Biopatent

from Wikipedia, the free encyclopedia

Under biopatents refers to patents in the biotechnological sector. These can be vaccines , diagnostics , but also inventions that affect animals and plants.

The first biopatent in the sense of a biotechnological invention was granted on July 24, 1843 by the Finnish Patent Office for a new process for the production of yeast cultures .

history

Louis Pasteur's patent on isolated yeast from 1873 is an early example of a patent on living things

The modern molecular biology that emerged in the 1960s and 1970s enabled entirely new drugs , vaccines , diagnostics and plant breeding methods , starting at the level of individual genes . The landmark decision of the Supreme Court of the United States in the case v Diamond. Chakrabarty (1980) marks a turning point in the history of intellectual property law in the biotechnological field. Since then, certain non-naturally occurring organisms have been patented, which has had a stimulating effect on the biotechnological industry.

International numbers and trends

In the 1990s, the number of international biopatent applications under the Treaty on International Cooperation in the Patent System (PCT) continued to grow , partly due to the Human Genome Project . After that, the number fell by an average of 3.6% per year, from 11,800 (2000) to 9,481 (2006). Meanwhile, the number of patent applications rose by an average of 6.5% per year. While in the mid-1990s biotechnology still had an average share of 10.6% of the total number of patent applications in a country, it was 6.7% in 2004–2006.

43.5% of PCT biopatent applications in 2006 came from the United States , followed by Germany (11.6%) and Japan (6.7%). Almost 4% came from the BRICS countries , primarily the People's Republic of China (1.9%), India (0.9%) and Russia (0.8%).

In Denmark , the share of biopatents and total patents in the period 2004–2006 was 15.8%, more than twice as high as in the sum of the other countries. Belgium , Singapore and Canada also have a relative advantage when it comes to biopatents with a share of more than 10%.

Economics

The fundamental problem that patent protection is supposed to solve is market failure , which results from the positive externality of research : As a rule, the social benefit of an invention is well above the private benefit. The state can combat this market failure by subsidizing research through taxpayers' money or by defining and protecting intellectual property rights.

State and supranational regulations

Different patent authorities often have different regulations and interpretations with regard to biopatents. The agreement on trade-related aspects of intellectual property rights aims to harmonize these regulations more closely. Many developing countries do not yet have such regulations.

European Union

The European Patent Office (EPA) has been granting patents on plants since 1989, but not on plant varieties and animal breeds and "essentially biological processes" for breeding plants or animals.

More than 300 animal patent applications were filed with the EPO between 1992 and 2002, but few patents were granted.

The currently valid basis for the granting of biopatents in the EU is Directive 98/44 / EC from 1998. The requirements for a patent in the biotechnological field do not differ from those in other areas: the invention must

  • be new
  • be commercially applicable, and
  • involve an inventive step.

Biological material that is isolated or produced from its natural environment with the help of a technical process is included. Are excluded from patentability

  • Plant varieties and animal breeds .
  • essentially biological processes for the production of plants or animals (e.g. crossing and selection). However, this non-patentability does not apply to inventions which have a microbiological process as their subject.
  • Inventions that tamper with the human germ line or include cloning of human beings and the use of human embryos for industrial or commercial purposes.
  • the human body and the discovery of individual components (e.g. genes). On the other hand, an isolated component of the human body or a component obtained in some other way by a technical process, including the sequence or partial sequence of a gene, can constitute a patentable invention.
  • Treatment methods in the field of surgery and therapy and diagnostic methods that are carried out on the human or animal body.
  • Processes for altering the genetic identity of animals which are capable of causing suffering in these animals without substantial medical benefit, and the animals produced with the aid of such processes.

The following questions, among others, are not clearly answered:

  • What exactly are “essentially biological processes”?
  • What are the criteria for patenting human gene sequences?

In a landmark decision in December 2010, the EPO confirmed the non-patentability of essentially biological processes. The reason was complaints from Syngenta (2003) and Unilever (2004) regarding patent rights already granted in the field of plant breeding to increase potentially anti-carcinogenic substances in broccoli and to reduce the water content of tomatoes. The EPO's Enlarged Board of Appeal ruled on March 25, 2015 that cultivated plants can be patented even if this is not possible for their cultivation method. The granted patents remain valid.

United States

The Plant Patent Act (PPA), issued in 1930, allowed asexually propagated plants to be patented , and more than 6,500 such patents have since been granted, mostly on ornamental plants . In 1985, the Board of Patent Appeals also allowed patents on plants that were sexually or in vitro propagated. The United States Supreme Court upheld this in 2001 in a case involving a hybrid corn variety .

The first patent applications on animals appeared in the 1980s. In 1987, the USPTO rejected an application for oysters with an extra set of chromosomes on the grounds of obviousness. In 1988 the first patent on a transgenic mouse was granted to two researchers at Harvard University .

Japan

In Japan patents are allowed on plants. From 1988 to 1998, 19 patents were issued on animals, most of them on transgenic animals .

China

A patent system was introduced in China in 1978, and its patent legislation came into effect in 1985. In 1980, China joined WIPO . Since then, Chinese patent law has been updated three times (1992, 1998, 2008).

As in the EU, surgical, therapeutic and diagnostic methods on human or animal bodies cannot be patented in China. Plant varieties and animal breeds are also excluded from patentability. Breeding methods and the resulting organisms are also only patentable if the methods are not “essentially biological”. Genes, DNA, RNA and chromosomes are patentable like other chemical substances.

India

Patents on plants are not allowed in India.

Effects

An international analysis of 177 patent-relevant policy measures in 60 countries over 150 years came to the conclusion that an expansion of patent protection promotes innovation (measured in granted patents per inhabitant) if patent protection was initially weak; on the other hand, hinders them if the patent protection was initially strong. Since a patent restricts the use of the invention by third parties, the likelihood that inventions will be disclosed increases with patent protection. Empirical studies show that the strength of patent protection has a great positive influence on licensing. On the other hand, stronger patent law can also encourage anti-competitive processes.

Bioethics

Various bioethical issues arise in connection with biopatents, e.g. B .:

  • Is It Ethical To Grant Exclusive Property Rights Over DNA Sequences ?
  • What consents should be obtained, from whom, before genetic resources are used to create a patented invention?
  • What ethical concerns arise with regard to the handling of exclusive usage rights, for example on diagnostics ?

The following bio-patents have led to significant bioethical and legal controversies:

Relaxin

Relaxin , a hormone that relaxes the uterus during childbirth and whose use could reduce the need for a caesarean section in difficult pregnancies, was first described in pigs in 1926. In 1976 relaxin was isolated at the Howard Florey Institute in Australia and its chemical structure was characterized. It was discovered that only human relaxin is suitable for medical purposes in humans. In order to obtain sufficient quantities of the hormone for research, it had to be synthesized. Therefore, the coding nucleotide sequence was cloned using recombinant DNA techniques , after which relaxin could be synthesized. The Howard Florey Institute argued that his invention was the gene sequence that encoded the unexpected second form of relaxin, as well as its synthetic form, produced using genetic engineering. In 1991 the institute received a patent from the European Patent Office . In 1992 this patent was criticized by the European Greens with the following arguments (the answer from the patent office below):

  • The alleged invention is not new as the hormone has always been present in the female human body.
    • The gene sequence itself is new because the DNA did not exist in nature in this form. The specifically human form of relaxin was also unknown until its discovery.
  • No inventive step had taken place as conventional methods were used to isolate the DNA.
    • Since the inventor presented a product to the public for the first time, the existence of which was previously unknown, the method was immaterial.
  • Relaxin was a discovery and therefore just as unpatentable as the moon or a newly discovered animal species .
    • The substance was newly isolated and characterized and was therefore not a discovery.
  • The patent is incompatible with public policy .
    • The patent is compatible with public policy.
  • The isolation of a gene from the tissue of a pregnant woman is a violation of human dignity , as she uses the pregnancy for a technical, profit-oriented purpose.
    • The tissue was voluntarily donated as part of gynecological operations. Many life-saving substances have been isolated, patented and publicly welcomed in this way.
  • The patenting of genes is a modern form of slavery , since parts of women are sold in pieces to commercial companies.
    • Gene patents do not imply any property rights to individual people. It is not a question of dismemberment, but rather the synthesis of the hormone.
  • Patents on human genes are equivalent to patents on human life and are therefore intrinsically immoral.
    • The patenting of individual human genes has nothing to do with the patenting of human life. Even if every gene in the human genome were cloned, it would be impossible to make a human from it. There is no difference between patenting individual genes and patenting other important human substances, such as adrenaline .

Crab mouse

The crab mouse was one of the first transgenic animals . In the early 1980s, Harvard Medical School made a genetically modified mouse that was particularly susceptible to cancer after an oncogene was introduced into its genome. The scientists involved hoped to gain new medical knowledge from the cancer mouse and applied for patents in several countries. This raised two questions for the patent system:

  • Should patents be granted for all animal breeds or plant varieties, especially higher mammals, even if they do not meet the patentability criteria?
  • How should moral questions about suffering from transgenic animals be dealt with?

The American Patent Office granted patent protection in 1988, with an explicit reference that it was a non-human animal. The European Patent Office dealt extensively with the case, which was only resolved in 2004. The EPO decided that the crab mouse was not a breed of animal. With regard to public ordre, the EPO used a hedonistic calculation that was supposed to weigh the positive consequences of patenting against the negative consequences. According to this calculation, the benefit for humans through medical research with the cancer mouse is greater than the moral concerns about animal suffering. Therefore, the patent application was finally granted in the EU.

The same benefit calculation by the EPO led to the rejection of a patent application by the Upjohn company in 1992 , which concerned a transgenic mouse that loses hair so that remedies against hair loss could be tested.

The crab mouse was not patented in Canada . The Supreme Court of Canada ruled in 2002 that higher life forms were not patentable because they were not made or assembled in the sense of an invention. A manufacture would relate to non-living products or animals. A composition is a mixture of substances or ingredients. Microorganisms , or an egg cell injected with an oncogene , however, are patentable. Other judges, however, argued that the non-naturally occurring change in the genetic material from which an animal is composed constitutes a composition in the sense of an invention.

Myriad

BRCA1 and BRCA2 are two genes that are linked to breast and ovarian cancer . When these genes have mutations, the likelihood of developing these cancers increases. It is therefore important to be able to identify these mutations for diagnosis and monitoring. The company Myriad Genetics Inc. sequenced BRCA1 first time in cooperation with the University of Utah , and both presented in 1994 an application for patent protection. They received patent protection for isolated DNA encoding a BRCA1 polypeptide and for a screening method . Together with Canadian and Japanese research centers, they received several patents on mutations of the genes in several countries.

These patents have been criticized from many quarters. Among others, the Social Democratic Party of Switzerland , Greenpeace Germany , the French Institut Curie and Assistance publique - Hôpitaux de Paris , the Belgian Society of Human Genetics, and the Dutch and Austrian governments opposed it. The main argument was that the alleged inventions did not meet the criteria for patentability.

At a deeper level, however, there were ethical and political concerns. In addition to the already known objections to the patentability of inventions derived from the human genome, it was feared that patent protection would make the further development of and access to diagnostic methods more difficult. In 2004 diagnostic methods related to BRCA1 were excluded from patenting.

Much of the debate, however, was not about the patents per se, but about the high prices Myriad charged for performing diagnostic tests. So the question arose whether the authorities should intervene in the licensing practice of the patent owners. In France, patent law was subsequently changed. The OECD subsequently developed guidelines for relatively open licensing practices.

On June 13, 2013, the United States Supreme Court issued a landmark decision banning patents on human genome. As a “product of nature” it cannot be patented. Artificially imitated genetic material, so-called cDNA, is not affected by the ban, "because it is not produced by nature". The verdict was preceded by a lawsuit brought by cancer patients, doctors and genetic researchers under the umbrella of the American Civil Liberties Union .

John Moore

In 1976, the doctor recommended David Golde of the UCLA the on hairy cell leukemia diseased John Moore removal of the spleen , to hinder a progression of the disease. Moore agreed. Golde considered the removed spleen tissue to be of value for biomedical research and, over the next three years, set up a cell culture of T lymphocytes from the spleen. Moore was not informed of this. Golde received a patent on the cell culture in 1984, which earned him significant income from two commercial contracts with biotechnology companies. Moore sued Golde on the grounds that the patent was his property and that Golde had violated his professional duties. The California Supreme Court ruled in 1990 that Moore had no claims because he was not one of the inventors. Also, a patient cannot have body parts that have been removed. However, the doctor would have the duty to inform the patient about a possible economic or personal interest in treatment.

Public opinion

No patents on seeds (cropped) .jpg

Surveys in Canada and the US show that the public in both countries see biopatenting as contributing to innovation, even though patenting causes discomfort to 50% of Canadians and 45% of Americans. The patenting of genes is often equated with the patenting of life. An additional concern is that the benefits of the protected inventions are not affordable for everyone. According to a survey conducted in 2002, 46% of Canadians believe that biopatenting is likely to pose more risks than benefits.

An analysis of Myriad print articles from Australia, Canada, the United Kingdom and the United States examined the potential impact of media coverage on public opinion. Only 55.9% of 143 articles contained a neutral representation of different views. 77.6% of the articles had a negative tenor, 6.29% a positive, and 16% a neutral. The Canadian coverage was significantly more negative than that of the other countries.

Web links

Individual evidence

  1. BMELV information portal on biopatents ( Memento from April 12, 2011 in the Internet Archive )
  2. a b c d e f g h i j H. S. Chawla: Patenting of Biological Material and Biotechnology. In: Journal of Intellectual Property Rights. Vol. 10, 2005, pp. 44-51 ( nopr.niscair.res.in PDF).
  3. a b c Bioethics and Patent Law: The Relaxin Case. In: WIPO Magazine. April 2006.
  4. Prabuddha Ganguli, Ben Prickril, Rita Khanna: Defining the Future: Emerging Issues in Biotechnology, Intellectual Property Rights and Technology Transfer. In: Prabuddha Ganguli, Ben Prickril, Rita Khanna: (Ed.): Technology Transfer in Biotechnology. A global perspective. Wiley, 2009, ISBN 978-3-527-31645-8 ( media.wiley.com PDF).
  5. a b c OECD (2009). OECD Science, Technology and Industry Scoreboard 2009, OECD Publishing. Pp. 66-67. doi : 10.1787 / 20725345 }
  6. a b c Biotechnology in European patents - threat or promise? ( Memento of the original from December 26, 2010 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. . European Patent Office, July 12, 2010.  @1@ 2Template: Webachiv / IABot / www.epo.org
  7. a b Legal protection: biotechnological inventions. Europa.eu, September 12, 2005.
  8. No European patents on essentially biological breeding processes ( Memento of December 26, 2010 in the Internet Archive ). EPO, December 9, 2010.
  9. “Essentially biological processes” on the test bench ( Memento from July 17, 2010 in the Internet Archive ). EPO, July 16, 2010.
  10. Plants may be patentable in Europe even if the methods by which they are produced are not. FB Rice, April 7, 2015.
  11. Kenneth G. Huang: China's Innovation Landscape . In: Science . tape 329 , no. 5992 , August 6, 2010, p. 632-633 , doi : 10.1126 / science.1190212 .
  12. ^ Jacqueline Lui: Patenting biotechnology inventions in China . In: Nat Biotech . tape 19 , no. 1 , 2001, p. 83-84 , doi : 10.1038 / 83589 .
  13. a b c d Bioethics and Patent Law: The Case of the Oncomouse. In: WIPO Magazine. June 2006.
  14. a b c d Bioethics and Patent Law: The Case of Myriad. In: WIPO Magazine. August 2006.
  15. No patents on human genes in America. faz.net, June 13, 2013.
  16. ^ Bioethics and Patent Law: The Cases of Moore and the Hagahai People. In: WIPO Magazine. September 2006.
  17. Timothy Caulfield, Edna Einsiedel, Jon F. Merz, Dianne Nicol: Trust, patents and public perceptions: the governance of controversial biotechnology research . In: Nat Biotech . tape 24 , no. 11 , October 2006, p. 1352-1354 , doi : 10.1038 / nbt1106-1352 .
  18. Timothy Caulfield, Tania Bubela, C J. Murdoch: Myriad and the mass media: the covering of a gene patent controversy . In: Genetics in Medicine . tape 9 , no. December 12 , 2007, pp. 850-855 , doi : 10.1097 / GIM.0b013e31815bf965 .