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PubMed1985

The patent system and cardiac pacing: is the system serving its users?

Patents have been utilized to protect technical innovations in pacemakers virtually since their inception and are becoming increasingly important to the industry. In the U.S. alone, about 100 patents are granted each year covering pacer-related technology and reflecting the main areas of technical development. The increase in the number of outstanding patents has been accompanied by a significant increase in patent litigation among pacer companies. The rate and cost of pacer-related patent litigation raises a question of whether the system is being used to its best advantage. A recommendation is made for an industry-sponsored board to aid in voluntary settlement of patent disputes.

Humans↗
PubMed2004

Are patents for methods of medical treatment contrary to the ordre public and morality or "generally inconvenient"?

"No one has advanced a just and logical reason why reward for service to the public should be extended to the inventor of a mechanical toy and denied to the genius whose patience, foresight, and effort have given a valuable new [discovery] to mankind" (Katopis CJ. Patents v patents: policy implications of recent patent legislation. St John's Law Review 1997;71:329). The law around the world permits the granting of patents for drugs, medical devices, and cosmetic treatment of the human body. At the same time, patentability for a method of treatment of the same body is denied in some countries on various public policy grounds. Is there any logical justification for this distinction? Are methods of medical treatment not as vital to the health or even to the life of a patient as drugs or medical devices? Why is a cosmetic result patentable and a curative result not?

Australia↗
PubMed2005

What are gene patents and why are people worried about them?

This article examines what it means to patent a gene. Numerous ethical concerns have been raised about the effects of such patents on clinical medical practice as well as on research and development. We describe what kinds of inventions are covered by human gene patents, give several examples and summarize the small body of empirical research performed in the US examining the effects of these patents. There is little evidence that early fears about gene patenting placing substantial restraints on research and clinical medicine have come to fruition. Nonetheless, there are areas of concern, and policy makers, physicians and the public should be alert to ensure that the net social benefits of patenting human genes are maintained.

Animals↗
PubMed2005

Genetic patent protection in the pharmaceutical and biotechnology industries.

Without patent protection, biomedical progress would be severely diminished. Conditions under the current patent regime are characterized by rapid advancement made possible by cooperative licensing, collaboration and partnerships between and among various entities, and the drive to bring successful products to market both in order to make profits and to further the cause of humanity. The financial advantages associated with patent-driven corporate participation are the lifeline of innovation. While granting limited periods of exclusivity under the patent system necessary to entice innovation is a calculated sacrifice, the enormous benefits of fully-disclosed pharmaceutical and genetic discoveries result in a handsome net benefit over the alternative of resource-limited research clouded by a shroud of secrecy as a substitute for patent protection. By examining characteristics of the pharmaceutical and biotechnology industries and the critical role the patent regime plays in driving investment in these areas, a clearer picture of the necessity of strong intellectual property rights in the context of genetics will emerge.

Biotechnology↗
PubMed2005

Policy conflicts: gene patents and health care in Canada.

Several recent gene patent controversies have energized and refocused the human gene patent debate in Canada. These include the use of the Myriad test for breast cancer by the provinces, patenting of the Severe Acute Respiratory Syndrome virus and a recent Supreme Court decision rejecting the patenting of 'higher life forms'. These cases place the emerging policy conflicts between the innovation and commercialization agenda of the government and the desire to provide equitable access to health care in sharp focus. Another challenge faced by Canada is the powerful influence of the United States in policy decisions. Although these issues have raised awareness about the possibility of reforming the patent system, Parliament has yet to consider any of the suggested reforms of the Canadian patent system and there are no formal proposals pending.

Animals↗
PubMed2005

Balancing innovation and access to healthcare through the patent system--an Australian perspective.

This article examines the enforcement of gene and other research tool patents in Australia. An empirical analysis of patenting practices in the Australian medical biotechnology industry showed heightened concern about the impact of patents on research and diagnostic testing, but provided little evidence to support these concerns at that time. Since then, the Australian company Genetic Technologies Ltd. has been enforcing its patents for non-coding DNA sequences. The governments of Australia are encouraging the biotechnology industry to better protect and enforce intellectual property rights, but recognize these needs to be balanced against access to healthcare. The article discusses proposals made by the Australian Law Reform Commission to adjust the balance, both by tightening the requirements for obtaining patents and by introducing various options to assist providers of diagnostic services and others in using patented inventions, but at the same time maintaining the incentive to innovate.

Australia↗
PubMed1993

Transcatheter occlusion of patent ductus arteriosus with adjustable buttoned device. Initial clinical experience.

BACKGROUND: Several devices are available for transcatheter occlusion of patent ductus arteriosus. Most of these devices either require complicated intracardiac maneuvering, have not been tried in humans, or need a large-sized sheath for implantation of the device. METHODS AND RESULTS: During a 26-month period ending November 1992, 14 patients underwent transcatheter closure of patent ductus arteriosus with an adjustable buttoned device delivered via a 7F sheath under an institutional review board-approved custom-made device protocol. The children were 15 months to 8 years of age with weight range of 7.2 to 19 kg. The patent ductus arteriosus measured from 2 to 7.5 mm (median, 3 mm) at the narrowest diameter and was conical, short, or tubular. They were occluded with devices measuring 15 to 20 mm. The ratio of pulmonary to systemic flow decreased (P < .01) from 1.9 +/- 0.6 (mean +/- SD; range, 1.3 to 3.2) to 1.05 +/- 0.1 (1 to 1.3). Continuous murmur of patent ductus arteriosus disappeared in all except 1 patient. Small residual shunts were detected by color Doppler studies in 4 of 14 patients (29%). All patients were followed for 1 to 24 months (mean, 6 +/- 7 months). The device was intact in all patients, and no breakage of the wires was noted. No shunts were seen in 12 of 14 patients (86%), and minute residual shunts were seen in 2 children. No major complications were encountered. CONCLUSIONS: It is concluded that transcatheter closure of patent ductus arteriosus with the adjustable buttoned device is feasible and effective and can be accomplished via small 7F sheaths; a 7F sheath is adequate for all ductal sizes; and the adjustable length of the loop accommodated all types of patent ductus arteriosus. Clinical trials on a larger number of patients are warranted.

Cardiac Catheterization↗
PubMed1997

Strategic options for brand-name prescription drugs when patents expire.

Pharmaceutical companies face a very hostile competitive environment from generic drugs once the patents on their brand name drugs expire. Depending on the country, such patents usually last 10-15 years but no sooner do the patents expire then copies of off-patent brand name drugs, called generics, are introduced, generally by smaller-size and lesser known companies, at significantly lower prices. As health care costs escalate all over the world, efforts to control medication costs have created a major market for generic prescription drugs, particularly in government funded hospitals and in dispensing general practitioner markets of the Asia Pacific and the third world. The world market for generics is estimated at US$20 billion, doubling in only five years and capturing over 30% of the market share. Because of adverse effects on sales and profitability due to the launching of generics, most research based companies that produce original brand-name patented drugs are forced to take counter measures to overcome this problem, particularly when R&D costs for new patents are skyrocketing. This paper develops a brief perspective on this problem and then examines the experiences of many multinational companies in the Singapore market in dealing with the problem. While several different approaches are identified, only one company experience appeared to work successfully and this is discussed in relative detail.

Commerce↗
PubMedDate not supplied

How do patents and economic policies affect access to essential medicines in developing countries?

This paper studies the relationship between patents and access to essential medicines. It finds that in sixty-five low- and middle-income countries, where four billion people live, patenting is rare for 319 products on the World Health Organization's Model List of Essential Medicines. Only seventeen essential medicines are patentable, although usually not actually patented, so that overall patent incidence is low (1.4 percent) and concentrated in larger markets. This and other results shed light on the policy dialogue among public health activists, the pharmaceutical industry, and governments that is often based on mistaken premises about how patents affect corporate revenues or the health of the world's poorest. Pragmatism and greater flexibility are urged, so that policy may better concentrate on the greater causes of epidemic mortality, which now pose unprecedented threats to global peace and security.

Developing Countries↗
PubMed2003

Patentability and maximum protection of intellectual property in proteomics and genomics.

The patenting of inventions in the proteomics and genomics fields has been prolific in the last few years and should continue in that vein for some years to come. The ingenuity by which inventions can be claimed increases so that even computerized methods for finding useful drugs based on the underlying genomic and proteomic information find their way into patents. However, with the increasing number of patents invalidated and the increasing number of exceptions to patent infringement; the value of new biotechnology patents is being whittled away. First, it may be hard to find potential infringers who improperly practice the claimed invention. Second, these potential infringers may practice in areas of the world where there is no patent protection. Third, the practice may be held by a court not to be infringing activity because it has as its aim the development of a new drug. Finally, the claims may be held invalid for lack of written description or enablement as the courts find mechanisms or reasons to narrow the allowable claims. With this setting, we must consider what can be done to best protect this new generation of inventive activity. Moreover, we must consider the possible demise of the drug pipeline should this trend to narrow protection continue.

Biotechnology↗
PubMedDate not supplied

Product-line extensions and pricing strategies of brand-name drugs facing patent expiration.

OBJECTIVE: This study proposed an alternative to brand loyalty as the explanation for the continued price rigidity of patent-expired brand-name prescription drugs despite the increase in market entry of generic drugs facilitated by the 1984 Drug Price Competition and Patent Term Restoration Act. Study hypotheses were to test (1) whether market entries of new-product extensions are associated with market success of original brand-name drugs before generic drug entry, and (2) whether original brand-name drugs exhibit price rigidity to generic entry only when they are extended. METHODS: The design is a retrospective follow-up study for the prescription drug brands that lost their patents between 1987 and 1992. The drug brands were limited to nonantibiotic, orally administered drugs containing only 1 active pharmaceutical ingredient. Information on patent expiration, entry of a product extension, and market success were determined from the U.S. Food and Drug Administration.s Orange Book, First DataBank, and American Druggist, respectively. Market success was defined as whether an original drug brand was listed in the top 100 prescriptions most frequently dispensed before facing generic entry. Product-line extension was defined as the appearance of another product that a company introduces within the same market after its existing product. Drug prices were average wholesale prices from the Drug Topics Red Book. The relationship between product-line extension and market success was examined using a logistic regression analysis. The price rigidity to entry was tested using a panel regression analysis. RESULTS: A total of 27 drug brands lost their patents between 1987 and 1992. Drug brands that achieved market success were 16 times more likely to be extended than were those that did not (OR=16, 95% confidence interval, 2.12-120.65). The price rigidity to entry existed in drug brands with extensions (beta=2.65%, P <0.033), but not in those brands without extensions (beta=-2.40%, P <0.001). CONCLUSION: This study provided some support for the alternative explanation to brand loyalty that a new product-line extension introduced for an original brand helps the original price be rigid despite the entry of generic drugs facilitated by the 1984 Drug Price Competition and Patent Term Restoration Act.

Costs and Cost Analysis↗
PubMed2005

Drug costs developments after patent expiry of enalapril, fluoxetine and ranitidine: a study conducted for the Netherlands.

BACKGROUND: In order to increase price competition, government regulations focus on controlling drug costs. Drug costs after patent expiry are an area of particular interest because the substitution of branded medication with generics represents an opportunity for lowering drug costs. However, drug costs may not decrease after patent expiry, because of a lack of price competition and different national pricing systems. AIM: The aim of this study was to investigate the trends in the use of generics after patent expiry for enalapril, fluoxetine and ranitidine and the subsequent changes, if any, in the costs of these medications. METHODS: A drug-utilisation study was performed using data from a large sample of Dutch pharmacies. Both volumes (measured as defined daily doses [DDD] per 1000 population) as well as drug costs (calculated per DDD) prior to and after patent expiry were calculated. Costs per DDD were compared using trend-line analysis. In addition, the relative market shares of the different trade channels (branded, parallel imported and generic) were compared before and after patent expiry. RESULTS: The costs per DDD decreased for all three drugs and, as expected, these costs decrease more rapidly after patent expiry. Significant differences in the trend lines were found for enalapril and fluoxetine. CONCLUSIONS: Despite relatively high reimbursement prices for generics in the Netherlands, this example from the Dutch pharmaceutical market demonstrates the benefit of generic substitution for containing pharmaceutical costs, which contrasts with concerns raised by the Dutch government.

Anti-Ulcer Agents↗
PubMedDate not supplied

The patentability of living organisms between science, law and ethics.

The approval on May 1998 of the European Union (EU) directive on the legal protection of biotechnological inventions has aligned Europe to the international trend about the patenting of biotechnologies. Many questions are still unresolved, i.e. the differences between the article 53b of the European Patent Convention (EPC), which prohibits patenting of plants and animal varieties, whereas the directive states that Oinvention whose object are plants or animals may be patented if the practicability of the invention is not technically confined to a particular plant or animal varietyO (article 12). Again, the interpretation of plants or animal species specificity and that on the threatening public order and morality (which inhibits patenting) may have doubtful interpretations, according to the different EU States morality and law (e.g. Denmark does not admit patentability of transgenic animals). Despite difficulties, biotechnology Research and Development for applications to medicine, veterinary sciences, agriculture and foods is continuously growing. Bioethical independent evaluations of the applications of biotechnologies and of their side-effects (risk for biodiversity of plants and animals, safety of procedures to save mankind, respect of human dignity and of fundamental human rights, etc.) are mandatory to link the interests of science and industrial productions together with those of mankind. This is the original meaning given by van Potter to the word bioethics, as a bridge to the future.

Animal Population Groups↗
PubMed2000

US files WTO complaints against Brazil over requirement for "local working" of patents.

At the end of May 2000, the US (later joined by the European Communities) filed a complaint against Brazil at the World Trade Organization (WTO), alleging Brazil was in violation of its obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement) and the 1994 General Agreement on Tariffs and Trade. Brazilian legislation that came into force in 1997 establishes that, in order to enjoy exclusive patent rights in Brazil, the holder of a patent on an invention must satisfy a "local working" requirement. In other words, the patent holder must "work" the patent in Brazil to enjoy full patent protection. If it fails to do this, the law says it shall be subject to the possibility of the government issuing a compulsory license, allowing someone else to use the invention and pay a royalty fee to the patent holder.

Anti-HIV Agents↗
PubMedDate not supplied

Transcatheter closure of patent ductus arteriosus in adults using the Amplatzer duct occluder: initial results and follow-up.

BACKGROUND: Surgical closure of patent ductus arteriosus in adult patients may be problematic. Transcatheter closure of patent ductus arteriosus is an established procedure. Recently, transcatheter closure of patent ductus arteriosus using the Amplatzer duct occluder has been shown to be safe and efficacious. We present our experience with this device in adults. METHODS AND RESULTS: Between January 2000 and January 2002,41 adult patients (31 females and 10 males) with a patent ductus arteriosus were referred for closure with the Amplatzer duct occluder. The median age was 35.6 years (range 18-70.7 years) and the median weight was 65.8 kg (range 32.7-164.5 kg). Of these 41 patients, 37 underwent attempted closure of the patent ductus arteriosus using the Amplatzer duct occluder. The device was successfully deployed in all patients except 1. Complete angiographic closure was seen Immediately after device deployment in 29 out of 36 patients (81%). Complete echocardiographic closure was demonstrated within 24 hours post-procedure in 34 out of 36 patients (94%), and at 6-month follow-up in 35 out of 36 patients (97%). No complications related to device implantation occurred in any patient. CONCLUSIONS: Closure of patent ductus arteriosus using the Amplatzer duct occluder is safe and effective in adults.

Adolescent↗
PubMed2002

[Patent protection in modern medical technology].

Inventions related to medical treatments and devices are due to specific regulations in the German, European and US patent Law much more difficult to obtain than inventions in the field of ordinary mechanics. In particular, inventions related to treatments of the human or animal body are excluded from patentability. In order to obtain at least some patent protection for such inventions the wording of the claims as well as the wording of the specification and preferred embodiments is very important. Patent protection is in most cases the only remedy to return the investment spent for the research. To maximize the possibility of patent protection in many countries, the timing of publication of the research result and filing of the patent application must be coordinated.

Equipment and Supplies↗
PubMed2000

Biomedical patents and ethics: a Canadian solution.

World Trade Organization member states are preparing for the upcoming renegotiation of the Agreement on Trade-Related Aspects of Intellectual Property Rights. One of the important elements of that renegotiation is the ethical considerations regarding the patenting of higher life forms and their component parts (e.g. DNA and cell-lines). The interface between the genetic revolution, patentability, and ethical considerations is the subject of this article. The author identifies, explores, and critiques four possible positions Canada may adopt in respect of patentability of biomedical material. First, Canada could do nothing. This approach would mean keeping biomedical materials outside the patent system and outside the stream of commerce. Canada would simply wait for an international consensus to develop before adopting a position of its own. Second, Canada could go it alone. It could implement a policy that balances the incentive effects of patents with the need to incorporate ethical and social values into the decision-making process regarding the use of biomedical materials. In respect of this option, the author proposes a model whereby non-profit bodies would hold the exclusive rights to research, use, and exploit biomedical materials. Third, Canada could follow the United States, Europe, and Japan by providing for almost unrestricted patenting of biomedical materials. This would be the most industry-friendly alternative. The fourth and final option is to use the medicare system to promote discussion of ethical considerations involved in the use of biomedical materials. The power of provincial health agencies may be used as a lever to ensure the discussion of ethical considerations concerning the use of biomedical materials. The author concludes that the fourth and final option is the best alternative for Canada while waiting for an international consensus to emerge.

Animals↗
PubMed2001

International conflicts over patenting human DNA sequences in the United States and the European Union: an argument for compulsory licensing and a fair-use exemption.

The thought of a large biotech company holding an exclusive right to research and manipulate human genetic material provokes many reactions--from moral revulsion to enthusiasm about the possibilities for therapeutic advancement. While most agree that such a right must exist, debate continues over the appropriate extent of its entitlements and preclusive effects. In this Article, Professor Donna Gitter addresses this multidimensional problem of patents on human deoxyribonucleic acid (DNA) sequences in the United States and the European Union. Professor Gitter chronicles not only the development of the law in this area, but also the array of policy and moral arguments that proponents and detractors of such patents raise. She emphasizes the specific issue of patents on DNA sequences whose function has not fully been identified, and the chilling effect these patents may have on beneficial research. From this discussion emerges a troubling realization: While the legal framework governing "life patents" may be similar in the United States and the European Union, the public perceptions and attitudes toward them are not. Professor Gitter thus proposes a dual reform: a compulsory licensing regime requiring holders of DNA sequence patents to license them to commercial researchers, in return for a royalty keyed to the financial success of the product that the licensee develops; and an experimental-use exemption from this regime for government and nonprofit researchers.

Base Sequence↗