By Deborah L. Manjoney, MD, FACS

The vein therapy industry has been a victim of a number of patent infringement lawsuits over the last several years.  Millions of dollars have been spent by suppliers defending against these suits, and will ultimately lead to physicians bearing the cost of increases in medical supplies.  The claims of ‘”patent infringement” are not based on new medical device protection, but rather on assertions that a procedure or “method patent’” has been violated.  The physicians owning the patents contend that the application of existing technology has been applied in an entirely new fashion, and thus is protected by patent rights.  They fail to disclose litigation being undertaken on their behalf while continuing to promote their procedures to colleagues.

The use of medical method patents to protect intellectual property of the innovator is controversial and seen by many as unethical.  The concept of patenting medical procedures began in the 1980s, and has created a scenario that has served only a few physicians, creating some new billionaires.  It has spawned an entire generation of enthusiastic lawyers specializing in litigation in these matters.  Proponents of process or method patents include biotech and pharmaceutical companies and the American Bar Association, while opponents number a coalition of multiple medical societies and consumer advocacy groups. 

Worldwide, close to 80 countries, including Great Britain and Canada, currently disallow medical procedure patents.  Indeed, only the United States and Australia do have provisions for such protection of intellectual property.

The World Medical Association has issued a Statement on Medical Process Patents, taking the position that the practice “poses serious risks to the effective practice of medicine by potentially limiting the availability of new procedures to patients.”  It considers the practice “unethical and contrary to the values of professionalism…”

The American  Medical Association had historically prohibited medical patents of any sort beginning with the original 1847 edition of The Code of Ethics of the American Medical Association.  This opinion was revised in the 1950s to allow medical device patents, and later, patents related to human gene research.  The organization has continued to firmly oppose process and technique patents because of the danger that they could limit access and availability of innovative methods.  In 2006, the AMA reaffirmed this stance by restating the ethical responsibility of the physician to make advancements known to colleagues, without limitation of patents, in Principal V of the AMA’s Principal of Medical Ethics. 

Medical advances of the twentieth century were incredible and extreme.  These advances were achieved by creative physicians sharing their techniques in academic journals, at professional meetings, and with their own residents and trainees. The philanthropic or altruistic quality of medicine of the previous centuries is being lost.  Financial incentive played no role in incentivizing the quests to overcome the challenges of congenital abnormalities and world diseases. The physician innovators were dedicated individuals who toiled tirelessly to try to save lives or improve the quality of life of unfortunate victims.  It is true that pharmaceutical companies and manufacturers of medical equipment and supplies benefited more than the physician inventor.  But innovation and creativity exploded as the newly described techniques were modified and improved by other creative practitioners and researchers.

In 1996, an enforcement ban was signed by President Clinton to provide relief from the threat of litigation against physicians for performing medical procedures that were patented. This amendment had been championed by two physician lawmakers, U.S. Rep. Greg Ganske (R-Iowa) and U.S. Sen. Bill Frist (R-Tenn.).  The legislation was strongly urged by the Medical Procedure Patent Coalition.  (This group included the American Academy of Dermatology, the American College of Surgeons, and the American College of Radiology, organizations of which most vein specialists are members.)  However, the ban does not protect a commercial manufacturer or vendor from an “inducement to use” clause that allows lawyers to argue that a vendor has promoted the use of a patented procedure, and thus infringed the patent.

Patients and practicing vein specialists will indeed be the losers in the battle over patent infringements in several ways.  Advancements and improvements in technology will be limited by process or method patents since a very broad definition of ‘method’ is argued by lawyers.  Costs for services in an office or vein center will increase, reducing the physician’s net revenue for service, while insurance companies will continue to accrue substantial savings from vein therapy being performed outside of hospitals.  Reimbursement will certainly not increase.  Provision of services may no longer be feasible through insurance contracts, and likely it will not be cost effective to provide care for the Medicare patient. This will indeed restrict services to those able to pay out of pocket.

Physicians have long been burdened with growing overhead from unreasonable malpractice fees due to frivolous suits and ridiculous awards.  Now, additional litigation will indirectly affect medical practice because of the need by suppliers to pass on costs when they are pummeled by obscene awards.  Or worse, suppliers will be able to up charge because they have forced competitors out of business. 

Perhaps it is the inequitable reimbursement for medical and surgical services that leads innovative physicians to seek compensation at the expense of their colleagues.  The patient ultimately becomes the victim, not the beneficiary of this practice.  VTN

Deborah L. Manjoney, MD, FACS, opened the Wisconsin Vein Center and MediSpa in 2002 where she offers offer a range of non-invasive and minimally invasive services. She is a Diplomate of both the American Board of Surgery and the American Board of Thoracic Surgery, and has specialized for 19 years in cardiovascular and thoracic surgery.