Biological patent

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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]

Contents

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] [6] In October 2015, the High Court of Australia 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. The OncoMouse was one of the first transgenic mice developed for use in cancer research, and the first mammal to be the subject of a patent application. Writing for the majority, Bastarache J. asserted that it was the role of Parliament to address whether higher life forms should be patentable. [11] In contrast, the United States Patent & Trademark Office issued the patents covering methods for providing a cell culture from a transgenic non-human anima to Harvard College. The patent was also allowed in Europe before eventually being revoked in 2006 for a failure to pay fees and file translations. [12] Although animals cannot be patented, Canada allows for the patent of antibodies obtained through immunizing animals. [13]

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. Further, antigens which have not been previously characterized are also patentable. [13]

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. [14] [15] In Association forMolecular 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. [16] 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. [17]

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. [18]

In the case of the oncomouse, the European Patent Office (EPO) allowed for the patent. The EPO's patent standards prohibits patents for inventions contrary to ordre public and morality. Patents also could not be issued for “animal varieties or essentially biological processes for the production of…animals”. The EPO undertook a utilitarian balancing test to make their determination on the ordre public and morality exceptions. They found that the likelihood of advancing cancer research and medical benefits outweighed potential suffering of the animal. The EPO also determined that the oncomouse was not an animal variety, and thus not excluded. An amended patent with claims limited to mice was issued. [12]

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. [19]

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, [20] insulin, [21] vitamin B12, [22] and various genes. [23] A landmark ruling by the U.S. Supreme Court in June 2013 declared naturally occurring DNA sequences ineligible for patents. [24]

Ethics

Patenting genes

Gene patents are a form of intellectual property which provide the patent holder with the exclusive right to exclude others from making, using, selling, or importing the invention for a specified period of time, typically twenty years. [25]

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. [26] Some say that living materials occur naturally, and therefore cannot be patented. [27] Along with concerns about the commodification of human life, the medical community has also warned that gene patents can inhibit the practice of medicine and progress of science. [28] For example, the American Medical Association's stance is that gene patents inhibit access to genetic testing for patients and hinder research on genetic disease. [29] A contrary position is that forbidding patents on biotechnological innovations 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 favour biological patents because they require disclosure of information to the public. [30]

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. The cost of research and development for innovations such as biologics is extremely high. Such protection regimes help to protect innovators from free-riders. [31] Based on these provisions, it is unlikely that many countries will prohibit patents on genes altogether. [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. [27]

The last major ethical issue involving gene patents is how the patents are used post-issuance. 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. There is potential that holders of biotechnology patents will 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 favour 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. [27]

Patents relating to the diagnosis, treatment and prevention of COVID-19

In light of the COVID-19 pandemic, several companies around the world raced to develop testing, vaccines, and cures for COVID-19. This required a substantial investment of time and money, and patents were used to protect this innovation. Patent holders are able to refuse licensing for third-parties to manufacture the patented medicine, creating a monopoly for the patent holder and lower supply levels. Furthermore, patent-holders control pricing for licensing and access. This patent-regime has the potential to limit access to life-saving vaccines and cures, especially for those in poor countries. [32] Pharmaceutical industry executives diminished the idea of sharing intellectual property, arguing that companies would have no incentive to innovate if their patents were considered worthless during a pandemic. However, health advocates argue that taxpayers substantially contributed to the development of the vaccines and they should thus be regarded as global public goods. [33]

A lack of access to medication and vaccines is especially problematic during a global pandemic. In April 2020, the Director General of the World Health Organization supported a proposal by Carlos Alvarado, to create a pool of rights for testing medicine and vaccine with free access or affordable licensing terms for all countries. He asked all companies, countries, and research institutions to support “open data, open science, and open collaboration.” He warned that poorer countries would be the hardest hit by the pandemic and failure to assist could prolong the pandemic. [34]

Instead, patent-holders have undertaken case-by-case negotiations to form exclusive licensing contracts. This approach is criticized by the global health community as being too slow, especially where variants are concerned. Further, some poor countries such as South Africa paid more per dose for vaccines than rich countries and the European Union. [33]

One potential remedy is for States to implement compulsory patent licenses. These licenses give the State power to grant permission to third parties to formulate generic versions of the medicine for use in that state. This is beneficial to states with lesser buying power. However, such initiatives are not popular with industry. [35] In March 2020, Israel became the first country to issue a COVID-19 related compulsory license under Section 104 of the Patent Statute. This provision allowed Israel to undermine the patent regime for national defence purposes. No consultation with the patent-holder is required and there is no right for judicial review. The permit allowed Israel to import a generic version of Kaletra from India to treat COVID patients. [36] Canada's Bill C-13, which came into force in March 2020, allows the Commissioner of Patents to allow the country to produce, sell, and use a patented invention if the Federal Minister of Health deems there to be a public health emergency. Although no consultation with patent-holders is required, the country will compensate them with an amount “the Commissioner considers to be adequate remuneration in the circumstances.” [36] Germany also has allowed its Federal Health Minister to take executive action to make medicines available in return for adequate compensation. France amended their patent law to preclude the need for amicable negotiations with patent-holders where urgency exists. [37]

These issues may also be addressed through use of voluntary licensing proposals. Alternatively, public pressure on patent holders may play a significant role. For example, Labrador Diagnostics LLC, which purchased patents from the defunct Theranos, brought an action, and sought an injunction against BioFire Diagnostics for making COVID-19 diagnostic tests. The action was abandoned after public backlash. [35]

See also

Related Research Articles

<span class="mw-page-title-main">Patent</span> Type of legal protection for an invention

A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention. In most countries, patent rights fall under private law and the patent holder must sue someone infringing the patent in order to enforce their rights.

A software patent is a patent on a piece of software, such as a computer program, libraries, user interface, or algorithm.

The patentability of software, computer programs and computer-implemented inventions under the European Patent Convention (EPC) is the extent to which subject matter in these fields is patentable under the Convention on the Grant of European Patents of October 5, 1973. The subject also includes the question of whether European patents granted by the European Patent Office (EPO) in these fields (sometimes called "software patents") are regarded as valid by national courts.

<span class="mw-page-title-main">European Patent Office</span> One of the two organs of the European Patent Organisation

The European Patent Office (EPO) is one of the two organs of the European Patent Organisation (EPOrg), the other being the Administrative Council. The EPO acts as executive body for the organisation while the Administrative Council acts as its supervisory body as well as, to a limited extent, its legislative body. The actual legislative power to revise the European Patent Convention lies with the Contracting States themselves when meeting at a Conference of the Contracting States.

The OncoMouse or Harvard mouse is a type of laboratory mouse that has been genetically modified using modifications designed by Philip Leder and Timothy A Stewart of Harvard University to carry a specific gene called an activated oncogene. The activated oncogene significantly increases the mouse's susceptibility to cancer, and thus makes the mouse a suitable model for cancer research.

As with all utility patents in the United States, a biological patent provides the patent holder with the right to exclude others from making, using, selling, or importing the claimed invention or discovery in biology for a limited period of time - for patents filed after 1998, 20 years from the filing date.

Novelty is one of the patentability requirement for a patent claim, whose purpose is to prevent issuing patents on known things, i.e. to prevent public knowledge from being taken away from the public domain.

<span class="mw-page-title-main">Directive on the legal protection of biotechnological inventions</span> European Union directive in the field of patent law

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions is a European Union directive in the field of patent law, made under the internal market provisions of the Treaty of Rome. It was intended to harmonise the laws of Member States regarding the patentability of biotechnological inventions, including plant varieties and human genes.

Patentable, statutory or patent-eligible subject matter is subject matter of an invention that is considered appropriate for patent protection in a given jurisdiction. The laws and practices of many countries stipulate that certain types of inventions should be denied patent protection. Together with criteria such as novelty, inventive step or nonobviousness, utility, and industrial applicability, which differ from country to country, the question of whether a particular subject matter is patentable is one of the substantive requirements for patentability.

In patent law, an inventor is the person, or persons in United States patent law, who contribute to the claims of a patentable invention. In some patent law frameworks, however, such as in the European Patent Convention (EPC) and its case law, no explicit, accurate definition of who exactly is an inventor is provided. The definition may slightly vary from one European country to another. Inventorship is generally not considered to be a patentability criterion under European patent law.

There are four overriding requirements for a patent to be granted under United Kingdom patent law. Firstly, there must have been an invention. That invention must be novel, inventive and susceptible of industrial application.

This is a list of legal terms relating to patents and patent law. A patent is not a right to practice or use the invention claimed therein, but a territorial right to exclude others from commercially exploiting the invention, granted to an inventor or their successor in rights in exchange to a public disclosure of the invention.

<span class="mw-page-title-main">Myriad Genetics</span> American biotechnology company

Myriad Genetics, Inc. is an American genetic testing and precision medicine company based in Salt Lake City, Utah, United States. Myriad employs a number of proprietary technologies that permit doctors and patients to understand the genetic basis of human disease and the role that genes play in the onset, progression and treatment of disease. This information is used to guide the development of new products that assess an individual's risk for developing disease later in life, identify a patient's likelihood of responding to a particular drug therapy, assess a patient's risk of disease progression and disease recurrence, and measure disease activity.

<span class="mw-page-title-main">TRIPS Agreement</span> International treaty on intellectual property protections

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international legal agreement between all the member nations of the World Trade Organization (WTO). It establishes minimum standards for the regulation by national governments of different forms of intellectual property (IP) as applied to nationals of other WTO member nations. TRIPS was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) between 1989 and 1990 and is administered by the WTO.

In United States patent law, a composition of matter is one of the four principal categories of things that may be patented. The other three are a process, a machine, and an article of manufacture. In United States patent law, that same terminology has been in use since the first patent act in 1790.

On 29 March 2010, the US District Court for the Southern District of New York found several of the patent claims on the BRCA1 and BRCA2 breast cancer genes held by Myriad Genetics to be invalid. The patents were initially issued on the basis that the genes were isolated and purified to a non-naturally occurring state, however the court found, amongst other things, that the purification was not markedly different from a product of nature and thus was not patentable. The ruling may have implications for holders of other gene patents and the patentability of other naturally occurring substances. It has the potential to directly affect the operation of the healthcare and medical research industries, particularly with regards to cancer treatment and prevention, and may alter the accessibility of such therapies to patients.

Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), was a Supreme Court case, which decided that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” However, as a "bizarre conciliatory prize" the Court allowed patenting of complementary DNA, which contains exactly the same protein-coding base pair sequence as the natural DNA, albeit with introns removed.

<span class="mw-page-title-main">Jorge L. Contreras</span>

Jorge L. Contreras is an American legal scholar and attorney who is recognized as a leading global authority on intellectual property law, technical standardization and the law and policy of human genomics.

<span class="mw-page-title-main">Acuitas Therapeutics</span> Canadian biotechnology company

Acuitas Therapeutics Inc. is a Canadian biotechnology company based in Vancouver, British Columbia. The company was established in February 2009 to specialize in the development of delivery systems for nucleic acid therapeutics based on lipid nanoparticle (LNP) technology, a key component of the mRNA vaccines deployed for COVID-19.

<span class="mw-page-title-main">Patentable subject matter in the United States</span>

Patentable subject matter in the United States is governed by 35 U.S.C. 101. The current patentable subject matter practice in the U.S. is very different from the corresponding practices by WIPO/Patent Cooperation Treaty and by the European Patent Office, and it is considered to be broader in general.

References

  1. 1 2 3 4 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. ↑ "Tim Vines, Thomas Faunce, Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65: Should Gene Patent Monopolies Trump Public Health?, Journal of Law and Medicine". SSRN   2333294.
  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. ↑ Harvard College v. Canada (Commissioner of Patents), 2002 SCC 76
  12. 1 2 "Bioethics and Patent Law: The Case of the Oncomouse". www.wipo.int. Retrieved 2021-04-10.
  13. 1 2 "Patenting Antibody-Based Biologics In Canada - Intellectual Property - Canada". www.mondaq.com. Retrieved 2021-04-10.
  14. ↑ Lipkus, Nathaniel (2016). "Ground Breaking Settlement Changes Landscape for genetic medicine in Canada". Archived from the original on 2021-04-10.
  15. ↑ "Patenting in Canada: Do These Genes Fit? | Blakes". blakes.com. Retrieved 2021-04-10.
  16. ↑ 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.
  17. ↑ Ali-Khan, Sarah E.; Gold, E. Richard (November 2017). "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. PMC   5682567 . PMID   28492533.
  18. ↑ 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.
  19. ↑ 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
  20. ↑ Crouch D (23 May 2012). "Guest Post: Myriad Misunderstanding of Parke-Davis v. Mulford". Patentlyo. Retrieved 26 Mar 2017.
  21. ↑ "Why People with Diabetes Can't Buy Generic Insulin". Johns Hopkins Medicine. 18 Mar 2015. Retrieved 26 Mar 2017.
  22. ↑ Zuhn D (9 Jun 2009). "Gene Patenting Debate Continues". PatentDocs: Biotech & Pharma Patent Law & News Blog. Retrieved 26 Mar 2017.
  23. ↑ 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.
  24. ↑ Association for Molecular Pathology v. Myriad Genetics , 569 U.S. ___ (2013) Archived 2013-06-13 at the Wayback Machine
  25. ↑ Cook-Deegan, Robert; MD. "Gene Patents". The Hastings Center. Archived from the original on 2021-04-17. Retrieved 2021-04-17.
  26. ↑ Dresser R. 1988. Ethical and Legal Issues in Patenting New Animal Life. Jurimetrics 28:399-435
  27. 1 2 3 4 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
  28. 1 2 Andrews, LB (2000). "Genes and Patent Policy: Rethinking IP Rights". Nature Reviews Genetics. 3 (10): 803–8. doi:10.1038/nrg909. PMID   12360238. S2CID   13822192.
  29. ↑ "Gene Patenting".
  30. ↑ Caulfield, TA; Gold, ER (2000). "Genetic Testing. Ethical Concerns, and the Role of Patent Law". Clinical Genetics. 57 (5): 370–75. doi:10.1034/j.1399-0004.2000.570507.x. PMID   10852371. S2CID   40855297.
  31. ↑ Reighman, J (1995). "Universal Minimum Standards of Intellectual Property Protection under the TRIPS Component of the WTO Agreement". The International Lawyer. 29: 345.
  32. ↑ King, Mike (2020-08-03). "Patents, private governance and access to vaccines and treatments for Covid-19". Journal of Medical Ethics blog. Retrieved 2021-04-17.
  33. 1 2 "Is a vaccine a private patent or a global public good?". Christian Science Monitor. 2021-03-01. ISSN   0882-7729 . Retrieved 2021-04-17.
  34. ↑ "WHO Director-General's opening remarks at the media briefing on COVID-19 - 6 April 2020". www.who.int. Retrieved 2021-04-17.
  35. 1 2 Zohny, Hazem (2020-04-16). "Covid-19, Patents & Healthcare: The Need for A (Bio)ethics Space within Patent Law". Journal of Medical Ethics blog. Retrieved 2021-04-17.
  36. 1 2 "The key covid-19 compulsory licensing developments so far | IAM". www.iam-media.com. Retrieved 2021-04-17.
  37. ↑ "Vaccines and patents: how self-interest and artificial scarcity weaken human solidarity". British Politics and Policy at LSE. 2021-02-09. Retrieved 2021-04-17.
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