In ruling on a case called KSR v. Teleflex, the U.S. Supreme Court today struck down its previous standard of “obviousness” and came up with a new standard that is expected to make it harder to obtain patents and easier to challenge their validity. The medical device industry, much of whose value derives from patents, needs to take note.
The San Francisco law firm Morrison & Forester sees the impact this way:
“The Court’s opinion suggests that patents which are based on new combinations of elements or components already known in a technical field are quite likely to be found obvious under its view of the correct analysis – a development that will likely lead to many more patents being found obvious in the electronics field but should have less impact in the life sciences field.
The Court explicitly rejected the Federal Circuit’s longstanding view that a patent cannot be proved obvious merely by showing that the combination of elements was “obvious to try.” This holding may have more impact on patents in the electronics field than in the life sciences technologies.
The Court instructed lower courts that the existence of conflicting expert testimony on the issue does not necessarily create an issue of material fact preventing summary judgment. This holding, together with the Court’s clear lowering of the bar for proving a patent obvious, will make it easier to obtain summary judgment that a patent is obvious.
While it will likely take four to five years to resolve exactly how the lower courts and the patent office will apply the new standard, the Supreme Court’s decision in KSR will clearly make it easier for the patent office to reject proposed patent claims, and easier for defendants in patent litigation to prove that issued patents are invalid because they are obvious under the new test.
The new test for obviousness, which will apply to challenges to patent validity regardless of whether the patent issued before or after the KSR decision, may also impair the value of previously issued US patents, because it makes it easier to challenge them in litigation, and to ask the patent office to reconsider the decision to issue the patent (a “reexamination” proceeding).”
Today is the public meeting on the new version of the Medical Device User Fee and Modernization Act, which must be passed by Congress by the end of September. If there is any potential stumbling block to its passage, it will likely come out in this meeting. Hopefully nothing will emerge to block the proposal, which increases but stabilizes user fees and delineates much more sensible performance goals for FDA.
The meeting location has been changed to FDA’s White Oak site in Silver Spring, MD, due to flooding at the original site.
Becton Dickinson (Franklin Lakes, NJ) wants to get a test on the market that can tell the difference between regular staph infections and drug resistant forms in just two hours. The test was developed by GeneOhm, which BD acquired for $230 million last year. BD estimates that the most dangerous strain of staph annually affects 125,000 people in the United States. The serious illness not only threatens the lives of patients but also costs hospitals billions of dollars in treatment and hospital stays. An article in the Star Ledger notes that BD’s rights to its MRSA test that is already on the market has come under fire from BioMerieux. The French company alleges that it licensed some of the underlying technology to GeneOhm and has requested arbitration to end the licensing agreement, according to the article.
MRSA, which stands for methicillin-resistant Staphylo coccus aureus, is the most dangerous strain of staph, as it is resistant to certain antibiotics.
Much has been written today about a New England Journal of Medicine article that nine in 10 doctors accept gifts from drug and device companies. Of course that has prompted more hand-wringing over whether the ties between clinicians and industry are too close. But there is little mention of the benefits of these ties. I can’t speak to the drug industry, but yes, ties between doctors and device companies do bring benefits to patients. Device development is necessarily an iterative and collaborative process between doctors and device companies. Doctors have to be able to use the device in order for it to work — and thus there are legitimate reasons to have doctors involved in product design, or serve as consultants, or what have you. The same is not necessarily true for drugs.
But as usual, the coverage offers almost no distinction between the drug industry and the device industry, even if doctor-industry ties are much more justified for devices.
In fact, the only voice of reason appears buried at the very end of the Bloomberg News piece. All media covering the device industry should understand what Harvard Medical School professor Thomas Stossel has to say, and why he said it [emphasis added]:
“The ties between industry and medicine should be encouraged, said Thomas Stossel, a professor of medicine at Harvard Medical School, in a telephone interview today. About 85 percent of medical progress can be attributed to the work of drug and device companies, while 15 percent stems from public funding.
`The corporate involvement in medicine is a natural, evolutionary adaptation to opportunity,’ Stossel said. `Products beget more products. They need to be marketed, because doctors need to know they exist. It’s a natural, symbiotic relationship.’”Â
Of course these arrangements have potential for abuse. That is why AdvaMed’s Code of Ethics exists. But it’s time for the media to stop assuming that these arrangements will always lead to abuse.
A blood test under development may detect more prostate tumors than the current test, and could eliminate thousands of unneeded biopsies, reports the Washington Post. The test, EPCA-2, is being developed by Oconome, Inc. (Seattle) and a research team at Johns Hopkins University (Baltimore). The current test, PSA, produces a lot of false positives, and 80% of the biopsies that result from it come back negative. A study published yesterday in the journal Urology suggests that EPCA-2 is better than PSA at finding real positives and avoiding false positives.
For those who are keeping score about when the media cites device companies when there is a medical breakthrough, the Post piece does give credit to Oconome, but not until the eighth paragraph.
In a release published on devicelink.com, Medtronic announced that it has exercised its option to acquire the O-arm Imaging System from Breakaway Imaging LLC. Terms of the deal were not disclosed. The system will be added to the image-guided surgery portfolio at Medtronic’s Navigation division. Medtronic believes it has potential for use in minimally invasive spine surgeries, among other applications. The system provides surgeons with 3-D images, as well as multi-plane 2-D, and fluoroscopic imaging.
Venture investing in the first quarter of 2007 was at its highest level since the end of 2001, which is great news for medical device startups. Medical device firms garnered more than $1 billion of the $7.1 billion invested by venture firms from January to March of this year, according to a MoneyTree report featured in the Boston Globe. Analysts believe that large device companies are turning to smaller ones for innovative products to keep the pipeline flowing, mirroring a similar trend involving large drug companies and small biotech ones.
The Boston Globe has a piece analyzing the Boston Scientific-Guidant deal one year after it was consummated, and it comes to some unexpected conclusions. A number of investors and analysts believe the company is stronger today because of the deal, because it would have been significantly weakened without it. The market for its core business before the deal, stents, has declined over the past year thanks to studies that have questioned their safety and efficacy. Whereas the market for implantable heart devices has started to rebound over the past year. So, while the much-maligned deal has not achieved what Boston Scientific management hoped for, it has made the firm much healthier than it would have been had it continued to rely on stents so heavily. CEO Jim Tobin is quoted as saying Boston Scientific would be in “deep doodie” without Guidant. If he’s willing to go on the record with that kind of comment, you know he means it.
If you don’t integrate human factors engineering into your design control, you may face eventual consequences from FDA, regardless of your product’s classification, said Pat Patterson of Agilis Consulting (Cave Creek, AZ) last night. She spoke at a meeting of the RAPS New York/New Jersey chapter. Regulatory affairs folks should be aware that PMA applications need to include data on whatever usability tests and other human factors studies were performed, and that failure to include them will raise a red flag, she said. Such data is usually not necessary for 510(k) applications, but if a 510(k) product has a significant use-related problem, FDA will ask to see human factors testing data, she added. And if such testing was never done, a firm could get in serious trouble with the agency. “FDA wants you to show what you did in terms of figuring out what predictable things could go wrong,” she said. “`Nothing’ is the wrong answer.”
Clinical trial data is not a substitute for human factors data, nor is a standard Failure Mode and Effects Analysis, nor especially is a labeling comprehension review, she stressed.
With the buzz about stem cells it’s easy to forget that the technology is still in early stages and at best it is a promising technology. This is especially true for stem cell grafting of spinal cord injuries. For one thing, explains Scott Wittemore at the Society for Biomaterials annual meeting, in vitro results show that stem cells easily differentiate. However, in vivo stem cells do not. He says that there seems to be a mechanism in the spinal cord that inhibits the necessary differentiation. To combat this difficulty—one among many—Wittemore says bioengineers must turn to biomaterials in combination with stem cells to find successful implants. Fiber and channel-based guidance, as well as incorporating ligands, can help regulate cell interactions as well as control differentiation and function of transplanted cells. Wittemore works at the Kentucky Spinal Cord Injury Research Center and Departments of Neurological Surgery and Anatomical Sciences and Neurobiology at the University of Louisville School of Medicine.  Â
