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Crucell Terug naar discussie overzicht

Draadje Patenten.

18 Posts
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  1. flosz 15 augustus 2009 11:52
    Laatste gegevens, d.d. 11-08-2009.

    Patents:

    The Company strengthened its patent position in the field of AdVac® technology
    by the acquisition of a portfolio of patents pertaining to the manufacturing and
    downstream processing of adenoviruses from Introgen Therapeutics Inc.

    In Q2 2009 Crucell was granted a total of 21 new patents, including patents for:
    • Production of influenza virus for the production of vaccines using PER.C6®
    technology, in the USA (2 patents)
    • Production of viruses for the production of vaccines using PER.C6®
    technology, in the USA
    • Aspects of improved adenoviral AdVac® vectors and AdVac® technology, in
    Hong Kong
    • AdVac®-based malaria vaccines, in the USA
    • Production of antibody fragments using PER.C6® expression technology, in
    the USA
    • Improvements in PER.C6® expression technology, in Hong Kong
    • Elements of STAR® technology, in Israel
    • Targeting of adenovirus to specific cell types, in Europe
    hugin.info/132631/R/1333815/316333.pdf

    Uit jaarverslag 2008.

    PER.C6® well protected

    Our PER.C6® technology is protected by numerous
    patents. In addition, in order to benefit from our
    proprietary technology, potential customers not
    only need our know-how, but also our PER.C6® cells,
    which are only available from us under agreement.
    These agreements put certain restrictions on further
    dissemination and use of the PER.C6® cells. This
    combination of protections – patented know-how
    and the need to have access to the actual PER.C6®
    cells results in the PER.C6® technology being the
    best protected human cell technology in the world.

    There were also positive developments for our
    intellectual property. We were successful in
    opposing European patents of our competitors as
    we managed to obtain complete revocations of
    European patents owned or controlled by GenVec,
    Genentech, Baxter, Novartis Vaccines & Diagnostics,
    Wellcome Foundation (GlaxoSmithKline (GSK)),
    and others. In addition, we obtained a favorable
    decision from the South-Korean Supreme Court in
    the longstanding invalidity law suit in South Korea
    against GSK’s multivalent Hepatitis B virus vaccine
    patent. These developments further paved the way
    for Crucell’s pipeline development activities and
    marketed products. Conversely, we were successful
    in defending our own PER.C6 and AdVac patents
    against attacks by its competitors. Except for
    one PER.C6 patent that has been maintained in
    amended form and is now pending before the
    board of appeal, all PER.C6 patents have survived
    opposition before the European Patent Office
    essentially intact.

    In March 2005, we extended the CRADA with the
    US NIH and continue to develop this vaccine and
    will use the Ebola vaccine results in the development
    of Marburg and lassa vaccines. In addition, we
    obtained an exclusive license to certain NIH patents
    to develop and commercialize recombinant vaccines
    against Ebola.

    Intellectual property
    Our success and ability to compete depends in
    large part on our ability to protect our proprietary
    technology and information, and to operate without
    infringing on the intellectual property rights of others.
    We rely on a combination of patent, trademark
    and trade secret laws, as well as confidentiality,
    assignment and licensing agreements, to establish
    and protect our proprietary and intellectual property
    rights. Our policy is to actively seek patent protection
    of our intellectual property in the US and Europe,
    as well as in other jurisdictions as appropriate.
    We engage European and Dutch patent attorneys
    that file, prosecute, defend and enforce patent rights
    as well as manage our patent portfolio. Our patent
    portfolio comprised 1677 active cases (i.e. granted
    patents in force or pending patent applications) as
    of December 31, 2008. We aggressively protect our
    inventions and employ a proactive filing strategy
    with respect to patent applications. Our portfolio
    management involves active commercialization
    and enforcement strategies combined with
    disposal of cases that we no longer consider
    commercially attractive.
    The following table reflects the total number of
    active cases (pending or granted) through December
    31, 2008, organized according to our different fields
    of operation. All figures include acquired and jointly
    owned patent cases, but exclude patent positions
    licensed-in from third parties.

    2008 Patent filings
    Pending/Granted/Active
    Vaccines (1) 259/ 367 /626
    Antibodies (2) 141/ 77 /218
    Technology (3) 268/ 344/ 612
    Gene Therapy 50 /171 /221
    Total 718/ 959/ 1,677
    (1) Vaccines patent filings relate to AdVac-based, live viral vector vaccines based on our
    proprietary measles technology, our virosomal technology and classical whole inactivated
    virus, split and sub-unit vaccines.
    (2) Antibodies patent filings relate to antibodies and/or drug targets, excluding the enabling
    technologies that are classified as technology.
    (3) Technology patent filings primarily relate to cell-based production technology, adenoviral
    vector technology, STAR-technology and related technology, functional genomics and
    target and antibody discovery technology.

    Patent filings
    In 2008, we filed patent applications for four new
    inventions, in the fields of vaccines and technology.
    Our new filings in the vaccine field in 2008 reflect
    our efforts to further strengthen our patent portfolio
    in support of product development programs in that
    area. The new filings in the technology area relate to
    our continuing effort to protect and commercialize
    the PER.C6 technology and related uses of the PER.C6
    cell lines, as well as our AdVac technology. Since we
    are not actively involved in gene therapy research
    and development, no new filings were made in that
    area during 2008.
    We maintain a geographically diversified filing
    strategy, depending on our technological and
    business needs, as well as our view of long-term
    economic trends and developments in legal
    systems in various parts of the world. As of
    December 31, 2008, we had 64 pending applications
    in the EU(1), 110 pending applications in the US(2),
    21 international patent applications (so called
    Patent Cooperation Treaty (PCT) applications(3))
    and 523 applications in the rest of the world(4).
    A significant number of our pending patent
    applications are filed under the PCT, which offers a
    cost-effective method to seek provisional worldwide
    protection in more than 100 countries and territories
    for 30 or 31 months from the filing date. The decision
    to divide the PCT application into territories in
    which a granted patent is desired may be postponed
    until the obtainable scope of protection and the
    technical and commercial usefulness of the
    invention becomes clearer. During the pendency of
    a European patent application, a single application
    may designate 35 countries but is counted as one
    pending application. As soon as the European patent
    application is granted it may be validated for each of
    the designated countries by filing a translation into
    the official language of that designated state. Once
    such a translation has been filed, we count each such
    patent as a separate patent.
  2. flosz 15 augustus 2009 11:55
    Vervolg.
    1) EU refers to filings made under the European Patent Convention. The EU figures do not
    include European patent applications designated in PCT applications while still in the
    international phase.
    (2) US figures do not include US patent applications designated in PCT applications while still
    in the international phase.
    (3) Figures reflect PCT applications still in the international phase. Our PCT applications
    routinely designate all territories and contracting states that are party to the PCT per the
    international filing date.
    (4) Rest of world consists of Australia, Brazil, Canada, China, India, Israel, Japan, Hong Kong,
    Mexico, New Zealand, Norway, Russia, Singapore, South Africa and South Korea. Rest of
    world figures do not include PCT applications designating these countries while still in the
    international phase.

    Patents
    At December 31, 2008, we owned or co-owned 601
    granted patents in the EU territory, 83 patents in the
    US and 275 patents in the rest of the world.
    The following is a summary of the intellectual
    property rights related to our major products and
    product developments.

    Epaxal and Inflexal V
    Epaxal and Inflexal V are the two virosomal
    products which are protected by the patent family
    ‘Immunostimulating and immunopotentiating
    reconstituted influenza virosomes and vaccines
    containing them’, which will expire in 2012. In addition,
    the hepatitis A strain used to produce Epaxal is
    claimed in a patent family which will expire in 2012.

    Other products
    We have no patent protection for the active
    substances of Quinvaxem, Hepavax-Gene, Vivotif,
    Dukoral and MoRu-Viraten.
    We seek patent protection, whenever possible,
    commercially feasible and appropriate, in respect
    of any technology or product development that
    is important to our business. Together with our
    affiliates in Switzerland, Sweden, Italy and Korea,
    we have several platform technologies and
    consequently our intellectual property (IP) activities
    concentrate on protecting these technologies and
    any improvements thereof in the main worldwide
    vaccine markets of Europe, the US, Canada, Japan
    and Australia. However, because some vaccine
    markets are outside these countries, we have also
    sought protection in other countries, such as Korea,
    India and China. The IP portfolio is constantly
    reviewed to decide on maintenance of individual
    patents or patent families considering parameters
    such as actual product performance, product
    development, patent term, options for
    commercialization or out-licensing of non-core IP.
    Our IP tasks are coordinated and patents are filed on
    a worldwide basis by specialized patent attorneys.

    Patent enforcement and proceedings
    We may need to litigate or institute administrative
    proceedings such as oppositions to a patent to
    enforce or uphold our intellectual property rights or
    determine the validity and scope of the proprietary
    rights of others. Likewise, from time to time it may
    be necessary to defend our patents in litigation
    or administrative patent proceedings such as
    opposition proceedings. We believe that litigation
    can play a significant role in defining and protecting
    our intellectual property rights. We are aware,
    however, that legal and administrative proceedings
    can be costly and time-consuming, and result in a
    diversion of resources. As an alternative to litigation,
    we may enter into licensing, including cross-licensing,
    arrangements as a means of clarifying the status
    of our intellectual property rights.

    Oppositions against patents from the Group
    In 2005, each of Probiogen, CEVEC Pharmaceuticals
    and Serono filed oppositions with the European
    Patent Office against one or more of our PER.C6
    patents. All PER.C6 technology patents were
    upheld after first instance opposition proceedings.
    The PER.C6 patents pertaining to protein and virus
    production are no longer subject to opposition
    proceedings. The basic PER.C6 patent is currently
    under appeal, with Crucell as the only appellant and
    CEVEC Pharmaceuticals as party as of right. The
    outcome of appeal proceedings can only improve
    Crucell’s position.
    Cell Genesys has filed an opposition against our
    European patent related to our AdVac technology.
    Following the withdrawal of Cell Genesys from
    the opposition a swift resolution of the maintain
    opposition in Crucell’s favor is now underway.
    In addition to protecting our intellectual property
    rights, our commercial success also depends on our
    ability to operate without infringing the intellectual
    property rights of others. We monitor patent
    applications to the extent available, patents issued
    and publications of discoveries in scientific or patent
    literature to keep abreast of the activities of others in
    our field and, with the assistance of our internal and
    external patent counsel and other external advisors,
    assess whether our activities or products infringe
    the patents or proprietary rights of third parties.
    A number of third parties have been granted patents
    that cover technologies related to ours and similar
    patents may be granted in the future. We believe
    that our current activities do not infringe any valid
    claims of patents or any other proprietary rights
    of third parties. We will consider the intellectual
    property rights of others as we continue to identify
    and develop potential products and may have to
    enter into licensing or other agreements or use
    alternative technologies.

  3. flosz 15 augustus 2009 11:57
    Oppositions against patents from competitors
    Our subsidiary Berna Biotech Korea Corporation
    (formerly Green Cross Vaccine Corporation) and
    our partner Novartis (formerly Chiron) lodged
    opposition against a patent of GlaxoSmithKline
    (GSK) in Korea. The patent relates to multivalent
    vaccine formulations, such as our pentavalent
    vaccine Quinvaxem. In response to the opposition,
    the patent was revoked by the Korean Intellectual
    Property Office in December 2004 on the grounds
    that the subject-matter claimed in the patent lacks
    novelty. GSK appealed that decision to the Korean
    Patent Court. After a hearing which took place in
    April, 2006, the Korean Patent Court dismissed the
    appeal in June, 2006. GSK has appealed this decision
    before the Korean Supreme Court. In 2008, the
    Korean Supreme Court confirmed the decision by
    the Korean Patent Court and declared the patent
    to be invalid. This decision is final.
    In 2005, we filed opposition against a European
    patent held by Novartis Vaccines and Diagnostics
    (formerly: Chiron) related to certain aspects of the
    production of influenza viruses in cell culture. The
    patent was revoked during oral proceedings.
    In addition, production of Quinvaxem requires a
    particular vaccine component that may become the
    subject of a patent dispute between either GSK and
    us or GSK and our supplier of that component. The
    patent on that particular component, held by GSK,
    is currently under opposition before the patent
    office and a definitive outcome on the validity of
    the patent is expected to take a number of years.
    A negative outcome of this opposition proceeding
    could lead to infringement proceedings between
    GSK and us or GSK and our supplier, although we
    believe that neither we nor our supplier would be
    held to have infringed or be infringing that patent.
    The outcome of legal disputes is invariably difficult to
    predict with accuracy, but in the event GSK were to
    prevail in infringement proceedings against us, this
    would adversely affect our business.

    Technology licenses from third parties
    We licensed numerous technology and patents for
    specific use as part of our technology platforms from
    a number of third parties.
    We entered into a technology license agreement
    with Xoma in the field of bacterial expression
    technology. This license allows us to develop diagnostic
    and therapeutic antibodies in the
    field of infectious disease using phage-display
    technology. The agreement provides us with options
    to expand the license to cover additional disease
    fields. Under the terms of the agreement, we pay
    Xoma milestone payments and royalties on products
    as and when developed and marketed using the
    licensed technology.
    We also hold a license under the phage antibody
    display patent portfolio owned or controlled by
    MedImmune (formerly Cambridge Antibody
    Technology) and MRC, a cross-license with
    Transgene S.A. under which we granted to Transgene
    a non-exclusive PER.C6 license for the manufacture
    and sale of certain types of vectors for use in gene
    therapy, and a license for phage antibody-display
    technology and part human, or chimeric, binding
    proteins and molecules from Enzon Corporation’s
    subsidiary, SCA Ventures, Inc.
    In the field of vaccines, we have concluded an
    agreement with the Rockefeller University in New
    York, US. According to the agreement, we have the
    exclusive rights to use and exploit the Rockefeller
    patents related to ex vivo and in vivo targeting of
    dendritic cells with the use of viral vectors.
    The Group has licensed adjuvation technology called
    ISCOMS from Isconova AB for the development,
    manufacturing and commercialization of improved
    influenza vaccines.
    When licensing our technology to third parties we
    seek to obtain access to any improvement patents
    by our licensees via so-called grant-back provisions
    to reduce the risk of being exempted from using
    such improvements for our own benefit, or that
    of our licensees.

    Technology licenses to third parties
    We have issued certain licenses on an exclusive
    basis. These licenses generally state that we will
    not provide the licensed technology to a party
    other than the exclusive licensee for use in the
    area covered by the exclusive license. These licenses
    also generally provide for higher payments than
    non-exclusive licenses.
    hugin.info/132631/R/1312469/304318.pdf

    Voor de liefhebbers die eens lekker in de patenten willen struinen:
    nl.espacenet.com/search97cgi/s97_cgi....
    (Les van Biocon erbij: Het gaat om de prioriteitsdatum en niet de publicatiedatum)
  4. flosz 15 augustus 2009 11:58
    quote:

    flosz schreef:

    11-08-2009.
    The Company strengthened its patent position in the field of AdVac® technology
    by the acquisition of a portfolio of patents pertaining to the manufacturing and
    downstream processing of adenoviruses from Introgen Therapeutics Inc.
    hugin.info/132631/R/1333815/316333.pdf
    Also on April 7, 2009, the auction resulted in the sale of Introgen’s production-related intellectual
    property assets to Crucell BV, a biotechnology company based in The Netherlands (www.crucell.com). The terms of this agreement called for Crucell to pay Introgen $425,000 plus a
    35% royalty on any license fees generated from the Introgen patents. Additionally, the terms of the
    Crucell agreement provide Western General (Vivante) clear, royalty-free use of the patents in the conduct of its business, provided that Western General’s clients will be required to have a license for commercial sales of products that use this IP. Lastly, the sale agreement also granted to Western General (Vivante) a license to Crucell’s PER.C6 cell line for its clients’ use in preclinical and phase 1 human clinical studies. This sale closed on May 15, 2009. The up-front sale amount as well as the ongoing license fee payments will provide an additional means by which unpaid debts and investment in Introgen shares can be recovered.

    www.introgen.com/images/website224/20...
    INTROGEN THERAPEUTICS INC
    FORM 10-Q
    (Quarterly Report)
    Filed 08/08/08 for the Period Ending 06/30/08

    Crucell Holland has filed with the EPO an opposition to a European patent we own that covers an adenovirus production process. This
    proceeding is in its early stages. An oral hearing date has not yet been set.
    tinyurl.com/mys5dg
    www.iex.nl/forum/topic.asp?forum=228&...
  5. flosz 15 augustus 2009 11:59
    Confirmation of Bogoch Replikins Influenza Patents By Harvard-CDC and Scripps-Crucell Data (March 20, 2009)

    Boston, March 20, 2009. Replikins, Ltd. announced today that data recently published from Harvard-CDC and Scripps-Crucell in Nature1 and Science2 confirms the 2001 discoveries by Dr. Samuel and Elenore Bogoch of peptides in the hemagglutinin unit of influenza, which they named Replikins, which are shared across flu strains, conserved over time, associated with the last three pandemics of 1918, 1957 and 1968, as well as current H5N1 outbreaks, and are the basis of broad spectrum flu vaccines. The Replikins sequences, as specified by the Bogoches, are the subject of granted patents from 2001 and a 2005 monograph3.
    The amino acid contact points between the neutralizing antibody and the virus that the Harvard-CDC and Scripps-Crucell investigators both observed, out of over 500 possible sites, are in the influenza Replikins. The confirming groups' data also verified the Bogoch 2001 findings of conservation of these very Replikins peptides over decades, and the sharing of Replikins between strains of influenza, making general flu vaccines possible for the first time.
    The Replikins peptides, associated with rapid replication, are quantitatively trackable and predictive of the intensity, timing, and country of outbreak. The company's FluForecast® software has correctly predicted recent H5N1 outbreaks and the countries in which they were going to occur.4
    Replikins, which are quantitatively related to lethality in influenza and other infectious diseases, such as HIV, anthrax, and malaria, as well as cancer, and a range of animal diseases, are the subject of synthetic vaccines in development at the Company.
    1. Sui, J. et al. "Structural and functional bases for broad-spectrum neutralization of avian and human influenza A viruses.", Nature Structural and Molecular Biology, published online:22 February,2009, doi:10.1038-nsmb.1566.
    2. Ekeirt, D.C. et al, "Antibody Recognition of a Highly Conserved Influenza Virus Epitope", Science DOI: 10.1126-science.1171491, Science Published online, Feb. 26 2009
    3. Bogoch S. and Bogoch, E.S. Replikins, the Chemistry of Rapid Replication. With examples in influenza, HIV, AIDS, SARS, Malaria, and Cancer. Begell House,Inc. New York, Wallingford, U.K. ISBN 1-56700-200-5, 2005.
    4. On-line: see 'Replikins Press', 2006 - 2008. (Press release #12 Indonesia Reports Experiencing Human H5N1 Mortality Increase, as Predicted Last Year by Replikins' FluForecast® Quantitative Virus Analysis (June 8, 2007)

    REPLIKINS, Ltd. 38 the Fenway, Boston, MA 02215.
    Contact: jjosephson@replikins.com
    www.replikins.com/release.html#article25
    www.iex.nl/forum/topic.asp?forum=228&...
  6. MeawandMoo1 15 augustus 2009 12:30
    quote:

    flosz schreef:

    Confirmation of Bogoch Replikins Influenza Patents By Harvard-CDC and Scripps-Crucell Data (March 20, 2009)

    Boston, March 20, 2009. Replikins, Ltd. announced today that The Replikins sequences, as specified by the Bogoches, are the subject of granted patents from 2001 and a 2005 monograph3.
    The amino acid contact points between the neutralizing antibody and the virus that the Harvard-CDC and Scripps-Crucell investigators both observed, out of over 500 possible sites, are in the influenza Replikins. The confirming groups' data also verified the Bogoch 2001 findings of conservation of these very Replikins peptides over decades, and the sharing of Replikins between strains of influenza, making general flu vaccines possible for the first time.
    [/quote]
    Reeds in een eerder stadium van Crucell Investor Relations ontvangen,

    Hieronder (in het blauw = nu quoted) de antwoorden op uw vragen.

    In de hoop u voldoende te hebben geïnformeerd,

    Met vriendelijke groeten,
    *******************************************

    Geachte heer, mevrouw
    In uw persbericht van 26 februari 2009, wordt aangegeven dat de patenten op uw antibodies tegen griep wereldwijd en daarmee uw ontdekking goed beschermd is.
    Recentelijk is door de firma Bogoch Replikins aangegeven dat de ontdekking een bevestiging is van hun ontdekking en reeds bescherming van patenten geniet.

    In hoeverre is Crucell’s claim nog geldig en wat heeft dit (aankomend) dispuut gevolgen voor de verdere ontwikkeling van CR6261?
    Teruggrijpende naar het verleden, CEVEC Pharmaceutics, de reactie van Crucell heeft lang op zich laten wachten. Bent u (als bedrijf) van plan om duidelijkheid te verschaffen over de huidige patentrechten van Crucell?
    (Bijvoorbeeld, waar de claim van Bogoch Replikins geen vat op hebben en daarmee Crucell’s patenten overeind blijven.)

    [quote=Crucell]
    De claim dat onze bevindingen een bevestiging zouden vormen van hetgeen Bogoch et al. al in 2000 hebben gevonden berust ons insziens op een vergissing. De replikines van Bogoch hebben geen enkele gelijkenis met de bindingsplaatsen van onze antistoffen. De octrooien van Bogoch hebben geen enkele betrekking op de Crucell antistoffen, of wat dan ook, waarover Crucell in het door u genoemde persbericht gewag maakt. De beweringen en de octrooien van Bogoch zullen dan ook geen enkele invloed hebben op de commercialisering van de antistoffen door Crucell.
    [/quote]
    Ten aanzien van ontdekking van H3 varianten /familie; door de heer Brus is aangegeven dat men bezig was om een artikel te schrijven om de ontdekking bekend te maken. Wanneer wordt dit artikel ingediend en wanneer wordt deze
    gepubliceerd?

    [quote=Crucell]
    Vanuit concurrentieoverwegingen doet Crucell geen mededelingen over (het tijdstip van) nog te publiceren artikelen.
    Nu, een aantal maanden later ben ik het "gewraakte" artikel nog steeds niet tegen gekomen.
    Sprake van een "red herring"?
  7. [verwijderd] 20 augustus 2009 09:36
    De Jager verruimt Octrooibox

    Nieuwsbericht | 20-08-2009 | Belastingen op inkomen, winst en vermogen

    Staatssecretaris De Jager verruimt de mogelijkheden voor innovatieve ondernemers om gebruik te maken van de Octrooibox. Ondernemers kunnen voortaan verliezen op de exploitatie van octrooien volledig in plaats van gedeeltelijk verrekenen met de belastbare winst.

    Staatssecretaris De Jager: ‘Innovatieve ondernemers zijn ontzettend belangrijk voor de Nederlandse economie. Met deze maatregel wil ik innovatieve bedrijven die het door de kredietcrisis moeilijk hebben permanent een steuntje in de rug geven.’

    Bedrijven die bijvoorbeeld uitvindingen of technische toepassingen ontwikkelen (zgn. immateriële activa) en daarvoor octrooi hebben gekregen, kunnen gebruik maken van de octrooibox. Hierdoor zijn opbrengsten uit deze zelfontwikkelde activa belast met een tarief van 10%. Door de verruiming van de Octrooibox worden eventuele verliezen niet voor 10% maar volledig verrekenbaar met de belastbare winst.

    Dit besluit van staatssecretaris De Jager wordt vrijdag 21 augustus gepubliceerd in de Staatscourant.

    ============
    Dus resultaat uit octrooien leveren geen 10% belasting teruggave op maar, normaal vpb tarief.

    Ik neem aan dat de exploitatie van Crucell's octrooi portfolio nu nog negatief is, dus deze wijziging levert direct bottom-line op.

  8. [verwijderd] 20 augustus 2009 10:35
    quote:

    winx08 schreef:

    Ik neem aan dat de exploitatie van Crucell's octrooi portfolio nu nog negatief is, dus deze wijziging levert direct bottom-line op.
    Moeten er wel NL-winsten zijn waarmee gecompenseerd kan worden. Tot die tijd geen bottom-line effect.

    Voor de rest wel interessante info overigens!
  9. Mr sponge 20 augustus 2009 12:05
    quote:

    winx08 schreef:

    ============
    Dus resultaat uit octrooien leveren geen 10% belasting teruggave op maar, normaal vpb tarief.

    Ik neem aan dat de exploitatie van Crucell's octrooi portfolio nu nog negatief is, dus deze wijziging levert direct bottom-line op.

    Dit wordt al besproken in de CC van de Q2 cijfers. Ik heb nu geen tijd om die nog eens te luisteren. Maar in de CC geeft Crucell aan hoeveel verlies men opgebouwd heeft in Nederland. Tevens geeft men aan dat dit geld gaat opleveren op het moment dat er licentie inkomsten binnen gaan komen(Crucel hoeft dan minder of geen belasting betalen). Dus zie/luister de CC.
  10. [verwijderd] 20 augustus 2009 14:12
    quote:

    Mr sponge schreef:

    Tevens geeft men aan dat dit geld gaat opleveren op het moment dat er licentie inkomsten binnen gaan komen(Crucel hoeft dan minder of geen belasting betalen). Dus zie/luister de CC.
    Ik lees wat anders, namelijk " Door de verruiming van de Octrooibox worden eventuele verliezen niet voor 10% maar volledig verrekenbaar met de belastbare winst."

    Plannen per morgen in de staatscourant. Wellicht had Kruimer voorkennis ?
  11. flosz 25 september 2009 07:08
    quote:

    flosz schreef:

    [quote=flosz]
    11-08-2009.
    The Company strengthened its patent position in the field of AdVac® technology
    by the acquisition of a portfolio of patents pertaining to the manufacturing and
    downstream processing of adenoviruses from Introgen Therapeutics Inc.
    hugin.info/132631/R/1333815/316333.pdf
    [/quote]
    Also on April 7, 2009, the auction resulted in the sale of Introgen’s production-related intellectual
    property assets to Crucell BV, a biotechnology company based in The Netherlands (www.crucell.com). The terms of this agreement called for Crucell to pay Introgen $425,000 plus a
    35% royalty on any license fees generated from the Introgen patents. Additionally, the terms of the
    Crucell agreement provide Western General (Vivante) clear, royalty-free use of the patents in the conduct of its business, provided that Western General’s clients will be required to have a license for commercial sales of products that use this IP. Lastly, the sale agreement also granted to Western General (Vivante) a license to Crucell’s PER.C6 cell line for its clients’ use in preclinical and phase 1 human clinical studies. This sale closed on May 15, 2009. The up-front sale amount as well as the ongoing license fee payments will provide an additional means by which unpaid debts and investment in Introgen shares can be recovered.

    www.introgen.com/images/website224/20...
    INTROGEN THERAPEUTICS INC
    FORM 10-Q
    (Quarterly Report)
    Filed 08/08/08 for the Period Ending 06/30/08

    Crucell Holland has filed with the EPO an opposition to a European patent we own that covers an adenovirus production process. This
    proceeding is in its early stages. An oral hearing date has not yet been set.
    tinyurl.com/mys5dg
    www.iex.nl/forum/topic.asp?forum=228&...

    Friday, September 25, 2009
    Introgen Therapeutics' Houston unit gets new life
    Investors acquire unit of bankrupt biopharm firm to forge new contracts
    The Houston operation of Introgen Therapeutics Inc., an Austin-based biopharmaceutical company that filed for bankruptcy last December, has been acquired out of bankruptcy by a group of Houston investors and has signed a major contract with The University of Oxford in the United Kingdom.
    Introgen, a former publicly traded company that had most of its manufacturing operations in Houston, filed for Chapter 11 bankruptcy protection on Dec. 3, 2008 (see “Houston arm will be centerpiece of Introgen reorganization effort,” Dec. 12, 2008).
    Former Introgen Chief Operations Officer David Enloe was tapped to serve as the company’s CEO after Introgen filed for bankruptcy and the previous CEO and officers resigned.
    The assets of the company were divided into three groups: Manufacturing patents, therapeutic drug assets and manufacturing-related assets — including a facility and documentation required to manufacture third-party biologic drugs and clinical trials.
    In early June, an unnamed group of private Houston investors quietly purchased Introgen’s manufacturing-related assets and formed a new contract manufacturing organization called Vivante GMP Solutions Inc., based in Houston.
    The new firm was born out of an Introgen subsidiary focused on contract manufacturing that was formed not long before the bankruptcy filing. That technical subsidiary’s 15 employees all now work for Vivante.
    Unlike Introgen, Vivante is “really not engaged in developing our own drugs,” Enloe says. “We’re engaged in the business of biotechnology and helping others manufacture drugs.”
    Prior to the bankruptcy, Introgen had struggled to get its lead product, the head and neck cancer drug Advexin, approved. Last September, the U.S. Food and Drug Administration declined Introgen’s request to market Advexin, which the company had spent more than a decade developing.
    Introgen’s stock plunged to 6 cents on the news. Then, in November 2008, the firm laid off 30 of its 45 employees in Houston and Austin. Those who remained worked for Introgen’s Houston-based contract manufacturing subsidiary, which has now become Vivante.
    “We were in the process of spinning out Vivante when Introgen had to file for bankruptcy,” says Enloe, “so we had to continue the process as a purchase of assets and spin it out in a different way.”
    Enloe, who came on board as Introgen’s first employee when the company was formed in 1995, owns a minority interest in the new entity but did not directly invest in it.
    _______________________

    A large Dutch biotech firm called Crucell NV purchased Introgen’s adenovirus manufacturing patents and later licensed them back to Vivante. Crucell also licensed one of its proprietary technologies to Vivante.
    ________________________
    Enloe says the divestiture of Introgen’s therapeutic drug assets is currently being negotiated, with “the hopes of a sale happening very soon.” Enloe continues to work with what remains of Introgen — which is no longer being traded publicly — on an advisory basis.
    Introgen does not have any remaining employees but still owns the company’s therapeutic assets.
    While a reorganization plan has been put forth to the bankruptcy courts, Enloe doesn’t believe Introgen will survive the bankruptcy.
    But the surviving company, Vivante, is not only alive, it’s signing significant contracts, including one with Oxford University.
    Vivante’s primary focus is the contract manufacturing of biologics for academic institutions, biotechnology companies and biopharmaceutical firms. A number of privately held biotech companies have already hired the firm to produce their materials as well as to help conduct clinical studies for cancer and infectious-disease vaccines.
    The company retained its early customers throughout the bankruptcy — as an Introgen subsidiary — and was able to keep doing business. Since its reincarnation, Vivante has added some additional clients, including Oxford. Earlier this year, the Bill & Melinda Gates Foundation awarded the prestigious university a $20.6 million grant to create a WorldWide Antimalarial Drug Resistance Network as a global resource to ensure efficacious use of antimalarial drugs.

    Volledig art. via:
    houston.bizjournals.com/houston/stori...
  12. flosz 20 oktober 2009 00:32
    quote:

    flosz schreef:

    Confirmation of Bogoch Replikins Influenza Patents By Harvard-CDC and Scripps-Crucell Data (March 20, 2009)

    Boston, March 20, 2009. Replikins, Ltd. announced today that data recently published from Harvard-CDC and Scripps-Crucell in Nature1 and Science2 confirms the 2001 discoveries by Dr. Samuel and Elenore Bogoch of peptides in the hemagglutinin unit of influenza, which they named Replikins, which are shared across flu strains, conserved over time, associated with the last three pandemics of 1918, 1957 and 1968, as well as current H5N1 outbreaks, and are the basis of broad spectrum flu vaccines. The Replikins sequences, as specified by the Bogoches, are the subject of granted patents from 2001 and a 2005 monograph3.
    The amino acid contact points between the neutralizing antibody and the virus that the Harvard-CDC and Scripps-Crucell investigators both observed, out of over 500 possible sites, are in the influenza Replikins. The confirming groups' data also verified the Bogoch 2001 findings of conservation of these very Replikins peptides over decades, and the sharing of Replikins between strains of influenza, making general flu vaccines possible for the first time.
    The Replikins peptides, associated with rapid replication, are quantitatively trackable and predictive of the intensity, timing, and country of outbreak. The company's FluForecast® software has correctly predicted recent H5N1 outbreaks and the countries in which they were going to occur.4
    Replikins, which are quantitatively related to lethality in influenza and other infectious diseases, such as HIV, anthrax, and malaria, as well as cancer, and a range of animal diseases, are the subject of synthetic vaccines in development at the Company.
    www.replikins.com/release.html#article25
    www.iex.nl/forum/topic.asp?forum=228&...

    En Sam & Elenore schudden weer wat moois uit de mouw….
    The centrality of the Replikins(TM) to influenza has been confirmed recently
    by the data of two independent groups, Harvard-CDC and Scripps-Crucell. Their
    findings demonstrate that inhibitory antibody lands on and binds selectively
    to the very peptides that the Drs. Bogoch have previously identified as
    Replikins(TM).
    Vol in de kuiten………en vasthouden!

    New Non-Biological Synthetic Replikins(TM) Vaccines Shown to Be Effective and
    Fast; WorldVaccines(TM), Ltd Formed for Testing and Distribution
    Old Biological Vaccines for Emergent Diseases - Too Little, Too Late
    BOSTON, Oct. 19 /PRNewswire/ -- There is increasing evidence that, with best
    intent, current biological technology cannot supply the world's six billion
    humans, and animal populations, with vaccines against emerging diseases at a
    rate that can contend with a disease's rapid appearance and change, e.g.,
    before the disease has come and gone. In view of Replikins Ltd.'s
    demonstration that Replikins(TM) chemically synthesized vaccines produced in
    seven days can be effective, the company today proposed these new vaccines as
    a solution to the problem of these emerging diseases. Furthermore, it
    established WorldVaccines(TM), Ltd to test and distribute synthetic
    Replikins(TM) vaccines.

    As the first batches of the biological H1N1 ("Swine Flu") vaccines reach
    consumers worldwide, seven months after the flu outbreak, this small biotech
    firm in Boston today announced that it has created the first truly synthetic
    influenza vaccine that targets the broad range of A influenza viruses
    including H1N1, H5N1, H9N2, and H3N2, which was shown to be effective against
    the H5N1 (Avian Flu) virus. TransFlu(TM) is the first truly synthetic
    cross-strain pan-influenza vaccine.

    In an independent study published in the peer-reviewed journal Avian Diseases,
    the synthetic Replikins TransFlu(TM) vaccine was shown to be effective in
    decreasing infectivity and completely blocking excretion of LPAI H5N1 virus in
    chickens, permitting for the first time the possibility of blocking animal
    virus reservoir development, a major precursor of human disease.

    Both TransFlu(TM) and Taura Syndrome Virus vaccines were manufactured in seven
    days; kilogram amounts could be made in a few weeks, rather than six to 12
    months needed for biological vaccine production. The cost to produce the
    synthetic vaccine is also far less than the cost of current biological
    production methods. Given the demonstrated effectiveness and rapid
    availability, it appears inevitable that synthetic Replikins(TM) vaccines will
    eventually replace biological vaccines.

    Further, until now, all influenza vaccines have been produced in biologically
    living cells. Whether whole virus or recombinant virus sections are reproduced
    in eggs, kidney, hamster, E.coli, or other cells, these living cells provide
    the obligatory contamination in the vaccine of thousands of unwanted
    immunogenic proteins, the potential for other virus contamination (viruses
    only reproduce in living cells), and the need for potentially toxic
    preservatives.

    Over the last decade, Drs. Samuel and Elenore Bogoch have been developing
    vaccine-manufacturing methods that are non-biological, based on software
    algorithms designed to study virus structure, and organic chemistry. The new,
    completely synthetic Replikins(TM) Vaccine Technology1-4 targets a group of
    genomic peptides that they discovered and named Replikins(TM). These genomic
    peptides were found to be conserved in viruses cross-strain over decades, and
    to be related to rapid replication and epidemic outbreaks.
    The centrality of the Replikins(TM) to influenza has been confirmed recently
    by the data of two independent groups, Harvard-CDC and Scripps-Crucell. Their
    findings demonstrate that inhibitory antibody lands on and binds selectively
    to the very peptides that the Drs. Bogoch have previously identified as
    Replikins(TM).
    www.reuters.com/article/pressRelease/...

    Uit de mailbox van M&M(zie post d.d.15 aug 09, 12:30): De claim dat onze bevindingen een bevestiging zouden vormen van hetgeen Bogoch et al. al in 2000 hebben gevonden berust ons insziens op een vergissing. De replikines van Bogoch hebben geen enkele gelijkenis met de bindingsplaatsen van onze antistoffen. De octrooien van Bogoch hebben geen enkele betrekking op de Crucell antistoffen, of wat dan ook, waarover Crucell in het door u genoemde persbericht gewag maakt. De beweringen en de octrooien van Bogoch zullen dan ook geen enkele invloed hebben op de commercialisering van de antistoffen door Crucell.
  13. flosz 27 april 2010 19:05
    Regio KvK Den Haag topper in octrooiaanvragen
    dinsdag 27 april 2010, 10:04 uur
    De regio Den Haag is na Brabant (o.a. Philips) het gebied met de meeste octrooiaanvragen van Nederland. Niet alleen Shell in Den Haag zorgt voor deze hoge score, ook in Delft (techniek) en het Westland (tuinbouw) zijn veel bedrijven met octrooiaanvragen gevestigd. Dit blijkt uit het onderzoek ´Octrooien in Nederland´ (over periode 2003-2007) dat EIM heeft uitgevoerd in samenwerking met het NL Octrooicentrum en de Kamer van Koophandel.
    ……….
    En op de zesde plaats staat Crucell, het biosciencebedrijf uit Leiden dat o.a. vaccins produceert.
    www.infothuis.tv/index.php?s=3&c=3449...
  14. MeawandMoo1 27 april 2010 20:51
    quote:

    flosz schreef:

    Octrooien in Nederland (over periode 2003-2007)

    Op de zesde plaats staat Crucell, het biosciencebedrijf uit Leiden dat o.a. vaccins produceert.
    www.infothuis.tv/index.php?s=3&c=...
    2008 Patent filings
    ..............Pending..Granted...Active
    Vaccines(1)...259.......367......626
    Antibodies(2).141........77......218
    Technology(3).268.......344......612
    Gene Therapy...50.......171......221
    Total.........718.......959.....1,677

    2009 Patent filings
    ..............Pending..Granted...Active
    Vaccines(1)...324.......628......952
    Antibodies(2).217........84......301
    Technology(3).186.......363......549
    Gene Therapy...33........66.......99
    Total.........760......1141.....1,901

    Op het eerste gezicht een interessante toename over het geheel. Nadeel is dat in 2009 Crucell van een bedrijf de "intellectual property" gekocht heeft. Hoeveel patenten gekocht zijn is bij mij niet bekend. Puur op gevoel op basis van het aantal publicaties op "pubmed" en octrooien, zijn de laatste jaren "vanuit eigen ontwikkeling" zeer mager geweest.

    Alleen al uit dit oogpunt is versterking en uitbreidinig op R&D gewenst; zeker het indien verstrekken van licenties en toestaan gebruik van ontdekkingen royalties oplevert.

  15. flosz 30 april 2010 18:18
    In re: INTROGEN THERAPEUTICS, INC., INTROGEN TECHNICAL SERVICES, INC., Chapter 11, Debtors.
    Case Nos. 08-12442-CAG, 08-12443-CAG, Jointly Administered Under Case No. 08-12442-CAG.
    United States Bankruptcy Court, W.D. Texas, Austin Division.
    April 29, 2010.
    MEMORANDUM OPINION CONFIRMING DEBTOR'S PLAN OF REORGANIZATION
    CRAIG A. GARGOTTA, Bankruptcy Judge

    www.leagle.com/unsecure/page.htm?shor...
    ************
    In 2009, we acquired the patent portfolio of former Introgen Therapeutics related to adenovirus manufacturing, downstream processing and formulation. Under the agreement, the estate of Introgen Therapeutics is eligible to
    receive a royalty if we license the acquired patent assets to an unaffiliated third party.
    hugin.info/132631/R/1401132/356214.pdf

    Crucell today announces a patent license and a vendor network manufacturing service license agreement with US-based Vivante GMP Solutions. The patent license agreement grants Vivante a worldwide, non-exclusive license of intellectual property to conduct development and manufacture using Crucell's adenoviral-based patent portfolio. The vendor network manufacturing service license agreement grants Vivante a non-exclusive license to utilize Crucell's PER.C6® cell line in the manufacture of gene therapy and vaccine products for Vivante's clients through Phase 1 clinical trials. Financial details of the agreement were not disclosed. [October 2009].

    Vivante GMP Solutions Enters into License Agreements with Crucell
    Vivante GMP Solutions, Inc. ('Vivante'; www.vivante-gmp.com) today announced that it has finalized its license agreements with Dutch biopharmaceutical company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX).
    Both a patent license and a vendor network manufacturing service license agreement were executed. The patent license agreement grants Vivante a worldwide, non-exclusive license of intellectual property to conduct development and manufacture using the adenoviral-based patent portfolio acquired by Crucell from Introgen Therapeutics, as announced by Crucell on August 11, 2009. The vendor network manufacturing service license agreement grants Vivante a non-exclusive license to utilize Crucell’s PER.C6® cell line in the manufacture of gene therapy and vaccine products for Vivante’s clients through Phase 1 clinical trials. Manufacture of products for use in Phase 2 clinical trials and beyond requires a separate license from Crucell.

    www.vivante-gmp.com/aboutus/011410.html
    Zie post 25 sep 09, 07:08.
  16. flosz 9 november 2010 15:05
    Patents:

    In Q3 2010 Crucell was granted a total of 34 patents, including patents for:

    Aspects of PER.C6® recombinant protein glycoform expression technology, in the U.S.
    Different aspects of improved adenoviral AdVac® vectors, in India, in Canada and in Singapore
    Cell lines for improved adenovirus production, in Australia
    Elements of STAR® technology, in Europe, in Singapore and in the U.S.
    Chimeric adenoviruses that can target different specific cell types, in the U.S.
    Improvements in influenza virus isolation using PER.C6® technology, in Korea
    Genetically engineered Vibrio choleraestrains, in Europe
    hugin.info/132631/R/1460291/399531.pdf
  17. [verwijderd] 9 november 2010 15:17
    quote:

    flosz schreef:

    Patents:

    Elements of STAR® technology, in Europe, in Singapore and in the U.S.
    STAR????

    Ik dacht dat dat al afgeschreven was?
    Wellicht 'interessanter can we dachten" voor J&J?

    Dirk
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ASIT biotech 2 697
ASMI 4.108 39.657
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Auplata 1 55
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