Merck & Co. and TEVA, Ltd. Face Legal Issues

This past week both Merck and Teva Pharmaceutical Industries, Ltd. faced legal complications concerning select drug products. Merck received a subpoena from U.S. regulators regarding marketing techniques of three drugs: Temodar, PegIntron, and Intron A in addition to dealing with problems from the Enviornmental Protection Agency. Similarly, TEVA was sued by GlaxoSmithKline and Pfizer for patent infringement on the HIV drug Epzicon. Continue reading for source articles and more details.

[FirstWord] Merck & Co. disclosed Monday in an SEC filing that it received a subpoena from the US Department of Justice as part of a “federal health care investigation under criminal statutes” into the company’s marketing of three drugs acquired in its merger with Schering-Plough. Merck spokesman Ron Rogers said the drugmaker is cooperating with the probe.

Specifically, the agency requested information from January 2004 to the present on the brain cancer drug Temodar (temozolomide), hepatitis C therapy PegIntron (pegylated interferon alfa-2b), and Intron A (interferon alfa-2b), which is approved for the treatment of certain cancers and other conditions. Sales of the drugs totalled $481 million, $319 million and $96 million, respectively, in the first six months of this year.

Separately, Merck revealed that the justice department and Environmental Protection Agency (EPA) are pursuing civil penalties of more than $2 million against the company for alleged violations of environmental regulations at two Pennsylvania facilities. The action results from the EPA’s inspection of the West Point and Riverside sites in 2006, and Merck’s submission of information to the agency. However, the drugmaker indicated that it believes it has meritorious defences against the allegations.

In addition, Merck said that it agreed to pay a $260 000 fine and sign a consent decree to resolve alleged environmental violations at its Las Piedras facility in Puerto Rico in connection with an EPA inspection in 2008.

[Bloomberg] Teva Pharmaceutical Industries Ltd. (TEVA), the world’s largest generic-drug maker, was sued by a joint venture of GlaxoSmithKline Plc (GSK) and Pfizer Inc. (PFE) for infringing a U.S. patent for the HIV drug Epzicom.

Teva has applied to the U.S. Food and Drug Administration for permission to sell generic Epzicom tablets in violation of a 2002 patent, lawyers for ViiV Healthcare said in an Aug. 5 complaint filed in federal court in Wilmington, Delaware.

Teva’s FDA submission “constitutes infringement” and “ViiV will be irreparably harmed” by the low-cost version of Epzicom if it’s sold before the patent expires in 2016, according to court papers.

GlaxoSmithKline, based in Brentford, England, and New York- based Pfizer announced the ViiV joint venture to combat HIV in 2009. The lawsuit seeks a permanent injunction to block Israel- based Teva’s U.S. sales of the drug and damages if the generic medicine is sold.

ViiV has facilities in Brentford and at Research Triangle Park in North Carolina, according to court papers.

Teva spokeswoman Denise Bradley declined to comment on the suit

The case is ViiV Healthcare UK Ltd. v. Teva Pharmaceuticals USA Inc., U.S. District Court for the District of Delaware (Wilmington).

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