Lilly sues Teva over Evista
Recalling that Ariad sued Lilly over Evista (with Ariad getting its patent through the Bayh-Dole Act), one now has Lilly suing Teva over Evista under provisions of the Hatch-Waxman Act.
From the Indianapolis Star:
Eli Lilly and Co. sued an Israeli generic drug maker in federal court in Indianapolis to try to prevent it from selling a generic version of the Lilly osteoporosis drug Evista.
Lilly accused Teva Pharmaceutical Industries Ltd. of patent infringement for trying to put its drug on the U.S. market. Lilly has several patents on the active ingredient in Evista, with the latest expiring in 2017. Teva's application to put a generic version of Evista on the market is a typical first step by a generic company to challenge a patent on a brand-name medication.
Evista was Lilly's fourth-best-selling drug last year, with sales of $1 billion.
***
Separately, Teva also received tentative ap-
proval for its ANDA to market its generic version
of Eli Lilly’s osteoporosis treatment Evista
(raloxifene HCl) 60-mg tablets.
The brand product had annual sales of ap-
proximately $691 million in the U.S. for the
twelve months ending Dec. 31, 2007, based on
IMS sales data.
Teva is involved in patent lawsuit with Eli
Lilly in the U.S. District Court for the Southern
District of Indiana over the drug. In the suit, Lilly
alleges Teva’s product will infringe on four
patents covering Evista — the ’050, ’968, ’049
and ’086 patents.
***UPDATE
from the Indianapolis Business Journal:
The most aggressive generic company is Israel-based Teva Pharmaceutical Industries Ltd., which is in the process of acquiring Barr. Lilly is engaged with Teva in fights over Alimta, another cancer drug Gemzar and an osteoporosis drug Evista.
Teva has made a practice of launching generic copies of a drug even before it has won a court victory.
These moves, called “at-risk launches” because Teva can pay up to triple damages if it fails to break a patent, have forced some pharma companies into early settlements. For example, Sanofi-Aventis SA decided to settle with Teva out of court over a challenge to its allergy pills Allegra-D and Nascort. In exchange for royalty payments, Teva agreed to wait until June 2011 before selling generic copies.
According to a count by Bloomberg News, Teva has successfully pulled off 13 at-risk launches since 2004.
Teva and Lilly could face off in this way next year over Evista. Teva already won tentative approval from the FDA to launch a generic version of Evista, whose patents begin to expire in 2012. Evista generated sales of $1.1 billion last year.
That launch has been stayed until March 9—the same day Lilly and Teva are scheduled to start a court trial over the patent.
Neither company is commenting on the case. But some analysts are watching it closely.
Goldman Sachs & Co. analyst Jami Rubin cites the potential patent litigation over Evista as one of two key risk factors facing Lilly, according to a Nov. 6 research report.
Boris, the Citigroup analyst, devoted an entire research note to Lilly’s patent risks.
“We rate Lilly High Risk, largely because of a period of considerable generic risk in 2011-13 that is mitigated in part by a solid drug pipeline,” he wrote Nov. 16.
See also Barron's
From the Indianapolis Star:
Eli Lilly and Co. sued an Israeli generic drug maker in federal court in Indianapolis to try to prevent it from selling a generic version of the Lilly osteoporosis drug Evista.
Lilly accused Teva Pharmaceutical Industries Ltd. of patent infringement for trying to put its drug on the U.S. market. Lilly has several patents on the active ingredient in Evista, with the latest expiring in 2017. Teva's application to put a generic version of Evista on the market is a typical first step by a generic company to challenge a patent on a brand-name medication.
Evista was Lilly's fourth-best-selling drug last year, with sales of $1 billion.
***
Separately, Teva also received tentative ap-
proval for its ANDA to market its generic version
of Eli Lilly’s osteoporosis treatment Evista
(raloxifene HCl) 60-mg tablets.
The brand product had annual sales of ap-
proximately $691 million in the U.S. for the
twelve months ending Dec. 31, 2007, based on
IMS sales data.
Teva is involved in patent lawsuit with Eli
Lilly in the U.S. District Court for the Southern
District of Indiana over the drug. In the suit, Lilly
alleges Teva’s product will infringe on four
patents covering Evista — the ’050, ’968, ’049
and ’086 patents.
***UPDATE
from the Indianapolis Business Journal:
The most aggressive generic company is Israel-based Teva Pharmaceutical Industries Ltd., which is in the process of acquiring Barr. Lilly is engaged with Teva in fights over Alimta, another cancer drug Gemzar and an osteoporosis drug Evista.
Teva has made a practice of launching generic copies of a drug even before it has won a court victory.
These moves, called “at-risk launches” because Teva can pay up to triple damages if it fails to break a patent, have forced some pharma companies into early settlements. For example, Sanofi-Aventis SA decided to settle with Teva out of court over a challenge to its allergy pills Allegra-D and Nascort. In exchange for royalty payments, Teva agreed to wait until June 2011 before selling generic copies.
According to a count by Bloomberg News, Teva has successfully pulled off 13 at-risk launches since 2004.
Teva and Lilly could face off in this way next year over Evista. Teva already won tentative approval from the FDA to launch a generic version of Evista, whose patents begin to expire in 2012. Evista generated sales of $1.1 billion last year.
That launch has been stayed until March 9—the same day Lilly and Teva are scheduled to start a court trial over the patent.
Neither company is commenting on the case. But some analysts are watching it closely.
Goldman Sachs & Co. analyst Jami Rubin cites the potential patent litigation over Evista as one of two key risk factors facing Lilly, according to a Nov. 6 research report.
Boris, the Citigroup analyst, devoted an entire research note to Lilly’s patent risks.
“We rate Lilly High Risk, largely because of a period of considerable generic risk in 2011-13 that is mitigated in part by a solid drug pipeline,” he wrote Nov. 16.
See also Barron's
posted by Lawrence B. Ebert at 8:15 PM
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