Most of us have taken, or at least interacted with, medicine at some point or another in our lives. This can range from more “simple” over-the-counter drugs to more complex medicines specifically designed for exact illnesses. Considering the Covid-19 era we are going through and as search for a vaccine is at the highest possible speed, it is important to have at least a general idea on how medicines are developed for our use. This article aims to explore how a complicated mix of chemical compounds in a laboratory end up as pills on a shelf in your local pharmacy. We will also explore a brief history of pharmacology, where drugs get their names, how drugs come into fruition, the various affects that drugs can have on our bodies, along with the discrepancies that exist between them in regard to when, how, and why they should be taken.

Pharmacology is the study of the interactions that occur between a living organism and the chemicals that affect normal or abnormal biochemical functions. It includes the study of how a drugs can affect our biological systems, such as individual organs or an entire part of the body, and how the body overall responds to the drug. The discipline encompasses the sources, chemical properties, biological effects and, therapeutic uses of drugs. Substances with medicinal properties are considered pharmaceuticals, whereas drugs given for therapeutic purposes are usually called medications. Drug therapy, which is also called pharmacotherapy, is the use of drugs to prevent, diagnose, and treat signs, symptoms, and disease processes. When prevention or cure is not a reasonable goal, relief of symptoms can greatly improve quality of life and the ability to function properly on a day-to-day basis. Developing an understanding of this craft can allow us to better appreciate how molecules interact to form the drugs and medicines that can change our lives, and perhaps even allow us to contemplate their complex creation and existence.

In its most simplistic definition, a medication is a substance that is ingested or placed onto the body in order to cure a disease or condition (antibiotics are given to cure an infection), treat a medical condition (anti-depressants are given to treat depression), relieve symptoms of an illness (pain relievers are given to reduce pain), given to prevent diseases (flu vaccine helps to prevent the person from complications of having the flu).

Source of drugs

Historically, drugs were mainly derived from plants, animals, and minerals. Morphine, insulin, and iron are all commonly used examples of their respective sources. Belief in the curative powers of plants and certain substances rested exclusively upon traditional knowledge. But empirical information was not subjected to critical examination. Until the end of the 19th century, medicines were made by natural organic or inorganic products including mostly dried or fresh plants and their parts. These compounds might contain substances that possess healing properties or reactions that exert a toxic effect. It is important to remember that many fruits, vegetables, and plants still possess great power despite not having a “modern” origin.

Most drugs used nowadays are synthetic chemical compounds manufactured in laboratories which are synthesized by altering the chemical structure of an existing drug. The first drug of a particular group of drugs are called prototypes. For example, morphine is the prototype of opioid analgesics, and penicillin is the prototype of antibacterial drugs. Drug classifications and prototypes are defined and most new drugs can be assigned to a group. We must be hopeful and continue to search far and wide for cures for all  diseases, whether they be organic or synthetic, since our world is full of an infinite amount of possibilities and discoveries.

Drug names

The systematic naming of pharmaceutical drugs is called “drug nomenclature.” Drugs primarily have three types of names: chemical names, generic names, and trade names. The chemical names are the scientific names that often sound complex and are based upon the molecular structure of a drug. During development, the company will apply for regulatory approval of the drug by the relevant national regulatory agency, such as the U.S. Food and Drug Administration (FDA), and will be granted a generic name for it. Generic names usually indicate, via their stems, what drug class the drug belongs to. For example, oseltamivir is an antiviral drug because its name ends in the -vir suffix.

After development, testing, and regulatory acceptance of a drug, the pharmaceutical company gives the drug a trade name, which is a standard term in the pharmaceutical industry for a brand name or trademark name. Many drugs have multiple trade names which can reflect separate marketing strategies in different countries, manufactured by different companies, or both.

Drug investigation

A new drug investigation is the beginning of the journey of a chemical compound to a drug that will be used in clinics. The testing process of a chemical compound begins with animal studies to determine potential beneficial uses and also potential toxic side effects of the candidate compound.  The results from these animal studies are reviewed, and if the results are satisfactory, the compound then undergoes clinical trials in humans that people can voluntarily sign up for. Most clinical trials use a randomized, controlled experimental design that involves selection of subjects according to established criteria, random assignment of subjects to experimental groups, and administration of the test drug to one group and a control substance to another group.

Patent protection

New drugs that are developed by pharmaceutical companies will be covered under patent protection. This means that only the pharmaceutical company that holds the patent is allowed to manufacture, market, and eventually profit from the drug. This is seen as a return on the company’s investment that it took to develop the drug, which may require years of work and millions of dollars, along with an incentive for developing other drugs. Other pharmaceutical companies cannot manufacture and market the drug during the patent period.

Usually, the drug patent is awarded for around twenty years in the United States, however the number of years varies across countries and drugs. Pharmaceutical companies apply for a patent long before the clinical trial period even begins. The effective patent period after the drug has finally received approval is often around seven to twelve years. After the patented period expires the drug can be manufactured and sold by other companies. The drug is referred to as a generic drug at this point, and they are required to be therapeutically equivalent and much less expensive than trade name drugs.

Pharmacoeconomics

Pharmacoeconomics involves all of the costs that are accrued due to drug therapy and experimentation including those related to purchasing supplies, dispensing the drug, storing it, administrative fees, laboratory and other tests that are used to monitor patient responses, and losses from expiration. The length of a patient’s illness or hospitalization is also considered. While the most important factor is the health of the patient the costs for treatment are increasingly being considered as a major factor when choosing medications, and research projects that compare costs have greatly increased in recent years. The goal is to make it easier for patients to choose the most cost-effective drugs that combine high quality treatment at an affordable price. For drugs or regimens of similar efficacy and toxicity, there is considerable pressure upon doctors and pharmacies to prescribe less costly drugs for shorter duration.

Prescription and non-prescription drugs

In many countries, consumers have two legal routes of access to therapeutic drugs. One route involves a prescription or order from a licensed health care provider, such as a physician, dentist, or nurse practitioner. The other route is by over-the-counter (OTC) purchase of drugs that do not require a prescription. Both of these routes are regulated by various drug laws that change from country to country. Acquiring and using prescription drugs for non-therapeutic purposes, by persons who are not authorized to have the drugs or for whom they are not prescribed, is illegal.

The rejection of drugs in modern society

Nowadays, there are some people who deny various kinds of treatments because of their religious beliefs. This category of people is only a minority, as the majority of religions advocate for people to be healthy and to take care of their health as much as they can. In almost all belief traditions, the human body is believed to be a trust, and in case of any disease, the most appropriate and fastest treatment methods should be used. Even substances that are not normally permitted are allowed by scholars to be used if the person’s safety is concerned. For believers, the most important goal in life is to worship God, and for this to be possible the body must be healthy.

One day, people asked Prophet Muhammad, peace be upon him:

“Should we make use of medical treatment?”

He replied: “Make use of medical treatment, for God has not made a disease without appointing a remedy for it, with the exception of one disease, namely old age.”

People are encouraged to seek out those remedies and to use them with skill and kindness. Let us also remember that Jesus, peace be upon him, too, was very active in his ministry of healing. He showed by God’s permission miracles like curing the blind and the deaf, and bringing the dead back to life. Thus, religions do not refuse treatment with any available methods, and they even strongly encourage treatment and prevention of diseases.

Religions are also well known to treat stress, which wreaks havoc on the mind and body. It is still not known exactly how stress harms our health, but researchers have found that chronic psychological stress is associated with body’s losing its ability to regulate the inflammatory response. It has been shown that the effects of psychological stress on the body’s ability to regulate inflammation can promote the development and progression of disease. We know that religions and beliefs give people hope and significantly decrease the stress.

Human beings are the most precious creation, and health is necessary for us to achieve the purpose of our existence. Using scientific medicine together with faith and religion can help people to protect their health. Being the science of drugs and by investigating new drug therapies, pharmacology helps us exactly with that.

History of Pharmacology

Claudius Galen (129–200 A.D.) was the first person who attempted to consider the theoretical background of pharmacology.

Ali al-Tabari (838 A.D.) Medieval Islamic physicians used natural substances such as Papaver somniferum Linnaeus, poppy, and Cannabis sativa Linnaeus, hemp as a source of medicinal drugs. Although poppy had medicinal benefits, Ali al-Tabari explained that the extract of poppy leaves was lethal, and the extracts and opium should be considered poisons (4).

Theophrastus von Hohenheim (1493–1541), also known as “Paracelsus”, began to question doctrines from antiquity. He prescribed chemically defined substances with such success that professional enemies had him prosecuted as a poisoner. Against such accusations, he defended himself with the thesis that has become an axiom of pharmacology:

“If you want to explain any poison properly, what then isn‘t a poison? All things are poison, nothing is without poison; the dose alone causes a thing not to be poison.”

Johann Jakob Wepfer (1620–1695) was the first to use animal experimentation for pharmacological or toxicological actions.

Rudolf Buchheim (1820–1879) founded the first institute of pharmacology at the University of Dorpat (Tartu, Estonia) in 1847, which firstly made pharmacology as an independent scientific discipline. In addition to a description of effects, he strove to explain the chemical properties of drugs.

Oswald Schmiedeberg (1838–1921), together with his many disciples, helped to establish the high  reputation of pharmacology. He partnered with pathologist Bernhard Naunyn (1839–1925) to found the first journal of pharmacology, which has since been published without interruption.

After 1920, the pharmacological industry had their own pharmacology laboratories outside established university institutes. After 1960, departments of clinical pharmacology were set up at many universities and in industry.

References

1. Clinical Drug Therapy: Rationales for Nursing Practice – Seventh 7th Edition, Lippincott Williams &Wilkins.
2. Basic&Clinical Pharmacology, 12^th Edition, McGrawHill Lange.
3. Modern Pharmacology with Clinical Applications, Sixth Edition, Charles R. Craig and Robert E. Stitzel, Lippincott Williams &Wilkins.

With the full extent of its use not being understood at the time of its establishment, the project emerged mainly with the pharmaceutical mission to predict, detect, treat, and cure diseases that were caused by genetic anomalies by identifying the genetic information in the human organism.

The desire for such a project was something akin to, or even beyond, the desire to climb Mount Everest, for it aimed to find out something that was unknown at the time. In such fields of biology as cell biology, immunology, and neurology the specialists need genetic information from human organism. The genetic information that an individual organism inherits from its parents can open a door to answer the questions of how an individual develops, how long an individual will live, or how the various species on Earth have lived over many generations.

New developments followed one upon another with the emergence of the Human Genome Project. When the famous Scottish sheep, Dolly, was cloned in 1997, it still seemed to be theoretically impossible to clone a human being. American scientists cloned an ape named Tetra which shared 98 per cent of the same genetic information as human beings. Soon after this, the scientists began to suggest that that all that remained to be cloned was humans.

Dr. Richard Nicholson, the editor of the Bulletin of Medical Ethics, noted that there is no danger in cloning humans, as long as the techniques of doing so are kept under control. If a dictator, however, were to get hold of this information, they would be able to produce an army of genotypically identical soldiers.

The most exciting scientific study of recent years of the Genome Project is that it is trying to develop a complete gene map of an individual organism. According to scientists, a human body has between thirty thousand and fifty thousand genes. All genetic features identifying an individual are found in the gene sequences of the DNA molecules. Eye color, character traits, IQ, and all the illnesses a person may possibly develop are all hidden in the genes. The genome carries all the hereditary features that determine all of life’s diversity, determining whether an organism is human or another species, or ape; all living things have their own genomes. The human genome, which is the full complement of genetic material, and which resembles large tablets recording the history of ancient civilizations, is distributed among 23 sets of chromosomes. It is comprised of approximately three billion letters and is the biological record of our destiny.

Ethical, Legal, and Social Issues

In H. G. Wells’ classic novel The Island of Dr. Moreau (1896), Dr. Moreau conducts hybrid experiments on animals that result in twisted masses of flesh, half-man, half-animal. When the European Patent Office allowed the Australian company Amrad to obtain new embryos by combining human and animal cells, this led to a revival of genetic fears, more than a hundred years after the story of Dr Moreau was published. Not surprisingly, this event alarmed several civilian organizations, including Greenpeace. In a press statement made in Hamburg, Greenpeace drew attention to the fact that we might face “dangerous creatures” in the future that would be created from such techniques. Probably one of the most disturbing facts was that the patent did not disclose how these creatures were to be used. Greenpeace voiced opposition to this for the following reason: “A patent grants its owner the exclusive control over his/her invention. Therefore, patents on life fundamentally change our perception and understanding of living nature and our relationship towards it. Living organisms, which have been ‘created’ by industry and which can be patented cannot have a value of their own, since they are only considered an invention of human beings. Thus they can be exploited without any ethical concerns.”

According to the patent, the embryonic stem cells derived from humans, mice, birds, sheep, pigs, cattle, goats, or fish could be used. The patent covers a “method of producing a non-human chimeric animal” by mixing human and animal embryonic cells: human stem cells are integrated into animal embryos. As a result, the created chimeras are non-human, but they may contain human organs, body parts, nerve cells, and even human genetic codes.

Experts state that the system of producing chimeras is completely different from that of cloning and they drew attention to the risks involved. For example, a virus like the one that caused mad-cow disease could easily pass from one species to another.

The Media Joins the Issue

Thanks to the great interest people have shown in the future of genetic studies, we frequently come across news reports that deal with the topic. However, we would like to note that titles like “the homosexuality gene has been found” or “genetic solution to talkativeness discovered” infuriate genetic scientists. Dr Arnold Munnich says that media aims to raise interest by misinforming the public with subjects like “obesity gene” or “laziness gene”; they merely oversimplify the issue. Dr Munnich emphasizes that a gene means nothing by itself.

The Danger of Abuse

The researches who have worked toward improving gene technology have performed some good for humanity; this is without a doubt. However, there is the risk of abuse. The discoveries in this field may be worth a great deal financially; when we add the rivalry between companies and countries, it seems highly likely that legal bans and ethical rules will be ignored. Some people even object to all kinds of genetic research, not only their abuse. They say that the abuse of seemingly useful genetic technology practices in the future is possible, as has happened in other fields of technology; nuclear researches and laser technology also used to be innocent studies at the very beginning. But we cannot object to the use of electricity just because it is also used for executing people with electric chairs.

Governments and international organizations are quite sensitive to ensure that gene technology will only be used for the good of humanity. There are several international organizations interested in the ethical dimension of the issue. There are certain rules and regulations that establish the fundamental principles that will prevent the abuse of genetic studies, and protect the biodiversity and ecological balance. It is forbidden to carry out research on human cloning and altering human embryos. In the past, dictators like Adolf Hitler attempted to abuse gene technology in this respect. The ruthless Dr Joseph Mengele tried to clone his Fuhrer from the epitel cells he took from him.

Will Confidentiality be Respected?

Another concern brought about by new diagnosis methods and tests is that the principle of patient confidentiality, which has existed for centuries like a secret agreement between doctors and their patients, has begun to be debated, even violated. We usually talk about such “confidentiality” when the information is likely to be harmful for the patient if publicized. From this perspective, the results obtained by genetic tests can be evaluated as such. It is one of the duties of doctors to maintain patient confidentiality. On the other hand, if the relevant data is also likely to harm society, the hospital staff, and those around the patient, then the doctor can face a dilemma.

Some of the possible problems that may be faced due to the mapping of human genome will be that employers could be provided with forehand knowledge about the potential genetic diseases of applicants; they may know whether the person to be employed will be a future financial burden to the company if they carry such genetic risks as cancer or Parkinson’s. In this way new standards of employment will be developed. Even though systematical public surveys do not indicate any significant dangers at hand, it would be nearly impossible to stop rumors. Several people may be denied insurance if they have the genes for a fatal disease. Another may be dismissed from their job for the same reason. In the USA, it is illegal in 39 states to issue insurance policies according to genetic test results, and it is also illegal in 15 states to expel employees according to these. However, employers and insurance agents take advantage of the gaps in relevant laws and they secretly make use of genetic tests. According to research carried out in 1999, 30% of medium-sized or small businesses use such tests to promote and dismiss their employees.

Psychologically, it does not seem likely that people would consent to their status being determined by genetic tests. Would you really like to face your genetic disadvantages? A survey made with cooperation of Time magazine and CNN revealed that half of the participants did not want to know.

The Fate of an Unborn Baby

Deciphering the book of life unfortunately brings along ethical problems. The discovery of our genetic codes can also lead to other humans controlling the future of the human race. The critical question is “Can scientists produce human beings with the desired physical and mental qualities?” If so, genomic science may enable biologists to prepare a list of spare parts, parents may “order” a baby, and as altering our children or ourselves gets easier, we may be less tolerant against those who have not been altered. Lori Andrews of Kent University wonders if we were to be informed of mental defects, obesity, shortness or other undesired characteristics beforehand, whether the parents of those babies would still allow them to be born into a society that scorns such qualities. Even now, it is not uncommon to see some doctors and nurses criticize the parents of babies who are born with pre-detectable defects. If we assume that all parents have “ordered” babies, God knows what kind of a world we will have.

What Should the Aim of Such Practices Be?

Genetic studies should aim to prevent or treat illnesses, not to “enhance” genes. The opportunities offered by genetics should not be a mass elimination medium used by employers or a mechanism of spotting potential criminals in the hands of oppressive regimes. The Almighty One Who has been running the order of our universe so perfectly has granted us some keys to its mysteries. Why should we not do our best and use them for the good of humanity?

References

• Sasson, A., Biotechnologies in Developing Countries: Present end Future, UNESCO Publishing, Paris: 1993.
• McKusick, V.A., “First South-North Human Genome Conference”, Genomics 14, 1121-1123 (1992).
• Barnhart, B. J., “The department of energy (DOE) human genome initiative,” Genomics 5: 657-60,(1989).
• Ferguson-Smith, M. A., “European Approach to the Gene Project,” The Taseb J. 5:61-5 (1991).
• Malakoff, D., Service, R.F., Science, 16 Feb. 2001.
• Dulbecco, R., “The Italian genome project,” Genomics 9:404-5, (1991).
• McKusick, V. A., “Mapping and Sequencing the Human Genome,” J. Med. 320:910-15, New England: 1989.
• Murray, R.K. et al, Harper’s Biochemistry, Appleton & Lange, 1993.
• Neyzi, O., Ertugrul, T., Pediatri, Nobel T›p Kitabevi, Vol. II, Istanbul: 1993.
• Harrison’s Principles of Internal Medicine, International Edition.
• Nature Medicine, Vol. 7, No.4, Apr. 2001.
• Science, No.290, 1 Dec. 2000.
• Nature Reviews, Genetics, Jan. 2001.

Religion and Science: The Institute on Religion in an Age of Science, Inc., will convene on July 29-August 4, 2001. The topic, Human Meaning in a Technological Culture, will explore and evaluate how these powerful [information and biotechnoloy] technologies redefine, for better and for worse, human identity and meaning, as well as ideas about reality and God. www.iras.org.

Call for Papers: The European Society for the Study of Science and Theology (ESSSAT) has issued a call for papers. Details about its conference, to be held during March 19-24, 2002, are now available. www.esssat.org.

The Future of Religion? The World Network of Religious Futurists will meet in Minneapolis, MN, July 29-31, 2001. Attendees are scholars and activists from around the world who study the future of their religious tradition in view of world civilization. www.wfs.org.

Interesting Books: Mariano Artigas, The Mind of the Universe: Understanding Science and Religion; Robert Herrmann (ed.), Expanding Humanity’s Vision of God: New Thoughts on Science and Religion; Arnold Benz, The Future of the Universe: Chance, Chaos, God?; Ted Peters (ed.), Science and Theology: The New

Consonance; Ian Barbour, When Science Meets Religion; Reuven Firestone, Children of Abraham: An Introduction to Judaism for Muslims; Khalid Duran, Children of Abraham: An Introduction to Islam for Jews; Michael Shermer, How We Believe: The Search for God in an Age of Science. www.amazon.com.

African History in for a Rewrite: Professor John Hunwick and Northwestern University have received a $1 million Ford Foundation grant to study sub-Saharan Africa’s written traditions. In 1999, Hunwick discovered 3,000 Arabic manuscripts held by a Timbuktu family since 1592. He hopes to prove sub-Saharan Africans were not illiterate, and therefore uncivilized, before European colonialism. www.chicago-tribune.com.

In Society

Patent Fight Ended: Last year, 2.5 million Africans died from AIDS because they could not afford medicine. Large pharmaceutical companies, citing intellectual property rights, went to court to block South Africa’s efforts to get a WTO wavier to import far cheaper generic drugs on the grounds of national emergency. The companies withdrew their case on April 19, 2001, claiming that harsh international criticism was not a factor. http://dailynews.netscape.com.

Human Trafficking: The recent deaths of 58 out of 60 illegal Chinese immigrants in Europe highlights the problem of human trafficking. The UN estimates that those involved make $8 billion to $12.3 billion annually in profits. www.cnn.com.

Patenting Gene Data: Biotechnology firms are seeking exclusive ownership of the pure scientific formulas that represent genes. Critics claim this would make any recording and storing of formulas illegal without the patent holder’s permission, effectively ending some genetic research. At least 16 such patents are now pending at the Canadian Patent Office, and similar ones in America and elsewhere. Legal scholars and intellectual property experts fear that the free flow of genetic knowledge and innovation is at stake. www.nationalpost.com.

New Data Transmission Record: French and Japanese engineers have squeezed more than 10 trillion bits per second through single optical fibers. This record capacity equals about 150 million simultaneous phone conversations. www.techreview.com.

In Science

Return to Mars: NASA launched its Mars Odyssey orbiter on April 7, 2001. When it lands on Mars during October 2001, it will map the surface’s chemical and mineral makeup, determine Mar’s radiation level and how it might affect future astronauts, locate near-surface water, and map mineral deposits from past water activity. www.nasa/gov.

A Biological First: Biologists have mapped the entire genetic code of Arabidopsis thaliana, a plant belonging to the mustard family. Scientists expect applications in agriculture (the genetic manipulation of rice, wheat, and other crops) and medicine (many medicines come from plants). www.popsi.com.

RNA Chips: RNA switches clustered on a gold-coated silicon surface can identify different strains of E.coli found in bacterial cultures. Scientists hope to develop RNA chips that can reveal the molecular composition of complex mixtures better than current DNA biochips. Future uses are seen in detecting drugs, toxins, metabolites, proteins, and nucleic acids. www.techreview.com.

New Cancer Treatment: Molecularly targeted therapy drugs recognize and attack specific molecules unique to specific cancers. The model drug leading the way is Glivec (STI571), which fights CML, a cancer characterized by excessive white blood cell overproduction. Such drugs are designed by working backward from a known abnormal molecule specific to a certain type of cancer, and thus have a limited use. Glivec is getting a priority FDA review. http://abcnews.go.com.

Virtual Reality Update: Computer scientists affiliated with the National Tele-Immersion Initiative have produced a prototype virtual office. Digital cameras that monitor movements from various angles, head-mounted tracking gear, polarized glasses, and screens mounted at right angles to your desk allow you to see your colleague’s office. All images are life-size and 3D. www.popsci.com.

There has been strong opposition to the idea. The issue was discussed in the U.S. and Europe as long ago as the early 20th century. In 1980, the U.S. Supreme Court held in Diamond v. Chakrabarty that: ‘anything under the sun made by man’ is patentable. The court considered a distinction between a product of nature and a product of human invention or intervention as the decisive factor, rather than the distinction between sentient life and insentient matter. In ex Parte Allen, the Board of Appeal held that an oyster was patentable because it had been genetically altered by human intervention. In the end of the U.S. Patent Office ruled non-naturally occurring non-human multicellular living organisms, including animals, to be patentable. More recently, in 1988, Harvard University was granted a patent on a transgenic mammal named ‘Once Mouse’.

Is the situation any different in Europe? In Germany, inventions in the field of biology were not, in principle, excluded from patent protection, the Federal Supreme Court decided in the Red Dove. The European Patent Convention or EPC, signed in Munich and ratified in 1977, came into force on 1 June 1978 in the member states. Article 53 of the EPC provides that European patents shall not be granted in respect of:

a. inventions, the publication or exploitation of which would be contrary to ‘public order’ or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the contracting states;

b. plant or animal varieties or essentially biological processes for the production of plants or animals. This provision does not apply to microbiological processes or the products thereof.

This article contains three exceptions to patentability of plant and animals.

1. Animal varieties and plant varieties.

2. Essentially biological processes for the production of plant and animals.

3. Inventions which are contrary to ‘public order’ or ‘morality’.

1. What is the meaning of the term variety?

This question was debated by the Examining Division’s decision (EPOR 4 (1990)) in regard to Once Mouse. The application was made by Harvard University for a patent for a genetically modified animal which was to be used to cure cancer.

The application was refused:

a. on the grounds of non-reproducibility under Article 83 of the EPC. Although the application was based on claims related to all non-human mammalian animals, actual tests had only been done on mice: it could not be assumed that the same manipulation could be successfully performed on other mammals without inventive skill; and,

b. on the grounds that the legislators had intended to exclude animals in general from patentability under Article 53 (b).

However the Board of Appeal did not see any reason to limit the claims under Article 83. Also, the Board did not agree with the Examining Division’s interpretation of Art 53 (b) as excluding animals as such from patent protection. They pointed out that the legislators must have intended the phrase ‘animal varieties’ to be more narrowly construed than ‘animals’. The Board, therefore, held the question to the Examining Division.

On reconsideration, the Division decided that ‘Once Mouse’ did not fall under the terms of the ‘variety’ exemption. It concluded that in relation to Article 53 (b) claims directed to non-human mammals generally did not fall within the scope of the terms ‘animal variety’, (race animale).

The ‘variety’ exemption was also considered in the Giba-Geiy Case by the Technical Board of Appeal.

In- this case, the claimed invention satisfied the requirements of patentability but the Examining Division refused to grant a patent because the subject matter fall into scope of the Art. 53 (b).

Contrary to the Division’s view, the Europe Patent Office (EPO) Technical Board argued that 53(b) excludes only plant varieties and it is clear that ‘plant’ is different from ‘plant varieties’. According to the Board, ‘plant variety’ means stability of characteristics within specific tolerances after every individual propagation or propagation cycle. The Board of heed that 53(b) excludes ‘only the plants or their propagating material in the fixed form of the plant variety.’

2. Another problematic clause under Article 53(b) concerns ‘essentially biological processes for the production of plants and animals’ which are excluded with the proviso that ‘this exclusion does not apply to microbiological processes or products thereof’.

Two main question arises here. Firstly: what differentiates ‘essentially biological processes’ from ‘microbiological processes’?

Llewelyn has assumed that ‘an essentially biological process could be defined, most simply, as one where natural methods are the dominant influence’. The EPO defined ‘essentially biological process’ as dependent on the extent to which there is technical intervention by man in the process. If such intervention plays a significant part in determining or controlling the result the process will not be an ‘essentially biological’ one.

It has been held by the EPO Board, in the context of plants in Lubrizal/Hybrid Plants, that the meaning of ‘essentially biological process’ must be judged on the basis of the essence of the invention, taking into account the totality of human intervention and its impact on the result achieved.’ Human intervention may also mean that the process is not ‘a purely biological’ one even though the intervention made by only a trivial contribution.

The Draft Directive established a new and different approach, namely that a distinction must be made between naturally occurring substance itself and the product in a useful form, which results from human intervention in isolating it from its natural environment.

Art 53(b) says that ‘essentially biological processes’ are not patentable but the Draft Directive provides that this only covers traditional biological breeding activities thereby and rescues the interventions in ‘essentially biological process’ from non-patentability.

The most significant element of Article 53(b) is its inclusion of the products of microbiological processes. This means that a plant or animal produced by a ‘microbiological process’ falls outside the scope of the exclusionary provision of Art 53 (b) and is therefore patentable. It could be said that the aim was specifically to enable products of microbiological processes to be patented, i.e. all genetically engineered plant and animal.

Again, the problem is one precise definition. How does one decide that a process which has been carried out is a ‘microbiological’ one? EPO guidelines explain that ‘microbiological’ covers the processes used by micro-organisms and processes used for producing micro-organisms. Also, ‘micro-organism’ includes material such as plasmids and viruses (which have been used to create new plant genetic matter) and cell lines. All such process are patentable. The Draft Directive similarly rules (in its Article 5) that processes which either use or operate upon a micro-organism, or result in a micro-organism, should be considered microbiological and thus eligible for patent. It goes further: ‘the word micro-organism shall be interpreted in its broadest sense as including all microbiological entities capable of replication, e.g. as comprising, inter alia, bacterium fungi . . . and cells.’

3. The third exception is on the grounds of immorality. Art 53 (a) provides that a patent should not be granted in respect of inventions, the publication or exploitation of which would be contrary to ‘Public Order’ or ‘morality’. In other words, if the public considers an invention ‘immoral’ a patent would not be granted.

But, the Examining Division ruled in regard to ‘Once Mouse’ that irrespective of whether the public considered it moral or immoral, such inventions incontrovertibly assisted mankind in the care of ‘widespread and dangerous’ diseases. The Technical Board of Appeal pointed out in its recommendations to the Division that the possible suffering to animals and risks to the environment should be balanced against the invention’s usefulness in meeting human needs (diagnosis, treatment, food supply for a rapidly growing world population) on the other hand. The Division stated that ‘the invention would reduce the overall level of animal suffering by reducing the number of animals used in conventional animal testing.

Considerable doubts remain. Whether or not ‘Once Mouse’ may help save people dying from cancer, who is to guarantee that mice or other animals will not be manipulated to which achieve a cure for baldness or other trivial (but commercially ‘compelling’) purpose. What is the excuse for creating a very unhappy, transgenic rat to cure a widespread but non-lethal condition such as acne?

Genetic engineering should be the subject of general legislation rather than ‘patent law’ especially in respect of ‘immorality’. 

Conclusion

The development of new features in plants and animals using microbiological methods is a long, difficult, expensive process with no guarantee for success. Therefore patents which have been granted by appropriate and competent bodies need to cover not only the first generation of the altered animals or plants but also their progeny which are then the result of natural breeding: and this was allowed in the claims of the Harvard Patent.

Despite strong arguments on several grounds, a new invention related to living matter should not be prevented from securing a patent. It is also our view that the distinction between patentable and non-patentable should be made on the basis of human intervention (especially in relation to microbiological processes) rather than on the basis of sentient or insentient matter.

However the patentability of human life or any part of human life must always be regarded as unacceptable in principle because human life should not be subject to commercialism: it would open the way to a new form of slavery.

• References
• CHRISRIE, A. (1989) ‘Patent for plant innovation’ EIPR, 3.
• CORREA, C. (1992) ‘Biological resources and intellectual property rights’ EIPR, 5.
• NOTT, R. (1992) ‘Patent protection for plant and animals’ EIPR, 3, p.79.
• PAVER, M. (1992) ‘All animals are patentable but some are more patentable than others’, Patent World, March, 9.
• WHAITE, R.& JONES, N. (1989) ‘Biotechnological patent in Europe’, The Draft Directive, EIPR, 5.