Written by: Jocelyn Bosse
Advisory: This article discusses major plot points from Season One of Orphan Black.
CONTENTS
1 Introduction
2 Jurisdiction
3 Myth One: “Patents are Forever”
4 Myth Two: “Anything can be Patented”
5 Myth Three: “Patents are Secret”
6 Patents and National Security
7 Ownership of Humans
8 Legality of Cloning
1 Introduction
Many ethical and legal issues which arise from recent technological and scientific advances are explored in the cult television show, Orphan Black.[1] The protagonist, Sarah Manning, discovers that she is one of an unknown number of illegal clones, and in her quest for answers, grapples with questions of identity and body autonomy. The issues are brought to a head in the season one finale, in which evolutionary developmental biologist (and one of the clones), Cosima Niehaus, deciphers a synthetic DNA sequence in her genome to reveal a message: THIS ORGANISM AND DERIVATIVE GENETIC MATERIAL IS RESTRICTED INTELLECTUAL PROPERTY.[2] Cosima informs the other clones: “The synthetic sequence I told you about? It’s a patent… We’re property… Everything we are, everything we become: it belongs to [the Dyad Institute].”
Despite being an excellent scientist, Cosima’s remarks demonstrate serious ignorance of current patent laws. Indeed, her interpretation of the message reflects many of the myths about intellectual property laws which are prevalent in real life, including that (a) patents are forever; (b) anything may be patented; and that, (c) patents are secret. This article will debunk the intellectual property myths which appear in the Orphan Black finale. Pursuant to some remarks by Cosima’s lab partner in season two, the article will conclude with a discussion about the prevalent use of government secrecy orders over patents for the protection of national security, and some final notes about physical property rights and the legality of human cloning.
2 Jurisdiction
Intellectual property – like all law – varies between countries.[3] Though filmed in Canada, the creators of Orphan Black have indicated that the show takes place in “Generica” – a hybrid of Canada and the United States of America.[4] However, the question of jurisdiction is further complicated by the existence of clones across the globe, including England, Germany, Ukraine, Italy, Finland, Austria, France, and probably other nations.
Ever since the establishment of the World Intellectual Property Organization (WIPO) in 1967,[5] there has been considerable harmonisation of patents laws across the globe. Despite the ambiguity of the show’s jurisdiction, we can still make overall statements about the legal position of the clones in Orphan Black by reference to international law and the patent laws of relevant countries (especially the USA, Canada, the EU, Australia, and New Zealand).
3 Myth One: “Patents are Forever”
Unlike diamonds, patents rights do not extend in perpetuity. Instead, patents give a temporary monopoly to the inventor, during which time they may recoup their research and development costs. Upon expiration of the patent, the invention enters the public domain.[6]
The first patents under the Statute of Monopolies 1624 (UK) were granted for fourteen years, but since the signing of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (‘TRIPS’), patents have a non-renewable term of twenty years.[7] While term extensions are available under rare circumstances (e.g. delay in the application process in Canada, or the five-year pharmaceutical extensions in Australia), none of those exceptions would apply to human clones.
In Canada, the 20-year term was introduced in October 1989;[8] however, the Orphan Black clones were born in 1984,[9] so any patents would have been subject to the previous rule that patents expired after 17 years. Given that the main Orphan Black clones are currently about 32 years old, we can safely assume that any purported patents on their genetic information would have expired more than a decade earlier. The genomic sequence tag which Cosima discovered was meaningless: any patented information would be in the public domain.
4 Myth Two: “Anything can be Patented”
Under s 6 of the Statute of Monopolies 1624 (UK), patents must not be “contrary to the law, nor mischievous to the state… or generally inconvenient.” As for modern patent laws, Article 27 of the TRIPS Agreement allows countries to exclude patentable subject matter in order to protect “ordre public” and morality; this includes, for example, protection of human, animal or plant life or health, and the environment. Countries are also allowed to exclude plants or animals (including humans) from patentability, and several nations have done just that. The TRIPS terminology was borrowed from borrowed from Article 53(a) of the European Patent Convention (‘EPC’), and the European Board of Appeals defined the concept of ordre public as covering the protection of public security and integrity of individuals as part of society.[10] The EU Directive on Biotechnological Inventions[11] clearly prohibits patents on human clones:
Article 5
1. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions…
Article 6
1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation.
2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable:
(a) processes for cloning human beings;
(b) processes for modifying the germ line genetic identity of human beings;
(c) uses of human embryos for industrial or commercial purposes; …
The Canadian Supreme Court has held that higher life forms (defined as multicellular organisms, including plants, mice, and humans) are not patentable subject matter.[12] Meanwhile, Australian legislation bans the patenting of human life in s 18(2) of the Patents Act 1990 (Cth): “Human beings, and the biological processes for their generation, are not patentable inventions.” The Deputy Commissioner of Patents has held that s18(2) extends to any entity which might reasonably claim the status of a human being, so the genetically modified clones would still fall within that exception.[13] Likewise, human clones are excluded under s 15 of the New Zealand Patents Act 2013 for reasons of ordre public and morality.[14]
The position is less concrete in the United States. The US Patent and Trademark Office has granted a patent in 2001 for a method for producing embryos from unfertilised eggs, to create cloned livestock.[15] Despite concerns that the patent would extend in to human cloning, the USPTO maintained a policy of refusing patents for human-related cloning on the grounds of a purported violation of the 13th amendment to the US Constitution, which prohibits slavery.[16] Although the 13th amendment is no longer invoked, patents related to human cloning are still not granted by the USPTO.
As such, the Orphan Black clones would definitely not be subject to patents in the EU, Australia, New Zealand or Canada. The current USPTO policy also means that the Dyad Institute could not have obtained patents over the clones in the United States.
5 Myth Three: “Patents are Secret”
The original “letters patent” were developed in the 1600s as a trade-off between inventors and the Crown: the British monarch would grant a monopoly over the invention, while the details of the invention had to be fully disclosed for the benefit of society.[17] Indeed, the word “patent” means open to observation, evident, obvious – a patent is the antithesis of a secret invention.
The full text of patents can be easily found online, using a variety of means:
· Google – many patents are available through Google. For example, the patent for entertaining a cat with a laser pointer (don’t panic, it lapsed back in 2007) is publicly available here (https://www.google.com/patents/US5443036).
· International – the UN World Intellectual Property Organisation (WIPO) has a database of patent applications via Patentscope (http://www.wipo.int/patentscope/en/). Note, however, that there is no such thing as an “international patent” – WIPO merely facilitates the application process across different countries. Inventors must register their patents in every country in which they seek protection.
· Canada – the Canadian Intellectual Property Office (CIPO) allows you to freely search their patents database here (http://www.ic.gc.ca/opic-cipo/cpd/eng/search/basic.html).
· United States of America – the US Patent and Trademark Office has a searchable register here (http://patft.uspto.gov/netahtml/PTO/search-bool.html).
· Australia – the database in found on the IP Australia website (http://pericles.ipaustralia.gov.au/ols/auspat/quickSearch.do)
· New Zealand – the Intellectual Property Office of New Zealand has their database here (https://www.iponz.govt.nz/about-ip/patents/search/).
· Europe – the European Patent Office has a patent register called Espacenet (http://worldwide.espacenet.com/?locale=en_EP).
Consequently, if the Dyad Institute had patented the genetic information of the Orphan Black clones, it would be freely accessible on the patent register of each country where a patent was held, and probably available on Google. Cosima could have avoided many hours of scientific research into her own genome by simply looking up the patent numbers on the USPTO or CIPO Registers. Only one category of patents can be kept secret: those which are subject to secrecy orders in the interests of national defence.
6 Patents and National Security
In Season Two of Orphan Black, Cosima discusses the patents with her lab partner, who remarks that “The Dyad was just a contractor. It could be a secret military patent.” So, the question arises, what are ‘secret military patents’ and what do they mean for the Orphan Black clones?
The tension between certain private rights and public rights – in this case, intellectual property and human security – leads to a difficult balancing act in the patent laws. Although disclosure is one of the hallmark principles of patent law, publication of the details of certain inventions can pose risks to national security, especially if they relate to chemical, biological or nuclear weapons.[18] Governments are often concerned that the information disclosed in patent documents will end up in the “wrong hands,” particularly patents on weaponry and explosives which could be used by terrorist groups. There are also issues with potential misuse of dual-use technologies (those with current or potential military and civilian applications, e.g. ammonium nitrate, which could be used to produce propellant for ballistic missiles, but is mainly used in the manufacture of fertilisers).[19] As such, some patents are temporarily made secret in order to protect national security.
International Secrecy Orders
Article 73 of the TRIPS Agreement sets out “Security Exceptions” and provides that Member states need not furnish information where disclosure would be contrary to its essential security interests. Likewise, Article 4 of the Patent Law Treaty 2000 (‘PLT’) stipulates that “nothing in this Treaty and the Regulations shall limit the freedom of a Contracting Party to take any action it deems necessary for the preservation of essential security interests.”[20]
Secrecy Orders in the USA
During World War I, the US Congress authorised the Patent and Trademark Office to temporarily classify certain defence-related patents in the interests on national security.[21] The legislation was extended during World War II to allow the Commissioner of Patents to prevent publication or disclosure of a patent where it might be “detrimental to the public safety or defence,” as well as to compensate the applicant if the subject matter of the patent is used by the military.
The laws were eventually replaced with the Invention Secrecy Act 1951 (US), which allows the American Federal Government to issue secrecy orders via the Commissioner of Patents, which are subject to an annual renewal process, except in times of war or national emergency. The use of these orders has been on the rise:[22] 5,445 secrecy orders were in effect in 2013, and 5,579 in 2015.[23] For example, Juliet Marine Systems developed a stealth boat which was unexpectedly made subject to a secrecy order in October 2009, thereby forbidding them from filing patents overseas or disclosing anything to potential investors until the order was lifted two years later.[24]
Other Jurisdictions
In Canada, the Minister of National Defence may take ownership of a patent for “any invention in instruments or munitions of war,”[25] and has the power to make the invention secret under s 20(5). The inventor(s) become(s) subject to s 4 of the Security of Information Act, and are thereby banned from communication of any details of the invention without the authority of the Minister of National Defence. Under s 20(9) of the Patents Act, the information may be kept secret until the expiration of the patent, or until it is waived by the Minister.
The Australian Department of Defence is empowered under s 152 of the Patents Act 1990 (Cth) to prohibit the publication of the details of a patent application, at which point it must be handled by a patent examiner with the requisite security clearance.[26] The prohibition order may remain in force until the expiration of the patent, unless it is revoked by the Department of Defence. Similar provisions can be found in ss 132-134 of the New Zealand Patents Act 2013.
However, while Cosima’s lab partner raised a very interesting point about the potential use of secrecy orders over patents, the fact remains that human clones are not patentable (and if they were, the patents would have expired). There can be no secrecy order if there is no valid patent to begin with.
7 Ownership of Humans
As far as tangible property rights are concerned, the message in Cosima’s genome asserted proprietary rights over her body, and any derivative material. Since the abolition of slavery, there has been a strict legal separation of property rights and personhood. In fact, property rights over human body parts have arguably been excluded from legal protection for two millennia: the Roman jurist, Ulpian, gave the maxim dominus membrorum suorum nemo videtur (“no one is the owner of their own limbs”), which has been interpreted in the English law to mean that a living human body cannot be the object of property rights.[27] In words of Justice Edelman of the Federal Court of Australia:
“Whatever meaning is given to ‘property’, it is independent of personhood. The antithesis of ‘property’ is personhood. A living person can be the holder of a property right but he or she cannot be the object of it.”[28]
The Romans would also consider the deceased clones to be res extra patrimonium and res extra commercium; a corpse is generally inviolable and unsaleable.[29] In modern jurisprudence, the Supreme Court of California has affirmed the Roman principles: the Court in Moore v Regents of the University of California[30] rejected a property claim over Moore’s own body parts (his spleen, blood, skin, and sperm) which had been used without consent for commercial purposes. Justice Panelli, in the plurality judgment, remarked:[31]
“Neither the Court of Appeal's opinion, the parties' briefs, nor our research discloses a case holding that a person retains a sufficient interest in excised cells to support a cause of action for conversion. We do not find this surprising, since the laws governing such things as human tissues, transplantable organs, blood, fetuses, pituitary glands, corneal tissue, and dead bodies deal with human biological materials as objects sui generis, regulating their disposition to achieve policy goals rather than abandoning them to the general law of personal property… The ramifications of recognizing and enforcing a property interest in body tissues are not known, but are greatly feared for the effect on human dignity of a marketplace in human body parts, the impact on research and development of competitive bidding for such materials, and the exposure of researchers to potentially limitless and uncharted tort liability.”
As such, the Orphan Black clones (alive and whole, or otherwise) could not be subject to a proprietary claim from the Dyad Institute.
8 Legality of Cloning
The law is concerned with two main types of cloning: (i) therapeutic cloning, which is the use of clonally propagated stem cells for the purposes of scientific research and medical treatment, and (ii) reproductive cloning, in which a cloned embryo is implanted into a womb.[32] While therapeutical cloning is legal in many states, the Orphan Black clones were created by reproductive cloning, which is generally illegal.
In March 2005, the United Nations General Assembly adopted the Declaration on Human Cloning, which called on members to adopt all measures necessary to prohibit human cloning inasmuch as it is incompatible with human dignity and the protection of human life.[33] The Declaration also called upon members to prohibit the application of genetic engineering techniques that may be contrary to human dignity and to prevent the exploitation of women in the application of life sciences. However, the Declaration has no binding authority over UN members, and would have no impact upon the legality of producing the Orphan Black clones.
Article 3(d) of the Charter of Fundamental Rights of the European Union explicitly prohibits reproductive human cloning. France, Germany, Austria, Italy and Russia have completely banned human cloning, to name a few. In the United Kingdom, reproductive cloning is banned,[34] while therapeutic cloning has been tightly regulated by the Human Fertilisation and Embryology Authority since 1990.[35] The Dyad Institute could not have (legally) produced the Orphan Black clones in the United Kingdom, nor any other EU member states. Furthermore, the Council of Europe has specifically banned reproductive cloning in the Convention on Human Rights with Regard to Biomedicine 1997, which held to apply in European countries where no legislation has been passed to address the legality of human cloning.[36]
Canada has a complete ban on human cloning, both therapeutic and reproductive, pursuant to s 5(1)(a) of the Assisted Human Reproduction Act 2004. As such, the Orphan Black clones could not have been created there. Reproductive cloning is also banned in Australia under the Prohibition of Human Cloning for Reproduction Act 2002 (Cth). Although the desire to improve scientific research and medical treatment meant that the ban on therapeutic cloning was lifted in 2006,[37] the reproductive cloning conducted by the Dyad Institute would still be illegal in Australia.[38]
The picture is more complicated in the United States, where the Congress has repeatedly failed to enact legislation to address human cloning, and there are no Federal laws with respect to human cloning.[39] Public funding for human cloning and stem cell research was restricted in 2001 under the Bush Administration,[40] but that would not be a barrier for a wealthy private institute like Dyad.[41] While fifteen states ban reproductive cloning,[42] the Dyad Institute could have produced the Orphan Black clones in other parts of the country. Nevertheless, the Dyad Institute would have no legal control over Sarah Manning, Cosima Niehaus, or the other clones. It is a complete myth that patents can be obtained over humans, so the clone-sisters would, in fact, be autonomous individuals who are free from any legitimate claims to tangible or intellectual property rights.
The mass-production of human clones by a malevolent corporation might still be pure science fiction, but the legal questions raised by Orphan Black are no less important to the real world. Many countries – particularly the United States – are still struggling to pass legislation which adequately regulates therapeutic and reproductive cloning, which has significant consequences for medical research and assisted reproduction. Furthermore, the use of government secrecy orders illustrates the difficult balancing act between the protection of national security, and the promotion of private innovation. While the fictional clones in Orphan Black are (incorrectly) concerned by the Dyad Institute’s intellectual property rights over their bodies, real people across the globe stand to benefit, or suffer, from the enforcement of poorly-understood patent laws, and the legislative control of human cloning.
[1] BBC America, Orphan Black (16 June 2016) <http://www.bbcamerica.com/shows/orphan-black/>. The first season aired in March-June 2013.
[2] Tim Surette, Orphan Black Season 1 Finale Review: Same, Same But Different (2 June 2013) TV.com <http://www.tv.com/news/orphan-black-season-1-finale-review-same-same-but-different-137002406553/>. The DNA tag was based on ASCII (American Standard Code for Information Interchange) coded basepairs.
[3] Article 4bis, Paris Convention for the Protection of Industrial Property 1883.
[4] Marsha Lederman, ‘How Canada is becoming the sci-fi nation’, The Globe and Mail (online), 13 April 2013 <http://www.theglobeandmail.com/arts/television/how-canada-is-becoming-the-sci-fi-nation/article11157191/?page=2>.
[5] Convention Establishing the World Intellectual Property Organization, signed at Stockholm on 14 July 1967. WIPO administers the Convention for the Protection of Industrial Property 1883, which deals with patents and related rights.
[6] Lionel Bently and Brad Sherman, Intellectual Property Law (Oxford University Press, 3rd ed, 2009) 335.
[7] Article 33: “The term of protection available shall not end before the expiration of a period of twenty years counted from the filing date.” See also: Patents Act 1990 (Cth) s 67.
[8] Patent Act, RSC 1985, c P-4, s 44.
[9] Orphan Black Wiki, Sarah Manning (21 June 2016) <http://orphanblack.wikia.com/wiki/Sarah>.
[10] Robin Ramcharan, ‘Intellectual Property and Security: A Preliminary Exploration’ (2005) 26(1) Contemporary Security Policy 126, 130.
[11] Council Directive 98/44/EC on the Legal Protection of Biotechnological Inventions [1998] OJ L 213/13, art 5-6.
[12] Harvard College v Canada (Commissioner of Patents) [2002] 4 SCR 45 [155].
[13] See Re Luminis Pty Ltd & Fertilitescentrum AB (2004) 62 IPR 420.
[14] Relevantly, the New Zealand legislation lists the following exceptions: (i) a process for cloning human beings, (ii) a process for modifying the germ line genetic identity of human beings, and (iii) the use of human embryos for industrial or commercial purposes.
[15] US 6211429 B1 “Complete oocyte activation using an oocyte-modifying agent and a reducing agent” (Priority Date: 18 June 1997) <http://google.com/patents/US6211429>.
[16] Andrew Pollack, ‘Debate on Human Cloning Turns to Patents’, The New York Times (online), 17 May 2002 <http://www.nytimes.com/2002/05/17/us/debate-on-human-cloning-turns-to-patents.html>.
[17] Mark J Davison, Ann L Monotti and Leanne Wiseman, Australian Intellectual Property Law (Cambridge University Press, 2nd ed, 2012) 409.
[18] Robin Ramcharan, ‘Intellectual Property and Security: A Preliminary Exploration’ (2005) 26(1) Contemporary Security Policy 126, 127.
[19] Ibid 133.
[20] The treaty entered into force in 2005, though Canada and Germany have not yet acceded.
[21] Act of 6 October 1917, ch 95, § 42, 40 Stat 394.
[22] G W Schultz, ‘Government Secrecy Orders on Patents have Stifled more than 5000 Inventions’ <https://www.wired.com/2013/04/gov-secrecy-orders-on-patents/>. There is a heavy penalty upon those who breach a secrecy order: a fine of up to $10,000 or up to 2 years imprisonment.
[23] Federation of American Scientists, Invention Secrecy Activity (as reported by the Patent & Trademark Office) <http://www.fas.org/sgp/othergov/invention/stats.html>.
[24] Caroline Winter, ‘This Stealth Attack Boat May Be Too Innovative for the Pentagon’ (22 August 2014) Bloomberg Businessweek <http://www.bloomberg.com/news/articles/2014-08-21/juliet-marines-ghost-boat-will-be-hard-sell-to-u-dot-s-dot-navy>.
[25] Patent Act, RSC 1985, c P-4, s 20(1).
[26] Bill McFarlane, ‘How to Keep a Secret: Prohibition Orders on Patents’ (25 August 2012) <http://www.mondaq.com/australia/x/193566/Patent/how+to+register+a+patent>.
[27] R v Bentham [2005] UKHL 18 [14] (Lord Rodger), citing D.9.2.13pr (Ulpian). Following the Australian High Court decision of Doodeward v Spence (1908) 6 CLR 406, the principle has seen modern adaptation in cases which concern the posthumous use of sperm samples for in vitro fertilization (IVF), which eroded the previous hostility of the English courts towards consideration of human biological material as “property”: Jonathan Yearworth & Ors v North Bristol NHS Trust [2009] 2 All ER 986; for an American example, see Hecht v. Superior Court of Los Angeles County (1993) 20 Cal. Rptr. 2d 275.
[28] James Edelman, ‘Property Rights to our Bodies and their Products’ (2015) 39(2) University of Western Australia Law Review 47, 53.
[29] Henk AMJ Ten Have and Jos VM Welie (eds), Ownership of the Human Body: Philosophical Considerations on the Use of the Human Body and its Parts in Healthcare (Kluwer Academic Publishers, 1998) 69.
[30] (1990) 51 Cal. 3d 120.
[31] The opinion from Panelli J was joined by Lucas, Eagleson and Kennard JJ, Arabian J concurring.
[32] See Australian Stem Cell Foundation, ‘Fact Sheet 4: Therapeutic Cloning’ (July 2010) <http://www.stemcellfoundation.net.au/docs/fact-sheets/fact-sheet-4---therapeutic-cloning-(somatic-cell-nuclear-transfer).pdf>.
[33] General Assembly Adopts United Nations Declaration on Human Cloning by Vote of 84-34-37’ (8 March 2005) <http://www.un.org/press/en/2005/ga10333.doc.htm>.
[34] Human Reproductive Cloning Act 2001 (UK), which was repealed and superseded by the Human Fertilisation and Embryology Act 2008 (UK). Section 3 of the 2008 Act forbids reproductive cloning.
[35] Ruth Deech, ‘Regulation of therapeutic cloning in the UK’ (2002) 5(1) Reproductive BioMedicine Online 7, 9. The cloning regulations under the Human Fertilisation and Embryology Act 1990 (UK) were challenged in the UK High Court by the ProLife Alliance in November 2001, which triggered the enactment of emergency legislation. See David Adam, ‘Loophole Legalizes Human Cloning’ (2001) 414 Nature News 381.
[36] The Convention is relevant, for example, in The Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings was passed in 2001, and Article 1 prohibits “any intervention seeking to create a human being genetically identical to another human being alive or dead.”
[37] Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 (Cth).
[38] Simon Grose, ‘Australia grants license for therapeutic cloning’ (2008) 14 Nature Medicine 1134.
[39] Many bills have been introduced, e.g. HR4808 - Stem Cell Research Advancement Act of 2009, but never passed. Issues related to abortion have been a key barrier to the successful enactment of human cloning legislation over the years, while the strong lobbying efforts of the biotechnology industry was partially behind the failure to enact laws in the late 1990s. The Food and Drug Administration has claimed authority over reproductive cloning, but it seems unlikely that its purported regulatory jurisdiction would stand up to legal challenge. See <http://www.npr.org/news/specials/cloning/faq_blanknav.html>.
[40] The 2001 statement was supplemented by Executive Order 13435 of June 20, 2007.
[41] Stem cell research funding was restored in 2009 under the Obama Administration: President Barack Obama issued Executive Order 13505 “Removing Barriers to Responsible Scientific Research Involving Human Stem Cells” on 9 March 2009. The Order made no comment on human cloning.
[42] Reproductive cloning is banned in Arkansas, California, Connecticut, Iowa, Indiana, Massachusetts, Maryland, Michigan, North Dakota, New Jersey, Rhode Island, South Dakota, Florida, Georgia, and Virginia.