The goals of the patent system include incentivizing would-be inventors to produce new and useful products and processes that will ultimately benefit society. 337 As such, patents should be granted for inventions that are in the public interest. “Clearly the bargain of patent protection implies a goal or teleology to the right: societal needs for the new and useful product must be met.”338 The notion of the public interest dimension of intellectual property is reflected in the US Constitution. For instance, Article 1, Section 8, clause 8 of the US Constitution of 1787, ensures that the state promotes the freedom of arts and sciences:
The Congress shall have Power …To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.
In safeguarding the freedom of arts and sciences, exclusive rights are bestowed insofar as they enable progress.339 The public interest is the reason for granting
exclusive rights, but it can also be a reason for limiting them. 340 This line of reasoning rests on the social obligation theory341 and Gregory Alexander’s conception of
335 Ibid.
336 Henry, C. & J. Stiglitz. “Intellectual Property, Dissemination of Innovation and Sustainable Development” in Global Policy. Volume 3, Iss.3, October 2010 at 239.
337 See supra note 4, Burk & Lemley at 1580.
338 Lametti, D. “The Concept and Conceptions of Intellectual Property as Seen Through The Lens of Property” in Science and Law in the Prism of Comparative Law. G. Comandé, G. Ponzanelli (eds.).
Torino: Giappichelli, 2004 at 276.
339 Geiger, C. “Implementing Intellectual Property Provisions in Human Rights Instruments: Towards a New Social Contract for the Protection of Intangibles,” Max Planck Institute for Innovation and Competition Research Paper No. 14-10. 2014 at 17.
340 See supra note 332, Geiger, C. at 153-176.
341 See, for example: Coombe, R. “Objects of Property and Subjects of Politics: Intellectual Property Laws and Democratic Dialogue,” in Texas Law Review, Vol. 69, pp. 853-1883, 1991; Netanel, Neil.
“Copyright and a Democratic Civil Society,” in Yale Law Journal, Vol. 106, pp. 283-387, 1996 and Fisher, W. “Reconstructing the Fair Use Doctrine,” in Harvard Law Review, Vol. 101, pp. 1659-795, June 1988.
97
“property-as-propriety”: “[P]roperty is the material foundation for creating and maintaining the proper social order, the private basis for the public good.”342
This idea is developed on the basis of Aristotle’s idea that private property can promote the common good, as it promotes like responsibility, yet at the same time, encourages citizens to practice the virtue of generosity:
For the superintendence of properties being divided among the owners will not cause these mutual complaints, and will improve the more because each will apply himself to it as to private business of his own; while on the other hand virtue will be exercised to make ‘friends' goods common goods,’ as the Proverb 3 goes, for the purpose of use… for individuals while owning their property privately put their own possessions at the service of their friends and make use of their friends' possessions as common property…It is clear therefore that it is better for
possessions to be privately owned, but to make them common property in use; and to train the citizens to this is the special task of the legislator.343
Therefore, Aristotle maintained that the common good could be maintained with the legal creation of private property, with the intention that private property owners will, in turn, share their property with others as common property, which will create an altruistic society.
Metaphorically, the process of applying for a patent ensures that an object has an objective social utility-it must be <<useful>> - and the patent register objectifies the object or process that it is the subject-matter of the monopoly. In short, a patent is an object of social wealth which can be the subject of a general duty in rem on the part of non-holders not to interfere, and thus, can be safely considered to be an object of property in the analytic sense.”344
If the social bargain no longer favours society, then society has every right to remove or alter that social construction. In UK case law, Lord Hoffman elaborated in Kirin-Amgen v. Hoechst Marion Roussel345 on the primary object of the state in granting a monopoly:
342 Alexander, G. “Property as Propriety” in Nebraska Law Review. Vol. 77, 1998 at 668.
343Aristotle. Aristotle in 23 Volumes, Vol. 21, translated by H. Rackham. Cambridge: Harvard University Press; London, William Heinemann Ltd. 1944 at 1263a.
344 Lametti, D. “The Concept and Conceptions of Intellectual Property as Seen Through The Lens of Property” in Science and Law in the Prism of Comparative Law. G. Comandé, G. Ponzanelli (eds.).
Torino: Giappichelli, 2004 at 276.
345 Kirin-Amgen, Inc. v Hoechst Marion Roussel Ltd. [2004] UKHL 46 (21 October 2004). The case was between Amgen and Transkaryotic Therapeutics (TKT) regarding the scope of Amgen’s patent to their method of producing erythropoietin (EPO). The issue was whether TKT’s process violated Amgen’s patent since it made use of the same gene, or whether TKT’s process was a new way of producing the same protein which does not violate Amgen’s patent. Lord Hoffman interpreted Amgen’s patent claim as being restricted to the original claim, where the use of the DNA sequence to produce EPO in a host cell, which should not include TKT’s different technique.
98
[T]he social contract between the state and the inventor which underlies patent law. The state gives the inventor a monopoly in return for an immediate disclosure of all the information necessary to enable performance of the invention. That disclosure is not only to enable other people to perform the invention after the patent has expired. If that were all, the inventor might as well be allowed to keep it secret during the life of the patent. It is also to enable anyone to make immediate use of the information for any purpose which does not infringe the claims.346
The general benefits derived by the public from the disclosure of an invention come from being able to use the information during the patent term, provided it is a non-infringing use. Lord Hoffman asserted that Amgen’s patent should not block others from using basic information about the DNA sequence to invent around the patented method of creating erythropoietin.347 Patent law, then, does not exist as an end in itself, but as a means to an end of achieving a function.348 This is because the patent system is not a natural entity, but a human construction. In other words, patent rights perform a social function, and the key concept behind social function is ‘balance.’349 As Manuel Desantes notes:
The patent system should serve a purpose that is not getting a monopoly, but to encourage innovation and development. That is why the patent system is a social contract where society should win more than the patent holder.350
This means that there are no absolute rights that can be practised in a self-centred custom without any concern for the effects.351 An example of the limits to a patent holders’ property right is the existence of research exceptions in Europe. In the US, march-in rights apply to federally funded research, where any patented products or processes are required to be licensed. However, march-in rights do not apply to
privately funded institutions. These limits are put in place by the state because as part of the social bargain of patents, there is an expectation on behalf of society that a patent holder must make use of the patent productively. In granting a property right to an
346 Ibid at 77.
347 Erythropoietin (epo) is a hormone that regulates red blood cell production.
348 Geiger, C. “‘Constitutionalising’ Intellectual Property Law? The Influence of Fundamental Rights on Intellectual Property in the European Union” in International Review of Intellectual Property and Competition Law. Vol. 37, No.4, 2006 at 375.
349 See supra note 332, Geiger, C. at 157.
350Desantes, Manuel. “Past, present and future of patent protection and patent litigation in Europe.”
European Patent Convention Course. London, Queen Mary University of London. Centre for Commercial Law Studies. March 18, 2014. Lecture.
351 See supra note 332, Geiger, C. at 158.
99 object of social wealth to an entity to the exclusion of others, there is a societal
expectation that the resource is used in an acceptable way - or else governance tools like compulsory licenses or revocation of the patent can be justified. As a result of these levers that are built into the patent system,352 it can be maintained that the patent system is suitable in its current state and can continue to justify the grant of patents on
inventions derived from human genetic materials, and that they are necessary in providing incentives for the creation of technology.
It is worth mentioning that good patents are meant to be a barrier.353 As a part of the social bargain, the patent holder has a right to be compensated and rewarded for granting permission to others to use their product or process. It is important to note that the object of property in a patent is what is defined in the patent application’s claim and description-nothing more and nothing less. The perception that some institutions hold a monopoly right to genetic information raises concerns, particularly with regards to the potential consequences for further innovation.354 If someone obtains a patent, it does not mean that individual ‘owns’ the claimed gene sequence or protein. What the patent holder ‘owns’ are the commercial activities surrounding the biological material such as using it to develop a genetic testing kit or therapy, or licensing it to other companies.
Other parties may look at it or do research with it, but they cannot commercialize it unless they pay the patent holder.
352 See supra note 4, Burk & Lemley.
353 Jacob, R. “IP Law: Keep Calm and Carry On?” in Current Legal Problems. Vol. 66, 2013 at 398.
354 Stiglitz, J. “How Intellectual Property Reinforces Inequality” in New York Times. July 14, 2013.
opinionator.blogs.nytimes.com/2013/07/14/how-intellectual-property-reinforces-inequality/. Accessed January 3, 2014. Likewise, a Marxist approach to patents is that they are intrinsically flawed and have no place in a socialist system. There are three main arguments against capitalist patent systems: (i) they stifle the talents of the masses because workers are disinclined to invent when their labours only enrich the capitalists, (ii) they repeatedly hinder the use of the most sophisticated technologies because the
capitalists conspire to engineer markets and (iii) they cultivate industrial secrecy which obstructs the flow of significant technical knowledge because patent owners try to reduce the distribution of useful
information pertaining to their inventions. Martens, J. Secret Patenting in the U.S.S.R. and Russia. Sante Fe: Deep North Press, 2010 at 32.
100 3.5.3. Accommodating human genetic inventions within patent law
The patent system has struggled to keep up with the pace of developments in biotechnology, yet the policy of choice in biotechnology rich countries is a pro-patent,
“open doors” approach. This practice has recently been subject to legal evaluation both in Europe and the US, in which there has been a narrowing in the scope of patentable subject matter for biological materials. Court decisions challenging the patentability of human biological materials per se have been accompanied by patent offices issuing statements directing their patent examiners not to grant patents for certain subject matter. For instance, a day after the Myriad decision 355 the USPTO issued a memorandum explicitly stating that naturally occurring nucleic acids are not patent-eligible merely because they have been isolated. “Examiners should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 U.S.C. §101.”356 This decision may seem to signify a change in approach towards patenting genetic matter, and commentators have pointed out that the decision is a significant departure from US patent practice over the past thirty years since a genetically modified oil-eating
bacterium was held to be eligible subject matter for patenting in Diamond v.
Chakrabarty.357
A number of commentators propose that patent law should be changed to take into consideration the particular needs of the biotech industry. Some scholars suggest that genetic material is exceptionally more complex than any mechanical apparatus and this should be reflected in patent policy.358 Another position is that patents on human
355 Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 12-398 (2013)
356 Commissioner for Patents, USPTO. Memorandum: Supreme Court Decision in Association for Molecular Pathology v. Myriad Genetics, Inc. June 13, 2013.
357 Diamond v. Chakrabarty, 447 U.S. 303 (1980)
358 See Keller, E. Making Sense of Life: Explaining Biological Development with Models, Metaphors and Machines. Cambridge: Harvard University Press, 2003; Dutfield, G. “DNA patenting: implications for public health research”, in Bulletin of the World Health Organization. Vol. 84, Iss. 5, pp. 388-392, 2006.
Meanwhile, Nobel laureate John Sulston notes: “We are right at the beginning, not the end; we don’t
101 genetic materials are inappropriate359, while others dispute the types of inventions that should be protected.360 Others contend that genes should be protected under a sui generis system.361 Some suggest that the non-obviousness standard should be higher,362 or that the scope of DNA sequence patents should be limited.363
In considering the elements of the social contract of the patent system, one must be willing to evaluate the social consequences of restricting the use of human genes by granting gene patents. James Watson notes that there are social consequences of restricting the use of human genes. Emphasizing the informational nature of human genes, Watson explains that they can reveal information that can be important in life-or-death situations:
The information contained in our genes lets us predict our future. With a gene sequence in hand, we can know with some degree of certainty whether we will develop cancer, a neurological disease, or some other malady. This information should not be monopolized by any one individual, company, or government.364
Watson argues that patents for human genes are not necessary in incentivizing scientists to continue research and develop biotechnology inventions. Rather, the area
know what most of the genes look like, or when or where they’re expressed. The genome alone doesn’t tell you any of these things. Nevertheless, the information is there as a resource and a toolkit to which people will come back again and again as they build up knowledge of the complete structure of the body from the foundation.” Sulston, J. and G. Ferry. The Common Thread: Science, Politics, Ethics and the Human Genome. Great Britain: Bantam Press, 2003 at 287-288.
359 See Gallini, N. “The Economics of Patents: Lessons from Recent U.S. Patent Reform” in Journal of Economic Perspectives. Vol. 16, No. 2, pp. 121-154. Spring 2002.
360 For a general overview, see: OECD. Genetic Inventions, Intellectual Property Rights and Licensing Practices, Report of a Workshop Organized by the OECD Working Party on Biotechnology, at 11.
www.oecd.org/dataoecd/42/21/2491084.pdf. Accessed February 5, 2012; see Burk, D. “Patenting Transgenic Human Embryos: A Nonuse Cost Perspective” in Houston Law Review. Vol. 30, pp. 1650-68, 1993-1994. Burk argues that the benefits from patenting transgenic human embryos are dubious and may not be overcome by the benefits of the incentive. “Offering such a costly incentive in areas where it is unclear that society wishes to encourage activity is a strategy guaranteed to maximize the probability that the societal benefit from the patent will never exceed its costs.” (1659)
361 For discussion, see Palombi, L. Gene Cartels: Biotech Patents in the Age of Free Trade. Cheltenham:
Edward Elgar Publishing Ltd., 2009 and Litman, M. “The Legal Status of Genetic Material” in B.
Knoppers et al (eds.) Human DNA: Law and Policy: International and Comparative Perspectives. The Hague: Kluwer Law International, 1997 at 27.
362 See Dastgheib-Vinarov, S. “Higher Nonobviousness Standard for Gene Patents: Protecting Biomedical Research from the Big Chill” in Marquette Intellectual Property Law Review. Vol.4, 2000 at 157-158 (advancing that the court should raise the non-obviousness standard to bring stability to biotechnology).
363 See Wilson, J. “Patenting Organisms: Intellectual Property Law Meets Biology,” in D. Magnus, A.
Caplan & G. McGee (Eds). Who Owns Life? New York: Prometheus Books, 2002 at 42. Wilson advances narrow process claims and few product claims to prevent ‘blocking’ future innovations.
364 Brief of James D. Watson as Amicus Curiae in Support of Neither Party. The Association of Molecular Pathology, et al., v. Myriad Genetics, Inc., et al., No. 12-398, 2013 at 14.
102 which requires patent protection are the technologies that use human genes, which is why he argues human genes should be accessible to as many researchers.365 However, the financial realities in the biotechnology sector must also be taken into consideration in asking whether patents are necessary for human genetic materials.