Houston Chronicle

Ruling means faster pace for generic biotech drugs

- By Sam Hananel

WASHINGTON — A unanimous Supreme Court is speeding up the time for generic biotech drugs to become available to the public in a ruling that means a loss of billions in sales to the makers of original versions.

The justices ruled Monday in favor of generic drugmaker Sandoz in its dispute with rival Amgen over a near-copy of Amgen’s cancer drug Neupogen.

The case involves biologics — drugs made from living cells instead of chemicals. The drugs have led to major advances in treating diseases, but come at steep prices.

A 2010 law allows cheaper generic versions known as biosimilar­s to be produced after a 12-year exclusive run for the original.

Writing for the court, Justice Clarence Thomas said the law does not require companies making biosimilar­s to wait an extra six months after gaining Food and Drug Administra­tion approval before selling the drugs.

The extra time can add billions of dollars in additional sales to the original drugmakers before biosimilar­s enter the market. In other rulings: • The Supreme Court is giving Microsoft Corp. another chance to stop a class action lawsuit filed by owners of the Xbox 360 video game system who claim the console has a design defect that scratches game discs.

The unanimous ruling said game owners could not use a procedural tactic to appeal a lower court decision denying them class action status.

Microsoft has sold millions of Xbox 360 consoles since 2005 and says only 0.4 percent of owners report disk scratching. The company says that damage in many cases was caused by consumer misuse and that the game contains warnings not to move the console while a disk is inside.

• The Supreme Court won’t hear an appeal from former Qwest Communicat­ions Internatio­nal CEO Joseph Nacchio seeking an $18 million tax refund on money he gained from illegal stock sales.

The justices left in place a lower court ruling that said the money was not tax deductible.

Nacchio was convicted in 2007 of selling $52 million in stock of Denverbase­d Qwest based on inside informatio­n. He was ordered to forfeit $44 million and to pay a $19 million fine. He also was sentenced to five years and 10 months in prison.

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