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Teva Pharmaceutical Industries is opening another front in its battle to protect its biggest source of profit - the drug Copaxone, one of the few that the Israeli drug company has developed in-house. As last week closed, Teva sued Mylan, alleging that Mylan's application to sell a copycat version of the multiple sclerosis drug Copaxone was infringing on certain patents. It also sued the Indian company Natco over similar claims.

Teva says Mylan's application relates to Teva's U.S. patents, which cover the chemical composition of the blockbuster drug, pharmaceutical compositions containing it, and methods of using it. The patents are listed in the U.S. Food and Drug Administration's Orange Book and extend through May 24, 2014, Teva said in a statement.

Mylan signaled its intent to sell generic Copaxone in June 2008, when it announced a supply deal with India's Natco Pharma.

Teva's lawsuit comes exactly one month after U.S. regulators accepted an application by Mylan and Natco for review. The application is for permission to market a generic version of Copaxone, scientifically known as glatiramer acetate. Their application challenges the patent protecting Copaxone.

Under American law, Teva's lawsuit, which it filed in the U.S. District Court for the Southern District of New York, would restrict approval of Mylan's generic version of the drug for up to 30 months - April 2012 - or until a court ruling in favor of Mylan, whichever comes first.

Copaxone is a blockbuster drug for Teva, which ordinarily specializes in generic drugs - meaning, copycat versions of drugs made originally by other companies, which battle just as fiercely to protect their own patents. Copaxone is responsible for roughly 20% to 25% of Teva's net profit, a proportion expected to increase after April 2010, which is when Teva will stop paying royalties to Sanofi-Aventis.

At present Teva pays the French drug company a quarter of its Copaxone sales figures in North America as royalties, because the two companies allied on marketing the drug in that region back in 1996. They share sales costs and gross profit for Copaxone in equal parts.

In April 2008 Teva and Sanofi-Aventis entered into a new agreement that gives Teva sole responsibility for marketing Copaxone in North America. But it agreed to continue to pay royalties to Sanofi-Aventis for two years.

Copaxone is the leading therapy for multiple sclerosis in the United States. Its share of the market is 32%, while rival drug Avonex made by Biogen Idec commands a 30% market share. During the second quarter of 2009, Teva's sales of Copaxone jumped 32% against the same period of 2008, to $438 million, in no small part because Teva raised its price three times in the last year.

Global sales of Copaxone grew by 21% in the second quarter year-over-year to $682 million.

Outside the United States, Copaxone's market share is 28%, compared with 25% for Avonex.

Teva also has lawsuits pending against Momenta and Sandoz, which belongs to the Novartis drugs group. Those lawsuits date from August 2008, after the two companies filed the month before for permission to market generic versions of Copaxone. Because of Teva's lawsuit, neither Momenta or Sandoz can launch generic versions of the drug before February 2011.

Human trials, yea or nay?

The danger of the threat to Teva's bottom line depends on the U.S. Food and Drug Administration, and whether it agrees or rejects Teva's position regarding human clinical trials.

Teva argues that the watchdog must demand human clinical trials of copycatting companies before approving any generic version of Copaxone. The trials would be meant to prove that the generic version of the drug is effectively identical to the original, and does not endanger the patient. Teva insists that the generics should be inspected for their impact on the taker's immune system.

The basis of Teva's position is that Copaxone is a highly complex drug. Because of the difficulty in characterizing its molecular structure, Teva says it doubts that any company could prove beyond doubt that its version is identical to the original Copaxone. The slightest error in characterizing the chemical structure of the drug could affect its activity, says Teva, and compromise the patient's safety.

Meanwhile, the High Court of Justice turned down Teva's appeal of a January 2008 lower court ruling. The District Court judge, Avi Zamir, had rejected Teva's request for closed-door arbitration in London to settle its legal dispute with a company called Proneuron. The agreement between the two companies explicitly sets London as the venue for arbitration in the event of dispute.

Proneuron sued Teva in April 2007, demanding restitution of its rights to a molecule called COP-1, which is the basis of Copaxone. It claimed that Teva had violated the co-licensing agreement between the two companies and conducted trials of COP-1 to treat amytrophic lateral sclerosis, while knowing full well from previous experiments that it wouldn't work and if anything, might even harm the taker.