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PubMed2002

Patents and research--an uneasy alliance.

Critics of the patent system have argued that rather than promoting the progress of science and the useful arts, the patent system as it exists in the United States and perhaps elsewhere may actually inhibit such progress. Much of the criticism has been focused on patenting of research tools. The author attempts to evaluate the extent of this effect, and to suggest some possible modifications to the patent system to address its shortcomings. She considers the advantages attributed to the patenting system-providing incentives for finance and development and spurring creativity-with the disadvantages perceived by the academic community, including impediments to the communication of research findings and other transaction costs. Also examined are possible options for mitigating these problems, including legislative restrictions of certain subject matter from patentability, or strengthening the criteria used in review of patent applications, especially non-obviousness and utility. In addition, the author discusses potential "post-patent solutions," such as legislative or other restrictions on licensing.

Cooperative Behavior↗
PubMed2005

Patent ductus arteriosus, indomethacin and necrotizing enterocolitis in very low birth weight infants: a population-based study.

BACKGROUND: Patent ductus arteriosus is a risk factor for the development of necrotizing enterocolitis. The use of indomethacin to treat patent ductus arteriosus in preterm infants may either decrease the incidence of necrotizing enterocolitis by stabilizing or closing the ductus arteriosus or increase its incidence by a direct constricting effect on mesenteric blood vessels. The authors sought to evaluate the interrelationship between patent ductus arteriosus, treatment with indomethacin and the risk of necrotizing enterocolitis in very low birth weight infants. METHOD: The Israel National database includes prospectively collected data on 99% of all very low birth weight infants in Israel. The study population comprised 6146 infants of 24-34 weeks' gestation born between 1995 and 2000. The effect of patent ductus arteriosus on necrotizing enterocolitis was assessed using multiple regression analysis. RESULTS: Necrotizing enterocolitis occurred in 5.5% (n = 343) of all infants, in 9.4% of infants with patent ductus arteriosus and in 8.9% of infants who received indomethacin. The occurrence of necrotizing enterocolitis was independently associated with the presence of patent ductus arteriosus among infants not treated with indomethacin (odds ratio, 1.85) and those who received indomethacin therapy (odds ratio, 1.53). Indomethacin therapy in absence of patent ductus arteriosus was not associated with an increased risk of necrotizing enterocolitis (odds ratio, 0.72). CONCLUSIONS: Patent ductus arteriosus is an independent risk factor for the development of necrotizing enterocolitis in very low birth weight infants. Therapy with indomethacin did not have a significant effect on the risk for necrotizing enterocolitis.

Cardiovascular Agents↗
PubMed2005

Patent issues in drug development: perspectives of a pharmaceutical scientist-attorney.

The major purpose of this article is to emphasize the need for pharmaceutical scientists to have a better understanding of patent fundamentals. This need is illustrated by analyses of key scientific and legal issues that arose during recent patent infringement cases involving Prozac, Prilosec, and Buspar. Economic incentives for drug discovery and development clash with societal needs for low-cost pharmaceuticals in the United States and all over the world. The Hatch-Waxman Act of 1984 was enacted to promote public health by balancing the interests of brand name and generic companies. Patent protection, which provides a monopoly for a limited time, is aimed to provide such incentives. Creation of patents requires the interaction between scientists and lawyers, an endeavor made difficult by the differing intellectual spheres of their respective disciplines. Therefore, in the first place, a thorough understanding of patent fundamentals among pharmaceutical scientists will help them work more efficiently with patent attorneys. Second, it will enable them to appreciate the strengths and weaknesses of individual patents, which is critical in developing strategies amidst the ongoing patent tug-of-war between brand-name and generic companies.

Drug Industry↗
PubMedDate not supplied

[Echocardiographic post-neonatal progress of preterm neonates with patent ductus arteriosus].

OBJECTIVE: To identify clinical and echocardiography predictors of the spontaneous closure of patent ductus arteriosus in preterm neonates. METHODS: Sixty-one consecutive preterm neonates (gestational age 30+/-2 weeks, birth weight 1.2+/-0.2 kg) were evaluated by echocardiogram on their third day of life and those with patent ductus arteriosus were selected for a prospective cohort. Echocardiography was repeated weekly until they reached term. Based on their progress, the sample population was divided into two groups, depending on whether spontaneous closure of patent ductus arteriosus took place (Group A) or not (Group B). The prevalence of clinical signs of patent ductus arteriosus and echocardiography findings at baseline were compared between the groups. RESULTS: Patent ductus arteriosus was found in 21 neonates (34%). Spontaneous closure was observed during follow-up of seven patients (Group A, 33% of those with patent ductus arteriosus), in contrast with the remaining 14 patients (Group B, 67%). Clinical signs of patent ductus arteriosus were present in 14% of the patients in Group A, compared with 71% in group B (p = 0.01). At baseline, Group B had a larger ductus diameter in relation to Group A (2.6+/-0.6 mm vs. 1.4+/-0.6 mm; p = 0.003). The area under the ROC curve in relation to ductus diameter was 0.93 (p = 0.003) and 100% sensitivity for identifying cases without spontaneous closure was obtained at the cutoff point of 1.7 mm, while 100% specificity was observed taking 2.2 mm as the cutoff. CONCLUSIONS: In preterm neonates, a patent ductus arteriosus greater than 2.2 mm on the third day of life predicts no spontaneous closure and suggests a need for early treatment, especially when associated with clinical signs.

Birth Weight↗
PubMed1993

Patents for genetically modified animals.

Should genetically engineered animals be patented? This issue has been one of the most contentious as lawmakers have grappled with how best to protect intellectual property. Since the 1980 case of Diamond v. Chakrabarty, in which the U.S. Supreme Court ruled that a living microorganism is patentable, the U.S. Patent and Trademark Office has determined that plants and nonhuman animals can be patented. These policy decisions have led to congressional debate on whether animals should be patentable subject matter. Patenting of living organisms is unique for three reasons: the invention itself is alive; the invention in some instances can reproduce itself; and the invention sometimes cannot be adequately described for patent specification purposes, leading to the need for deposit of the invention for patent purposes.

Animals↗
PubMed2002

Research-tool patents: issues for health in the developing world.

The patent system is now reaching into the tools of medical research, including gene sequences themselves. Many of the new patents can potentially preempt large areas of medical research and lay down legal barriers to the development of a broad category of products. Researchers must therefore consider redesigning their research to avoid use of patented techniques, or expending the effort to obtain licences from those who hold the patents. Even if total licence fees can be kept low, there are enormous negotiation costs, and one "hold-out" may be enough to lead to project cancellation. This is making it more difficult to conduct research within the developed world, and poses important questions for the future of medical research for the benefit of the developing world. Probably the most important implication for health in the developing world is the possible general slowing down and complication of medical research. To the extent that these patents do slow down research, they weaken the contribution of the global research community to the creation and application of medical technology for the benefit of developing nations. The patents may also complicate the granting of concessional prices to developing nations - for pharmaceutical firms that seek to offer a concessional price may have to negotiate arrangements with research-tool firms, which may lose royalties as a result. Three kinds of response are plausible. One is to develop a broad or global licence to permit the patented technologies to be used for important applications in the developing world. The second is to change technical patent law doctrines. Such changes could be implemented in developed and developing nations and could be quite helpful while remaining consistent with TRIPS. The third is to negotiate specific licence arrangements, under which specific research tools are used on an agreed basis for specific applications. These negotiations are difficult and expensive, requiring both scientific and legal skills. But they will be an unavoidable part of international medical research.

Developing Countries↗
PubMed2002

Patenting DNA.

The protection of inventions based on human DNA sequences has been achieved mainly through application of the patent system. Over the past decade, there has been continuing debate about whether this use of intellectual property rights is acceptable. Companies and universities have been active during this period in filing thousands of patent applications. Although many have argued that to claim a DNA sequence in a patent is to claim a discovery, patent law allows discoveries that are useful to be claimed as part of an invention. As the technology to isolate DNA sequences has advanced, the criterion for inventiveness, necessary for any invention to be eligible for filing, has become more difficult to justify in the case of claims to DNA sequences. Moreover, the discovery that a gene is associated with a particular disease is, it is argued, to discover a fact about the world and undeserving of the status of an invention. Careful examination of the grounds for allowing the patenting of DNA sequences as research tools suggests such rewards will rarely be justified. The patenting of DNA sequences as chemical intermediates necessary for the manufacture of therapeutic proteins is, however, reasonable given that the information within the sequence is applied to produce a tangible substance which has application as a medicine. Despite the legal, technical and political complexities of applying the flexibilities with the current law, it is argued that much could be achieved in the area of patenting DNA by raising the thresholds for patentability.

Animals↗
PubMed2004

[The disquieting consequences of granting patents on human genes for healthcare and scientific research in The Netherlands].

The granting of a patent by the European Patent Office to Myriad Genetics on the sequence of the BRCA-1 gene in 2001 prompted the Dutch Minister of Healthcare and the Minister of Education, Culture and Science to ask for advice. The Royal Netherlands Academy of Arts and Science (KNAW) prepared a report in 2003 entitled: 'The consequences of granting patents on human genes for scientific research in The Netherlands'. Another recommendation (by Van de Bunt) entitled: 'A code of gene patenting' was also published in 2003. The KNAW report recommends, among others: a redefinition of the 'research exemption' and renewed discussion on a 'grace period'. The Van de Bunt report concludes, among other things, that some holders of gene patents cause unwanted side effects, but that the patent system itself provides sufficient possibilities to prevent these side effects. In a comment on both reports, the Dutch Ministry of Healthcare concluded: 'There is no reason to change the current patent system'. One should be more critical, however, and favour the possibility of a 'diagnostic exemption' in which DNA-diagnostics would be excluded from patenting.

Biomedical Research↗
PubMed2006

Functional annotation and analysis of Korean patented biological sequences using bioinformatics.

A recent report of the Korean Intellectual Property Office (KIPO) showed that the number of biological sequence-based patents is rapidly increasing in Korea. We present biological features of Korean patented sequences though bioinformatic analysis. The analysis is divided into two steps. The first is an annotation step in which the patented sequences were annotated with the Reference Sequence (RefSeq) database. The second is an association step in which the patented sequences were linked to genes, diseases, pathway, and biological functions. We used Entrez Gene, Online Mendelian Inheritance in Man (OMIM), Kyoto Encyclopedia of Genes and Genomes (KEGG), and Gene Ontology (GO) databases. Through the association analysis, we found that nearly 2.6% of human genes were associated with Korean patenting, compared to 20% of human genes in the U.S. patent. The association between the biological functions and the patented sequences indicated that genes whose products act as hormones on defense responses in the extra-cellular environments were the most highly targeted for patenting. The analysis data are available at http://www.patome.net.

Base Sequence↗
PubMed1995

Identification of patent foramen ovale permitting paradoxic embolism.

OBJECTIVES: We sought to analyze the morphologic and functional characteristics of the patent foramen ovale in patients with different clinical likelihoods for paradoxic embolism. BACKGROUND: The incidence of patent foramen ovale is increased in patients with otherwise unexplained arterial ischemic events. Because signs of venous thrombosis are absent in most patients, the diagnosis of paradoxic embolism is often questioned, even when patent foramen ovale is the only potential explanation for the ischemic event. METHODS: Seventy-eight patients with a patent foramen ovale detected by contrast transesophageal echocardiography were studied: 21 patients with an otherwise unexplained arterial ischemic event and clinical evidence implying paradoxic embolism (group I), 30 patients with an unexplained ischemic event but no clinical evidence for paradoxic embolism (group II) and 27 patients without an ischemic event (group III). RESULTS: During transesophageal contrast echocardiography, patients in group I had more severe right to left shunting (mean +/- SD 52 +/- 16% of the left atrial area filled with contrast medium) and a wider opening of the patent foramen ovale (7.1 +/- 3.6-mm separation between the septum primum and the septum secundum) than did patients in group II (35 +/- 15% and 4.4 +/- 3.2 mm, respectively, p < 0.001) or group III (23 +/- 12% and 3.0 +/- 2.0 mm, respectively, p < 0.001). The incidence of atrial septal aneurysm was similar in the three groups. Severe contrast shunting (> or = 50% of the left atrial area filled with contrast medium) and wide opening of the patent foramen ovale (> or = 5-mm separation) revealed a high sensitivity (71% and 86%, respectively) and high specificity (86% and 96%, respectively) for identification of group I patients. CONCLUSIONS: Right to left contrast shunting is more severe and opening of the patent foramen ovale is larger in patients with ischemic arterial events considered to be due to paradoxic embolism. In patients with a patent foramen ovale as the only potential cause for ischemic events and no signs of venous thrombosis, morphologic and functional variables assessed by transesophageal echocardiography may be helpful in estimating the likelihood of paradoxic embolism.

Adult↗
PubMed1994

Characteristics of patent foramen ovale associated with cryptogenic stroke. A biplane transesophageal echocardiographic study.

BACKGROUND AND PURPOSE: Patent foramen ovale is associated with ischemic stroke in patients without a clearly identifiable etiology for stroke (cryptogenic stroke). Paradoxical embolization is thought to be a potential mechanism. However, patent foramen ovale is also found in patients with known cause of stroke. Therefore, using contrast transesophageal echocardiography, we characterized the patent foramen ovale in cryptogenic stroke patients to assess morphological factors that may contribute to paradoxical embolization. METHODS: Contrast transesophageal echocardiographic studies of 74 consecutive patients referred for ischemic stroke were reviewed. Twenty-three patients with patent foramen ovale were identified. These patients were classified as having strokes of determined origin or cryptogenic strokes according to criteria developed for the Stroke Data Bank of the National Institute of Neurological Disorders and Stroke. Separation of septum primum from secundum and the number of microbubbles appearing in left atrium were then quantitated. These parameters were compared between patients with cryptogenic stroke and those with known cause of stroke. RESULTS: The patent foramen ovale dimension was significantly larger in patients with cryptogenic stroke compared with patients with an identifiable cause of stroke (2.1 +/- 1.7 mm versus 0.57 +/- 0.78 mm [mean +/- SD]; P < .01). The number of microbubbles was also greater in patients with cryptogenic stroke compared with patients with an identifiable cause of stroke (13.9 +/- 10.7 versus 1.6 +/- 0.8 [mean +/- SD]; P < .0005). CONCLUSIONS: Patients with cryptogenic stroke have larger patent foramen ovale with more extensive right-to-left interatrial shunting than patients with stroke of determined cause. Transesophageal echocardiographically identifiable characteristics of patent foramen ovale may be important in defining the clinical significance of individual patent foramina.

Adult↗
PubMed1993

Positive end-expiratory pressure increases the right-to-left shunt in mechanically ventilated patients with patent foramen ovale.

OBJECTIVE: To determine the effect of the presence of a patent foramen ovale on the right-to-left shunt in patients with respiratory failure who receive positive end-expiratory pressure (PEEP). DESIGN: Convenience sample with randomized application of PEEP. SETTING: General intensive care unit of a university teaching hospital. PATIENTS: A total of 46 mechanically ventilated patients with respiratory failure requiring an inspired oxygen concentration of at least 50% and a PEEP of at least 5 cm of H2O. INTERVENTION: Randomized application of PEEP (0 and 10 cm of H2O). MEASUREMENTS: A patent foramen ovale was detected by saline contrast transesophageal echocardiography. The alveolar-to-arterial oxygen difference and the right-to-left shunt were calculated from arterial and venous blood gas sampling. RESULTS: In patients without a patent foramen ovale (n = 39), the alveolar-to-arterial oxygen difference and the shunt fraction decreased (-50 mm Hg [95% CI, -21 to -67] and -0.05 [CI, -0.03 to -0.07], respectively) after adding PEEP (10 cm of H2O). In patients with a patent foramen ovale (n = 7), minimal changes were noted in the alveolar-to-arterial oxygen difference (4 mm Hg, P > 0.2), but the shunt fraction increased (0.05, CI, 0 to 0.09). Adding PEEP (10 cm of H2O) increased the shunt fraction in 6 of 7 (86%) patients with a patent foramen ovale, whereas the shunt increased in only 7 of 39 (18%) patients without a patent foramen ovale (P < 0.007). CONCLUSIONS: A patent foramen ovale was found in 7 of 46 patients (15%; CI, 6% to 29%) with acute respiratory failure. This condition is a common cause of lack of improvement in oxygenation with the addition of PEEP in the mechanically ventilated patient. In patients with a patent foramen ovale, the right-to-left shunt is usually increased by using PEEP.

Acute Disease↗
PubMed2002

DNA-sequence patenting: National Society of Genetic Counselors (NSGC) position paper.

In November 2000, the Genetic Services Committee of the National Society of Genetic Counselors (NSGC) convened a working group to draft a position paper on patenting DNA-sequences. The mandate of the group was to produce general position statements that support the perspective and needs of consumers of DNA-based genetic tests and therapies (our patients and their families) and participants in DNA-based genetic research. After review and discussion of the literature on DNA-sequence patenting issues, the working group drafted position statement points that support current United States Patent and Trademark Office (USPTO) guidelines; broad licensing of DNA-sequence patents; nonenforcement of DNA-sequence patents in noncommercial research; reasonable royalty rates; an informed consent process for research participants that discloses whether they can share in any financial rewards relating to the project; the development of guidelines for licensing of DNA-sequence patents; and the establishment of oversight organizations to monitor licensing of DNA-sequence patents. These position statements were approved by the NSGC Board of Directors in the fall of 2001.

Base Sequence↗
PubMed2003

Are DNA patents bad for medicine?

This paper considers the potential benefits and harms of DNA patenting for biomedical research and medical practice. It argues that, all things considered, the benefits of patenting DNA outweigh the harms, although societies should adopt policies designed to prevent or mitigate the harms associated with patenting. Some of these policies include: (1) reinforcing the research exemption for academic researchers, (2) raising the "bar" for the criteria of patentability, (3) restricting the scope of patents, (4) disclosing conflicts of interest related to DNA patents, (5) sharing the economic benefits of patenting with patients, and (6) providing insurance coverage for some types of genetic tests.

Biomedical Research↗
PubMed1998

Patenting computer-designed peptides.

The problem of designing new peptides that possess specific properties, such as bactericidal activity, is of wide interest. Recently, attention has focused on the use of Computer-Aided Molecular Design techniques in parallel with more traditional 'synthesise and test' methods. These techniques may typically use Genetic Algorithms to optimise molecules based on Neural Network models that predict activity. In this paper we describe a successful application of this Molecular Design methodology that has resulted in novel bactericidal peptides of real value. A key issue for commercial utilisation of such results is the ability to protect the intellectual property rights associated with the discovery of new molecules. Typically peptide patents use structural templates of amino acid hydrophobicity-hydrophilicity that define highly regular peptide patent spaces. In an extension of established patenting practice we describe a patent application that uses a Neural Net predictive model to define the regions of peptide space that we claim within the patent. This formalism makes no a priori assumptions about the regularity of the patent space. A preliminary comparative investigation of the shape and size of this and other bactericidal peptide patent spaces is conducted.

Algorithms↗
PubMed2006

Analysing DNA patents in relation with diagnostic genetic testing.

In the ongoing debate concerning DNA patents, there is a need for empirical data. We aim at creating this data set for DNA patents related to diagnostic genetic testing. To this end we developed two tools to facilitate this process. First, we set up a search strategy to find the relevant patents. Second, we provide a claim classification template to assist the user in the assessment of the subject matter covered by the patent claims and in creating a comprehensive overview of the patent situation within this field. These tools have been used in a pilot study on 11 selected hereditary disorders. In addition, a detailed analysis of the familial breast and ovarian cancer genes patents retrieved by the developed search strategy and their claim classification, after meticulous reading of the documents, allowed us to better describe the problems which medical geneticists and researchers might face when dealing with the patented technology.

Algorithms↗
PubMed1996

U.S. patent documents on the Internet: an information resource for research in alternative and complementary medicine.

The US patent literature is a valuable source of information and research data relevant to studies in alternative and complementary medicine. Many patent publications contain detailed historical reviews, case reports, clinical trials, pilot studies, and basic biological research, any of which may give scientific insights, notwithstanding the controversies surrounding the issues of some patents, such as those of products of traditional medicinal plants. Much of the scientific, efficacy, and safety data necessary to obtain a patent is unpublished elsewhere. This paper gives an account of the recent experiment to make the full text of U.S. patents documents openly and freely available on the Internet, gives an example of browsing such a document from the AIDS Patents database, and provides examples of searching on-line on the Patents Abstracts database together with a miscellany of recent abstracts relevant to alternative and complementary medicine.

Complementary Therapies↗
PubMed1997

Does the risk of infective endarteritis justify routine patent ductus arteriosus closure?

OBJECTIVES: The risk of infective endarteritis in patients with patent ductus arteriosus seems to have declined during the last 30-40 years, and cases of patent ductus arteriosus complicated by infective endarteritis are now very rare. Moreover, with the introduction of antibiotics, there has been a dramatic reduction in mortality from infective endocarditis. Despite these changes, however, the prevention of infective endarteritis has remained the principal indication, apart from haemodynamic reasons, for surgical patent ductus arteriosus closure. The aim of this study was to ascertain whether prevention of infective endarteritis is still a justifiable indication for routine closure in all cases of patient ductus arterious. METHODS: The records of 270 paediatric and adult cases of patent ductus arteriosus was reviewed with respect to infective endarteritis. All Swedish death certificates issued during the period 1960-93 were checked for the occurrence of patent ductus arteriosus in combination with infective endarteritis. RESULTS: There had been no cases of infective endarteritis over an aggregate of 1196 years at risk. Of nearly three million deaths in Sweden during the period 1960-93 two cases were due to infective endarteritis as a complication of patent ductus arteriosus. CONCLUSION: The present findings suggest routine closure of a patent ductus arteriosus, for the sole purpose of eliminating the risk of infective endarteritis, is unnecessary.

Adult↗