CNTF, a compound that analysts have said has a U.S. marketpotential of $300 million to $400 million, will go before a PTOinference hearing in an dispute between RegeneronPharmaceuticals Inc and Synergen Inc.

The Patent and Trademark Office has said Regeneron's patentfor CNTF (ciliary neurotrophic factor), filed in September 1989,is allowable. Synergen received a patent for the compound inMarch 1991, but Fredric Price, Regeneron's chief financialofficer, claims his company invented the compound beforeSynergen.

"If we didn't believe that we invented this before Synergen, wewould never have applied for a patent interference," said Price."The PTO looked at our data and decided to issue theinterference."

No date has been set for the hearing.

Paul Layland, spokesman for Boulder, Colo.-based Synergen,said that his company had expected an interference to bedeclared, but that it is too early to anticipate the outcome. "Wewill be the senior party, which means Regeneron has theburden of providing the proof," he said.

The first party to get FDA approval for CTNF, a designatedorphan drug, will receive exclusive marketing rights for severalyears and certain tax benefits.

"It's a development race, and the first to market getsexclusivity," said Regeneron's Price. "We're now focusing on thedevelopment rights and making sure we're first to market."

According to Price, neither company has broached thepossibility of an out-of-court settlement.

"Synergen has not approached us and vice-versa," Price said."Cross-licensing is certainly a possibility, but it is only one wayof resolving the issue, and is not based upon any discussions todate." Price added that long-term litigation would only delaythe commercialization process of CNTF.

Tarrytown, N.Y.-based Regeneron is in Phase I multicentertrials with CNTF. Regeneron was the first company to beginhuman trials of CNTF as a possible treatment of amyotrophiclateral sclerosis (ALS, commonly known as Lou Gehrig'sdisease), a progressive and inevitably fatal disease.

CNTF promotes the survival of motor neuron cells thatdegenerate and die in people with ALS. Price said he couldn'testimate when Phase II trials of the compound would begin.

According to Price the worldwide patient market for ALS isabout 75,000. However, the compound looks promising forseveral other indications, including muscular dystrophy and inperipheral neuropathies, a disorder that causes numbness inlimbs, both in association with diabetes and a side effect ofchemotherapy.

-- Michelle Slade Associate Editor

(c) 1997 American Health Consultants. All rights reserved.

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