April is not yet complete, but two items of interest already bear noting. One of these is perhaps the most important patent case to be heard by the Supreme Court in a long time, at least where life sciences are concerned. The other is of broader but no less intense interest to device makers.
Myriad at SCOTUS
Leading off is the April 15 hearing of the Myriad case at the Supreme Court, a hearing during which Justice Elena Kagan remarked that the Patent and Trademark Office is "very patent-happy." Of all the comments signaling a jurist's likely vote, this was the most obvious. However, as reported in the April 16 edition of Medical Device Daily, Justice Anthony Kennedy also mused that a loss of patent protection leading to taxpayer funding of most such research is an "insufficient" reason to overturn the Myriad patent for portions of the BRCA 1 and 2 genes.
If I had to guess (I don't, but I will anyway), I'd guess the final tally is 5-4, with Chief Justice John Roberts breaking the tie. I'm not entirely sure what Roberts will do, but I'd point out how far out on a rhetorical limb he went to vote that the Affordable Care Act is constitutional. His deference to established law – there is nothing in the statute to prohibit gene patents, and the practice has been to grant them – suggests which way he'll go. The outcome will thus be a narrow win for Myriad.
Needless patient deaths and device makers
One of the sessions at this year's annual meeting of the Medical Device Manufacturers Association detailed an effort by industry and others to improve patient safety by encouraging more routine use of patient monitoring equipment. For the moment, we'll set aside the question of whether Leah's Law is appropriate, but I'm of the view that device makers have to be careful about the optics of their efforts to bolster the use of their offerings.
I'm not questioning the sincerity of device makers that give of their time and money in this effort, but there will be skeptics, and it won't take much to trigger a backlash. Beyond that, the session resurrected a report filed in November 2010 by the Office of Inspector General at the Department of Health and Human Services alleging that 180,000 Medicare patients die needlessly in hospitals each year thanks to events that "contributed to their death."
I have no doubt that providers are skeptical of those numbers, and rightly so. Part of the skepticism stems from the likelihood that many of those events did nothing to hasten the patient's demise, or hastened it by mere hours or even minutes. That's not to excuse sloppy care, but I've always been wary of these kinds of government claims, including IOM's 1999 report "To Err is Human." Let's face it, neither of these reports would constitute a first instance of government getting it flatly wrong, let alone the first time our government pushed an argument out of bounds to make a point.
For device makers, one of the hazards here is that providers will return the favor by insisting that devices and equipment in the hospital be fully interoperable, and start making the argument that lack of device interoperability is killing patients, thus sparking a PR war. And frankly, the last thing anyone needs is a turf war between device makers and hospitals, but that's what we'll get if device makers overplay their hand.