September 2012 Posts

India Flexes Its Muscles against Big Pharma

India Flexes Its Muscles against Big Pharma

Mark Crawford

Outsourcing to India is one thing; getting patent protection is another. Big pharma is entrenched in several high-profile cases in the Indian court system, including:

  • Bayer’s challenge to a decision by the patent office that forces it to license its drug, Nexavar, to an Indian firm
  • The patent office revoked Roche’s patent for Valcyte, which the company is appealing
  • India rejected two patent applications by Gilead for its HIV drug Viread; the case is under appeal
  • In 2006 India refused to grant Novartis a patent for its leukemia drug Glivec—Novartis is now challenging that decision in court

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Product Liability: How Exposed Are You?

Mark Crawford

According to regulatory compliance expert James Kolka, management too often ignores the legal and financial threats posed by product liability lawsuits.

“Management often believes that compliance with FDA’s Quality System Regulation (QSR) protects the company from product liability exposure,” says Kolka. “Consequently, the task of product liability management is invisible and not audited. It seems to materialize when there is a lawsuit and a mad scramble to find who is or should have been responsible.” (more…)