Genetic Engineering and The Law of Patents in Uganda

By Ivan Ojakol*

 
Abstract:

I will go about this essay in the following ways; I will start by defining what genetic engineering is, the purpose of patenting in this area and then will look at the patentability of the subject as far as intellectual property is concerned. I will state some of the genetic research tools and examples of patents that exist in this field and proceed to look at the criticisms and controversies entailed in the patentability of genetic engineering especially as far as morality is concerned. That will then lead me to my conclusion.

Essay:

Genetic engineering is basically concerned with tailoring the genes of an organism so that the newly modified organism will have desired characteristics. It is the direct human manipulation of an organism’s genetic material in a way that does not occur under natural conditions.

According to John R. Rudolph in A study of Issues Relating to the Patentability of Bio-Technological Subject Matter, It is part of a broader subject called bio-technology which can be defined as the synergistic union of biological life sciences and the technologically based industrial arts. They are more or less one and the same with genetic engineering.

This field, because of the gulf in development and scientific research in western countries vis-à-vis African ones is mainly active in the west. It is a research intensive industry requiring highly trained and dedicated scientists, expensive laboratories and manufacturing facilities. That is why all or most of the authorities on the subject originate from countries like the US, Canada and the United Kingdom and these have had a profound effect on other countries. 

Particular international agreements like the TRIPS (Trade Related Intellectual Property Rights) agreement, the European Union Directive on the Enforcement of Intellectual Property Rights, European Patent Convention 1973 and Paris Convention for the Protection of industrial Property (1883) are of great significance as far as this subject is concerned.

The purpose of patents in bio-technology and genetic engineering is to promote progress in science and technology. It holds the key to tomorrow’s medicine. Through bio-technology and genetic engineering, future doctors and medical people will have a plethora of weapons to fight against disease, injury and age.

Patents in this field stimulate innovation in bio-technology companies by encouraging the dedication of people, capital, and time to the search for a new drug. According to Beth and Zei in Patenting genes and genetic research tools: Good or bad for innovation, If the search is successful, those who have invested will obtain a substantial reward for taking the risk. This is in line with the justification for intellectual property rights which is that people should be entitled to the fruits of their labour or a reward for the sweat of their brow. 

The TRIPS Agreement under Article 70 (9) consolidates this position where it provides for the protection of pharmaceutical and agricultural chemical products, data submitted by the originator which secured such authorization and this stops a second application for authorization during the term of the exclusive marketing rights even if the “follower” generic company generates its own data.

The TRIPS agreement under Article 27.3(b), provides for the patentability of micro-organisms and essentially biological processes for production of plants and animals.

The European Union Directive on the Enforcement of Intellectual Property Rights under Article 4, provides for the patentability of inventions which concern microbiological or other technical process or product obtained by such a process. It further provides under Article 5 that an isolated element from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene may constitute a patentable invention.

In the first case that granted a patent as far as bio-technology and genetic engineering was concerned, Diamond v Chakrabarty 447 U.S 303 (1980) where an oil eating bacterium was found to be patentable; it was held that an invention is patentable because it is a “non-naturally occurring manufacture or composition of matter, a product of human ingenuity having a distinctive name, character and use.”

In Graham v John Deere Co. 383 US, at 12-17., Mr. Justice Douglas reminded that the inventions most benefiting mankind are those that “Push back the frontiers of chemistry, physics and the like.”

Patent offices in the west have for years granted patents over genetic material whether human or otherwise- whether a gene, DNA sequence, EST as long as they meet the tests of novelty, non-obviousness and utility or industrial application, they are patentable. 

Patents must fulfill the ultimate objective of encouraging the development of genetic technologies into products for the public good. Through that limited monopoly of 20 years, innovation is encouraged. Though it can also be argued on the other side that this limited monopoly granted to patent holders allows them to prevent others from independently investigating and offering new products. 

It is argued that when only one organization is able to provide a particular clinical service, it becomes more difficult to evaluate service or compare its quality with competing products. I will address this in detail later in the essay.

The requirements for registering bio-tech patents include;

Novelty:

The invention must be novel. Novel means new. Section 10 of The Industrial Properties Act, 2013 of Uganda states that an invention is new if it is not anticipated by prior art or where a person who is highly skilled in the relevant area could not derive the invention from a combination of prior disclosed art. 

In a nutshell, a patent will be barred if the invention was invented by another at least one year prior to the patent filing date or if the inventor or another had publically used or offered it for sale more than one year prior to the patent filing date. In Chiron Corp v Organon [1994] FSR 202, the inventive step lay in using the expression screening in an unconventional manner to identify a protein.

Non-obviousness or inventive step:

The Industrial Properties Act, 2013 (under section 11) of Uganda states that an invention is new if it is not anticipated by prior art relevant to the application claiming inventions it would not have been obvious to a person skilled in the art. 

A patent will not be granted if the differences between the subject matter sought to be protected and the prior art renders the subject matter as a whole obvious at the time the invention was made to a person having ordinary skill in the art. When determining obviousness, the law attempts to look through the lenses of a person skilled in the art of invention. 

For instance, although a new function or use for a known protein may not be obvious to everyone, but obvious to a trained biologist who is cognizant of all that had been reported in the literature about the particular protein, then the patent cannot be granted in such a case. So the fact that nucleic and amino acid sequencing are well known does not mean that novel sequences discovered using these standard procedures are “obvious” and thus unpatentable. The relevant inquiry is obvious in view of well-known structures.

Utility or industrial application:

Section 12 of The Industrial Properties Act states that

“An invention shall be industrially applicable if according to its nature, it can be made or used in any kind of industry including….medicine...”

The new process, machine or manufacture must be useful. The patent specification must provide at least one practical use for the invention. The United States Patents and Trademarks Office has set forth a three-pronged test; the utility must be “specific, substantial and credible”

For example, U.S patent no. 6 6,025,154 to human genome sciences claims polynucleotides encoding a human G-protein chemokine receptor designated as HDGNR10. The patent specification points out that compounds such as soluble form HDGNR10 which inhibit the activation of membrane bound HDGNR10 receptor may be employed to treat “allergy, atherogenesis, malignancy, histamine, anaphylaxis, among others.

Disclosure is paramount when registering a patent and is statutorily provided for. The European Union Directive on the Enforcement of Intellectual Property Rights under Article 5 (2), states that the industrial application of a sequenced or partial sequence of a gene must be disclosed in the patent application. In the case of Biogen v Medeva [1996] 3 IPR 438, it was held that claims 1 and 2 of the Biogen European Convention were invalid since the claims were drafted in very wide terms.

Written description:

The inventor must describe the invention in sufficient detail to demonstrate that, at the time the patent was filed, he or she was in full possession of the invention. In Regents of California v Eli Lilly& Co., the court invalidated a species claim to “human insulin c DNA,” where the only nucleic acid sequence specification described in the patent specification was obtained from a rat. Court held that an adequate written description of DNA…requires a precise definition such as by structure, formula, chemical name or physical properties.

Enablement:

This is meant to ensure that a person having ordinary skill in the art is will be able to make and use the invention after reading the patent specification. For some materials that are difficult to enable through a written description, a deposit of the materials in an appropriate repository is required. 

This position is in line with section 16 (1) (a) of the Industrial Properties Act, 2013 of Uganda that states that where an invention involves a micro-biological process, the invention shall only be regarded disclosed if a culture of the micro-organism has been deposited with a depository institution not later than the date of filing the application. 

For example, the necessary enablement for a novel SNP associated with Alzheimer’s-a team of researchers analyze the genomic DNA from a population of Alzheimer’s patients and discover that the DNA from many of these patients contains a novel SNP that is not present in genomic DNA from subjects that do not have Alzheimer’s and do not have a family history of it. 

What must be disclosed in the patent application to support these claims is that particular SNP as well as sequences that hybridize the SNP as per Patenting genes and Genetic Research Tools: Good or bad for innovation? By Beth E. Arnold and Eva Ogielska-Zei.

Best mode:

To satisfy the best-mode requirement, the inventor must disclose the optimal way to practice the invention, if such a way is in fact known at the time of filing.

Definiteness:

This requirement obliges the patent applicant to draft one or more claims particularly pointing out and distinctly claiming the subject matter that the applicant regards as his invention. A person skilled in the art ought to be able to decipher the boundaries of the claimed invention from the claim language. 

However, a number of claims are still being issued with the broader “comprising” language for example claims to nucleic acid sequences can in theory be broadly drafted to cover not only the particular nucleic acid but any nucleic acid that “comprises” it.

Some genetic research tools include; a wide range of laboratory assays, reagents and processes including informatics algorithms.

However, genetic engineering and bio-technology patents have raised a lot of dust and controversy over the years including questions of morality;

Further more, Source book on Intellectual Property Law by Peter j. Groves also state that scientists among them noble laureates are quoted suggesting that genetic research may pose a serious threat to the human race.

Concerns have been raised over the patentability of human genetic material, through public protests and international statements from politicians. For example, the June 2000 statement by French Minister Elizabeth Gulgou, that human genetic patents violate French ethical norms. This points to the politically charged nature of the gene-patenting debate.

Even international bodies have raised this concern like the 1997 UNESCO Declaration on the Human Genome and Human Rights states that the human genome in its natural state shall not give rise to financial gains.

The critics of bio-tech patents posit that the European Union Directive and TRIPS Agreement are designed to allow all categories of patents. They are neo-colonial instruments used by the west to impose their policies on Africa and the under developed world.

The opponents argue that the human experience cannot be commoditized. That gene-patenting is a gross violation of human life. That it is unethical and contrary to basic human rights as it creates unnecessary suffering in animals and is contrary to public order and morality. In Why bio-tech patents are patently Absurd-Scientific Briefing on TRIPS and related issues, The hit or miss technologies associated with many of the inventions are inherently hazardous to human life and bio-diversity.  

The European Patent Convention under Article 54 (2) stipulates that a method of treating the human body by surgery or therapy or of diagnosis practiced on the human or animal body is unpatentable. The TRIPS Agreement under Article 6 also excludes from patenting, commercial exploitation contrary to “ordre public or morality” such as human cloning, use of embryos for industrial or commercial purposes and modifications of animals causing substantial medical benefit.

The opponents of gene-patents contend that they all involve biological processes not under the control of scientists. That they cannot be regarded as innovations but expropriations from life. That they involve acts of plagiarism of indigenous knowledge. It has been labeled “bio-piracy”

Notwithstanding this strong opposition to the granting of gene-patents, the European Patents Office and other areas in the west continue to grant controversial patents. Mainly basing on the argument of economics, in other words, this is an impetus for private investment. Companies invest as much as $800m in research. 

The decision of the Canadian Court of Appeal in the Onco-mouse (1990) EPOR 4 and (1case is a good example of how public policy and morality are not considered. In that case, the patent application seeking a patent on a genetically modified mouse was first rejected, on appeal; the Court held that it is the legislature to decide the policy issue and not the patent office.

Some of the most controversial patents are;

Stem cells which can be isolated from embryos, fetuses, newborns and adults. The most controversial aspect of this is the therapeutic human cloning which involves using nuclear transplant cloning to create a human embryo. The UK became the first country in 2001 to approve of such procedure.

Patents of genes of plants. There are 229 patents on rice; the diet of the world’s poorest. This has affected farmers’ rights to create new varieties or to preserve existing ones. This has adverse effects on food security in Africa.

These patents have also jeopardized the entire health system of countries that depend on indigenous medicine. These patented drugs are even very expensive for poor countries to afford.

In conclusion, I posit and contend that despite the major short comings of gene-patenting, it should not be done away with; rather there is need for greater enforcement of the regulatory mechanisms so that humanity does not lose its soul to capitalism and commercialism.

Books and references for further reading

Statutes:

TRIPS Agreement

European Patents Convention, 1973.

European Union Directive on the Enforcement of Intellectual Property Rights.

Industrial Properties Act, 2013.

1997 UNESCO Declaration on the Human Genome and Human Rights.

Books:

Peter J. Groves; Source book on Intellectual Property Law; Cavendish Publishing Limited, 1997.

Others:

John R. Rudolph; A study of issues Relating to patentabilty of bio-technological subject matter. Gowling, Strathy & Henderson.

Timothy Caulfield, E. Richard Gold and Mildred K. Cho; patenting human genetic material: refocusing the debate

Dr. Mae-Wan Ho; Why Bio-tech Patents are Patently Absurd-Scientific Briefing on TRIPS and related issues. Institute of Science in society London House, 24 Old Gloucester St. London WCIN 3 AL, UK.

* Ivan Ojakol is the President of the Uganda Christian University Law Society.