Medical and Dental Device Patenting Blog : Medical and Dental Patent Lawyer & Attorrney : John Rizvi : Gold & Rizvi Law Firm : Florida, Serving Miami, Ft. Lauderdale, Orlando, Tampa, Florida

       CDEX, Inc. demonstrated two chemical detection innovations in their medical patent portfolio at a recent trade show in Las Vegas, NV (CNNMoney, December 18, 2007). The two patent pending devices are ValiMed (TM) Medical Validation System and Meth Scanner (TM), both of which were duly received for their advanced ability to determine the chemical composition of medication (ValiMed) or the presence of narcotics (Meth Scanner).

       ValiMed, which is credited with "saving lives in hospitals across the nation," determines whether the medication inside the package--and not just the label--contains the medication to which it claims. Furthermore, it is easy to use with a simple declaration of "validated" or "not validated." I can picture the trade show audience of national and international hospital executives, pharmacists, and other industry representatives nodding their heads in approval at as this adds a considerable safety measure, which has broad implications for patients as well as financial bottom lines.

    Meth Scanner is a patent pending medical device that is a useful narcotics detector inside and outside of hospitals. As a complement to this scanner, CDEX also unveiled their new Fentanyl Validation System, which strengthens the procedures for preventing "narcotic diversion in medical facilities." Meth Scanner is one in a wide portfolio of patented/patent pending innovations designed to determine the presence of narcotics, including devices that can integrate their detection technology into medical products that already exist.

       It's hard to imagine a broader category for medical innovation than that of safety. CDEX has certainly made a big business of this, and maybe you can, too.

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        The Rosilin Institute, which stunned the world when they cloned Dolly the Sheep, have secured additional cloning patents, as announced in Earth Times (December 11, 2007). This further strengthens their position in this field and has broad agriculture and medical implications. The new patents (U.S. Patent Nos. 7,304,204 and 7,307,198) cover methods of using differentiated cells to clone ungulate animals, fetuses, and embryos.

       These patents join a portfolio of patents owned by the Rosilin Institute for cloning using "foundational somatic cell nuclear transfer (SCNT)," which is managed and licensed by Start Licensing, Inc. Other patents in Rosilin's portfolio include U.S. Patent No. 7,232,938 for a cloning process that uses "fusion or microinjection of a quiescent ungulent donor cell," a method that has been used to clone a farm animals, rodents, and cats and dogs.

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       Consumer interest in organic and natural products—those devoid of harmful environmental toxins—continues to escalate and broaden into more and more categories. Even in the most mainstream areas of the United States, organic products are taking up more and more shelf space, indicating the patenting opportunities for organic solutions are also on the rise.

        According to an article at ScienceCentric.com (December 4,2007), researchers at the Universidat Juate I and the Spanish Research Council know this. They have patented a method for removing pollutants from bivalve mollusks before we consume them. Bivalve mollusks include the shellfish who typically breed in shallow water and filter sea water to gather in nutrients—and pollutants—for instance, clams, mussels, and oysters. Compared to the current techniques of flushing the shellfish with sterile, filtered water or applying hydrostatic pressure, the researchers' patented technique reportedly removes the pollutants much more efficiently, at two to four times the speed and in increasing the mollusks' tolerance for "oxidative stress."

       Environmental toxins have been linked to cancer and certain neurological disorders (e.g., Parkinson's Disease), as well as degenerating other functions within our systems. As these researchers, other scientists and medical practitioners, and entrepreneurs in areas far afield show us, organic solutions are solutions we can use and, in some cases, vitally need. Look into your own field of expertise—what uninvented organic solution might advance our bodies' abilities to develop and/or function? I, for one, would love to know, and, from what I've seen, the world would, too.

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        Novartis announced their patented Gleevac® is proving to stop a life-threatening form of leukemia in its tracks (CNN Money, December 9, 2007). Clinical trials have shown significant successes in halting a particular form of the disease known as Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) even into its most advanced stages. 1,100 newly diagnosed patients participated in the study with clinicians following their treatment throughout the course of the disease's progression.

         Left untreated, Ph+ chronic myeloid leukemia progresses into advanced stages in three to five years, after which patients typically reach the final "blast crisis phase"—a severe and fatal final stage. Gleevac was shown to stave off the disease's progression when given continuous treatment with Gleevac in the initial stage. Side effects are, of course, numerous and something to be considered. However, side effects notwithstanding, even among those in the late stages Gleevac performed well, indicating that Novartis will likely do well with this patented pharmaceutical drug. See press release for full details.

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        An article in today's online edition of BBC News (BBC News Online, December 7, 2007) explored the ins and outs of "reprogramming skin cells" to combat sickle cell anemia. Researchers at the Whitehead Institute of Biomedical Research in Massachussetts are conducting intense research to discover a safe way to turn skin cells into stem cells. Partly, this is to skirt around the controversy surrounding the use of stem cells and partly it reflects the ready abundance of skin cells.

       And, herein lies the patenting opportunity as well as the heart of the ethical debate. The researchers have yet to find a way to keep the reprogrammed skin cells from making random DNA changes elsewhere in the body, which can lead to dangerous complications like cancer. This is because, at the moment, researchers are using retroviruses to insert therapeutic genes into  skin cells to create what they call "induced pluripotent stem cells," or IPS. Retroviruses are volatile and "can disrupt genes that should not be disrupted or activate genes that should not be activated," which, of course, can lead to harmful side effects.

    Developing a patented "delivery system that doesn't integrate itself into the genome" is the specific area of opportunity, but I wonder if it's possible? Stem cells themselves are pluripotent, meaning they are able to be transformed into any type of cell within the body. The team continues to conduct research to discover the secrets within our cells and DNA, and maybe one day (and maybe sooner than we think) it will become a patented reality. On the other hand, maybe we cannot hope to wholly control or transform our cells--the most fundamental unit of our lives--without unintended, disastrous consequences. A patented impossibility?

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