[Congressional Record Volume 141, Number 161 (Wednesday, October 18, 1995)]
[Senate]
[Pages S15291-S15292]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. FRIST:
  S. 1334. A bill to amend chapter 28 of title 35, United States Code, 
to provide for noninfringing uses of patents on medical and surgical 
procedures; to the Committee on the Judiciary.


        the medical procedures innovation and affordability act

 Mr. FRIST. Mr. President, I rise today to introduce 
legislation that will address what I believe is a growing problem in 
the medical community. It may come as a surprise to my colleagues in 
the Senate, to health care consumers, and even to some physicians, that 
the U.S. Patent and Trademark Office issues patents for purely medical 
procedures.

  Most physicians are unaware that patents can be issued for medical 
procedures, and even if they were, few would seek to limit the ability 
of other physicians to use the most up-to-date and effective procedures 
in providing health care. Yet, an alarming trend of obtaining and 
enforcing medical procedure patents is on the rise in the medical 
community, and I strongly believe that a legislative solution is 
necessary.
  Mr. President, for most of our history, advancements in medical 
procedures, independent of a new medical device or pharmaceutical, were 
not considered patentable. In 1954, the Patent Office reversed its 
prior rulings and issued a decision which has been interpreted to 
provide broad authority for the issuance of medical method patents. The 
increasing incidence of the issuance of these patents is in conflict 
with broader health policy goals.
  Mr. President, advances in health care are encouraged and fostered in 
an atmosphere where professionals share their research and publish the 
results of their work. Physician specialties conduct annual meetings to 
discuss the latest techniques, and important discoveries are published 
and subject to the critical peer review process. There is simply an 
element of unfairness if doctors are allowed to claim ownership of 
procedures which were developed based on years of cooperative clinical 
experience and research.
  A recent lawsuit, and increasing demand for the payment of royalties 
on patented medical procedures, has caused a growing concern that the 
issuance of medical method patents will increase the cost of health 
care, and quite possibly, keep physicians from providing the best 
treatment available. For example, in 1993, Dr. Samuel Pallin, an 
Arizona ophthalmic surgeon, sued Dr. Jack Singer, a Dartmouth Medical 
School professor of ophthalmology, for patent infringement involving a 
technique for stitchless cataract surgery. Dr. Pallin sought a patent 
on the technique, even though many ophthalmic surgeons, including 
Dartmouth's Dr. Singer, were using this technique before Dr. Pallin 
sought his patent.
  And this is not an isolated example. Medical method patents issued in 
recent months include patents relating to implanting a knee prosthesis, 
closing an incision in muscle tissue, calculating the risk of coronary 
heart disease, using donor plasma for ear infections, diagnosing 
Alzheimer's disease, treating rheumatoid arthritis, performing laser 
surgery without damaging nearby tissue, treating bone disorders, 
treating aneurysms, and the list goes on and on. Obviously, doctors and 
others have begun to realize that if the practice of granting and 
enforcing medical method patents continues to spiral, they must protect 
themselves 

[[Page S 15292]]
by seeking patents on procedures they use. That prospect is 
frightening.
  Mr. President, the practice of enforcing medical patents against 
physicians and other health care providers has profoundly negative 
implications for the entire health care field. And that is why I am 
introducing legislation that would provide an exception from the 
definition of patent infringement for medical and surgical procedures. 
With this approach, physicians and others will still be entitled to 
seek and obtain a medical method patent, but there will be no 
infringement if the procedure is used by other physicians or other 
licensed health care practitioners. And because the legislation does 
not impose a ban on the issuance of medical method patents, there 
should be no concern that the legislation would prohibit biotechnology 
companies from enforcing their patent rights against commercial users 
with respect to any patentable advancements in areas such as gene 
therapy, cell therapy, or with respect to new uses for well-known 
drugs. Additionally, Mr. President, there is an explicit exemption for 
the commercial manufacture of drugs, medical devices and any other 
products regulated by the Food and Drug Administration, which should 
also provide substantial protection for the biotechnology industry.
  Mr. President, more than 80 nations, including Japan, Germany, Great 
Britain, and France, prohibit the issuance of medical method patents. 
Increased enforcement of medical method patents will increase health 
care costs, limit access to quality health care, and ultimately put 
patient privacy at risk. The legislation I am introducing will limit 
the enforcement of medical method patents against physicians, while 
preserving the rights of the biotechnology industry. I believe this 
legislation is both balanced and necessary, and I urge my colleagues to 
support its passage.

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