Healthy Skepticism Library item: 19174

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Publication type: news

White A, Bodoni S
Bayer Among Drug Firms in EU Probe of Patent Deals
Bloomberg Businessweek 2011 Jan 17
http://www.businessweek.com/news/2011-01-17/bayer-among-drug-firms-in-eu-probe-of-patent-deals.html

Notes:

(Updates with Roche response starting in ninth paragraph.)

Full text:

Bayer AG was among drug firms told by European Union antitrust officials to submit details of patent-settlement deals that may be used to delay the sale of generic versions of medicines.

“A selected number” of unidentified companies must hand in a copy of all agreements from last year “relevant” to the 27-nation EU region, the European Commission said in a statement today. Bayer, Europe’s largest drug and chemical maker, received a request, said Rolf Ackermann, a spokesman for the Leverkusen, Germany-based company. He declined to comment further.

Patent settlements “are an area of particular concern because they may delay the market entry of generic medicines,” Joaquin Almunia, the EU’s competition commissioner, said in the statement.

Antitrust regulators on both sides of the Atlantic are focusing on how settlements between companies that make branded medicines and generic producers might harm consumers. AstraZeneca Plc, the U.K.’s second-biggest drugmaker, and Nycomed A/S said last month they were raided by EU officials as part of a probe into possible anti-competitive practices.

The commission, the EU’s executive arm, said today it will use the information it gleans from companies for a report in the first half of 2011. The move follows an earlier study of drug- industry settlements from mid-2008 to the end of last year.

Ulcer Drug

“At this point in time, we’re not aware of any request from the commission on this matter,” said Sarah Lindgreen, a spokeswoman for AstraZeneca, in an e-mail. AstraZeneca has said the EU antitrust raids at its offices concerned the ulcer drug Nexium.

Drug developers use a variety of techniques to delay generics, the EU said in a 2009 report.

“This is still a hot topic with ongoing cases,” Lesley Ainsworth, a partner in London with law firm Hogan Lovells, said in an e-mail. “Continuing the monitoring will in itself tend to discourage the sorts of reverse-payment deals that the EC and U.S. authorities are concerned about.”

Roche Holding AG “was asked to submit information and copies of relevant settlement agreements,” as part of the EU’s pharmaceutical sector inquiry, Annette Walz, a spokeswoman for the Basel, Switzerland-based company, said in an e-mail, referring to an industry probe started in 2008. “We have provided all information requested in time” to the commission.

Walz said she was unable to say if the company has been asked to give further details.

Appeal Pending

AstraZeneca has an appeal pending at the EU’s top court against a 2005 decision by the commission to fine it for flouting antitrust rules to keep generic competitors off the market.

Nycomed hasn’t received a request as part of the information-gathering process announced by the commission today, said Beatrix Benz, a spokeswoman for the Zurich-based company.

Yossi Koren, a spokesman for Teva Pharmaceutical Industries Ltd., the world’s largest maker of generic drugs, didn’t immediately answer a call to his office or respond to an e-mail request for comment.