Having just posted on the topic of method patents, it is of interest that a major news item recently was the issuance of just such a patent by the U.S. Patent Office. This particular patent claims to cover the method, technique or skill set associated with the placement of transobturator slings in men for the treatment of urinary incontinence. As we have stated, we believe such patents to be of interest only and not enforceable. Method patents are unethical and as such the AMA has clearly stated it’s position in this regard. In addition, in Europe, the European Union agreements essentially outlaw method patents.
We believe these types of patents to be unethical not only in regard to attempts by medical professionals (physicians and surgeons) to obtain or enforce them, but also attempts by companies and the device and pharmaceutical industry to do so. Such patents are designed to extract payments not only for the use of a patented device or piece of equipment but for any time a technique is used, regardless of the device or drug chosen. This is clearly against the Hippocratic Oath’s admonition to teach all in the profession.
We are not sure why the US Patent Office is willing to issue so called method patents. As noted, the European Union does not recognize these patents and we believe them to be unenforceable in the United States. Congress needs to address the potential loophole in the law, no doubt the one that is attempting to be taken advantage of here, which allows method patents related to a specific patented drug or device. The conundrum here is that there are often multiple drugs or devices which are patented for the treatment of the same condition or disease state. As such, the drugs or devices are generally used in similar if not exactly the same manner. Thus, attempts to patent the method of use, beyond the actual device, creates a limitation on other companies (i.e. competitors) from marketing their products to physicians and surgeons to be used as they see fit. In the end these patents must be enforced against the surgeon or physician and we are unsure of why any company would seek to take such action.
Additionally, method patents are blatantly anti-competitive and as such may run afoul of the Federal Trade Commission (FTC). We would urge Congress, the FTC, US Patent Office and others involved in this issue to come together to resolve the matter once and for all, much as has been the case in Europe. If a method patent is unethical and anti-competitive for a physician, it is unethical and anti-competitive when obtained by industry. We hope Congress will act. In the meantime, we would urge any company that holds a “method patent”, to think twice before seeking to enforce the patent against providers, who in essence are their real customers . . . jomaxx and obi jo
United States Patent 7,686,760 Anderson , et al, Transobturator surgical articles and methods – http://patft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=7,686,760.PN.&OS=PN/7,686,760&RS=PN/7,686,760
American Medical Systems Awarded Surgical Method Patent for Implantation of AdVance(R) Male Incontinence Slings – http://phx.corporate-ir.net/phoenix.zhtml?c=122198&p=irol-newsArticle&ID=1432312&highlight
AMS issued U.S. patent covering surgical methodology for implanting AdVance Male Sling – http://www.news-medical.net/news/20100529/AMS-issued-US-patent-covering-surgical-methodology-for-implanting-AdVance-Male-Sling.aspx
American Medical Systems (AMMD) Receives Patent for AdVance Male Sling Implementation Methodology – http://www.streetinsider.com/Corporate+News/American+Medical+Systems+(AMMD)+Receives+Patent+for+AdVance+Male+Sling+Implementation+Methodology/5683797.html
American Medical Systems Awarded Surgical Method Patent for Implantation of AdVance(R) Male Incontinence Slings Grants AMS Exclusive Patent Coverage for Transobturator Surgical Procedure – http://www.cnbc.com/id/37397243/American_Medical_Systems_Awarded_Surgical_Method_Patent_for_Implantation_of_AdVance_R_Male_Incontinence_Slings_Grants_AMS_Exclusive_Patent_Coverage_for_Transobturator_Surgical_Procedure
American Medical Systems Awarded Surgical Method Patent for Implantation of AdVance(R) Male Incontinence Slings – http://www.myfoxal.com/Global/story.asp?S=12560095
Method Patents: Unethical in Medicine and Surgery – http://realhealthreform.wordpress.com/2010/06/10/method-patents-unethical-in-medicine-and-surgery/
Some Physicians and Surgeons Seek to Apply Patents to Techniques – http://www.associatedcontent.com/article/5485100/some_physicians_and_surgeons_seek_to.html?cat=3
Ethical Issues in the Patenting of Medical Procedures – http://www.ama-assn.org/ama1/pub/upload/mm/369/ceja_1a95.pdf
Germany: G1/07: EPO Enlarged Board Rules on Methods of Surgery – http://www.mondaq.com/article.asp?articleid=98352
EPO clarifies patentability of diagnostic methods – http://www.lexology.com/library/detail.aspx?g=95d083f2-38db-49e6-b7b6-0ad4a511bfc0
Patent infringement liability changes – h ttp://www.physiciansnews.com/law/1097meyers.html
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