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Patent prosecution strategies for biotechnological inventions.

This article describes patent prosecution strategies for new biotechnological inventions. The first part of the article discusses general strategies for patent prosecutors, including several prosecution considerations and methods for increasing patent prosecution speed. The second part of the article presents patent prosecution challenges in genomics and bioinformatics-related patents and provides solutions to these challenges. The last part of the article discusses how ethical and public policy issues play a role in the patentability of biotechnological inventions.

Biotechnology↗

The inventions of John Blease.

Though he had no formal training in engineering, John Blease of Merseyside invented numerous devices that greatly benefited the practice of anaesthesia. Starting with the turning of component parts for simple anaesthetic machines in the 1930s, he was introduced to clinical anaesthesia and became skilled in the art of dental anaesthesia. In the early 1940s he developed the all-purpose Alfo-Blease anaesthetic machine. In 1945 he designed an intermittent positive pressure ventilator, which was used successfully around Liverpool. After World War II he improved this into the Blease 'Pulmoflator', which was the first British positive-pressure ventilator in commercial production. From then until the early 1960s he patented many other inventions, duly utilized in the manufacture of anaesthetic equipment, in which industry the Blease name survives in the company he founded.

Anesthesiology↗

The invention and development of blood gas analysis apparatus.

In 1953, the doctor draft interrupted Dr. Severinghaus' anesthesia and physiology training and sent him to the National Institutes of Health as director of anesthesia research at the newly opened Clinical Center. He developed precise laboratory partial pressure of carbon dioxide (PCO(2)) and pH analysis to investigate lung blood gas exchange during hypothermia. Constants for carbon dioxide solubility and pK' were more accurately determined. In August 1954, he heard Richard Stow describe invention of a carbon dioxide electrode and immediately built one, improved its stability, and tested its response characteristics. In April 1956, he also heard Leland Clark reveal his invention of an oxygen electrode. Dr. Severinghaus obtained one and constructed a stirred cuvette in which blood partial pressure of oxygen (PO(2)) could be accurately measured. Technician Bradley and Dr. Severinghaus combined these, making the first blood gas analysis system in 1957 and 1958, and shortly thereafter, they added a pH electrode. Blood gas analyzers rapidly developed commercially. Dr. Severinghaus collaborated with Astrup and other Danes on the Haldane and Bohr effects and their concepts of base excess during two sabbaticals in Copenhagen. Work with both Astrup and Roughton on the oxygen dissociation curve led Dr. Severinghaus to devise a modified Hill equation that closely fit their new, better human oxygen dissociation curve and a blood gas slide rule that solved oxygen dissociation curve, PCO(2), pH, and acid-base questions. Blood gas analysis revolutionized both clinical medicine and cardiorespiratory and metabolic physiology.

Blood Gas Analysis↗

Inventing a new diagnostic test for vaginal infection.

Bacterial vaginosis, which is underdiagnosed in clinical practice, has a characteristic fishy smell because of production of diamines. This smell is the basis of a visual rapid diagnostic test that is technically simple to perform. The test has been patented in Europe and America, and a licence agreement has been negotiated. This paper describes the process from idea to invention to patenting and licensing. The combined costs of research and patenting were met by a multinational company in return for rights to exploit the patent invention. The process has taken nine years and has needed clinical, scientific, legal, and commercial input to get the test to the marketplace.

Costs and Cost Analysis↗

Effects of invented spelling and direct instruction on spelling performance of second-grade boys.

Four second-grade boys, 2 rated by their classroom teacher as below average and 2 as above average in basic language skills, participated in a 16-week spelling investigation. The participants alternately received, in counterbalanced order, 5 weeks of an invented spelling approach that incorporated 15-min creative writing periods and 5 weeks of direct instruction that involved 15-min periods of guided practice on spelling word lists. At the end of 10 weeks, each condition was replicated for 3 additional weeks. Although direct instruction resulted in more targeted words spelled correctly, invented spelling resulted in more nontargeted words spelled correctly, higher preference ratings by children, and higher teacher ratings of the quality of 3 of the children's writing samples.

Child↗

[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↗

Government-owned inventions; availability for licensing. National Institutes of Health, Public Health Service, DHHS. Notice.

The inventions listed below are owned by agencies of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Calcium-Binding Proteins↗

Government-owned inventions; availability for licensing. National Institutes of Health, Public Health Service, DHHS. Notice.

The inventions listed below are owned by agencies of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Adenine↗

Government-owned inventions; availability for licensing. National Institutes of Health, Public Health Service, DHHS. Notice.

The inventions listed below are owned by agencies of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Biosensing Techniques↗

Government-owned inventions; availability for licensing. National Institutes of Health, Public Health Service, DHHS. Notice.

The inventions listed below are owned by agencies of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Government↗

Government-owned inventions; availability for licensing. National Institutes of Health, Public Health Service, DHHS. Notice.

The inventions listed below are owned by agencies of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Animals↗

Government-owned inventions; availability for licensing. National Institutes of Health, Public Health Service, DHHS. Notice.

The inventions listed below are owned by agencies of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Cell Transplantation↗

Patenting biotechnologies: the European Union Directive 98/44/EC of the European parliament and of the council of 6th July 1998 on the legal protection of biotechnological inventions.

Before the Directive 98/44/EC of the European Parliament and the Council of 6th July 1998, notwithstanding some decisions of the European Patent Office (still presently under opposition) and some patents already granted by the Italian Patent Office, the existing legal framework did not allow the patentability of living organisms in the European Community countries. The Directive has dramatically changed the perspectives. It ensures free circulation of patented biotechnological products harmonising the national legal system of each Member State, guaranteeing compliance with the European Patent Convention signed in Munich on 5th October 1973, the Trade-Related Aspects of Intellectual Property Rights agreement of 15th April 1994 and the Rio de Janeiro Convention on Biological Diversity of 5th June 1992. The legal basis of the Directive and the fundamental principles of protection are that discoveries as such are not considered patentable. Plant and animal varieties as such, as well as essentially biological procedures for the production of plants and animals are excluded from protection by patent. On the contrary, the new field of patentability covers plants and parts of animals with new introduced genetic characters. Methods of surgical and therapeutic treatment and diagnostic methods applied to animal bodies are not considered inventions suitable for industrial applications and excluded from protection by patents. Biological materials and material isolated from its natural environment and isolated elements of the human body with technical processes may be patented. Excluded from patentability are inventions that are contrary to law and order or public morality as well as processes for human cloning for reproductive purposes and for modifying the germ-line genetic identity of human beings, as well as the use of human embryos. The processes for modifying the genetic identity of animals without any substantial medical benefit for man (with the exception of studying new medicinal products useful for treating serious diseases such as cancer, hepatitis or AIDS, by means of Oanimal modelsO) are also excluded. The rights of farmers are also guaranteed, by allowing them to re-sow seeds and freely use breeding stock covered by patents on their farms, without paying costly royalties to the holders of patents.

Animals↗

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↗

The invention and reinvention of cardiac pacing.

Two primitive pacemakers were invented between 1925 and 1932, demonstrating that adequate knowledge existed to pace the heart for brief periods. Heart specialists ignored these interesting inventions. In contrast, Zoll's announcement of external pacing in 1952 spurred intense interest and an outpouring of research. The reasons for the different response of heart specialists in the 1950s have to do with improved medical understanding of cardiac arrhythmias, growing confidence that cardiac resuscitation was possible, and the expansion of hospital-based medicine after World War II.

Bradycardia↗

[Fifty years of the heart-lung machine. Report on the pioneers and heroes and about the circumstances that led to the great invention, which allowed the treatment, and in many cases, the cure of heart illnesses].

In 1953 DNA was discovered and the Everest was conquered but also a great invention was developed: the heart-lung machine, which allowed the treatment, and in many cases, the cure of most cardiovascular illnesses. In fact, on May 6, 1953 John Gibbon crowned with success the work of his entire life closing for the first time an atrial septal defect in a young woman using a heart-lung machine of his own invention. Before that, surgeons had explored other roads like hypothermia, cooling the patient in a cold water tub and then rapidly performing the surgical correction of a heart malformation. After his first success, the following 4 patients of Gibbon died, which led him to abandon heart surgery and produced a generalized pessimism about extracorporeal circulation. However, a year later Walton Lillehei reverted this situation with the introduction of controlled cross-circulation in which a patient, usually a child, was connected to a "donor", usually his father or mother, whose heart and lung served as a pump and oxigenator, allowing the performance of open heart surgery. Finally, it was Lillehei again who a year later introduced the bubble oxigenator, simple and inexpensive, opening the doors of open heart surgery to all surgeons around the world. For this, and many other reasons, Walton Lillebei is considered by most surgeons as the "Father of Open Heart Surgery". Lillehei visited Chile in 1963 and operated on a patient in the surgical theaters of the Hospital Clínico de la Universidad Católica and was named an Honorary Member of the School of Medicine of this University. Before that, in 1957 Helmut Jaeger at the Hospital Luis Calvo Mackenna performed the first successful surgical closure of an atrial septal defect with extracorporeal circulation in Chile using a De Wall-Lillebei bubble oxigenator.

Cardiac Surgical Procedures↗

Patent protection for Aspergillus-related inventions.

Patents are important indicators of trends in biotechnological developments. Patents involving Aspergillus have stimulated growth in bioindustry, particularly in the fermentation and food industries. Patent specifications of Aspergillus-related inventions contain a voluminous amount of technical information and scientific data concerning Aspergillus biotechnology. A review of U.S. patents where Aspergillus cultures are cited in the disclosure demonstrates the value and versatility of the fungus. Identifying and evaluating these inventions is one measure of assessing the technical changes resulting from the use of Aspergillus cultures and of helping the industry maintain its innovative edge.

Aspergillus↗

[Biotechnological invention patents: a legal-economic analysis].

Not without controversy, patents have traditionally been considered as elements which stimulate and protect inventive activity. In this article, we look at the economic advantages of a patent system and also at the possible critcisms. We then examine the application of patents in modern biotechnology. After concluding that current intellectual property laws do not come out clearly against the protection of biotechnology inventions, we then review the proposals for European Union regulation in the form of a directive which would clarify patenting possibilities.

Biotechnology↗