European Commission s strategy for single market Using Bolar and the SPC Wavier to Stimulate Growth in the EU Ravinder Chahil Director of Intellectual Property Polpharma Group SA 8 March 2016 Content Commission s Growth Agenda Proposals by the Commission SPC Wavier Summary and timelines Bolar State of play Models for amendment UK/ES 1
Growth Agenda (1) Commission Communication (28.10.15; COM(2015) 550; page 15) To strengthen EU-based manufacturing and competitiveness in industry sectors whose products are subject to regulated market authorisations, the Commission will explore a recalibration of certain aspects of patent and SPC protection. An SPC manufacturing waiver could allow the European generic and biosimilar medicines industries to create thousands of high-tech jobs in the EU and many new companies. An update of the scope of the EU patent research exemption would lead, among other things, to a smooth supply of active pharmaceutical ingredients throughout the Single Market. Growth Agenda (2) Commission Communication (28.10.15; COM(2015) 550; page 15) To strengthen EU-based manufacturing and competitiveness in industry sectors whose products are subject to regulated market authorisations, the Commission will explore a recalibration of certain aspects of patent and SPC protection. An SPC manufacturing waiver could allow the European generic and biosimilar medicines industries to create thousands of high-tech jobs in the EU and many new companies. An update of the scope of the EU patent research exemption would lead, among other things, to a smooth supply of active pharmaceutical ingredients throughout the Single Market. 2
Growth Agenda (3) Commission Communication (28.10.15; COM(2015) 550; page 15) To strengthen EU-based manufacturing and competitiveness in industry sectors whose products are subject to regulated market authorisations, the Commission will explore a recalibration of certain aspects of patent and SPC protection. An SPC manufacturing waiver could allow the European generic and biosimilar medicines industries to create thousands of high-tech jobs in the EU and many new companies. An update of the scope of the EU patent research exemption would lead, among other things, to a smooth supply of active pharmaceutical ingredients throughout the Single Market. Actions specified (Page 15): Growth Agenda (4) Actions: The Commission will come forward with initiatives to consolidate and modernise the intellectual property framework, including measures to support the use of intellectual property by SMEs. It will consult, consider and propose further measures, as appropriate, to improve the patent system in Europe, notably for pharmaceutical and other industries whose products are subject to regulated market authorisations. As announced under the Digital Single Market Strategy, it will review the EU intellectual property enforcement framework in 2016, supporting a follow the money approach to commercial-scale infringements. 3
SPC Regulation SPC Wavier - Advanced Manufacture Propose to modify regulation to permit acts of infringement that would permit; Stockpiling for eventual sale into the EU on day 1 ( Advanced Manufacture ) Export to patent free states ( Export ) Underlying patent right is unaffected. SPC Wavier Advanced Manufacture Product Number Days Advantage 0 of 9 products have US entry date advantage NA 9 of 9 products have an EU advantage of Average Advantage 1230 days 4
EU based industries SPC Wavier Advanced Manufacture Could then supply other states from within the EU Exploit the commitment to high quality as an export driver Jobs and Growth (See paper by Vicente & Simōes) State of play; SPC Wavier Advanced Manufacture Charles River impact study completed 23 February 2016 (awaiting publication) Parliament preparing its position paper on the SPC Wavier Original timetable was for a draft on the amendment by June 2016 (?). 5
Bolar Article 10 (6) Directive 2001/83/EC Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products. Implemented by Directive Differences between Member States; cf Italy vs UK See also Astellas v- Polpharma S.A. (Poland c.f Germany) Generic submissions under Directive 2001/83/EC A8 submissions (Clinical Trials) Health Technology Assessments Bolar 6
Bolar (UK) UK Patents Act Submissions during the 2012 consultation included the following costs and issues with the UK bolar: 60% of innovative molecules having some potential infringement Concerns on potential costs included: 5.6 million in potential litigation costs 135-900k in FTO work Stakeholders advised not to conduct trials in the UK Knock effects on CROs, clinical research and testing Concern that HTA studies outsourced outside the UK Admin burden of tech transfers, material transfer agreements. Respondents asked to bring legislation in line with Germany ( Clinical Trials ) Bolar (UK) (6D) For the purposes of subsection (5)(b), anything done in or for the purposes of a medicinal product assessment which would otherwise constitute an infringement of a patent for an invention is to be regarded as done for experimental purposes relating to the subjectmatter of the invention. - See SI 2005/2759 7
Bolar (UK) (6E) In subsection (6D), medicinal product assessment means any testing, course of testing or other activity undertaken with a view to providing data for any of the following purposes (a) obtaining or varying an authorisation to sell or supply, or offer to sell or supply, a medicinal product (whether in the United Kingdom or elsewhere); (b) complying with any regulatory requirement imposed (whether in the United Kingdom or elsewhere) in relation to such an authorisation; (c) enabling a government or public authority (whether in the United Kingdom or elsewhere), or a person (whether in the United Kingdom or elsewhere) with functions of Bolar (UK) (6E)(c) In subsection (6D), medicinal product assessment means any testing, course of testing or other activity undertaken with a view to providing data for any of the following purposes (i) providing health care on behalf of such a government or public authority, or (ii) providing advice to, or on behalf of, such a government or public authority about the provision of health care, (iii) to carry out an assessment of suitability of a medicinal product for human use for the purpose of determining whether to use it, or recommend its use, in the provision of health care. 8
Bolar (ES) Art 52.1 (b) in force on 01.04.2017 The rights conferred by a patent do not extend: (b) to acts carried out for experimental purposes relating to the subject matter of the patented invention; (c) to acts carried out to studies and trials necessary to obtain an authorization of pharmaceutical drugs in Spain or abroad and the corresponding practical requirements, including the preparation, obtaining and use of the active substance for such purposes. 9