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Here's a guest post from Dr Seigen Tsukuda (Ohno & Partners, Japan, right) on patent term extensions in that important jurisdiction. Our thanks go both to Dr Tsukuda and to Darren Smyth (EIP)) for procuring it on our behalf and giving it the benefit of his editorial scrutiny.
Introduction
Patent
systems differ from nation to nation, and the practice relating to patent term
extension (PTE) shows an extreme example of such variation. The Japanese PTE system is quite distinct
from those of Europe and United States. Significant
features of the present Japanese PTE procedure are as follows.
(1) Although it is required that an authorized
pharmaceutical product falls within the scope of a claim of the patent, it is
NOT required that the claim recites (specifies) any active ingredient. Thus, patents relating to drug delivery
systems (DDS), for example, can be extended in principle.
(2) Multiple extensions are available for a
single patent (but the term of extension may not exceed 5 years).
(3) Multiple patents belonging to the same
patentee can be extended based on a single authorization.
The
idiosyncrasy of the Japanese system has increased even further recently. In order to elucidate the current situation, let
us look briefly into the Patent Act provisions and the history of Japanese PTE
practice.
Relevant provisions of
Japanese Patent Act
Article
67 paragraph 2 provides conditions for PTE, mentioning "Where there is
a period during which the patented invention is unable to be worked because
... disposition [authorization] ... is necessary to obtain for the working of
the patented invention, the duration of the patent right may be extended ...,
by a period not exceeding 5 years."
Art
68-2 provides effects of PTE, i.e. "Where the duration of a patent right is
extended ..., such patent right shall not be effective against any act other
than the working of the patented invention for the product which was the
subject of the disposition [authorization] ... which constituted the reason for
the registration of extension (where the specific usage of the product
is prescribed by the disposition [authorization], the product used for that
usage)." [Japanese Patent Act]
PTE examination practice at
JPO until 2011
Conventionally,
the JPO assumed that "product" and "usage" recited in
Article 68-2 should be interpreted as "active ingredient(s)" and
"effect and efficacy" respectively.
Based on this assumption, the JPO further interpreted Article 67
paragraph 2 as meaning that a PTE can only be based on an authorization that is
"new" in terms of a combination of "active ingredient(s)"
and "effect and efficacy". For
example, let us assume a case where an authorization is obtained for a pharmaceutical
product using a new DDS technology, and the DDS technology is protected by a
patent. In this case, according to the
JPO practice, the patent could NOT be extended so long as there is a previous
authorization corresponding to a pharmaceutical product whose active ingredient,
effect and efficacy are the same for those of the newly authorized pharmaceutical
product. It is not relevant whether the
previously authorized pharmaceutical product falls within or outside the claims
of the subject patent (situation was similar to MIT case [C-431/04]).
According
to Article 67 paragraph 2, a PTE may be allowed "when there is a period
during which the patented invention is unable to be worked". Under the Japanese Pharmaceutical Affairs
Act, it is not permitted to market a pharmaceutical product of new formulation
or new dosage until a new corresponding authorization is obtained, even if a previously
authorized pharmaceutical product contained the same active ingredient and was authorized
for the same effect and efficacy. It
could thus be argued that there is "a period during which the patented
invention is unable to be worked". Accordingly,
since late 1990s, new-drug developers have been struggling in courts arguing that
the above JPO's practice is not legitimate.
Supreme Court decision in
April 2011
Finally,
on 28 April 2011, the Supreme Court gave a decision determining that the above
JPO practice is not legitimate [H21(Gyo-hi)326: Takeda v Commissioner of Patents].
According to the decision, an application for a PTE cannot be rejected
based on a previous authorization if a pharmaceutical product authorized by the
previous authorization does not fall within the scope of any of the claims of
the subject patent for which PTE is applied.
The decision opened a door for PTE of a patent protecting a new
formulation, such as DDS drugs. [H21(Gyo-hi)326]
Revised examination guidelines
in December 2011
Forced
by the Supreme Court decision, the JPO revised its examination guidelines for PTE
in December 2011. The revised guidelines
are fairly complicated, but could be summarized as follows. An application for a PTE based on a new
authorization for a new pharmaceutical product cannot be rejected if an old pharmaceutical
product authorized by a previous authorization falls outside the scope of all
of the claims of the subject patent. On
the other hand, if the old pharmaceutical product falls within the scope of a broadest
claim of the subject patent, the application for PTE must be rejected so long
as the old and new pharmaceutical products do not differ in term of the elements
described in the broadest claim of the subject patent.
For
example, assume a case in which a new pharmaceutical product is a new
formulation including active ingredient A and excipient polymers B and C2, where
the old pharmaceutical product was a formulation including active ingredient A
and excipient polymers B and C1. In this
case, a PTE will not be allowed if an independent claim of the subject patent
simply recites active ingredient A, or a combination of active ingredient A and
excipient polymer B. On the other hand, a
PTE may be allowed if the independent claim of the subject patent recites a
combination of active ingredient A and excipient C (C1 and C2 are examples of
C).
There
remained a question of whether such revised guidelines (to refuse a PTE if the
independent claim only recites active ingredient A, or a combination of active
ingredient A and excipient polymer B) are in accordance with Article 67
paragraph 2, because marketing of the new pharmaceutical product (A+B+C2) is
not allowed under authorization for the old pharmaceutical product (A+B+C1). It may be possible to argue that "there
is a period during which the patented invention is unable to be worked" in
respect of the pharmaceutical product (A+B+C2) until a new authorization is
obtained for the new pharmaceutical product (A+B+C2), even though the patented
invention was able to be worked in respect of the old pharmaceutical product
(A+B+C1). New-drug developers again
fought in courts questioning whether JPO's revised practice is legitimate or
not. [Revised Guidelines]
Intellectual Property High
Court (IPHC) Grand Panel decision in May 2014
On
30 May 2014, the Grand Panel of IPHC rendered a decision determining that the
revised examination guidelines are not legitimate [2013(Gyo-Ke)10195: Genentech v Commissioner of Patents]. According to the decision, if an
authorization is new in terms of a combination of components (not only active
ingredients), quantity, administration, dosage amount, effect and efficacy, the
application for a PTE shall not be refused based on a prior authorization. This means that a PTE may be allowed based on
any substantially new authorization, so long as the subject patent covers the
newly authorized pharmaceutical product.
The
decision also mentioned in obiter dictum
that, during the extended period, the patent will cover only a drug within both
the scope of claim of the patent and the scope of the authorized pharmaceutical
product in respect of “components (not only active ingredients),
administration, dosage amount, effect and efficacy”, and equivalents or
substantially identical products thereof.
Since the PTE system was established in 1988 in Japan, there has been no
legal precedent determined in ratio
decidendi what is the claim scope of an extended patent. [2013(Gyo-Ke)10195]
Practical suggestions
As
mentioned above, under the current examination guidelines, a PTE is allowed on a
patent-by-patent basis, and examination will be performed based on the broadest
claim of a patent. In a case where a
prior authorized pharmaceutical product falls within the broadest claim and there
is a reason for rejection with respect to the broadest claim, a PTE is not
allowed even if the old pharmaceutical product falls outside a narrower
dependent claim (and the new pharmaceutical product falls within the dependent
claim). However, if a divisional
application including the dependent claim is filed to separate the claim from
the independent broadest claim of the parent, and a secondary patent is
obtained, a PTE may be allowed for such secondary patent under the current
examination guidelines, based on the authorization for the new pharmaceutical
product. If the patentee may wish to
obtain a PTE corresponding to a dependent claim in the future, it is
recommended to file a divisional application to establish a patent specifically
directed to the invention of the dependent claim, describing the invention as
an independent claim.
It
should also be kept in mind that the current examination guidelines have been disapproved
by the Grand Panel decision and the situation is quite unstable. The JPO appealed against the Grand Panel
decision, and the case is still pending at the Supreme Court. It is expected that a decision will be given
within a few years. The JPO's practice
has not substantially been changed since December 2011, but it is quite
possible the guidelines will be revised again after a new Supreme Court
decision. If the Supreme Court affirms the
Grand Panel decision, then a PTE will become more easily allowed, but the scope
of protection provided by an extended patent will become more restricted. In 2011, the Supreme Court decision stopped
all PTE examination at the JPO until the examination guidelines were revised
and fixed. It is therefore recommended
that, whenever a new pharmaceutical product is authorized in Japan, an application
for a PTE shall be considered for any patent covering the new pharmaceutical
product, even if the PTE might appear unallowable based on the present
guidelines.
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