Data Exclusivity and Marketing Protection

Transcription

1 Data Exclusivity and Marketing Protection International Conference Innovation and Competition in Life Sciences Law University of Basel, Faculty of Law, 9 June 2017 Professor Dr iur Claudia Seitz, M.A. (London), Attorney-at-Law, University of Basel, Faculty of Law

2 Outline I. Background II. III. IV. IP Protection vs Data Exclusivity Data Exclusivity and Marketing Exclusivity Competition Law Assessment V. AstraZeneca (Losec) VI. Conclusion Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 2

3 I. Background bringing a new drug on the market reqquires marketing authorization = approval of authority(ies) requirements for marketing authorization / R&D include drug discovery efficacy confirmatio n preclinical studies clinical studies (phases I, II, III) review/ approval high investments in time and money investment in time on average it takes years to discover and develop a new drug investment in money on average it takes years to discover and develop a new drug compared to other industries the pharmaceutical industry needs high investments compared with market authorization requirements Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 3

4 II. IP Protection vs Data Exclusivity patents / SPCs = exclusive right to prevent others from expoiting an invention without the consent of the patentholder patent term: 20 years from filing date patent protected invention cannot be used without market approval patent may only have a few years of protection left limitation of use of patent term need for a patent-term-extension mechanism to compensate for the time lost in obtaining market approval Supplementary Protection Certificate (SPC) drug innovator shall be incentivized for time lost in obtaining market approval in order to develop new drugs data exclusivity = protection of drug clinical data submitted to the authorities for market approval to prove safety and efficacy under the protection of data exclusivity the data cannot be relied on by other companies for a certain period of time for obtaining market approval without the holder s authorization after the period other companies may apply for market approval using the same data and avoid the costs associated with generating their own data 3 however: other companies are not precluded from generating their own data to obtain market approval market entry cannot be prevented Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 4

5 II. IP Protection vs Data Exclusivity patents / SPCs = exclusive right to prevent others from expoiting an invention without the consent of the patentholder patent term: 20 years from filing date patent protected invention cannot be used without market approval patent may only have a few years of protection left limitation of use of patent term need for a patent-term-extension mechanism to compensate for the time lost in obtaining market approval Supplementary Protection Certificate (SPC) drug innovator shall be incentivized for time lost in obtaining market approval in order to develop new drugs data exclusivity = protection of drug clinical data submitted to the authorities for market approval to prove safety and efficacy under the protection of data exclusivity the data cannot be relied on by other companies for a certain period of time for obtaining market approval without the holder s authorization after the period other companies may apply for market approval using the same data and avoid the costs associated with generating their own data 3 however: other companies are not precluded from generating their own data to obtain market approval market entry cannot be prevented Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 5

6 II. IP Protection vs Data Exclusivity patents / SPCs data exclusivity = exclusive right to prevent others from expoiting an invention without the consent of the patentholder = protection of drug clinical data submitted to the authorities for market approval to prove safety and efficacy exclusivity is absolute exclusivity is relative Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 6

7 II. IP Protection vs Data Exclusivity patent, SPC and data exclusivity term of patent protection (20 years) time SPC for x months./. 5 years duration of admission procedure for market authorisation (x months) data exclusivity / protection of data package granting of patent / start of patent protection approval / granting of market authorization (day if approval = day for placing th product on the market) end of patent proctection / start of SPC protection end of SPC protection Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 7

8 II. IP Protection vs Data Exclusivity specific regulations in the regulatory environment of pharmaceutical products data exclusivity 8+2 (+1) formula European Bolar exemption sunset clause data protection (exclusivity) of originator products permits to access data of a generic application but the generic version cannot be launched until the completition of the ten-year period originator products are granted a 8-year data exclusivity and 2-year market exclusivity additional 1-year is granted for new product indications permits research and initiation of generic activities prior to patent expiry possibility to cancel market authorization for pharmaceutical products that have not been in the market for 3 years after authorisation Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 8

9 III. Data Exclusivity and Marketing Exclusivity data exclusivity and marketing exclusivity according to the EU Commission data exclusivity marketing exclusivity = «period during which the dta of the original marketing authorisation holder relating to (pre-) clinical testeing is protected. Accordingly, [ ] data exclusivity refers to the eight-year protection period during which generic applicant may not refer to the information of the original marketing authorisation holder.» = «ten-year period after which generic products can be placed on the market.» [after 2005] [8 years data exclusivity + 2 years Marketing exclusivity (+ 1 year for a new indication)] Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 9

10 III. Data Exclusivity and Marketing Exclusivity data exclusivity and marketing exclusivity data/marketing exclusivity formula: (+ 1) 8 years 2 years 1 year data exclusivity marketing exclusivity generics application generics launch Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 10

11 III. Data Exclusivity and Marketing Exclusivity To what extent (scope and time) should other pharmaceutical companies (generic companies / competitors) be allowed to refer to the data? qestions regarding data exclusivity Is it unfair if competitors rely on the data without cost taking into consideration the high investments (time and money)? Should it be possible to competitors to rely on the data (against cost) due to «ethical» aspects (Declaration of Helsinki considers the duplication of clinical trials of human research projects as unethical and according to the legislation in the field of animal welfare duplication of vertebrate studies is prohibited)? Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 11

12 IV. Competition Law Assessment 3 types of in pharmaceutical markets therapeutic generic inter-brand between new, patented and innovative products of R&D companies between nonpatented versions of leading products on the market of generic companies between parallel imports of cheaper products from lowpriced MS into higher priced MS Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 12

13 IV. Competition Law Assessment 3 types of in pharmaceutical markets therapeutic generic inter-brand = between new, patented and innovative products additional specific protection due to regulatory data protection exclusivity for new pharmaceutical products law encourages innovation for these products as well: certain types of joint research and development, licensing, comarketing and co-distribution are exempted under the BERs (as long as the advantages of cooperation outweigh any negative impact on ) Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 13

14 IV. Competition Law Assessment 3 types of in pharmaceutical markets therapeutic generic inter-brand = between non-patented versions of leading products on the market of generic companies (= inter-brand ) once IP and data protection has been expired major and substantial impact on prices for pharmaceutical products in general for generic products as successor products (not for biosimilars) Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 14

15 IV. Competition Law Assessment 3 types of in pharmaceutical markets therapeutic generic inter-brand = between parallel imports of cheaper products from lowpriced MS into higher priced MS pro-parallel approach of the EU Commission (free movement of goods) Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 15

16 IV. Competition Law Assessment «EU s pharmaceutical are not working well: fewer new medicines are being brought to market, and the entry of generic medicines seems to be delayed» Pharma Sector Inquiry (2008): «examination whether agreements, such as settlements in patent disputes, have blocked or lead to delays in market entry and whether they have created artificial barriers to entry (through misuse of patent rights, vexatious litigation or other means)» findings of the EU Commission s final sector inquiry report (2009) market entry of generic drugs is delayed decline in the number of novel medicines reaching the market «the sector inquiry suggests that company practices are among the causes, but does not exclude other factors such as shortcomings in the regulatory framework» Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 16

17 III. Strategic Patenting and Registration? patent clusters and patent thickets «evergreening» as part of lifecycle management intervention in national regulatory processes pay for delay agreements / patent settlement agreements law infringements misleading registration information strategic use of litigation «tool box» (EU Commission): overall strategy: block generic market entry TFEU 101: restriction by object? TFEU 102: misuse of dominant position? Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 17

18 IV. Shortcomings in other Legal Frameworks? patent and registration strategies: law infringement or «shortcoming» in the legal framework? patent law (patents, SPC) other legal frameworks... «shortcoming» in the legal framework? regulatory law / (market authorization) social security law (eg reim-bursement re pharmaceutical products) Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 18

19 V. AstraZeneca (Losec) ECJ upheld Commission decision that AZ had abused ist dominant position for Losec in two ways: AZ made misleading representations to certain patent offices in Europe to obtain or maintain supplementary protection certificates (SPCs) that extended the exclusivity for Losec to which it was not entitled or only for a shorter duration AZ misused the regulatory system, by submitting requests for deregistration of the marketing authorisation for Losec capsules in certain MS in order to block or delay the entry of generic products replicating AZ s Losec and to prevent parallel imports of Losec first case in which to novel abuses were held to infringe TFEU 102 and the first time that the ECJ ruled on an abuse of a dominance case in the pharmaceutical sector Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 19

20 V. AstraZeneca (Losec) Supplementary Proctection Certificate (SPC) term of patent protection (20 years) time SPC for x months./. 5 Jahre duration of admission procedure for market authorisation (x months) data exclusivity / protection of data package EU Commission: AZ has indicated the «date of the first pricing decision» instead of «date of the first authorisation to place the product on the market» in order to obtain a longer period of protection misleading representations to the patent offices of certain MS in order to obtain or maintain SPCs for Losec purpose of extending patent protection to which ist as not entitled in oder to block generic outside the scope of «on merits» Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 20

21 V. AstraZeneca (Losec) open questions: misleading representations to obtain or maintain SPCs misuse of the regulatory system by deregistration of marketing authorisation for Losec capsules a simple mistake in communication with the patent office is unlikely to be enough to find an abuse highly misleading represantations made with the aim of leading public authorities into error is abusive it remains unclear as to what behaviour will amount to abusive conduct between these two extremes deregistration abuse is of limited relevance because of the change in the laws to avoid a repetition of the AZ case BUT: question remains whether and if yes, to what extent a dominant position leads to an obligation to maintain market authorisations for simplified authorisation procedures for competitors (generic companies) Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 21

22 VII. Conclusion Marketing authorisation procedures are in general national authorisations and have not (entirely) displaced by processes of decentralisation and harmonisation. This has an impact on the inter-brand (parallel trade). There a (still) significant regulatory barriers to free movement and in the EU MS. In the future biopharmaceutical products will play an increasingly important role due to new therapeutic possibilities. However, the successor products (biosimilars) will to a large extend not be in the scope of the discussion on data and marketing exclusivity. Competition law should not be used as a tool to cure mistakes for shortcomings in other legal frameworks. Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 22

23 Thank you! contact: Professor Dr. iur. Claudia Seitz, M.A., Attorney-at-law Faculty of Law, University of Basel Center for Life Sciences Law (CLSL), Peter Merian-Weg 8, CH-4002 Basel/Switzerland tel mail Claudia Seitz Data Exclusivity and Marketing Protection University of Basel Law Faculty 23