DR. SAMUEL PALLIN: (talking to patient) Well, hi, Mr. Dercoli. How are you today?
PAT DERCOLI: I'm very good.
DR. SAMUEL PALLIN: (talking to patient) Well, good.
FRED DE LAZARO: Pat Dercoli is one of hundreds of patients--
DR. SAMUEL PALLIN: (joking with patient) We have to stop meeting like this.
FRED DE SAM LAZARO: --who've come to Phoenix ophthalmologist Samuel Pallin for cataract surgery, the removal of a clouding in the lens of the eye that occurs with age.
DR. SAMUEL PALLIN, Ophthalmologist: (still talking to patient) Well, you can't beat this. Two months after surgery, cataracts in both eyes, lens implants, self-sealing incisions, no sutures, 20- 20 in each eye, no glasses. That's wonderful.
FRED DE SAM LAZARO: Cataract surgery was never complicated; however, for today's patients like Dercoli, it's also virtually painless. They no longer need stitches or spectacles, a major advancement, thanks to a new surgical technique which Dr. Pallin says he developed in 1991.
DR. SAMUEL PALLIN: This is a demonstration of my technique for cataract surgery.
FRED DE SAM LAZARO: The normal route for doctors is to publish an innovation in medical journals; however, Pallin's work was rejected at first of being of little importance. It took more than a year before it was accepted and published, but by then, Pallin had embarked on an alternate route, one growing in popularity among doctors. He took his new technique to the U.S. Patent Office.
DR. SAMUEL PALLIN: Many people were working on the same concept and I wanted to be sure that I recorded what I did and frankly took credit for what I did. And the other thing is under our system in this country, generally speaking, one is compensated for intellectual property.
FRED DE SAM LAZARO: After the Patent Office ruled that his technique, indeed, was unique, Pallin did something no other physician has yet done. He sued a Vermont clinic for infringement and sought royalty payments. Now, patents on pure knowledge or methods have long been frowned on by medical institutions and society. So Pallin's action has drawn sharp rebuke. Daniel Broderick head's Mayo's Office of Technology Transfer.
DANIEL BRODERICK, Mayo Clinic: I've never had a Mayo physician even ask a question of whether or not a pure method or pure procedure is patentable. Mayo certainly believes that we're here to educate as much as anything else, and the method of just how to do something, umm, is, is--shouldn't be patented and be subject to someone's exclusive use or exclusive rights. It belongs in the public domain for everyone to benefit from.
DR. BERNARD MORREY, Mayo Clinic: This is an example of an effort of our department to share surgical techniques with the orthopedic community.
FRED DE SAM LAZARO: Dr. Bernard Morrey is head of orthopedic surgery at the Mayo Clinic. He's also credited as co-author of a widely used method for elbow surgery.
FRED DE SAM LAZARO: You never thought to patent something like this?
DR. BERNARD MORREY: No. That never occurred to us. The, the idea of patenting a procedure didn't occur to us because there is no certainty that this was truly a unique idea, that somebody else had not had the idea, possibly even described it, we just weren't able to find in the literature, and so it would seem presumptuous to patent the idea, but it would seem appropriate to share the idea.
FRED DE SAM LAZARO: Beyond the ethical question of "owning a method," Dr. Morrey says there are practical and cost-related concerns. For instance, even if the patent office recognizes a method as unique, Morrey says in surgery, it's difficult to keep it that way.
DR. BERNARD MORREY: With any surgical procedure, at least in orthopedics, there's something of a joke that if we see a new procedure described and we do this procedure, we almost always modify it from the original description before we ever do it, and so there's virtually no procedure that is done precisely as the author has described it. And at what point does one's intellectual property, if that's what we're calling this, stop and my modification makes it different enough to where this is no longer a patented idea? This, this seems to me to be an issue that is almost impossible to adjudicate. I see litigation after litigation after litigation arising from this, from this realm of control. And if there is ever a sleeping giant in the cost of health care, it's the litigation issue.
FRED DE SAM LAZARO: Dr. Pallin argues that patents encourage innovation and that can lower costs. He cites his own example. By eliminating the cost of sutures in cataract surgery, he figures the system saves millions of dollars each year. And Pallin has no qualms about accepting a financial reward.
DR. SAMUEL PALLIN: The Hippocratic Oath to which many of us subscribed in medical school says that doctors will not be paid for teaching medical and surgical things to other doctors, and, yet, we all pay medical school tuition. When we go to learn a new technique with a laser, we may pay $3,000 for a weekend course. This is business. And business in America includes medical business. In fact, some of the corporations we are seeing in managed care, which is a hot subject right now, are paying their executives seven figures a year. No doctor earns that kind of salary.
FRED DE SAM LAZARO: Dr. Pallin also argues the medical establishment has a double standard on patents. He notes that the Mayo Clinic has patented several innovations involving devices like this artificial hip. The Mayo's Broderick says there's good reason for device patents, to attract companies to manufacture them.
DANIEL BRODERICK: Our motivation to develop that device, take it through the FDA at great expense and so forth, was some degree of certainty that they will have some exclusive right to sell that device into the marketplace and regain the money that they put into the development and further refinement of the device, in addition to make a profit.
DR. SAMUEL PALLIN: The Constitution of the United States indicates that the writings and discoveries of those engaged in the arts and sciences should be protected by patent law and instructed Congress to do so. They didn't say devices. They didn't say not methods. The writers of the Constitution said discoveries and writings.
DR. BERNARD MORREY, Mayor Clinic: Why is it that the development of a new device does not seem to threaten the very essence of medical education, whereas, patenting ideas does threaten the very essence of what our profession is all about. And there is no question that it does. It's kind of like asking one to define and to describe a soul.
FRED DE SAM LAZARO: Dr. Morrey says the medical establishment may seem to have a double standard that rewards only those who develop devices, but he says most doctors understand their Hippocratic Oath requires that knowledge, ideas be freely shared and taught for the benefit of patients.
DOCTOR: (in surgery) This one looks very good.
FRED DE SAM LAZARO: Dr. Pallin says patents and royalty payments should not hinder the sharing of ideas; however, in late March, he settled his Vermont lawsuit by agreeing not to seek royalties for the sutureless cataract procedure. Although Pallin was the first to take a case this far, the U.S. Patent Office has been granting a growing number of pure method medical patents, up to 15 a week. All this has prompted Congress to step in. The U.S. House is considering legislation backed by several physician groups that would outlaw the patenting of pure methods in medicine.