Wednesday, November 19, 2008

Medical Method Patents

Updated 3/2017 -- all links (except to my own posts) removed as many no longer active and it was easier than checking each one. 

Do you know anything about medical method patents?  I knew very little (and even now am no expert) when I noticed this very interesting article (first reference below) on the subject and how it is polarizing the phlebology community in the Oct/Nov 2008 issue of the Vein Therapy News. 
Medical method patents came along with the introduction of the  laser and Diomed’s endovenous laser ablation (EVL) procedure and the VNUS Medical Technologies Inc. Radio Frequency generator and it Closure system.
………………..The vein treatment industry in the United States has become an indecipherable web of legal entanglements over medical method patents, trade secret issues and other patent litigation that is complicated by pending cases and bankruptcies.  This has been further complicated by the speed –or rather lack thereof—of the court system in the United States in resolving the issue in a highly competitive marketplace with a high degree of conflict………..
The United States and Australia stand alone in defiance of 80 other countries in the world by allowing medical method patents.  Of the 100 or so medical method patents issued a month in the United States, about half are issued to foreign doctors who come here to register their patent because method patents are not allowed in their own country.

The second article listed below by David Gornish, Esq gives a nice summary of patents and definitions.  So what is a medical method patent?
Another area of particular interest to physicians is the patentability of medical methods, e.g., surgical procedures or methods of treatment (including new uses of existing drugs). In the United States, medical methods are patentable subject matter. The apparent catch-22 is that medical method patents cannot be enforced against doctors or hospitals. Naturally, the question arises as to what value a medical method patent has if it cannot be used to stop the very people likely to infringe.
The quick answer is that, while direct infringers (i.e., doctors) are shielded from liability for infringing medical method patents, indirect infringers (e.g., companies) are not. For example, where medical device companies or pharmaceutical companies design or promote their products specifically to be used in patented procedures or methods of treatment, the companies could be considered indirect infringers. Such companies may be inclined to purchase a license from the patent owner.

Back to the first article, and I would say this would apply to any area of medicine where method patent law/lawsuits are an issue.
When President bill Clinton signed the bill into law in 1996, physicians were granted limited immunity protecting them from suits alleging patent infringements.
While it might seem that this law would have pulled all the teeth from the arguments and issues being decided in court at great expense, it in fact moved the liability for infringement from the backs of infringing doctors and onto the backs of the companies from whom those doctors purchase the devices and procedure kits for the minimally invasive system used to treat varicose veins through the legal concepts of contributing to and inducing doctors to infringe the patents.
Just as water flows downhill, the real costs for royalties and litigation now moves from the company that has lost or settled a lawsuit to the doctor who buys products from that company. ……as more competition disappears, then prices will continue to rise.   Unlike a retailer who can always pass along the cost of overhead to customers in the form of higher prices, doctors cannot do that because medical reimbursement limits are locked in, and one doctor predicted this was going to end badly for phlebology as a whole……….
Although he said he has not yet personally encountered any problems, _________, is typical of may physicians in evaluating the effect of the medical method patents on his practice.  “Reimbursement is at rock bottom levels now, and I simply could not afford to shoulder additional un-reimbursed expenses,” he said of increased costs for supplies and royalties.  “Thus, my patients might be stuck with now outdated treatment, or be forced to seek the more current treatment from institutions with deeper pockets.”

I have never “invented” or radically “improved” a medical procedure and perhaps that is why I tend to think we should be a medical community sharing and teaching ideas/treatments.  I happen to agree with Dr. Goldman (3rd reference below)
“I am totally opposed to medical method patents.  It is a waste of time and money.  When we take our oath to be doctors, part of that oath is to teach and to advance patient care.  I think that some people have forgotten their oath and it’s appalling.  And it’s not even mostly the doctors.  There are a few doctors who have forgotten their oath, but mostly it is these business people.  They take advantage of well meaning physicians.?

Medical Method Patent Litigation Polarizes the Phlebology Community; Vein Therapy News, Vol 1, No 6, Oct/Nov 2008; by Larry Storer (online site is behind, but should eventually be available here)
Patent Laws for Physician Inventors by David Gornish, Esq; Physician's News Digest, May 2008
VNUS Patent Inventor, Mitch Goldman, Opposes Method Patent; Vein Therapy News, Vol 1, No 6, Oct/Nov 2008; by Larry Storer (online site is behind, but should eventually be available here)
VNUS Responds to Method Patent Litigation Article (Official response from VNUS Medical Technologies Inc.); Vein Therapy News, Vol 1, No 6, Oct/Nov 2008 (online site is behind, but should eventually be available here)
Patents on Medical Procedures and The Physician Profiteer by Susan leach DeBlasio; FindLaw for Legal Professionals (2004)
Should Patenting of Surgical Procedures and Other Medical Techniques by Physicians be Banned?  by Silvy A Miller; PTC Research Foundation of Franklin Pierce Law; IDEA: The Journal of Law and Technology, 1996 (pdf file)

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