July-December 2015
ISSN 2050-005X (Online); 978-1514857861 (ISBN-13); 1514857863 (ISBN-10)
This article addresses the issue of partly new inventions and the possibility of granting them patentability. The route of the analysis starts with the identification of the sectors in which this issue frequently arises. It consequently continues with finding and locating all those common characteristics of the circumstances under which the ‘phenomenon’-in-question arises. The interesting conclusion of this analysis is that the phenomenon of partially new inventions being granted patentability occurs mainly within the pharmaceutical (and chemicals) sector. This realization leads to even more substantial concerns, especially from a competition law perspective. That is because pharmaceutical (and chemicals) companies apply for – and get granted- patentability of partly new inventions to a wide extent. One of the questions at this point is whether this is causing a restriction to competition by threatening the delicate balances of the specific market. This question is answered through references not only to the law itself, including leading case-law from both the EU and the UK, but also to policy concerns and market-related considerations. Finally, the aforementioned findings are used in order to address the question of whether patentability should be granted to partly new inventions, whilst following a further analysis and assessment of relevant competition -and other- policy issues.
Keywords: patents, European Union, EPC 1973, EPC 2000, pharmaceuticals, competition law.
2 Paul Torremans, Holyoak and Torremans: Intellectual Property Law, Seventh Edition, Oxford University Press, 2013, Chapter 4.
3 UK Patent Act 1977, s. 1 (1) (a).
4 UK Patent Act 1977 s. 3.
5 UK Patent Act 1977 s. 4 (1).
6 Charlotte Waelde, Graeme Laurie, Abbe Brown, Smita Kheria, Jane Cornwell, Contemporary Intellectual Property, Third Edition, Oxford University Press, 2014, 439.
7 Eisai, G5/83 [1985] OJ EPO 64.
8 John Wyeth & Brother Ltd’s Application [1985] RPC 545.
9 Article 52 (4) of the EPC and s 4 (2) of the Act.
10 Horton, ‘Methods of Treatment and Second Medical Use’, Patent World 9, 2000.
11 See (G-1/83) Bayer and (G-7/83) Pharmuka, Decision of the Enlarged Board of Appeal dated December 5, 1984 [1985] OJ EPO 60.
12 T 19/86, OJ EPO 1989, 24, T 893/90 of 22 July 1993, T 233/96 of 4 May 2000, 51/93 of 8 June 1994, T 138/95 of 12 October 1999, T 290/86, OJ EPO 1992, 414, T 254/93, OJ EPO 1998, 285 and in the UK, see Actavis UK v Merck [2008] EWCA Civ 444 (CA).
13 Bristol Meyers Squibb Co v Baker Norton Pharmaceuticals [2001] RPC 1; American Home Products Co v Novartis Pharmaceuticals UK Ltd [2001] RPC 159.
14 Actavis UK Ltd v Merck & Co Inc [2008] EWCA Civ 444; [2008] RPC 26.
15 See case commentary on Actavis, Paul England, Clare McDonald, ‘Patents – the Court of Appeal upholds a patent for a new dosage regime’, E.I.P.R. 2008, 30(9), N68-71 and Genentech Case [1989] RPC 613.
16 http://www.epo.org/law-practice/case-law-appeals/recent/g080002ex1.html, section 7.1.3.
17 Julian Cockbain, Sigrid Sterckx, ‘Is the Enlarged Board of Appeal of the European Patent Office authorised to extend the bounds of the patentable? The G5/83 Second Medical Indication/EISAI and G2/08 Dosage Regime/ABBOTT RESPIRATORY cases’, IIC 2011, 42(3), 257-271 at 262.
18 The new Article 54(5) EPC eliminates any legal uncertainty on the patentability of further medical uses. It unambiguously permits purpose-related product protection for each further new medical use of a substance or composition already known as a medicine’, explanatory notes MR/l8/00, point 4.
19 Lionel Bently, Intellectual Property Law, Third Edition, Oxford University Press, 2009, p 481.
20 G-2/08 Dosage regime/ABBOTT RESPIRATORY, 2010 OJ EPO 456-494. See 42 IIC 215 (2011).
21 G-2/08 Dosage regime/ABBOTT RESPIRATORY, 2010 OJ EPO 456-494. See 42 IIC 215 (2011), at 490.
22 Julian Cockbain, Sigrid Sterckx, ‘Is the Enlarged Board of Appeal of the European Patent Office authorised to extend the bounds of the patentable? The G5/83 Second Medical Indication/EISAI and G2/08 Dosage Regime/ABBOTT RESPIRATORY cases’, IIC 2011, 42(3), 257-271 at 258.
23 See for example Actavis UK v Merck [2008] EWCA Civ 444 (CA).
24 G2/88 [1990] EPOR 73.
25 Eisai Case, supra note 6.
26 Gerald Paterson, ‘The novelty of Use Claims’, IIC 1996, 27(2), 179-190, at 184.
27 In the sense that, as Bently states, achieving the new purpose is seen as a ‘technical feature’ of the invention, Lionel Bently, supra, 483.
28 Supra at 10.3
29 See Bristol Myer’s Application [1975] RPC 127, which was under the Patent Act 1949.
30 T892/94 [1999] EPOR 516, 526, where novelty of purpose was not granted for the effect of the aromatic esters on the human skin, based on the argument that claimed effect was nothing more than a disclosure of already existing information.
31 See also on this issue Catherine Colston and Jonathan Galloway, Modern Intellectual Property Law, 3rd edition, Routledge, 2013, 183-184.
32 As noted by Bently in Lionel Bently, supra, p 482.
33 Tanya Aplin, Jennifer Davis, Intellectual Property Law, 2nd edition, Oxford University Press, 2013, 677.
34 [1996] RPC 76, 92.
35 Catherine Colston and Jonathan Galloway, supra, 183-184.
36 Catherine Colston and Jonathan Galloway, supra, 180.
37 The first case to consider selection patents in the UK was IG Farbenindustrie [1930] 47 RPC 289, 322-3.
38 IG Farbenindustrie [1930] 47 RPC 289.
39 Note however that Torremans, Holyoak and Torremans, supra, 70; see also Lionel Bently, supra 2009, 485, who places these requirements under novelty, whereas Winfried Tilmann sets them under inventive step; see Winfried Tilmann, ‘Validity of selective product claims’, Venice Conferences III and V, Lundbeck and Olanzapin, IIC 2010, 41(2), 149-169, at 160.
40 On this point see also Shell Refining Marketing & Marketing Co Ltd [1960] RPC 35 at 55.
41 See further Lionel Bently, supra, 485, Aplin, supra, 679-680, Colston, supra, 181.
42 Colston, supra, 181.
43 Lionel Bently, supra, 486 where he states that they can also apply to the discovery of new substances, new uses for old substances or even new purposes for old substances processed in old ways.
44 See especially the last case under the previous law: El Du Pont de Nemours & Co’s (Witsiepe’s) Application [1982] FSR 303; Boehringer Mannheim v Genzyme [1993] FSR 716; Beechan Group Ltd v Bristol Laboratories International SA [1978] RPC 521.
45 Dr Reddy’s Laboratories (UK) Ltd v Eli and Co Ltd [2009] EWCA 1362; [2010] RPC 9.
46 Ibid. at 35-37.
47 Ibid. at 39.
48 See for example Sanofi/Enantiomer, T658/91 [1996] EPOR 24 or Bayer/Diastereomers, T12/81 OJ EPO 296; [1979-85] EPOR B-308.
49 More on enabling disclosure, see General Tire & Rubber Co. v Firestone Tyre & Rubber Co [1972] RPC 457; Asaho Kasei Kogyo’s KK’s Application [1991] RPC 485; Biogen Inc v Medeva plc [1997] RPC 1.
50 See Synthon BV v Smithkline Beecham plc [2005] AII ER (D), 235, [2006] RPC 10 (HL), where the test applied was not enabling disclosure, but two different elements: disclosure and enablement.
51 See Bently, supra, 486-487.
52 And subsequent article 56 of the EPC.
53 Tanya Aplin, Jennifer Davis, supra, 685.
54 A. Griffiths, ‘Windsurfing and the Inventive Step’ [1999] IPQ 160, 163-164.
55 Windsurfing International Inc v Tabur Marine (Great Britain) Ltd [1985] RPC 59.
56 The questions are: (1) identify the inventive concept embodied in the patent in suit; (2) assume the mantle of the normally skilled but unimaginative addressee in the art at the priority date and impute to him what was, at that date, common general knowledge in the art in question; (3) identify what, if any, differences exist between the matter cited as being [state of the art] and the alleged invention; (4) ask whether, viewed without any knowledge of the alleged invention, those differences constitute steps which would have been obvious to the skilled man or whether they require a degree of invention Windsurfing International Inc v Tabur Marine (Great Britain) Ltd [1985] R.P.C. 59 at 73-74.
57 Pozzoli SPA v BDMD SA [2007] FSR 37 (CA).
58 Conor Medsystems Inc v Angiotech Inc [2007] ECWA Civ 5.
59 See further Holyoak and Torremans, supra, 76-79.
60 Pfizer Ltd Patent [2001] FRS (16).
61 Genentech Inc Patent [1989] RPC 147.
62 ibid., at 214.
63 See Torremans, supra, 81-82.
64 Ibid., 89.
65 Genentech, supra, 280.
66 Ibid., 221.
67 Ibid., 243.
68 See Torremans, supra, 86.
69 ‘…empirical research industriously pursued may lead to a patentable invention’, Genentech, supra, 241.
70 See on this one also Williams v Nye [1980] 7 RPC 62; it was a case of mosaicking, where the combination of two similar machines operating related functions in order to establish a new use, was found lacking inventiveness.
71 See section of novelty on selection patents.
72 For example, Pfizer/Penem, T1042/92 [1995] EPOR 207 and Sanofi/Enantiomer, T658/91 [1996] EPOR 24.
73 Sandvik Intellectual Property AB v Kennametal UK Ltd [2011] EWHC 3311, 185.
74 Dr. Reddy’s Laboratories (UK) Ltd v Eli Lilly & Co Ltd [2009] EWCA Civ 1362, [2010] RPC 9.
75 See Torremans supra, 87.
76 Lionel Bently, supra, 505.
77 Mentioned in Adolf Schindling/Illuminating device, T324/94 [1997] EPOR 146.
78 Samuel Parkes & Co v Cocker Brothers Ltd [1929] 46 RPC 241, 248.
79 As noted in Barry Bleidt, “Recent Issues and Concerns about Pharmaceutical Industry Promotional Efforts” (1992) 22(2) Journal of Drug Issues 413, in many cases marketing costs exceed even R&D costs in the pharmaceutical industry.
80 Moelnlycke AB v Procter & Gamble Ltd (No. 3) [1990] RPC 498, 503, as seen in Torremans, supra, 85.
81 Beloit Technologies Inc v Valmet Paper Machinery Inc [1995] RPC 705.
82 Jones Alison and Sufrin Brenda, EU Competition Law, 4th edition, Oxford University Press, 2011, 709-711.
83 Paul England, ‘Recent Developments in Pharmaceutical Secondary Patents in the light of the Commission’s inquiry into the Pharmaceutical Sector’, E.I.P.R. 2009 31(12), 614-622, 615.
84 Ibid.
85 European Commission, Competition DG, Pharmaceutical Sector Inquiry Final Report, 2009 http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/staff_working_paper_part1.pdf.
86 Supra, 615; When talking about generics, he states that they mostly want to evoke patents of innovators ‘variously described as “secondary”, “evergreening” or “life-cycle” patents. These patents do not protect the active ingredient that makes the drug effective as a treatment, but instead protect different physical forms of that drug, for example: different salts of the drug; dosage regimes; formulations; delivery devices and further medicinal uses’.
87 In order to understand the significance of the issue better see Johnson & Johnson and Novartis Case where the Commission fined the two companies for infringement of art 101 TFEU because they agreed with a generics company in the Netherlands that the latter would abstain from bringing the patented drug for the treatment of cancer after their patent expired, see Press Release http://europa.eu/rapid/press-release_IP-13-1233_en.htm, found in EU Focus, Johnson & Johnson and Novartis fined for delaying market entry of pain-killer, EU Focus 2014, 316, 6.
88 This is why, novelty should be, generally, given to those selections that entail restricted examples from the wider class which had not been tested or used before; in this way, no remonopolisation occurs, Catherine Colston and Jonathan Galloway, supra note 30, p 180-184.
89 For a thorough analysis see Steve D. Shadowen, Keith B. Leffler, Joseph T. Lukens, Bringing market discipline to pharmaceutical product reformulations, IIC 2011, 42(6), 698-725.
90 See for example the impact of drug accessibility on HIV/Aids, Rachel Roumet, ‘Access to patented anti-HIV/AIDS medicine: the South African experience’, E.I.P.R. 2010, 32(3), 137-141.
91 Amanda Odell-West, ‘A proposal to amend the medical exclusion within patent law to provide for the patentability of certain methods of treatment’, E.I.P.R. 2007, 29(12), 492-499.
92 EFPIA Factsheet: “Understanding patents and their vital role in medicine discovery”, 1, http://www.efpia.eu/Content/Default.asp?PageID=559&DocID=5348 [Last Accessed May 12, 2014].
93 Carlos M. Correa, ‘Efforts to raise the bar in patent examination need to be supported,’ IIC 2012, 43(7), 747-750, who claims that the bar to patentability should be raised talks about relevant initiatives undertaken mainly in Brazil and Australia.
94 Nicoleta Tuominen, ‘An IP perspective on defensive patenting strategies of the EU pharmaceutical industry’, E.I.P.R. 2012, 34(8), 541-551.
95 The Directorate General for Enterprise and Industry of the European Commission suggests that the position of EU originators should be strengthened through the implementation of measures. Russell Graeme Hunter, The Pharmaceutical Sector in the European Union, Intellectual Property Rights, Parallell Trade and Community Law, Juristförlaget, Stockholm, 2001, 13.
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1 LLM, International Commercial Law, University of Nottingham.
(2015). The Intricacies of Partly New Inventions: Should We Grant Patentability?. Legal issues Journal, 3 (2), https://www.legalissuesjournal.com/article/03-02-16072015/
