Jump to content

Biological patent: Difference between revisions

From Wikipedia, the free encyclopedia
Browse history interactively
← Previous editNext edit →
Content deleted Content added
VisualWikitext
Changed format of paragraphs (merged paragraphs)
→‎Biological patents in different jurisdictions: Added section on patentability of various biologics in Canada
Line 6: Line 6:
===Australia===
===Australia===
In February 2013, Judge Justice [[John Nicholas (judge)|John Nicholas]] ruled in the [[Federal Court of Australia]] in favour of a [[Myriad Genetics]] patent on the [[BRCA1]] gene.<ref>{{cite news|title = Landmark patent ruling over breast cancer gene BRCA1|date = February 15, 2013|last = Corderoy|first = Amy|url = http://www.smh.com.au/national/health/landmark-patent-ruling-over-breast-cancer-gene-brca1-20130215-2egsq.html|access-date = June 14, 2013|newspaper = [[Sydney Morning Herald]]}}</ref> This was a landmark ruling, affirming the validity of patents on naturally occurring [[DNA]] sequences. However, the [[U.S. Supreme Court]] came to the opposite conclusion only a few months later. The Australian ruling has been appealed to the Full Bench of the Federal Court; submissions in the case include consideration of the U.S. Supreme Court ruling.<ref>{{cite news|title = BRCA1 gene patent ruling to be appealed|date = March 4, 2013|last = Corderoy|first = Amy|url = http://www.smh.com.au/national/brca1-gene-patent-ruling-to-be-appealed-20130304-2fg1f.html|access-date = June 14, 2013|newspaper = [[Sydney Morning Herald]]}}</ref><ref>{{cite news|title = Companies can't patent genes, US court rules|date = June 14, 2013|last = Corderoy|first = Amy|url = http://www.smh.com.au/technology/sci-tech/companies-cant-patent-genes-us-court-rules-20130614-2o836.html|access-date = June 14, 2013|newspaper = [[Sydney Morning Herald]]}}</ref> This decision was decided in 2014, affirming Nicholas J's decision in favor of Myriad, confirming that isolated genetic material ([[gene]]s) are valid subjects of patents.<ref>{{cite news|url=http://www.timebase.com.au/news/2014/AT499-article.html |title=Full Federal Court Upholds Gene Patents: D’Arcy v Myriad Genetics Inc [2014] FCAFC 115}}</ref> As of June 2015 the case was pending hearing in the [[High Court of Australia]].<ref>{{cite web |url=http://www.hcourt.gov.au/cases/case_s28-2015 |title=D'Arcy v. Myriad Genetics Inc & Anor}}</ref> In October 2015 the Australian high court ruled that naturally occurring genes cannot be patented.<ref>{{cite news|url=https://www.newscientist.com/article/gene-patents-struck-down-by-australias-high-court/ |title=Genes can’t be patented, rules Australia’s High Court |website=www.newscientist.com |date=7 October 2015 |access-date=27 September 2018 }}</ref>
In February 2013, Judge Justice [[John Nicholas (judge)|John Nicholas]] ruled in the [[Federal Court of Australia]] in favour of a [[Myriad Genetics]] patent on the [[BRCA1]] gene.<ref>{{cite news|title = Landmark patent ruling over breast cancer gene BRCA1|date = February 15, 2013|last = Corderoy|first = Amy|url = http://www.smh.com.au/national/health/landmark-patent-ruling-over-breast-cancer-gene-brca1-20130215-2egsq.html|access-date = June 14, 2013|newspaper = [[Sydney Morning Herald]]}}</ref> This was a landmark ruling, affirming the validity of patents on naturally occurring [[DNA]] sequences. However, the [[U.S. Supreme Court]] came to the opposite conclusion only a few months later. The Australian ruling has been appealed to the Full Bench of the Federal Court; submissions in the case include consideration of the U.S. Supreme Court ruling.<ref>{{cite news|title = BRCA1 gene patent ruling to be appealed|date = March 4, 2013|last = Corderoy|first = Amy|url = http://www.smh.com.au/national/brca1-gene-patent-ruling-to-be-appealed-20130304-2fg1f.html|access-date = June 14, 2013|newspaper = [[Sydney Morning Herald]]}}</ref><ref>{{cite news|title = Companies can't patent genes, US court rules|date = June 14, 2013|last = Corderoy|first = Amy|url = http://www.smh.com.au/technology/sci-tech/companies-cant-patent-genes-us-court-rules-20130614-2o836.html|access-date = June 14, 2013|newspaper = [[Sydney Morning Herald]]}}</ref> This decision was decided in 2014, affirming Nicholas J's decision in favor of Myriad, confirming that isolated genetic material ([[gene]]s) are valid subjects of patents.<ref>{{cite news|url=http://www.timebase.com.au/news/2014/AT499-article.html |title=Full Federal Court Upholds Gene Patents: D’Arcy v Myriad Genetics Inc [2014] FCAFC 115}}</ref> As of June 2015 the case was pending hearing in the [[High Court of Australia]].<ref>{{cite web |url=http://www.hcourt.gov.au/cases/case_s28-2015 |title=D'Arcy v. Myriad Genetics Inc & Anor}}</ref> In October 2015 the Australian high court ruled that naturally occurring genes cannot be patented.<ref>{{cite news|url=https://www.newscientist.com/article/gene-patents-struck-down-by-australias-high-court/ |title=Genes can’t be patented, rules Australia’s High Court |website=www.newscientist.com |date=7 October 2015 |access-date=27 September 2018 }}</ref>

=== Canada ===
Per Canada’s ''Patent Act'', patents are granted by the Canadian Intellectual Property Office (CIPO). Patents will only be granted for “any new and useful art, process, machine, manufacture or composition of matter”, and improvements thereon.”<ref>''Patent Act'', <abbr>R.S.C.</abbr>, 1985, c. P-4, s 2.</ref> Patents will not be granted for “mere scientific principle or abstract theorem.”<ref>''Patent Act'', <abbr>R.S.C.</abbr>, 1985, c. P-4, s 8.</ref> In the case of pharmaceuticals, along with obtaining a patent, applicants must also seek approval from Health Canada. This process is governed by the ''Patented Medicines (Notice of Compliance) Regulations''.<ref>{{Cite web|last=Branch|first=Legislative Services|date=2017-09-21|title=Consolidated federal laws of canada, Patented Medicines (Notice of Compliance) Regulations|url=https://laws-lois.justice.gc.ca/eng/regulations/sor-93-133/FullText.html|access-date=2021-04-10|website=laws-lois.justice.gc.ca}}</ref>

In ''[[Harvard College v Canada (Commissioner of Patents)]],'' also referred to as the [[oncomouse]] case, the [[Supreme Court of Canada]] ruled that higher life forms were not patentable subject matter. Writing for the majority, Bastarache J. asserted that it was the role of Parliament to address whether higher life forms should be patentable.

Methods of medical treatment cannot be patented in Canada, however, medical use claims such as the use of an [[antibody]] for the treatment of a particular disease is patentable. Unlike many other jurisdictions, Canada allows for the patent of antibodies obtained through immunizing animals. Further, [[Antigen|antigens]] which have not been previously characterized are also patentable.<ref>{{Cite web|title=Patenting Antibody-Based Biologics In Canada - Intellectual Property - Canada|url=https://www.mondaq.com/canada/patent/1013754/patenting-antibody-based-biologics-in-canada|access-date=2021-04-10|website=www.mondaq.com}}</ref>

Gene patents confer a property right to the patent holder. While CIPO will grant patents for isolated [[Genomic DNA|gDNA]] and [[Complementary DNA|cDNA]], the [[Supreme Court of Canada]] has not yet ruled on gene patentability. However, in 2016 the Children’s Hospital of Eastern Ontario (CHEO) sought to invalidate five Canadian patents held by Transgenomic. The gene patents covered the genes associated with, and genetic testing for [[Long QT syndrome]]. The parties reached a settlement. The patent was not invalidated, but, Transgenomic provided Canadian health institutions the right to test Canadians for the disease on a non-profit basis.<ref>{{Cite web|last=Lipkus|first=Nathaniel|date=2016|title=Ground Breaking Settlement Changes Landscape for genetic medicine in Canada|url=https://www.osler.com/en/about-us/press-room/2016/ground-breaking-settlement-changes-landscape-for-g|url-status=live}}</ref><ref>{{Cite web|title=Patenting in Canada: Do These Genes Fit? {{!}} Blakes|url=https://blakes.com/insights/articles/2016/patenting-in-canada-do-these-genes-fit|access-date=2021-04-10|website=blakes.com|language=en}}</ref> In [[Association for Molecular Pathology v. Myriad Genetics, Inc.|''Association for'' ''Molecular Pathology v Myriad'']], the [[Supreme Court of the United States|United States Supreme Court]] determined that genes were unpatentable products of nature and that no intellectual property existed as nothing was invented.<ref>{{Cite web|last=LoTempio|first=Vincent|date=2017-04-18|title=Patenting DNA: Does Canada Have it Right?|url=https://www.lotempiolaw.com/2017/04/blog-2/can-patent-dna/|access-date=2021-04-10|website=Vincent LoTempio {{!}} Registered Patent Attorney, Trademark, and Copyright {{!}} 1-800-866-0039|language=en-US}}</ref> Given this decision, the majority of Canadian Long QT syndrome tests were previously outsourced to the United States. After the settlement, domestic testing levels increased in Canada. The terms of the settlement could set a precedent for the repatriation of further genetic testing.<ref>{{Cite journal|last=Ali-Khan|first=Sarah E.|last2=Gold|first2=E. Richard|date=2017-11|title=Gene patents still alive and kicking: their impact on provision of genetic testing for long QT syndrome in the Canadian public health-care system|url=https://www.nature.com/articles/gim201743|journal=Genetics in Medicine|language=en|volume=19|issue=11|pages=1253–1259|doi=10.1038/gim.2017.43|issn=1530-0366}}</ref>


===Europe===
===Europe===

Revision as of 16:03, 10 April 2021

Patent law
Overviews
Procedural concepts
Patentability requirements and related concepts
Other legal requirements
By region / country
By specific subject matter
See also

A biological patent is a patent on an invention in the field of biology that by law allows the patent holder to exclude others from making, using, selling, or importing the protected invention for a limited period of time. The scope and reach of biological patents vary among jurisdictions,[1] and may include biological technology and products, genetically modified organisms and genetic material. The applicability of patents to substances and processes wholly or partially natural in origin is a subject of debate.[1]

Biological patents in different jurisdictions

Australia

In February 2013, Judge Justice John Nicholas ruled in the Federal Court of Australia in favour of a Myriad Genetics patent on the BRCA1 gene.[2] This was a landmark ruling, affirming the validity of patents on naturally occurring DNA sequences. However, the U.S. Supreme Court came to the opposite conclusion only a few months later. The Australian ruling has been appealed to the Full Bench of the Federal Court; submissions in the case include consideration of the U.S. Supreme Court ruling.[3][4] This decision was decided in 2014, affirming Nicholas J's decision in favor of Myriad, confirming that isolated genetic material (genes) are valid subjects of patents.[5] As of June 2015 the case was pending hearing in the High Court of Australia.[6] In October 2015 the Australian high court ruled that naturally occurring genes cannot be patented.[7]

Canada

Per Canada’s Patent Act, patents are granted by the Canadian Intellectual Property Office (CIPO). Patents will only be granted for “any new and useful art, process, machine, manufacture or composition of matter”, and improvements thereon.”[8] Patents will not be granted for “mere scientific principle or abstract theorem.”[9] In the case of pharmaceuticals, along with obtaining a patent, applicants must also seek approval from Health Canada. This process is governed by the Patented Medicines (Notice of Compliance) Regulations.[10]

In Harvard College v Canada (Commissioner of Patents), also referred to as the oncomouse case, the Supreme Court of Canada ruled that higher life forms were not patentable subject matter. Writing for the majority, Bastarache J. asserted that it was the role of Parliament to address whether higher life forms should be patentable.

Methods of medical treatment cannot be patented in Canada, however, medical use claims such as the use of an antibody for the treatment of a particular disease is patentable. Unlike many other jurisdictions, Canada allows for the patent of antibodies obtained through immunizing animals. Further, antigens which have not been previously characterized are also patentable.[11]

Gene patents confer a property right to the patent holder. While CIPO will grant patents for isolated gDNA and cDNA, the Supreme Court of Canada has not yet ruled on gene patentability. However, in 2016 the Children’s Hospital of Eastern Ontario (CHEO) sought to invalidate five Canadian patents held by Transgenomic. The gene patents covered the genes associated with, and genetic testing for Long QT syndrome. The parties reached a settlement. The patent was not invalidated, but, Transgenomic provided Canadian health institutions the right to test Canadians for the disease on a non-profit basis.[12][13] In Association for Molecular Pathology v Myriad, the United States Supreme Court determined that genes were unpatentable products of nature and that no intellectual property existed as nothing was invented.[14] Given this decision, the majority of Canadian Long QT syndrome tests were previously outsourced to the United States. After the settlement, domestic testing levels increased in Canada. The terms of the settlement could set a precedent for the repatriation of further genetic testing.[15]

Europe

European Union directive 98/44/EC (the Biotech Directive) reconciled the legislation of biological patents among certain countries under the jurisdiction of the European Patent Organisation.[1] It allows for the patenting of natural biological products, including gene sequences, as long as they are "isolated from [their] natural environment or produced by means of a technical process."[1]

The European Patent Office has ruled that European patents cannot be granted for processes that involve the destruction of human embryos.[16]

Japan

Under the umbrella of biotechnology, applications for patents on biological inventions are examined according to general guidelines for patents. In response to requests for additional clarity, the Japan Patent Office (JPO) set forth specific guidelines for biology-related inventions. Over the years, the JPO has continued to amend these guidelines to clarify their application to new technologies. These amendments have broadened the scope of patents within the biotechnology industry. The Japanese Patent Act requires that patented inventions be “industrially applicable”, i.e. they must have market or commercial potential. The JPO explicitly lists “medical activities” among inventions that fall outside the scope of industrially applicable inventions, meaning that methods of surgery, therapy, and the diagnosis of human diseases cannot be patented.[17]

United States

Main article: Biological patents in the United States

In the United States, up until 2013 natural biological substances themselves could have been patented (apart from any associated process or usage) if they were sufficiently "isolated" from their naturally occurring states. Prominent historical examples of such patents include those on adrenaline,[18] insulin,[19] vitamin B12,[20] and various genes.[21] A landmark ruling by the U.S. Supreme Court in June 2013 declared naturally occurring DNA sequences ineligible for patents.[22]

Ethics

The patenting of genes is a controversial issue in terms of bioethics. Some believe it is unethical to patent genetic material because it treats life as a commodity, or that it undermines the dignity of people and animals by allowing ownership of genes.[23] Some say that living materials occur naturally, and therefore cannot be patented.[24] The American Medical Association's stance is that gene patents inhibit access to genetic testing for patients and hinder research on genetic disease.[25]While some feel that a patent on living material is unethical, others[who?] believe that not allowing patents on biotechnological inventions would also be unethical. Supporters of this idea suggest that patents allow the public, as well as policy makers, to hold the owner of the patent(s) accountable. They favor biological patents because they require disclosure of information to the public.[26] Agreements such as the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) require members of the World Trade Organization (WTO) to have intellectual property protection laws in place for most biological innovation[why?], making it unlikely that many countries will prohibit patents on genes altogether.[24] Some [who?] say that patenting genes only commodifies life if a patent applies to an entire human being, arguing that[who?] patents on single body parts do not violate human dignity.[27]

Another area of controversy in genetic patenting is how gene samples are obtained. Prior consent is required to collect genetic samples, and collection of samples from people requires consent at the national and community levels as well as the individual level. Conflicts have resulted when consent is not obtained at all three levels. The question of benefit sharing also arises when obtaining genetic samples, specifically the potential responsibility of the collector to share any benefits or profits of the discoveries with the population or person from whom the sample came.[24]

The last major ethical issue involving gene patents is how the patents are used post-issuance. A major concern [who?] is that the use of patented materials and processes will be very expensive or even prohibited to some degree by conditions the patent owner sets.[28] Limiting access like this would directly impact agricultural institutes and university researchers, among others. Some [who?] fear that holders of biotechnology patents would exploit their rights in order to make larger profits, at the potential expense of farmers, healthcare patients, and other users of patented technologies. The ethics of using patents to increase profits are also debated. A typical argument in favor of biotech patents is that they enable companies to earn money that the companies in turn invest in further research. Without these patents, some worry that companies would no longer have the resources or motives to perform competitive, viable biotech research.[24]

See also

References

  1. ^ a b c d Sharples, Andrew (2011-03-23). "Gene Patents in Europe Relatively Stable Despite Uncertainty in the U.S." Genetic Engineering and Biotechnology News. Retrieved 2013-06-13.
  2. ^ Corderoy, Amy (February 15, 2013). "Landmark patent ruling over breast cancer gene BRCA1". Sydney Morning Herald. Retrieved June 14, 2013.
  3. ^ Corderoy, Amy (March 4, 2013). "BRCA1 gene patent ruling to be appealed". Sydney Morning Herald. Retrieved June 14, 2013.
  4. ^ Corderoy, Amy (June 14, 2013). "Companies can't patent genes, US court rules". Sydney Morning Herald. Retrieved June 14, 2013.
  5. ^ "Full Federal Court Upholds Gene Patents: D'Arcy v Myriad Genetics Inc [2014] FCAFC 115".
  6. ^ "D'Arcy v. Myriad Genetics Inc & Anor".
  7. ^ "Genes can't be patented, rules Australia's High Court". www.newscientist.com. 7 October 2015. Retrieved 27 September 2018.
  8. ^ Patent Act, R.S.C., 1985, c. P-4, s 2.
  9. ^ Patent Act, R.S.C., 1985, c. P-4, s 8.
  10. ^ Branch, Legislative Services (2017-09-21). "Consolidated federal laws of canada, Patented Medicines (Notice of Compliance) Regulations". laws-lois.justice.gc.ca. Retrieved 2021-04-10.
  11. ^ "Patenting Antibody-Based Biologics In Canada - Intellectual Property - Canada". www.mondaq.com. Retrieved 2021-04-10.
  12. ^ Lipkus, Nathaniel (2016). "Ground Breaking Settlement Changes Landscape for genetic medicine in Canada".{{cite web}}: CS1 maint: url-status (link)
  13. ^ "Patenting in Canada: Do These Genes Fit? | Blakes". blakes.com. Retrieved 2021-04-10.
  14. ^ LoTempio, Vincent (2017-04-18). "Patenting DNA: Does Canada Have it Right?". Vincent LoTempio | Registered Patent Attorney, Trademark, and Copyright | 1-800-866-0039. Retrieved 2021-04-10.
  15. ^ Ali-Khan, Sarah E.; Gold, E. Richard (2017-11). "Gene patents still alive and kicking: their impact on provision of genetic testing for long QT syndrome in the Canadian public health-care system". Genetics in Medicine. 19 (11): 1253–1259. doi:10.1038/gim.2017.43. ISSN 1530-0366. {{cite journal}}: Check date values in: |date= (help)
  16. ^ Decision G2/06 of 25 November 2008, WARF/Stem Cells (OJ EPO 2009, 306). See also Decision T 2221/10 of 4 February 2014, Culturing stem cells/TECHNION.
  17. ^ iPS Cell Technology Spurs Biological Patenting in Japan (PDF), World Intellectual Property Review, May 2013, archived from the original (PDF) on 2013-12-30, retrieved 2013-08-06
  18. ^ Crouch D (23 May 2012). "Guest Post: Myriad Misunderstanding of Parke-Davis v. Mulford". Patentlyo. Retrieved 26 Mar 2017.
  19. ^ "Why People with Diabetes Can't Buy Generic Insulin". Johns Hopkins Medicine. 18 Mar 2015. Retrieved 26 Mar 2017.
  20. ^ Zuhn D (9 Jun 2009). "Gene Patenting Debate Continues". PatentDocs: Biotech & Pharma Patent Law & News Blog. Retrieved 26 Mar 2017.
  21. ^ Cook-Deegan R, Heaney C (22 Sep 2010). "Patents in Genomics and Human Genetics". Annu Rev Genom Hum Genet. 11: 383–425. doi:10.1146/annurev-genom-082509-141811. PMC 2935940. PMID 20590431.
  22. ^ Association for Molecular Pathology v. Myriad Genetics, 569 U.S. ___ (2013) [1] Archived 2013-06-13 at the Wayback Machine
  23. ^ Dresser R. 1988. Ethical and Legal Issues in Patenting New Animal Life. Jurimetrics 28:399-435
  24. ^ a b c d Marchant GE. 2007. Genomics, Ethics, and Intellectual Property. Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices. Ch 1.5:29-38
  25. ^ "Gene Patenting".
  26. ^ Caulfield, TA; Gold, ER (2000). "Genetic Testing. Ethical Concerns, and the Role of Patent Law". Clinical Genetics. 57: 370–75. doi:10.1034/j.1399-0004.2000.570507.x.
  27. ^ Resnik, DB (2001). "DNA Patents and Human dignity". The Journal of Law, Medicine & Ethics. 29 (1): 152–165.
  28. ^ Andrews, LB (2000). "Genes and Patent Policy: Rethinking IP Rights". Nature Reviews Genetics. 3: 803–8. doi:10.1038/nrg909.

External links

  • Relevant legal provisions of the European Patent Convention:
    • Article 53(a) EPC: "Exceptions to patentability" (formerly Article 53a EPC 1973)
    • Rule 28 EPC: "Exceptions to patentability" (formerly Rule 23c EPC 1973), barring the patentability of, notably, "processes for cloning human beings" (Rule 28(a) EPC); "processes for modifying the germ line genetic identity of human beings" (Rule 28(b) EPC); and "uses of human embryos for industrial or commercial purposes" (Rule 28(c) EPC)
Retrieved from "https://en.wikipedia.org/w/index.php?title=Biological_patent&oldid=1017065005"