Merck Tells Of 'Tortured Path' In Making Asthma Drug

Merck & Co. (MRK) took a "tortured path" in developing its blockbuster asthma and allergy drug Singulair, a lawyer for the company told a judge Monday in an effort to ward off early generic competition.

In opening statements of a federal trial, Merck's outside attorney, Matthew Powers, said the U.S. patent for Singulair was valid and enforceable, and that Teva Pharmaceutical Industries Ltd.'s (TEVA) attempt to sell a generic version of the drug before the patent's 2012 expiration should be blocked. Teva argues the patent is invalid and unenforceable.

"Singulair was a revolutionary advance in the treatment of asthma," Powers told Judge Garrett Brown of the U.S. District Court for the District of New Jersey. "It should be respected. It should not be copied."

Singulair, which was introduced in 1998, generated $4.3 billion in worldwide sales last year, or 18% of total Merck sales. Merck, Whitehouse Station, N.J., is counting on preserving its monopoly on Singulair until the patent expires in 2012, particularly as the company deals with various other problems.

Israel-based Teva has applied for U.S. Food and Drug Administration approval of a generic version of Singulair, and Merck filed suit in 2007 to block such a launch. Both companies are hoping for a ruling by late summer, when a mandatory stay on Teva's generic Singulair launch is due to expire.

Powers said the validity of Merck's patent for Singulair was bolstered by the fact that its competitors tried and failed to find a drug similar to Singulair that would treat asthma, including Eli Lilly & Co. (LLY) and Wyeth (WYE). He noted Merck itself tested several hundred compounds against asthma before arriving at Singulair.

Also, Singulair's mechanism - blocking substances in the lungs known as leukotrienes - represented a new line of attack on asthma versus older treatments such as inhaled medications. Powers also pointed to Singulair's commercial success as evidence of its novelty.

A former Merck chemist, Robert Young, took the witness stand to begin detailing the long path of Singulair's development after he joined Merck in the 1970s and began working on asthma research. He cited several examples of Merck experimental compounds that held early promise but which failed in animal or human studies due to problems with safety or effectiveness, setbacks he called " very disappointing."

"Unfortunately, there is no blueprint to take you to the right compound," said Young, who left Merck in 2006 after a nearly 30-year career there.

Teva's lawyer, Ralph Gabric, told a different story about Singulair in his opening statement. He said Monday the success of the heavily advertised Singulair has more to do with Merck's marketing muscle and less to do with the innovation behind the drug.

"Singulair sells like a blockbuster drug, but performs like a middle-of-the- road drug" in real-world use, Gabric said in his opening statement.

Gabric argued the Singulair patent is invalid because prior research - including a paper published by Merck's Young in 1989 - would have taught anyone skilled in the art of drug development how to invent Singulair. The paper contained a model of a so-called leukotriene receptor. Under patent law, a patent can be declared invalid if so-called "prior art" rendered the claimed invention obvious.

Under cross-examination by Teva's lawyers, Young conceded that the model published in his paper was useful in searching for new compounds.

Merck attorney Powers disputed Teva's claim in his opening statement, saying much more work than Young's paper was required to arrive at Singulair, and it wasn't obvious.

At issue is whether a crucial molecular change to create the molecule that became Singulair was an obvious, incremental step from Merck's previous attempts or whether it was truly innovative.

Young testified that he didn't believe that the change would work and that a fellow researcher "was wasting his time" with such an effort.

But Teva contends that Merck's enormous effort to find a drug that blocked leukotrienes isn't relevant and that Merck's research efforts in the 1980s had been rewarded with published papers and patents.

"What is relevant is what was obvious in 1991," when the Singulair patent was issued, said Gabric. "The invention of [Singulair] was not a patentable invention at that time"
Also, Gabric said the Singulair patent shouldn't be enforced because Merck obtained it "under false pretenses." He said that when Merck applied for the patent in the 1990s, the company didn't submit Young's 1989 paper to the patent- office reviewer. Powers said the paper wasn't material to the application, and that Merck wasn't trying to deceive the patent office by not submitting it.

Later in the day, Merck also called Mark Labelle, a Merck medicinal chemist for 15 years, to testify about the various advances and setbacks in finding a leukotriene antagonist that would be safe and effective.

The trial is expected to last about a week and will include testimony from both Merck and Teva employees, and outside experts.

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