Biotechnology is the use of biological processes, organisms, or systems to manufacture products intended to improve the quality of human life. Humans have been harnessing biology for thousands of years to make food such as bread and cheese, and medical products derived from plants.
The earliest biotechnologists were farmers who developed improved species of plants and animals by cross breeding. In recent years, technical advances have enabled the field to grow into the major player it is today, touching all aspects of life.
Inventors have been filing applications for biotechnology patents for over a hundred years. Patent No. GB 178701625, granted in the United Kingdom in 1787, claimed a yeast-like composition to be used for baking, prepared from mashed potatoes. On 29 July 1873, microbiologist Louis Pasteur patented his improved yeast-making method at the French Patent Office.
Biotechnology is an important industrial sector for the European economy, providing employment and growth for European society and countless useful medical and other products for its citizens.
It covers a vast field ranging from medical and pharmaceutical products (55% of all patents in biotechnology) to industrial processes (41%) and agriculture, which comprises just 4%.
Advances in the life sciences and pharmaceutical sector have had an impact on life expectancy and the quality of life. Most modern medicines are based on biotechnology.
One of the earliest biomedicaments was insulin, a life-saving drug for diabetics. Over the years many improved forms of insulin have been developed, and this continuous innovation has been supported by patents granted for the new compounds.
Other patented medical inventions have provided breakthroughs in DNA fingerprinting, paternity testing and blood transfusions, where patented tests to check donated blood for the presence of deadly viruses have improved patient safety.
Many anti-cancer drugs based on patented human gene sequences are prolonging the lives of cancer patients, such as Herceptin for breast cancer and Avastin, for colon and other cancer. Humira, a patented medicament based on human gene sequences used to treat auto-immune diseases such as arthritis, was the world's best-selling medicine in 2014. Eight out of the top 10 best-selling medicaments were biological in origin and covered by patents.
It is enormously expensive and time-consuming to develop a new drug and obtain market approval, and the necessary funds are largely provided by venture capital supplied by investors.
Drug companies would not be able to fund costly clinical trials and research without being able to claim exclusive rights to recoup these investments. Patents are also an effective barrier to illicit copying of medicines and the health risks associated with unauthorised copycat versions.
Patents constitute a limited exclusive right only: Once the patent has expired (after a maximum of 20 years), the invention falls in the public domain and can be used by anyone without paying royalties. National authorities work with pharmaceutical companies to negotiate lower prices for medical products, and after the patent has expired, cheaper generic copies may enter the market.
The patent system also creates transparency: Patent applications are published 18 months after filing, so they disclose detailed information about the latest technical improvements.
The British scientist developed a genetically modified mosquito which, when released into the wild, mates with female mosquitoes to produce sterile progeny. This reduces disease-carrying mosquito populations by over 90% and so helps to eradicate diseases such as Dengue fever, yellow fever and zika.
She is the inventor of a gene-based breast cancer test. This test evaluates tumour tissue for the 10-year risk of cancer recurrence, thus identifying high-risk patients who actually require chemotherapy, and low-risk patients who will remain cancer-free without having to undergo toxic chemical treatments.
Lee developed a DNA-based instant blood diagnostic kit that allows on-the-spot detection of infectious diseases such as HIV, hepatitis B and chlamydia. Unlike other tests, the cartridges do not require cold storage or transport, making them perfectly suited for countries with a poor technical infrastructure.
As with all other technologies, inventions in biotechnology are generally considered patentable under the law and the same general patent examination rules and processes apply to all inventions.
At the EPO, biotechnology represents about 4% of all patent applications filed: 6 048 of the total number of 160 022 European patent applications received in 2015 concerned biotechnology.
In the vast majority of cases, patent applications in this field are uncontroversial. Public debate concerns a very small number of patent applications related specifically to animals and plants.
The EPO examines all patent applications diligently. Across all technologies, fewer than half of the applications filed become a patent. In biotechnology, the grant rate is significantly lower: less than 30% of the patent applications filed become a European patent.
The EPO uses powerful tools and very comprehensive databases when performing a search to determine whether the invention claimed in a patent application is new or not.
To avoid undue privatisation of traditional knowledge already in the public domain, the EPO also searches specialised databases, such as the Indian Traditional Knowledge Digital Library, which provides information related to Indian traditional medicine for patent offices. In 2009 the EPO signed an agreement with the Indian government granting EPO examiners online access to this database. The EPO also consults databases relating to other traditional knowledge, in particular databases describing Chinese and Korean traditional knowledge.
The EPO grants patents in strict accordance with its legal basis, the European Patent Convention (EPC) and takes ethical considerations into account when granting patents. Inventions whose exploitation is deemed to be contrary to Article 53 EPC are not patentable. The law lists exceptions to patentability for ethical reasons, among them human cloning, modification of the human genome and commercial uses of human embryos.
For patents in biotechnology the rules of the EU's Directive on the legal protection of biotechnological inventions ("Biopatent Directive") also apply. The Directive for instance clarifies that human genes, plants and animals are patentable when all conditions for a patent are fulfilled. The Directive became part of the EPC in 1999.
The EPO voluntarily follows the rulings of the European Court of Justice on the correct interpretation of the Directive, and has incorporated such rulings into its working practice in biotechnology.
The EPO engages with stakeholders of the patent system and the public in open and transparent discussions. We closely co-operate with the EU institutions and inform them on important developments in the field of biotechnology patents. We recently began a close co-operation with the Community Plant Variety Office on questions relating to patents on plants.
Anyone - companies, NGOs, or individuals - who considers that a particular patent should not have been granted can file an opposition within nine months of its grant. The opposition statement must be reasoned and supported by evidence, for example published documents. The patent is then re-examined by a new division of three examiners, and both the patent proprietor and the opponent are heard in a public hearing. The outcome can be rejection of the opposition, maintenance of the patent in an amended, more limited form, or revocation of the patent.
Some biotech patents have been opposed by public organisations because of concerns of a possible abuse of the monopoly by the patent holder. Examples of this are the patents held by Myriad Genetics for the genes BRCA-1 and BRCA-2, which are associated with a predisposition to breast cancer, and for a diagnostic test for the presence of mutant form of these genes in a woman's genome.
However, the EPO has no influence on the price of patented products. Its highest judicial instance, the Enlarged Board of Appeal, ruled that the EPO is not tasked with taking the economic effects of the grant of a patent into account when examining a patent application.
Governments can counter a perceived abuse of a patent monopoly by, for example, granting a compulsory licence against a patent holder to enable generics companies to sell the same product more cheaply, negotiating with patent holders to reduce the price of patented medicines, and using competition laws.
A recent study by the World Health Organization (WHO) found that in 2013, 95% of the 375 pharmaceutical compounds listed as essential medicines are not or no longer covered by a patent. Many pharmaceutical companies offer their drugs at lower prices in developing countries, or grant licences to generics companies to manufacture them there.
Plants that have been purposefully altered to carry a new characteristic, such as resistance to pests or droughts, or enhanced yield, are generally considered patentable under the law. Such inventions usually concern modifications introduced by genetic engineering ("GM plants"), but other technical processes are also used to obtain such changes. To be patentable, these plants need to be novel and inventive.
Fifty years ago breeders were able to create new plant varieties only in a non-technical and random manner, by crossing promising plants with others and hoping by chance to obtain new plants with the desired characteristic or trait. That was why it was decided when drawing up the EPC that plant varieties were not technical and should not be patentable, but protected by a different type of intellectual right, the Plant Variety Right. This grants its owner exclusive rights to sell the plant variety for a number of years.
In the 1990s, applications for plants concerned only genetically modified (GM) plants. But modern breeding methods involving biotechnology have greatly sped up the breeding process and there is a gradual move away from introducing foreign genes into plants to improving conventionally bred ones, by methods such as marker-assisted breeding, in a repeatable manner.
Most patent applications for plants concern genetically modified, transgenic plants; there are about 300 per year, whereas there are only about 70 applications per year for "non-GM" plants. The number of applications for conventional plants is less than 0.05% of all patent applications filed with the EPO (the figure for GM plants is about 0.2% of all applications).
The law does not allow patents on breeding processes which involve classical breeding steps such as crossing and selection. This also means that no patents are granted on certain novel breeding methods such as marker-assisted breeding.
In November 2016, the European Commission adopted a Notice setting out its views that according to the intentions of the legislator for the Biopatent Directive, plants produced by non-technical processes such as crossing and selection should not be patentable. On a proposal of the EPO, its Administrative Council decided to amend the relevant legal regulations to clarify that the plants exclusively obtained by such processes are also not patentable. This clarification took effect on 1 July 2017. Only plants made by technical methods are now patentable, in accordance with the Notice and with European patent law. This was confirmed by the Enlarged Board of Appeal in opinion G 3/19.
Under the EU's plant variety system, breeders may use protected varieties for further breeding, and commercialise the resulting new varieties without a licence from the owner of the earlier variety. This principle is called a breeders' exemption.
The patent system does not have such an exemption. However, the planned Unitary Patent foresees a limited breeders' exemption. This allows free use of patented plant material for breeding, with a licence from the patent owner required to commercialise new varieties bearing the patented trait. Once the Unitary Patent comes into force, the exemption will take effect in the EU.
The EPO and the Community Plant Variety Office have agreed to enhance their co-operation. The two organisations will share working practices regarding the use of their databases and other work tools, and organise joint training activities for their experts.
In Europe farmers are not disadvantaged by patents for plants. The Farmer's Privilege provides that a farmer is free to sell the product of his fields, whether the seed he bought is patented or not. The farmer may also save seed from his harvest and use them to plant his fields the next year. Both farmers and consumers benefit from the incentive given to innovation in plant breeding by intellectual property rights.
Patents for a human gene often form the basis for many life-saving drugs. The EPO does not grant patents for genes without a known activity, or for unidentified gene fragments. For a patent to be granted for a human gene, its activity must have been described in the patent application and not be obvious. Patents for human genes do not confer any rights to the human body.
Applicants tend to withdraw their applications when they receive negative reports from the EPO on the patentability of their invention. The number of patent applications refused by the EPO therefore is generally quite low. However, there are many examples of rejected patent biotech applications.
In the area of human genes, numerous applications were refused because the function of the gene had not been convincingly demonstrated in the application. Examples include application 97930715 and 01981441, both concerning human gene sequences said to be promising targets for the manufacture of medicaments. Application 96903521 was refused on ethical grounds because it claimed human embryonic stem cells which at the time of filing could only be isolated by destroying human embryos, which is not allowable under the EPC.
Like plants, animals are patentable according to the law. The patent applications filed with the EPO mostly concern transgenic (genetically modified) mice and rats used in medical research. However, the EPO takes ethical considerations into account: If the transgenic invention is found to make the animal suffer, it may only be patented if it brings a substantial medical benefit to humans (or animals).
As with plants, conventional breeding methods for animals are not patentable either. No patents for farm animals produced by such conventional breeding methods have been granted by the EPO.