IVD Technology
Magazine
IVDT Article Index
Originally published November, 1997
IVD patent wars continue
A new wave of patent litigation is giving increased importance to the ongoing wars over intellectual property rights in the IVD industry.
Young entrepreneurial companies are finding that the best protection against a takeover is a well-guarded idea. And market leaders are discovering that if they don't protect their patents, imitators will swamp the market.
"If a company is successful, its product will be reverse-engineered and copied," says patent attorney Stephen Glazier of Pillsbury, Madison & Sutro (Washington, DC).
Two lawsuits reflect the current trend. In late August, Vysis, Inc. (Downers Grove, IL), won a federal court ruling in San Francisco against Oncor, Inc. (Gaithersburg, MD). The court issued a broad pretrial ruling that a patent on University of California technology for fluorescent in situ hybridization (FISH) DNA probes licensed exclusively to Vysis was novel and unobvious. The court also held that Oncor's Coatosome DNA probes had infringed on the patent.
The decision was the more remarkable because it was handed down before the case went to trial. Officials for Oncor put the best face on the defeat, noting that 95% of their product base was unaffected—and that they will still have their day in court.
"It's actually very good news," says Oncor's director of diagnostics programs Patrick Muraca. "The judge has left open the question of whether the patent was procured fraudulently."
But lawyers for Vysis say it will be difficult for Oncor to prove its contention that a UC professor intentionally defrauded the U.S. Patent and Trademark Office.
According to Vysis general counsel William E. Murray, "intense research competition" is the driving force behind the latest round of patent suits. Vysis expects the FISH DNA patent to have broad application for diagnosis of cancers, heart disorders, and prenatal defects. According to Murray, a single breast cancer probe currently up for FDA approval has an estimated annual market value of $175 million.
The Vysis-Oncor suit also demonstrates the importance of patents in an age of product complexity, Murray says. Today's most valuable products have multiple components patented by different companies. The firms that triumph will be the ones that combine a group of patents for maximum clinical effect.
"Patents are trading chips," Murray says. "No one company has all the pieces."
Another important components case was filed last June by market leader Roche Diagnostics Systems, Inc. (Somerville, NJ). Roche filed to protect the cuvette component of its COBAS Mira automated chemistry test instrument after Ritter GmbH of Germany entered the European market with a competing product, Roche officials say.
The cuvette, the plastic cup that holds reagents, is hardly the jewel of the Roche patent family. But the company says that protecting it is crucial to maintaining the value of its COBAS Mira product, which represents 25% of Roche's $625-million worldwide diagnostics sales.
"We are very serious about protecting our patents," Roche public affairs director Paula Evangelista says emphatically. — Gale Holland
