Chapter 5 Patent policy and the extension of patentable subject matter Introduction This chapter discusses a variety of aspects relating to the patenting of biological research. An introduction is given to patents, explaining the legal requirements of patentability before discussing the ‘social contract’ rationale for the patent system and the aligned requirements of disclosure and publication. Under this rationale, it is assumed that the patent system rewards inventions which fulfil these requirements and that the system disseminates technical information to inform future innovation. Through a brief description of a number of landmark cases, it will then be shown that the notion of patentable subject matter has expanded in recent decades to include upstream basic biological research. These cases include Diamond v Chakrabarty, Association for Molecular Pathology v Myriad Genetics, the ongoing questions surrounding the WARF patents and the case of Brüstle v Greenpeace. Alongside this account, it will be shown that the patents in question have been the subject of considerable controversy, attracting commentaries from a wide variety of groups including eminent scientists. These comments will be used to highlight a number of concerns about upstream patenting which are elaborated upon in the final part of the chapter. This concluding part will consider the ability of the patent system to cope with upstream biological patents, specifically the ability of the system to capture upstream ‘inventions’ and disseminate the related scientific information. Modern patent rights Intellectual property (IP) is a collective term which refers to “any form of original creation that can be bought or sold”. There are a number of forms of IP rights (IPRs), each covering a different type of ‘original creation’ including trademarks, designs, copyrights and, the focus of this thesis, patents. Today, patents are used to protect inventions. A patent provides the patent owner exclusive rights to control the use of a patented invention, preventing others from making, using, importing or selling the invention in the territory where the patent has been granted for up to 20 years. The
system reflect its mission – to encourage invention and diffusion of technology; and its costs reflect its modus operandi, which is to restrict the use of inventions.” The justification acknowledges the centrality of the patentability requirements and the potential value of disclosure in achieving the anticipated economic benefits of the system. Under this model, patents are argued to encourage and facilitate innovation. This is based on two main assumptions: 1) the grant of exclusive patent rights provides an incentive for socially and economically desirable levels of invention and innovation; and 2) the system requires disclosure of information and knowledge on which innovators may build which may otherwise be kept secret. More explicitly, the rationale details that in order to achieve economic growth, the patent system is required to incentivise innovation and knowledge transfer through the grant of monopoly rights. In this way, patents can be viewed as a form of social contract: society grants inventors exclusive rights over their inventions in return for disclosure of information on which other innovators may build. Guellec and van Pottelsberghe, two former chief economists of the EPO, consider the patent system from such an economic perspective: “… the aim of the patent system is economic in nature: it is to foster innovation and growth”. This growth is facilitated by disclosure through the patent system: “It is one aim of the patent system to make disclosure a preferred option to the inventor. Disclosure facilitates follow up inventions … As Werner von Siemens, a vocal advocate of patents in the late nineteenth century, once said: ‘Because by patenting each new thought is carried into the world; one hundred minds may take it up, may steer it to completely different paths and make good use of it’” … The major source of new technology is new knowledge, relating to science, technology, business or other … Technical change is accelerated, and less costly, when researchers have access to more knowledge, to more ideas that they could combine, recombine and test.” In this way, disclosure is claimed to improve the speed and efficiency of invention in society “which is central to economic growth”. ‘Social contract’ and the patent system Within the modern consequentialist justification, patents can be construed as a form of ‘social contract’ in which a patent is offered in return for public disclosure of an innovation. Society forgoes potential loss through the exclusionary rights provided
Knowledge of competitor’s patents A few participants knew of particular competitors with patents providing comments including: “Yes, particular patents and a particular author that I know has already patented something and so of course then I would look at other things that they would have done.” (Interviewee 12) “I have looked up particular … as in Thomson J. … and big Californian names.” (Interviewee 1) Two interviewees said that they became aware of competitor’s patents in the context of being part of a company, for example one said: “[W]e definitely looked at the WARF patents … that was very much in the context of setting up our company and trying to work out the relationship with what we could do academically, what we could do commercially and what we could transfer academically to the company.” (Interviewee 3) But the participant took the view that: “Ultimately that is going to be the CEO and the business development guys’ jobs. I mean I will keep in touch with the literature and they will probably be keeping more in touch with the patent landscape.” (Interviewee 3) This is an example of scientists ‘buffering’ their engagement with patent information (further discussed in section 8.4.5). Another interviewee commented that they had previously looked at patents to gauge what competitors might be working on, and planning on working on, in the future: “Obviously you want to see what art there is and things like that … you can gain quite a lot from patents that you wouldn’t otherwise gain from a paper … It is different because you get a sort of feel for what people are really trying to work on, the downstream steps, because they often put in claims specific to this.” (Interviewee 1) This, whilst awareness of the general existence of patents in their field was high amongst the interviewees, their knowledge of particular patents varied greatly.
terminology was avoided to further test the participants understanding of the information). All participants were able to determine that the UK territory is not covered by the US patent but the situation concerning the EP patent was less well understood. On the front page of the EP patent application document it indicates the application has designated the UK; this can be seen by the letters ‘GB’ under the heading ‘Designated Contracting States’. While three participants assumed that EP patents cover the UK, with comments such as “If it is European then yes”, others were less sure: “Presumably” and “I think so” and “I’m never quite sure about that one actually … I’ve looked at all that information before and not been sure.” Several thought that the EP document did not, either because they thought the UK was not included in the EP patent application, or they were looking for ‘UK’, not ‘GB’: “I can’t see us there, UK.” (Interviewee 9) Third party observations The participants were asked if they thought they could question a patent before it was granted. None knew of the specific opportunity to file third party observations, and many remarked that they would not use it even if they did, they would simply disregard the information if they thought that the patent did not fulfil the patentability requirements: “A: Do you know anything about whether you can question a patent at any point if you doubted it? I: I think that if I saw something like that I would just disregard it rather than wanting to actually file something against it.” (Interviewee 13) Others indicated they wouldn’t use the opportunity because they wouldn’t read patent applications: “If you read those circulars [such as emails about the UKNSCN digests] then maybe you could say ‘I knew that and it was obvious’ … but I wouldn’t read it because I couldn’t care … Most scientists would say ‘I will wait till the paper comes out.’” (Interviewee 4) Notwithstanding this, several participants said they thought such observations would be useful in facilitating expert review in the examination process: “I do think that needs to be done because scientists will know more than the examiner about the field and what has already been done. Yes, for somebody related to that field I think that could be really useful.” (Interviewee 12)
Total 120 100 Table 3: Survey responses to the question ‘Which of the following best describes your primary area of research?’ Which of the following best describes your primary area of research? Total population f % Stem cell science 37 30.8 Biomedical science 20 16.7 Molecular biology 2 1.67 Genetics 3 2.50 Biochemistry 10 8.33 Other 22 18.3 Structural biology 4 3.33 Microbiology 5 4.17 Physiology 2 1.67 Evolutionary biology 1 0.83 Medicine 14 11.7 Total 120 100 Table 4: Survey responses of the total population and subpopulations to the question: ‘Have you ever seen a patent document?’ and chi-squared test results for paired subpopulations Have you ever seen a patent document? Stem PhD Students Part Not part Total Valid Yes 6 (60.0) 36 (50.0) 32 (74.4) 8 (25.0) 24 (100) 13 (26.0) 42 (51.2) No 4 (40.0) 36 (50.0) 11 (25.6) 24 (75.0) 37 (74.0) 40 (48.8) 10 72 43 32 24 50 82 Missing 27 11 16 10 38 Total 37 83 59 42 24 50 120 Chi2 value 0.351 (1 cell <5, 25%, min 4.88) 18.0 35.5 Significance N/A 0.000 0.000
Table 5: The responses of the total population and subpopulations to the question: ‘Have you ever been part of a patent application?’ and chi-squared test results for paired subpopulations Have you ever been part of a patent application? Stem Other PhD Students Seen Not seen Valid Yes 2 (50.0) 22 (31.4) 23 (59.0) 24 (64.9) 24 (32.4) No 2 (50.0) 48 (68.6) 16 (41.0) 23 (100) 13 (35.1) 37 (100) 50 (67.6) 4 70 39 23 37 37 74 Missing 33 13 20 19 5 3 46 Total 37 83 59 42 42 40 120 Chi2 0.596 (2 cells <5, 50%, min 1.3) 25.8 35.5 Significance N/A 0.000 0.000
Plomer A and Tsarapatsanis D, ‘The Asymmetry of Human Dignity as a Fundamental Value and Constitutional Right in Europe’ in Zaccardi G (ed), Global Community Yearbook of International Law and Jurisprudence 2012 edition (OUP 2012) Porter G and others, ‘The patentability of human embryonic stem cells in Europe’ (2006) 24 Nature Biotechnology 653 Public and Corporate Economic Consultants, Strengthening the Contribution of English Higher Education Institutions to the Innovation System: Knowledge Exchange and HEIF Funding. A report for HEFCE (PACEC 2012) Public Patent Foundation, Opening Brief of Appellant in Consumer Watchdog v WARF (2013) –––, ‘WARF Stem Cell Patents’ <> accessed 13 April 2014 Radder H, ‘A Deflationary, Neo-Mertonian Critique of Academic Patenting’ in Suárez M, Dorato M and Rédei M (eds), EPSA Epistemology and Methodology of Science (Springer 2010) Rai AK, ‘Regulating Scientific Research: Intellectual Property Rights and the Norms of Science’ (1999) 94 Nw UL Rev 77 Rai AK and Cook-Deegan R, ‘Moving beyond “isolated” gene patents’ (2013) 341 Science Rai AK and Sampat BN, ‘Accountability in patenting of federally funded research’ (2012) 30 Nature Biotechnology 953 RCUK, ‘Impact Policies: Intellectual Property’ <> accessed 11 April 2014 –––, ‘Increasing the economic impact of the Research Councils’ (2007) <> accessed 23 April 2014 –––, ‘Pathways to Impact’ <> accessed 10 April 2014 –––, ‘RCUK Policy and Guidelines on Governance of Good Research Conduct’ (2013) <> accessed 07 April 2014 –––, ‘RCUK Review of the UK National Stem Cell Network (UKNSCN) A full - survey results ’ <> accessed 05 April 2014 –––, ‘Terms and Conditions of Grants ’ (2013) <> accessed 10 April 2014 REF2014, ‘FAQs: Research Outputs (REF2)’ <> accessed 07 April 2014 –––, ‘REF 01.2011 Decisions on assessing research impact’ (2011) <> –––, ‘REF 2014 Citation data’ <> accessed 07 2014 –––, ‘Research Excellence Framework’ <> accessed 23 April 2014
Teddlie C and Tashakkori A, Foundations of mixed methods research: Integrating quantitative and qualitative approaches in the social and behavioral sciences (Sage 2009) Thambisetty S, ‘The Evolution of Sufficiency in Common Law’ LSE Legal Studies Working Paper No 6/2013 <> accessed 23 April 2014 Thomson J, Primate Embryonic Stem Cells (US 5,843,780 ) (WARF 1998) –––, Primate Embryonic Stem Cells (US 6, 200, 806) (WARF 2001) –––, Primate Embryonic Stem Cells (US 7, 029, 913) (WARF 2006) Thomson JA and others, ‘Embryonic Stem Cell Lines Derived from Human Blastocysts’ (1998) 282 Science 1145 Thomson Reuters, ‘A bibliometric analysis of regenerative medicine’ (2011) <https://> accessed 23 April 2014 Thursby JG and Thursby MC, ‘University Licensing and the Bayh-Dole Act’ (2003) 301 Science 1052 Thursby MC, Introducing Technology Entrepreneurship to Graduate Education: An Integrative Approach (Emerald Group Publishing Ltd 2005) TSB, ‘About the Cell Therapy Catapult’ accessed 23 April 2014 –––, ‘Guide to Technology Strategy Board Collaborative Research and Development Competitions ’ (2011) accessed 11 April 2014 Tseng Y-H, Lin C-J and Lin Y-I, ‘Text mining techniques for patent analysis’ (2007) 43 Information Processing & Management 1216 UK Patents Act 1977 (as amended) An unofficial consolidation produced by Patents Legal Section 1 October 2013 UK Stem Cell Initiative, ‘Report & Recommendations’ (2005) <> accessed 23 April 2014 UKIPO, ‘Examination Guidelines for Patent Applications relating to Biotechnological Inventions in the Intellectual Property Office ’ <> accessed 07 April 2014 –––, ‘Intellectual Asset Management for Universities’ (2011) <> accessed 23 April 2014 –––, ‘Inventions involving human embryonic stem cells’ (2003) <> accessed 05 April 2014
Weaver DF and Barden C, ‘Don't overlook the rigorously reviewed novel work in patents’ (2009) 461 Nature 340 Webb and others, Unobtrusive Measures: Non-reactive Research in the Social Sciences (Rand McNally 1966) Wellcome Trust, ‘Conditions under which a grant is awarded’ <> accessed 10 April 2014 –––, ‘Policy on intellectual property and patenting ’ <> accessed 10 April 2014 –––, ‘Wellcome Trust-funded intellectual property: exploitation consent and standard revenue/equity-sharing agreement (CRSA/12/2009)’ < > accessed 11 April 2014 Wellings P, Intellectual property and research benefits (BIS 2008) Wilson T, A Review of Business-University Collaboration (BIS 2012) WIPO, ‘Offices for which PCT national phase information is available in PATENTSCOPE Search Service’ <> accessed 05 April 2014 –––, ‘PATENTSCOPE Content of the Database’ < > accessed 05 April 2014 Yamanaka S, Nuclear Reprogramming Factor (EP 1 970 446) (2011) Zarzeczny A and others, ‘iPS Cells: Mapping the Policy Issues’ (2009) 139 Cell 1032 Anonymous sources ‘The case: Myriad at the Supreme Court (Fitzpatrick Cella Haper & Scinto LLP)’ (2013) <> accessed 13 April 2014 ‘Cellular Dynamics International IPO (as filed with the Securities and Exchange Commission on June 3, 2013. Registration No. 333)’ (2013) <> accessed 05 April 2014 ‘Peer to patent’ <> accessed 13 April 2014 ‘Regenerative Medicine Expert <https://> accessed 10 April 2014 ‘Request for ex reexamination patent number 5, 843, 780 Primate Embryonic Stem Cells’ (2006) <> accessed 13 April 2014