[Congressional Record Volume 142, Number 138 (Monday, September 30, 1996)]
[Senate]
[Pages S12023-S12024]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                       MEDICAL PROCEDURES PATENTS

 Mr. FRIST. Mr. President, I am very pleased that the omnibus 
appropriations bill being considered today includes S. 2105, 
legislation I introduced regarding the enforcement of patents for pure 
medical procedures. I greatly appreciate Senator Gregg's efforts to 
include this provision.
  Patent law has been a cornerstone of both law and economics since the 
founding of our Nation. The issuance of patents was one of the few 
powers expressly granted to the Federal Government by the Constitution.
  Patents allow inventors to recoup their investment and thereby 
encourage continuous innovation. Without the protection of patents, 
individuals, and businesses would be reluctant to invest their time, 
money, and energy into developing new technologies.
  While the appropriateness of patents in general has long been 
established, it has been somewhat controversial with respect to health 
care. Initially, the medical community took a dim view of the 
patentability of therapeutic drugs or devices. Many felt that it was 
morally wrong to profit from improvements in medical care. For 
instance, the first application for a patent on aspirin was denounced 
as an attempt to blackmail human suffering.
  In time, however, the medical community and others came to realize 
that, without the benefit of patent law, many improvements in medical 
care would never materialize.
  As in other areas of human endeavor, improvements in health care 
often require significant investments of time and money. Without the 
ability to recoup these investments through patents, critical research, 
and development would never get off the ground.
  The appropriateness and importance of allowing patents for 
pharmaceuticals and medical devices is now well-established. But the 
appropriateness of patenting medical innovations that do not involve 
drugs or devices but are simply improvements in surgical or medical 
techniques remains highly controversial. I think for good reason.
  Unlike innovations in medical drugs and devices, innovations in pure 
procedures--such as discovering a better way to suture a wound or set a 
broken bone--are constantly being made without the need of significant 
research investments.
  Allowing a doctor to enforce a patent on such improvements would have 
disastrous effects. Furthermore, innovations in surgical and medical 
procedures do not require the midwifery of patent law. They will occur 
anyway as they have throughout history.
  My legislation would prevent the enforcement of so-called pure 
medical procedure patents against health professionals. It would in no 
way, however, change patent law with respect to biotechnology, medical 
devices, drugs. or their methods of use. As a result, this narrowly 
tailored legislation would in no way discourage the important research 
being done in these areas of medicine.
  I intended to offer my legislation as an amendment to the Commerce, 
Justice, State appropriations bill because a related amendment was 
offered by Congressman Ganske when the House considered this bill. That 
amendment--which passed overwhelmingly by a vote of 295-128--took a 
very broad brush approach. It would have prohibited the Patent Office 
from issuing any medical procedure patents.
  Because the scope of the Ganske amendment was not clearly defined, it 
could have impacted many worthwhile patents in biotechnology and 
pharmacology. Accordingly, representatives of these industries came to 
me after the passage of the Ganske amendment to express their interest 
in crafting an alternative approach. The legislation included in this 
bill is the result of that effort.
  Because the Commerce, Justice, State appropriations bill was never 
considered on the Senate floor, I did not have the opportunity to offer 
my legislation as an amendment. I am pleased, however, that this 
legislation was nonetheless included in this omnibus bill as an 
alternative to the Ganske language.
  My legislation enjoys the support of the American Medical Association 
as well as numerous medical specialty groups that are very concerned 
about this matter. And, while the biotech and pharmaceutical industries 
opposed the Ganske amendment, they were instrumental in crafting this 
narrower approach.
  The need for this legislation stems from the recent case of Pallin 
versus Singer. The facts of this case are very compelling. In 
performing cataract surgery, an ophthalmologist by the name of Dr. 
Pallin chose not to stitch the cataract incision because the patient 
was experiencing heart problems.
  When Dr. Pallin later discovered that the incision healed better 
without the stitch, he sought and was awarded a patent for ``no 
stitch'' cataract surgery. Dr. Pallin subsequently sought to license 
this procedure for a fee of $4 per operation. Although the no-stitch 
procedure was widely used, few surgeons were willing to meet Dr. 
Pallin's demands.
  In 1994, Dr. Pallin brought a patent infringement suit against 
another eye surgeon and his affiliated hospital. After incurring nearly 
$500,000 in legal defense costs, a settlement was finally reached. The 
settlement, however, does not foreclose the prospect of future lawsuits 
of this kind.
  There is legitimate concern that Pallin represents the future unless 
we nip it in the bud.
  My legislation is very narrow in scope. It would simply prevent the 
enforcement of patents against health professional or their affiliated 
facilities for pure procedure patents such as Dr. Pallin's. It does not 
impact in any way the patentability of medical devices, drugs, or their 
methods of use.
  This change in law is essential. Allowing health professionals to be 
sued for using innovations in pure medical or surgical procedures would 
have four disastrous consequences.
  First, health care costs would explode if doctors charged licensing 
fees for every new surgical or medical techniques they developed. There 
are thousands of new medical and surgical techniques developed every 
year.

[[Page S12024]]

  Permitting innovative doctors to charge a fee every time their new 
technique was used would be a windfall for the doctor but a huge and 
costly burden for the patient community. Because these innovations 
would occur anyway, these additional costs would be wholly unnecessary.
  Second, it would greatly jeopardize patients' right to privacy. In 
order to know if a patent was infringed upon, patent holders could 
demand access to surgical notes and other detailed medical records to 
know precisely what kinds of procedures were used. Not only would this 
raise serious privacy concerns, but providing all of these records 
would be an administrative nightmare.
  Third, allowing pure procedure patents would undermine the medical 
community's tradition--and ethical duty--of freely exchanging 
information for the benefit of patients. As a surgeon, I know first 
hand that medical training involves a very important social contract 
between health professionals. Making improvements in surgical or 
medical care and sharing those innovations with others is a critical 
part of the medical profession's commitment to advancing its art.
  I was fortunate enough to innovate in my capacity as a heart 
transplant surgeon, but I always understood that my innovations were 
possible because I stood on the shoulders of giants.
  I was able to advance the science of heart transplants because I had 
the benefit of superb teachers who themselves were great innovators. 
For me to have sought patents on new surgical techniques would have 
violated this social contract.
  Fourth, it will open the door to FDA regulation of all aspects of 
medical practice.
  While the FDA regulates medical devises and pharmaceuticals, it has 
no authority to regulate the general practice of medicine. The response 
to those who have advocated comprehensive FDA regulation of medical 
practice has been that checks and balances already exist to assure that 
patients receive appropriate care. One of those checks is the peer 
review process. If we undermine the peer review process but injecting 
patent-seeking into the heart of the practice of medicine, we will have 
opened the door for proponents of more expansive FDA regulation.
  If we accept the argument that innovations in pure procedures should 
be treated no differently than innovations in drugs or devices for 
purposed of patent law, we open ourselves up to the argument that they 
should be treated no differently for other purposes as well--including 
FDA regulation.
  Not only would pure procedure patents have disastrous effects on 
health care, they are unnecessary to encourage innovation.
  It is important that we not lose sight of the underlying purpose of 
patent law. Its function is not to reward innovations after the fact. 
Its purpose is to encourage innovation that would not occur otherwise. 
This rationale does not apply to innovations in pure medical and 
surgical procedures because such innovations have and will continue to 
occur without the benefit of patent law.
  Further, unlike innovations in medical devices or drugs, pure-
procedure innovations do not require huge investments of capital. As 
Dr. Pallin's no stitch cataract surgery indicates, most breakthroughs 
are discovered in the course of treatment. This is partly why the AMA's 
Code of Medical Ethics holds pure-procedure patents to be unethical.
  Doctors have an ethical duty to seek the best care for their 
patients. This includes the duty to innovate when necessary. Also, 
recognition among one's peers for innovation and excellence is a 
tremendous incentive for doctors. Every doctor wants the cachet of 
publishing an article in a medical journal detailing their innovation. 
Finally, to augment these private motivations to innovate, millions of 
dollars in public and private grants are available each year to advance 
pure-procedure technology further.
  As a result, not only would allowing pure procedure patents to be 
enforced against doctors be detrimental to health care, it would not 
serve the underlying purpose of patent law which is to encourage 
innovation.
  In closing, I want to thank Congressman Ganske with whom I have been 
working for the past year on this important subject. His amendment 
provided the impetus to address this important matter in the waning 
days of this Congress.
  I also want to thank Senator Gregg and his staff for their strong 
support. Without Senator Gregg's commitment, this legislation would not 
have been possible.
  Finally, I want to assure opponents of my legislation that I take 
seriously their concerns and will be the first to join them in 
revisiting this issue if its unwitting effect is to chill medical 
innovation. While I do not believe this will be the effect, I agree 
that it warrants a watchful eye.

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