Judge Sympathetic To Diabetes Patients’ Need Pfizer Product

NEW YORK CITY (AP) — The public’s need for a “new and less invasive treatment for diabetes” will keep Pfizer’s inhalable insulin product Exubera on the market while a court considers whether Pfizer infringed on Danish drugmaker Novo Nordisk’s patents, a judge ruled December 14.

As he denied a request to immediately halt distribution of Exubera, US District Judge Leonard Sand did not indicate how he expects to eventually rule after a trial and full airing of claims by Novo Nordisk that Pfizer violated five of its patents. No trial date was set.

He said in a written ruling that the evidence and arguments by both sides “raises substantial questions as to the alleged infringement by Pfizer” and that it would be best resolved “through closer inspection at trial.”

At stake is the US market for drugs to treat the 21 million Americans who suffer from diabetes. At a hearing to decide whether sales of Exubera would be stopped pending trial, Judge Sand heard no witnesses and lawyers argued the merits of only one of the patents at stake.

Novo Nordisk sued Pfizer earlier this year, saying Exubera infringes on its inventions and would do irreparable harm to its reputation and its sales.

Judge Sand said Novo’s attempts to show irreparable harm for both its current market standing and for future sales of its own inhalable insulin were speculative. He wrote that stopping “the release of a new and less invasive treatment for diabetes would quite obviously be contrary to the public interest, particularly in the interval between now and trial.”

Jim Shehan, attorney for Novo Nordisk, said the Denmark-based company looked forward to a full trial on its claims.

“We don’t think the ruling impairs the strength of our underlying case,” he said.

Mr Shehan called patents “the lifeblood” of innovative products produced for eight decades by the company, which employs about 22,000 full-time employees in 79 countries and markets its products in 179 countries.

“You spend a lot of time and money getting them and want them to be respected,” he said.

At a recent hearing, Stephanie Wheeler, a Novo Nordisk lawyer, told Judge Sand that Exubera violates Novo Nordisk’s patents covering insulin delivery to the lungs. Novo Nordisk expects to produce its own inhalable insulin product by 2011.

Ms Wheeler predicted Pfizer would eventually market Exubera to diabetes patients who require insulin injections despite its claims that it will only initially market the product to those who take drugs orally to fight the disease.

After the Food and Drug Administration approved Exubera on January 27, Pfizer began marketing the drug through diabetes specialists in July. Initially marketed through 5,300 physicians, Pfizer expects a wider launch through an additional 66,000 physicians by March.

Vanessa Aristide, a Pfizer spokeswoman, said that patients who take insulin injections can take Exubera.

“If they choose to change from injections to Exubera, it’s as effective,” Ms Aristide said.

She said Exubera was being rolled out slowly to ensure that physicians, nurses, educators, and patients were properly educated about its use.

Pfizer spokesman Bryant Haskins said the company welcomed the ruling but was aware that a trial on the claims by Novo Nordisk remained ahead.

“We think it’s to the patient’s benefit to have this option available to them,” he said.

Ms Wheeler had argued that Novo Nordisk, which shares nearly half of the market for Americans who require insulin injections to control diabetes, could suffer irreparable damages because studies show as many as 89 percent of people who rely on injections would switch to an inhaled drug if they could.

She said 70 percent of Novo Nordisk’s revenues stem from insulin injection whereas Pfizer is a diversified pharmaceutical giant that could withstand delaying sales of its product until after a trial on the merits of the patent claims.

Rudolf E. Hutz, a Pfizer lawyer, told Judge Sand at the hearing that Exubera does not violate Novo Nordisk’s patents because its inhaler requires ordinary breathing techniques that cannot be covered by a patent.

Even before he ruled, Judge Sand seemed concerned that those with diabetes would be deprived of a new option for treatment if he blocked Exubera.

“What about the patients sorely in need of an alternative?” Judge Sand asked. “While Novo’s interest in preserving its niche is certainly a factor, it isn’t the only factor.”

Mr Hutz handed Judge Sand the product during the hearing and demonstrated how it works, saying it uses “the same instinctive [breathing] maneuver people have used for smoking cigarettes for years.”

The attorney said Pfizer “has spent literally billions of dollars” in trials of the product, manufacturing and stockpiling costs and to get Food and Drug Administration approval. He said the public should not be deprived of an alternative to “the dreaded injection” in the treatment of a disease that in the United States represents the second biggest driver of health care costs and the third or fourth cause of deaths.

Mr Hutz added that other companies were preparing to enter the market with inhalable insulin that would ensure that Novo Nordisk is not first to market even if Judge Sand blocked Pfizer.