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This excerpt taken from the ELN 20-F filed Feb 26, 2009. Patents
and Intellectual Property Rights
Our competitive position depends on our ability to obtain
patents on our technologies and products, to defend our patents,
to protect our trade secrets and to operate without infringing
the valid patents or trade secrets of others. We own or license
a number of patents in the United States and other countries.
These patents cover, for example:
Tysabri is covered by a number of issued patents and
pending patent applications in the United States and many other
countries. We have a basic U.S. patent, which expires in
2017, for Tysabri covering the humanized antibody and its
use to treat MS. Additional U.S. patents and patent
applications of Elan
and/or our
collaborator Biogen Idec that cover (i) the use of
Tysabri to treat irritable bowel disease and a variety of
other indications and (ii) methods of manufacturing
Tysabri, generally expire between 2012 and 2020. Outside
the United States, patents and patent applications on the
product and methods of manufacturing the product generally
expire between 2014 and 2020, and may be subject to additional
patent protection until 2020 in the nature of Supplementary
Protection Certificates. International patents and patent
applications covering methods of treatment using Tysabri
would generally expire between 2012 to 2020.
In addition to our Tysabri collaboration with Biogen
Idec, we have entered into licenses covering intellectual
property related to Tysabri. We pay royalties under these
licenses based upon the level of Tysabri sales. We may be
required to enter into additional licenses related to
Tysabri intellectual property. If these licenses are not
available, or are not available on reasonable terms, we may be
materially and adversely affected.
Table of Contents
The fundamental U.S. patent covering the use of Prialt
to produce analgesia expires in 2016. A further
U.S. patent covering the stabilized formulation of
Prialt expires in 2015.
The basic U.S. patent for Maxipime expired in March
2007. An ANDA for a generic version of cefepime hydrochloride
was approved by the FDA on June 18, 2007, and marketing of
the generic product began immediately thereafter. Following this
introduction of generic cefepime to the market, our revenues
from, and gross margin for, Maxipime were materially and
adversely affected.
The basic U.S. patent for Azactam expired in October
2005. Azactam will likely face generic competition, which
is expected to have a substantial adverse effect on our revenues
from, and gross margin for, this product.
The primary patents covering Elan’s NanoCrystal
technology expire in the United States in 2011 and in some
countries outside the United States in 2012. We also have
numerous U.S. and international patents and patent
applications that relate to our NanoCrystal drug
optimization technology applicable to poorly water-soluble
compounds.
In addition, we have a robust patent estate resulting from our
Alzheimer’s disease research.
This excerpt taken from the ELN 20-F filed Feb 28, 2008. Patents
and Intellectual Property Rights
Our competitive position depends on our ability to obtain
patents on our technologies and products, to defend our patents,
to protect our trade secrets and to operate without infringing
the valid patents or trade secrets of others. We own or license
a number of patents in the United States and other countries.
These patents cover, for example:
Tysabri is covered by a number of issued patents and
pending patent applications in the United States and many other
countries. We have a basic U.S. patent, which expires in
2017, for Tysabri covering the humanized antibody and its
use to treat MS. Additional U.S. patents and patent
applications of Elan
and/or our
collaborator, Biogen Idec, which cover: (i) the use of
Tysabri to treat irritable bowel disease and a variety of
other indications and (ii) methods of manufacturing
Tysabri, generally expire between 2012 and 2020. Outside
the United States, patents and patent applications on the
product and methods of manufacturing the product generally
expire between 2014 and 2020, and may be subject to additional
patent protection until 2020 in the nature of Supplementary
Protection Certificates. International patents and patent
applications covering methods of treatment using Tysabri
would generally expire between 2012 to 2020.
In addition to our Tysabri collaboration with Biogen
Idec, we have entered into licenses covering intellectual
property related to Tysabri. We will pay royalties under
these licenses based upon the level of Tysabri sales. We
may be required to enter into additional licenses related to
Tysabri intellectual property. If these licenses are not
available, or are not available on reasonable terms, we may be
materially and adversely affected.
The fundamental U.S. patent covering the use of Prialt
to produce analgesia expires in 2016. A further
U.S. patent covering the stabilized formulation of
Prialt expires in 2015.
The basic U.S. patent for Maxipime expired in March
2007. An ANDA for a generic version of cefepime hydrochloride
was approved by the FDA on June 18, 2007 and marketing of
the generic product began immediately thereafter. Following this
introduction of generic cefepime to the market, our revenues
from, and gross margin for, Maxipime were materially and
adversely affected.
The basic U.S. patent for Azactam expired in October
2005. Azactam is expected to face generic competition,
which is expected to have a substantial adverse effect on our
revenues from, and gross margin for, this product.
The primary patents covering Elan’s NanoCrystal
technology expire in the United States in 2011 and in some
countries outside the United States in 2012. We also have
numerous U.S. and international patents and patent
applications that relate to our NanoCrystal drug
optimization technology applicable to poorly water-soluble
compounds.
In addition, we have a robust patent estate resulting from our
Alzheimer’s disease research.
This excerpt taken from the ELN 20-F filed Feb 28, 2007. Patents
and Intellectual Property Rights
Our competitive position depends on our ability to obtain
patents on our technologies and products, to defend our patents,
to protect our trade secrets and to operate without infringing
the valid patents or trade secrets of others. We own or license
a number of patents in the United States and other countries.
These patents cover, for example:
Patents for products extend for varying periods according to the
date of patent filing or grant and the legal term of patents in
various countries. The actual protection afforded by a patent,
which can vary from country to country, depends upon the type of
patent, the scope of its coverage and the availability of legal
remedies in the country.
Tysabri is covered by a number of pending patent
applications and issued patents in the United States and many
other countries. Elan has a basic US patent for Tysabri
covering the humanized antibody and its use to treat MS,
which expires in 2014, subject to any available patent term
extensions. Additional US patents and patent applications of
Elan and/or
its collaborator, Biogen Idec, which cover i) the use of
Tysabri to treat irritable bowel disease and a variety of
other indications and ii) methods of manufacturing
Tysabri generally expire between 2012 and 2020. Outside
the United States, patents and patent applications on
i) the product and methods of manufacturing the product,
and ii) methods of treatment would generally expire in the
2014 to 2016 and 2012 to 2020 timeframes, respectively. If
Tysabri receives regulatory approval in those
jurisdictions, those patents may be eligible for supplemental
protection certificates.
In addition to our Tysabri collaboration with Biogen
Idec, we have entered into licenses covering intellectual
property related to Tysabri. We will pay
royalties under these licenses based upon the level of
Tysabri sales. We may be required to enter into
additional licenses related to Tysabri intellectual
property. If these licenses are not available, or are not
available on reasonable terms, we may be materially and
adversely affected.
The fundamental US patent covering the use of Prialt to
produce analgesia expires in 2011. A further US patent covering
the stabilized formulation of Prialt expires in 2015. One
of our patents covering Prialt may qualify for a US
patent term extension of up to five years.
The basic US patent for Maxipime expires in March 2007.
However, two US patents covering Maxipime formulations
may provide patent protection until February 2008. The basic US
patent for Azactam expired in October 2005. Maxipime
and Azactam are expected to face generic competition, which
is expected to have a substantial adverse effect on our revenues
from, and gross margin for, these products.
The primary patents covering Elan’s NanoCrystal
technology expire in the United States in 2011 and in
countries outside the United States in 2012. We also have
numerous US and international patents and patent applications
that relate to our NanoCrystal drug optimization
technology applicable to poorly water-soluble compounds.
In addition, we have a large patent estate resulting from our
Alzheimer’s disease research.
Our products are sold around the world under brand name, logo
and product design trademarks that we consider in the aggregate
to be of material importance. Trademark protection continues in
some countries for as long as the mark is used and, in other
countries, for as long as it is registered. Registrations
generally are for fixed, but renewable, terms.
Table of Contents
This excerpt taken from the ELN 20-F filed Mar 30, 2006. Patents
and Intellectual Property Rights
Our competitive position depends on our ability to obtain
patents on our technologies and products, to defend our patents,
to protect our trade secrets and to operate without infringing
the valid patents or trade secrets of others. We own or license
a number of U.S. and foreign patents.
These patents cover:
Patents for products extend for varying periods according to the
date of patent filing or grant and the legal term of patents in
various countries. The actual protection afforded by a patent,
which can vary from country to country, depends upon the type of
patent, the scope of its coverage and the availability of legal
remedies in the country.
Tysabri is covered by a number of pending patent
applications and issued patents in the United States and many
foreign countries. Elan has a basic U.S. patent for
Tysabri covering the humanized antibody and its use to
treat MS, which expires in 2014, subject to any available patent
term extensions. Additional U.S. patents of Elan
and/or its
collaborator, Biogen Idec, which cover i) the use of
Tysabri to treat irritable bowel disease and a variety of
other indications and ii) methods of manufacturing
Tysabri expire generally between 2012 and 2020. Outside
the United States, patents on i) the product and
methods of manufacturing the product, and ii) methods of
treatment generally expire in the
2014-2016
and
2012-2020
timeframe, respectively. If Tysabri receives regulatory
approval in those jurisdictions, those patents may be eligible
for supplemental protection certificates.
In addition to our Tysabri collaboration with Biogen
Idec, we have entered into licenses covering intellectual
property related to Tysabri. We will pay royalties under
these licenses based upon the level of Tysabri sales. We
may be required to enter into additional licenses related to
Tysabri intellectual property. If these licenses are not
available, or are not available on reasonable terms, we may be
materially and adversely affected.
The fundamental U.S. patent covering the use of Prialt
to produce analgesia expires in 2011. Two further
U.S. patents covering: (i) the commercial, stabilized
formulation of Prialt, and (ii) a method for
preventing progression of neuropathic pain expire in 2015. One
of our patents covering Prialt may qualify for a
U.S. patent term extension of up to five years.
The basic U.S. patent for Maxipime expires in March
2007. However, two U.S. patents covering Maxipime
formulations may provide patent protection until February
2008.
The basic U.S. patent for Azactam expired in October
2005. Azactam is expected to face generic competition,
which is expected to have a substantial adverse effect on our
revenues from, and gross margin for,
Azactam. However, to date, no generic
Azactam product has been approved.
The primary patents covering Elan’s NanoCrystal
technology expire in the U.S. in 2011 and in countries
outside the U.S. in 2012.
We also have more than 130 U.S. and international patents and
patent applications that relate to our NanoCrystal drug
optimization technology applicable to poorly water-soluble
compounds.
Our products are sold around the world under brand name, logo
and product design trademarks that we consider in the aggregate
to be of material importance. Trademark protection continues in
some countries for as long as the mark is used and, in other
countries, for as long as it is registered. Registrations
generally are for fixed, but renewable, terms.
Table of Contents
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