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PubMed1996

Norms for patents concerning human and other life forms.

The rationale of patients on transgenic organisms leads to the startling notion of the human qua infringement. The moral reasons by which we may tenably reject such notion are not conclusive as to human life forms outside the body. A close look at recombinant DNA experimentation reveals ingenious processes, but not entities that the body lacks. Except for artificial genes, the genes of biotechnology are found on chromosomes, albeit nonconsecutively, and their uninterrupted transcripts appear in messenger RNA. An enhanced form of protection for ingenious processes, the "human methods patent," is proposed and defended as a replacement for product patents. The proposed patent would pertain to biotechnology manufacturing and genetic intervention in somatic and germ cells. A counterpart could govern nonhuman life forms. It is argued that compulsory licensing protections should be a condition of such patent. Contrary to the conservative assumption that statutory sobriquets suffice, the reckoning of what qualifies as a patentable ingenious process will continue to require systematic scientific guidance.

Animals↗

PubMed2001

Transcatheter coil closure of large patent ductus arteriosus with 0.052-inch Gianturco coils using myocardial biopsy forceps in a 70-year-old woman.

Small patent ductus arteriosus is generally closed in children using a transcatheter coil. This is done less often in older patients or those with large patent ductus arteriosus. We report successful antegrade transcatheter coil closure of patent ductus arteriosus in a 70-year-old woman. Into the patent ductus arteriosus, using flexible myocardial biopsy forceps, we placed two large 0.052-inch Gianturco coils, which were easily used as multipurpose vascular occlusion coils. The forceps and the coils were readily available and provided complete occlusion. Other delivery devices cannot deliver such large coils. Transcatheter coil closure thus appears to be safe and effective for closing large patent ductus arteriosus in the elderly.

Aged↗

PubMed2000

Are natural gene sequences patentable?

The title question is answered in the affirmative. The patentability of natural gene sequences is based on general principles of patent law, and depends on novelty, inventive steps and industrial applicability of the subject matter to be patented. Patentability is further confirmed by the particular articles of the European Patent Convention and the recent EC Directive on the legal protection of biotechnological inventions.

Base Sequence↗

PubMed2004

Dynamic competition in pharmaceuticals. Patent expiry, generic penetration, and industry structure.

This paper investigates patterns of industrial dynamics and competition in the pharmaceutical industry, with particular reference to the consequences of patent expiry in different countries. We focus on the competition at the level of single chemical entities, distinguishing between original brands and generic products. Quarterly data, spanning from July 1987 to December 1998, on sales of pharmaceutical products in four countries (USA, UK, Germany, and France) constitute the basis of our analysis. All the products containing major molecules whose patent expiration date lies between 1986 and 1996 are included in our sample. We show how diffusion of generics is linked to the characteristics of the market and investigate how price dynamics of original products are affected by generic competition. Our empirical investigation shows that the dynamics of drug prices and the competition by generic drugs vary significantly across countries. This heterogeneity notwithstanding, a clear distinction seems to emerge. On the one hand, systems that rely on market-based competition in pharmaceuticals promote a clear distinction between firms that act as innovators and firms that act as imitators after patent expiry. Here, original products enjoy premium prices and exclusivity profits under patent protection, and face fierce price competition after patent expiry. On the other hand, in systems that rely on administered prices, penetration by generic drugs tends to be rather limited. Its descriptive and preliminary nature notwithstanding, our analysis seems to have relevant implications at different levels of generality, especially for Europe.

Costs and Cost Analysis↗

PubMed2005

Can drug patents be morally justified?

This paper offers a few elements of an answer to the question to what extent drug patents can be morally justified. Justifications based on natural rights, distributive justice and utilitarian arguments are discussed and criticized. The author recognizes the potential of the patents to benefit society but argues that the system is currently evolving in the wrong direction, particularly in the field of drugs. More than a third of the world's population has no access to essential drugs. The working of the patent system is an important determinant of access to drugs. This paper argues that drug patents are not easily justified and that the 'architecture' of the patent system should be rethought in view of its mission of benefiting society.

Human Rights↗

PubMed2005

Ethics and patentability in biotechnology.

The systems of patent rights in force in Europe today, both at the level of national law and on the regional level, contain general clauses prohibiting the patenting of inventions whose publication and exploitation would be contrary to "ordre public" or morality. Recent years have brought frequent discussion about limiting the possibility of patent protection for biotechnological inventions for ethical reasons. This is undoubtedly a result of the dynamic development in this field in the last several years. Human genome sequencing, the first successful cloning of mammals, and the progress in human stem cell research present humanity with many new questions of an ethical nature. Directive 98/44 of the European Parliament and of the Council of July 6, 1998, on the Legal Protection of Biotechnological Inventions created a new basis for patent protection in this field of technology. Based on the European experience to now, however, it must be said that patent law is not the right place to legislate the consequences of the morality of an invention.

Bioethics↗

PubMed1983

Noninvasive evaluation of Blalock-Taussig shunts: determination of patency and differentiation from patent ductus arteriosus by doppler echocardiography.

Pulsed Doppler echocardiography has been used to detect continuous turbulent flow in the right pulmonary artery after Blalock-Taussig shunts. Since continuous turbulent flow could also arise from patent ductus arteriosus (frequently present in the neonate), continuous turbulent flow in the right pulmonary artery is not specific for Blalock-Taussig shunt function. We evaluated 35 Blalock-Taussig shunts from suprasternal or high parasternal approach for flow in the right pulmonary artery, and in the Blalock-Taussig shunts themselves. From precordial approach, Doppler evaluations of the main pulmonary artery were also made in search of flow characteristic of patent ductus arteriosus. Doppler detection of flow within the Blalock-Taussig shunts indicated shunt patency, and indicated that continuous turbulent flow in the right pulmonary artery was not due to only patent ductus arteriosus. Shunts were proven patent in 31 patients, occluded in four. Twelve patients also had patent ductus arteriosus. By Doppler, the right pulmonary artery had continuous turbulent flow in 30 of 31 patients in whom the right pulmonary artery was found. From the suprasternal or high parasternal approach, the right Blalock-Taussig shunts were detected by marked continuous turbulent flow directed away from the transducer, between the aortic and superior vena caval flow signals. Left Blalock-Taussig shunts had similar directional continuous turbulent flow. Prosthetic shunts were identified by the dense shunt material. Twenty-four of 31 functional shunts were identified, and all contained continuous turbulent flow. Three left-sided shunts were missed. All four occluded shunts were identified by Doppler, and had no lumen flow within.(ABSTRACT TRUNCATED AT 250 WORDS)

Diagnosis, Differential↗

PubMed1990

Prevalence of additional cardiovascular anomalies in patients referred for transcatheter closure of patent ductus arteriosus.

Catheter closure of the patent ductus arteriosus is now a reality. The purpose of this study was to establish the prevalence of associated cardiovascular defects and the accuracy of echocardiography in patients referred for transvenous ductal closure. This study reviewed 146 patients seen from 1981 to 1988: 126 with only a patent ductus arteriosus (Group I) and 20 with additional cardiovascular anomalies (Group II). Groups I and II did not differ significantly in age, gender or physical examination except for the presence of a continuous murmur (Group I 100% versus Group II 80%, p less than 0.001). A left patent ductus arteriosus was visualized by two-dimensional echocardiography in 96% of patients and was evident by Doppler study in 100%. A patent ductus arteriosus was not seen in six patients including a patient who was found to have only a collateral network from the aorta to the main pulmonary artery. The 12 patients with noncardiovascular abnormalities such as Down's syndrome were more likely than the overall group to have additional cardiovascular anomalies (6 of 12, p = 0.001). The cardiovascular anomalies encountered were varied. Eight of the 20 patients with such anomalies had only a restrictive ventricular septal defect in addition to the patent ductus arteriosus. Significant anomalies found at catheterization included two thoracic arteriovenous malformations and an isolated right carotid artery draining into the right pulmonary artery by way of a right ductus arteriosus. This study indicates that echocardiography is an effective diagnostic technique in this patient group. A thorough cardiac catheterization with angiography should be performed before implantation of a ductal device.

Child, Preschool↗

PubMed1991

Transcatheter closure of a large patent ductus arteriosus with the clamshell septal umbrella.

In 14 patients undergoing transcatheter closure of a large (greater than 4 mm diameter) patent ductus arteriosus, occlusion was attempted with use of the Bard Clamshell septal umbrella. Patient age ranged from 0.7 to 30.4 years. Isolated patent ductus arteriosus was present in 11 patients; 3 had additional congenital heart lesions. Moderate or severe pulmonary hypertension was present in four patients. The diameter of the patent ductus arteriosus ranged from 4.5 to 14 mm, as determined by contrast injection through an 11F sheath or by balloon sizing; it appeared larger by this method than by the standard angiographic method. All 14 patent ductus arteriosi were successfully closed. Prior embolization of a Rashkind umbrella was the reason for using a Clamshell device in three patients; one additional embolization of a Clamshell device occurred. All errant devices were retrieved at cardiac catheterization, without associated hemodynamic instability. No other complications occurred. Among the 14 patients, 11 had complete ductal closure by Doppler color flow mapping at last follow-up and 3 had trivial residual flow. All four patients having associated complex lesions or pulmonary hypertension, or both, had symptomatic improvement after the procedure, although one child (with Shone's anomaly) died 3 months later. The Clamshell device provides stable and effective closure of a large patent ductus arteriosus, and allows transcatheter closure to be offered to some patients who were previously considered unsuitable for this procedure.

Adolescent↗

PubMed1994

Transcatheter patent ductus arteriosus occlusion: application in the small child.

OBJECTIVES: This study intended to evaluate application of transcatheter occlusion of the patent ductus arteriosus in children < 10 kg body weight. BACKGROUND: Transcatheter occlusion of the patent ductus arteriosus in the child weighing > 10 kg has been proved safe and effective. METHODS: We reviewed 74 consecutive patients weighing < 10 kg (median 8.1 kg, range 3.98 to 10) and aged 4 to 30 months (median 13 months) who underwent patent ductus arteriosus occlusion between June 1986 and November 1992. A modification of the delivery system to facilitate application in small children is described. RESULTS: A 12-mm device was implanted in 50 patients and a 17-mm device in 24. Three device embolizations occurred early in the experience, and one required removal because of hemolysis associated with a moderate residual shunt. One 17-mm device was removed at catheterization because of acute compromise to left pulmonary artery flow after implantation. Prevalence of residual shunting was 33% at 6 months, 20% at 12 to 18 months and 17% at 2-year follow-up and was not related to device, age, weight or size of the patent ductus. Altered flow to the left pulmonary artery was noted in seven patients (9.9%), with more significant compromise associated with the 17-mm device. CONCLUSIONS: Transcatheter patent ductus arteriosus occlusion is feasible in the small child < 10 kg, particularly with the use of a modified delivery system. However, implantation of a 17-mm device in this patient population may impair flow to the left lung and should be reserved for the symptomatic child.

Cardiac Catheterization↗

PubMed1996

Effect of ligation of patent ductus arteriosus on left ventricular performance and its determinants in premature neonates.

OBJECTIVES: The purpose of this study was to determine in preterm newborn infants the effects of ductal ligation on ventricular performance and its determinants: preload, afterload and contractility. BACKGROUND: Neonatal ventricular performance is highly sensitive to afterload. Therefore, the increase in systemic vascular resistance associated with ligation of a patent ductus arteriosus might worsen ventricular performance in the preterm infant. METHODS: All 14 premature infants undergoing patent ductus arteriosus ligation in a 1-year period at our institution underwent echocardiography at three times: before, immediately after and 24 h after ligation. Indexes studied included ventricular performance (fractional area change), preload (left ventricular end-diastolic dimension), afterload (end-systolic wall stress) and contractility (the difference between the measured and predicted velocity of circumferential fiber shortening). Blood pressure was measured; systemic resistance was calculated. These data were compared with those of 14 preterm infants without patent ductus arteriosus. RESULTS: The infants with patent ductus arteriosus had higher values for ventricular performance (mean +/- SD fractional area change 60 +/- 9% vs. 52 +/- 11%, p < 0.05) and lower values for wall stress (22 +/- 6 vs. 44 +/- 17 g/cm2, p < 0.05) before ligation than did the control group. At 24 h after ligation, ventricular performance was not significantly changed (fractional area change 60 +/- 9% to 57 +/- 12%). There were significant increases in blood pressure and systemic vascular resistance but no changes in wall stress or contractility. CONCLUSIONS: Ventricular performance is higher in premature infants with than in those without patent ductus arteriosus because afterload is lower in the former group. Although ductal ligation increases blood pressure and systemic resistance, wall stress and ventricular performance are maintained. Our results suggest that the premature newborn maintains ventricular performance during stress, at least in part, by manipulating afterload.

Blood Pressure↗

PubMed1977

Transposition of the great arteries with intact ventricular septum and patent ductus arteriosus.

At the time of initial balloon atrial septostomy a patent ductus arteriosus was found with angiography in 39 of 81 infants with transposition of the great arteries with intact ventricular septum. By angiographic criteria the ductus shunt was considered small in 21 infants and large and significant in 18. In contrast to the usual clinical presentation of neonates with transposition and intact ventricular septum, 12 of these 18 infants with a significant patent ductus arteriosus had only slight cyanosis and 8 presented with tachypnea out of proportion to the degree of cyanosis. Ten of the 18 infants had no continuous murmur, bounding pulses, mid-diastolic rumble or differential cyanosis. Clinically occult narrowing or closure occurred, presumably gradually and relatively late, in six infants. Acute early narrowing or closure, spontaneous (six infants) or surgically produced (three infants), occurred usually within the 1st month of life and was associated with a marked decrease in arterial oxygen saturation in eight infants, often with a rapid clinical deterioration. Persistence of a large patent ductus arteriosus for several months appears to be associated with an increased incidence of early pulmonary vascular disease. Therapeutic considerations for the infant with a large patent ductus arteriosus after initial balloon atrial septostomy include: (1) careful initial follow-up of the infant in clinically stable condition in case the ductus arteriosus should acutely narrow or close and the patient require urgent palliative or corrective surgery; (2) urgent early closure of the ductus in the infant with overt left heart failure with concurrent atrial septectomy or preferably primary corrective surgery; and (3) elective closure of a persistent significant patent ductus arteriosus before age 4 months with concurrent corrective surgery in the infant in clinically stable condition.

Abnormalities, Multiple↗

PubMed1980

Management of patent ductus arteriosus in preterm babies.

There is a higher incidence of delayed closure of the patent ductus arteriosus in premature babies with respiratory distress syndrome. From July, 1975, to December, 1977, 57 small, preterm infants with patent ductus arteriosus were diagnosed at our neonatal intensive care unit. From July, 1975, until September, 1976 (first period), 23 patients were diagnosed, and 11 underwent surgical ligation of a patent ductus arteriosus. There were 3 early deaths. From October, 1976, until December, 1977, out of a total of 34 patients with diagnosed patent ductus, 18 were treated with indomethacin, and only 3 required ligation. Our present policy for patent ductus arteriosus with respiratory distress syndrome in the premature baby is to initiate early treatment with indomethacin. If this treatment fails and the infant's status deteriorates, we perform early surgical ligation of the ductus in order to minimize the time on mechanical ventilation and lessen the chances of the development of bronchopulmonary dysplasia.

Ductus Arteriosus↗

PubMed2001

Gene patents: socially acceptable monopolies or an unnecessary hindrance to research?

Why should patents be granted on genes? This question is a provocative and troubling issue currently facing society. Looking at the commercial realities of gene patents, I conclude that on balance their effect is to retard, rather than to stimulate, both scientific and economic progress. The monopolies awarded by patents on genes as novel chemicals are not therefore in the public interest. Society would benefit from immediate change in the policy of patent offices to limit the allowance of patents on genes to specified uses with only narrow claims.

Biotechnology↗

PubMed2006

Initial clinical experience in transcatheter closure of large patent arterial ducts in infants using the modified and angled Amplatzler duct occluder.

OBJECTIVE: To establish the feasibility and efficacy of closing large patent arterial duct in infants, using the modified and angled variants of the Amplatzer duct occluder. BACKGROUND: Closure of large patent arterial ducts by inserting devices in sick and underweight infants, particularly those weighing around 5 kilograms, remains a challenge. Bigger devices require larger delivery sheaths and may cause obstruction either to the aorta or left pulmonary artery. Negotiating a large device is difficult or impossible, as the sheath gets kinked. Because of these problems, such underweight infants with large ducts who are failing to thrive, and in left ventricular failure with associated lesions, are typically referred for surgery, often leading to higher morbidity and mortality. METHODS: We attempted to close such large patent arterial ducts using the new Amplatzer occluder, modified with single layer of polyester, and the angled occluder, with no polyester material, inserted through a specially braided kink-resistant sheath. RESULTS: Closure was achieved in 10 infants, with mean age of 8.2 months, mean weight of 5.5 kilograms, the lowest weighing 3.9 kilograms. The mean size of the patent ducts was 6.3 millimetres, with the largest measuring 8.6 millimetres. We implanted 6 modified and 4 angled occluders. In one patient, suffering from hydronephrosis, a 14/12 angled device embolized and was retrieved, but the patient died. In the remaining patients, all ducts were closed completely, with no obstruction to either the aorta or left pulmonary artery. On follow up, all showed excellent clinical improvement. CONCLUSION: Complete closure of very large patent arterial ducts is now possible, even in very sick and underweight infants, using the large but low profile custom-made angled or modified versions of the Amplatzer occluder.

Balloon Occlusion↗

PubMed2003

Patenting human genes: when economic interests trump logic and ethics.

To date, over 5,000 applications have been filed with United States Patent Office for patents on human genes. More than 1,500 of these applications have been granted. Other jurisdictions are experiencing a similar rush to mine and protect genomic gold. This paper argues that although many jurisdictions allow the patenting of human genes, this is ethically indefensible and amounts to an unjustified appropriation of a general human heritage. Economic and legal arguments in favour of patenting are considered and rejected. Reference is made to the Wellcome Trust Consortium's initiative and the Merck Gene Index Project, which place patented genetic information into the public domain.

Biotechnology↗

PubMed1997

Structure and function in gene patenting.

The United States patent system treats DNA sequences as large chemical compounds in determining their patentability. This approach has been helpful to those who seek to patent previously unidentified DNA sequences, but it may prove less advantageous from the perspective of those who elucidate biological functions and disease relevance of previously identified genes. A current controversy over patent rights for DNA sequences encoding leptin receptors provides a useful case study for illustrating some of the issues that are likely to arise in applying doctrine derived from chemical patent cases in the context of gene discovery.

Animals↗

PubMed2001

Recurrent cerebrovascular events associated with patent foramen ovale, atrial septal aneurysm, or both.

BACKGROUND: Patent foramen ovale and atrial septal aneurysm have been identified as potential risk factors for stroke, but information about their effect on the risk of recurrent stroke is limited. We studied the risks of recurrent cerebrovascular events associated with these cardiac abnormalities. METHODS: A total of 581 patients (age, 18 to 55 years) who had had an ischemic stroke of unknown origin within the preceding three months were consecutively enrolled at 30 neurology departments. All patients received aspirin (300 mg per day) for secondary prevention. RESULTS: After four years, the risk of recurrent stroke was 2.3 percent (95 percent confidence interval, 0.3 to 4.3 percent) among the patients with patent foramen ovale alone, 15.2 percent (95 percent confidence interval, 1.8 to 28.6 percent) among the patients with both patent foramen ovale and atrial septal aneurysm, and 4.2 percent (95 percent confidence interval, 1.8 to 6.6 percent) among the patients with neither of these cardiac abnormalities. There were no recurrences among the patients with an atrial septal aneurysm alone. The presence of both cardiac abnormalities was a significant predictor of an increased risk of recurrent stroke (hazard ratio for the comparison with the absence of these abnormalities, 4.17; 95 percent confidence interval, 1.47 to 11.84), whereas isolated patent foramen ovale, whether small or large, was not. CONCLUSIONS: Patients with both patent foramen ovale and atrial septal aneurysm who have had a stroke constitute a subgroup at substantial risk for recurrent stroke, and preventive strategies other than aspirin should be considered.

Adolescent↗