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This excerpt taken from the LLY 10-K filed Feb 22, 2010. Business
Development
These excerpts taken from the LLY 10-K filed Oct 21, 2008. Business
Development
Legal,
Regulatory, and Other Matters
In October, the United States Supreme Court denied the petitions
for certiorari that were filed by Teva Pharmaceuticals and
Dr. Reddy’s Laboratories, bringing to an end the two
companies’ challenges to the validity of Lilly’s
U.S. Zyprexa patent.
In June, we received notice of two court rulings by the Canadian
Federal Court and the German Patent Court that permit the entry
of generic olanzapine (Zyprexa) by competitors into the Canadian
and German markets. Generic olanzapine is now available for sale
by competitors in Canada and Germany.
Table of Contents
We have reached agreements with claimants’ attorneys
involved in U.S. Zyprexa product liability litigation to
settle a total of approximately 31,200 claims against us
relating to the medication. Approximately 1,235 claims remain.
As a result of our product liability exposures, since the
beginning of 2005, we have recorded aggregate net pretax charges
of $1.61 billion for Zyprexa product liability matters.
In March 2004, we were notified by the U.S. Attorney’s
office for the Eastern District of Pennsylvania (EDPA) that it
had commenced an investigation relating to our
U.S. marketing and promotional practices for Zyprexa,
Prozac®,
and Prozac
Weeklytm.
In November 2007, we received a grand jury subpoena from the
EDPA requesting documents related to Zyprexa.
In the United States, the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA) continues to
effectively provide a prescription drug benefit under the
Medicare program (known as Medicare Part D). Various
measures have been discussed
and/or
passed in both the U.S. House of Representatives and
U.S. Senate that would impose additional pricing pressures
on our products, including proposals to legalize the importation
of prescription drugs and either allow, or require, the
Secretary of Health and Human Services to negotiate drug prices
within Medicare Part D directly with pharmaceutical
manufacturers. Additionally, various proposals have been
introduced that would increase the rebates we pay on sales to
Medicaid patients. We expect pricing pressures at the federal
and state levels to continue.
In 2007, the Centers for Medicare and Medicaid Services released
a final rule seeking to implement sections of the Deficit
Reduction Act of 2005. This rule relates to the Medicaid program
and among other things, sets out a methodology for the
calculation and use of Average Manufacturer Price and Best Price
for pharmaceuticals. We have implemented the final rule, which
has the effect of reducing net selling prices for Medicaid
sales; however, we do not expect the impact to be material to
our consolidated results of operations, liquidity, or financial
position.
International operations also are generally subject to extensive
price and market regulations, and there are many proposals for
additional cost-containment measures, including proposals that
would directly or indirectly impose additional price controls or
reduce the value of our intellectual property protection.
Business Development
Legal, Regulatory, and Other Matters In October, the United States Supreme Court denied the petitions for certiorari that were filed by Teva Pharmaceuticals and Dr. Reddy’s Laboratories, bringing to an end the two companies’ challenges to the validity of Lilly’s U.S. Zyprexa patent. In June, we received notice of two court rulings by the Canadian Federal Court and the German Patent Court that permit the entry of generic olanzapine (Zyprexa) by competitors into the Canadian and German markets. Generic olanzapine is now available for sale by competitors in Canada and Germany.
Table of ContentsWe have reached agreements with claimants’ attorneys involved in U.S. Zyprexa product liability litigation to settle a total of approximately 31,200 claims against us relating to the medication. Approximately 1,235 claims remain. As a result of our product liability exposures, since the beginning of 2005, we have recorded aggregate net pretax charges of $1.61 billion for Zyprexa product liability matters. In March 2004, we were notified by the U.S. Attorney’s office for the Eastern District of Pennsylvania (EDPA) that it had commenced an investigation relating to our U.S. marketing and promotional practices for Zyprexa, Prozac®, and Prozac Weeklytm. In November 2007, we received a grand jury subpoena from the EDPA requesting documents related to Zyprexa. In the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) continues to effectively provide a prescription drug benefit under the Medicare program (known as Medicare Part D). Various measures have been discussed and/or passed in both the U.S. House of Representatives and U.S. Senate that would impose additional pricing pressures on our products, including proposals to legalize the importation of prescription drugs and either allow, or require, the Secretary of Health and Human Services to negotiate drug prices within Medicare Part D directly with pharmaceutical manufacturers. Additionally, various proposals have been introduced that would increase the rebates we pay on sales to Medicaid patients. We expect pricing pressures at the federal and state levels to continue. In 2007, the Centers for Medicare and Medicaid Services released a final rule seeking to implement sections of the Deficit Reduction Act of 2005. This rule relates to the Medicaid program and among other things, sets out a methodology for the calculation and use of Average Manufacturer Price and Best Price for pharmaceuticals. We have implemented the final rule, which has the effect of reducing net selling prices for Medicaid sales; however, we do not expect the impact to be material to our consolidated results of operations, liquidity, or financial position. International operations also are generally subject to extensive price and market regulations, and there are many proposals for additional cost-containment measures, including proposals that would directly or indirectly impose additional price controls or reduce the value of our intellectual property protection. These excerpts taken from the LLY 10-K filed Feb 29, 2008. Business
Development
Legal,
Regulatory, and Other Matters
In October, the United States Supreme Court denied the petitions
for certiorari that were filed by Teva Pharmaceuticals and
Dr. Reddy’s Laboratories, bringing to an end the two
companies’ challenges to the validity of Lilly’s
U.S. Zyprexa patent.
In June, we received notice of two court rulings by the Canadian
Federal Court and the German Patent Court that permit the entry
of generic olanzapine (Zyprexa) by competitors into the Canadian
and German markets. Generic olanzapine is now available for sale
by competitors in Canada and Germany.
We have reached agreements with claimants’ attorneys
involved in U.S. Zyprexa product liability litigation to
settle a total of approximately 31,200 claims against us
relating to the medication. Approximately 1,235 claims remain.
As a result of our product liability exposures, since the
beginning of 2005, we have recorded aggregate net pretax charges
of $1.61 billion for Zyprexa product liability matters.
In March 2004, we were notified by the U.S. Attorney’s
office for the Eastern District of Pennsylvania (EDPA) that it
had commenced an investigation relating to our
U.S. marketing and promotional practices for Zyprexa,
Prozac®,
and Prozac
Weeklytm.
In November 2007, we received a grand jury subpoena from the
EDPA requesting documents related to Zyprexa.
In the United States, the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA) continues to
effectively provide a prescription drug benefit under the
Medicare program (known as Medicare Part D). Various
measures have been discussed
and/or
passed in both the U.S. House of Representatives and
U.S. Senate that would impose additional pricing pressures
on our products, including proposals to legalize the importation
of prescription drugs and either allow, or require, the
Secretary of Health and Human Services to negotiate drug prices
within Medicare Part D directly with pharmaceutical
manufacturers. Additionally, various proposals have been
introduced that would increase the rebates we pay on sales to
Medicaid patients. We expect pricing pressures at the federal
and state levels to continue.
In 2007, the Centers for Medicare and Medicaid Services released
a final rule seeking to implement sections of the Deficit
Reduction Act of 2005. This rule relates to the Medicaid program
and among other things, sets out a methodology for the
calculation and use of Average Manufacturer Price and Best Price
for pharmaceuticals. We have implemented the final rule, which
has the effect of reducing net selling prices for Medicaid
sales; however, we do not expect the impact to be material to
our consolidated results of operations, liquidity, or financial
position.
International operations also are generally subject to extensive
price and market regulations, and there are many proposals for
additional cost-containment measures, including proposals that
would directly or indirectly impose additional price controls or
reduce the value of our intellectual property protection.
Business Development
Legal, Regulatory, and Other Matters In October, the United States Supreme Court denied the petitions for certiorari that were filed by Teva Pharmaceuticals and Dr. Reddy’s Laboratories, bringing to an end the two companies’ challenges to the validity of Lilly’s U.S. Zyprexa patent. In June, we received notice of two court rulings by the Canadian Federal Court and the German Patent Court that permit the entry of generic olanzapine (Zyprexa) by competitors into the Canadian and German markets. Generic olanzapine is now available for sale by competitors in Canada and Germany. We have reached agreements with claimants’ attorneys involved in U.S. Zyprexa product liability litigation to settle a total of approximately 31,200 claims against us relating to the medication. Approximately 1,235 claims remain. As a result of our product liability exposures, since the beginning of 2005, we have recorded aggregate net pretax charges of $1.61 billion for Zyprexa product liability matters.
In March 2004, we were notified by the U.S. Attorney’s office for the Eastern District of Pennsylvania (EDPA) that it had commenced an investigation relating to our U.S. marketing and promotional practices for Zyprexa, Prozac®, and Prozac Weeklytm. In November 2007, we received a grand jury subpoena from the EDPA requesting documents related to Zyprexa. In the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) continues to effectively provide a prescription drug benefit under the Medicare program (known as Medicare Part D). Various measures have been discussed and/or passed in both the U.S. House of Representatives and U.S. Senate that would impose additional pricing pressures on our products, including proposals to legalize the importation of prescription drugs and either allow, or require, the Secretary of Health and Human Services to negotiate drug prices within Medicare Part D directly with pharmaceutical manufacturers. Additionally, various proposals have been introduced that would increase the rebates we pay on sales to Medicaid patients. We expect pricing pressures at the federal and state levels to continue. In 2007, the Centers for Medicare and Medicaid Services released a final rule seeking to implement sections of the Deficit Reduction Act of 2005. This rule relates to the Medicaid program and among other things, sets out a methodology for the calculation and use of Average Manufacturer Price and Best Price for pharmaceuticals. We have implemented the final rule, which has the effect of reducing net selling prices for Medicaid sales; however, we do not expect the impact to be material to our consolidated results of operations, liquidity, or financial position. International operations also are generally subject to extensive price and market regulations, and there are many proposals for additional cost-containment measures, including proposals that would directly or indirectly impose additional price controls or reduce the value of our intellectual property protection. | EXCERPTS ON THIS PAGE:
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