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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Osmolarity  vs. Osmolality - What a difference a single letter makes! 

Can getting a single letter of the alphabet wrong in an issued patent spell disaster when it comes to litigating against infringers?  Unless the mistake is seen as being a minor typographical error that can be corrected by filing a certificate of correction, the answer is a resounding yes.

 

Hats off to Peter Zura of The 271 Patent Blog for his post on Central Admixure Pharmacy Services v. Advanced Cardiac Solutions (06-13-07).

 In this case, Central Admixture Pharmacy Services sued Advanced Cardiac Solutions for patent infringment relating to a chemical solution used duriing heart surgery. 

A certificate of correction was sought on the patent and was issued by the patent office to replace all instances of the word "osmolarity" with the word "osmolality".

You might be thinking that all the certificate does is change the "R" in osmolaRity with a "L" so that it reads osmolaLity.  Well, yes, BUT.... 

Whether or not the certificate of correction is proper depends upon whether the change is a clerical or typographical nature or if it constitutes new matter or would require re-examination.  Although the district court found the certificate of correction proper, the CAFC disagreed and found that the result of the correction was to broaden the claims since the corrected claims using the term osmolaLity cover less concentrated solutions than the original osmolaRity.

Yikes!  Needless to say, non-technical proofreaders or computerized spell-check and grammar checking programs (gasp!) are not adequate alternatives to a careful final review of a patent application by someone familiar with the technical vocabulary of the invention.

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 As a Fort Lauderdale Patent Attorney, I have been fortunate enough to practice within a stone's throw of the annual meeting location one of the most exciting and interesting expositions on medical and dental innovations in the united States, namely,  the Florida International Medical Exposition or FIME for short.    

 

If you are a medical or dental device innovator, this is one tradeshow you DO NOT want to miss.  It will take place from August 12 - 15, 2009, at the Miami Beach Convention Center.  With over 20,000 professionals from the industry in attendance, you will be in very good company.

 

 If you do attend, please join me on Thursday, August 13, 2009, at the Florida International Medical Exposition where I will deliver a presentation entitled:

 

                   Preservation of Legal Rights in Medical Innovations

Thursday, August 13, 2009, 1:00 p.m. to 2:00 p.m.

Miami Beach Convention Center

 

More information about FIME 2009 is available at www.fimeshow.com with a full schedule of seminars and educational presentations at www.edufime.com.

 

 

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Although my practice is national in scope, I take particular interest in Florida's medical and dental patenting landscape.  Recently, I ran across an article regarding Accubreak Pharmaceuticals, Inc. (ABP) of Plantation, Florida that caught my interest.

Accubreak Pharmaceuticals, Inc. (ABP) will action six medical patent applications through IPAuctions, Inc. according to an article on www.auctioninfo.org on June 13, 2009. 

Accubread Pharmaceuticals, Inc. has a number of Florida medical patents developed at their headquarters in South Florida directed towards the creation of tablets that can be easily divided by hand into exact smally doses for tablet splitting.  The complete article is available here.

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    In the online edition of Time magazine, an article reports that asthma inhalers containing chlorofluorocarbons (CFCs) will be illegal for production or sale as of December 31st of this year, because of known detriments of CFCs to the environment. Medical patent attorneys and innovators should look for opportunities to create greener inhalers, particularly as current options are inconvenient.

    The current greener asthma inhalers require a specific cleaning procedure to prevent clogging, and they also tend to be more expensive. The CFC-free options on the market today include "GlaxoSmithKline's Ventolin HFA, Schering Plough's Proventil HFA and Ivax Corp.'s Proair HFA." These contain albuterol; another inhaler from Sepracor--their Xopenex HFA--contains a similar medication, levalbuterol.

    As a medical patent attorney (or at least a patent attorney with a particular specialty and expertise in medical patents anyway), I look forward with interest to green alternatives in asthma inhalers, which are both more convenient and less costly to the consumer. Something to make us all breathe a little easier.
 

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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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    Medication accounts for a great majority of medical patents, though every medication has its side effects. There's no doubt medicine is saving lives and yet there are clear medical patent opportunities to minimize the risks associated with them. The main difficulty, as you in the medical community may be aware, is that medication is designed to handle a specific issue within the body. However, everything within the body is connected and the challenges in treating one area without impacting any other is significant.

    One such area where improvements are needed is in treating prostate cancer as a new study describes the difficulties patients have in selecting the treatment plan with the lowest side effects (AP via CNN Health). The study, published on March 19, 2008 in the New England Journal of Medicine, studied four prostrate cancer treatments: surgery, standard radiation, radioactive seeds (for patients in the early stages), and hormone therapy.

    The side effects of the various treatments were related to sexual and urinary complications. Hormone therapy in combination with radiation "had a big effect on men's vitality and sexuality." Similarly, radioactive pellets created sexual problems, as well as "discomfort in urinating." Surgery, too, impacted sexual performance and a small percentage had trouble with incontinence one to two years after the surgery. Bowel problems, such as rectal pain and a higher frequency of trips to the bathroom were associated to varying degrees with the treatment plans. And, this is, in fact, my point: while the side effects I've described varied depending on the therapy used, they were present with all of them.

    Looking ahead, I'm wondering where medical patent innovation may take us, where we may find remedies, in medicine and otherwise, that reduce or eliminate side effects. And, I specifically wonder whether taking a more holistic, systemic view in the treatment of any medical issue may lead to medical patent innovations and developments that will help us recover and thrive.

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    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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    (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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