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PubMed2004

Patents and access to drugs in developing countries: an ethical analysis.

More than a third of the world's population has no access to essential drugs. More than half of this group of people live in the poorest regions of Africa and Asia. Several factors determine the accessibility of drugs in developing countries. Hardly any medicines for tropical diseases are being developed, but even existing drugs are often not available to the patients who need them. One of the important determinants of access to drugs is the working of the patent system. This paper first maps out some facts about the global patent regime that has emerged as a consequence of the conclusion of the WTO-TRIPs Agreement in 1994. Attempts to construct a moral justification of the patent system have been based on three grounds: natural rights, distributive justice, and utilitarian arguments. This paper examines to what extent and on which grounds drug patents can be justified. The final section looks at the so-called 'Doha Declaration on the TRIPs Agreement and Public Health', which was adopted by the WTO Ministerial Conference two years ago, recognising the primacy of public health over the interests of patent proprietors.

Developing Countries↗

PubMed1992

Genes, patents, and product development.

In the past year, the National Institutes of Health (NIH) has filed patent applications on more than 2750 partial complementary DNA sequences of unknown function. The rationale for the filings--that patent protection may be necessary to ensure that private firms are willing to invest in developing related products--rests on two premises: first, that NIH may obtain patent rights that will offer effective product monopolies to licensee firms, and second, that unless NIH obtains these rights now, firms will be unable to obtain a comparable degree of exclusivity by other means, such as by obtaining patents on their own subsequent innovations. Neither premise is clearly wrong, although both are subject to doubt in view of statements from industry representatives that the NIH patenting strategy will deter rather than promote product development.

Biomedical Research↗

PubMed2006

Declaration of patent applications as financial interests: a survey of practice among authors of papers on molecular biology in Nature.

OBJECTIVES: To determine whether authors of scientific publications in molecular biology declare patents and other potential financial interests. DESIGN: Survey of a 6-month sample of papers related to molecular biology in Nature. METHODS: The esp@cenet worldwide patent search engine was used to search for patents applied for by the authors of scientific papers in Nature that were related to molecular biology and genetics, between January and June 2005. RESULTS: Of the 79 papers considered, four had declared that certain authors had competing financial interests. Seven papers in which no financial interests were declared had authors with patent applications that were based on the research in the paper or were closely related to it. Another paper had two authors with connections to biotechnology companies that were not disclosed. CONCLUSION: Two thirds of the papers in which authors had patent applications or company affiliations that might be considered to be competing financial interests did not disclose them. Failure to disclose such information may have negative implications on the perception of science in society and on its quality if the possible bias is hidden. Journals should make greater efforts to ensure full disclosure, and scientific institutions should consider failure to disclose financial interests as an example of scientific malpractice. Establishing a register of interests for scientists is one way to increase transparency and openness.

Biotechnology↗

PubMed2002

Patenting genes and genetic research: good or bad for innovation?

Our goal with this article is to inform the debate over gene patenting, by providing an understanding of (a) the scope of patent claims that are actually being issued on genetic inventions in the United States, (b) the issues that impact their enforcement, and (c) the role that patents and patent licensing play in the commercialization of genetic technologies and products. We conclude by discussing whether the current legal regime effectively balances the beneficial role of patents in the development of new genetic technologies and products against negative impacts on genetic research or clinical genetic testing, or whether the current laws should be amended.

Algorithms↗

PubMed1996

Longer patents for increased generic competition in the US. The Waxman-Hatch Act after one decade.

The 1984 Waxman-Hatch Act had two main objectives. Title I was designed to promote price competition by establishing an abbreviated new drug application (ANDA) process for generic market entry. Title II was designed to encourage drug innovation by restoring some of the patent life lost during the lengthy FDA regulatory process. In this paper, we consider whether these twin objectives have been realised during the first decade of the Act's existence. First, we investigate the pattern of generic and brand name prices and market shares for the major products whose patents expired between 1984 and 1993. A regression model indicates that generic competition has been intensifying significantly in recent periods. Major brand name products now typically lose more than half their market share within the first year after patent expiration. In addition, we examine changes in patent protection for new chemical entities introduced over the period 1984 to 1993. For 1991 to 1993 new drug introductions, the average effective patent life was 11.8 years with 2.3 years resulting from Waxman-Hatch extensions. In the final section of the paper, we consider how the US law compares with that in Europe and discuss possible legislative improvements in the 1984 Act.

Cost Control↗

PubMedDate not supplied

[Drug patents and other ways to protect pharmaceutical research].

Pharmaceutical research constitutes a significant cost for pharmaceutical companies. Because of the importance of the financial investment in research projects, companies must protect their discoveries. There are multiple ways to do this. First, the legal avenue can be divided into three parts: a pharmaceutical company can protect a new drug by a patent, then an additional patent or a secondary patent; moreover, since 1992 in Europe, the pharmaceutical industry has been able to extend a patent by the "Supplementary Protection Certificate" (le Certificat Complémentaire de Protection [CCP]). The nonjuridical way is to use the chiral "switch", which can extend patents close to expiring, thus enhancing profitability.

Drug Industry↗

PubMedDate not supplied

[Patent rights and biotechnological inventions].

In spite of all the controversy surrounding it and the problems encountered in the process leading to its adoption, the Directive on the legal protection of biotechnology inventions does not feature anything substantially new compared to the criteria used by patent offices in determining whether inventions of this type can be patented. The Directive's originality stems not so much from the interpretation given of patenting requirements but rather from the legal importance attached to issues of public policy or morality. It sets out and interprets for the member states of the European Union what is meant by the term. However, in our opinion this regulation of morality reflects above all else an attempt to satisfy the views of sectors opposed to the Directive. Clearly, there is some doubt as to whether in practice patents for genetic material can be turned down because they run counter to morality, except in blatant cases of immorality (applications for patents for human embryos, etc).

Animals↗

PubMedDate not supplied

Ethical limitations in patenting biotechnological inventions.

In order to connect ethical considerations with practical limits to patentability, the moral judgement should possibly move from the exploitation of the invention to the nature and/or objectives of Research and Development (R&D) projects which have produced it: in other words, it appears quite reasonable and logical that Society is not rewarding unethical R&D activities by granting intellectual property rights. As far as biotechnology R&D is concerned, ethical guidance can be derived from the 1996 Council of EuropeOs OConvention for the protection of human rights and dignity of the human being with regard to the application of biology and medicineO, whose Chapter V - Scientific research - provides guidelines on: i. protection of persons undergoing research (e.g. informed consent); ii. protection of persons not able to consent to research; iii. research on embryos in vitro. As far as the specific point of patenting biotechnology inventions is concerned, the four exclusions prescribed by Directive 98/44/EC (i.e. human cloning, human germ-line gene therapy, use of human embryos for commercial purposes, unjustified animal suffering for medical purposes) are all we have in Europe in terms of ethical guidance to patentability. In Italy, in particular, we certainly need far more comprehensive legislation, expressing SocietyOs demand to provide ethical control of modern biotechnology. However it is quite difficult to claim that ethical concerns are being raised by currently awarded biotechnology patents related to living organisms and material thereof; they largely deal with the results of genomic R&D, purposely and usefully oriented toward improving health-care and agri-food processes, products and services. ONo patents on lifeOO can be an appealing slogan of militants against modern biotechnology, but it is far too much of an over-simplified abstraction to become the Eleventh Commandment our Society.

Biotechnology↗

PubMed2002

[Patentability of living material: public health concerns (1/2)].

A TOPICAL SUBJECT: The patentability of living material provokes debate in the scientific and medical world, but also concerns the political and legal circles. REGARDING PATENTS: Laws govern intellectual property rights and patients. There are contradictory arguments advanced by those who are in favour or who are opposed to patents, and particular problems related to the patenting of living organisms, particularly since the progress made in genomic research. ESSENTIAL PUBLIC HEALTH REQUIREMENTS: It is important to underline the limits imposed by the protection of intellectual property, regarding the access by all to any progress issued from research. The provisions must be widened in order to bypass the patents, when the health and nutrition of populations are at stake. It is essential to come to the universal accessibility, particularly in developing countries, to all innovations and that all knowledge be shared.

Animals↗

PubMed2002

[Transcatheter treatment of patent ductus arteriosus].

Isolated patent ductus arteriosus accounts for 10 to 18% of all cardiovascular malformations. Transcatheter closure of the patent ductus arteriosus has now become established practice with a high success rate and a low incidence of complications. Many devices have been proposed during the last 20 years. The use of some of these devices has largely been abandoned for different reasons: high costs, the need of large transvenous sheaths and the high incidence of late residual shunts. The devices currently available (Amplatzer duct occluder, buttoned device, DuctOcclud coil, Gianturco-Grifka vascular occlusion device, detachable coils) render the embolization of a patent ductus arteriosus relatively easy, with a short hospital stay. We feel that this is the treatment of choice for the majority of patients with a patent ductus arteriosus. The aim of this article was to review our experience and report the state-of-the-art in transcatheter patent ductus arteriosus therapy.

Balloon Occlusion↗

PubMed2003

Antibacterial agents: patent highlights January to June 2003.

This review presents an overview of 38 patents published between January and June 2003 on different classes of antibacterial agents. Patent disclosures on novel oxazolidinone and macrolide derivatives with strong antibacterial activity continue to dominate patent publications in recent years. A use patent of a linezolid formulation for ear infections in infants and pre-operative procedure is highlighted. Disclosures on novel dual action oxazolidinone-quinolone hybrids designed to overcome bacterial resistance and new macrolide derivatives with antimycobacterial activity are also presented. Patents on beta-lactam and quinolone antibiotics focus on the development of new processes and formulations to improve cost, purity and stability of existing agents in clinical use. Novel antibacterial agents (DNA polymerase and D-glutamate racemase inhibitors) as potential lead compounds are also presented.

Anti-Bacterial Agents↗

PubMed2002

WTO: US and Argentina settle dispute over patents and data protection.

In May 2000, supplementing an earlier complaint filed in May 1999, the US filed a complaint against Argentina, alleging that its patent laws violate the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property (the TRIPS Agreement). The gist of the US complaint was that Argentina's law failed to provide: (1) adequate protection against "unfair" commercial use of undisclosed test data submitted in order to get market approval of pharmaceutical products; (2) certain safeguards for compulsory licences on an invention granted on the basis of inadequate working by the patent holder; and (3) adequate measures to prevent infringements of patent rights. The US also alleged that Argentina denies certain exclusive rights of patent holders, such as the exclusive right to import the patented product into the country. At the end of May 2002, the US and Argentina notified the WTO that they had reached a "mutually agreed solution," without prejudice to their respective rights and obligations under WTO agreements, and the US has withdrawn its complaint.

Argentina↗

PubMed2004

"Sufficiency" for living organism inventions under the Patents Act 1990 (Cth).

The Patents Act 1990 (Cth) requires a complete specification to describe the invention. This description is central to the policy objective that the statutory rights under the Patents Act 1990 (Cth) are exchanged for disclosure of the invention, including how to make the invention. In addressing these requirements for "micro-organisms", the Patents Act 1990 (Cth) adopted the Budapest Treaty on the International Recognition of the Deposit of Micro-organisms for the Purposes of Patent Procedure (Budapest Treaty) recognising that the "invented" organism itself may be necessary to make and use the invention, and that a formal description may be of limited value or practicability. The scope of the Budapest Treaty does not, however, extend to a significant class of living organisms outside the class defined by the term "micro-organism". This article reviews the application of the description requirements for living organism inventions under the Patents Act 1990 (Cth) and concludes that some form of public availability or deposit requirements are necessary for invented living organisms that are outside the scope of the Budapest Treaty's "micro-organisms".

Animals↗

PubMed2005

[Diagnosis and surgical treatment of 102 cases of ventricular septal defect with patent ductus arteriosus].

OBJECTIVE: To summarize the experience of diagnosis and surgical treatment of ventricular septal defect with patent ductus arteriosus. METHODS: We retrospectively analyzed the clinical data of 102 cases of ventricular septal defect combined with patent ductus arteriosus who underwent surgical treatment. Preoperative ultrasonic cardiogram (UCG) showed ventricular septal defect combined with patent ductus arteriosus in 82 cases and ventricular septal defect in 20 cases. RESULTS: The hospital mortality was 4.9% (5/102). The reasons for death included low cardiac output syndrome (1 case), pulmonary hypertension crisis (2 cases) and respiratory failure (2 cases). In the remaining patients,the perioperative complications included lung infection (7 cases), pulmonary atelectasis (5 cases), hydrothorax (1 case), and pulmonary hypertension crisis (2 cases); and all the 15 patients recovered lastly. The pulmonary hypertension of all living patients decreased to some degree. The therapeutical effectiveness was satisfactory. CONCLUSION: Ventricular septal defect with patent ductus arteriosus is easy to be confused with ventricular septal defect clinically. At the same time,it is diffcult to form a correct diagnosis in some patients by UCG preoperatively. To prevent the occurrence of perfusive lung, it is important to reinforce preoperative diagnosis and exploration during operation. Because pulmonary hypertension in patients with ventricular septal defect with patent ductus arteriosus emerges early and develops quickly, it tends to result in organic pulmonary hypertension which can make patients lose operation chances and influence the long-term therapeutical effect. Surgical operation should be performed as soon as possible. Optimal operative timing and proper perioperative management play important roles in surgical results.

Abnormalities, Multiple↗

PubMed2003

Patent law--balancing profit maximization and public access to technology.

This article addresses the contemporary issue of balancing the need for patent protection for intellectual property with the resulting restriction of public access to new technology. The author argues that patent law protects private property rights rather than creating monopolies. Additionally, the author discusses how restricting access to patented technology, such as pharmaceuticals, can affect public health problems, such as the HIV/AIDS epidemic in developing nations. The author then concludes with some proposals for making patented technology available to people in developing nations who need access to such technology but who are unable to afford its high costs due to patent protection.

Anti-HIV Agents↗

PubMed2005

Grant's Application: it's time for a new approach to a "public interest" exclusion from patentability.

This article reviews the recent IP Australia decision in Grant's Application [2004] APO 11 about an innovation patent for a way of protecting assets against a loss of ownership as a result of a legal liability. The significance of this decision was to expose the tortured reasoning necessary to exclude from patentability an invention that was arguably contrary to the "public interest". The article asserts that the effect of the decision revoking the patent was correct, but that the reasoning points to a need to reconsider the "public interest" limits on patentability. The article then considers the approach that should be adopted in formalising a "public interest" exemption from patentability that is practical and generally applicable.

Australia↗

PubMed2004

The human genome, property of all: opportunities under the ALRC inquiry into gene patenting and human health.

This article highlights the revolutionary and dramatic implications brought about by the advances in genetics. Among the myriad of legal problems involved, gene patenting is regarded as one of the most controversial. In a critical evaluation of the current inquiry into gene patenting and human health, the author argues that the Australian Law Reform Commission falls short of a thorough recommendation by failing to grant due recognition to the Universal Declaration on the Human Genome and Human Rights. Starting with the fundamental premise that the human genome is the 'heritage of humanity', it is argued that the fruits of genetic research must flow back to humankind, and any law reform process must thereby ensure that the economic and health benefits of genetic research are available to all. Specifically, the Patents Act 1990 (Cth) should be amended to include the 'medical treatment' defence to patent infringement, following the lead of overseas jurisdictions. It should also incorporate an 'experimental use' defence to ensure an unhindered approach to research and development. In doing so, the patent law regime will be truly balancing the interests at stake, which will accommodate more fully Australia's domestic needs and international obligations.

Advisory Committees↗

PubMed2006

Transcatheter treatment of "pulmonary artery hypertension" due to patent ductus arteriosus and pulmonary artery stenosis.

The association between large, left-sided patent ductus arteriosus and severe, peripheral, right pulmonary artery stenosis with no other cardiac malformation is an unreported condition that might be misdiagnosed as pulmonary hypertension due to long-standing ductal shunt. A 57-year-old man with supposed hypertensive patent ductus arteriosus underwent confirmatory cardiac catheterization. At angiography, a severe pre-hilar right pulmonary artery stenosis (peak pressure gradient, 65 mmHg) was found to complicate the hemodynamic picture of a moderate-to-large patent ductus arteriosus (QP/QS, 1.7:1), by causing pulmonary hypertension (mean pressure, 65 mmHg) and left-to-right pulmonary flow imbalance. Both lesions were treated in a single procedure of right pulmonary artery stenting and patent ductus arteriosus closure, after which the pulmonary artery pressure significantly decreased (mean, 35 mmHg). In our opinion, a thorough hemodynamic evaluation followed by pulmonary angiography should be mandatory before proceeding to patent ductus arteriosus closure in the adult patient who has "hypertensive" ductus, in whom possible associated malformations can be missed due to a poor echocardiographic window.

Cardiac Catheterization↗