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PubMed2000

Effect of multiple-source entry on price competition after patent expiration in the pharmaceutical industry.

OBJECTIVE: To analyze the effect of multiple-source drug entry on price competition after patent expiration in the pharmaceutical industry. DATA SOURCES: Originators and their multiple-source drugs selected from the 35 chemical entities whose patents expired from 1984 through 1987. Data were obtained from various primary and secondary sources for the patents' expiration dates, sales volume and units sold, and characteristics of drugs in the sample markets. STUDY DESIGN: The study was designed to determine significant factors using the study model developed under the assumption that the off-patented market is an imperfectly segmented market. PRINCIPAL FINDINGS: After patent expiration, the originators' prices continued to increase, while the price of multiple-source drugs decreased significantly over time. By the fourth year after patent expiration, originators' sales had decreased 12 percent in dollars and 30 percent in quantity. Multiple-source drugs increased their sales twofold in dollars and threefold in quantity, and possessed about one-fourth (in dollars) and half (in quantity) of the total market three years after entry. CONCLUSION: After patent expiration, multiple-source drugs compete largely with other multiple-source drugs in the price-sensitive sector, but indirectly with the originator in the price-insensitive sector. Originators have first-mover advantages, and therefore have a market that is less price sensitive after multiple-source drugs enter. On the other hand, multiple-source drugs target the price-sensitive sector, using their lower-priced drugs. This trend may indicate that the off-patented market is imperfectly segmented between the price-sensitive and insensitive sector. Consumers as a whole can gain from the entry of multiple-source drugs because the average price of the market continually declines after patent expiration.

Drug Costs↗
PubMed1994

Patenting medical inventions.

Medical, dental, nursing, and biomedical personnel often perform critical research that can lead to patents. Similarly, patentable discoveries can be made during the normal course of medical practice, e.g., the development of new biocompatible polymers, improved dental materials, new or modified catheters, new laboratory diagnostic tests, and improved medical devices. Many inventions may not be patented in federal organizations due to the lack of information available on the patenting process. In this article, the financial benefits that can be derived from patenting inventions are discussed, as well as the different types of patents that can be obtained, the conditions for patentability, bars or restrictions to obtaining a patent, the importance of proper record keeping, and the steps to take toward getting an invention patented.

Patents as Topic↗
PubMed1993

The cough test is superior to the Valsalva maneuver in the delineation of right-to-left shunting through a patent foramen ovale during contrast transesophageal echocardiography.

A patent foramen ovale may result in paradoxical embolization and serious morbidity. Thus a sensitive method to diagnose a patent foramen ovale is important. It is unknown whether the cough test or the Valsalva maneuver is superior in delineating right-to-left shunting through a patent foramen ovale during contrast transesophageal echocardiography. Thus we studied 73 consecutive patients (53 men and 20 women), aged 54 +/- 16 years (range 18 to 79 years), during elective transesophageal echocardiography. Contrast transesophageal echocardiography was performed from a four-chamber view during quiet respirations, Valsalva maneuver, and cough test. In the entire group the incidence of a patent foramen ovale was higher during the cough test (32/73) as compared with the Valsalva maneuver (24/73, p < 0.025) and quiet respirations (18/73, p < 0.005). All subjects with a patent foramen ovale during the Valsalva maneuver had a positive contrast transesophageal echocardiogram during the cough test. In subjects (n = 55) without a patent foramen ovale during quiet respirations, the incidence of a patent foramen ovale was higher during the cough test (15/55) as compared with the Valsalva maneuver (9/55, p < 0.05). In a subgroup (N = 17) of patients with nonhemorrhagic stroke (n = 11), transient ischemic attack (n = 2), or peripheral embolus (n = 4), the cough test had a higher yield (9/17) in delineating a patent foramen ovale as compared with the Valsalva maneuver (7/17) but did not reach statistical significance. These data demonstrate that the cough test is superior to the Valsalva maneuver in delineating a patent foramen ovale during contrast transesophageal echocardiography.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1992

Patent foramen ovale in patients with haemodynamically significant pulmonary embolism.

The prevalence of a patent foramen ovale is about 1 in 4. In cases with venous thromboembolism and raised right heart pressures, a patent foramen ovale may permit paradoxical emboli, which could complicate the course of patients with pulmonary embolism. Echocardiography enables detection of a patent foramen ovale in life. We have studied 85 patients who presented with haemodynamically significant pulmonary embolism as judged by clinical, echocardiographic, or haemodynamic indices and who had an echocardiographic evaluation for patent foramen ovale. 33 patients (39%) had a patent foramen ovale. Clinical symptoms suggestive of paradoxical embolism were more likely in patients with than in those without a patent foramen ovale (39% vs 6%, p = 0.00034), with new neurological deficits occurring in 11 patients (9 vs 2, p = 0.005) and a vascular occlusion in 8 (7 vs 1, p = 0.0096). Arterial oxygen tension was lower in patients with a patent foramen ovale (mean 55 [SD 14] vs 62 [16] mm Hg, p = 0.038). Mortality was not different between the two groups (27% vs 19%). Cardiopulmonary complications in terms of resuscitation, intubation, or the use of catecholamines were more frequently observed in patients with a patent foramen ovale (48% vs 23%, p = 0.028). Patients with a patent foramen ovale and haemodynamically significant pulmonary embolism are more likely to have arterial hypoxaemia and vascular occlusions, possibly due to paradoxical emboli.

Adult↗
PubMed2006

Switch patterns before and after patent expiry of omeprazole: a case study in The Netherlands.

BACKGROUND: An increase of therapeutic substitution after patent expiry might have a negative effect on cost-savings generated with newly introduced generic drugs. To evaluate influences of patent expiry on therapeutic substitution, switch behaviour before and after patent expiry was investigated. AIM: To describe proton pump inhibitor use and investigate substitution patterns from omeprazole before and after patent expiry. METHODS: Data were obtained from the InterAction DataBase. Proportional proton-pump inhibitor use was identified per quarter during the study period 2000-2003. For the second part two cohorts--one before and one after patent expiry--were defined. The number of switchers was quarterly identified during 2-year follow-up period. For statistical analyses the chi-square test and hazard ratio were used. RESULTS: In proportional use, a downward trend for omeprazole was found. After patent expiry, significantly more patients switched to other proton pump inhibitors (P < 0.001). The hazard ratio of 0.62 (95% CI: 0.57-0.69), indicates that for every six patients switching before patent expiry, 10 patients switch after patent expiry. CONCLUSION: After patent expiry more patients switch to another proton pump inhibitor. In light of the total savings achieved with generic omeprazole, the importance of this negative impact on total cost-savings on proton pump inhibitors is unclear.

Cohort Studies↗
PubMed1993

Patent foramen ovale: is stroke due to paradoxical embolism?

BACKGROUND AND PURPOSE: A patent foramen ovale has been reported to be significantly more frequent in young stroke patients than in matched control subjects, and paradoxical embolism has been suggested as the main mechanism of stroke in this situation. The present study was designed to test this hypothesis. METHODS: Sixty-eight consecutive patients under 55 years of age presenting with an ischemic stroke had an extensive workup, including transesophageal echocardiography with contrast. We compared the prevalence of criteria for the diagnosis of paradoxical embolism in patients with and without a patent foramen ovale. RESULTS: A patent foramen ovale was found in 32 patients (47%). A Valsalva-provoking activity was present at stroke onset in six patients with a patent foramen ovale and in eight patients with no patent foramen ovale (chi 2 = 0.1, nonsignificant). Clinical/radiological features suggestive of an embolic mechanism were not more frequent in patients with a patent foramen ovale. Clinical evidence of deep vein thrombosis was present in one patient with a patent foramen ovale and in none of the others. No occult venous thrombosis was found in a subgroup of patients with a patent foramen ovale and no definite cause for stroke who underwent venography (n = 13). CONCLUSIONS: Our results do not support the hypothesis that paradoxical embolism is the primary mechanism of stroke in patients with a patent foramen ovale.

Adult↗
PubMed1992

Patent foramen ovale as a risk factor for cryptogenic stroke.

OBJECTIVE: To determine and compare the prevalence of patent foramen ovale in patients with stroke of undetermined origin (cryptogenic) and in patients with stroke of determined origin to assess the possible role of patent foramen ovale as a risk factor for cryptogenic stroke. DESIGN: Cross-sectional study with nested case-control analysis. PATIENTS: A total of 146 patients (73 men, 73 women) with acute ischemic stroke referred to the echocardiography laboratory for evaluation. SETTING: Neurovascular Unit and Echocardiography Laboratory, Columbia-Presbyterian Medical Center, New York, New York. MEASUREMENTS: Patients were considered to have strokes of determined origin or cryptogenic strokes according to National Institute of Neurological Disorders and Stroke (NINDS) Stroke Data Bank criteria. The presence of patent foramen ovale was assessed by contrast echocardiography, performed blinded for type of stroke. The association between patent foramen ovale and type of stroke was tested after correcting for patients' demographic variables and stroke risk factors. RESULTS: The overall prevalence of patent foramen ovale was 26 of 146 patients (18%; 95% Cl, 11.4% to 24.6%). Patients with cryptogenic stroke (31%) had a significantly higher prevalence of patent foramen ovale than did patients with an identifiable cause of stroke (69%) in both the younger (less than 55 years; 48% compared with 4%; P less than 0.001) and the older (greater than or equal to 55 years; 38% compared with 8%; P less than 0.001) age groups. Multiple logistic regression analysis was used to identify the presence of a patent foramen ovale as strongly associated with the diagnosis of cryptogenic stroke (odds ratio, 7.2; Cl, 2.4 to 21.7), irrespective of patient age and other stroke risk factors. CONCLUSIONS: Patients with cryptogenic stroke have a higher prevalence of patent foramen ovale than patients with stroke of determined cause in all age groups, even after correcting for the presence of recognized stroke risk factors. This identifies patent foramen ovale as a risk factor for cryptogenic stroke. Regardless of patient age, contrast echocardiography should be considered when the cause of stroke is unknown.

Adult↗
PubMed1995

[Advertisements in newspapers and magazines about patent medicines in the Meiji era (The first dissertation) (Part 2)].

On January 20th of the 10th year of the Meiji era (1877) the government enforced the laws regulating patent medicines. Since then patent medicines were frequently attacked in the newspapers. Abuses of patent medicines became the target of criticism. Yukichi Fukuzawa had carried his comments against abusing patent medicines in "Minkanzasshi" for 4 days from March 24th in the 11th year of the Meiji era. Abuses of patent medicines prevented medical science from progressing. He pointed out the responsibility of newspapers which printed advertisement of ineffective patent medicines. "The kanayomi" which was a small newspaper company refuted his comments. Jihei Morita published the magazine "Houtan" in person, and he ran many advertisements about patent medicines. In October in the 15th year of the Meiji era, the law, which imposed a tax on patent medicines was enacted. In addition to the censure against patent medicines were an account in the newspaper successively. However, at the same time, these accounts had serious consequences the traders of medicine and they went to law by the reason which they led to serious interference with their business.

Advertising↗
PubMed2006

Ethical questions to ponder in the European stem cell patent debate.

Patents may be refused in Europe on ethical grounds. Whereas in the past this issue has arisen only infrequently, recent developments in human embryonic stem cell research have given rise to conflicting opinions in Europe as to the approach that should be adopted in relation to patents. The United Kingdom Patent Office has adopted a positive policy towards inventions involving human embryonic stem cells, but the European Patent Office has to date refused to grant patent applications involving similar subject-matter. A series of legal questions on the role of ethics in granting European patents is now to be considered for clarification by the European Patent Office. The answers to these questions should eventually resolve the debate on the patenting of human embryonic stem cells throughout Europe.

Biotechnology↗
PubMed2006

The European opposition against the BRCA gene patents.

In 2001, the European Patent Organisation (EPO) granted 3 patents on the BRCA1 gene (EP-B-699754, EP-B-705903, EP-B-705902) to Myriad Genetics. The patents, and the option of the patent holder to strictly exert its monopoly right by requesting that all diagnostic testing be done at its laboratory in the United States, has evoked strong reactions in Europe. Several opposition procedures have been started against these patents. After oral hearings at the EPO in Munich in May 2004, the first patent was revoked due to errors contained in the initially filed sequence. At oral proceedings in January 2005, the other two patents were severely limited in scope. The discussion on inventive step on the cloning of the BRCA1 gene - other than the one that relates to the priority date - has not taken place. In other words, the EPO has not questioned the patentability of this gene per se. The author participated in the hearings in Munich and would like to give the genetic community a firsthand account of the case.

Breast Neoplasms↗
PubMed2000

An analysis of moral issues affecting patenting inventions in the life sciences: a European perspective.

Following the 1980 US Supreme Court decision to allow a patent on a living organism, debate has continued on the moral issues involved in biotechnology patents of many kinds and remains a contentious issue for those opposed to the use of biotechnology in industry and agriculture. Attitudes to patenting in the life sciences, including those of the research scientists themselves, are analysed. The relevance of morality to patent law is discussed here in an international context with particular reference to the law of the European Patent Convention administered by the European Patent Office (EPO). The EPO has been the principal forum for opposition to such patents and the few cases under dispute in the EPO are reviewed, including patents for the onco-mouse, human relaxin gene, and the PGS herbicidally resistant plant (gmo). Morality provisions in the European Parliament and Council Directive 98/44/EC are also summarised.

Animals↗
PubMed1992

International distribution of dental materials publications and patents.

International patterns of research and development in the field of restorative dental materials were examined with data on publications (1981-85) and patents (1979-88). It was found that United States-based authors produced approximately one-half of all dental materials journal articles published worldwide, while US inventors had nearly the same share of the US dental materials patents. During the periods studied, the share of US patents in dental materials awarded to US inventors declined, while the share of US patents awarded to Japanese inventors rose. The role of the United States in research (as measured by journal articles) remained stable. Nations differed in the degree to which their researchers specialized in particular research areas. US-based authors and inventors were relatively over-represented in prosthetic materials and under-represented in dental cements, an area in which the British and the Japanese concentrated more of their activity. There was some, but not complete, agreement in the patterns of national specialization as indexed by patent and publication data. When dental materials data were compared with data for broader fields of science and technology, important differences were found. For publications, US-based authors displayed greater dominance in dental materials than in the fields of dentistry, chemistry, and materials science. US-based inventors' share of US dental materials patents was smaller than their share of all US patents. These analyses demonstrated that it was possible to use indicators derived from publication and patent data files to conduct insightful studies of a discrete specialty of science and technology.

Databases, Bibliographic↗
PubMed2006

Patent pools and diagnostic testing.

There is increasing concern that overlapping patents in the field of genetics will create a costly and legally complex situation known as a patent thicket, which, along with the associated issues of accumulating royalty payments, can act as a disincentive for innovation. One potential means of preventing this is for the patent holders to enter into a so-called patent pool, such as those established in the electronics and telecommunications industries. Precedents for these also exist in the field of genetics, notably with the patents pertaining to the SARS genome. In this review, we initially address the patent pool concept in general and its application in genetics. Following this, we will explore patent pools in the diagnostic field in more detail, and examine some existing and novel examples of patent pools in genetics.

Animals↗
PubMed2003

Competition policy in patent cases and antitrust.

The article that follows examines the competition policy reflected in the decisions of the Court of Appeals for the Federal Circuit in its patent cases. The court's views on this subject have been manifested most plainly in decisions that have transformed the law concerning infringement under the doctrine of equivalents and claim construction. In both categories, the court narrowed patent scope by reason of its desire to protect competitors. The article argues that the court's premise in prescribing narrower claim scope reflected an incomplete view of competition policy. The court's analysis overlooked the benefits to competition provided by patents, which stimulate inventions and their development. The article traces the development of antitrust jurisprudence and demonstrates how respect for the contribution of patents to competition and skepticism of free-riding has evolved, particularly beginning in the 1970s. The article draws a parallel between the Court's reasoning about competition policy, on the one hand, and the rejected views of Justices Hugo Black and William O. Douglas and abandoned patent-antitrust jurisprudence, on the other. The Federal Circuit's decision in Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 234 F.3d 558 (Fed. Cir. 2000), on the subject of equivalents is considered in the paper. In that decision, the majority adopted a new rule that completely barred infringement under the doctrine of equivalents of any claim limitation where, in prosecution, there had been a narrowing amendment relating to patentability. In the past, prosecution estoppel foreclosing equivalents had been subject to a "flexible bar," which, in some circumstances, allowed for equivalence notwithstanding such an amendment. The article points out that because almost all patents are amended during prosecution, the effect would be to allow widespread copying of patented inventions by trivial modifications of any narrowed claim limitation. The incentive to innovate in the future would be correspondingly diminished and the expectations of past patentees would be correspondingly altered.

Antitrust Laws↗
PubMed2002

Pharmaceutical patents and price controls.

BACKGROUND: Since 1995, every member-country of the World Trade Organization (WTO) has agreed to honor a 20-year patent-life, from the date of a pharmaceutical company's application for the patent, in the country of application. Patent protection retards competitive imitation of an invented product. This kind of protection is particularly important for pharmaceuticals, because pharmaceuticals that are not derived from biotechnology can be imitated easily and inexpensively. The economic function of a patent is to allow a period of above-normal profits for a technically and commercially successful product; these profits stimulate further investment and invention. However, direct price controls, or permutations of direct price controls on pharmaceutical compounds, can fully or partially circumvent the economic intent of patent agreements. OBJECTIVE: This paper formulates an economic model that takes into account demand and cost/supply dimensions of the output and pricing of a hypothetical pharmaceutical, extrapolating about the respective effects of direct price controls and lack of price controls, and describing permutations of direct price controls in different countries. RESULTS: The pharmaceutical industry depends on patents to fund the development and introduction of new products. A country can indirectly circumvent the economic logic of a patent by using price controls, but it cannot shift the economic costs of such a policy to another country that does not use price controls. Instead, less money is available for research and development (R&D). CONCLUSIONS: Pharmaceutical price controls allow some countries to avoid the constraints of patent agreements without breaking those agreements outright. This, in turn, reduces the amount of profit available for further R&D, which is a detriment to consumers worldwide.

Commerce↗
PubMed1999

Patenting in biotechnology: a review of the 20th symposium of ECB8.

The patenting of biotechnological inventions is practically in harmony with the general requirements of patent protection. It stands still in the foreground of interests since this is the only technical field where the living material itself may be the subject matter of patents. In consequence ethical problems have arisen first of all in the patenting of human cells and genes in which there is no agreement between R&D firms, patent offices and green movements. This has called for the elaboration of special Directives. On the other hand, patent systems are instrumental in safeguarding biodiversity. This review gives a picture of the patenting situation in biotechnology in the European Patent Office and in Hungary, the host country of the Congress. It also gives practical advice to biotechnological researchers on how to draft the applications and to observe the time limits, as well as on the necessity and possibilities of the deposit of microorganisms.

Biotechnology↗
PubMed2003

Patenting nonassociated polymeric structures (NAPS): implications for structural genomic data release.

The intellectual property laws that govern patent rights should provide a reasonable balance between the competing concerns of open access and exclusivity. Open access can facilitate knowledge dissemination and collaboration in furthering science. On the other hand, exclusivity can ensure interest and financial investment in scientific research and development. In recent days, the appropriate balance between open access and exclusivity has been a focus of public debate, particularly with regard to genomic inventions and their applications. In seeking to reconcile the timing of structural genomic data release with certain efforts to secure intellectual property rights, the International Structural Genomics Organisation joins others confronting this controversy. This paper seeks to inform the discussion with an overview of the U.S. standards for patenting nonassociated polymeric structures (NAPS), which include polynucleotides or polypeptides of unknown biological significance, and their corresponding structural data. In the United States, the present ability to obtain patent rights to these discoveries appears problematic given the requirement of specific, substantial and credible utility, among other things. Without demonstrable utility, NAPS and NAPS-related data likely will not be entitled to patent protection, whether the U.S. Patent & Trademark Office rejects NAPS claims as unpatentable in the first instance, or the U.S. federal courts invalidate NAPS claims in later patent litigation. As such, the improbability of obtaining enforceable patent rights to NAPS might undermine the rationale for delaying structural genomic data release to allow for the filing of patent applications in this regard.

Expressed Sequence Tags↗
PubMed2000

Genetic testing, ethical concerns, and the role of patent law.

This article examines the changing debate over gene patenting and the possible connection between patent law and the ethical and policy concerns associated with the use of genetic testing technologies (e.g. the premature implementation and inappropriate marketing of genetic tests). Arguably, patent law helps to form the market forces that lead to these concerns. It is suggested that existing safeguards fail to control these concerns because of, for example, a lack of provider knowledge and an absence of an adequate regulatory framework. While patent law can be associated with a number of ethical and policy concerns, the article also suggests that patent law may have a positive role in reducing them. Patent law provides policy makers and the public with a focal point - the patent holder - upon which to attach accountability for ethical and legal conduct. The article concludes by inviting policy makers to consider the ways in which patent law could be modified in order to optimize its constructive influence.

DNA↗