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This excerpt taken from the LLY 10-K filed Feb 22, 2010. Overview
Intellectual property protection is critical to our ability to
successfully commercialize our life sciences innovations and
invest in the search for new medicines. We own, have applied
for, or are licensed under, a large number of patents in the
United States and many other countries relating to products,
product uses, formulations, and manufacturing processes. There
is no assurance that the patents we are seeking will be granted
or that the patents we hold would be found valid and enforceable
if challenged. Moreover, patents relating to particular
products, uses, formulations, or processes do not preclude other
manufacturers
4
from employing alternative processes or from marketing
alternative products or formulations that might successfully
compete with our patented products. In addition, from time to
time, competitors or other third parties assert claims that our
activities infringe patents or other intellectual property
rights held by them, or allege a third-party right of ownership
in our existing intellectual property.
Outside the United States, the adequacy and effectiveness of
intellectual property protection for pharmaceuticals varies
widely. Under the Trade-Related Aspects of Intellectual Property
Agreement (TRIPs) administered by the World Trade Organization
(WTO), over 140 countries have now agreed to provide
non-discriminatory protection for most pharmaceutical inventions
and to assure that adequate and effective rights are available
to all patent owners. Because of TRIPs transition provisions,
dispute resolution mechanisms, and substantive limitations, it
is difficult to assess when and how much, if at all, we will
benefit commercially from this protection.
When a product patent expires, the patent holder often loses
effective market exclusivity for the product. This can result in
a severe and rapid decline in sales of the formerly patented
product, particularly in the United States. However, in some
cases the innovator company may achieve exclusivity beyond the
expiry of the product patent through manufacturing trade
secrets, later-expiring patents on methods of use or
formulations, or data-based exclusivity that may be available
under pharmaceutical regulatory laws.
Some of our current products, including Erbitux, Forteo, ReoPro,
and Xigris, and many of the potential products in our research
pipeline, are biological products (“biologics”).
Currently, generic versions of biologics cannot be approved
under U.S. law. Competitors seeking approval of biologics
must file their own safety and efficacy data, and address the
challenges of biologics manufacturing, which typically involves
more complex and costly processes than those of traditional
pharmaceutical operations. However, certain health care reform
bills recently debated in Congress included provisions that
would create a regulatory pathway to allow generic biologics.
Under these proposals, the innovator would receive data-based
exclusivity for a period of years following regulatory approval
for marketing. Even in the absence of new legislation, the
U.S. Food and Drug Administration (FDA) is taking steps
toward allowing generic versions of certain biologics.
These excerpts taken from the LLY 10-K filed Feb 27, 2009. Overview
Intellectual property protection is, in the aggregate, material
to our ability to successfully commercialize our life sciences
innovations. We own, have applied for, or are licensed under, a
large number of patents, both in the United States and in other
countries, relating to products, product uses, formulations, and
manufacturing processes. There is no assurance that the patents
we are seeking will be granted or that the patents we have been
granted would be found valid and enforceable if challenged.
Moreover, patents relating to particular products, uses,
formulations, or processes do not preclude other manufacturers
from employing alternative processes or from marketing
alternative products or formulations that might successfully
compete with our patented products. In addition, from time to
time, competitors or other third parties assert claims that our
activities infringe patents or other intellectual property
rights held by them, or allege a third-party right of ownership
in our existing intellectual property.
Outside the United States, the adequacy and effectiveness of
intellectual property protection for pharmaceuticals varies
widely. Under the Trade-Related Aspects of Intellectual Property
Agreement (TRIPs) administered by the World Trade Organization
(WTO), over 140 countries have now agreed to provide
non-discriminatory protection for most pharmaceutical inventions
and to assure that adequate and effective rights are available
to all patent owners. Because of TRIPs transition provisions,
dispute resolution mechanisms, and substantive
limitations, it is still too soon to assess when and how much,
if at all, we will benefit commercially from these changes.
When a product patent expires, the patent holder often loses
effective market exclusivity for the product. This can result in
a severe and rapid decline in sales of the formerly patented
product, particularly in the United States. However, in
some cases the innovator company may achieve exclusivity beyond
the expiry of the product patent through manufacturing trade
secrets, later-expiring patents on methods of use or
formulations, or data-based exclusivity that may be available
under pharmaceutical regulatory laws.
Some of our products, including Erbitux, Forteo, ReoPro, and
Xigris, are biological products, or biologics. Additionally,
many of the potential products in our research pipeline are
biologics. Currently, generic versions of biologics cannot be
approved under U.S. law. Competitors seeking approval of
biologics must file their own safety and efficacy data, and
address the challenges of biologics manufacturing, which
involves more complex and costly processes than those of
traditional pharmaceutical operations. However, the law could
change in the future to allow generic biologics. Even in the
absence of new legislation, the U.S. Food and Drug
Administration (FDA) is taking steps toward allowing generic
versions of certain biologics.
Overview Intellectual property protection is, in the aggregate, material to our ability to successfully commercialize our life sciences innovations. We own, have applied for, or are licensed under, a large number of patents, both in the United States and in other countries, relating to products, product uses, formulations, and manufacturing processes. There is no assurance that the patents we are seeking will be granted or that the patents we have been granted would be found valid and enforceable if challenged. Moreover, patents relating to particular products, uses, formulations, or processes do not preclude other manufacturers from employing alternative processes or from marketing alternative products or formulations that might successfully compete with our patented products. In addition, from time to time, competitors or other third parties assert claims that our activities infringe patents or other intellectual property rights held by them, or allege a third-party right of ownership in our existing intellectual property. Outside the United States, the adequacy and effectiveness of intellectual property protection for pharmaceuticals varies widely. Under the Trade-Related Aspects of Intellectual Property Agreement (TRIPs) administered by the World Trade Organization (WTO), over 140 countries have now agreed to provide non-discriminatory protection for most pharmaceutical inventions and to assure that adequate and effective rights are available to all patent owners. Because of TRIPs transition provisions, dispute resolution mechanisms, and substantive
limitations, it is still too soon to assess when and how much, if at all, we will benefit commercially from these changes. When a product patent expires, the patent holder often loses effective market exclusivity for the product. This can result in a severe and rapid decline in sales of the formerly patented product, particularly in the United States. However, in some cases the innovator company may achieve exclusivity beyond the expiry of the product patent through manufacturing trade secrets, later-expiring patents on methods of use or formulations, or data-based exclusivity that may be available under pharmaceutical regulatory laws. Some of our products, including Erbitux, Forteo, ReoPro, and Xigris, are biological products, or biologics. Additionally, many of the potential products in our research pipeline are biologics. Currently, generic versions of biologics cannot be approved under U.S. law. Competitors seeking approval of biologics must file their own safety and efficacy data, and address the challenges of biologics manufacturing, which involves more complex and costly processes than those of traditional pharmaceutical operations. However, the law could change in the future to allow generic biologics. Even in the absence of new legislation, the U.S. Food and Drug Administration (FDA) is taking steps toward allowing generic versions of certain biologics. These excerpts taken from the LLY 10-K filed Oct 21, 2008. Overview
Intellectual property protection is, in the aggregate, material
to our ability to successfully commercialize our life sciences
innovations. We own, have applied for, or are licensed under, a
large number of patents, both in the United States and in other
countries, relating to products, product uses, formulations, and
manufacturing processes. There is no assurance that the patents
we are seeking will be granted or that the patents we have been
granted would be found valid and enforceable if challenged.
Moreover, patents relating to particular products, uses,
formulations, or processes do not preclude other manufacturers
from employing alternative processes or from marketing
alternative products or formulations that might successfully
compete with our patented products. In addition, from time to
time, competitors or other third parties assert claims that our
activities infringe patents or other intellectual property
rights held by them, or allege a third-party right of ownership
in our existing intellectual property.
Outside the United States, the adequacy and effectiveness of
intellectual property protection for pharmaceuticals varies
widely. Under the Trade-Related Aspects of Intellectual Property
Agreement (TRIPs) administered by the World Trade Organization
(WTO), over 140 countries have now agreed to provide
non-discriminatory protection for most pharmaceutical inventions
and to assure that adequate and effective rights are available
to all patent owners. Because of TRIPs transition provisions,
dispute resolution mechanisms, and substantive limitations, it
is still too soon to assess when and how much, if at all, we
will benefit commercially from these changes.
When a product patent expires, the patent holder often loses
effective market exclusivity for the product. This can result in
a severe and rapid decline in sales of the formerly patented
product, particularly in the United States. However, in
some cases the innovator company may achieve exclusivity beyond
the expiry of the product patent through manufacturing trade
secrets; later-expiring patents on methods of use or
formulations; or data-based exclusivity that may be available
under pharmaceutical regulatory laws.
Overview Intellectual property protection is, in the aggregate, material to our ability to successfully commercialize our life sciences innovations. We own, have applied for, or are licensed under, a large number of patents, both in the United States and in other countries, relating to products, product uses, formulations, and manufacturing processes. There is no assurance that the patents we are seeking will be granted or that the patents we have been granted would be found valid and enforceable if challenged. Moreover, patents relating to particular products, uses, formulations, or processes do not preclude other manufacturers from employing alternative processes or from marketing alternative products or formulations that might successfully compete with our patented products. In addition, from time to time, competitors or other third parties assert claims that our activities infringe patents or other intellectual property rights held by them, or allege a third-party right of ownership in our existing intellectual property. Outside the United States, the adequacy and effectiveness of intellectual property protection for pharmaceuticals varies widely. Under the Trade-Related Aspects of Intellectual Property Agreement (TRIPs) administered by the World Trade Organization (WTO), over 140 countries have now agreed to provide non-discriminatory protection for most pharmaceutical inventions and to assure that adequate and effective rights are available to all patent owners. Because of TRIPs transition provisions, dispute resolution mechanisms, and substantive limitations, it is still too soon to assess when and how much, if at all, we will benefit commercially from these changes. When a product patent expires, the patent holder often loses effective market exclusivity for the product. This can result in a severe and rapid decline in sales of the formerly patented product, particularly in the United States. However, in some cases the innovator company may achieve exclusivity beyond the expiry of the product patent through manufacturing trade secrets; later-expiring patents on methods of use or formulations; or data-based exclusivity that may be available under pharmaceutical regulatory laws. These excerpts taken from the LLY 10-K filed Feb 29, 2008. Overview
Intellectual property protection is, in the aggregate, material
to our ability to successfully commercialize our life sciences
innovations. We own, have applied for, or are licensed under, a
large number of patents, both in the United States and in other
countries, relating to products, product uses, formulations, and
manufacturing processes. There is no assurance that the patents
we are seeking will be granted or that the patents we have been
granted would be found valid and enforceable if challenged.
Moreover, patents relating to particular products, uses,
formulations, or processes do not preclude other manufacturers
from employing alternative processes or from marketing
alternative products or formulations that might successfully
compete with our patented products. In addition, from time to
time, competitors or other third parties assert claims that our
activities infringe patents or other intellectual property
rights held by them, or allege a third-party right of ownership
in our existing intellectual property.
Outside the United States, the adequacy and effectiveness of
intellectual property protection for pharmaceuticals varies
widely. Under the Trade-Related Aspects of Intellectual Property
Agreement (TRIPs) administered by the World Trade Organization
(WTO), over 140 countries have now agreed to provide
non-discriminatory protection for most pharmaceutical inventions
and to assure that adequate and effective rights are available
to all patent owners. Because of TRIPs transition provisions,
dispute resolution mechanisms, and substantive limitations, it
is still too soon to assess when and how much, if at all, we
will benefit commercially from these changes.
When a product patent expires, the patent holder often loses
effective market exclusivity for the product. This can result in
a severe and rapid decline in sales of the formerly patented
product, particularly in the United States. However, in
some cases the innovator company may achieve exclusivity beyond
the expiry of the product patent through manufacturing trade
secrets; later-expiring patents on methods of use or
formulations; or data-based exclusivity that may be available
under pharmaceutical regulatory laws.
Overview Intellectual property protection is, in the aggregate, material to our ability to successfully commercialize our life sciences innovations. We own, have applied for, or are licensed under, a large number of patents, both in the United States and in other countries, relating to products, product uses, formulations, and manufacturing processes. There is no assurance that the patents we are seeking will be granted or that the patents we have been granted would be found valid and enforceable if challenged. Moreover, patents relating to particular products, uses, formulations, or processes do not preclude other manufacturers from employing alternative processes or from marketing alternative products or formulations that might successfully compete with our patented products. In addition, from time to time, competitors or other third parties assert claims that our activities infringe patents or other intellectual property rights held by them, or allege a third-party right of ownership in our existing intellectual property. Outside the United States, the adequacy and effectiveness of intellectual property protection for pharmaceuticals varies widely. Under the Trade-Related Aspects of Intellectual Property Agreement (TRIPs) administered by the World Trade Organization (WTO), over 140 countries have now agreed to provide non-discriminatory protection for most pharmaceutical inventions and to assure that adequate and effective rights are available to all patent owners. Because of TRIPs transition provisions, dispute resolution mechanisms, and substantive limitations, it is still too soon to assess when and how much, if at all, we will benefit commercially from these changes. When a product patent expires, the patent holder often loses effective market exclusivity for the product. This can result in a severe and rapid decline in sales of the formerly patented product, particularly in the United States. However, in some cases the innovator company may achieve exclusivity beyond the expiry of the product patent through manufacturing trade secrets; later-expiring patents on methods of use or formulations; or data-based exclusivity that may be available under pharmaceutical regulatory laws. This excerpt taken from the LLY 10-K filed Feb 28, 2007. Overview
Intellectual property protection is, in the aggregate, material
to our ability to successfully commercialize our life sciences
innovations. We own, have applied for, or are licensed under, a
large number of patents, both in the United States and in other
countries, relating to products, product uses, formulations, and
manufacturing processes. There is no assurance that the patents
we are seeking will be granted or that the patents we have been
granted would be found valid and enforceable if challenged.
Moreover, patents relating to particular products, uses,
formulations, or processes do not preclude other manufacturers
from employing alternative processes or from marketing
alternative products or formulations that might successfully
compete with our patented products. In addition, from time to
time, competitors or other third parties assert claims that our
activities infringe patents or other intellectual property
rights held by them. While there can be no assurance, we do not
believe that any such claims will have a material adverse effect
on our results of operations, liquidity, or financial position.
Outside the United States, the adequacy and effectiveness of
intellectual property protection for pharmaceuticals varies
widely. Under the Trade-Related Aspects of Intellectual Property
Agreement (TRIPs) administered by the World Trade Organization
(WTO), over 140 countries have now agreed to provide
non-discriminatory protection for most pharmaceutical inventions
and to assure that adequate and effective rights are available
to all patent owners. However, in many countries, this agreement
will not become fully effective for many years. It is still too
soon to assess when and how much, if at all, we will benefit
commercially from these changes.
When a product patent expires, the patent holder often loses
effective market exclusivity for the product. This can result in
a severe and rapid decline in sales of the formerly patented
product, particularly in the United States. However, in some
cases the innovator company may achieve exclusivity beyond the
expiry of the product patent through manufacturing trade
secrets; later-expiring patents on methods of use or
formulations; or data-based exclusivity that may be available
under pharmaceutical regulatory laws.
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