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PubMed2003

Effects of patents and licenses on the provision of clinical genetic testing services.

The growth of patents that include genetic sequences has been accompanied by concern about their impact on the ability of physicians to provide clinical genetic testing services and to perform research. Therefore, we conducted a survey of clinical laboratory directors that perform DNA-based genetic tests to examine potential effects. We performed a telephone survey between July and September in 2001 of all laboratory directors in the United States who were members of the Association for Molecular Pathology or who were listed on the GENETESTS:org website. One hundred thirty-two of 211 (63%) laboratory directors were interviewed. Ten of these were excluded because they did not conduct DNA-based genetic tests. Almost all performed genetic tests for clinical purposes. Half performed tests for research purposes as well. Twenty-five percent of respondents reported that they had stopped performing a clinical genetic test because of a patent or license. Fifty-three percent of respondents reported deciding not to develop a new clinical genetic test because of a patent or license. In total, respondents were prevented from performing 12 genetic tests, and all of these tests were among those performed by a large number of laboratories. We found 22 patents that were relevant to the performance of these 12 tests. Fifteen of the 22 patents (68%) are held by universities or research institutes, and 13 of the 22 patents (59%) were based on research funded by the United States Government. Overall, respondents reported that their perceptions of the effects of patents on the cost, access, and development of genetic tests, or data sharing among researchers, were negative. In contrast, most respondents felt that patents did not have an effect on the quality of testing. We conclude that patents and licenses have had a significant effect on the ability of clinical laboratories to develop and provide genetic tests. Furthermore, our findings suggest that clinical geneticists feel that their research is inhibited by patents. The effects of patents and licenses on patients' access to tests, and the costs and quality thereof, remains to be determined.

Data Collection↗
PubMedDate not supplied

[Opposition to Myriad Genetics patents and their total or partial revocation in Europe: early conclusions].

The proceedings instituted against three European patents held by the US company Myriad Genetics, on the BRCA1 gene and the breast cancer diagnosis gene, resulted in the total or partial revocation of these patents. These decisions put an end to the legal monopoly claimed by Myriad Genetics on the BRCA1 gene and on breast cancer gene tests, and left the field open to European geneticists to develop and implement their test methods within the framework of a clinical not-for-profit organization. The opposition procedure, through which any actor is allowed to challenge European patents, was used by geneticists doctors in Europe to refuse the emergence of an industrial monopoly on a medical service offered in a clinical context. The decision to revoke or strongly limit these patents was based on the European Patent Office's refusal to establish an invention priority on a sequence that had errors at the time the application was filed by the patent holder, in September 1994. The patent holder was granted an invention priority only on 24 March 1995, when it filed an application for a corrected sequence of the gene. But by then the BRCA1 gene sequence had already been divulged in a public data base, Genbank, from October 1994, notably by Myriad. Myriad Genetics' patents were thus victims of the patent race that prompted the firm to file multiple patent applications on insufficiently validated sequences, and of the conflict between diffusion in the public domain and the novelty requirement. Opposition to the patents, undertaken by a coalition of medical institutions, human genetic societies, two States, Holland and Austria, an environmental protection organization (Greenpeace), and the Swiss Labour Party, made it possible to preserve and develop the clinical economy of genetic tests in Europe. It resulted in amendments to intellectual property laws in France and thus extended the possibility of using compulsory licences for public health purposes to in vitro diagnosis.

Animals↗
PubMed2002

Human gene patents.

The concept of a patent on a human gene seems foreign to most people. Even those who understand the fundamentals of the patent system seem bewildered and confused by many issues relating to human genes. This article describes the scope and limitations of gene patents and the types of exemptions that have been proposed or allowed. It addresses and clarifies these and other issues, including the often reported and misdirected question, Who "owns" one's genes? The paper reviews the historical origins of patents as a mechanism to provide incentives for innovation. It also discusses the legal criteria unambiguously supporting patenting of human genes that are isolated and purified apart from their naturally occurring context. Concerning enforcement and issues related to academic research, there is no U.S. statutory exemption for non-commercial research on patented subject matter, but a narrow, judicially-created exemption does permit use of patented subject matter for non-commercial purposes. Patents and licenses on gene-based diagnostic tests are properly enforceable and do not permit academic or other clinical practitioners to practice such tests without license or other authorization from the patent holder. The paper concludes that an effective legal system cannot draw sharp distinctions that some genes or uses are patentable to some parties while other genes are not. In addition, precluding certain genes from patentability would be shortsighted in that it would create prohibitions that might well be regretted in the future.

Genetic Research↗
PubMed1997

Gentamicin pharmacokinetics in neonates with patent ductus arteriosus.

OBJECTIVES: To determine the effect of patent ductus arteriosus on the pharmacokinetics of gentamicin in neonates and to examine whether any particular pharmacokinetic parameter is of value as a marker of patent ductus arteriosus. DESIGN: Cohort study of neonates treated with gentamicin, according to a standard dosing protocol. SETTING: A 24-bed, Level III, neonatal intensive care unit. PATIENTS: Neonates treated with gentamicin at the time of admission to the neonatal intensive care unit, using a standard protocol, and who were < 36 wks of gestational age. INTERVENTIONS: All patients received a gentamicin loading dose, and had gentamicin concentrations measured at 2 and 12 hrs after this dose, in order to determine pharmacokinetic parameters and calculate the optimum maintenance dose. Those neonates subsequently diagnosed to have patent ductus arteriosus, based on clinical suspicion and echocardiographic confirmation, were compared with those neonates without clinically suspected patent ductus arteriosus. Gentamicin pharmacokinetic parameters were calculated using a one-compartment model. MEASUREMENTS AND MAIN RESULTS: A total of 322 courses of gentamicin were administered (patent ductus arteriosus, n = 106; control, n = 216). Gentamicin clearance was decreased in the patent ductus arteriosus group vs. the control group (40.02 vs. 44.73 mL/kg/hr; p < .0108). Volume of distribution was greater for patent ductus arteriosus patients (0.61 L/kg) than for controls (0.54 L/kg) (p < .0002). Also, volume of distribution was a useful marker for presence of patent ductus arteriosus, with a 92% specificity for patent ductus arteriosus. CONCLUSIONS: Gentamicin dosing should be altered in neonates with patent ductus arteriosus to reflect the impact of higher volume of distribution and lower clearance. When the gentamicin volume of distribution exceeds 0.7 L/kg, it may be of predictive value for the presence of patent ductus arteriosus.

Anti-Bacterial Agents↗
PubMed2006

A clearing house for diagnostic testing: the solution to ensure access to and use of patented genetic inventions?

In genetic diagnostics, the emergence of a so-called "patent thicket" is imminent. Such an overlapping set of patent rights may have restrictive effects on further research and development of diagnostic tests, and the provision of clinical diagnostic services. Currently, two models that may facilitate access to and use of patented genetic inventions are attracting much debate in various national and international fora: patent pools and clearing houses. In this article, we explore the concept of clearing houses. Several types of clearing houses are identified. First, we describe and discuss two types that would provide access to information on the patented inventions: the information clearing house and the technology exchange clearing house. Second, three types of clearing houses are analysed that not only offer access to information but also provide an instrument to facilitate the use of the patented inventions: the open access clearing house, the standardized licences clearing house and the royalty collection clearing house. A royalty collection clearing house for genetic diagnostic testing would be the most comprehensive as it would serve several functions: identifying patents and patent claims essential to diagnostic testing, matching licensees with licensors, developing and supplying standardized licences, collecting royalties, monitoring whether users respect licensing conditions, and providing dispute resolution services such as mediation and arbitration. In this way, it might function as an effective model for users to facilitate access to and use of the patented inventions. However, it remains to be seen whether patent holders with a strong patent portfolio will be convinced by the advantages of the royalty collection clearing house and be willing to participate.

Access to Information↗
PubMed1994

Patent foramen ovale and brain infarct. Echocardiographic predictors, recurrence, and prevention.

BACKGROUND AND PURPOSE: Paradoxical embolism through a patent foramen ovale is a recognized cause of stroke, but clinical predictors, recurrence rate, and prevention of brain infarcts in patients with patent foramen ovale have not been determined. We reviewed transesophageal echocardiographic records to ascertain echocardiographic predictors and optimal prophylaxis for patent foramen ovale-related infarcts. METHODS: A patent foramen ovale was identified in 74 patients during 615 transesophageal echocardiograms by color Doppler or saline contrast during a 60-month period. On the basis of final clinical situation, the patients were divided into the following groups: group 1, infarct with patent foramen ovale a likely cause (n = 16); group 2, infarct with patent foramen ovale an unlikely cause (n = 23); and group 3, no infarct (n = 35). Transesophageal echocardiograms were reviewed to assess patent foramen ovale characteristics and associated cardio-embolic sources without knowledge of clinical details or group assignment. Follow-up after a patent foramen ovale-related infarct was obtained by telephone or written correspondence in 15 of 16 group 1 patients. RESULTS: Atrial septal aneurysms were more common in group 1 (38%) compared with group 2 (10%) and group 3 (8%) (P = .02). Contrast right-to-left shunting occurred in 88% of group 1 (P = .06) and 86% of group 2 (P = .07) compared with 60% of group 3. Prevention of recurrence in subjects with presumed patent foramen ovale-related brain infarcts varied. Aspirin was usually chosen after initial brain ischemia. Warfarin and patent foramen ovale closure were usually reserved for subjects with symptoms of brain ischemia while taking aspirin or those who required warfarin or cardiac surgery for other indications. No recurrent infarcts occurred in 15 patients during a mean follow-up period of 28 months. CONCLUSIONS: Atrial septal aneurysm and right-to-left shunt may be predictive of a patent foramen ovale that predisposes a patient to stroke. Aspirin may provide sufficient infarct prophylaxis after initial ischemia. Warfarin and surgical correction should likely be reserved for those in whom aspirin is not effective or those who require warfarin or cardiac surgery for other reasons until prospective studies are available.

Adult↗
PubMed2003

Patent protection for structural genomics-related inventions.

Recently there have been some important developments with respect to the patentability of inventions in the field of structural genomics. The leaders of the European Patent Office (EPO), Japan Patent Office (JPO) and the United States Patent Office (USPTO) came together for a trilateral meeting to conduct a comparative study on protein 3-dimensional (3-D) structure related claims in an effort to come to a mutual understanding about the examination of such inventions. The three patent offices were presented with eight different cases: 1) 3-D structural data of a protein per se; 2) computer-readable storage medium encoded with structural data of a protein; 3) protein defined by its tertiary structure; 4) crystals of known proteins; 5) binding pockets and protein domains; 6) and 7) are both directed to in silico screening methods directed to a specific protein; and 8) pharmacophores. The preliminary conclusions reached at the trilateral meeting provide clarity regarding the types of inventions that may be patentable given a specific set of scientific facts in a patent application. Therefore, the guidance provided by this study will help inventors, attorneys and other patent practitioners who file for patent protection on structural genomics-based inventions both here and abroad comply with the patentability requirements of each office.

Europe↗
PubMed2004

Costs and benefits of genomics patents.

Genomics patents are controversial on religious, ethical, legal, and economic grounds. An economic approach is desirable for valuing the patent system generally, and genomics patents in particular, in terms of its stated constitutional objective, which is to 'promote progress'. Several types of criticisms and warnings have been issued regarding the suitability of genomics inventions for patent protection; here these are evaluated in the context of more general concerns about the efficacy of the patent system. As with the patent system more generally, it is difficult to specify an alternative mechanism for producing inventions that has attributes (such as decentralized resource allocation, speed of therapeutic discovery, and financing by beneficiaries) that are predictable enough to serve as a benchmark against which to judge the current regime, which is dominated by genomics patents. The current patent regime can be expected to produce commercializable therapies reasonably reliably, while many proposed alternatives hearken back to a regime that did not produce commercializable therapies with as great speed or variety. Therefore, the onus appears to lie on the critics to create a model with the desirable properties of the patent system, but with fewer of its acknowledged weaknesses, such as 'monopoly' pricing and 'patent thickets'.

Costs and Cost Analysis↗
PubMed2006

Predicting commercial success for Australian medical inventions patented in the United States: a cross sectional survey of Australian inventors.

OBJECTIVES: To examine the commercial development of Australian medical patents and identify the determinants of their being used in innovations (new or improved products or production processes). DESIGN: Cross-sectional survey with a nested case-control study. PARTICIPANTS AND SETTING: 177 inventors listed as the first Australian on medical patents granted in the United States between 1 January 1984 and 30 December 1994, and surveyed in 1998-1999. MAIN OUTCOME MEASURE: A series of predictor variables (including characteristics of the patents; characteristics of the inventors; ideas, advice and funding during commercialisation; and the process of commercialisation) for whether or not a patent became an innovation. RESULTS: Half (89/177) of the medical patents became innovations, with 34% generating a total of A $287 million (13% over $1 million) in annual sales a median of 8 years after the patent had been granted. A patent was more likely to become an innovation if the inventor was employed by industry at the time of invention (odds ratio [OR], 3.2; 95% CI, 1.1-9.2), had invested their own finances (OR, 2.8; 95% CI, 1.0-7.4), and if the patent had been licensed (OR, 4.6; 95% CI 1.7-12.7), led to further patents (OR, 3.2; 95% CI, 1.0-10.4) and involved an industry partner in its commercial development (OR, 10.1; 95% CI, 3.6-27.7). It was less likely to become an innovation if finance came from a research funding agency (OR, 0.3; 95% CI, 0.1-0.8) and if interest from Australian industry was judged by inventors as "poor" (OR, 0.6; 95% CI, 0.4-0.9). CONCLUSIONS: Medical patents in the US listing Australian inventors are more likely to become innovations if they originate from industry rather than the public sector, and if inventors are willing to invest their own finances.

Australia↗
PubMed2002

ACOG. Committee opinion: number 277, November 2002. Patients, medicine and the interests of patients: applying general principles to gene patenting.

New technologies and the translation of research into clinical medicine are essential to patient care. Those who develop useful drugs, diagnostic and screening tests, and medical technologies have the right to expect a fair return for their efforts and risks. Current interpretations of patent law (particularly regarding gene patenting), however, have the potential to impede both medical advances and patient care. Patenting policies must balance the open exchange and use of information with making the pursuit of such knowledge financially rewarding. The Committee on Ethics and the Committee on Genetics of the American College of Obstetricians and Gynecologists maintain that patents on medical or surgical procedures are ethically unacceptable. Physicians may obtain patents on surgical and diagnostic instruments that they have developed, but such instruments should be made available to others at a fair and reasonable cost. Patents for genes as "compositions of matter" enable patent holders to control future applications of the genes and should not be granted. Patents should be granted only for specified uses or applications of genes or sequences. If composition-of-matter patents on genes continue to be enforceable, such patents on genes with clinical application is should be subject to federal regulation and oversight to ensure availability on reasonable terms for research and clinical use.

Genes↗
PubMed2004

Using the written description requirement to limit broad patent scope, allow competition, and encourage innovation in biotechnology.

The biotechnology research and development process is extremely expensive and companies must attract investors to this high-risk industry to pay for these costs. Biotechnology companies rely on their ability to exclude others from exploiting the benefits of their research through patent protection to attract these investors. Consequently, they seek strong patent protection for their inventions by claiming a broad scope of patent protection for their inventions. Biotechnology is an industry where the scope of protection should be limited. Science-based technologies exploit the perceived technological opportunities from recent scientific developments, concentrating the attention of many inventors on the same areas. This poses several unique problems. First, only the first of several inventors will receive a patent to the invention. Second, due to publicly available, basic techniques, the actual contribution made by the inventor may be relatively small. Finally, there is a significant risk that permitting an overbroad patent scope may permit original patentees to control a variety of improvements and a number of applications. Additionally, a broad scope of protection for an invention tends to cause underutilization of many potential inventions or improvements. By limiting the scope of protection, one allows competitors to utilize these potential inventions or improvements and encourages the advancement of the technology. Traditionally, courts have used the scope of the disclosure to limit a patent with an overly broad scope of protection. The Federal Circuit is correctly applying the written description requirement as part of the disclosure to limit broad claim scope in biotechnology patents. The written description requirement is separate from the enablement requirement and applies to all claims. By requiring a written description to allow a PHOSITA to determine the structural characteristics of the claimed invention, the Federal Circuit is able limit biotechnology patents with overly broad patent scope. Recognizing that particular technologies will become more established as biotechnology matures giving rise to different issues in setting the appropriate level of patent scope, the court allowed the written description requirement to mature in tandem with advances in biotechnology to meet these new developments.

Biotechnology↗
PubMed2005

Patent foramen ovale: paradoxical connection to migraine and stroke.

PURPOSE OF REVIEW: In this article we aim to elucidate the relationship between patent foramen ovale, cryptogenic stroke and migraine. RECENT FINDINGS: Small observational and case-control studies indicate that patients with cryptogenic stroke have a higher incidence of patent foramen ovale. Prospective trials could not show a higher stroke recurrence risk with isolated patent foramen ovale. The combination of patent foramen ovale and atrial septal aneurysm might carry a higher recurrence risk. Secondary prevention with acetylsalicylic acid is as effective as oral anticoagulation, but carries a lower bleeding risk. Whether patent foramen ovale closure prevents recurrent strokes is under investigation. Case-control studies and retrospective analyses indicate comorbidity between patent foramen ovale and migraine, in particular migraine with aura. Recent retrospective studies indicate a reduction in migraine frequency after patent foramen ovale closure (intended for stroke prevention). These studies, however, have major methodological limitations. Therefore patent foramen ovale closure cannot be recommended for the prevention of migraine with aura. SUMMARY: At present routine percutaneous closure of isolated patent foramen ovale cannot be recommended for patients with cryptogenic stroke. Patent foramen ovale closure should not be used for the prevention of migraine.

Heart Septal Defects, Atrial↗
PubMedDate not supplied

Life forms protectable as subjects of US patents--microbes to animals (perhaps).

Scientists, businessmen, universities, and industries with fundamental or peripheral interests in technology as applied to life processes will be keenly interested in recent US Patent Office decisions. These decisions indicate that new higher life forms, animal or plant, are proper subjects of patents if they are not naturally occurring (and are not human, in the case of animals). In contrast to plants and other organisms, genetically modified animals have had no mode of protection as intellectual property except possibly as trade secrets or utility patents. The Ex parte Allen decision, reached by the Patent Office Board of Appeals and Interferences, directly addressed the issue of animal patentability in view of the broad reading of 35 U.S.C. section 101 by the US Supreme Court in the Chakrabarty decision. The subject invention concerned polyploid oysters. Claims directed toward polyploid oysters produced by a particular process were rejected under 35 U.S.C. section 103 and section 101. The Board, reversing the 35 U.S.C. section 101-based rejection in view of the Chakrabarty decision, indicated that the claimed polyploid oysters were non-naturally occurring manufactures or compositions of matter within the confines of patentable subject matter under 35 U.S.C. section 101. A similar decision affecting the patentable status of plants or segments thereof had previously been reached by the Patent and Trademark Office in the case of Ex parte Hibberd, 227 U.S.P.Q. 443 (Bd. Pat. App. 1985). The Hibberd utility patent application concerned "genetically engineered" maize which had high levels of the tryptophan.

Animals↗
PubMed1996

Cost and efficacy of surgical ligation versus transcatheter coil occlusion of patent ductus arteriosus.

OBJECTIVE: The purpose of this study was to compare cost and efficacy of surgical closure of patent ductus arteriosus using new critical pathway methods with outpatient transcatheter coil occlusion of patent ductus arteriosus. METHODS: Surgical techniques included a transaxillary, muscle-sparing thoracotomy, triple ligation of the patent ductus arteriosus, no chest tube, and discharge from the hospital within 24 hours. Transcatheter coil occlusion of patent ductus arteriosus was done as an outpatient procedure. Costs were compared with inclusion of all hospital and professional charges. RESULTS: From July 1994 until March 1996, 20 patients underwent coil occlusion of patent ductus arteriosus and 20 patients underwent surgical closure of patent ductus arteriosus. Duration of hospitalization was significantly less for the patients receiving coil occlusion (11 +/- 6 hours) as compared with that for the patients having surgical ligation (28 +/- 7 hours, p < 0.05). Total charges were similar for surgical ligation ($7101 +/- $408) as compared with those for coil occlusion ($7104 +/- $886, p > 0.05). Morbidity in coil occlusion included inability to occlude the patent ductus arteriosus in two patients (2/20, 10%) and residual patency in two patients (2/18, 11%). Morbidity in the surgical group included nausea and vomiting necessitating hospitalization for more than 36 hours in one patient (1/20, 5%), transient left recurrent laryngeal nerve palsy in one (1/20, 5%), and pneumothorax in two patients (2/20, 10%). There were no instances of residual patency in the surgical group. CONCLUSIONS: Transaxillary thoracotomy without tube thoracostomy and with critical pathway methods allows safe and effective ligation of a patent ductus arteriosus with early hospital discharge. This surgical method has similar cost, higher efficacy rate, and applicability in all patients as compared with newer transcatheter coil occlusion techniques for closure of a patent ductus arteriosus.

Adolescent↗
PubMed1995

The politics of patent legislation in biotechnology: an international review.

The realization of the economic value of the genetic resources has prompted an international debate about property rights to genetic resources. The international debate pertaining to patenting of genetic material is the main theme of this chapter. As a backdrop for the international debate, the chapter starts out with a summary of the main events and arguments in the expanding scope of patent legislation in biotechnological inventions. Summing up, the new biotechnologies represent a tool which meets the legal requirements for patenting biological material. From the industry's point of view, biotechnology also necessitates patenting. On the negative side, defending a patent is often a long and costly business, and the trend is that patenting will mainly benefit the bigger and stronger companies and thus weaken public control over the rapid developments in biotechnology. A central argument in the chapter is that without sophisticated biotechnological tools, trained scientists, and adequate infrastructure, patenting is, as yet, hardly a viable solution for the majority of developing countries. Gene-rich developing countries fear that developments in patent legislation will pave the way for increased Northern control over Third World natural resources. The International Convention on Biological Diversity goes some way in making amends to this situation, but the gene-poor, least developed countries may still have reason to fear that they will lose access to breeding material. In a long-term perspective, the implications may be detrimental for resource conservation in developing countries. In conclusion, the patent question seems to remain unresolved and may still be one of the most likely stumbling blocks for future ratifications and implementation of the Biodiversity Convention.

Animals↗
PubMed1998

Patenting medical and surgical techniques: an ethical-legal analysis.

Considerable controversy has recently arisen regarding the patenting of medical and surgical processes in the United States. One such patent, viz. for a "chevron" incision used in ophthalmologic surgery, has especially occasioned heated response including a major, condemnatory ethics policy statement from the American Medical Association as well as federal legislation denying patent protection for most uses of a patented medical or surgical procedure. This article identifies and discusses the major legal, ethical and public policy considerations offered by proponents and opponents of such patents. The existing literature divides up into those who favor such patents essentially without qualification, and those who condemn and wish to outlaw them. We advance a compromise position where administrative and legislative action is called for to provide more specific guidelines regarding the patentability of such processes by the Patent and Trademark Office. Our position, in sum, will be that too much is at stake in this complicated area for either the blanket prohibition, or wholesale, uncritical acceptance, of the patenting of medical and surgical processes or techniques.

American Medical Association↗
PubMed2007

Inventors as investigators: the ethics of patents in clinical trials.

CONTEXT: The Bayh-Dole Act and renewed emphasis on translational research have stimulated patenting activities at universities. PURPOSE: To examine how different institutions manage possible patent-related conflicts of interest in human subjects research, and to provide an ethical analysis and recommendations. METHOD: Policies of nine major professional organizations, 13 of the largest recipients of federal biomedical funding in the United States and Canada, and 17 biomedical journals were canvassed. Disagreements in policies were used as the basis for analyzing the ethics of inventorship in clinical trials. RESULTS: Policies varied along three lines. First, some policies did not define patent inventorship as a potential conflict of interest. Second, some of those that did define it as such used licensing as a trigger for conflict of interest management. Third, several policies imposed presumptive restrictions on an investigator's participation in a trial involving his or her invention. CONCLUSIONS: The author defends on ethical grounds restrictive policies on patent holding in clinical trials and rejects objections to restrictive policies. The author recommends five policies: (1) any related patent holding should always be disclosed to IRBs and research subjects, (2) investigators who hold conflicting patents should be presumptively barred from certain activities in a study, (3) institutional interests in patents should be managed and disclosed to research subjects, (4) IRBs should also be informed of an investigator's filed (not just held) patents on an experimental agent, and (5) the stringency of policies should be adjusted according to a patent's earning potential and the risk associated with a study.

Academic Medical Centers↗
PubMed1989

Life forms protectable as subjects of U.S. patents -- microbes to animals (perhaps).

Scientists, businessmen, universities and industries with fundamental or peripheral interests in technology as applied to life processes will be keenly interested in recent U.S. Patent Office decisions. These decisions indicate that new higher life forms, animal or plant, are proper subjects of patents if they are not naturally occurring (and are not human in the case of animals). In contrast to plants and other organisms, genetically modified animals have had no mode of protection as intellectual property except possibly as a trade secret or utility patent. The Ex parte Allen decision, reached by the Patent Office Board of Appeals and Interferences, directly addressed the issue of animal patentability in view of the broad reading of 35 U.S.C. section 101 by the U.S. Supreme Court in the Chakrabarty decision. The subject invention concerned polyploid oysters. Claims directed toward polyploid oysters produced by a particular process were rejected under 35 U.S.C. section 103 and section 101. The Board, reversing the 35 U.S.C. section 101 - based rejection in view of the Chakrabarty decision, indicated that the claimed polyploid oysters were non-naturally occurring manufactures or compositions of matter within the confines of patentable subject matter under 35 U.S.C. section 101. A similar decision affecting the patentable status of plants or segments thereof had previously been reached by the Patent and Trademark Office in the case of Ex parte Hibberd, 227 U.S.P.Q. 443 (Bd. Pat. App. 1985). The Hibberd utility patent application concerned "genetically engineered" maize which had high levels of the tryptophan.

Animals↗