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The latorre patent issue: Extortion or entrepreneurship
THE LATORRE PATENT ISSUE: EXTORTION OR ENTREPRENEURSHIP GARY LEIFER, From the Kansas City Urological
Beginning in March 1994, most urologists across the country began receiving letters from Men’s Health Resources, Inc. (MHR) informing us that they had acquired the rights to US patent no. 4,127,118 issued to Alvaro Latorre. MHR claims that the patent, “Method of Effecting and Enhancing an Erection,” encompasses all treatments of impotence based on penile injection of vasodilators. The letter goes on to state that anyone prescribing such treatment is infringing on the patent and subject to damages. MHR was willing to “accommodate” those physicians wishing to continue such treatment by issuing a license for such use for $350. This entitled the physician to the use and prescription of this method for the remainder of the calendar year 1994. An additional $650 is required for 1995. This clearly raises practical as well as ethical issues for individual urologists across the country, but even more pointedly for those of us who practice in the same metropolitan area where MHR is based. The practical issue is the validity of the patent and the financial impact its enforcement has on the urological community; the ethical issue is whether a medical or surgical procedure should be patentable. HISTORICAL
BACKGROUND
One of the early articles on the mechanism of erection was published in 1933 by Henderson and R0epke.i They demonstrated that acetylcholine, a known vasodilator, produced an erection when injected intra-arterially essentially into the pudendal artery. They were aware that this would result in the drug directly perfusing the erectile tissue within the penis. An article in the Journal of Urology by Newman, et al.2 in 1964 documented the production of an erection by perfusing saline into one corpus. They Submitted: October November 22, 1994
U ROLOCW
24, 1994, accepted
(with
/ MAY 1995 I VOLUME 45, NUMBER 5
revisions):
M.D.
Society, Kansas City, Missouri
documented cross-circulation between the corpora. They believed that arterial vasodilation with or without venous occlusion was the mechanism underlying erections. The drugs that Latorre later used for direct penile injection were known vasodilators well in advance of the patent application.3 Latorre’s patent application in 1977 describes a dual syringe device for the simultaneous injection of an appropriate vasodilator in both corpora simultaneously. The drugs of preference he indicated were isoxsuprine, nylidrin, tolazoline, and nicotinyl alcohol. His only experience with the technique apparently was with self-injection, as no human or animal studies are cited anywhere. The scope of the patent is defined by the claims listed below: 1. A method of enhancing an erection of the penis by injecting into the penis a predetermined amount of an appropriate vasodilator. 2. The method of claim 1, wherein multiple injections into the penis are made simultaneously. 3. The method of claim 1, wherein the injection is into the corpora cavernosa. 4. The method of claim 1, wherein the injection is into the corpus spongiosum. 5. The method of claim 1, wherein the injection is subcutaneous, into the area of the dorsal arteries. 6. The method of claim 1, wherein said vasodilator is a sympathomimetic amine. 7. The method of claim 6, wherein said sympathomimetic amine is nylidrin hydrochloride. 8. The method of claim 1, wherein said vasodilator is an adrenergic blocking agent. 9. The method of claim 8, wherein said adrenergic blocking agent is tolazoline hydrochloride. 10. The method of claim 1, wherein said vasodilator is isoxuprine hydrochloride. 11. The method of claim 1, wherein said vasodilator is nicotinyl alcohol. Dr. Latorre apparently never attempted to enforce or profit from this patent from 1978 to 1988. In 1988, Surgitek acquired conditional rights to
725
the patent, but patent firms in New York and Connecticut advised them that it was invalid and unenforceable. Surgitek ultimately did not pursue it, and the rights were returned to Latorre. After Dr. Latorre’s death in 1992, his widow sold the rights to Pos-T-Vat, Inc. Ultimately, MHR has acquired these rights. VALIDITY ISSUES In a memorandum (April 20,1994), Michael Pretl, legal counsel for the American Urological Association (AUA), summarized why a number of patent attorneys believe the patent is invalid. First, “prior art” had already disclosed and discussed a method of local injection of vasodilators to produce an erection. The Latorre method should therefore have been “anticipated” under patent law. Second, his method should have been found “obvious” under patent law, because the mechanics of the process were well known and would be apparent to a person of ordinary skill in the specialty. Third, there was a suggestion that prior research was not disclosed to the patent office and the application was therefore submitted in “bad faith.” ETHICAL
ISSUES
Should a medical or surgical procedure be patentable? Ours is not the only specialty to face this issue. An ophthalmologist has been sued for using a new type of incision for cataract surgery What has happened to our Hippocratic ideals? Section 9.08 from the Code of Medical Ethics of the American Medical Association (AMA) is: NEW MEDICAL PROCEDURES: In the ethical tradition expressed by Hippocrates and continuously affirmed thereafter, the role of the physician has been that of a healer who serves patients, a teacher who imparts knowledge of skills and techniques to colleagues, and a student who constantly seeks to keep abreast of new medical knowledge. Physicians have an obligation to share their knowledge and skills and to report the results of clinical and laboratory research. This tradition enhances patient care, leads to the early evaluation of new technologies, and permits the rapid dissemination of improved techniques. The intentional withholding of new medical knowledge, skills, and techniques from colleagues for reasons of personal gain is detrimental to the medical profession and to society and is to be condemned. Prompt presentation before scientific organizations and timely publication of clinical and laboratory research in scientific journals are essential elements in the foundation of good medical care.
The AMA is trying to address these issues, and a number of resolutions were introduced at the annual meeting in June 1994. These all strongly oppose the patenting of medical or surgical procedures. It is hoped that efforts made at a con-
726
gressional level will lead to legislative the patent laws.
reform
of
ROLE OF THE AMERICAN UROLOGICAL ASSOCIATION Although the AUA is clearly both an educational and a political organization, most of us also believe that it should also be a service organization to represent the interests of the membership. We in Kansas City were very disappointed that a strong leadership role was not taken by our parent organization. It was our hope that the AUA would take up this challenge, but all they have offered is moral support. It is awfully easy for individuals who are geographically remote to say that it is unlikely that you “locals” are going to be sued or recommend that we pay the $1000 for the 18-month period to avoid the hassle. There are times when things have to be done for principle. The Kansas City Urological Society was unanimous in believing that this was one of them. We are additionally disappointed that the AUA, with $26 million dollars in its treasury, would not contribute any of the $6000 it has cost to file a challenge with the patent office. They claim that involving themselves in a commercial effort could jeopardize their tax-free status. I think that this issue is important enough for them to have sought an Internal Revenue Service ruling before making that decision. Our patent challenge was filed in September. We all hope the results will be favorable and come in time to benefit our colleagues both locally and nationally. Long-term, I urge all of you to write your legislative representatives about patent reform. Current law can only increase the cost of health care as the patent fees are passed on to the consumer. Gary Leifer, M.D. President Kansas City Urological Society Kansas City, MO ACKNOWLEDGMENT. To the Osbon Corporation and their attorneys, Dority and Manning of Greenville, South Carolina, for providing our organization and our patent attorneys with all of their research materials. REFERENCES 1. Henderson V, and Roepke M: On the mechanism of erection. Am J Physiol 106: 441-448, 1933. 2. Newman H, Northrup J, and Devlin J: Mechanism of human penile erection. J Urol 91: 350-353, 1964. 3. Goodman L, and Gilman A: The Pharmacologic Basis of Therapeutics. New York, Macmillan, 1975, pp 467-475, 477-513, 542-547, 736-737.
UROLOGY@
/MAY
1995
I VOLUME
45, NUMBER
5
EDITORIAL COMMENT When we are confronted by a “lion” (in the lion’s den), we are conditioned to do battle, all the while hoping that help is on the way. Moral support lends encouragement but is rarely sufficient in fighting even the good fight. The farreaching effects of this issue cannot be discounted for a moment. On October 7, 1994, Eli Lilly and Co., responding to an inquiry from the Director of Health Policy for the AUA, confirmed to the AUA its decision to limit distribution of papavarine hydrochloride “to hospitals and equivalent settings where the product is used for its indicated purposes as set forth in the product literature” (letter from Eli Lilly and Company, Philhp R. Reid, M.D, Vice President Lilly Research Laboratories, to Stephanie Mensh, Director, Health Policy, AUA, Inc., October 7, 1994). This decision was in response to allegations by a Kansas City law firm and their insistence that Lilly either obtain a license on the use patent for the administration of papavarine for intracavernosal injection or restrict its distribution to avoid such use. The issue of use patents and the licensing of surgical techniques is slowly infiltrating our borders from overseas. Per-
U ROLOCY@ I MAY 1995 I VOLUME 4.5. NUMBER 5
sonal communications document the concerns of US physicians who have contacted physicians abroad in an effort to learn more about the questionable surgical techniques now being used in Europe for penile elongation (augmentation phalloplasty). These inquiries were followed up soon after by contact from an overseas licensing company more than willing to sell a license to the physician permitting him to use certain techniques in the United States. There can be no doubt in our minds that we must address these unsavory trends in the strongest terms. The Kansas City Urological Society is to be complimented (and supported) for initiating action that attempts to refute the claims made by those who hold the rights to the Latorre patent. The editors of Urology@ are also to be commended for bringing this issue into national focus in a scientific journal. William L. Furfow, M.D., F.A.C.S. Emeritus Professor of Urology Naples, FL 33940
727
Beginning in March 1994, most urologists across the country began receiving letters from Men’s Health Resources, Inc. (MHR) informing us that they had acquired the rights to US patent no. 4,127,118 issued to Alvaro Latorre. MHR claims that the patent, “Method of Effecting and Enhancing an Erection,” encompasses all treatments of impotence based on penile injection of vasodilators. The letter goes on to state that anyone prescribing such treatment is infringing on the patent and subject to damages. MHR was willing to “accommodate” those physicians wishing to continue such treatment by issuing a license for such use for $350. This entitled the physician to the use and prescription of this method for the remainder of the calendar year 1994. An additional $650 is required for 1995. This clearly raises practical as well as ethical issues for individual urologists across the country, but even more pointedly for those of us who practice in the same metropolitan area where MHR is based. The practical issue is the validity of the patent and the financial impact its enforcement has on the urological community; the ethical issue is whether a medical or surgical procedure should be patentable. HISTORICAL
BACKGROUND
One of the early articles on the mechanism of erection was published in 1933 by Henderson and R0epke.i They demonstrated that acetylcholine, a known vasodilator, produced an erection when injected intra-arterially essentially into the pudendal artery. They were aware that this would result in the drug directly perfusing the erectile tissue within the penis. An article in the Journal of Urology by Newman, et al.2 in 1964 documented the production of an erection by perfusing saline into one corpus. They Submitted: October November 22, 1994
U ROLOCW
24, 1994, accepted
(with
/ MAY 1995 I VOLUME 45, NUMBER 5
revisions):
M.D.
Society, Kansas City, Missouri
documented cross-circulation between the corpora. They believed that arterial vasodilation with or without venous occlusion was the mechanism underlying erections. The drugs that Latorre later used for direct penile injection were known vasodilators well in advance of the patent application.3 Latorre’s patent application in 1977 describes a dual syringe device for the simultaneous injection of an appropriate vasodilator in both corpora simultaneously. The drugs of preference he indicated were isoxsuprine, nylidrin, tolazoline, and nicotinyl alcohol. His only experience with the technique apparently was with self-injection, as no human or animal studies are cited anywhere. The scope of the patent is defined by the claims listed below: 1. A method of enhancing an erection of the penis by injecting into the penis a predetermined amount of an appropriate vasodilator. 2. The method of claim 1, wherein multiple injections into the penis are made simultaneously. 3. The method of claim 1, wherein the injection is into the corpora cavernosa. 4. The method of claim 1, wherein the injection is into the corpus spongiosum. 5. The method of claim 1, wherein the injection is subcutaneous, into the area of the dorsal arteries. 6. The method of claim 1, wherein said vasodilator is a sympathomimetic amine. 7. The method of claim 6, wherein said sympathomimetic amine is nylidrin hydrochloride. 8. The method of claim 1, wherein said vasodilator is an adrenergic blocking agent. 9. The method of claim 8, wherein said adrenergic blocking agent is tolazoline hydrochloride. 10. The method of claim 1, wherein said vasodilator is isoxuprine hydrochloride. 11. The method of claim 1, wherein said vasodilator is nicotinyl alcohol. Dr. Latorre apparently never attempted to enforce or profit from this patent from 1978 to 1988. In 1988, Surgitek acquired conditional rights to
725
the patent, but patent firms in New York and Connecticut advised them that it was invalid and unenforceable. Surgitek ultimately did not pursue it, and the rights were returned to Latorre. After Dr. Latorre’s death in 1992, his widow sold the rights to Pos-T-Vat, Inc. Ultimately, MHR has acquired these rights. VALIDITY ISSUES In a memorandum (April 20,1994), Michael Pretl, legal counsel for the American Urological Association (AUA), summarized why a number of patent attorneys believe the patent is invalid. First, “prior art” had already disclosed and discussed a method of local injection of vasodilators to produce an erection. The Latorre method should therefore have been “anticipated” under patent law. Second, his method should have been found “obvious” under patent law, because the mechanics of the process were well known and would be apparent to a person of ordinary skill in the specialty. Third, there was a suggestion that prior research was not disclosed to the patent office and the application was therefore submitted in “bad faith.” ETHICAL
ISSUES
Should a medical or surgical procedure be patentable? Ours is not the only specialty to face this issue. An ophthalmologist has been sued for using a new type of incision for cataract surgery What has happened to our Hippocratic ideals? Section 9.08 from the Code of Medical Ethics of the American Medical Association (AMA) is: NEW MEDICAL PROCEDURES: In the ethical tradition expressed by Hippocrates and continuously affirmed thereafter, the role of the physician has been that of a healer who serves patients, a teacher who imparts knowledge of skills and techniques to colleagues, and a student who constantly seeks to keep abreast of new medical knowledge. Physicians have an obligation to share their knowledge and skills and to report the results of clinical and laboratory research. This tradition enhances patient care, leads to the early evaluation of new technologies, and permits the rapid dissemination of improved techniques. The intentional withholding of new medical knowledge, skills, and techniques from colleagues for reasons of personal gain is detrimental to the medical profession and to society and is to be condemned. Prompt presentation before scientific organizations and timely publication of clinical and laboratory research in scientific journals are essential elements in the foundation of good medical care.
The AMA is trying to address these issues, and a number of resolutions were introduced at the annual meeting in June 1994. These all strongly oppose the patenting of medical or surgical procedures. It is hoped that efforts made at a con-
726
gressional level will lead to legislative the patent laws.
reform
of
ROLE OF THE AMERICAN UROLOGICAL ASSOCIATION Although the AUA is clearly both an educational and a political organization, most of us also believe that it should also be a service organization to represent the interests of the membership. We in Kansas City were very disappointed that a strong leadership role was not taken by our parent organization. It was our hope that the AUA would take up this challenge, but all they have offered is moral support. It is awfully easy for individuals who are geographically remote to say that it is unlikely that you “locals” are going to be sued or recommend that we pay the $1000 for the 18-month period to avoid the hassle. There are times when things have to be done for principle. The Kansas City Urological Society was unanimous in believing that this was one of them. We are additionally disappointed that the AUA, with $26 million dollars in its treasury, would not contribute any of the $6000 it has cost to file a challenge with the patent office. They claim that involving themselves in a commercial effort could jeopardize their tax-free status. I think that this issue is important enough for them to have sought an Internal Revenue Service ruling before making that decision. Our patent challenge was filed in September. We all hope the results will be favorable and come in time to benefit our colleagues both locally and nationally. Long-term, I urge all of you to write your legislative representatives about patent reform. Current law can only increase the cost of health care as the patent fees are passed on to the consumer. Gary Leifer, M.D. President Kansas City Urological Society Kansas City, MO ACKNOWLEDGMENT. To the Osbon Corporation and their attorneys, Dority and Manning of Greenville, South Carolina, for providing our organization and our patent attorneys with all of their research materials. REFERENCES 1. Henderson V, and Roepke M: On the mechanism of erection. Am J Physiol 106: 441-448, 1933. 2. Newman H, Northrup J, and Devlin J: Mechanism of human penile erection. J Urol 91: 350-353, 1964. 3. Goodman L, and Gilman A: The Pharmacologic Basis of Therapeutics. New York, Macmillan, 1975, pp 467-475, 477-513, 542-547, 736-737.
UROLOGY@
/MAY
1995
I VOLUME
45, NUMBER
5
EDITORIAL COMMENT When we are confronted by a “lion” (in the lion’s den), we are conditioned to do battle, all the while hoping that help is on the way. Moral support lends encouragement but is rarely sufficient in fighting even the good fight. The farreaching effects of this issue cannot be discounted for a moment. On October 7, 1994, Eli Lilly and Co., responding to an inquiry from the Director of Health Policy for the AUA, confirmed to the AUA its decision to limit distribution of papavarine hydrochloride “to hospitals and equivalent settings where the product is used for its indicated purposes as set forth in the product literature” (letter from Eli Lilly and Company, Philhp R. Reid, M.D, Vice President Lilly Research Laboratories, to Stephanie Mensh, Director, Health Policy, AUA, Inc., October 7, 1994). This decision was in response to allegations by a Kansas City law firm and their insistence that Lilly either obtain a license on the use patent for the administration of papavarine for intracavernosal injection or restrict its distribution to avoid such use. The issue of use patents and the licensing of surgical techniques is slowly infiltrating our borders from overseas. Per-
U ROLOCY@ I MAY 1995 I VOLUME 4.5. NUMBER 5
sonal communications document the concerns of US physicians who have contacted physicians abroad in an effort to learn more about the questionable surgical techniques now being used in Europe for penile elongation (augmentation phalloplasty). These inquiries were followed up soon after by contact from an overseas licensing company more than willing to sell a license to the physician permitting him to use certain techniques in the United States. There can be no doubt in our minds that we must address these unsavory trends in the strongest terms. The Kansas City Urological Society is to be complimented (and supported) for initiating action that attempts to refute the claims made by those who hold the rights to the Latorre patent. The editors of Urology@ are also to be commended for bringing this issue into national focus in a scientific journal. William L. Furfow, M.D., F.A.C.S. Emeritus Professor of Urology Naples, FL 33940
727