Free Answering Brief in Opposition - District Court of Delaware - Delaware

Case 1:04-cv-00174-JJF Document 112-2 Filed 08/22/2005 Page 1 014
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BENITEC ANNOUNCES LITIGATION STATUS
2 December 2004
Benitec {ASX: BLT). In order to correct any misinformation or misunderstandings relating to
Benitec’s patent position, the Company is making this statement to correct the record.
Benitec currently has ten issued patents, including U.S.A. (1 ), U.K.(2) and Australia {2) and such
issued patents have been through a process of exantination prior to their issue in the countries
concerned.
Benitec currentiy holds LIoyci’s of London patent insurance to protect and defend its entire
patent estate and has held such insurance for the past three years. Benitec’s core patents reiating
to its proprietary ddRNAi technoiogy are held in co~ownership with CSIRO of Australia.
Benitec’s strategy is to protect its proprietary intellectual property by issuing licenses for both
commercial research and for therapeutic development. In order to protect the interests of Benitez:
shareholders to receive a substantiai return on their investment in the deveiopment of ddRNAi
, drugs in the future, Benitec has initiated three infringement actions against companies using
3 Benitee’s technology without a license. Two of those companies settled with Benitez: by taking
licenses earlier this year.
Benitez: commenced proceedings against Nucleonics, Inc. in March of 2004 as they were
obviously infringing on Benitec‘s issued patent estate, of which Nucieonics was aware. Benitez:
was advised that Nucleonies was in the process of raising in excess of U.S. $40 million from
U.S. investors using Benitec’s ddRNAi technoiogy, which was the subject of an issued patent in
the United States dated June 2003. Benitec thought it necessary and important to bring to the
attention of the prospective investors in Nucleonics the existence of Beuitec’s issued patents and
to ensure that Benitec could not be criticized at a later date of having known of uiiriogement, but
of having taken no action to protect Benitec’s intellectual property, or the interests of
Nucieonics’ own investors.
The current status ofthe litigation with Nucieonics is as follows: ·
l. Benitec has commenced infringement proceedings against Nucleonics based upon
evidence of infringement of Benitec’s ddRNAi technology in Nucieonics’ drug
deveiopment program.
2. There are currentiy three motions (applications) before the U.S. District Judge in
Delaware brought by Benitec relating to the faiiure of Nucleonics to provide documents
and information in support of their defense as is required under the rules of court
procedure. As a result of such failure to provide supporting infomation, Benit: has
sought a ruling prohibiting Nucieonics from producing supporting infomation at a later
date in such proceedings.
3. As i·$ucleonics’ attorneys act for both Nucieonics and Carnegie institute of Washington,
Benitec applied to the court suggesting this contlict of interest and that Nucleonics’
attorneys be prevented from disclosing confidential infomation to Camegic’s attorneys,
from the same law time. This was opposed by Nuc1eonics’ attorneys. Benitec’s motion
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Case 1:04-cv-00174-JJF Document 112-2 Filed 08/22/2005 Page 3 of 4
has been recently granted by the court and restricts Nuc}eonics’ attorneys Rom acting for
both Nucleonies and Carnegie. Nueteonics has requested the court to reverse its ruling.
4. Benitec has also filed a request under the ‘*discoveiy" process to Nuc1eonics’ investors in
order to determine the state of the investo1·s’ reliance upon Nucieonies’ infringing
research as important to their investment decisions.
5. Nucteonics has recently filed an appiieation with both the Australian and the United
States patent offices for re·exatnination of Eeniteds and CSIRO’s co»owned patents in
each of those junsdictions. The process is one of application, initial review by the patent
office examiner and then upon issuance of the exarniner’s initial review, Benitec and
CSIRO have the opportunity to respond to each and every point made by the examiner.
This is the position in Australia where Benitec now has two months within which to
respond to the examiner’s comments. It is aiso open to Benitec to make amendments to
any of the claims within such patent to rebut arguments made by the examiner and/or
clarify the scope ofthe claims.
6. Benitec has received a request for a research license from Nucleonics through Promega
and this is currently being reviewed by Benitec’s U.S. attorneys of record, Morrison &
Foerster LLP.
T It is Benitee’s position that it will continue to defend itself against Nuc1eonies’ baseiess
5 attacks on its patent position and any attempt to narrow the proper scope of Benitetfs
claims. Benitec is committed to enforcing its ieaciing position over ddRNAi and to
ensuring that its shareholders will receive appropriate benefit for the investment they
have made over a number of years in bringing this revolutionary technology to market.
Benitec firmly believes that the re-examination proceedings will ultimately serve to
strengthen Benitec’s patent portfolio and confirm the novelty of Benitec’s pioneering
ddRNAi technology. _ i
It should also be noted that Benitec’s patents and claims differ in each jurisdiction and that any
alterations made to the Australian patent through the re—exarnination process wilt have no effect
on its patents in other jurisdictions. it is precisely because of the importance of ddRNAi that
Benitec‘s issued patent estate has come under attack from Nucleonics, which depends upon
Beniteds technology to progress its drug development activities.
Benitec is very aware of the statements being circulated by the Chief Executive Officer of
Nticleonics to the press throughout the U.S.A. and elsewhere. These statements are being
reviewed in the context of the current litigation and in the event of such statements being found
to be incorrect, Benitec will have no hesitation in bringing direct proceedings for corrective
action.
Ligdate on Promega Litigation
To ensure that the market is entirely brought up to date with Benitec’s current litigation, the
position in relation to Promega is as foliowsz -
I. Benitec commenced proceedings against Promega in the courts of Delaware to obtain a
declaration confirming the autornatic conversion of the license to non-exclusive on the
grounds of failure to make due payment.
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2. Benitec has filed for judgment in its favor on the pleadings, essentialiy a summary
proceeding, and is awaiting the coutt’s decision.
3. Promega has in return filed a motion for a preliminary injunction by which Benitec
would be prevented from undertaking the iicensing which was the subject of the
agreement with Promega. Benitec: has opposed such application on a number of grounds
and this application is now before the Delaware court. In the event of issuance of an
injunction (limited to the original Eicense terms), Promega would be required to provide a
bond to secure Benitec.
it is not Benitec’s intention to respond to the market after every pronouncement from either of
Nucieonics and/or Promega as these matters are before the court for adjudication. However, in
the event of any material matter relating to such litigation, this wiii be brought to the immediate
attention of both the market and shareholders.
About Benitec _
Benitec is an internationai biotechnoiogy company focused on developing therapeutics to
treat serious diseases using its proprietary RNAi technology. It is listed on the Australian
Stock Exchange and has its clinical operations centred in Mountain View, Caiifomia. its lead
. therapeutic programs are Hepatitis C, HIV and cancers.
Uris press release contains forward-looking statements that reflect the Compony's current expectation
regarding future events. Forword·looA·ing statements involve risks and uncertainties. Actual events could
dwbr moterialiiwjrom those prqiected herein and depend on o number offoctors including the success of
the Comprmyir research strategy, the applicability of the discoveries made therein, the .succes.§i:l and
timely completion ofclinicol studies and the uncertainties related to the regulatory process.
CONTACTS:
BENITEC, LTD. BENITEC, iNC.‘tJS
John McKinley Sally Brasheats
+1408 48D 5842 + i 650 564 9850 it 110.5
[email protected] [email protected]
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