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PubMedDate not supplied

Patent tactics in molecular diversity: things that get around, come around (or: there are always exceptions to the rule).

Certain activities which would constitute infringement of a U.S. patent can come within a statutory exemption when the activity is carried out to obtain FDA approval. Exemptions to infringement provided by 35 U.S.C. section 271(e)(1) are discussed along with recent cases interpreting this statute. The evolution of the statute in providing an exemption to activities necessary to obtain FDA marketing approval is described to provide background, legislative intent and show a comparative of the law before and after 1984 when 271(e)(1) was enacted. By analyzing recent cases, criteria for qualifying an activity as exempt from infringement are described--as are activities that do not qualify for the 271(e)(1) exemption. Overall there appears to be a trend to more broadly allowing for activities to qualify as exempt from infringement. This trend may affect the value of patents and determine which technologies a company will seek patent protection on.

Biotechnology↗
PubMed2003

Differential pricing for pharmaceuticals: reconciling access, R&D and patents.

This paper reviews the economic case for patents and the potential for differential pricing to increase affordability of on-patent drugs in developing countries while preserving incentives for innovation. Differential pricing, based on Ramsey pricing principles, is the second best efficient way of paying for the global joint costs of pharmaceutical R&D. Assuming demand elasticities are related to income, it would also be consistent with standard norms of equity. To achieve appropriate and sustainable price differences will require either that higher-income countries forego trying to "import" low drug prices from low-income countries, through parallel trade and external referencing, or that such practices become less feasible. The most promising approach that would prevent both parallel trade and external referencing is for payers/purchasers on behalf of developing countries to negotiate contracts with companies that include confidential rebates. With confidential rebates, final transactions prices to purchasers can differ across markets while manufacturers sell to distributors at uniform prices, thus eliminating opportunities for parallel trade and external referencing. The option of compulsory licensing of patented products to generic manufacturers may be important if they truly have lower production costs or originators charge prices above marginal cost, despite market separation. However, given the risks inherent in compulsory licensing, it seems best to first try the approach of strengthening market separation, to enable originator firms to maintain differential pricing. With assured market separation, originators may offer prices comparable to the prices that a local generic firm would charge, which eliminates the need for compulsory licensing. Differential pricing could go a long way to improve LDC access to drugs that have a high income market. However, other subsidy mechanisms will be needed to promote R&D for drugs that have no high income market.

Developing Countries↗
PubMed2000

Patenting human genetic material: refocusing the debate.

The biotechnology industry has become firmly established over the past twenty years and gene patents have played an important part in this phenomenon. However, concerns have been raised over the patentability of human genetic material, through public protests and international statements, but to little effect. Here we discuss some of these concerns, the patent authorities' response to them, and ways in which to address these issues and to move the debate forward using current legal structures.

Bioethics↗
PubMed2003

Is there a future for 'speculative' gene patents in Europe?

In the face of increasing public opposition to patents claiming property in gene sequences, is it right to deny the validity of patent applications that seem to have firm, if somewhat hypothetical, scientific basis? In this article we review the recent state of the law in Europe as it applies to gene patents in order to determine whether there is any hope for the modern heirs of Galilean innovation.

Animals↗
PubMed2003

A guide to drug discovery. Protecting your inventions: the patent system.

Whether you work for a multi-national pharmaceutical company, a biotech start-up or a university, a knowledge of the patent system is essential for understanding how best to protect the fruits of your research. The aim of this article is to give an overview of what a patent is, how you might get one and the rights that a patent confers.

Biomedical Research↗
PubMed2006

Models for facilitating access to patents on genetic inventions.

The genetics community is increasingly concerned that patents might lead to restricted access to research and health care. We explore various measures that are designed to render patented genetic inventions accessible to further use in research, and to diagnosis and/or treatment. They include the often-recited research or experimental-use exemption, conventional one-to-one licensing and compulsory licensing, as well as patent pools and clearing-house mechanisms. The last two alternatives deserve special attention in the area of human genetics.

Access to Information↗
PubMed2002

Genes and patent policy: rethinking intellectual property rights.

Concerns about human gene patents go beyond moral disquiet about creating a commodity from a part of the human body and also beyond legal questions about whether genes are unpatentable products of nature. New concerns are being raised about harm to public health and to research. In response to these concerns, various policy options, such as litigation, legislation, patent pools and compulsory licensing, are being explored to ensure that gene patents do not impede the practice of medicine and scientific progress.

Biotechnology↗
PubMed2000

Intraoperative recurrent laryngeal nerve monitoring during video-assisted throracoscopic surgery for patent ductus arteriosus.

OBJECTIVE: To develop a technique to identify and localize the recurrent laryngeal nerve (RLN) during video-assisted thoracoscopic surgery (VATS) for patent ductus arteriosus. DESIGN: Prospective clinical study. SETTING: Children's hospital. PARTICIPANTS: Sixty infants and children scheduled for elective closure of patent ductus arteriosus. INTERVENTIONS: With parental informed consent, 60 infants and children undergoing elective VATS for patent ductus arteriosus were studied. A thin, pencil-point, Teflon-coated, stimulating probe allowed direct stimulation (<2 mA, 100-msec pulse width) of the left RLN inside the thorax. A commercially available 4-channel neurologic monitor recorded compound evoked electromyograms (EMGs) from the left RLN and right RLN (as control) by needle electrodes placed percutaneously in the neck. Hoarseness, stridor, feeding difficulties, and voice changes were assessed postoperatively. MEASUREMENTS AND MAIN RESULTS: Left RLN EMGs were easily obtained in 59 of the 60 patients. The surgeon correctly identified the RLN visually once in the first 7 patients; this ability subsequently improved. EMG localization of the location or course of the RLN altered dissection, clip size, or clip position in 37 of 59 patients. CONCLUSION: Intraoperative EMG to identify location and route of the RLN was easy to perform, was effective in identifying RLN position, and appeared to facilitate dissection and clipping of the ductus.

Adolescent↗
PubMed2001

[Echocardiographic findings before and after interventional occlusion of persistently patent ductus arteriosus with the amplatzer duct occluder].

AIM: The Amplatzer duct occluder(R) is a new system for interventional occlusion of persistently patent ductus arteriosus. The purpose of our study was to determine, whether adequate evaluation of this occluder system can be obtained by echocardiography. METHOD: From 11/1999 until 12/2000, 18 patients were included in the study. All underwent interventional occlusion of a patent ductus arteriosus with the Amplatzer duct occluder(R). Echocardiography was performed on admission, on day one and three and six months following the intervention. RESULTS: The mean age of our patients was 4.8 years (9 months - 18.7 years, median 3.2 years), the mean weight was 18.4 kg (6.5 - 66 kg, median 14 kg). All echocardiographic findings prior to intervention were confirmed during cardiac catheterization. Following intervention we were able to visualize the occluder system and its relation to surrounding structures in all patients. In none of our patients we found an obstruction of the left pulmonary artery. In 1/18 patients there was a minor protrusion of the distal occluder into the descending aorta. Doppler-sonography however revealed no obstruction. Complete occlusion of the ductus arteriosus was confirmed by color Doppler echocardiography in all patients within 5 days, in 17/18 patients no residual shunt was detectable within 24 hours. CONCLUSION: According to our experience the results of interventional occlusion of patent ductus arteriosus in children and adolescents can be well determined by echocardiography.

Adolescent↗
PubMed2002

Interruption of patent ductus arteriosus in children: robotically assisted versus videothoracoscopic surgery.

OBJECTIVES: If robotic surgery is to be widely used, the risks must be equivalent to those of standard techniques. This study analyzes the feasibility, safety, and efficiency of a robotically assisted technique for patent ductus arteriosus closure and compares the results with those of the videothoracoscopic technique. METHODS: During 2000, 56 children weighing 2.3 to 57 kg (mean, 12 kg) underwent surgical closure of a patent ductus arteriosus. They were distributed into 2 groups: 28 patients (group 1) underwent the videothoracoscopic technique, and 28 (group 2) underwent a robotically assisted (Zeus; Computer Motion, Inc, Goleta, Calif) approach. Operative and postoperative surgical data were studied. RESULTS: Operative time was significantly higher in the robotically assisted group. One conversion in videothoracoscopy was necessary, but no thoracotomy was required. Three persistent shunts were detected at postoperative echocardiography and were treated by means of application of a new clip with videothoracoscopy (1 in group 1 and 2 in group 2). No permanent laryngeal nerve injury and no hemorrhage were noted. The mean hospital stay was 3 days in both groups. CONCLUSIONS: Robotically assisted closure of a patent ductus arteriosus is comparable with closure by means of the videothoracoscopic technique. However, it requires a longer operative time because of the increment in complexity.

Adolescent↗
PubMed1996

Flows of knowledge from universities and federal laboratories: modeling the flow of patent citations over time and across institutional and geographic boundaries.

The extent to which new technological knowledge flows across institutional and national boundaries is a question of great importance for public policy and the modeling of economic growth. In this paper we develop a model of the process generating subsequent citations to patents as a lens for viewing knowledge diffusion. We find that the probability of patent citation over time after a patent is granted fits well to a double-exponential function that can be interpreted as the mixture of diffusion and obsolescense functions. The results indicate that diffusion is geographically localized. Controlling for other factors, within-country citations are more numerous and come more quickly than those that cross country boundaries.

Canada↗
PubMed2005

PatGen--a consolidated resource for searching genetic patent sequences.

UNLABELLED: Compared to the wealth of online resources covering genomic, proteomic and derived data the Bioinformatics community is rather underserved when it comes to patent information related to biological sequences. The current online resources are either incomplete or rather expensive. This paper describes, PatGen, an integrated database containing data from bioinformatic and patent resources. This effort addresses the inconsistency of publicly available genetic patent data coverage by providing access to a consolidated dataset. AVAILABILITY: PatGen can be searched at http://www.patgendb.com CONTACT: rjdrouse@patentinformatics.com.

Abstracting and Indexing↗
PubMed1997

Transcatheter closure of patent arterial ducts using controlled-release coils.

OBJECTIVE: To determine the efficacy of transcatheter closure of patent arterial ducts using controlled-release coils. DESIGN: Transcatheter closure of patent arterial ducts was attempted in 52 patients using controlled-release coils. SETTING: For the study, four tertiary paediatric cardiology units were used, two of which were in the U.K., one in Italy and one in Turkey. PATIENTS: The 52 patients ranged in age between 3-5 months and 61 years (median 3-5 years), and weighted between 4.5 kg and 62 kg. The duct diameters were 1 mm to 6.5 mm. RESULTS: In four patients the ducts were too large for safe release of the coils. In the remaining 48, one coil was inserted in 33 patients, two coils in nine, three coils in four and four coils in two patients. Immediately at the end of the procedure, the duct was completely occluded in 26/47 (55%) patients. Haemolysis occurred in one patient, in whom the coil was removed by a snare catheter and a large umbrella device was implanted with resolution of the haemolysis. Coil embolization to the pulmonary artery occurred in five (10%) patients. All were easily retrieved and replaced by larger coils. At the latest follow-up by colour Doppler echocardiography, the duct was completely occluded in 44/47 (94%) patients. CONCLUSIONS: Transcatheter closure of patent arterial ducts by controlled-release coils is effective and safe. Even when more than one coil is inserted the technique is still less cumbersome and considerably cheaper than transcatheter umbrella closure.

Child, Preschool↗
PubMed1997

Problems encountered during introduction of Gianturco coils for transcatheter occlusion of the patent arterial duct.

OBJECTIVE: To define the problems encountered during transcatheter occlusion of the patent arterial duct using Gianturco coils. METHODS: Between January 1994 and November 1995, 93 patients were admitted in whom it was intended to occlude the patent arterial duct using Gianturco coils. Anterograde transcatheter coil occlusion was performed via the femoral vein in 81 patients. In the remaining 12 the procedure was done via the femoral artery. RESULTS: Coils were implanted successfully in 82/93 (88%) patients. In 11 patients the procedure was a failure. In 19/93 patients (20%), inadvertent embolization of the coil occurred. The coils were retrieved in all except one patient. In 17 of these patients, new coils were then reimplanted successfully. Doppler echocardiography after the procedure showed that in 9/82 (11%) patients the left pulmonary artery Doppler peak velocity exceeded 1.5 m.s-1 (mean 1.2 m.s-1) raising concern about left pulmonary artery branch stenosis. The complete occlusion rate at discharge from hospital was 72/82 (88%). Follow-up ranges from 1 day to 14 months (mean 2/12 months) in the 82 patients in whom successful deployment of coils was possible. In two patients, the arterial duct became occluded at follow-up. One additional patient had complete occlusion after reocclusion using another coil. Thus, after short-term follow-up a total of 75/82 patients (91.4%) have a completely occluded arterial duct after coil implantation. CONCLUSION: Transcatheter occlusion of the patent arterial duct using Gianturco coils is an effective and safe technique. In the learning curve there is a relatively high rate of inadvertent embolization, but the coils can be retrieved in the vast majority of patients. The complication rate is offset by the high early occlusion rate and the inexpensiveness of the procedure.

Adolescent↗
PubMed1998

Thoracoscopic interruption of patent ductus arteriosus compromises cardiopulmonary function in newborn pigs.

UNLABELLED: Interruption of patent ductus arteriosus (PDA) using video-assisted thoracoscopic surgery (VATS) has recently been introduced into clinical practice. To study cardiovascular and pulmonary function during VATS, we treated 16 newborn pigs (weight 1421+/-44 g) with PDA with conventional surgical interruption (CSI; n = 7) or interruption via VATS (n = 9). Measurements of hemodynamics and gas exchange were performed before, during, and after surgery. Systemic perfusion was calculated using Fick's equation. Stress hormones (ACTH, epinephrine, and norepinephrine) were determined before and after surgery. The duration of the surgical procedure was 41+/-8 min for CSI and 49+/-9 min for VATS (mean+/-SEM). With VATS, PaO2 decreased during and after surgery (P < 0.05), whereas alveolar-arterial PO2 difference (PA-aO2) and PaCO2 were increased (P < 0.05). Compared with CSI after surgery, PaO2 with VATS was decreased (130+/-10 vs 171+/-12 mm Hg; P < 0.05). Systemic perfusion was lower during VATS (76.7% of baseline) than during CSI (107% of baseline; P < 0.05). Heart rate, mean arterial pressure, and right ventricular end-diastolic pressure remained unchanged with both treatments. Stress hormones were comparable between groups. We conclude that systemic perfusion and oxygenation were impaired during VATS compared with CSI. Therefore, VATS may be contraindicated in pediatric patients with minor cardiopulmonary reserve. IMPLICATIONS: We studied the cardiopulmonary effects of endoscopic interruption of the patent ductus arteriosus in an animal model of newborn pigs. Gas exchange and systemic perfusion were impaired compared with conventional interruption of the patent ductus arteriosus after thoracotomy.

Animals↗
PubMedDate not supplied

Nonsurgical closure of patent ductus: an experimental study.

A technique is described for potential use in the nonsurgical closure of patent ductus arteriosus. Occlusion is accomplished with an Ivalon umbrella, inserted via a catheter placed percutaneously into the femoral artery. The technique was tested in thirteen dogs with surgically created shunts closely simulating patent ductus arteriosus. In two cases, the Ivalon plug was undersize; and incomplete occlusion occurred, but without embolization of the plug. In one case, the umbrella emoblized due to improper positioning. Several dogs with successfully occluded ductus were observed from two weeks to six months postoperative. In all cases, the ductus remained closed. The technique has potential application in patients with a small and long patent ductus.

Animals↗
PubMed1995

Transcatheter occlusion of patent ductus arteriosus using a newly developed self-expanding device. Evaluation in a canine model.

RATIONALE AND OBJECTIVES: A new occlusion device designed for use in a patent ductus arteriosus was tested in an animal model. METHODS: The device consists of a self-expanding conical-shaped stainless steel mesh, with hooks encircling the expanding end acting to secure the device within the ductus. A screw thread at the apex allows attachment to a stylet, and a 6 F delivery system is used. Placement of the device was attempted in 20 canines that previously had a vascular graft surgically inserted between the descending thoracic aorta and main pulmonary artery, creating the patent ductus model. Angiographic follow-up at regular intervals was performed over a 3-month period. RESULTS: Early cases resulted in device misplacement and migration because of inaccurate assessment of ductus position and size. In 15 canines the device was placed within the ductus and regularly assessed over the 3-month placement period. Ductus occlusion occurred within 1 week in 12 of 13 dogs (92%) when device placement was considered ideal. In two dogs where significant protrusion of the device from the ductus was evident (either into the aorta or main pulmonary artery) ductus closure was delayed but present by 3 months, resulting in a 93% overall closure rate at this time. In one dog, the ductus remained partially opened. CONCLUSIONS: This self-expanding patent ductus arteriosus occlusion device is promising. The 6 F delivery system is advantageous over other devices currently available, making it more suited for use in the pediatric population. Accurate assessment of the ductus is imperative, however, to enable correct device sizing. The screw thread system allows the device to be repositioned if desired prior to deployment.

Animals↗
PubMed1996

Transcatheter closure of patent ductus arteriosus using controlled-release coils.

Controlled-release coils have become available recently for the closure of patent ductus arteriosus (PDA). Transcatheter closure of patent arterial ducts was attempted in 13 patients, ranging in age from 5 months to 15 years, mean 4.1 years. Implantation of controlled-release PDA coils was attempted via the femoral artery through 5 Fr catheters in all cases except one, in whom both the femoral arterial and venous routes were used. The procedure was successful in 10 of the 13 patients. In these, the pulmonary artery systolic pressure ranged between 25 and 42 mmHg and the duct diameter varied from 1.5 to 6 mm at its narrowest point. Six of the patients received a single coil. Two coils were inserted in three patients and three coils in one patient. In three patients the ducts were too large for safe release of the coils, despite attempted implantation of up to three coils simultaneously. These coils were easily withdrawn into the catheter. Immediately at the end of the procedure, the duct was completely occluded in nine of the 10 patients, and in one patient there was a small residual flow. The procedure time varied between 35 min and 2.5 h, mean 81 min and the fluoroscopy time varied from 5 to 78 min, mean 25 min. None of the patients experienced hemorrhage, diminished lower extremity pulse, hemolysis or infection. In one patient, a 5 mm coil embolized into the right pulmonary artery soon after release. It was retrieved with a snare, then 8 mm and a 5 mm coil were implanted satisfactorily in the arterial duct. At follow-up by color Doppler echocardiography, the duct was completely occluded in all patients. Transcatheter closure of patent arterial ducts by controlled-release PDA coils is effective and safe. Even when more than one coil is inserted, it is still cheaper than transcatheter umbrella closure. This method is therefore of great value, particularly in less affluent countries.

Adolescent↗