OMRF, drug company settle patent lawsuit
OMRF, drug company settle patent lawsuit

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By Jim Stafford

Published: February 15, 2008

Somewhere along the road from drug discovery to commercialization, the relationship fell part between Oklahoma Medical Research Foundation and the company that licensed its intellectual property to create the drug Soliris.

As approval of the drug by federal regulators neared in 2006, Connecticut-based Alexion Pharmaceuticals declared that the intellectual property licensed from OMRF didn't apply to Soliris.

Alexion said it would not pay royalties of 6 percent based on sales of the product that were part of its licensing agreement with OMRF.

So, the Oklahoma City-based medical research foundation filed a lawsuit in federal court in 2007 to protect its intellectual property and future income from the drug discovery. It claimed the technology upon which Soliris was based was developed in the 1980s by then OMRF scientists Drs. Peter Sims and Therese Wiedmer.

Thursday, OMRF and Alexion closed that tumultuous chapter in their relationship. The two entities issued a joint statement that said a settlement had been reached, with the pharmaceutical company agreeing to pay $10 million for all rights to the patents.

"The main issue with us that led us to this dispute we had with Alexion is that we thought they weren't behaving according to the agreement we had in place and that we worked on for years,” said Dr. Stephen Prescott, OMRF president. "These OMRF scientists, Dr. Sims and Dr. Wiedmer, not only did they make the discovery and patent it, they even helped found the company, or OMRF helped found the company.”

The OMRF scientists discovered an effective treatment for a rare blood disorder called paroxysmal nocturnal emoglobinuria, or PNH, which is a debilitating and life-threatening disease.

"They worked on this for many years,” Prescott said. "They didn't just discover it and throw it over the transom; they worked hard on what ultimately became a life-saving treatment for patients.”

The lawsuit was filed in U.S. District Court in Tulsa and was only the second OMRF has filed over a patent dispute out of more than 40 active license agreements, Prescott said.

In a joint statement released by OMRF and Alexion on Thursday, David Keiser, president and chief operating officer of the publicly traded company thanks OMRF for its contributions to Soliris.

"Complex scientific breakthroughs are often built by combining research advances from different sources,” Keiser said.

The drug has been only on the market as an FDA approved drug for only about a year. Alexion sells Soliris to patients at an annual price tag of about $389,000, according to the lawsuit that OMRF filed.

One of those patients is Dr. Gregory Watkins, a 58-year-old McAlester dentist who was diagnosed with PNH in 1995. The genetic disease caused him to suffer from bouts of anemia and fatigue with symptoms of severe abdominal and head pain.

He had researched and read about the discoveries of the OMRF researchers, but was not able to participate in clinical trials. So, it wasn't until the drug received FDA approval that Watkins began taking Soliris.

"I started taking it in April, and it's like a miracle drug for this disease,” Watkins said. "It's finally like I have my life back.”

Only about one to two people per million suffer from PNH, Watkins said.

"It's a real rare disease,” he said. "There are only a handful of PNH patients in Oklahoma.”

The patent dispute and resulting lawsuit won't deter OMRF from pursuing licensing deals with other drugs developed at the foundation, Prescott said.

"In fact, in any discovery like this we will always have a royalty component to any license we would negotiate,” he said.

The favorable settlement assures donors to OMRF that their dollars can be turned into a discovery that makes a difference in people's lives, said Adam Cohen, the foundation's general counsel.

"This just closes a chapter and lets Steve and everyone at OMRF get out of the courtroom and back into the lab, which is where we always want to be,” Cohen said.