Pharmaceutical Innovation and Regulatory Data Protection Friends or Foes?

Transcription

1 Pharmaceutical Innovation and Regulatory Data Protection Friends or Foes? Meir Pugatch, EIPIN Meeting, Munich, April 2015

2 Presentation overview The value of pharmaceutical innovation IP and pharmaceutical IPRs the eternal debate Demystifying regulatory data protection (RDP) RDP, innovation and access open questions with some initial data RDP and future outlook biologics and biosimilars

3 HIV/AIDS Survival functions: 1993 vs Prob. of survival 90% 80% 70% 60% 50% 40% 30% 20% 10% 54% 3% Survival function 1/1/1993 Survival function 1/1/2000 0% Years since diagnosis Source: Frank Lichtenberg, Presentation to the Stockholm Network, 2008

4 Pharmaceutical innovation saves lives! 25% Trends in CVD-related events in 14 countries 20% 19,50% % % 11% 8,40% 5% 4,60% 4,80% 0% No. of deaths due to heart attack during hospitalization No. of heart attack cases up to 6 months following hospitalization 2% No. of heart failure or pulmonary edema during hospitalization Source: K.A. Fox et Al., 2007; Analysis: Pugatch-Consilium, 2014

5 Pharmaceutical innovation saves money! Drug utilization and hospital utilization by AIDS patients prescriptions per patient hospital admissions per patient Source: Frank Lichtenberg, Presentation to the Stockholm Network,

6 Pharma sector is unique 800mil -1.5bil ($US) average R&D costs years average duration of R&D process 1:5,000 chances of success, 1:3 chances for ROI 7-10 years effective exclusivity period 1.2 years average time for market entry of follow on competing product A sector in which companies are competing against their own products (generics) Up to 80% reduction in global sales following generic market entry

7 FDA approvals NMEs (chemical drugs) BLAs (biological drugs) Source: Pharma Marketing Blog, 2015

8 We are talking about big money Top 10 blockbuster drugs to lose exclusivity in 2015: Brand name MAH Patent expiry date (US) Global sales (2013) 1 Abilify Otsuka/BMS April 2015 $8.03 Billion 2 Lantus Sanofi February 2015 $7.34 Billion 3 Glivec Novartis July 2015 $4.69 Billion 4 Neulasta Amgen October 2015 $4.39 Billion 5 Epogen/Procrit Amgen/Janssen May 2015 $1.95 Billion (Epogen) 6 Integrilin Merck May 2015 $1.86 Billion 7 Baraclude BMS April 2015 $1.57 Billion 8 Tracleer Actelion November 2015 $1.57 Billion 9 Namenda Actavis April 2015 $1.53 Billion 10 Zyvox Pfizer May 2015 $1.35 Billion

9 IPRs mitigate the risks of failure by protecting success Source: PhRMA, Biopharmaceutical Research Industry Profile, 2013.

10 Yet IPRs are part of the existential debate regarding to access to medicines Hypothetical illustration of the access dilemma R&D costs of a new vaccination Production cost per vial No. of patients able to pay up to $300 per package No. of patients able to pay up to $100 per package Innovative drug $1,000,000 $10 5,000 5,000 Generic drug $100,000 $10 Price Therefore of drug at cost Big Pharma is $110 while $20 generic ma Which one is the good/bad guy?

11 Patents Major IP forms in the pharma sector Patent Term Extension (PTE/SPC) extends protection term by up to 5 years from the date of patent expiration Regulatory data protection (RDP) Orphan & Pediatric drugs exclusivity same as data exclusivity, but cover rare diseases and children 7 years in the US, 10 years in the EU Trademarks

12 RDP in context A relatively new form of intellectual property (first introduced in the US in 1984) A NON standardized form of intellectual property different scope, terms, form and strength of protection Subject to serious debates, but also to some confusion. Rising regulatory and economic significance globally!

13 RDP: What is it and why do we need It? RDP is a specific type of IPRs to protect biopharmaceutical and agriculture products Aimed at protecting and safeguarding proprietary data gathered and collected during clinical testing of a product Allows innovator to prevent third parties from relying on data Legal and economic rationale for RDP based on concept of trade secrets TRIPS article 39.3 requires member states to protect data from unfair commercial use (though does not specify the time period, nor the scope of protection)

14 RDP and clinical development Source: Pugatch Consilium (2014)

15 Patents Vs. RDP Patents - Market exclusivity derives from the LEGAL right of the patent owner to prevent others from using the subject matter of the patent without his/her consent RDP- Market exclusivity derives from the COST & TIME associated with the creation of a pharmaceutical registration file

16 Non-disclosure and Non-reliance Two layers of protection of RDP: 1. Non-disclosure: Aims to ensure that rival companies do not gain access to original product registration file 2. Non-reliance: Aims to prevent a generic substitute relying on and benefiting from an approved registration file e.g. for bioequivalence tests Layer of reliance (indirect vs. direct) has generally been basis for different interpretations on unfair commercial use of submitted clinical data This has been the case in developed mature markets as well as emerging and developing countries

17 Periods and scope of RDP still vary in different countries Developed countries between 8 to 12 years EU RDP provided by Article 10 of Directive 2004/27/EC (amending 2001/83/EC) New pharmaceutical products 8+2 formula: 8 years data exclusivity 2 years of marketing exclusivity (in which generic companies would be allowed to submit bio-equivalence tests); and additional year of protection for new indications Developing countries between 0 to 6 years for submitted clinical data

18 Source: GIPC and Pugatch Consilium (2014)

19 Source: GIPC and Pugatch Consilium (2014)

20 Open questions still remain Market exclusivity How many drugs in a given country are sensitive to RDP in terms of the exclusivity period? In which cases would the exclusivity of RDP extend beyond the term of patent protection? Protection How many drugs rely on test data protection as their primary mode of IP protection (Taxol ) Prices What are the implications in terms of the costs of drugs as a result of RDP in a given country (will prices increase?) Access How many drugs are not registered in a given country due to the lack of RDP, what are the implications for public access? Investments in clinical research What is the link between RDP in a given country and investments in clinical trials in the healthcare centers in that country?

21 IP and RDP do impact CTs intensity in different countries Source: Pugatch Consilium (2014)

22 RDP Biologics and Biosimilars Overall, the generic industry aimed at chemicallysynthesized, small-molecule drugs For Drug Regulatory Authorities (DRAs), generic approval pathway was quite straightforward, based mostly on bioequivalence tests However, biological drugs comprise of large and complex structures whose full characterization and precise replication is extremely difficult, if not impossible Hence, follow-on biosimilars cannot be considered as generic, nor be approved by the same pathway

23 New pathways are formed Among developed countries, designated legislative and regulatory pathways were formed for the assessment & evaluation, approval and monitoring of biosimilars Country/R egion DRA Biosimilar pathway year of introduction Key highlights EU EMA 2004 In 2006 adopted guidelines on quality, non-clinical and clinical expectations for similar biologic medicinal products US FDA 2014 Different terminology: +10 follow-on biologics available since 1997 Canada Health Canada 2010 Biosimilars are referred to as Subsequent Entry Biologics (SEBs); permits entry for Biosimilars even if reference product is not registered in Canada

24 EU Biosimilars approved in major markets 10 US (as follow-on biologics) 8 6 Australia Japan Canada 3

25 RDP terms for biologics in selected countries US 12 EU 10+1 Japan 8 Canada 8 Australia 5 Israel

26 To conclude RDP is here to stay and is likely to increase in geographical scope (i.e. more countries will adopt RDP) In most cases, patents will still remain the dominant IPRs form for pharmaceuticals (esp. in developing countries) Still, for the more complex and sensitive drugs, or for drugs that do not benefit from patent protection in a given country, RDP will become essential for development and launch RDP will become especially important in the context of biologics and biosimilars