A new patent pending medical device – based on scientific research – proves even simple innovations to existing products can be very lucrative.

Surgical masks haven't changed too much since 1918. It was the year of the Spanish Flu pandemic, and surgeons adopted cotton gauze masks during surgery to protect themselves from patient diseases.

The interest in masks as germ barriers was based on the work of Joseph Lister, who developed asuccessful system of antiseptic surgery (based on Louis Pasteur's' at the time controversial germ theory).

Since then, there has been much innovation in surgical masks. Lighter materials. More comfortable straps. Anti-glare strips. And of course, bacterial filtration. All worthy of new patents.

A New Patent for an Old Medical Invention

Despite all the new additions, one major problem remained…unique facial features.

Since surgical masks are a mass-produced item, there is no possible way for them to perfectly fit every face. And surgical masks that do not have a completely air-tight fit do not completely prevent the spread of germs.

A new medical patent aims to change that.

I recently came across a press release about a patent from Cantel Medical Corporation for a new type of surgical mask. And it shows how medical research can lead to new patents.  Click here if you would like to read the press release.   One paragraph in particular reveals how this new patent resulted directly from a medical study:

A recent study, published in the September 2010 issue of the American Journal of Infection Control quantified the ability of medical face masks to minimize the spread of infection.  The study, entitled "Quantifying Exposure Risk and Mask Protection," found that a tighter-fitting mask may offer as much as 100-fold greater infection control benefit than standard, loose-fitting masks.

The press release goes on to explain how ill fitting masks are "rolling out a red carpet for dangerous infectious material to bypass the mask" and that proper fitting face masks are cheap insurance against infectious disease.

Takeaways for the Medical Device Inventor

 Studies and medical research are great starting points for possible medical patents for two reasons:

1.    Facts and figures of what needs to be improved

Usefulness is one of the first criteria the patent examiners use to determine if an idea is patentable. The study mentioned above found that "tighter-fitting masks may offer as much as 100-fold greater infection control benefit than standard, loose-fitting masks."

2.    Proof there is a need.

There isn't much good to a new medical or dental idea, unless there is a need, or demand for the innovation.  Looking into medical studies is one way to try and keep your finger on the pulse of medical demand.  Including a reference to the study in the patent application is sometimes a good idea and can be very persuasive to a Patent Examiner of this need.

Spending some time digging through medical research could give you the next big idea.

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I am in San Francisco, California, attending the Annual Medical Device Patenting Conference.  It is a great conference with superb speakers with expertise in the patenting and commercialization of medical devices. 

More details are available here and summarized below:

Best Practices for Top Medical Device Executives in Development of IP Documentation, Protection of Patents in the US and Abroad, and Licensing of IP in Commercial Partnerships. 

About the Conference

Beginning at the outset of device research and development, executives must examine the emerging technology, it’s potential future as a commercial product, and the documentation which will protect it and the company for years to come. Doing business in a global environment gives way to indefinite opportunity for medical device manufacturer’s but also open them up to competition and vulnerability on an international scale. Executives today must be more aware than ever of patent requirements and legal protection world-wide. Global oversight does not supersede the importance of IP protection internally as well as with corporate partners.

 Topics to Include

• Technology Transfer and Licensing: Academic Perspective
• The 2009 Patent Reform Act and Updates
• Confidentiality Agreements and Privacy with External Providers
• Patent Prosecution
• Where to File: Early-Stage Strategy
• Carrying out Litigation for Protection in Asia
• Innovation Incubator: Looking at IP and Seeing a Successful Product
• VC Perspective: Initial Steps in IP Development Effect Funding
• M&A Activity: Buyer Assessment of IP
• Freedom to Operate Analysis: Panel Discussion
• Collaborative Infrastructure of IP Protection
• Assessing and Maximizing the Strength of Intellectual Property
• Joint Development Agreements

 

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    Think medical patents couldn't derive from a state known largely for its cheese? The University of Wisconsin-Madison begs to differ, and the students who flock to their biomedical engineering program from all over the country agree. Taking an unusual experiential approach, UW-Madison sets itself apart by offering students the opportunity to solve real-life clinical issues through research and design.

    This leads to ongoing medical patent opportunities for its students, who can watch their accomplishments from conception to completion--and in the field resolving medical needs. In the full article at Newswise, biomedical engineering chair and department head Robert Radwin says their program is unparalleled. "Almost every engineering program has a senior design experience, but all our BME students work on projects throughout their curriculum. You can only do this in Wisconsin, and students come here because of this curriculum."

    Among recent students who have sought or received medical patents for their innovative medical designs are undergraduates Claire Flanagan and Ashley Huth and alumni Chris Westphal. Flanagan and Huth filed a provisional medical patent application for a syringe that can separately "store liquid and solid components, and mix and administer a solution." This is to solve a contemporary challenge in delivering "complex and multi-component therapeutics" according to UW-Madison professor W. John Kao. Westphal was part of a team that developed and manufactured a device to help researchers study hamstring injuries using MRIs.

    The list of collaborative and independent innovation is long and ongoing, as are the opportunities for students to commemorate their efforts with medical patents (and ensuing profits). "I think the opportunity of being able to get a [medical] patent before you get your undergraduate degree lingers in the minds of many students while they are designing and building their devices," says Westphal. Imagining crossing leaving the stage with a diploma and a medical patent in hand, and I believe Mr. Westphal is right on the money.

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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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       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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       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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Naturex, a French company, has patented an extract from the common ash tree, which is reportedly linked to weight loss. According to an article on NutraIngredients.com (November 27, 2007, McNally), the company will launch the product in the U.S., Asia, and Europe to meet growing consumer demand for natural products to promote weight management.

Naturex's patent covers the extraction and purification of the key compound "secoiridoids" found within the ash tree. I have noticed a great deal of consumer interest in natural alternatives in a wide range of categories, most importantly food and beverages and health and beauty aids, leaving the patenting opportunities for holistic/natural ingredients wide open.

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In the last couple of weeks, John Edwards has been creating a stir with talk of offering research cash prizes for the research and development of "breakthrough" drugs—but no patent to go with it. According to Scott Malone (November 13, 2007, Reuters), this is part of Edwards $120B plan to provide healthcare to all Americans.

My question is: If you really want to give generic drug manufacturers an incentive, why not offer them patent protection as a part of the package?

True, removing patent protection gives generic manufacturers a chance to jump into the market sooner, where now they have to wait until the big guys' pharmaceutical patents expire. However, this advantage is short-sighted on two fronts.

First, by not offering the monopoly granted with patent protection, the marketplace would flood with competitors indistinguishable from each other, which would make the profit margins shrink considerably, not to mention quickly.

Secondly, as I mentioned in a previous post, consumers value patented brand names in prescription drugs to a far greater degree than their generic counterparts. If you want to widen the landscape to give the little guys a chance, I'm all for it. But, give them their full due in patent protection, which enables them to compete from a position of strength through proprietary control.

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When it comes to patented drugs, perception is reality, and perception yields big business. Eli Lilly certainly knows this. By 2010, they are expected to have earned a combined $12B for three of their "blockbuster" patented drugs: cancer battling Gemzar, antidepressant Cymbalta, and Evista for osteoporosis (Barron's online, 19 November 2007).

Consumers pay more for patented brand name drugs, because they simply feel they work better. This may be attributed to feeling brand name drugs are more well researched, connecting to the advertising that supports such drugs, or perhaps believing the generic versions have less of the critical ingredient(s). Whatever underlies the perceptions, pharmaceutical companies continually recognize the value of patented drugs in their yearly profits.

However, a pharmaceutical company cannot monopolize the market with their patents interminably. The 20-year patent limit set by the United States Patent and Trademark Office ensures that other drug companies can participate in the market. Typically, drug companies receive their patents well before they have completed all their research and drug trials and before they are FDA approved. Acknowledging this, the USPTO offers drug companies a five year extension on their patent protection; however, the actual time a patented drug is in the market is approximately 14 years. This leaves generic drug manufacturers room to enter the market and grow their businesses.

And, as competitors bide their time, market analysts watch drug companies closely--and measure their worth by a factor of whether and when their drug patents will expire and what new patents are in the works. With several of Eli Lilly's blockbuster drug patents set to expire in the near future and uncertainty over whether their new clot-preventing Prasugrel will be a strong rival to Bristol-Myers Suibb's Plavix, investor anxieties are running high. Eli Lilly remains hopeful. We'll just have to wait and see. Continue Reading...

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An article in The Economist sheds some light on the present patenting scenario, and provides an interesting perspective. It says,

Inventive Japan grants more patents than any other country. In 2002-05, on average 1,213 were given out for every million people, according to data collected for 82 countries by the Economist Intelligence Unit.

The corresponding figures for the United States are about a third in comparison to Japan. Surprisingly, size seems to be a determining factor, as the article goes on to state,

Generally, small countries grant the most patents. Switzerland, Sweden and Finland benefit from clusters of world-class companies in high-tech sectors and a highly educated workforce. Israel can thank its well-educated immigrants. Crumbling Cuba grants more patents than fast-growing India or China, though both countries are better known for their ability to copy, rather than create, intellectual property.

According to the WIPO Patent Report, 2007 Edition, the number of patent applications in the US is at an all-time high. By patent applications count, Medical Technology is the fastest growing technical field. And this surge is putting an enormous amount of pressure on the patent office. But nevertheless, Japan seems to be way ahead. Maybe it’s time we inject some more professional vigor into the patenting system to come up to speed.

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According to the data released in the WIPO Patent Report, 2007 Edition,

The three fastest growing technical fields from 2000 to 2004 were medical technology (+32.2%), Audio-visual technology (+28.3%) and information technology (+27.7%).

This is based on the number of patent applications filed from 2000 to 2004. The figures for the corresponding years are –

2000 – 55,813

2001 – 59,415

2002 – 61,569

2003 – 72,229

2004 – 73,789

In addition, the report also states that the major portion of this activity is concentrated in the United States; and also goes on to mention how the patent offices are being overburdened due to this great surge in activity.

In such a hectic field of activity, it is of paramount importance that applicants have proper knowledge and/ or guidance about the various intricate rules and regulations concerning patents so that their work can proceed smoothly without any hitches caused because of inadvertent mistakes. As the activity surges, the need for taking professional help in this regard increases too.

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The patent office is beginning a pilot program of sending electronic office actions and replacing the paper version. USPTO will let a few participants into the program starting from August 31. Not only is this convenient, this would be a step forward in rapidly clearing the bottlenecks in a situation where the patent office is being flooded with patent applications, riding on the wave of the boom in medical technology patents.

Excerpt from the announcement e-mail -

e-Office Action Pilot Program

The USPTO is hosting a pilot program for customers to evaluate and comment on the usability and functionality of the e-Office Action program. As an alternative to receiving new outgoing correspondence related to a patent application in paper via postal mail, this program sends the pilot participant an e-mail notification to directly access outgoing documents in Private PAIR.

The pilot will be entering Phase IV on August 31, 2007, and USPTO will open registration in the pilot to a limited number of new participants at this time.

If you would like to provide feedback on the e-Office Action Pilot Program or if you would like to participate in the pilot and need additional information, please send an e-mail to PAIR@uspto.gov.

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The latest post in the McBru Blog poses this question. Quite surprising, given the fact that there is a huge surge in medical technology patents, and the Patent Office is being deluged with patent applications. An excerpt,

The latest worldwide patent report came out recently. It is a fascinating document. See if you can guess who files the most patents and wins by almost every measure (such as patent density, patents per R&D dollar, etc). Did you guess USA? Wrong. Did you guess China. Nope. It's Japan.

When it comes to sizing up the Asian tigers, don't count out Japan yet. Though its population is aging rapidly, its government barely able to govern due to voter backlash against its leadership, its ability to irk the Chinese by rewriting history, and the near-complete lack of opportunities for women, Japan is staying on top of the patent race. By almost any measure, Japan is exceeding all other nations in the world in patent filings, especially technical patents.

The problems at our end may be the huge number pending applications in the patent office, and the fact that errors and improper filings create continuous logjams. The solution is simple; increase awareness and inject a healthy dose of professionalism from the first step of the process. The kinks would be smoothened out automatically.

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In the backdrop of patent application surges and a boom in medical patents, a report titled ‘The Means to Compete’ by the Economist Intelligence Unit of The Economist, sheds some light on the relation between patents and innovation, an issue which is generating considerable debate at this time.

..the indicators used in the index—public and private expenditure on R&D, and the generation of patents, royalties and licence fees— provide a good picture of the overall R&D environment and innovation-oriented activity in countries.

Japan, South Korea and Taiwan are clear leaders in this category, and the US, Finland and Sweden are also strong performers. Companies’ prolific patent generation is the primary factor in East Asia’s high R&D index scores. Buoyant private-sector investment in R&D is also an important contributor to this region’s strong innovation environments, as it is in the US and Nordic countries. In the latter, the earning of healthy royalties and licence fees is another reflection of high levels of innovative activity.

While the indicators point to a strong co-relation between patents and innovation, a similar picture is seen throughout the world. As the same report mentions,

East Asian economies are prolific generators of patents, and along with the US they are noteworthy for high levels of private-sector investment in R&D, which is integral to product and service innovation…

The consensus seems clear.

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I got a taste of things to come just after I’d posted my observations ‘The Patent-Innovation Circle of Progress’. Many of my friends in the profession called up to express their opinions, one side or the other. My follow-up post ‘Patents Lead to Breakthroughs in Medical Technology’ generated even more heat, although you’ll notice that I was just quoting from previously published articles in both cases.

The debate is now raging in many parts of the web. I found the Mises Economics Blog’s response to a post in the Patent Law Blog (Patently-O) quite interesting. Dennis Crouch (Patently-O) summarized Meurer & Bessen’s arguments from their upcoming book “Do Patents Work?” to pose the question ‘Do Patents Discourage Innovation?’ The very next day, Stephan Kinsella came up with a ‘So What?’ on the Mises Economics Blog; responding to Crouch’s statement that

Meurer & Bessen do not suggest dismantling the patent system — rather, they believe that a number serious reform measures are needed to shift the balance back to a positive state where patents incentivize innovation.

with a tart reply,

Yes, what we need is a new Five Year Plan!

Regular debates on various issues indicate the health of a profession. Five Year Plan or not, that’s what we really need!

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After reading my post ‘The Patent-Innovation Circle of Progress’, many of my friends called me up to express their opinions, for or against. After hearing all sorts of views, I’d like to point out here that I hadn’t drawn any inferences in my post; I simply made an observation based on a couple of quotes in an article in Law.com.

But whether or not everyone agrees that patents and innovations complement each other, what struck me from talking to so many people was that they believed that this was a very new issue. I’d like to draw your attention to an article in the New York Times which was published more than a decade ago (May 13, 1995).

An excerpt:

"Some people mistakenly assume that breakthrough medical technologies will occur without patents, but they will not," said Lisa Raines, vice president for government affairs at the Genzyme Corporation in Cambridge, Mass., which is working on gene therapies for cystic fibrosis and also owns part of a company that is developing transgenic goats that produce valuable drugs in their milk.

Ms. Raines noted that biotechnology companies must raise tens of millions of dollars years before they have a marketable product, and patents provide the only assurance of being able to profit in the event that high-risk research is successful.

Same issue. Same conclusion.

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As I reported in yesterday’s post ‘New Patent Appeals Need to be Clear and Precise’, the Board of Patent Appeals and Interferences (BPAI) is presently experiencing a large increase in the number of ex parte appeals. From 3,349 appeals in FY 2006, the Board expects the figures to cross 4000 and 5000 in FY 2007 and FY 2008 respectively.

The patent office is not only having to create new rules to help the Board handle this increase in appeals, they are also hiring more people to handle the increasing pressure. An article in Law.com quotes a patent office spokesperson to highlight this phenomenon:

A spokesman for the U.S. Patent and Trademark Office had no exact figures for medical-method patents, confirming only that "because we are seeing an increase in medical/ surgical method applications," more hires are being sought.

 

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A few days ago, I had drawn your attention to an article touting a surge in medical patents in the past few years.  According to the article in Law.com, about 100 medical-process patents are now being issued every month.

I also couldn’t help noticing how a couple of views quoted in the same article explained so clearly how patents and innovations complement each other -

"My business is booming," said patent lawyer Glen Belvis of Chicago's Brinks Hofer Gilson & Lione, who credits technological advances for driving the medical-patent boom. "As a patent lawyer, I have a ton of great, innovative things that I can now protect."

Raciti (Patent Attorney) views such patents as essential to both inventors and the medical community. "What it does is it provides something for other companies to work around. The patent is out there. It's wide open. The whole world looks at it and thinks, 'How do I get around it?' That inspires more creativity and more development," Raciti said.

So innovations lead to patents, and patents lead to innovations… Interesting point.

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The patent office is working towards implementing changes in its rules for limiting continuations and number of claims examined. The final version of the changed rules will be available in the Federal Register which will be published after a few days.

Excerpt from the internal e-mail -

OMB Approves Claims and Continuation Changes

On July 9, 2007, the Office of Management and Budget concluded its review of the Continuations and Claims rule changes. The final rules will be made public when they are published in the Federal Register, which is expected to be later this summer. The rules will become effective at least 60 days after publication in the Federal Register, and no earlier than October 1, 2007.

The abstracts of the rules currently available on the Federal Regulatory Information Web site here and here reflect the abstracts of the Continuations and Claims notices of proposed rule -making that were published in January, 2006.

An internal USPTO team is currently working on details of implementing the rule changes. Examiners and managers will be given information and training on the new rules once they are published in the Federal Register. Additionally, management is currently discussing with POPA the appropriate process for negotiating any impacts the rules package may have.

These changes would permit the Office to use the patent examining resources presently absorbed by applications that contain a disproportionate number of claims to the examination of new applications. This would allow the Office to reduce the backlog of unexamined applications. It would help ease the burden on the patent office and increase the efficiency of the whole process in the face of a major increase in the number of patent applications over the past few years, led by a surge in medical technology patent applications.

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A Secure Ambulation Mode (S.A.M.) physical therapy device is being used by Walter Reed Army Medical Center, Washington D.C., to help patients recover from traumatic spinal cord and brain injuries.

Technology for Today reports that S.A.M. is based on a technology developed at NASA Goddard Space Flight Center. The patents were licensed from NASA by Enduro Medical Technology (East Hartford, CT), which added a joint mechanism to the walker to enable greater ease of use. S.A.M. allows patients to stand or walk, whether they have a sense of balance or not.

Enduro donated a S.A.M. unit to Walter Reed to facilitate rehabilitation for military patients, including soldiers returning home from service in Iraq. At Walter Reed, the device is being used to help patients with a variety of traumatic injuries to the spinal cord and brain.

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Recently, the Patent Reform Act of 2007 was approved by the U.S. House Judiciary Committee. It closely tracks a similar bill passed by the Senate Committee last week. This acquires added significance in light of the fact that numerous companies had put forward a series of complaints concerning an increase in the number of frivolous patents in recent years.

Sen. Patrick Leahy informed that infringement damages would be limited, “unless the claimant shows that the patent’s specific contribution over the prior art is the predominant basis for market demand for an infringing product or process.” The bill calls for an intervening time period during which a newly-issued patent could be put under the spotlight and be analyzed by interested parties.

For the first time, the bill gives concerned parties and public opinion a handle to overturn bad decisions, which many feel have increased dramatically in recent times. But only time will now tell how effective the new law will be in restraining frivolous patents.

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Not surprisingly, yet another article is touting the surge in medical patents in the past few years.  According to an article in Law.com, medical process patents are being issued by the United States Patent & Trademark Office at twice the rate they were in the 1980's.

 According to the article:

"Many physicians are constantly coming up with new techniques and devices. They have started to see some of their colleagues strike it big with patents, so they have tried to do the same," said Dragseth of the Minneapolis office of Fish & Richardson.

Dragseth cited the recent case of Dr. Gary Michelson, who in 2005 received a $1.35 billion settlement after suing a medical device company over his patented spinal surgical technique that speeds recovery. Medtronic v. Michelson, No. 01cv2373 (W.D. Tenn.).

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The latest issue of the New York Times carries an article which discusses the inherent value of patents. Other than touching on an age old debate, the article also draws attention to the rising trend of patent litigation -

Domestic litigation costs alone, meanwhile, soared to $16 billion in 1999 from $8 billion in 1997.

Things have probably become worse since then. For instance, patent litigation is up: there were 2,318 patent-related suits in 1999, and 2,830 in fiscal 2006 (though that’s down from the peak year, 2004, when 3,075 were filed). Mr. Bessen (a lecturer at Boston University’s law school and co-author of an upcoming book on the topic, “Do Patents Work?”) said awards in patent cases also seemed to be up, though he was less confident in that data.

Mr. Bessen, thinks that things are going to get a lot worse before they get better.  What’s your take on the matter?

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How important are patents to the growth on an economy? A report, ‘Economic Effects of Intellectual Property-Intensive Manufacturing’, by economists Robert Shapiro and Nam Pham throws some light on this issue. According to these renowned economists, most of the value of America’s large businesses can be traced to patents and trademarks. An excerpt –

The creation and adoption of new ideas — in a word, innovation — is a very powerful factor that helps to determine progress of modern economies. Economists trace 30 percent to 40 percent of all U.S. gains in productivity and growth over the course of the 20th century to economic innovation in its various forms. Today, some two-thirds of the value of America’s large businesses can be traced to the intangible assets that embody ideas, especially the intellectual property (IP) of patents and trademarks. Promoting and protecting new intellectual property should be a high priority for U.S. policymakers.

From a medical point of view, this is even more important. As the report goes on to state,

IP-intensive manufacturing produced much more value per employee than non-IP-intensive manufacturing — some $181,000 per worker, per year, compared to less than $106,000 — and in the most IP-intensive industry, pharmaceuticals, an average worker produced more than $425,000 in value every year.

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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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According to the WIPO Patent Report, 2007 Edition,

Worldwide filings of patent applications have grown at an average annual rate of 4.7% since 1995 to a total of more than 1.6 million in 2005. The growth rate is comparable to the overall increase in economic activity over the same period. Patents granted worldwide have increased at an average annual rate of 3.6% to about 600,000 in 2005. At the end of 2005, there were approximately 5.6 million patents in force worldwide.

The graph below will give you a clearer idea about how explosive the growth has been in recent years -

The report mentions that the fastest growing technical field from 2000 to 2004 was medical technology (+32.2%).

The worldwide picture reflected above has been felt even more keenly in the United States. The WIPO Patent Report states -

Patent offices of Japan and the United States of America receive the largest amount of patent applications followed by North East Asian emerging States, namely China and the Republic of Korea and large industrialized European States.

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