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

    According to Claudia Wallis, knee replacements surgeries will increase by 525% by 2030 (CNN Health, March 6, 2008, Photo Morgana/Corbis). As a U.S. Registered Patent Attorney, I recognize the opportunities this figure represents in the various ways the medical community could help people prevent the need for this surgery or handle life afterwards as appropriate. The increase is partly attributable, it seems, to the earlier onset of osteoarthritis (age 65 as opposed to 70) coupled with a desire for these younger older citizens to remain active.

    It also brings to mind the undeniable fact that, as Baby Boomers are now nearing retirement, this population segment will explode in the years to come. This, of course, means that there will be an increased need for medical products, supplies, and services designed to keep up with the needs. Moreover, as the aging population increases, so too will the opportunity to acquire a medical patent. Attorneys involved in patenting, as I am, should be on the lookout for medical patents geared toward the elderly, tracking ideas as they develop, so that we can astutely advise our medical patent clients of the degree to which their ideas are/are not patentable.

    Wallis also reports that the number of hip replacements will "more than double, rising from 285,000 to 573,000," which further increases the need to fortify and support aging bones. Moreover, as obesity is indicated as a high risk factor, promoting healthier lifestyles is another source of opportunity. Should you find yourself in need of a medical patent attorney, feel free to call me at (866) 433-2288. I handle other areas of patent law, but have particular expertise in this regard.

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   (HealthTech Wire, February 11, 2008) Medical patent seekers--and patent seekers in other communities for that matter--are relieved by the rejection of  section 4 of the Patent Reform Act of 2007, which would have limited penalties for patent infringement.

    In response to last week's letter from the Department of Commerce explaining their agreements and disagreements with the Patent Reform Act, general counsel for the Advanced Medical Technology Association Christopher White issued a statement applauding the rejection of section 4.

    "AdvaMed applauds the Department of Commerce's continued support for a strong patent system, which allows America's medical technology industries to innovate tomorrow's life-saving, life-enhancing treatments." White continued, speaking out against the language in the Patent Reform Act, which he (and many others) believe would "reduce the incentive to innovate" and "may actually encourage patent infringement."

    In describing the importance of the role of innovating in the medical field, White described the medical technology industry as a "highly innovative" one that "brings tremendous value to patients through short life-cycles and rapidly improving technology." He further explained that even tiny innovations can "significantly advance the safety and effectiveness" of a particular medical device.

    As a medical patent attorney, I've seen the difference small improvements to medical technology and devices can make. Moreover, as an ardent supporter of continual innovation, I, too, am relieved that the patent system will retain its integrity and strength.

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    (Los Angelos Times, February 4, 2008) Medical patent opportunities for "bloodless solutions" have been actualized in a wide range of medical devices in technology. With patients increasingly concerned with the risks associated with transfusions, the trend appears to be growing.

    And, it's backed by a growing number of medical practitioners. In fact, the L.A. Times reports that approximately 125 hospitals currently offer bloodless or transfusion-free programs, compared with only 35 in 1994. As a medical patent attorney, I was interested to read of the various ways patient and physician concerns have translated into medical patent opportunities in new and innovative devices and techniques.

    Blood conservation is of particular emphasis, and a variety of techniques are being used to minimize the loss of blood that occurs as a result of many illnesses. Additionally, current medical patents exist for "innovative medications" that meet the same purpose. Surgical devices, too, have been devised and patented to stop the loss of blood during surgery.

    Threats of infectious disease may be a leading factor in the trend, but a number of other transfusion-based risks run along side it. Allergies, for one, are a concern; patients can have mild to severe reactions upon receiving someone else's blood. Moreover, human error accounts for patients receiving the wrong blood type during a transfusion, with often disastrous results.

    Experts in transfusion dispute the risks, saying they're somewhat "overstated"; however, the concern seems to be growing. Safety, overall, is of continued concern, and it's natural that it should spillover into the medical community. As a medical patent attorney, I notice a lot of medical and other trends in the news and in the form of patent applications that cross my desk.

    I believe this is a trend that will be here for some time. If you have a medical patent idea in this or any other area, feel free to contact me at my Florida patent law firm, Gold & Rizvi, P.A., or at JohnRizvi@IdeaAttorneys.com or 1-866-433-2288.

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    I posted the information below in a separate blog I run for people interested in non-medical patents. However, I thought it would be of use to this community as well.

    The question being discussed is how 'at-risk' patent holders are for having their patents revoked. And the short answer is...very little.

    . The United States Patent and Trademark Office doesn't make it easy to get a patent. Florida patent attorneys like myself work through excruciating details to secure the approval of our clients' patent applications. The USPTO also expends significant resources in determining an inventor's eligibility for patent protection and is necessarily reluctant to take a patent away once it's been issued--absent strong evidence that a mistake was made.

    I read an article yesterday about the USPTO's decision to tentatively nullify four patents held by Gilead Sciences, which cover a drug that treats AIDS patients (San Jose Mercury News, January 24, 2008). A consumer advocacy group up the coast from Florida (in New York) called the Public Patent Foundation is the third-party challenger in this case, claiming Gilead's patents are invalid, because they'd publicly disclosed the technology behind the drug.

    This brings up something I consistently counsel Florida patent seekers (and patent seekers everywhere) against. It is vitally important not to publicly disclose your idea--and in fact not to disclose it except under absolute necessity--before filing for a patent. The USPTO can, and certainly will, reject a patent application for an idea already in the public eye.

    Now, I doubt that Gilead, having already secured their four patents, will have their patents revoked. (Even the Public Patent Foundation admits the unlikeliness of this.) And, Gilead, which earned $3.1 Billion in sales based on their patents, says they will "vigorously defend each and every claim." With that big a business riding on it, I'm sure they will.

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       Applied DNA Sciences has filed multiple patent applications for technologies that serve to protect the authenticity of patented branded products (Medical Patent News, January 23, 2008). The technology works within hand-held scanners, which optically read their "SigNature DNA," a coding embedded by Applied DNA Sciences.

    As a U.S. Registered Florida Patent Attorney, I find this concept interesting. The idea behind it is preserving the authenticity of our patented products. And, authenticity is a key element in medical patents and, for that matter, any kind of patent. In the medical field, for one, we know that drug patents are among the most highly prized and valuable patents you can hold.

    Think of authenticity as a broader platform in the medical community. What brands of supplies, pharmaceuticals, and equipment do you trust most? Which feel, as the Coke slogan goes, like "the real thing"? No doubt others in the medical field feel strongly about particular (patented) brands.

    Patients, too, find comfort in brands they know and trust. Are you in the process of inventing something for use by medical staff? By patients? How are you imbuing authenticity within your product's concept? When an idea is innovative enough, being first is itself the strongest voice of authenticity.

    In this vein, you can see why patenting is so important. So, I'm interested in Applied DNA Sciences' hopefully soon-to-be-patented authenticator. And, interested in seeing of others are as interested in authenticity as I am.

    If you're interested in authenticating your medical invention with a patent, contact me at 866-433-2288 or JohnRizvi@IdeaAttorneys.com.

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       As a Florida Patent Attorney, I track the news relevant to innovators in the medical field and post them here in my blog. Rather than straight reporting, one of the things I do is to give you insights you can use in your own innovations. For instance, today I read that the U.S. Patent Office has issued a patent for Hythiam Inc.'s PROMETA® alcohol and chemical dependence treatment program. I'll give you the scoop on what their patent covers, but I'll also point out the larger health trends the patent links to with the aim of spurring on your own ideation development.

       First, the scoop.

       According to an article at PharmaLive.com (Business Wire, LA, January 10, 2008) PROMETA® is a patented treatment program designed for healthcare providers with patients dependent on alcohol, cocaine, and methamphetamine independently or in combination. It's a holistic treatment program that incorporates nutritional supplements, psychosocial/other therapies chosen by the patient and her treatment provider, and FDA-approved medication given orally and intravenously, which are "separately administered in a unique dosing algorithm."

        As with any treatment program, PROMETA® was developed with the goal of "sustained recovery," What makes it patentable is partly the specifics of the integrated approach and partly the integration itself, which comes at alcohol and chemical addiction from disparate perspectives: the psychology of the individual on his own and in regard to his social environment, his physical health and potentially associated nutritional deficiencies, and a medical/pharmacological perspective.

       And, herein lies the insight.

       This treatment program fuses three macro cultural trends: 1.) An increasing emphasis on the mind-body connection; 2.) an underlying belief that no one perspective is universally "right;" and 3.) a belief that success with patients is borne partly in their own sense of responsibility and involvement.

         Interest in the mind-body connection in particular is a trend that has continued to grow over the last several years, and you can see this in patented products in virtually every category, including fitness, publishing, alternative health practices, the expansion of nutraceuticals into even our soda, etc.

        So, looking at the innovation you're currently or considering working on: Do any of these trends factor in? Could/should they? Or, is there another macro trend evident in your design? Honing in on a trend at play in the larger culture is a way of sharpening your idea and its development. I'm always looking for ways larger cultural trends impact and push forward innovation and would love to help keep the good ideas going with patents and trademarks that protect original, ingenious thinking.

        Contact me if you have an idea you'd like to protect - (866) 433-2288.

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      The focus on how our psychological impacts our physical health is a trend that continues to gain momentum in medical communities and in the general populace. It occurs to me that patent opportunities are abundant in this area in the form of products and patented regimens that might improve our mental outlook.

       One such area of opportunity is in combating chronic anxiety, according to recent research, which was reported on by today's edition of the Florida SunSentinel online (January 7, 2008, Sunsentinel.com). The American College of Cardiology published the research, which indicates that "chronic anxiety can significantly increase the risk of a heart attack. Men are reportedly at greater risk.

       While medicine is prescribed to keep cholesterol low and diabetes under control, a researcher at the New York University School of Medicine in commentary about the study said that all too often "we don't look at the psychological aspect of a patient's care." She urges doctors to look beyond traditional risk factors to see where what's going on in a patient's head might be impacting their heart. For the full study, click here.

       I believe an understanding of the mind-body connection is a trend that will continue to grow and represents a tremendous opportunity for the budding medical and health minded inventor. I look forward to seeing more products that can help people tackle issues at their source, and I will post additional information here as I come across it. As always, if you have an idea you'd like to pursue I'm happy to discuss it with you at no charge -- 866.433.2288.

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       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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Acivena has announced the USPTO has granted a patent (#7,285,573) for use of their proprietary drug candidates to battle ALS (amyotrophic lateral sclerosis), otherwise known as Lou Gherig's disease. This patent joins an expanding portfolio of Acivena drugs for treating ALS, all aimed at slowing the disease's progress and "improving the quality of life for patients."

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   Just when you thought tobacco had cemented its position as the world's leading Bad Guy, the Central Tobacco Research Institute in southern India has secured patent rights for the extraction of solanesol. According to an article at Medindia.net, the institute extracts solanesol for its use in combating cancer and cardiac conditions?of all things. It's interesting to consider which tobacco is more responsible for: causing cancer or curing it?

    Those knowledgeable about folk medicine say that tobacco has long been used for medicinal purposes of one sort or another. Apparently, they're not the only ones who want to cash in on tobacco's viability. Nanjing Huaguan Development Of Biotechnology Company in China is eagerly awaiting shipments of solanesol, as they export it to medical companies who use it in the synthesis of drugs to combat cancers, ulcers, and cardiac issues.

    For Florida inventors or inventors anywhere, for that matter, especially for those in the medical field, it might be an interesting exercise to think about alternative uses for ingredients, processes, ideas. Maybe by looking at something from an usual angle, we might come up with an insight or idea that leads to true innovation.

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Will the big guys win? Following FDA approval of Micera for anemic patients in the United States, Roche is still held back by Amgen's patent infringement case.

As one of the largest domestic biotech companies, Amgen currently dominates the anemia market with Aranesp and Epogen. A court decided in favor of Amgen last month, and they are filing an injunction in Boston today to prevent Roche from marketing Micera in the U.S. According to the November 15, 2007 online edition of the NJ Star Ledger, the injunction is a foregone conclusion.

This surely comes as a crushing blow to Roche, especially having cleared the significant hurdle of FDA approval.

It's nice to see the little guy win when it happens, but maybe what this story really tells us is—when it comes to medical patents (or any patent for that matter) size doesn't matter. But, being first does.

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If you are interested in securing an existing medical patent, IPAuctions has one 'for sale.' Sedum Laboratories, Inc.'s founder has recently passed away, and the company has decided to sell its primary patent for Ionically Formulated Biomolecule Microcarriers (USPTO Reg. # 6,645,525).

The patent covers a cost-efficient drug delivery technology that can "encapsulate and release drugs, peptides, and polynucleotides in biologically active form." The auction begins November 26th and ends November 29th.

In considering purchasing a patent, it is important to look at the broadness of the patent's claims, as this is significant towards marketing success. Consulting with a registered U.S. Patent Attorney is advisable, and I am available should you wish to discuss this or any other available patent, or any patenting issue for that matter.

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