In the mid-1990s, Dr. Samuel Pallin patented a type of stitch-less cataract surgery procedure. He attempted to license the patent to other ophthalmologists. One such surgeon was Dr. Jack Singer. Singer not only refused the demand for royalties, but started a broad political movement against medical procedure patents. Singer argued he actually devised the procedure before Pallin’s patent was filed. Pallin said he was not interested in the money, but recognition. Pallin had submitted a manuscript of his technique to the Journal of Cataract and Refractive Surgery, but it was not accepted for publication.
Hence, the battle.
In a mass mailing to colleagues, Singer wrote:
Dr. Singer [is] vigorously defending this action. We see no merit in the specific allegations, nor do we agree with the underlying premises of Dr. Pallin’s suit, i.e., that surgeons can or should patent the shape of incisions, or that giving reports on your own surgical experiences at professional meetings can constitute inducement of infringement. We believe that such patenting and such interpretation of what constitutes infringement is inconsistent with the applicable code of professional conduct and the advancement of medical science through the free and open exchange of ideas.
In describing a settlement offer, Pallin’s attorney noted:
Dr. Pallin has stated on a number of occasions that he would never seek an injunction or an unreasonable royalty from a surgeon or anyone else so you and Dr. Singer may be assured that no one will be stopped from using this incision in the future. At the most they will be asked to pay a small royalty.
Eventually, the court issued a Consent Order declaring the patent claims invalid and noninfringed and ordering Pallin not to make any further enforcement attempts. The Pallin v. Singer litigation thus ended, having resulted in no pathbreaking ruling on the patentability of medical procedures.
Congress ultimately passed 35 U.S.C. § 287(c) in 1997. That statute eliminates remedies against physicians for infringement of many medical procedure patent claims. The gist of the legislation was that medical procedures could still be patented, but enforcement for damages against physicians would be a near-impossible task. There’s be no pot of gold waiting at the end of the rainbow.
(Without getting into the weeds, there are exceptions.
If the medical or surgical procedure includes the use of (1) a patented machine, manufacture or composition of matter that results in infringement of the patented machine, manufacture or composition of matter, or (2) the practice of the patented use of a composition of matter that would result in infringement of the patented composition of matter, or (3) the practice of a process that infringes a biotechnology patent, then the activity does not comprise a ‘medical activity’ that falls within the exception to the enforcement of the patent.
What does this mean? If, for example, the patented medical procedure is tied to a patented medical device, then, yes, lawsuits for damages are possible. But, from a practical perspective, that is not much different from being sued for infringing on the patented medical device alone.)
In addition to Congress, medical societies also weighed in.
In 1994, the AMA House of Delegates voted to oppose the practice of medical and surgical patents, deeming them unethical. Another medical society, the American Academy of Orthopaedic Surgeons, reached the same conclusion:
Medical Procedure Patents may impede the advancement of medicine, curtail academic access, compromise peer review, place unreasonable limits on the research community, directly interfere with the education of new physicians, and interfere with the physician-patient relationship and the quality of medical care provided to the patient. Under these circumstances, the patenting of “pure” medical procedures or techniques would be unethical.
Physicians contribute to the medical literature advancing the field for all to use. Medical progress depends upon the free flow of information. Placing a lock on the use of such information conflicts with how physicians have practiced medicine from time immemorial. Given that pure medical procedure patents are unenforceable and that medical societies deem them unethical, I can’t understand why practitioners would pay tens of thousands of dollars to prosecute such patent claims. Perhaps it is for the recognition and street cred.
What do you think?
ABOUT THE AUTHOR
Jeffrey Segal, MD, JD
Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.
Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.
If you have a medico-legal question, write to Medical Justice at infonews@medicaljustice-staging.shfpvdx8-liquidwebsites.com.
There are several moving parts here. First there’s the question of patenting anything. If a patent is allowable for something, then unless patent laws are rewritten to permit ~only~ that something and things like it to enjoy patent protection, then disallowing anything that is deemed patentable constitutes unequal protection of laws, and is thus unconstitutional. That Congress decided to pass a law disallowing the prosecution of obvious infringement doesn’t make that decision legal or constitutional, it only makes it something Congress decided to pass.
Disallowing patent rights for the technique smacks of the Big Three’s virtually criminal infringement on Bob Kearns’ patents for the intermittent windshield wiper. While government was only involved in Kearns’ case in providing the venue for litigation, the speciousness of the auto manufacturers’ arguments rivals the government’s for Pallin’s.
Next is the issue of what kind of protection a technique–as distinct from a drug or device–is appropriate. Thinking about it, it seems that a copyright rather than a patent would be the right protection. That would work to the inventor’s credit since copyrights are typically good for 99 years and are renewable; patents today are good for 20 years from date of filing. Even though Dr. Pallin’s paper was not accepted for publication, he could have accomplished the same thing by paying to publish it in a newspaper after copyrighting the text.
This area remains hazy: I haven’t looked up the particulars of the first GUI’s and computer mice, but between them and operating systems–among other pieces of software–the issue of protection, and mechanisms to achieve it are still contentious areas of law. Does MicroSoft patent or copyright their stuff? Intangibles need to be treated uniformly; I’m not sure they are.
Ethics is another dimension of the question. Medicine and related fields (pharmacology, nursing, etc.) are intrinsically different from all other professions in that peoples’ lives are literally in the balance. If a lawyer loses a case, (apart from a capital one), his client doesn’t die. If an athlete–many of whom vastly out earn all but very few physicians and surgeons–doesn’t perform or (heaven forfend) and actor muffs a few lines, no one really cares. (The only ethical question I see for any of them is their public lives meshing with their professional ones–something that, by the way, doctors can’t allow to happen in their own lives.)
So, is it ethical to withhold a superior technique in exchange for money? It probably is. But is that how you want to be remembered? If, say, Pallin declined to operate on someone because they couldn’t pay him, would that be unethical? Why would it be? Same argument here dealing with the use of the technique.
Disclosure: I have about 20-30 patents on devices I’ve invented, and I have retired on proceeds from them and the company they spawned (Micrus Endovascular Corporation, bought by J&J in 2010). What I made practicing medicine would have been far, far less than that. I also published any number of procedures that are in common use today for which I’ve been paid exactly nothing in royalties, even in recognition: what becomes common practice doesn’t get footnoted in dictations, and I’m more than fine with that. I content my self knowing that imitation is the sincerest form of flattery.