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PubMed1992

Atrial natriuretic peptide in the diagnosis of patent ductus arteriosus.

The aim of this study was to measure plasma atrial natriuretic peptide in preterm infants with a patent ductus arteriosus before and after closure with indomethacin. Atrial natriuretic peptide was measured in 28 preterm infants with clinical and echocardiographic evidence of a patent ductus arteriosus and in eight preterm infants who did not develop clinical evidence of a patent ductus arteriosus. Plasma concentration of atrial natriuretic peptide was measured by radioimmunoassay. In 18 infants the patent ductus arteriosus closed after one course of indomethacin; atrial natriuretic peptide levels decreased from median 1240 pg/ml (range 201-5483 pg/ml) to 266 pg/ml (range 62-1108 pg/ml). In four infants the patent ductus arteriosus closed after two courses of indomethacin and two infants had surgical ligation after indomethacin treatment failed. The patent ductus arteriosus closed spontaneously in four infants (atrial natriuretic peptide median level 152 pg/ml, range 61-495 pg/ml). In the eight infants without patent ductus arteriosus, atrial natriuretic peptide level was median 224 pg/ml (range 38-876 pg/ml). Measurement of plasma atrial natriuretic peptide concentration has a role in predicting when indomethacin treatment is indicated.

Atrial Natriuretic Factor↗

PubMedDate not supplied

The shifting functional balance of patents and drug regulation.

Patents are often portrayed as the necessary reward to compensate pharmaceutical firms for the huge costs and risks associated with Food and Drug Administration (FDA)-mandated clinical trials of new drugs. But the relationship between the patent system and other regulation of drugs is more complex than this simple formulation suggests. Drug regulation operates in tandem with patents to make proprietary products profitable, and patents themselves increasingly threaten to limit profitability by diverting profits elsewhere. At the same time, resistance to high drug prices is prompting new state and federal regulatory initiatives that threaten to reduce the value of drug patents. The distinctive intertwining of patents with other regulatory regimes and the shifting role of patents in the biopharmaceutical sector call into question how this singular success story for innovation policy will play out in the future.

Drug Approval↗

PubMed2003

Patenting of genome research results.

In light of the enormous investments for the sequencing of genomes and the subsequent development of pharmaceuticals, obtaining patents for these results is a major goal of companies working in this area. This article focuses on the present situation concerning the possibility to obtain patent protection for genome research results, in particular at the European Patent Office (EPO), in the US and in Japan. Trilateral projects have recently been established to consolidate the cooperation for the administration of the practice to search, examine and grant patent applications in order to gain possible mutual benefits. Accordingly, this article aims to assist people working in the field of genomic research to understand the basic principles of obtaining patents for DNA inventions in light of the practice of the EPO, the United States Patent and Trademark Office (USPTO) and the Japanese Patent and Trademark Office (JPTO).

Drug Industry↗

PubMed2005

The quest for market exclusivity in biotechnology: navigating the patent minefield.

A patent is a legal device that grants an inventor market exclusivity over a new invention or medication. Market exclusivity can mean tremendous economic rewards for the patent holder because it provides the inventor with a monopoly over the invention for the 20-year patent term. Obtaining a patent and retaining market exclusivity can be a treacherous process, especially in the arena of biotechnology patents. Scientific, legal, and practical considerations must be carefully weighed to best protect an inventor's rights. This article explores some common patenting pitfalls as well as emerging issues that are specific to the area of biotechnology patenting.

Biotechnology↗

PubMed2006

DNA patenting: implications for public health research.

I weigh the arguments for and against the patenting of functional DNA sequences including genes, and find the objections to be compelling. Is an outright ban on DNA patenting the right policy response? Not necessarily. Governments may wish to consider options ranging from patent law reforms to the creation of new rights. There are alternative ways to protect DNA sequences that industry may choose if DNA patenting is restricted or banned. Some of these alternatives may be more harmful than patents. Such unintended consequences of patent bans mean that we should think hard before concluding that prohibition is the only response to legitimate concerns about the appropriateness of patents in the field of human genomics.

Base Sequence↗

PubMed2001

The use of renal Doppler ultrasonography to diagnose patent ductus arteriosus in preterm infants.

OBJECTIVE: To prospectively study the diagnostic usefulness of altered renal waveforms in patent ductus arteriosus. METHODS: We studied preterm infants undergoing echocardiography for a suspected patent ductus arteriosus. A spectral Doppler display was acquired for both renal arteries, and a resistive index was obtained. Sensitivity, specificity, and likelihood ratios were calculated using a clinically significant patent ductus arteriosus (>1.5-mm diameter on color Doppler ultrasonography) as the standard of reference. RESULTS: Fifty infants had 78 scans. A significant patent ductus arteriosus was present on 39 scans. When the renal resistive index was greater than 1.0, the likelihood ratio for a significant patent ductus arteriosus was 24.8 (specificity, 97.2%; SD, 3.8%). When the renal resistive index was 1.0 or less, the likelihood ratio for a significant patent ductus arteriosus was 0.2 (sensitivity, 77.2%; SD, 9.4%). CONCLUSIONS: Renal resistive index measurement is a simple investigation that can predict a significant patent ductus arteriosus in patients without congenital heart disease or other causes of diastolic runoff when echocardiography is unavailable.

Ductus Arteriosus, Patent↗

PubMed1999

Disease gene patents: overcoming unethical constraints on clinical laboratory medicine.

The rapidly growing number of disease gene patents--patents that claim all methods for diagnosis of a particular genetic condition--threatens the ability of physicians to provide medical care to their patients. In the past, patented diagnostic tests were made broadly available to the medical community in the form of test kits or licenses to use the patented test. Disease gene tests, however, are being monopolized by a small number of providers. Monopolization of medical testing services: (a) threatens to restrict research activities; (b) creates unacceptable conflicts of interest; (c) may reduce patient access to testing; (d) may lead to inequitable extensions of patent terms on tests and related discoveries; and (e) grants to patent holders the ability to dictate the standard of care for testing, and to otherwise interfere with the practice of medicine. Because of the risks raised by monopolization, amendment of the patent law to require compulsory licensing of physicians providing medical services is recommended.

Clinical Chemistry Tests↗

PubMed2003

The attack of the clones: patent law and stem cell research.

This article considers the integral role played by patent law in respect of stem cell research. It highlights concerns about commercialization, access to essential medicines and bioethics. The article maintains that there is a fundamental ambiguity in the Patents Act 1990 (Cth) as to whether stem cell research is patentable subject matter. There is a need to revise the legislation in light of the establishment of the National Stem Cell Centre and the passing of the Research Involving Embryos Act 2002 (Cth). The article raises concerns about the strong patent protection secured by the Wisconsin Alumni Research Foundation and Geron Corporation in respect of stem cell research in the United States. It contends that a number of legal reforms could safeguard access to stem cell lines, and resulting drugs and therapies. Finally, this article explores how ethical concerns are addressed within the framework of the European Biotechnology Directive. It examines the decision of the European Patent Office in relation to the so-called "Edinburgh patent", and the inquiry of the European Group on Ethics in Science and New Technologies into "The Ethical Aspects of Patenting Involving Human Stem Cells".

Animals↗

PubMed2003

[The generic Research and Development possibilities after Hungary accessed th European Patent Convention].

January 1, 2003 Hungary became a member of the Munich Convention on the Grant of European Patents (European Patent Convention, EPC). As from January 1, 2003 European patents may be claimed and obtained also for Hungary and European applications may be filed with the Hungarian Patent Office as well. This paper focuses on the exceptional generic R&D possibilities which can harmonize in harmony with all the claims of the Union in spite of the fact that it does not follow general European limitations and practises. Based on the amended Hungarian Patent Law (No. XXXIII of 1995 on the Protection of Inventions by Patents; Article 19 (6)b)) the exclusive right of exploitation shall not extend to acts done for experimental purposes relating to the subject matter of the invention, including experiments and tests necessary for the registration of medicines as well. The national and international legal history and background of the operative Hungarian Patent Law are also presented roughly. The paper deals with the divergence of the originator-generic industry and the EU-USA industry and with the incoherence within the EU itself on the early testing permissions and limitations.

Europe↗

PubMed1987

A patent law primer for clinical chemists and other scientists.

Patenting and commercialization by academic scientists, despite potential drawbacks, are on balance highly desirable if technology is to be transferred from the laboratory to the public use, and if the scientist and his institution are to be encouraged to participate in this transfer. If that premise is accepted, there is much that academic institutions can do to foster utilization of their biotechnological discoveries. Such institutions should have a patent policy that is known to all and that includes a professional patent administrator and clear administrative procedures for carrying out such policy. Scientists should be trained to recognize and protect their inventions and to appropriately disclose their inventions to their patent officers. Ideally, scientists should know the rudiments of the patent statutes of their own country and should be aware of what constitutes trade secrets. Scientists should be given guidance in working with patent attorneys in the preparation and prosecution of patent applications. Finally, given human nature, institutions should see to it that their scientists are provided with a suitable environment in which to invent, and appropriate incentives to do so.

Chemistry, Clinical↗

PubMedDate not supplied

Association of patent ductus arteriosus and phototherapy in infants weighing less than 1000 grams.

To determine the relationship of phototherapy and patent ductus arteriosus, we analyzed prospectively collected data on 295 infants with birth weight of 501 to 999 gm admitted from 1984 through 1988. Seventy-four percent were evaluated by an imaging study to aid in the detection of a silent patent ductus arteriosus. Overall incidence of patent ductus arteriosus in the study population was 63%. Infants who received phototherapy (n = 128) had an increased incidence of patent ductus arteriosus compared with those who did not receive phototherapy (76% vs 53%). There was an association of patent ductus arteriosus and phototherapy (p < 0.05) when we analyzed the data with a stepwise regression model that controlled for the effects of gestational age, birth weight, gender, race, diagnosis of hyaline membrane disease, mechanical ventilation, patent ductus arteriosus imaging studies, prophylactic indomethacin, peak total and indirect bilirubin values, and the occurrence of abnormal serum sodium values. We conclude that the use of phototherapy is associated with an increased incidence of patent ductus arteriosus in extremely low birth weight infants.

Ductus Arteriosus, Patent↗

PubMed2006

Effects of patent blue on human retinal function.

BACKGROUND: Dye solutions for intraoperative staining of epiretinal membranes and the internal limiting membrane improve the visualisation of these thin structures and facilitate their removal. Lately, the application of patent blue for staining of the internal limiting membrane has been proposed as an alternative to the standard procedures during macular hole surgery. In the present study we investigated the effects of patent blue 0.48% on human retinal function. METHODS: An isolated human retina preparation was perfused with a standard solution and the electroretinogram (ERG) was recorded repeatedly. After recording of stable ERG amplitudes the nutrient solution was substituted by a commercially available patent blue solution. The duration of retinal exposure to the dye solution was varied between 15 s and 4 min. Thereupon, the preparation was reperfused with standard solution for 2 h. The percentage of b-wave reduction after exposition was calculated. RESULTS: No effects on the human ERG were seen after 15 and 30 s of dye application. Reversible reductions of the b-wave amplitude were found for an exposure period of 60 and 120 s, respectively. After 4 min of patent blue application a persistant b-wave amplitude reduction by 40% was found. CONCLUSIONS: Patent blue affects human retinal function when applied for at least 1 min. However, no irreversible effects on the human ERG were seen even after 2 min of retinal exposure to patent blue. Thus, toxic effects on retinal function after intraoperative short-term application of patent blue 0.48% appear unlikely to occur.

Coloring Agents↗

PubMed2026

Adaptive proteomic remodeling and eNOS upregulation in luminal endothelium and perivascular adipose tissue of patent saphenous vein grafts after CABG.

OBJECTIVE: Long-term patency of saphenous vein grafts (SVGs) remains a significant challenge in coronary artery bypass grafting (CABG). The biological factors underlying successful human grafts are poorly understood. We aimed to characterize the structural and molecular features associated with successful graft function. METHODS: Patent and occluded SVG and internal thoracic artery (ITA) grafts were obtained from explanted hearts of CABG patients undergoing heart transplantation for end-stage heart failure not attributable to graft failure, along with freshly harvested ITA and SVG controls. Samples underwent histomorphological analysis, immunohistochemistry (IHC), and liquid chromatography-tandem mass spectrometry (LC-MS/MS) proteomics. RESULTS: Patent ITA (ITA-P) showed minimal intimal hyperplasia with medial reinforcement, whereas patent SVGs (SVG-P) had organized, α-smooth muscle actin (αSMA)-positive myofibroblast-rich neointima. Endothelial nitric oxide synthase (eNOS) was markedly upregulated in patent grafts at two sites-the luminal endothelium and adventitial microvessels within perivascular adipose tissue (PVAT)-and lost at both sites in occluded SVG (SVG-O). Adventitial CD31-positive microvessels were significantly increased in patent grafts. Proteomically, ITA-P and SVG-P shared a largely common adaptive proteome enriched in translation, RNA processing, and extracellular matrix (ECM) organization, with shared upstream activation of NR4A3, EGFR, and STAT1, and conduit-specific signatures (IGF-1/RUNX2 in ITA-P; RETN/SRC/PTGES in SVG-P). PTGES was strongly expressed in the adventitia of SVG-P. CONCLUSIONS: Patent arterial and venous bypass grafts exhibited a shared adaptive phenotype characterized by dual-site upregulation of eNOS in both the luminal endothelium and the perivascular microvessels/PVAT. In SVG-P, PTGES was co-upregulated alongside eNOS, indicating a mechanistic link between the proteomic and IHC findings. These findings highlight the perivascular compartment as a site of adaptive, eNOS-associated changes in patent vein grafts.

Humans↗

PubMed2004

Patent foramen ovale, systemic embolization and closure.

The recognition, evaluation and treatment of patent foramen ovale has attracted increasing interest as the importance and frequency of paradoxical embolism has become better understood. The interest in this field has been driven largely by the widespread application of echocardiography with identification of a patent foramen ovale and/or an atrial septal aneurysm. The evaluation of the role of a patent foramen ovale in patients with a neurologic event is complex because the patent foramen ovale or atrial septal aneurysm may either be an innocent bystander or could be the etiologic mechanisms involved in the paradoxical embolus. In patients younger than 55 years, a causal relationship between a patent foramen ovale/atrial septal aneurysm and a neurologic ischemic event is considerably stronger than in those patients older than 55 years. In patients with a presumed diagnosis of paradoxical embolus in the setting of a patent foramen ovale, percutaneous closure is now possible and 2 devices are relatively widely used. Both of these devices reliably close the defect with a very acceptable risk profile and have been found in the longer term to be associated with excellent outcome. The exact role, however, that these devices play vis a vis continued medical therapy for prevention of recurrent events is being tested in 2 randomized clinical trials. The field continues to change with new technology being developed and with new applications. A recently exciting finding has been the identification that closure of a patent foramen ovale may be associated with dramatic improvement in symptoms of patients with disabling migraine headaches. Other potential applications of these devices include those patients who are deep-sea divers, in whom the potential for "bends" exists, or high altitude airplane pilots.

Echocardiography↗

PubMed2003

[Prevalence of patent foramen ovale in young patients with cerebral ischemic accident of unknown origin].

INTRODUCTION AND OBJECTIVE: Patent foramen ovale has been associated with stroke in young patients with cryptogenic stroke. The purpose of this study is to examine the prevalence of patent foramen ovale in this group of patients, as well as their anatomical and functional characteristics by contrast echocardiography, trying to determine ictus risk markers in young patients with acute ischemic stroke. PATIENTS AND METHOD: Prospective study of 90 patients under the age of 50 who were hospitalised consecutively due to a clinical presentation suggestive of stroke. No cause was found in 55 out of 90 (group I) and the rest, in which an stroke was finally disregarded, were used as the control group (group II). A transthoracic and transesophageal echocardiography examination with 2 types of contrast agents was performed in all patients to determine the presence of a patent foramen ovale and its anatomical and functional characteristics. RESULTS: Patent foramen ovale was observed more frequently in group I than in group II (43 versus 21%; p < 0.05). Among patients with a patent foramen ovale those with an ischemic stroke showed greater mobility of the oval membrane, more frequent large shunts of contrast in a single frame in the left heart, and more frequent shunts at rest. Transesophageal echocardiography without contrast showed a high sensitivity (90%) and specificity (93%) for detecting anatomically permeable foramen ovale whereas contrast transthoracic echocardiography showed a low sensitivity (13%). There were no differences between the two contrasts used. CONCLUSIONS: Near half of young patients with ischemic stroke of an unknown origin have a patent foramen ovale. A bigger mobility of the membrane of the oval cavity and a large degree of shunt contrast as well as shunt at rest detected by contrast transesophageal echocardiography, seem to identify patent foramen ovale patients with ischemic stroke. In these patients, transthoracic echocardiography has low sensibility for detecting permeability of the foramen ovale.

Adult↗

PubMed2000

Selective laparoscopic probing for a contralateral patent processus vaginalis reduces the need for contralateral exploration in inconclusive cases.

BACKGROUND/PURPOSE: Repair of an indirect inguinal hernia is the most common procedure performed by pediatric surgeons, yet the need for contralateral exploration remains controversial. This prospective study evaluated the use of laparoscopy combined with the selective use of probing to determine the presence or absence of a contralateral patent processus vaginalis (CPPV). METHODS: A consecutive series of 75 of the author's patients presenting with a unilateral inguinal hernia were studied. Laparoscopy was performed through the known hernia sac with CO2 insufflation utilizing a 4-mm 70 degrees telescope to inspect the contralateral inguinal region. A patent processus was diagnosed when an obvious opening through the internal ring was identified. In some patients this evaluation was found to be inconclusive because of the inability to determine accurately the length of the patent processus or to rule out a patent processus obscured by a veil of peritoneum. This group of patients was then evaluated selectively with a silver probe placed under direct vision through a 14-gauge intravenous catheter placed through the abdominal wall on the side in question to manipulate the peritoneum and directly measure the length of the potentially patent processus. A patent processus greater then 1.5 cm was considered positive. RESULTS: A total of 54 patients (72%) had a conclusive laparoscopic evaluation of the contralateral inguinal region with a CPPV clearly absent in 38 and an obvious CPPV present in 16. A total of 21 patients (28%) had inconclusive laparoscopy finding and were evaluated further with probing. The probing technique changed the determination of a CPPV in 15 patients (12 positive to negative and 3 negative to positive; P = .029, Fisher's Exact test). Probing resulted in a decrease in the overall rate of identification of a CPPV from 45% to 32%. CONCLUSION: In inconclusive cases, the addition of selective probing to the laparoscopic evaluation for a CPPV reduces the number of patent processus vaginalis found and the need for contralateral inguinal exploration.

Female↗

PubMed1999

Hepatic manifestations of familial patent ductus venosus in adults.

BACKGROUND: The ductus venosus connects the umbilical vein to the inferior vena cava during fetal life and subsequently closes rapidly after birth. It is known as patent ductus venosus when it remains patent in adulthood. PATIENTS: A 43 year old man with a history of panhypopituitarism presented with recurrent bouts of pedal oedema associated with fatigue, hypoalbuminaemia, and elevated prothrombin time. An ultrasound examination of his abdomen with Doppler revealed notable attenuation of the main portal vein with diminished intrahepatic branches; a computed tomography scan with angiography revealed a large collateral vein within the liver consistent with a patent ductus venosus. Sequential liver biopsies showed a considerable reduction in the calibre and number of the portal veins. His younger brother, who was diagnosed with alcohol related cirrhosis, suffered from intermittent bouts of encephalopathy and was found to have the same vascular lesion. A third brother was found to have a patent ductus venosus as well as two large hepatic masses consistent with focal nodular hyperplasia. CONCLUSION: The syndrome of familial patent ductus venosus has only previously been described in three infant brothers who presented with hepatic encephalopathy and fatty degeneration of the liver. This report documents three brothers with a patent ductus venosus presenting in adulthood with different manifestations of liver disease. The presence of the same vascular anomaly in three brothers is highly suggestive of a recessive genetic trait with an anatomical manifestation of patent ductus venosus.

Adult↗

PubMed1993

Comparison of diagnostic techniques for the detection of a patent foramen ovale in stroke patients.

BACKGROUND AND PURPOSE: The prevalence of a patent foramen ovale has been shown to be increased in patients with ischemic stroke. Transesophageal echocardiography, transthoracic echocardiography, and transcranial Doppler examination with contrast injection can all be used to search for a patent foramen ovale. We compared the accuracy of these techniques for identifying a patent foramen ovale in 49 patients with acute ischemic stroke or transient ischemic attack. METHODS: Transcranial Doppler examination of the right middle cerebral artery was performed during simultaneous transthoracic echocardiography with aerated saline injection, and again during transesophageal echocardiography; the latter was adopted as the "gold standard" for assessing the sensitivity of the other two tests. RESULTS: Contrast transesophageal echocardiography detected a patent foramen ovale in 19 of 49 patients (39%), during normal respiration in 15 of them and during Valsalva maneuver in 4. Transcranial Doppler correctly identified 13 patients with a patent foramen ovale and all 30 patients without it. Therefore, the sensitivity of transcranial Doppler was 68% (13/19), and its specificity 100% (30/30). The 6 patients misclassified by transcranial Doppler (false negatives) had a very small right-to-left shunt detected by transesophageal echocardiography. Contrast transthoracic echocardiography was found to be the least sensitive test, detecting a patent foramen ovale in only 9 of 19 patients (47%). The specificity of transthoracic echocardiography was 100% (30/30 patients). The low sensitivity of transthoracic echocardiography was principally due to the suboptimal image quality obtained in false-negative patients. Both transcranial Doppler and transthoracic echocardiography were more sensitive in patients with cryptogenic stroke than in patients with stroke of determined origin. This may indicate the presence of larger, more easily detectable shunts in patients with cryptogenic stroke. CONCLUSIONS: Transesophageal echocardiography is more sensitive than transcranial Doppler examination in detecting a patent foramen ovale, but only in cases of minimal right-to-left shunts, the clinical relevance of which remains to be established. The sensitivity of transthoracic echocardiography is heavily hampered by the frequency of inadequate heart visualization.

Aged↗