Introduction

The field of Biotechnology is rapidly advancing. Ever since the report of the first successful cloning of a sheep named Dolly in early 1997, advances in genetic engineering have gained attention globally. Virtually no day passes without reference to new developments in biotechnology, and most have legal implications. A few are studded with ethical controversies.

Modern research and development involves a great deal of time and money. Parties investing in such research are looking to protect their investment.  As a result of this, the patent process has become important in the field of Biotechnology.

For the purposes of this paper, the structure of contents is in three sections: -

1. Meaning and justifications of patenting biotechnological inventions.

2. Assessing the scope of patent to be granted and looking at the patentable subject matter in the biotechnology industry.

3. The debate on human cloning and conclusion.

Meaning

In the words of J. Curry, who gives a very wide definition to the term ‘Biotechnology’, it refers “to any technique that uses living organisms (or parts of organisms) to make or modify products, to improve plants or animals, or to develop micro organisms for specific uses.”[1]

Biotechnology can be seen as encompassing all technologies involving the processing of biological materials. Biotechnological inventions have already had a major impact on a number of industries, including medical research, agriculture, animal production and health, dairy, beverages, food, and waste processing. The potential applications of biotechnology are very wide and new applications of biotechnological inventions are constantly being developed. It is likely that in future, use of biotechnological innovations will be increasingly important to many sectors of industry in maintaining international competitiveness.

Justifications in Patenting Biotechnological inventions[2]

A question forming part of this section is whether or not it is appropriate to issue patents for biotechnological inventions. Many arguments have been raised against patenting of biotechnological inventions. In some cases, these arguments are valid and are of real concern. However, in other cases, they may stem from a general misunderstanding of biotechnology and its potential applications, of the patent system and its limitations, and of other forms of legislation that control the use of this technology.

Let us evaluate some concerns here: -

1. Morality – The genetic alteration of life is an emotional subject and there is no doubt that the debate on whether it is appropriate or not will continue and evolve with the developments in biotechnology. This will be the case whether such inventions are patented or not as further experimentation and advances in this area will not be prevented merely by prohibiting patents of life forms and genetic material. However, by allowing patents for such inventions, it may be considered as an encouragement and thus facilitate further research, development and use in this area.

2. Ownership and commercialization of life – Allowing patents for these types of inventions leads to the ownership and commercialization of life, and reduces life forms to ‘products of manufacture’. This seems somewhat misguided. The human race has claimed ownership of and has been exploiting nature, including life forms, to a commercial end for centuries. Further, now we can obtain genetically superior species of plants and animals; albeit via breeding programmes. The only difference between these past practices and the use of the current technology is that biotechnology makes it easier, and potentially more economical, for us to select desirable genetic traits.

3. Exploitation of country’s resources – There is widespread concern that granting patents for life forms and genetic material may encourage multinational companies to exploit the natural resources of a country without the authority and acknowledgement of, or reward to the country. However, the provisions of the Convention on Biological Diversity (the Rio Convention) of 1992, which as of 15.01.1999, 175 countries have ratified, gives signatory states the right to exploit their resources by establishing laws which prevent overseas companies from doing so.

4.      Indigenous people’s concern – Allowing patents for certain life forms and genetic material may be insensitive to the beliefs of indigenous populations and may exploit their knowledge. These issues are real and must be addressed.

Let us evaluate some more factors which justify patentability of biotechnological inventions: -

1. Biotechnology contributes to life saving medical treatments. Advances in biotechnology have enabled the development and increasing availability of life saving medication and contributed towards the eradication of disease.

2. Biotechnology may increase human welfare. Biotechnological inventions have the potential to provide increased and more reliable food harvests for the world's population, and to provide alternative means of producing goods that will use fewer resources. E.g.

3. Biotechnology may have positive environmental effects. Biotechnological advances may result in production processes and products that are less polluting and use less resources. There is also the potential to clean up existing pollution and to improve waste management through biotechnological processes. E.g. US $ 100 billion worth of crops are destroyed annually by soil-dwelling nematodes damaging crop plants. Chemical nematicides are the only option for crop protection, but these are among the most toxic and environmentally damaging pesticides that are in widespread use[3]. Biotechnological inventions serve as an alternative to this.

Scope – Broad vs. Narrow Patent scope[4]

Joseph Schumpeter raised an issue of whether a highly concentrated industry or a structurally more competitive one is best for technical change. Since then, this question has been a prime topic for research and controversy among economists.

Here, it is worth mentioning the analysis of two authors – Edmund Kitch and Robert Merges & Richard Nelson, in assessing the appropriate patent scope.

Edmund Kitch[5] – Prospect theory

This author is associated with designing a patent system that allows the inventor of the technology to have a broad patent scope initially to enable the pioneering inventor to plan, undertake or coordinate future developments. Kitch proposes this theory keeping in mind the waste and inefficiency associated with rivalrous development of technology.

Kitch further says that patents are granted after invention but before commercialization and this has two advantages:

1.      it allows “breathing room” for the inventor to invest in development without fear of another firm pre-empting the work.

2.      it allows the inventor to coordinate activities with those of potential imitators to reduce inefficient duplication of inventive effort.

Kitch prefers a single-firm dominance in respect of a technological prospect. He emphasizes that a firm can develop the prospect by itself. And in respect of the different parts of the prospect, the firm can engage in carefully controlled licensing agreements.

Thus, Kitch’s hypothesis stresses that granting broad patents is likely to make subsequent invention and development more orderly and productive.

Let us evaluate an example where broad patent was granted:

Patent was granted to Dr. Phillip Leder and Dr. Timothy Stewart of the Harvard Medical School for their successful work involving transgenic mice. They isolated a gene that is associated with cancer in mammals and then injected the same into a fertilized mouse egg, which yielded transgenic mice that are extremely sensitive to carcinogens.[6] Leder and Stewart claimed not only the technique they had used, or the particular transgenic mice variety they had created, but also on all “non-human transgenic animals” produced by their technique.  A significant question arising here is that whether substantial steps are required to get the same results in higher order mammals like dog or whether a transgenic cat produced using a different technique would fall outside the scope of infringement?

Merges and Nelson approach[7]

The authors propound a theory entirely different from Kitch and is based on the existence of competition in the industry. Following points are worth noting in their favour:-

1.      Past experiences have shown that when a firm had control over a broad technology, it became relaxed until faced with outside threat.

2.      Once a firm develops and becomes competent in one part of a ‘prospect’, it may be very hard for it to give much attention to other parts, even though the competitors feel tremendous scope there.

3.      The characteristic of ‘prospect’ for technological development is that no one knows for sure what is out there. Different parties are bound to see the prospects differently. The only way to find out what works and what does not is to let a variety of minds try.

4.      The licensing agreement criteria suggested by Kitch is impractical as per these authors. Substantial literature documents the steep transaction costs of technology licensing, and there is indirect evidence that these costs increase when major innovations are transferred.

Merges and Nelson acknowledge the fact that rivalry does lead to waste. But it argues the converse that there are major social dangers of letting the advance of a technology to be under the control of one or a few organizations. They also argue that granting limited patents would be more consistent with the enablement doctrine, which allows the inventor only what he has actually invented as spelled out in the specification.

Solution Recommended

A claim on particular product is clearly broader than one simply on a particular way of making that product. Thus, Merges and Nelson recommend that the product versus process issue in biotechnological inventions is an interesting variation on the patent scope issue. E.g. a product produced by Genentech using recombinant DNA technique was found to infringe a patent covering an old product, even though the recombinant version of the product was much simpler and cheaper to prepare.[8]

Patent Scope and Biotechnology Industry

Biotechnological inventions are concerned with processes occurring in living matter including animals, plants or microorganisms, the products so obtained and their industrial application. The field of their application is broad and covers, for example, the use of fungi in the bakery, wine and antibiotic industries, bacteria for the manufacture of vaccines, plant extracts and the like. Classical biotechnology was concerned with natural occurring biological processes and products and their improvement. This situation posed serious problems concerning patentability:

• Patentability of living matter that reproduces itself, that is, patentability of plants, animals and microorganisms.

• Patentability of chemical substances produced by living matter.

• Patentability of microorganisms extracted from natural sources.

New problems in patentability have arisen:

1.      Does the identification and separation by conventional methods of genes which code for well-known compounds represent a discovery or an invention? A classical example in this area is insulin, a protein that has been known for some time and is produced by a specific gene in the animal body. The structure of this gene was not known until recently.

2.      Are claims directed to genetically-engineered known compounds acceptable? For example, should a claim directed to "genetically engineered insulin" be allowed, notwithstanding that the inventor discovered only one of the many gene manipulation methods, or should the claim be limited to a product by process?

3.      Are functional claims often so broadly worded that they may prevent further research in a specific field for fear of infringement suits, acceptable of should the claims be limited to the actual description in the specification[9].

Requirements[10]

The prerequisites to render a biotechnological invention patentable may generally be described as:

1.      Novelty – The invention has to be new. This ensures that the granting of a patent will not provide a monopoly right to a party for something that was already known. Another unique thing about this qualification is that it differs between countries. Throughout the world, one of the following three main systems are adopted by different countries for assessing novelty:

§         Local Novelty – an invention must neither be publicly used nor published in the particular country in which the applicant seeks patent granting.

§         Relative Novelty – an invention must neither be published in any country in the world nor used publicly in the particular country in which the applicant seeks a patent.

§         Absolute Novelty – Prior to the filing of application, the invention must not have been published or publicly used in any country.

2.      Inventive Step – For patenting something, it must provide some advancement or step forward in technology. An alleged invention is said to lack an inventive step if it would be obvious to a person of general skill in the art. The degree of thought and imagination required to render an invention patentable will differ. However, in general, it is only a small degree of imagination or a small step above what was known previously, that shall constitute an inventive step.

3.      Utility – Another requirement for a patent is that the invention has industrial applicability, i.e. the invention must serve a practical purpose and be capable of use in some kind of industry.

Additional requirements to obtain a valid patent in case of biotechnology are:

1. An Enabling Disclosure – The constraint for an enabling disclosure is central to one of the main aims of the patent system; to promote disclosure of information to the public. The specification filed with the application for a patent must sufficiently describe the invention along with the best method by which it may be performed in enough details to allow a person of average skill in the relative field to rework the invention with no further experimentation or invention. To the extent it is to include a clear description of how to use an invention, this requirement overlaps with the utility principle.

2. The Deposit of Micro-organisms – This is essential to the need of filing an enabling disclosure. This is necessary as it would be near impossible to accurately describe in writing all the characteristics of the micro-organisms. A sample can be deposited in a recognized depository, e.g. American Type Culture Collection.

Case Study – NIH cDNA Patent Applications [11]

During the period June 1991 and February 1993, National Institutes of Health (NIH) filed three applications for allegedly novel human EST’s (expressed sequence tags). The applications sought protection for alleged inventions associated with the identification of approximately 6800 partial cDNA sequences or EST’s. The EST’s appeared to have been isolated by standard techniques used in the field of molecular genetics.

NIH claimed protection for each basic EST’s, full genes containing the EST’s, constructs containing the EST’s, panels of EST’s, antisense probes relating to the identified EST’s.

Let us now evaluate this patent application in terms of the requirements mentioned above: -

1. Novel – even though there is no concrete information or evidence here, we will assume that the EST’s were found to be novel in the form in which they were isolated.

2. Inventive Step – During the examination of the application, following objections were raised against claims directed to the method of isolating the EST sequences of the applications:

• The methods used principles and strategies commonly applied in molecular biology.

• That the methods were well-known was established in a number of publications

• The mere fact that the methods were used to isolate previously unknown sequences was not considered to impart any degree of inventiveness to the method.

3.      Utility – Consideration was given of the techniques utilized to put the EST’s to the use and which EST’s can be put to which uses. The following points of arguments featured:

§         The NIH stated uses for the EST’s which were known in the field of molecular genetics and precise techniques were previously available for carrying out these uses. The NIH did not suggest that the techniques which may be used to put the EST’s to use were any different from the techniques already known in the field. Based on these facts, it seems that the NIH had not invented any new technique for putting EST’s to use.

§         At the date of filing the patent specifications, none of the EST’s had been fully characterized in respect of what they may code for or where they mapped in the human genome. Thus, the uses suggested were merely speculative.

Thus, from the above, it was suggested that all the NIH appeared to have achieved was a mere discovery of a vast number of sequences obtained using well-established techniques.

4.      Enabling Disclosure – NIH specifications were severely lacking, as they did not disclose methods for putting any one of the identified sequences to a specific use. As a result, skilled person would not have been able to put the EST’s to use without first characterizing them and identifying which of the many sequences were of interest for one of the particular purposes alluded to in the specifications. This obviously would involve a considerable amount of experimentation.

Decision –

The NIH discoveries appeared to lack any inventiveness, did not provide an enabling disclosure and as a result did not establish that the EST’s had any immediate practical use. Amidst surrounding controversy and adverse examination reports from the US Patents and Trade Marks Office (PTO), the NIH abandoned these patent applications in February 1994.

What is Patentable in Biotechnology?[12]

After assessing the scope of Biotechnological inventions, we now turn to look at what parts of Biotechnology are patentable: -

A Protein?

Patent protection for a protein may be granted if, not been previously characterized, has been isolated from a natural resource in pure form.

A novel or known protein obtained via recombinant DNA technology may be patentable. E.g. a hormone expressed from a recombinant vector.

Micro-organisms?

§         A new strain of micro-organism produced artificially – this may include a micro-organism transformed by a recombinant vector.

§         A micro-organism newly isolated in pure form from a natural source.

§         A novel product produced by a micro-organism is patentable – e.g. antibiotics

§         If a product produced by the micro-organism is known, the process of producing the product using the micro-organism may be patentable.

Molecular Biological Techniques?

§         Novel techniques/processes for producing a particular product (protein/clone) may be patentable.

§         A known process used to produce a novel product is generally not patentable.

Cell Lines?

Yes, if artificially produced.

DNA, RNA, Amino Acid Sequences?

Random isolated sequences generally will not be patentable if they have no utility, i.e. they have no known use at the date of filing the application.

A Gene?

§         Newly isolated genes in pure form.

§         A gene to which alterations have been made.

§         A gene in recombinant form.

DNA/RNA Vectors?

Novel vectors created in the laboratory and used for cloning or expressing gene sequences may be patentable.

A Plant or Animal?

At present, there is much controversy over the patentability of plants and animals.

In many countries, it has generally been considered that an animal or plant or a process for producing an animal or plant is not patentable. However, views on this are changing and a number of patents have already been granted. E.g. the Harvard Oncomouse.

Plant varieties may be protected in most industrial countries by way of Plant Variety Rights – also called Plant Patents.

Conclusion

Given these broad guidelines, across the globe, each country has taken a different approach to biotech patent regulation. Let us evaluate the stand adopted by some countries[13]:

Australia’s approach to biotech patents is one of the most liberal.  In 1976, the Australian Patent Office (APO), in Rank Hovis McDougall Ltd.’s Application, held that living organisms are patentable, implying that they are inventable.  The Australian Patent Act contains no express prohibition against the patenting of life forms (aside from human beings).  The APO considers all living organisms excluding human beings as potentially patentable subject matter.

The US Patent Law has followed Australia’s liberal approach towards biotech patents.  The US Supreme Court decision in Diamond vs. Chakraborty (1980) opened the way for inventions relating to genetic engineering and living organisms, declaring them as inventable.  The United States Patent Office (USPTO) has since issued patents for over 6,000 genes, and about 1,000 of these relate to human genes.  However, in response to criticism that their gene patents are too liberal in defining what is invented, the US recently issued “utility guidelines” requiring stricter applicability standards.

In contrast, Europe adopts a more cautious approach towards granting biotech patents, which is addressed by the European Union Directive on the Legal Protection of Biotechnological Inventions.  The Directives include a non-exclusive list of unpatentable processes, for example, cloning, germ-line modifications, embryo processes, transgenic processes, etc. 

Article 27 of the TRIPS Agreement provides that members may exclude from patentability:

§         Inventions, the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment:

§         Diagnostic, therapeutic and surgical methods for the treatment of humans or animals.

§         Plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals excluding non-biological and microbiological processes.

Certainly, biotechnology as a whole has been the subject of enormous claims. In many ways, to talk about biotechnology in general is not helpful because we are really talking about problems concerning human beings, problems concerning plants, animals and environment. We have to decide to what extent we want our society to encourage or discourage research and development in this area. We have to look at the question of limits. Are there limits here, if so, how do we discover them, how do we accept them and how do we enforce the limits?

In the end, biotechnology should be treated as a great experiment. We really don't know yet where it is going. We don't know what it will do for us or to us. My own bias would be somewhere in the middle. If there are benefits, we will get to them eventually.

Contentious Issue– Human Cloning[14]

Scientists began cloning frogs in the 1950s. When a team from the Roslin Institute in Edinburgh successfully cloned an adult mammal for the first time in 1996, the possibility of human cloning came a step closer to reality. No one has managed to clone a human being yet, but several groups have announced that they plan to do so.

How is it done?

Dolly the sheep was cloned by transferring the nucleus of a body cell into an egg which had already had its nucleus removed. This is also known as nuclear transfer. It is likely that an attempt to clone humans would be based on the same method.

Why ban human cloning?

Most mainstream scientists are set against attempts at reproductive human cloning, including Ian Wilmut, the British embryologist who led the team which cloned Dolly the sheep, and Richard Gardner, who chaired a Royal Society working group on human cloning. The most persuasive argument is that the risks are far too great at present. It is feared that human cloning would be cruel, because the process may result in a large number of miscarriages and deformities before a human could be successfully cloned. For instance, it took 272 attempts to create Dolly. Even then, the child could not be guaranteed ongoing good health.

As Prof Gardner put it: "Our experience with animals suggests that there would be a very real danger of creating seriously handicapped individuals if anybody tries to implant cloned human embryos into the womb."

Many religious groups, including some Roman Catholic and Muslim organizations, also object to cloning. There are many ethical arguments for a ban, including fears that cloning humans will lead to "designer babies" with genetic traits selected by their parents, or a black market for embryos, and the creation of a "genetic underclass".

Recent Development[15]

Recent break-through in cloning involved tricking a human egg into starting to develop on its own, without benefit of a sperm. The idea is to use a person’s own DNA to make an embryo or, in the case of a woman, her own egg to make an embryo. Stem cells could then be extracted from these embryos and used to grow whatever cells or tissues a person might need — even whole organs for transplantation. This strategy would obviate the rejection problems that haunt transplants today, as an embryo created from the recipient’s own DNA would be the source of the replacement organs.  Thus, reiterating bringing this domain within the span of patenting Biotechnological Inventions.

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© Sahil Gupta, 5 April 2002, All Rights Reserved.