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PubMed2003

Human gene patents: the possible impacts on genetic services healthcare.

The patent system has been seen as a critical factor driving innovation in clinical medicine, particularly in medical devices and diagnostic assays. The licence terms and business model proposed by Myriad Genetics Inc. for testing the hereditary breast cancer susceptibility genes BRCA1 and BRCA2 could stifle innovation (particularly if other companies adopt similar business models), and are likely to limit the ability to provide high quality public genetic testing services in Australia. Under the Myriad model, testing for the BRCA1 gene would be undertaken by an organisation removed from the integrated public healthcare system. Based on overseas experience, Australia can expect a 2-3-fold increase in the cost of this testing, which will provide only partial information on the hereditary breast cancer status of the patient. Commercial exploitation of gene patents needs to be regulated to balance the patent holders' right to profit from their inventions (necessary to drive further innovation) and the public policy objective of high quality, equitable healthcare.

Australia↗
PubMed1998

New drugs for human use; clarification of requirements for patent holder notification--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to amend its regulations on notice of certification of invalidity or noninfringement of a patent to provide additional methods for new drug and abbreviated new drug applicants to provide notice to patent owners and new drug application (NDA) holders, without removing the existing means. These proposed amendments reflect current business practices and are intended to ensure that notice is provided to patent owners and NDA holders in a timely manner. FDA is also proposing to require certain applicants to submit to FDA a copy of the notice of certification.

Drug Approval↗
PubMed1976

[Electrocardiographic diagnosis of patent ductus atrio-ventricularis].

The paper deals with the diagnosis of defective development of the patent ductus atrioventricularis. Electrocardiographic changes in 81 patients with firmly established hemodynamic form of the patent ductus atrioventricularis, ascertained during surgery and catheterization, are summarized. Characteristic electrocardiographic signs of the defect distinguishing it from other congenital diseases and differential-diagnostic symptoms of diverse anatomo-hemodynamic forms of the patent ductus atrioventricularis were educed.

Adolescent↗
PubMed1999

Primary bronchomalacia and patent ductus arteriosus: simultaneous surgical correction in an infant.

We report the clinical course of a 6-month-old girl with recurrent infection of the left lung, persistent wheezing, and a suspected congenital heart anomaly (patent ductus arteriosus. Chest radiography revealed hyperinflation and slight inflammation of the left lung. Tracheobronchoscopy and left-sided bronchography showed a collapsed segment of the left main bronchus, 3 cm long. Computed tomography confirmed hyperinflation of the left lung and atelectasis of the superior lobe. There were no signs of extramural compression. Color-flow Doppler echocardiography confirmed the suspicion of patent ductus arteriosus. To the best of our knowledge, there is no other report in the literature of a patient with this combination of anomalies. After receiving 2 weeks of antibiotic treatment, the patient underwent surgical repair The patent ductus arteriosus was closed by means of a triple-ligature procedure, and during the same operation a bronchopexy was performed, securing the left main bronchus to the closed ductus tissue by means of sutures. There have been no complications in the postoperative period. Clinical follow-up, as well as echocardiography and bronchoscopy, have yielded normal results 14 months after surgery.

Abnormalities, Multiple↗
PubMed2000

Video assisted thoracoscopic ligation of patent ductus arteriosus. Technique of sliding loop ligation.

Variant video-assisted thoracoscopic surgical technique for closure of patent ductus arteriosus has been introduced. Although the endoscopic clipping device may be a preferred method for interruption of the patent ductus arteriosus, there is always the risk of inadequate clip placement and limitation of application in width of ductus arteriosus. In an effort to overcome this problem we have used a self-made endoscopic loop ligation in 10 patients and herein report the method. Only a small window and one port of access are necessary to dissect the patent ductus arteriosus from the surrounding tissues and to apply the extracorporeally created sliding loop. Successful ligation without shunt is obtained in all cases. The technique is simple and safe even in the presence of a wide ductus.

Child↗
PubMed2001

Transcatheter closure of patent ductus arteriosus with the Amplatzer duct occluder: short-term follow-up.

BACKGROUND: Transcatheter closure of the patent ductus arteriosus is a well established procedure. The objective of this study was to assess the effectiveness and the safety of the Amplatzer duct occluder. METHODS AND RESULTS: Occlusion of the patent ductus arteriosus was attempted in 23 patients. The median weight was 11.7 Kg (range, 5 kg - 42.4 kg) with a mean ductus diameter of 3.7 mm (range, 1.6 - 7.2 mm). The immediate closure rate was 86% with a closure rate of 100% at 6 months, 1 year and 2 years following device placement. There was one device embolization that occurred immediately following device placement. No patient had aortic narrowing or pulmonary artery stenosis following the procedure. CONCLUSIONS: The Amplatzer duct occluder is safe and effective in the closure of a patent ductus arteriosus up to 7.2 mm in diameter. Selecting a device at least 12 mm larger than the minimal ductal diameter can minimize embolization.

Alloys↗
PubMed2000

[Ibuprofen--a new application for pharmacological closure of patent ductus arteriosus in preterm infants. Preliminary report].

Patent ductus arteriosus (PDA) remains a frequent problem in premature infants, particularly with very low birth weight. Left-to-right shunting through the ductus may increase the risk of intraventricular hemorrhage, necrotizing enterocolitis, bronchopulmonary dysplasia and death. Indomethacin is the conventional pharmacologic treatment of patent ductus arteriosus (PDA). Although indomethacin is effective in closing PDA, its use may be associated with negative influences on renal, gastrointestinal and cerebral blood flow. More recently Ibuprofen has been tested; it can close the ductus arteriosus, but compared it with indomethacin, it has no negative influence on intestinal haemodynamics. On the basis of relevant literature, ibuprofen and indomethacin have been compared with regard to efficacy for closure of patent ductus arteriosus and side effects.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMedDate not supplied

[Deposition of microorganisms at patenting the invention and results for the inventor].

The standards of the patent legislation of Ukraine and other countries concerning the deposition of microorganisms at patenting of the invention and conditions for the availability of the deposited samples have been considered. The questions connected to practice of strains deposition in Ukraine which require the normative decision or specification in view of the tendency of development of patent legislation in the countries advanced in the sphere of the industrial property have been outlined.

Microbiology↗
PubMed1975

[Association of aortic coarctation with patent ductus arteriosus (analysis of clinical and surgical data].

A retrospective analysis of clinical and operative data was made covering 56 cases with combined coarctation of the aorta and patent ductus arteriosus. Prior to surgery both anomalies were recognized in 27 patients. Clinical data failed to furnish an reliable criteria as to the difference in anatomic variants of combined aortic coarctation and patent ductus arteriosus. The clinical picture and diagnosis of this congenital pathology are largely contingent upon the conspicuousness of each abnormality and consequently, on a definite orientation of the clinical diagnosis. There is a direct relation between the frequency of detection of the patent ductus arteriosus and its size.

Adolescent↗
PubMed1975

[Surgical treatment of patent ductus arteriosus].

The experience gained with 1400 operations for patent ductus arteriosus performed at the Clinic of the Hospital Surgery of the Gorky Medical Institute during the period from October 1955 through 1973 is presented. The total post-operative lethality comprised 1.3 per cent, it amounting to 6 per cent with complicated patent ductus arteriosus, to 3 per cent among children of junior age and to 0.1 per cent in cases of uncomplicated defect. An analysis of operative and post-operative complications along with a study into remote results of the surgical intervention helped define indications for the closure of the duct in patients with pulmonary hypertension and septic endarteritis. They also showed the possibility of a single-stage correction of combined congenital heart defects. Indications have been worked out for the surgical treatment of patent ductus arteriosus in infants and procedures for the closure of the duct, depending upon its apatomic variants and concomitant complications.

Adolescent↗
PubMed2001

Antitrust issues in the settlement of pharmaceutical patent disputes, Part II.

The settlement of patent disputes in the pharmaceutical industry, and the possible antitrust issues arising therefrom, are of notable concern to the Federal Trade Commission. In this Comment, based on his second speech on the subject, Commissioner Leary re-examines some of this earlier positions under the light of the Commission's further experience with these matters, and provides the industry with some additional objective standards under which it may legally operate. With the Hatch-Waxman Act as a backdrop for patent settlements between manufacturers of patented drugs and potential generic entrants to the market, the Commissioner reviews a variety of scenarios that may or may not be permissible. After initially noting the circumstances of presumptively valid settlements, Commissioner Leary reviews the often complex settlement structures that will be deemed unlawful when and if the finding of reverse payments is evidenced. Finally, the Commissioner concludes with a brief examination of other settlement structures and offers his general views as to their likely legality.

Antitrust Laws↗
PubMed2001

BioChem Pharma wins patent dispute over 3TC.

In December 2000, the US Board of Patent Appeals and Interferences, a branch of the US Patent and Trademark Office (USPTO), upheld BioChem Pharma's claim to hold the patent on 3TC.

Humans↗
PubMed2001

Living things, the human genome, and patents.

For many years, patents and living things have not gotten along well in people's minds; nevertheless, patents are a real right. Even though people accept that a farmer can own a cow or that a Parisian can own a dog, they do not seem to understand that it is possible to patent a recombinant micro-organism or a DNA sequence. This is probably because industrial property is a hybrid concept, which mixes rights and science. Thus, this field is prone to misunderstanding by scientists and jurists, because of its juridical aspects for the former and because of its scientific aspects for the latter. The general public,as a result has two avenues of extravagant questioning to follow and consider. Finally, if industrial property is applied to a living phenomenon, it is often almost impossible to explain in layman's terms the ins and outs of the problems that may arise.

Biotechnology↗
PubMedDate not supplied

Interruption of the aortic arch associated with patent ductus arteriosus and ventricular septal defect. Proposal of a new surgical technique for total correction.

A four-year-old girl underwent complete correction of the association of interruption of the aortic arch (Type A, Celoria and Patton's classification), patent ductus arteriosus, and ventricular septal defect. The surgical procedure consists of establishment of a continuity between the ascending and descending aortas utilizing the patent ductus arteriosus and the anterior wall of the pulmonary arterial trunk, reconstruction of the rest of pulmonary arterial trunk with pericardium, and closure of the ventricular septal defect. Though the patient expired from cerebral complications, the hemodynamic result after repair was quite satisfactory. The procedure described makes total correction of this complex anomaly feasible at one operation through a median sternotomy and seems to be a method of choice for most patients with this association of anomalies, unless there is severe narrowing of the patent ductus arteriosus.

Angiocardiography↗
PubMedDate not supplied

[Patenting human genetic material: ethical and legal implications].

If we introduce the subject of patents on human genetic material in a Bioethics Conference we must answer two questions. Firstly, whether the debate can be universalized, bearing in mind the national nature of norms governing intellectual property, and, secondly, whether there are links between patent law and ethics. Using the example of the patenting of biological material, we will see how this impacts on society, which, beyond the technical or legal knowledge required, is voicing its concern on the ethical level.

Bioethical Issues↗
PubMedDate not supplied

[Research and patents in the biomedical field].

Several infrastructures and structures are used in Italy for biomedical research but only few work for applied research, even if this country ranks 7th in the world for data published in peer review journals. Thus, few patents are presented by Italian researchers. To increase this activity and related products, a new law is needed. It should introduce a financial benefit for the researcher who develops the patent. In this way the law may stimulate investments and the production of more patents. However, public and private institutions should invest more.

Italy↗
PubMed2003

Percutaneous closure of window-type patent ductus arteriosus: using the CardioSEAL and STARFlex devices.

Transcatheter closure of patent ductus arteriosus is routinely performed using various devices. After the withdrawal of the Rashkind umbrella device from the market, the wide window-type patent ductus arteriosus has been difficult to close percutaneously. Two patients with this condition are presented: a 17-year-old man and a 62-year-old woman with short (4.5- and 5.2-mm-diameter, respectively) ductus. We successfully implanted a 17-mm CardioSEAL device in the 1st patient and a 23-mm STARFlex in the 2nd, with no residual shunt at follow-up (22 and 8 months, respectively). Although these devices (which follow the general design of the Rashkind umbrella) are usually applied to atrial septal defect closure, we believe that CardioSEAL and STARFlex implants could be the treatment of choice in percutaneous treatment.of window-type patent ductus arteriosus.

Adolescent↗
PubMed1999

Religious voices in biotechnology: the case of gene patenting.

On 18 May 1995, nearly 200 religious leaders joined with leading biotechnology critic Jeremy Rifkin in a press conference named the "Joint Appeal against Human and Animal Patenting," a move that many within the biotechnology industry could only interpret as seeking to inhibit biotechnological advance. What moral and religious concerns motivated this challenge to patenting? How could the biotechnology industry understand and respectfully attend to these concerns? What values were at play in the debates that followed the joint appeal? What lessons for future dialogue can be learned from attempts at conversation between the opposing positions? This essay is a report from a Hastings Center research project that accepted the task of addressing these questions. Specifically, the project focused on the patenting of human genetic material, a subset of the issues raised by the joint appeal.

Base Sequence↗