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PubMed2006

Patome: a database server for biological sequence annotation and analysis in issued patents and published patent applications.

With the advent of automated and high-throughput techniques, the number of patent applications containing biological sequences has been increasing rapidly. However, they have attracted relatively little attention compared to other sequence resources. We have built a database server called Patome, which contains biological sequence data disclosed in patents and published applications, as well as their analysis information. The analysis is divided into two steps. The first is an annotation step in which the disclosed sequences were annotated with RefSeq database. The second is an association step where the sequences were linked to Entrez Gene, OMIM and GO databases, and their results were saved as a gene-patent table. From the analysis, we found that 55% of human genes were associated with patenting. The gene-patent table can be used to identify whether a particular gene or disease is related to patenting. Patome is available at http://www.patome.org/; the information is updated bimonthly.

Amino Acid Sequence↗
PubMed1993

Patenting cDNA 1993: efforts and happenings (Human Genome Project; NIH: US PTO; onco-mouse; European Patents).

The National Institute of Health (NIH) and Dr. J.C. Venter applied for patents for the sequences of cDNA fragments from a brain library. The scientific community objected strenuously on emotional grounds. The NIH argues that these sequences might never be patentable even when completed. The issue became an international one with the British applying for patents to protect their position while the French, Italians and Japanese vowed not to patent cDNA. The United States Patent Trademark Office (US PTO) strongly rejected the NIH's application. The NIH is appealing the decision.

Animals↗
PubMed2005

The patent is political: the consequences of patenting the BRCA genes in Britain.

OBJECTIVES: The paper explores the attempt by an American biotechnology company, Myriad Genetics, to use its patent rights over the BRCA genes to transfer its technology of genetic testing for breast and ovarian cancer to Britain. It also investigates the responses of British scientists, health care professionals and patient advocates to this attempted technology transfer. METHODS: This paper is based on approximately 100 in-depth interviews, document analysis and ethnographic observation conducted in the United States and Britain from 1998 to 2001. RESULTS: The BRCA gene patents inspired political resistance and mobilized opposition to the patenting of genes in general. They also provided an opportunity for the British to assert their national identity as they argued that a British BRCA testing service needed to be available within the context of the National Health Service to all citizens equally. CONCLUSIONS: Patents are not only legal documents and technical descriptions, but political tools as well. As they are increasingly deemed vital to economic globalization, patents have become mobilizing tools for anti-globalization activists and non-governmental organizations from less developed countries, and for asserting local and national identities.

Breast Neoplasms↗
PubMed2005

Ethico-legal issues in biomedicine patenting: a patent professional viewpoint.

Over the last two decades, the ethical implications of patents for biological materials and processes have been the subject of spirited public debate between the many individuals and groups on which the patent system impacts. Whereas copyright, trade marks, and other species of Intellectual Property Rights (IPR) are widely acceptable, the patent system evokes criticism from many quarters, especially in relation to the legal protection of inventions in the Life Sciences. Some of these criticisms expressed by prestigious public organisations are addressed here from the patent professional standpoint.

Biotechnology↗
PubMed2002

The patentability of human beings: the effect of a proposed exclusion in the Patents Act 1953.

The author critically examines the debate over whether "human beings" ought to be patentable. The article outlines the choices between excluding just the patenting of whole organisms or parts of organisms. After considering New Zealand, Canadian, and European Union Patent law, the author concludes that at very least New Zealand must statutorily prevent the patenting of whole organisms.

Biomedical Research↗
PubMed2005

Patent and pre-patent detection of Echinococcus granulosus genotypes in the definitive host.

The detection of Echinococcus granulosus in dogs is important for epidemiological surveillance and evaluation of cystic hydatic disease control programs. We report the efficacy of two PCR-based methods to detect patent and pre-patent infection in dogs experimentally infected with E. granulosus. The detection is based on amplification of a fragment of a mitochondrial gene (Mit-PCR) and a DNA repetitive element (Rep-PCR) of E. granulosus. We tested the ability of both methods to detect several genotypes of the parasite. Both PCR methods could detect E. granulosus in pre-patent and patent periods, even when microscopical observation of eggs resulted negative in fecal samples. The Mit-PCR produced the same amplification pattern for all the parasite genotypes tested while the amplification patterns with the Rep-PCR differed among groups of strains. Fecal samples collected from dogs of an endemic area were diagnosed with more sensitivity than arecoline hydrobromide purgation. These molecular methods could be applied in the confirmation of coproantigen-positive fecal samples and to verify the success of control programs.

Animals↗
PubMed2000

A patent strategy for genomic and research tool patents: are there any differences between the USA, Europe and Japan?

The patenting of genomics and research tools, and its effects on the development of therapeutics are attracting considerable attention. Regardless of whether one is in favor of patents for this technology, it is not specifically excluded from patenting in most countries. Accordingly, it is imperative that a suitable global patent strategy be developed and followed to maximize both intellectual property rights and returns on R&D investment.

Journal Article↗
PubMedDate not supplied

Panel rules against Canada on patent terms for pre-TRIPS patents.

On 5 May 2000, the WTO Panel issued another ruling regarding patents of relevance to pharmaceutical products. Upholding a complaint by the US, the Panel ruled that Canada's Patent Act was in breach of the minimum patent terms for inventions required by the Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement).

Canada↗
PubMedDate not supplied

[Genetic comment on patenting of biotechnology inventions in the adaptation of the Spanish Patenting Law to the European framework].

The author comments on article 1 (Patentability) of Law 10/2002, 29 April, which modifies the country's existing Patent Law (11/1986, 20 March) to incorporate into Spanish legislation the provisions of EU Directive 98/44. The author compares the new Law and the Directive and gives a historical overview and ethical evaluation of the subject of the patentability of human genes.

Bioethical Issues↗
PubMed1998

Patents in combi-space: patent challenges in combinatorial chemistry

Patent protection of inventions relating to combinatorial chemistry is attended by special challenges. The "breakthrough" nature of the field together with the always complex and often arcane chemical manipulations, apparatus, and strategies which suffuse this field make it difficult to describe the inventions adequately. It can be a challenge to communicate effectively with official authorities charged with patent examination. Extraordinary effort is called for in clarifying such inventions such that their patentability can be appreciated. The utility of some types of inventions in this field may be open to question; clear statements of at least one acceptable utility-even if only a minor utility-is beneficial. Because a principal product of many aspects of combinatorial chemistry is information, e.g., the identification of a lead compound, offshore "piracy" is a risk. Domestic claim tie-ins may improve the ability to abate such piracy. Copyright 1998 John Wiley & Sons, Inc.

Journal Article↗
PubMed1995

Recurrent cerebrovascular events in patients with patent foramen ovale, atrial septal aneurysm, or both and cryptogenic stroke or transient ischemic attack. French Study Group on Patent Foramen Ovale and Atrial Septal Aneurysm.

Patent foramen ovale (PFO) and atrial septal aneurysm (ASA) have been identified as potential risk factors for stroke, but information about the risk of recurrent cerebral ischemia is scarce. The aim of this retrospective study was to assess the absolute risk of recurrent cerebrovascular events in 132 patients under 60 years of age with patent foramen ovale, atrial septal aneurysm (diagnosed by transesophageal echocardiography with a contrast study), or both and an otherwise unexplained stroke or transient ischemic attack (TIA). During a mean follow-up of 22.6 +/- 16 months, six patients had a recurrent stroke (n = 2) or a TIA (n = 4). No systemic embolism was observed. The actuarial risk of having a recurrent stroke was 2.3% (95% confidence interval, 0.6% to 8.2%) at 2 years, whereas the risk of having a stroke or a TIA was 6.7% (95% confidence interval, 3.1% to 14.2%) at 2 years. The average annual rates of recurrence were 1.2% and 3.4%, respectively. In patients with both PFO and ASA, the actuarial risk of a first recurrent stroke was 9.0% (95% confidence interval, 2.4% to 28.5%) at 2 years, with an average annual rate of recurrence of 4.4%. As a group, patients with patent foramen ovale, atrial septal aneurysm, or both and an otherwise unexplained stroke or TIA appear to have a low risk of recurrent stroke whatever the prophylactic antithrombotic therapy used. The association of ASA and PFO may be an indicator of a higher risk of recurrent stroke.

Adult↗
PubMed2000

Furosemide for symptomatic patent ductus arteriosus in indomethacin-treated infants.

BACKGROUND: Inhibition of prostaglandin synthesis mediates closure of the ductus arteriosus and renal side effects after indomethacin administration. Because furosemide increases prostaglandin production, it could potentially help prevent indomethacin-related toxicity but also decrease ductal response to indomethacin. OBJECTIVES: The primary objectives of this review were to assess (1) whether furosemide affects the incidence of failure of ductal closure after indomethacin and that of indomethacin-related toxicity and (2) the effect of furosemide on mid-term and long-term outcome. The secondary objective was to determine whether the effect of furosemide on renal function and water balance depends on prior extracellular volume (assessed by blood urea nitrogen [BUN]/creatinine ratio). SEARCH STRATEGY: We searched electronic databases (Medline, Embase and Cochrane) and selected abstract books, without language restriction. SELECTION CRITERIA: We selected studies with (1) random allocation to either indomethacin alone or indomethacin and furosemide and (2) analysis of either short-term risk-benefit ratio of furosemide, mid- or long-term outcome, or the relationship between extracellular volume at study entry and changes in renal function. DATA COLLECTION AND ANALYSIS: We assessed studies for possible bias and for quality of assessment of ductal patency. We assessed categorical variables using relative risk and absolute risk reduction. We assessed the effects of furosemide on renal function and fluid balance by comparing changes from baseline in the treatment group with those in controls. Subsets were determined a priori based on BUN/creatinine ratio at study entry. MAIN RESULTS: All 3 studies fulfilling the entry criteria had limitations, including possible or definite bias. There was substantial heterogeneity among studies. Furosemide administration did not significantly increase the risk of failure of ductal closure; however, sample size was insufficient to rule out even a 31% increase. In the subset with initial BUN/creatinine ratio > 20 mg/mg, 2 of 18 patients receiving furosemide could not complete a 3-dose course of indomethacin because of toxicity. Minimal or no information was available about any of the other main outcome variables. Furosemide increased urine output regardless of the initial BUN/creatinine ratio, leading to a 5% weight loss during a 3-dose course, an undesired effect in patients with initial BUN/creatinine ratio > 20 mg/mg. Furosemide increased creatinine clearance only in patients with initial BUN/creatinine ratio <20 mg/mg. REVIEWER'S CONCLUSIONS: There is not enough evidence to support the administration of furosemide to premature infants treated with indomethacin for symptomatic patent ductus arteriosus. Furosemide appears to be contraindicated in the presence of dehydration in those infants.

Cyclooxygenase Inhibitors↗
PubMedDate not supplied

Haggling for a patent: what a government would have to pay for prescription drug patents.

In previous papers (Guell, R. and Fischbaum, M. The Milbank Quarterly 1995; 73: 2 and Applied Economics letters in press), we established that the allocative inefficiency in the prescription drug industry is so pervasive that some remedy is warranted. In the first paper, we estimated a lower bound on this inefficiency at approximately $3 billion, with an upper bound of approximately $30 billion; all on total industry sales of approximately $50 billion. In the second paper, on a narrower set of drugs for which sales were $8 billion, we more precisely estimated this dead weight loss to be $5 billion. From this we showed that a system could exist whereby a government would purchase a drug patent from a willing seller, freely distribute it and reap significant efficiency benefits. In those papers we considered the possibility that the innovating firm would not want to relinquish the patent, but we assumed that they would be indifferent between being paid the expected net present value of future monopoly profits and reaping those uncertain profits over time. While that may be the case, a more likely scenario would be that a negotiation would take place. In the current paper I show the bargaining range that would exist under different risk preference assumptions and show that this range widens as each side becomes more risk averse and narrows if the government threatens to use its power of eminent domain. Lastly, I acknowledge the risk of firms "capturing' the government agents doing the negotiation. To conclude, I present the circumstances under which the proposed agency would likely improve societal welfare and contrast that with the circumstances where the presently inefficient system would be made more so by government intervention.

Costs and Cost Analysis↗
PubMed2000

Percutaneous closure of patent ductus arteriosus: complementary use of detachable Cook patent ductus arteriosus coils and Amplatzer duct occluders.

UNLABELLED: Several different devices were evaluated for the percutaneous closure of patent ductus arteriosus (PDA), and important drawbacks were found in all of them. To overcome these drawbacks, both detachable Cook PDA coils and Amplatzer duct occluders (ADO) were used for the percutaneous closure of PDA. A total of 54 patients underwent transcatheter occlusion of PDA at a median age of 4.5 years (range 0.5-29 years) and at a median weight of 19.5 kg (range 6-69 kg). Three patients were adults. Detachable Cook PDA coils were used in 26 patients with a median PDA diameter of 1.7 mm (range 1.1-2.2 mm) and ADO were used in 28 patients with a median PDA diameter of 3.8 mm (range 1.9-7.5 mm). Devices were successfully implanted in all 54 patients. Complete closure was achieved in 53 of 54 patients (98% closure rate). Median fluoroscopy time was 12 min (range 4-47 min). CONCLUSION: According to our experience, the complementary use of detachable Cook patent ductus arteriosus coils and Amplatzer duct occluders for the percutaneous closure of PDA can be recommended.

Adolescent↗
PubMed2003

Striae treated by a novel combination treatment--sand abrasion and a patent mixture containing 15% trichloracetic acid followed by 6-24 hrs of a patent cream under plastic occlusion.

BACKGROUND: Striae are a common cosmetic problem, especially for women. Little has been published about chemical peel treatment of striae. OBJECTIVE: To recount 5 years experience of striae treated by a novel combination treatment--sand abrasion and a patent mixture containing 15% trichloracetic acid followed by 6-24 h of a patent cream under plastic occlusion. MATERIALS AND METHODS: Sixty-nine females of various phototypes, aged 14-63 years, were treated at various anatomical sites: abdomen (43), lateral thighs (11), breasts (4), back (3), waist (3) and others (5). Striae of all types: fresh, old, mild and severe, were treated. Average follow up was 18 months. RESULTS: After 1-8 treatments (median 4.2), appearance of the striae improved by 70%. Results were best in fresher and more superficial striae. CONCLUSIONS: A novel combination treatment is reported which safely, predictably and effectively improved striae in all skin types.

Journal Article↗
PubMed1997

Retrievable patent ductus arteriosus plug for interventional, transvenous occlusion of the patent ductus arteriosus. Evaluation in lambs and preliminary clinical results.

RATIONALE AND OBJECTIVES: The clinically most widely used devices (Porstmann-plug, Rashkind-umbrella, Botallooccluder) have inherent specific limitations (eg, transarterial approach, residual shunts, limited retrieval). The authors assess practicability, efficacy, and tissue reaction of the new retrievable transvenous plug device for the occlusion of the persistent patent ductus arteriosus (PDA). METHODS: A foam plug (polyvinyl alcohol) is mounted on a titanium core pin where, at both ends, small legs (titanium nickel alloy) with titanium heads are anchored, to ensure safe fixation in the ductus. The device is introduced transvenously through a long sheath (Mullins sheath) and held by a modified biopsy forceps allowing complete retrieval until final release. A common lamb model of large PDAs (n = 11) was used to test for practicability and the histomorphologic outcome. Clinical results were obtained from a consecutive series of 16 patients (aged 13 to 71 years). RESULTS: In all lambs, placement of the plug within the PDA was possible. Histopathology (follow-up 10 to 215 days; mean 112 days) revealed an adequate ingrowing of the device and no pathologic foreign body reaction. The diameter of the human PDAs ranged from 3 to 7 mm (mean 5 mm). The size of the sheath used for introducing the plug (diameter 8 to 16 mm) ranged from 8 to 16 French. Fourteen of 16 PDAs were closed immediately after or on day 1 after implantation, 1 was closed after the 12-month follow-up, and 1 needed an additional plug after 30 months for definitive closure. CONCLUSIONS: The device demonstrated practicability and biocompatibility in our experimental lamb model and effectively closed the PDA in a consecutive series of 16 patients. A greater number of patients and a longer follow-up period are necessary for the definitive clinical assessment of the new device.

Adolescent↗
PubMed2006

Significant correlations between the flow volume of patent ductus venosus and early neonatal liver function: possible involvement of patent ductus venosus in postnatal liver function.

BACKGROUND: The biochemical features of portosystemic venous shunt with high flow volume are hypergalactosaemia, hyperammonaemia, prolonged blood coagulation time, and raised serum bile acid concentration. The ductus venosus remains open with shunt flow in most neonates for a certain period after birth. However, the effects of blood flow through the ductus venosus on neonatal liver function remain unclear. OBJECTIVE: To elucidate the effect of patency of the ductus venosus on liver function in early neonates. METHODS: Subjects were divided into three groups by gestational age (group I, 29-32 weeks; group II, 33-36 weeks; group III, 37-41 weeks). The shunt flow volume through the ductus venosus was examined serially using ultrasonography, and correlations between flow volume and liver function in the respective groups were calculated during the first week after birth. RESULTS: Group I had a higher flow volume and later functional closure than the other two groups. Plasma ammonia and serum total bile acid concentrations correlated with flow volume in groups I and II, and blood galactose and galactose 1-phosphate concentrations correlated significantly with flow volume in group III. Percentage hepaplastin also correlated significantly with flow volume in all groups, but plasma vitamin K concentration did not in any group. CONCLUSIONS: Patent ductus venosus has a considerable effect on crucial liver functions such as ammonia detoxification, blood coagulation, and regulation of serum total bile acid concentration in early neonates.

Ammonia↗
PubMed1983

The anatomical heterogeneity of hearts lacking a patent communication between the left atrium and the ventricular mass ('mitral atresia') in presence of a patent aortic valve.

Thirty-five hearts were studied with no patent communication between the left atrium and the ventricular mass ('mitral atresia'). In ten, an imperforate and hypoplastic membrane separated the left atrium from a hypoplastic left ventricle. The imperforate valve ranged from a tiny membrane with no evidence of tension apparatus, through a larger membrane supported by muscular columns in the ventricular inlet portion, to an aneurysmal imperforate sac attached to a single hypoplastic papillary muscle. The ventriculo-arterial connection was concordant in nine of the ten hearts and double outlet from the right ventricle in one. In one further heart, there was double inlet left ventricle with imperforate left atrioventricular valve, a rudimentary right ventricle and ventriculo-arterial discordance. In the other 24 hearts the muscular floor of the left atrium was completely separated by the atrioventricular sulcus from the ventricular mass (absent left atrioventricular connection). In 11 of these hearts, the right atrium was connected to a right ventricle and there was a posterior and left-sided rudimentary left ventricular chamber which had no connection with the atrial chambers. The left ventricle supported the aorta in five of the 11 hearts, but in the other six it was simply a pouch of left ventricular morphology. In ten cases the right atrium was connected to a dominant left ventricle. An anterior rudimentary right ventricle was present in each but had no connection with the atrial chambers. It was to the left of the left ventricle in seven, directly anterior in one and to the right in two cases. The right ventricle supported the aorta in eight cases, the pulmonary trunk in one and neither great artery in the remaining case. Lastly, there were three cases in which a sole ventricular chamber of indeterminate morphology was present and gave rise to both great arteries.

Aortic Valve↗