Secondary Patents Compounds Alternative structural forms; formulations, compositions, dosages, combinations; uses • Product patents (not processes) Why Might Countries Try to Minimize the Grant of Secondary Patents? To avoid extension of periods of patent protection • Patents on alternative dimensions of existing molecules and drugs can extend periods of market exclusivity (“ever-greening” or “lif. [...] What are the broader implications of having this sort of pharmaceutical patent system? Why do they work? Why do they Persist? Institutional Design Political Economy: State-Society Dynamics Why do they • Easy to use – instructions work? • No inter-agency coordination • Not reinventing patent law • Aided by not being in PCT • Fewer apps to examine • Apps don’t arrive with preliminary reports Why do. [...] What are the broader implications of having this sort of pharmaceutical patent system? Secondary Pharmaceutical Patents are Difficult to Obtain in Argentina: Implications for Access to Medicines Pautas à lower likelihood of secondary patent. [...] Does the drug have a primary patent in Argentina? YES è Avoid extension of term, beyond the primary Secondary Pharmaceutical Patents are Difficult to Obtain in Argentina: Implications for Access to Medicines Pautas à lower likelihood of secondary patent. [...] Does the drug have a primary patent in Argentina? YES NO è Avoid extension of term, è Early local availability of the drug, while still patented in other countries beyond the primary Wait, not so fast! Local production of the API? NO YES è Argentine lab makes drug • First global “generic?” Do primary patents cover the drug in other countries? YES NO è How to get the API? è Import API or final drug.
- Pages
- 22
- Published in
- Switzerland
Table of Contents
- The Political Economy of Pharmaceutical Patent Examination 1
- Argentina in Comparative Perspective 1
- Ken Shadlen 1
- London School of Economics and Political Science LSE 1
- South Centre 8 May 2024 1
- Background Globalization of Pharmaceutical Patenting 2
- 20 40 60 80 2
- 100 120 140 2
- 1960 2
- 1965 2
- 1970 2
- 1975 2
- 1980 2
- 1985 2
- 1990 2
- 1995 2
- 2000 2
- 2005 2
- Context and Focus 3
- Variation in TRIPS implementation in theory and in practice Not just what can countries do law but why countries respond as they do and how patent systems function political economy 3
- Main areas of variation regarding TRIPSpharmaceuticals Compulsory licenses 3
- Examination practices 3
- Argentinas 2012 Examination Guidelines 4
- Modeled on UN Guidelines Correa 2007 4
- 13 different types of patents and patent claims for 4
- Instructions to examiners for what they should 4
- How to reject using traditional patentability criteria Followed a study of granted patents by Arg 4
- Issued as Joint Resolution between 2 Ministries and 4
- Went into effect 8 May 2012 clear beforeafter Preceded by 2002 guidelines against 2 medical use 4
- The Political Economy of Pharmaceutical Patent Examination 5
- Argentina in Comparative Perspective 5
- 4 questions 5
- 1. Are they effective 5
- 2. Why do they work 5
- 3. Why have they persisted 5
- 4. What are the broader implications of having this sort of pharmaceutical patent system 5
- Primary vs. Secondary Patents 6
- Compounds Alternative structural forms formulations compositions dosages combinations uses patents not processes 6
- Product 6
- Why Might Countries Try to Minimize the Grant of Secondary Patents 7
- To avoid extension of periods of patent protection 7
- Patents on alternative dimensions of existing molecules and drugs can extend periods of market 7
- Secondary patents deposited later expire later 7
- Minimizing Secondary Patents via Examination Previous Research 8
- Basic approach 8
- Pharma patent applications filed in country 8
- Code primary vs secondary 8
- Study national prosecution histories and outcomes data in-country research 8
- Minimizing Secondary Patents via Examination Previous Research 9
- Basic approach 9
- Pharma patent applications filed in country 9
- Code primary vs secondary 9
- Study national prosecution histories and outcomes data in-country research 9
- Main findings 9
- Brazil and India Restrictions on secondary patents having minimal direct effects on patenting outcomes Gaps between laws on the books and laws in practice 9
- Argentina Examination guidelines to be more effective in minimizing secondary patents Laws on the books and laws in practice more aligned 9
- Argentina findings in previous research only suggestive Included in just 1 of the articles small share of applications with final outcomes under new guidelines 9
- Additional research needed longer time series outcomes before and after guidelines introduced 9
- 1. Pharmaceutical Patent Applications in Argentina 10
- Only applications with final outcomes 10
- N3065 10
- 2. Distinguish Primary vs. Secondary Applications 10
- Coding guide expert consultant reads and code each claim of each application 10
- Classification at application level any primary primary 10
- 3. Identify Argentina outcomes PATSTAT and INPI-AR 10
- Outcomes grants vs. refusals vs. abandonedwithdrawn combining INPIs 3 sub-categories Dates of decisions before 8 May 2012 Old and after 8 May 2012 New 10
- 4. In-country research to understand processes June 2022 November 2022 July 2023 10
- Presentation and discussion of preliminary findings with stakeholders industry lawyers 10
- Building on previous research on pharmaceutical patents in Argentina Shadlen 2017 10
- Data and Research 10
- Before and After 11
- Final INPI Outcomes by type of application and guidelines 11
- Granted Refused AbanWith Total 11
- Primary 11
- Old 11
- 10.56 .14 89.30 100.00 11
- New 11
- 12.28 2. 82 84.90 100.00 11
- Secondary 11
- Old 11
- 5.67 2.39 91.94 100.00 11
- New 11
- 3.56 18.53 77.91 100.00 11
- Over Time 12
- Final INPI Outcomes by type of application and year 12
- Primary Secondary 12
- Probability of Grant by type of application and guidelines 13
- Old New 13
- More likely 13
- More likely 13
- Primary Secondary 13
- The Political Economy of Pharmaceutical Patent Examination 14
- Argentina in Comparative Perspective 14
- 4 questions 14
- 1. Are they effective 14
- 2. Why do they work 14
- 3. Why have they persisted 14
- 4. What are the broader implications of having this sort of pharmaceutical patent system 14
- To do Update with applications that were pending but now 14
- Alternative codings of applications e.g. Claim1 only Consider other characteristics of applications e.g. 14
- Conduct regression analyses with controls Main takeaway suggestive findings from Sampat and Shadlen 2017 are supported by additional research 14
- Why do they work Why do they Persist 15
- Institutional Design Political Economy State-Society Dynamics 15
- Why do they work 15
- Easy to use instructions No inter-agency coordination 15
- Not reinventing patent law 15
- Aided by not being in PCT Fewer apps to examine 15
- Apps dont arrive with preliminary reports 15
- Why do they persist 15
- Hard to attack in courts pautas not cited 15
- Coordination challenges for eliminating or revising Joint Resolution 15
- Why do they work Why do they Persist 16
- Institutional Design Political Economy State-Society Dynamics 16
- Why do they work 16
- Easy to use instructions No inter-agency coordination 16
- Not reinventing patent law 16
- Aided by not being in PCT Fewer apps to examine 16
- Apps dont arrive with preliminary reports 16
- Monitoring and oversight by local industry CILFA preliminary examinations of published applications 16
- Works with member firms on oppositions 16
- Challenge granted patents 16
- Informal epistemic alliance between industry civil servants academics Drahos in Reverse 16
- Internalization of the guidelines by INPI 16
- Why do they persist 16
- Hard to attack in courts pautas not cited 16
- Coordination challenges for eliminating or revising Joint Resolution 16
- National sector appears united in opposition to secondary patents and support of guidelines Power of local pharma in political arena creates a high price for change 16
- Stability Milei USTR 16
- The Political Economy of Pharmaceutical Patent Examination 17
- Argentina in Comparative Perspective 17
- 4 questions 17
- 1. Are they effective 17
- 2. Why do they work 17
- 3. Why have they persisted 17
- 4. What are the broader implications of having this sort of pharmaceutical patent system 17
- To do Update with applications that were pending but now 17
- Alternative codings of applications e.g. Claim1 only Consider other characteristics of applications e.g. 17
- Conduct regression analyses with controls Main takeaway suggestive findings from Sampat and Shadlen 2017 are supported by additional research 17
- Secondary Pharmaceutical Patents are Difficult to Obtain in Argentina 18
- Implications for Access to Medicines 18
- Secondary Pharmaceutical Patents are Difficult to Obtain in Argentina 19
- Implications for Access to Medicines 19
- Secondary Pharmaceutical Patents are Difficult to Obtain in Argentina 20
- Implications for Access to Medicines 20
- Wait not so fast 21
- Secondary Pharmaceutical Patents are Difficult to Obtain in Argentina 21
- Implications for Access to Medicines 21
- Argentinas 2012 Guidelines and Access to Medicines 22
- Final Observations 22
- Need more research on the global production and trade of API 22
