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2019 | OriginalPaper | Chapter

Warner Lambert v Actavis: The Tricky Task of Examining Patent Infringement in New Medical Use Cases

Author : Christoph Spennemann

Published in: Intellectual Property and Development: Understanding the Interfaces

Publisher: Springer Singapore

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Abstract

A series of decisions taken by the United Kingdom’s Patents Court and the England and Wales Court of Appeal in 2015 and 2016 illustrate the complex task of examining infringements of patents related to new medical uses of known pharmaceutical products. The courts could not agree on the scope of new medical use claims. In addition, the Court of Appeal’s review of jurisprudence from other Member States of the European Union shows that EU courts have no uniform approach in an area of considerable economic importance to both originator and generic drug makers. This chapter reviews the decisions by the Court of Appeal in Warner Lambert v Actavis regarding the alleged infringement of Warner Lambert’s patent for a new use medicinal product. The purpose of the chapter is to show the important implications that judges’ decisions can generate for generic competition. This includes some reflections on the difficulties potentially arising in developing countries that have provided the patentability of new medical uses in their domestic patent laws, sometimes as a result of intellectual property obligations under free trade agreements.

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Warner-Lambert Company, LLC v (1) Actavis Group PTC EHF, (2) Actavis UK Limited, (3) Caduceus Pharma Limited, England and Wales Court of Appeal, 28 May 2015 (injunctive relief), available at http://www.bailii.org/ew/cases/EWCA/Civ/2015/556.html (accessed 28 April 2017) and Warner-Lambert Company LLC v (1) Generics (UK) Ltd (trading as Mylan), (2) Actavis Group PTC EHF, (3) Actavis UK Limited, (4) Caduceus Pharma Limited, England and Wales Court of Appeal, 13 October 2016 (main proceeding), available at http://eplaw.org/document/uk-warner-lambert-v-generics-and-actavis/ (accessed 28 April 2017). It may be noted that Warner Lambert belongs to the pharmaceutical firm Pfizer.

For this and the following description of the British health system see Court of Appeal, judgement on injunctive relief of 28 May 2015, paras. 11 ff. (hereinafter the “judgement on injunctive relief”).

For this and the following, see the summary of the procedural history in the Court of Appeal’s judgement on the main proceeding of 13 October 2016, paras. 3 ff. (hereinafter the “main judgement”).

See para. 156 of the judgement on injunctive relief.

Section 72.1(c) of the British Patents Act establishes that a patent may be revoked for insufficiency where “the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art.”

See summary of the procedural history, para. 5 of the main judgement.

For details, see paras. 51 ff. of the judgement on injunctive relief.

See para. 24 of the main judgement.

Ibid., para. 25.

The British provision is Section 60.1(b) and (c) of the Patents Act of 1977.

See paras. 104 ff. of the judgement on injunctive relief.

See para. 99 of the judgement on injunctive relief.

See para. 105 of the judgement on injunctive relief.

Ibid., para. 107.

Ibid., paras. 121, 122.

Ibid., para. 127.

Ibid., para. 124.

Ibid., para. 128.

Ibid., para. 126.

Ibid., para. 130.

Ibid.

Ibid., para. 131.

Ibid., para. 132.

See para. 195 of the main judgement, referring to a decision by the Tribunal de Grande Instance of 26 October 2015 (Warner Lambert and others v Sandoz and others, Case 15/58725).

Ibid., para. 190, referring, inter alia, to the German Bundesgerichtshof (i.e. the highest instance court for patent matters), decision of 14 March 2013 (Carvedilol II) and the Oberlandesgericht Düsseldorf, decision of 31 January 2013 (Cistus).

Court of Appeal, para. 77 of the judgement on injunctive relief, citing a translation of a decision of the Landgericht Düsseldorf of 19 December 2006.

Ibid., paras. 82–90, referring to Case 327 O 140/15, Warner-Lambert Company LLC v Aliud Pharma.

See summary of the Landgericht’s decision in the Court of Appeal’s judgement on injunctive relief, para. 90.

See para. 200 of the main judgement, referring to Case T 1673/11.

Ibid., para. 200.

See para. 191 of the main judgement and para. 81 of the judgement on injunctive relief.

See the summary by the Court of Appeal, para. 185 of the main judgement.

Ibid., paras. 213–215.

Ibid., para. 217.

See the summary in para. 100 of the judgement on injunctive relief.

Ibid., para. 136. The German and Dutch are discussed under paras. 83–98.

See para. 223 of the main judgement.

See para. 138 of the judgement on injunctive relief.

Ibid., para. 224.

See para. 126 of the judgement on injunctive relief.

Ibid., para. 130.

See para. 57. At the same time, and somewhat contradictory, the EPO Technical Board of Appeal (TBA) has considered that EPC 2000 product claims should have a broader scope than “Swiss” process claims (see reference in paras. 56, 58 of the decision on injunctive relief).

See New York Magazine (2013).

See Vandenbroeck et al. (2016), p. 6.

For example, Thailand in 2013 granted 1081 patents to non-residents, but only 68 to resident applicants. In Vietnam, 1123 patents were granted to non-residents in 2013, as compared to 59 patent grants to residents. Indonesia in 2013 received 6787 patent applications from non-residents, but only 663 from residents. In Sub-Saharan least-developed countries (LDCs), figures are much lower but show a comparable ratio. For instance, Ethiopia in 2007 (last available data) granted 13 patents to non-residents and 0 to residents. See WIPO Statistical Country Profiles at http://www.wipo.int/ipstats/en/statistics/country_profile/. Accessed 15 May 2017.

As compared to patents, residents in some developing countries make much more active use of utility models: Thailand in 2013 registered 1561 utility model applications from residents, as compared to only 48 applications from non-residents. In the same year, there were 226 utility model applications from residents in Vietnam, but only 47 from non-residents. Indonesia in 2013 received 233 resident applications for utility models, but only 116 such applications from non-residents. In Ethiopia, residents in 2007 filed 72 applications, as compared to one application by a non-resident. See WIPO Statistical Country Profiles.

Compensatory liability regimes have been suggested for various purposes in the literature (see e.g. Reichman (2000), pp. 1753 ff.) and by the United Nations Conference on Trade and Development (UNCTAD) for the specific purpose of promoting small scale improvements in the area of pharmaceuticals. For details see UNCTAD (2011), pp. 56, especially 61 ff. Under such a “use and pay” regime, the developer of a new use of a known product would be entitled to a compensation from each party that further develops or improves the new use, or develops another new medical use on the basis of the protected new use. By contrast, the developer of the protected use would not have the right to exclude competitors from using its incremental invention. For details, see UNCTAD (2011), pp. 61–62. The Swiss Patents Act provides a comparable, non-exclusive rights regime on biotechnological research tools. See in Article 40(b) letter F: “Any person who intends to use a patented biotechnological invention as an instrument or means for research is entitled to a non-exclusive licence.” Available at https://www.admin.ch/opc/en/classified-compilation/19540108/index.html. Accessed 15 May 2017.

New York Magazine. (2013). The cost of living. Stephen S. Hall. Retrieved May 12, 2017 from http://nymag.com/news/features/cancer-drugs-2013-10/index3.html.

Reichman, J. H. (2000). Of green tulips and legal kudzu: Repackaging rights in subpatentable innovation. Vanderbilt Law Review, 53(6), 1743–1798.

UNCTAD. (2011). Using intellectual property rights to stimulate pharmaceutical production in developing countries: A reference guide. UNCTAD/DIAE/PCB/2009/19. Retrieved May 15, 2017 from http://unctad.org/en/pages/PublicationArchive.aspx?publicationid=437.

Vandenbroeck, P., et al. (2016). Future scenarios about drug development and drug pricing. Retrieved May 12, 2017 from https://kce.fgov.be/sites/default/files/atoms/files/drugpricing_ENG_D30-06.pdf.

Title: Warner Lambert v Actavis: The Tricky Task of Examining Patent Infringement in New Medical Use Cases
Author: Christoph Spennemann
Publisher: Springer Singapore
Book: Intellectual Property and Development: Understanding the Interfaces
Print ISBN: 978-981-13-2855-8

Electronic ISBN: 978-981-13-2856-5

Copyright Year: 2019
DOI: https://doi.org/10.1007/978-981-13-2856-5_11