With more than 250 units making and marketing therapeutic products worldwide,
Of late, its largest division, the medical device and diagnostic operations that generates some 40% of the company’s total sales, has been a focus of some of its attention. In particular, it’s defending its product called Lifescan Ultra, used for glucose monitoring in diabetes patients, which is estimated to be a $10 billion market. Right now, J&J dominates the market for single-use strips necessary for patients to use the Lifescan Ultra diagnostic device to check their glucose levels.
J&J, the largest player in this market, filed in September 2011 a patent infringement suit against a small company called Decision Diagnostics and sought an injunction to stop the company from selling its product named Genstrip, an alternative glucose testing strip designed specifically for use with Lifescan Ultra meters.
“Currently there are no alternative testing strips available for diabetics who use J&J’s Lifescan Ultra meters,” says Keith Berman, CEO of Decision Diagnostics. J&J filed the injunction suit as Genstrip could potentially take a slice of J&J’s meter business. ”This has become a big stakes battle,” he says.
In response to J&J’s filing, Decision Diagnostics filed motions in both the California District and Federal Circuit Courts, and in late April 2013, with the U.S. Patent and Trademark Office (USPTO), challenging J&J's patent claims.
Subsequently, Decision won a stay to lift the injunction against Genstrip pending the outcome of an appeal of the trial judge’s injunction ruling. Berman says he strongly believes that his company will win the appeal which should also impact dramatically J&J’s patent infringement suit, which has dragged on since September 2011.
On Aug. 1, 2013, Decision Diagnostics filed counterclaims to the infringement suit against two of J&J's units, Lifescan Inc. and Lifescan Scotland, that alleged “misleading advertising.” According to Decision’s lawsuit, the J&J units “falsely convey to consumers that its One Touch@ system provides more accurate results than the competition, including the Genstrip.”
This marks the first time that J&J's medical products and diagnostics divisions have had to cope with a competitor alleging false advertising of a heretofore market leading product.
In August 2013, Decision was notified that a four-judge panel within the USPTO appeal structure had completed review of Decision's challenge to J&J's main patent and found that "upon consideration of the petition and patent owner preliminary response, we conclude that Pharmatech (a unit of Decision) has established a reasonable likelihood that it would prevail with respect to claims."
Decision Diagnostic has began the process of preparing to roll out the next generation product of Genstrip, which the company believes will fill a niche in the diabetes testing market that is still virtually unmet, says Berman.
Why the big fight over the testing strips? The diabetes testing market worldwide is estimated to be about a $23 billion yearly business, and experts estimate that by 2017, that market will grow to $30 billion. Among the diabetics who have tested their own glucose levels at home on a daily basis, some 3.4 million use or have used J&J’s Ultra meters.
An easy solution on this issue would be for J&J to resort to its active M&A strategy. With Decision’s low market capitalization, it wouldn’t be improbable to expect that J&J may just opt to gobble up Decision Diagnostics to add to its growing list of acquisitions. That way it would acquire Genstrip and get rid of both a competitive product and a potentially costly legal battle.
