March 28, 2024

European Officials Say Drug Makers Paid to Delay Generic Version

The case focuses on monthly payments that a Netherlands-based subsidiary of the American company Johnson Johnson made to Sandoz, a unit of the Swiss company Novartis. While the companies have said the payments were legitimate, the European Union’s antitrust chief said Thursday that the money probably changed hands to keep lower-cost versions of a drug called fentanyl off the market in the Netherlands.

European authorities are “determined to fight undue delays in the market entry of generic medicines,” Joaquín Almunia, the E.U. competition commissioner, said in a statement Thursday.

His office would not disclose the amount of money the Johnson Johnson unit in the Netherlands, Janssen-Cilag, paid to Sandoz. Nor would officials indicate whether the investigation would go beyond the Netherlands.

Fentanyl is widely used in Europe and the United States, typically paid for by government-provided health plans or, in many cases in the United States, by private insurance. Although the pricing of such drugs is usually negotiated behind closed doors, generic versions are typically much cheaper.

Mr. Almunia warned pharmaceutical companies against practices that raised costs for European governments, squeezed by austerity and an economic slowdown, which must buy medicines for state supported health care plans. It is “important to make sure that pharmaceutical companies do not free-ride our welfare state and health insurance systems, especially in this period of constraints on public spending,” he said.

A goal of European authorities has been to increase patient access to less costly medicines as name-brand drug patents worth tens of billions of euros expire. The end of a drug’s patent protection — typically up to 25 years in Europe — can hurt a pharmaceutical company’s bottom line, but benefits governments and private insurers by lowering their costs.

Patent expirations also open opportunities for generic competitors, which is why in some cases drug makers have been accused of paying generic competitors to delay bringing their products to market.

A preliminary investigation by Mr. Almunia’s office found that Janssen-Cilag made the payments to stop Novartis from selling generic fentanyl in the Netherlands for more than a year, from July 2005 until December 2006. That kept prices artificially high, according to the European Commission, the Union’s administrative body that enforces antitrust law.

Both companies will have the chance to formally respond to the accusation.

The commission, which first announced the inquiry in October 2011, can fine companies up to 10 percent of their annual global sales for antitrust abuses. Penalties are typically lower, though, because officials usually base fines on sales of the main product involved in the case, and then increase the amount based on the duration of the offense and other factors.

Fentanyl is a painkiller that is stronger than morphine, according to the commission. In skin-patch form, which is the type at issue in the investigation, the drug is used to relieve moderate to severe pain that lasts for a long time, does not go away and cannot be treated with other medications, according to the Web site of the U.S. National Library of Medicine. In lozenge form, fentanyl is used to treat sudden episodes of pain, known as breakthrough pain, in cancer patients who are already taking other painkillers, according to the Web site of Cephalon, a company owned by Teva of Israel, which markets the drug under the Actiq brand.

A spokesman for the Johnson Johnson subsidiary said in a statement that the company had not acted improperly. “Janssen continues to believe that these arrangements were legitimate,” the spokesman, Stefan Gijssels, said Thursday. “Janssen supports a sustainable health care system, where patients have access to both innovative and generic drugs,” he said.

Sandoz said in a statement that it and “Novartis operate to the highest of standards and take the position of the commission seriously.” It also indicated that it and Novartis would seek to rebut the accusations made by the commission by using their “rights of defense as provided for in the process.”

The case is the latest in a series of actions by authorities in Europe and the United States to crack down on so-called pay-to-delay tactics by pharmaceutical companies, and comes at a time when the biggest name-brand drug makers are losing billions of dollars in sales to generic competition as best-selling drugs lose their patent protection.

In the United States, the Supreme Court is scheduled in March to take up the issue of whether such deals in the pharmaceutical sector violate antitrust law.

Article source: http://www.nytimes.com/2013/02/01/business/global/eu-says-drug-makers-paid-to-delay-generic-version.html?partner=rss&emc=rss

U.S. Suit Sees Manipulation of Oil Trades

But on Tuesday, federal commodities regulators filed a civil lawsuit against two obscure traders in Australia and California and three American and international firms.

The suit says that in early 2008 they tried to hoard nearly two-thirds of the available supply of a crucial American market for crude oil, then abruptly dumped it and improperly pocketed $50 million.

The regulators from the Commodity Futures Trading Commission would not say whether the agency was conducting any other investigations into oil speculation. With oil prices climbing again this year, President Obama has asked Attorney General Eric H. Holder Jr. to set up a working group to look into fraud in oil and gas markets and “safeguard against unlawful consumer harm.”

In the case filed Tuesday, the defendants — James T. Dyer of Australia, Nicholas J. Wildgoose of Rancho Santa Fe, Calif., and three related companies, Parnon Energy of California, Arcadia Petroleum of Britain and Arcadia Energy, a Swiss company — have told regulators they deny they manipulated the market.

If the United States proves the claims, the defendants may give up $50 million in profits that were believed to be made as a result of the manipulation and also pay a penalty of up to $150 million.

The commodities agency says the case involves a complex scheme that relied on the close relationship between physical oil prices and the prices of financial futures, which move in parallel.

In a matter of a few weeks in January 2008, the defendants built up large positions in the oil futures market on exchanges in New York and London, according to the suit, filed in the Federal Court in the Southern District of New York.

At the same time, they bought millions of barrels of physical crude oil at Cushing, Okla., one of the main delivery sites for West Texas Intermediate, the benchmark for American oil, the suit says. They bought the oil even though they had no commercial need for it, giving the market the impression of a shortage, the complaint says.

At one point they had such a dominant position that they owned about 4.6 million barrels of crude oil, estimating that this represented two-thirds of the seven million barrels of excess oil then available at Cushing, according to lawsuits.

This type of oil is also the main driver of prices of the futures contracts, and their actions caused futures prices to rise, the authorities say. “They wanted to lull market participants into believing that supply would remain tight,” the agency said. “They knew that as long as the market believed that supply was tight and getting even tighter, there would be upward pressure on the prices of W.T.I. for February delivery relative to March delivery, which was their goal.”

The traders in mid-January cashed out their futures position, and then a few days later began to bet on a decline in oil futures, with Mr. Wildgoose remarking in an e-mail about the “inevitable puking” of their position on an unsuspecting market, the federal lawsuit says.

In one day, Jan. 25, they then dumped most of their holdings of West Texas Intermediate oil, and profited by the drop in futures.

The traders repeated the buying and selling in March 2008, and were preparing to do it again in April but stopped when investigators contacted them for information, the suit says.

Between January and April, average gas prices rose roughly to $3.50 a gallon, from $3. It was not until later in 2008, after the defendants had ceased their reported actions, that oil prices soared higher — reaching $145 that July. By the end of the year, prices had fallen to about $44. The Texas oil is now around $100.

Many other factors were at work, including tight oil supplies in the Middle East and fears that a growing global economy would consume more oil. Yet the enforcement action by the commodities regulator was the first credible evidence that a small group of traders also played a role in manipulating prices.

“This will  help to satisfy the desire to find a culprit and throw them under the wheels of justice,” said Michael Lynch, an oil market specialist at Strategic Energy and Economic Research, a consulting firm.

Calls to Arcadia Petroleum in London were not immediately returned. A person who answered the phone at Arcadia Energy in Switzerland said that he was unaware of the complaints and that Mr. Dyer and Mr. Wildgoose were on vacation and unavailable for comment.

In the last few years, the commission has settled a handful of cases of manipulation in the natural gas market.

In 2007, it settled charges for $1 million against the Marathon Petroleum Company for trying to manipulate West Texas Intermediate crude oil in 2003.

The agency brought an action similar to its latest case in 2008, asserting that Optiver Holding, a proprietary trading fund based in the Netherlands with a Chicago affiliate, used a trading program in 2007 to issue orders to manipulate the crude oil market. The case is pending. It involved claims of manipulation of futures contracts for light sweet crude, New York Harbor heating oil and New York Harbor gasoline.

Clifford Krauss contributed reporting.

Article source: http://www.nytimes.com/2011/05/25/business/global/25oil.html?partner=rss&emc=rss