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Limited Launch Of Teva’s Generic Evista Rejected By Court

This article was originally published in The Pink Sheet Daily

Executive Summary

Preliminary injunction blocks Teva’s launch; firm had planned to sell one million bottles in eight-month period.

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Legal Briefs: September Is a Mixed Bag For Brand Pharma Patents

Former InterMune CEO convicted of wire fraud for misleading press release: A California jury convicted W. Scott Harkonen of wire fraud for the creation and dissemination of false and misleading information about the efficacy of InterMune's Actimmune (interferon gamma-1b) as a treatment for idiopathic pulmonary fibrosis. The information was included in a press release the company issued in 2002 announcing the results of a clinical trial. The jury acquitted him of a misbranding charge of promoting the drug for an unapproved use. A grand jury indicted Harkonen for fraudulent promotion in 2008, two years after InterMune entered a deferred prosecution agreement with the Department of Justice and agreed to pay $36.9 million to resolve criminal charges and civil liabilities for fraudulent promotion (1"The Pink Sheet" DAILY, March 18, 2008). The government has prosecuted pharma execs in the past but has largely been unsuccessful in winning verdicts against them. Eight executives of TAP were acquitted in a 2001 case over pricing and marketing of the prostate cancer drug Lupron (leuprolide) and several Serono executives were acquitted in a case over marketing of the AIDS drug Serostim (somatropin) (2"The Pink Sheet," March 31, 2008)

Legal Briefs: September Is a Mixed Bag For Brand Pharma Patents

Former InterMune CEO convicted of wire fraud for misleading press release: A California jury convicted W. Scott Harkonen of wire fraud for the creation and dissemination of false and misleading information about the efficacy of InterMune's Actimmune (interferon gamma-1b) as a treatment for idiopathic pulmonary fibrosis. The information was included in a press release the company issued in 2002 announcing the results of a clinical trial. The jury acquitted him of a misbranding charge of promoting the drug for an unapproved use. A grand jury indicted Harkonen for fraudulent promotion in 2008, two years after InterMune entered a deferred prosecution agreement with the Department of Justice and agreed to pay $36.9 million to resolve criminal charges and civil liabilities for fraudulent promotion (1"The Pink Sheet" DAILY, March 18, 2008). The government has prosecuted pharma execs in the past but has largely been unsuccessful in winning verdicts against them. Eight executives of TAP were acquitted in a 2001 case over pricing and marketing of the prostate cancer drug Lupron (leuprolide) and several Serono executives were acquitted in a case over marketing of the AIDS drug Serostim (somatropin) (2"The Pink Sheet," March 31, 2008)

Teva Settlements Stick To Date of Entry Even As Legislative Debate Continues

Teva is taking a cautious approach in its patent settlements with brand firms - inking deals that meet the strict standards of pending legislation even as the bills are still under debate

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