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| LEGAL
SCENE |
Appeal
Against Court Ruling |
|
Pfizer Inc has declared that it would appeal against
a Canadian Federal Court ruling in favour of genetic
manufacturer Apotex in its challenge to a Pfizer patent
covering Lipitor.
The Canadian Federal Court had denied Pfizer's request
to prevent Apotex from launching a generic version of
Lipitor prior to the expiration of Pfizer's enantiomer
(calcium salt) patent in July 2010.
The Court's decision has no immediate commercial impact
because Lipitor is protected by other patents in Canada,
which are also the subject of legal challenges.
The ruling by the Federal Court has also no impact on
Lipitor patent litigation in other countries. |
| (Pfizer
Inc, May 15, 2008)
|
| Baxter
Wins Case
|
|
Baxter International Inc. has won a long running battle
in a patent infringement case, against Fresenius Medical
Care involving Fresenius Number One-selling hemodialysis
machine in the USA.
The US District Court for the Northern District of California,
issued opinions permanently enjoining Fresenius from
manufacturing its flagship product, affirming that it
infringes on Baxter's technology and awarding damages
to Baxter.
The Court order requires that Fresenius stop making,
using or selling the 2008K hemodialysis machine effective
January1, 2009. A royalty of 10% was also imposed on
the sale price of each infringing machine sold from
now till January 1, 2009, and a further 7% royalty was
imposed on all disposable products used with the infringing
2008K hemodialysis machines.The 2008K is, according
to Fresenius, its "cornerstone product" and
is the best selling hemodialysis machine in the marketplace
with over 90 percent market share .
In granting the injunction, the Court observed that
much of the hardship that Fresenius would face from
the injunction, was of its own doing because it did
not take any steps to design around the patents in suit.
In February 2007, the Court had upheld the validity
of Baxter's patents that had been challenged by Fresenius
in a 2003 lawsuit ruling that Fresenius failed to introduce
substantial evidence of invalidity. |
| (Medical
Patent News, Apr 7, 2008)
|
| Cellectis
Sues Precision BioSciences |
| Cellectis
SA, a world leader in rational genome engineering, has
announced that it had filed a patent infringement lawsuit
against Precision BioSciences in the Eastern District
Court of North Carolina,USA, seeking a declaration that
by making and selling certain meganucleases, Precision
Biosciences was infringing two Cellectis patents relating
to its proprietary meganucleases recombination systems.
The Precision BioSciences' meganucleases at issue are
intended to target site specific DNA breaks and effect
a genome modification in a given transgenic organism,
such as a plant.
The law suit seeks both monetary damages for infringement
as well as a permanent injunction preventing Precision
Biosciences from any further making, using, or selling,
of such meganucleases.
Since its creation in January 2000, and throughout its
development, Cellectis has made special efforts to protect
new discoveries made by its research team as well as
those of its partner, the world renowned Pasteur Institute.Cellectis
currently owns the exclusive rights to over 35 issued
patents and has 113 pending patent applications . Most
of these patents are based on Cellectis' fully integrated
genome engineering system referred to as its Meganuclease
Recombination Systems (MRSs).These systems offer natural
, precise, efficient and flexible genome surgery with
several applications among others in the therapeutic
area and in the plant science field.
Cellectis SA is a world leader in genome engieering
and genome surgery. The company is focused on developing
and producing custom made meganucleases for in vivo
DNA surgery and also provides new tools for rational
reverse genetics, and targeted recombination. Its products
induce unique site-directed double strand DNA breaks
in living cells and can be used in a wide variety of
biotechnological and therapeutic operations.
|
| (Cellectis
SA May 15, 2008)
|
Patent
Office Rules Struck |
| A
US Federal District Court sided with GlaxoSmithKline
PLC and struck down new patent rules which, according
to the British drug maker, were a threat to innovation.
The Court held that in making the regulations the US
Patent Office had overstepped its authority, as the
rules made substantial changes to the patent application
process which was outside the jurisdiction of the Patent
Office.
Glaxo had sued in October 2007 to block the implementation
of the US Patent and Trademark Office rules charging
that they would jeopardise about 100 of the company's
patent applications. The rules issued in August 2007
were intended to streamline the application process
by limiting how many times patent applicants could tweak
existing applications and how many claims they could
make about an invention.
Glaxo argued that such limitations would harm pharmaceutical
companies that frequently change the scope of their
applications as research and testing uncover additional
appplications to a drug. A spokesperson for Glaxo said
that the judgment was in support of innovation across
all industries. and it reaffirmed that all who wanted
to protect their inventions in the USA would be allowed
to seek protection on the full scope of their discoveries.
However, a spokesperson for the Patent Office said that
the agency was disappointed with the decision and was
considering the next steps.
The Biotechnology Industry Organisation which filed
papers in suport of Glaxo said that the rules would
have inhibited the ability of bitechnology innovators
to obtain adequate patent protection and would have
made it harder for them to get financing or new products. |
|
(GlaxoSmithKline, Apr 1, 2008) |
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Ranbaxy Settles Dispute with GSK
|
|
India based Pharmaceutical MNC Ranbaxy Laboratories
Ltd has announced that it has settled all matters relating
to possible patent litigation with GlaxoSmithKline(GSK)
relating to Sumatriptan Succinate tablets, the generic
version of GSK's Imitrex tablets.
The terms of the settlement provide that Ranbaxy may
distribute a generic version of Sumatriptan Succinate
tablets in the 25mg, 50mg, and 100mg, strengths in the
USA with an expected launch date in December 2008. Additional
terms of the agreement were not disclosed.
The annual market sales of Sumatriptan Succinate tablets
were $985 million. |
|
(Ranbaxy Labs, Jan 29, 2008)
|
| VNUS
Gets Notice of Allowability
|
| VNUS
Medical Technologies has announced that it has received
notice of allowability by the US Patent and Trademark
Office for a patent application, that is a continuation
of one of the three patents in the VNUS patent infringement
lawsuit against suppliers of endovenous laser products.
The newly allowed VNUS patent application was filed
as a continuation of VNUS's earlier US patent. The continuation
patent uses the same patent specification as the earlier
one.
VNUS has sued several endovenous laser manufacturers
for infringement of its patents and that law suit is
to begin trial later this year.
The newly allowed VNUS patent application contains claims
that recite methods of applying energy from an elongate
member leading to occlusion of a vein, where the elongate
member may be a fibre optic and the energy may be light
energy. Significantly before deciding to allow the VNUS
patent, the Patent Office reviewed references that include
those cited by the defendant endovenous laser companies
during the patent litigation in their attempt to invalidate
the earlier patent. |
|
(vnus.com, Apr 18, 2008) |
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