Comparison of the Non-patent Drug Exclusivities Available in the United States, Canada, Europe and Japan

Transcription

1 Comparison of the Non-patent Drug Exclusivities Available in the United States, Canada, Europe and Japan The International Economic Forum of the Americas Serge Lapointe, Ph.D. Partner, Patent Agent June 14, 2012

2 Introduction Drug development is long and very complex Only 1 out of 10,000 molecules 1 billion $ 1 medicinal product 0 5 yrs 10 yrs 15 yrs 20 yrs 25 yrs 10 years of research Commercialization 2

3 Introduction Exclusivity drives the pharmaceutical industry Innovators vs. Generics With different laws, governments try to achieve a balance: Need for new drugs vs. medicines at low cost 3

4 Introduction Drug development is long and very complex Real period of patent exclusivity and possible return on investment 1 medicinal product 0 5 yrs 10 yrs 15 yrs 20 yrs 25 yrs 10 years of research Commercialization Patent Expiry 4

5 Introduction Patents are not always available or the best vehicle Alternative form of protection exists and are essential for the pharma industry: «data exclusivity» cannot apply to the regulatory authorities «marketing exclusivity» no authorization granted by the authorities Essential in the life-cycle management of pharmaceuticals 5

6 United States

7 UNITED STATES World s largest market for pharmaceuticals Largest number of drug-related exclusivities Exclusivities for Innovators (6) Exclusivity for Generic companies (1) Biosimilar Biological Products 7

8 UNITED STATES Exclusivities for Innovators 30-Month Stay Under the Hatch-Waxman Act Legal regime by which the U.S. Food and Drug Administration (FDA) may be prevented from issuing an Abbreviated New Drug Application (ANDA) to a generic company Brand companies must list their patent(s) in the Orange Book When filing their ANDA, generic companies must address the patent(s) listed in the Orange Book If statement that the patent is invalid or will not be infringed, FDA will have to wait for a 30-month period before approving the ANDA 8

9 UNITED STATES Exclusivities for Innovators New Chemical Entity Exclusivity Available for any new drug containing a new chemical entity (NCE) Five (5) years of data and marketing exclusivity No approval of Abbreviated New Drug Application (ANDA) Orphan Drug Exclusivity Awarded only to drugs intended for the treatment of «rare disease or condition» Affecting less than 200,000 individuals in the U.S. No reasonable expectation of recovering development costs Seven (7) years of marketing exclusivity FDA is prevented from approving the same active drug for the same indication 9

10 UNITED STATES Exclusivities for Innovators New Use or New Formulation Exclusivity (New Clinical Study Exclusivity) Awarded only to drugs products that depend on new clinical investigation to support new therapeutic claims New formulations New indications of existing drug Three (3) years of marketing exclusivity FDA is prevented to approve an ANDA Pediatric Exclusivity Adds a six-month of marketing exclusivity to ANY existing exclusivity General exclusivity extension added to the end of any non-patent exclusivity Adds to the life of patented drug products listed in the Orange Book 10

11 UNITED STATES Exclusivities for Innovators Patent Term Extension or Patent Term Restoration Up to five (5) years to compensate for the delay before approval of the drug Limitations: The extension requires a valid and unexpired patent Only one patent may be extended per approved drug Extension period calculated on a day-by-day basis and is based on time spent in trials and time spent by FDA review Maximum of 14 years of patent term from the date of approval of the drug Advisable for the patentee to expedite issuance of the patent in order to maximize its extension 11

12 UNITED STATES Exclusivities for Generic Companies 180-Day Generic Product Exclusivity Aims to remove weak or non-infringed patents Available to the first generic company who successfully challenges the enforceability of a patent listed in the Orange Book Race to the market: 180-day period starts when the drug is first commercialized During the exclusivity period no other generic version of the same drug can be marketed Single most important motivator for the generic industry to challenge pharmaceutical patents 12

13 UNITED STATES Biosimilar Biological Products Top 10 Drug Products by Sales in 2014 Rank Product Company Technology WW Sales (m$) 1 Avastin Roche Monoclonal antibody 9,232 2 Humira Abbott & Eisai Monoclonal antibody 9,134 3 Rituxan Roche Monoclonal antibody 7,815 4 Enbrel Wyeth, Amgen & Takeda Recombinant product 6,583 5 Lantus Sanofi-Aventis Recombinant product 6,386 6 Herceptin Roche Monoclonal antibody 5,796 7 Crestor AstraZeneca Small molecule chemistry 5,739 8 Spiriva Boehringer Ingelheim Small molecule chemistry 5,552 9 Remicade SGP, J&J et Mitsubishi Tanabe Monoclonal antibody 5, Gleevec/Glivec Novartis Small molecule chemistry 5,136 13

14 UNITED STATES Biosimilar Biological Products New legislation enacted in 2010 to encourage innovation and promote competition for biological products Highly complex and many ramifications Two pathways: Biosimilars and Interchangables FDA regulatory approval requirements Newly available exclusivities Innovators: Up to 12 years of exclusive use of a reference biological products before biosimilars can be approved for marketing Generics: Exclusivity for the first product determined to be interchangeable with a pioneer reference biologic Can range from one (1) year after the first commercialization Up to forty-two (42) months after approval 14

15 Canada

16 CANADA Pharmaceutical sector is one of the most innovative and profitable industries 3% share of the global market 9 th largest world market Shared by brand-name and generic drug companies More than 390 pharmaceuticals More than 400 biotechs Mechanisms of protection much less extensive than the U.S. 16

17 CANADA Patented Medicine (NOC) Regulations Many similarities with the 30-month stay in the U.S. Brand companies must list their patents for an approved drug on the Patent register When filing an abbreviated new drug submission (ANDS) the generic companies must address the patents listed on the Patent register If the generic challenges the validity or infringement of the patent, the innovator may apply to the court for an order prohibiting the minister (Health Canada) Minister can not issue a NOC to the generic for a period of up to 24 months 17

18 CANADA Innovative Drugs Eight-year exclusivity protection for innovative drugs approved after June 17, 2006 a drug that contains a medicinal ingredient not previously approved in a drug by the Minister is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph Six (6) years of data exclusivity, plus Two (2) years of marketing exclusivity May subjected to further six-month extension for pediatric studies 18

19 CANADA Patent Term Restoration 20 years of patent protection under the Canadian Patent Act Unlike most industrial countries, NO patent term restoration or patent term extension in Canada 19

20 CANADA Subsequent-Entry Biologics Subsequent-Entry Biologics (SEBs) correspond to U.S. biosimilars Defined as a biologic product that is similar to and would enter the market subsequent to an approved innovator biologic product NO Exclusivity: SEBs are not considered to be innovative drug and cannot qualify for data protection SEBs are subject to regulatory restrictions about data protection awarded to another innovative product SEBs are subject to the NOC Regulations 20

21 Europe

22 EUROPE New Chemical Entity Most generous system for drugs submitted for authorization on or after November 1, 2005 Up to 11 years of exclusivity for a new chemical entity (NCE) Harmonized formula: 8 years of data exclusivity for an NCE Additional 2 years of marketing exclusivity and 1 additional year of marketing exclusivity if the new product is for treating a significant new indication 22

23 EUROPE Orphan Drugs and Pediatric Exclusivity Orphan drugs Disease affects no more than 5 people out of 10,000 in the European Union 10 years of marketing exclusivity from the date of approval An additional 2 years of market exclusivity can be granted to pediatric orphan drugs (i.e. total of 12 years) Pediatric Exclusivity Available for patented pediatric drugs Additional six-month extension to existing patent term extensions (SPCs) 23

24 EUROPE Patent Term Extension Patent term extensions may be obtained for pharmaceutical products through a Supplementary Protection Certificate (SPCs) Duration: Time lost between the filing date of the patent application and the date of first regulatory approval, minus 5 years Maximum term of SPC is 5 years 24

25 Japan

26 JAPAN The second-largest pharmaceutical market in the world Different legal mechanisms of exclusivity for innovators Up to 8 years of protection for NCEs (data exclusivity) 4-6 years of data exclusivity for certain improvements 10 years of data exclusivity for orphan drugs Up to 5 years of patent term extension 26

27 Summary of Non-patent Exclusivity or Patent Term Extension for Drugs Duration Type of Exclusivity or Extension U.S. Europe Japan Canada Delay by health authority approval 30 mths X X 24 mths New Chemical Entity (NCE) 5 yrs yrs 8 yrs 8 yrs Orphan Drug 7 yrs yrs 10 yrs X Pediatric 6 mths 6 mths 2 yrs 6 mths New Use or New formulation 3 yrs X 4/6 yrs X Patent Term Extension Max. 5 yrs Max. 5 yrs Max. 5 yrs X Biosimilars Max. 12 yrs same as NCE same as NCE X 27

28 Conclusions Pharma business model is challenged Increasing cost for R&D Longer clinical trials Lesser approval Patent expiration and litigation Sufficient time to recoup investment? How to attract companies and investors? 28

29 Conclusions Need for greater intellectual property protection in Canada Deficiencies in data protection and marketing exclusivities Only G8 country with no patent term extensions Shortcomings to be corrected as part of the ongoing negotiations of a free-trade agreement between Canada and the European Union? 29

30 Thank you! Serge Lapointe, Ph.D. Partner, Patent Agent DM