[Ip-health] Abbott obtains a CL on hepatitis C patent

[Judit Rius Sanjuan]

This week the U.S. Court of Appeals for the Federal Circuit reversed a
previous permanent injunction against Abbott and ordered the judge to
determine the terms of a compulsory license on a patent owner by
Innogenetics.

The decision is available at: http://www.cafc.uscourts.gov/opinions/07-1145.pdf

A previous KEI analysis of this case is available at:
http://www.keionline.org/index.php?option=com_content&task=view&id=43

Some news stories on the case:

http://www.dailyherald.com/story/?id=115698
Abbott wins new trial in Innogenetics hepatitis suit
Published: 1/17/2008 2:39 PM

Abbott Laboratories won a new trial in a dispute over a patent owned
by Belgium's Innogenetics NV for compounds used in tests for hepatitis
C.

The U.S. Court of Appeals for the Federal Circuit in Washington today
said a judge erred when she threw out an Abbott defense against the
Innogenetics patent. The appeals court tossed out the verdict and sent
the case back for further consideration. The court also overturned an
order that would prevent Abbott from using certain compounds in its
tests.

The two-year-old legal battle is over chemicals used to make genetic
tests to identify hepatitis C, a viral disease that causes an
inflammation of the liver. The Centers for Disease Control estimates
4.1 million Americans have been infected with the virus.

A federal jury in Wisconsin awarded Innogenetics $7 million in damages
in the case. The Federal Circuit said the jury award was based on past
damages and a fee for Abbott to enter the market. That conflicted with
the judge's order preventing Abbott from using certain compounds in
its hepatitis C tests in the future. The appeals court threw that
order out.

The court ordered the judge to determine the terms of a compulsory
license, such as conditioning sales on a royalty for each testing kit.

Abbott spokesman Scott Stoffel said officials at the Libertyville
Township-based company are reviewing the decision. Officials with
Innogenetics didn't immediately return messages left after regular
business hours in Belgium.

Ghent, Belgium-based Innogenetics is trying to develop vaccines for
Hepatitis B and C. Research into its most advanced Hepatitis C vaccine
was halted in September. The company is spinning off its vaccine-
development unit.

The appeals court upheld the finding that Abbott infringed the patent.
If Innogenetics wins again on validity, it wins the case.

The case is Innogenetics NV v. Abbott Laboratories, 07-1145, U.S.
Court of Appeals for the Federal Circuit. The lower court case is
Innogenetics NV v. Abbott Laboratories 05cv575, U.S. District Court,
Western District of Wisconsin (Madison).


http://money.cnn.com/news/newsfeeds/articles/djf500/200801180227DOWJONESDJONLINE000364_FORTUNE5.htm
Innogenetics Says US Court Backs Ruling In Abbott Patent Spat
Dow Jones
January 18, 2008: 02:27 AM EST
Edited Press Release

BRUSSELS -(Dow Jones)- Belgian biotech company Innogenetics NV
(INNX.BT) said Friday a U.S. court has backed an earlier ruling in a
patent infringement suit involving Abbott Laboratories (ABT),
including that the American pharmaceutical company must pay $10 million.

The United States Court of Appeals for the Federal Circuit yesterday
evening has affirmed the U.S. District Court's finding that Abbott
Laboratories infringed Innogenetics' patented Hepatitis C Virus
genotyping technology.

The Federal Circuit also upheld the jury's finding that Abbott pay
Innogenetics damages for infringement and sanctions for making a
baseless claim against Innogenetics, estimated to total approximately
$US10 million.

In a lengthy written decision issued yesterday, the Federal Circuit
rejected a myriad of issues raised by Abbott in Abbott's effort to
overturn the unanimous jury verdict in Innogenetics' favor. The
Federal Circuit also affirmed the district court's finding that Abbott
should be sanctioned and pay Innogenetics' attorneys fees related to
Abbott's baseless claim that Innogenetics had acted improperly in
obtaining its US HCV genotyping patent.

The result of the Federal Circuit decision is that Abbott must pay an
estimated $10 million in damages to Innogenetics, using current
exchange rates. During the appeal, Abbott challenged many of the
rulings made by both the district court and the jury.

In rejecting Abbott's challenges, the Federal Circuit affirmed the
district court's finding that Abbott infringed claims 1, 2 and 3 of
Innogenetics' Hepatitis C virus genotyping patent; dismissed all
challenges to the validity of claims 2 and 3 of the patent; affirmed
the jury's damages award; affirmed the district's finding that the
patent is enforceable; and affirmed the district court's sanctioning
of Abbott by ordering it to pay Innogenetics' attorneys fees resulting
from Abbott's baseless assertion that the patent was not enforceable
due to Innogenetics' conduct before the United States Patent Office.

The Federal Circuit reversed the district court's decision to
summarily rule on the validity of one of the patent's claims in light
of one piece of prior art; finding instead that the district court
should have allowed that question to be decided by a jury. The Federal
Circuit thereby remanded this issue back to the district court.

Importantly, because two of the three claims found to be infringed are
unaffected by this ruling, this reversal will not affect either the
determination that Abbott infringed Innogenetics' HCV genotyping
patent or the jury's determination that Abbott must pay damages for
its infringement. In reversing the district court's permanent
injunction against Abbott, the Federal Circuit replaced the permanent
injunction against Abbott with a compulsory license requiring Abbott
to pay Innogenetics a royalty on each future infringing product sold
by Abbott in the United States, or made by Abbott in the United States
and exported for sale worldwide.

The Federal Circuit left it to the district court to precisely
determine the amount of damages to be paid to Innogenetics, taking
into account accrued interest and the increased value of the Euro.
These proceedings also will result in the establishment of an
appropriate future royalty payment that Abbott must pay to
Innogenetics if it sells any more infringing HCV genotyping assays.

"We are pleased that the infringement verdict and the jury's
determinations on validity were affirmed in all respects by the
appellate court," said Christiaan De Wilde, Chief Executive of
Innogenetics. "Importantly, we are pleased with the appellate court's
decision to leave the earlier damages determination intact and we look
forward to taking, what we feel confident, are the final steps in
securing Innogenetics' victory."

The U.S. Court of Appeals for the Federal Circuit handles all patent
appeals.

Company website: http://www.innogenetics.com

By Brussels Bureau; Dow Jones Newswires; +32 2 741 1481;
djnews.brussels@ dowjones.com



Judit Rius Sanjuan
Attorney at Knowledge Ecology International
www.keionline.org / www.cptech.org
Phone: +1.202.332.2670, x18
Email: judit.rius@keionline.org