EU Announces Anti-trust Probe into a Cephalon – Teva Deal Concerning Generic Provigil

The European Union’s antitrust watchdog said Thursday it had launched an ex officio probe of U.S. pharmaceutical giant Cephalon Inc.’s alleged attempt to pay Teva Pharmaceutical Industries Ltd. to keep Modafinil, a generic version of narcolepsy drug Provigil off the market.

Provigil is a stay-awake drug that is used to treat the sleeping sickness narcolepsy and also became popular among night-workers such as truckers and has been tested for military use. It enables users to stay awake for days. (I couldn’t find any information as to whether it works during lectures).

The probe concerns a deal struck between the Cephalon and Teva that “may have had the object or effect of hindering the entry of generic Modafinil” into the European Economic Area.

The case arises from a December 2005 deal to settle patent infringement disputes in Britain and the United States, which saw Teva undertake not to sell its generic Modafinil products in the European single market before October 2012. The probe does not indicate “a definitive finding of an infringement. There is no set deadline for an outcome. Various side deals are also under investigation by US antitrust authorities.

Generic drugs are far cheaper, typicaly costing about 40 percent less than the first, patented drug. The EU has been probing the sector repeatedly since a report showed that the number of new drugs reaching the market annually had dropped by over a third since 2000 and that people were being deprived of innovative, affordable and safe medicine.

What is clear from this probe is that whilst supplementary protection certificates (SPC) are available in Europe to prolong patent protection for the first patent for a new drug, the European Union sees generic drug availability as in the public interest. The law tries to strike a balance and cartels that upset this delicate balance are unacceptable.

Categories: drugs, Patents, pharmaceuticals, Teva

4 replies

  1. From what I understand, Teva was offered “reverse payments” in the above case.
    I think these payments are legal in the U.S., I guess we can conclude they are not in the E.U.?

  2. I keep predicting the imminent demise of pay-for-delay patent litigation settlements in the US, especially since the FTC has had it in for reverse-payment deals for quite some time. But somehow they continue to survive. They most recently received a boon from Chief Justice Roberts’s pro-big-business U.S. Supreme Court, which refused to grant cert on the Bayer case. Maybe involvement of the EU (and its regulators’ investigation of the Cephalon/Teva deal) will add weight to the FTC’s position and pressure the U.S. courts or Congress into taking action against pay-for-delay arrangements.

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