TRENDS & PERSPECTIVES
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The patents concern the ability to monitor diabetes with minuscule blood samples—the size of the head of a pin—and get results in 10 seconds or less once the blood is in the test strip’s capillary chamber. Roche’s suit seeks to stop its competitors from selling their test strips to diabetes patients to use at home and requests a jury trial.
The Roche suit also names Diagnostic Devices Inc. (Charlotte, NC), Nova Biomedical Corp. (Waltham, MA), and Sanvita Inc. (Waltham, MA) as infringing on its patents relating to its electrochemical sensor technology in blood glucose monitoring.
In a statement, Scott Stoffel, Abbott’s director of external communications, says that Abbott believes Roche’s patents are invalid and that its lawsuit is without merit. Abbott has filed requests with the U.S. Patent and Trademark Office (PTO) seeking reexamination of the patents in the suit and has asked the court to stay the case until the PTO rules on the validity of the patents, Stoffel says.
The other manufacturers named in the suit declined to comment on the pending litigation. Roche also would not comment on its lawsuit.
While patent attorneys are not certain how successful Roche will be, they understand that it is being aggressive about protecting its patents because it spent a great deal on research and development of the technology.
“At this stage, success of the suit is somewhat unclear,” says Timothy B. McBride of Senninger Powers LLP (St. Louis). “It’s not likely Roche will be able to shut down all its competitors as it is a rare instance where a company can bring an entire industry to a grinding halt, especially in an industry that is so big.”
McBride says it is more likely that Roche would settle for a license agreement as it did with Home Diagnostics. “If infringement looks to be the case,” he says, “then generally, a license will result.”
McBride adds that although Roche calls for a jury trial in the suit, it is likely to want to settle because patent lawsuits are very expensive. “Even a very simple patent lawsuit on a very simple mechanical device could cost upwards of $1.5 million in legal fees alone,” he says.
However, McBride says, Roche could be opening itself to countersuits. “I am sure that Abbott, Bayer, LifeScan, and the others have patents surrounding their diabetes technology. So in addition to them saying that they don’t infringe on Roche’s two patents, they may countersue saying Roche’s products infringe patents covering their test strips or devices.”
Doug Limbach, an attorney with Shay Glenn LLP (San Mateo, CA), says that by asking the court to stop its competitors, Roche is taking a very strong position. However, he too believes that eventually Roche will settle with most of the companies involved
“The stakes are so huge that if Roche tried to drive all these companies out of business, they would pour so much into fighting back that it would be tough for Roche to ever prevail,” says Limbach. “That’s why I imagine at some point they would find a way to settle this with financial terms.”
Limbach says Roche faces some hurdles because to receive a patent, one of the conditions the inventor must prove is that the technology is something that is not obvious. Roche’s competitors could argue that the idea of making test strips faster and able to use smaller sample sizes was obvious to anyone working in the test strip field in the late 1990s, he says.
Limbach adds that Roche’s argument is further weakened because its patents cover results rather than methods. “The U.S. Supreme Court has long held that a patent claim must include novel method steps or structural limitations, rather than merely claiming the functional result that is obtained by the method or apparatus,” he says.
