again!
On 25 February 2005, the Court of Appeal pronounced its judgment
in the case of Saint Gobain PAM SA v Fusion Provida Limited &
others. [2005]
EWCA Civ 177.
The issue in the case was whether the European Patent granted to Saint Gobain was obvious, and therefore invalid in light of
prior art.
The patent related to an external coating technique for buried
iron-based pipes, which uses a zinc/aluminium alloy in the place of
zinc, to enhance the life of buried pipes by several years as the
coating limits the damage caused by diverse soil conditions. Fusion
Provida argued that this was obvious on the basis of prior art
described in an academic paper written by Johnsson in December 1998,
entitled “Corrosion resistance coating of Al, Zn and their alloys”,
published before the priority date of patent.
The Court of Appeal highlighted the duties of an appellant court as
laid down in Biogen v Medeva, before agreeing with Justice
Pumfrey’s evaluation on the question of obviousness. In that case,
it had been held that an appellate court should be very cautious in
assessing a factual evaluation of the judge at first instance, since
an assessment of obviousness was not a question of principle, but
rather a matter of degree, and specific findings of fact in the
judgment, even by the most competent judges, could be inherently
incomplete statements of impression made on them by the primary
evidence.
The Court of Appeal held that despite the fact that there existed a
common general knowledge of the use of zinc/aluminium alloys in the
place of zinc as an anti-corrosion coating for above-ground and
marine pipes for years, no-one had tried it on buried pipes. The
reason was due to a different sort of damage suffered by buried
pipes, namely the formation of white rust both under the outer layer
and as a scab on damaged areas. The earlier paper by Johnsson was
silent on the problems faced by buried pipes, and thus would not
have encouraged a trial of such techniques by a person skilled in
the art. Thus, viewed in the light of these historical
considerations, the patent was far from being obvious.
The Court further stated that for an obviousness attack to succeed,
the prior art should provide more than a mere possibility of
inclusion of something within the research programme of a person
skilled in the art. It should be more-or-less self-evident from the
prior art that what is being tested ought to work and in assessing
such a scenario, historical considerations cannot be left out and
will form an integral part of the evaluation process. This reasoning
appears more logical as it provides a better evaluation of prior art
in the contextual framework rather than from an abstract viewpoint.
9. Consultation on Compulsory Licensing of Pharmaceutical Patents for Export to Countries with Public Health Problems
On 1 March 2005, the UK Patent Office sought to solicit views
from interested parties on the European Commission’s proposal
COM(2004) 737 for a “Regulation on compulsory licensing of patents
relating to manufacture of pharmaceutical products for export to
countries with public health problems”.
The draft Regulation proposed by the European Commission will allow
EC-based generic manufacturers to produce generic versions of
patented drugs for export to countries with insufficient
manufacturing capacity. Under the World Trade Organisation (WTO)
Trade Related aspects of Intellectual Property Agreement (TRIPS),
developing countries unable to produce generic drugs locally find it
difficult to import cheap medicines. This is because Article 31(f)
of the agreement requires that compulsory licences are granted
“predominantly for the supply of the domestic market”.
The WTO Decision of the 30 August 2003 addressed this issue by
allowing national authorities to grant compulsory licences for
export to these developing countries. The European Commission’s
proposal is intended to create the regulatory framework for this
system to operate in the European Union Member States, and therefore
prevent distortion of competition which might arise through
divergent national approaches and, in particular, prevent
re-importation into the Community of goods produced under these
compulsory licences. Therefore, the UK Patent Office is collecting
the views of all interested parties on the aspects of the proposal,
including the following:
- The licences will be based upon applications by those wishing to produce the pharmaceuticals, who must show clear evidence that they have received a specific request from an eligible country to supply a certain amount of the product required. In order to be eligible, a country must be a member of the WTO that either qualifies as a “least-developed” member, or has notified the Council for TRIPS of its intention to utilise this system.
- Applicants must prove that they have “made efforts to obtain authorisation from the right holder on reasonable commercial terms”. National authorities are competent for determining the length of the “reasonable period of time” during which such efforts must be performed. Moreover, when a situation of national emergency has been declared by an importing WTO member, the period of time will be shortened. The competent authority will also fix an adequate remuneration due to the right holder.
- The re-importation into the Community of products made under a compulsory licence is prohibited. The following anti-diversion measures are established: generics must be identified through peculiar labelling and packaging and, where feasible, without a significant impact on price, and the colour and the shape of the medicine must differ from the patented product.
- Finally, applicants are required to demonstrate that generic products are as safe and efficacious as those authorised for marketing in the Community. A proper scientific opinion procedure and derogations from data protection and caducity rules are provided.
The UK government has welcomed the draft Regulation and supports
the speedy implementation of the proposal. It considers that an
appropriate balance has been reached between the interests of right
holders and the necessity of developing countries obtaining
immediate access to essential medicines at affordable prices.
Nevertheless, the effects of this proposal will depend on the
commercial incentives for generic companies to exploit the
opportunity it presents.
The deadline for responding to the UK Patent Office’s consultation
is 23 May 2005.
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