panel 2 - kevin Outterson
-
Upload
rea-brasil -
Category
Health & Medicine
-
view
163 -
download
2
description
Transcript of panel 2 - kevin Outterson
![Page 1: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/1.jpg)
Pharmaceutical Patent
Policy Options For Brazil
Kevin [email protected]
Associate Professor of Law
Boston University School of Law
1
![Page 2: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/2.jpg)
Topics
• Patent Failure
• Pharmaceuticals
• ACTA
2
![Page 3: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/3.jpg)
Topics
• Patent Failure
• Pharmaceuticals
• ACTA
3
![Page 4: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/4.jpg)
Why don’t patents work like
property?
Land
• Registry, third party verification, deference to fact-finders
• Physical possession
• Low risk of invalidity, title insurance
Patents
• Hidden claims, low quality opinion letters, little deference
• Scope broader than embodiments; patents and claims are cheap
• No insurance, relatively high risk of invalidity
Bessen & Meurer, BU Law: Patent Failure
![Page 5: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/5.jpg)
5
?
An expensive mistake!
The Notice Function of Property Law
![Page 6: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/6.jpg)
Notice Function of Patent LawKodak v. Polaroid
• Failed attempt to invent around
• Patent review started seven years before product launched
• 250 patents reviewed, “67 written and countless oral opinions”
• 50 potential imaging chemistries reviewed
• $900 million damages and interest (1980s)
6
![Page 7: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/7.jpg)
Evidence Suggests Much
Infringement Is Inadvertent
• Defendants are large, spend a lot on R&D, and
obtain a lot of patents (not classic pirates or free
riders) – only 4% are found to be copyists
• Increasing R&D increases hazard of lawsuit
7
![Page 8: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/8.jpg)
E-Data Lawsuits
• Freeny invented retail kiosk that would produce music recorded on cassette tapes
• Patent claim language was abstract, possibly covered all sales over the internet
• E-Data got the Freeny patent and asserted it against 75,000 e-commerce sites, licensed 139 companies, and filed 43 lawsuits
• Poor notice because meaning of claim language was unstable
• “Material object” (1980: cassette tape, 2000: hard drive?)
• “Point-of-sale location” (1980: store, 2000: home?)
8
![Page 9: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/9.jpg)
Search Cost
• Patent flood
– E-commerce firm faces b/w 4000 – 11,000 patents
– Semiconductor firm faces hundreds of patents
– 3G standard 7600 patents
• Perverse willfulness doctrine
• “Distant” plaintiffs
9
![Page 10: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/10.jpg)
Patent Failure 10
No industry overlap28%
Weakly overlapping industries
43%
Same primary industry29%
Parties to Lawsuit
![Page 11: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/11.jpg)
Evidence on search
• Cockburn & Henderson survey:
– 65% of firms do not conduct a patent search before
initiating product development
• 39% of applicants disclose zero prior art patents
(research personnel told not to read patents)
11
![Page 12: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/12.jpg)
12
0
500
1,000
1,500
2,000
2,500
3,000
3,500
1970
1972
1974
1976
1978
1980
1982
1984
1986
1988
1990
1992
1994
1996
1998
2000
2002
2004
2006
Patent Lawsuits Filed in U.S. District
Courts
![Page 13: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/13.jpg)
Suits/R&D ($b):
1987: 1.7
1999: 2.9
Patent Failure 13
Litigation Growth
![Page 14: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/14.jpg)
Pharma Offers Clearer Notice
• Lipitor: Trans-6-[2-(3- or 4-carboxamido-
substituted pyrrol-1-yl)alkyl]-4-hydroxypyran-2-
ones
• Olanzapine:
Patent Failure 14
![Page 15: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/15.jpg)
Technology Differences Suggest
Notice Problems
Probability
suit/patent
Claim Con-
struction
Value
($1,000)
All 2.0% 1.00 78
Chemical 1.1% 0.84 333
Biotech 3.2% 2.37 NA
SW 4.6% 2.18 55
BM 13.7% 6.67 NA
![Page 16: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/16.jpg)
Patent Reform to Improve Notice
• Make patents more transparent
– continuation reform
– better disclosure
• Better claim interpretation
– Specialized trial courts
– Expand PTO claim construction activity
– More deference to PTO and trial courts
• Robust definiteness requirement
• Limit remedies against innocent infringers
![Page 17: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/17.jpg)
Helpful Steps by Courts
• eBay -- increases bargaining power of defendants and reduces “patent tax”
• Seagate -- decreases deterrent to patent clearance
• Festo -- improves scope clarity
• KSR, In re Fisher -- stem patent flood
• In re Bilski -- decreases abstract claiming 17
![Page 18: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/18.jpg)
Implications for Brazil
• Don’t accept US IP law as the gold
standard
• Don’t accept standards tougher
than US law
• Look for local allies – industries
that might not be IP maximalists
![Page 19: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/19.jpg)
Pharmaceuticals
• Patent Failure
• Pharmaceuticals
• ACTA
19
![Page 20: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/20.jpg)
Static v. Dynamic Effects
• Static losses from higher prices
• Dynamic gains from sales incentivizing
R&D
• US deploys many balancing features
20
![Page 21: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/21.jpg)
Static v. Dynamic: Global
• Static losses are higher and dynamic
losses are lower in poorer countries (FM
Scherer & others)
• Welfare losses from differential pricing
failures are greater in countries with
higher Gini coefficients (Flynn, Hollis,
Palmedo, JLME 2009)
21
![Page 22: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/22.jpg)
Bottom Line:
Countries should exercise
significant flexibilities
in Rx patents based on
wealth & inequality
22
![Page 23: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/23.jpg)
US Rx Policy Debates
• Hatch-Waxman generic entry &
regulatory linkage in FTAs
• Biosimilar legislative debate in US
Congress: 5 v. 12 years of DE
• Ebay = liability rule = CL
• KSR & progeny = nonobviousness
• Reimbursement
23
![Page 24: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/24.jpg)
Bottom Line:
• Don’t accept anything
stronger than current US law
• Evaluate US IP flexibilities
24
![Page 25: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/25.jpg)
Post-TRIPS Rx Options 1
• Pipeline patents (Cendrowski, 2009)
• Article 31 CL (scope) (Outterson, 2009)
• Parallel importation/global exhaustion
rule (Outterson, 2005)
• Functional Article 31bis (Abbott &
Reichman JEL 2007; Goodwin AJLM 2008)
• Prizes (Love & Hubbard; Hollis & Pogge)25
![Page 26: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/26.jpg)
Post-TRIPS Rx Options 2
• Promote generics
–Reduce evergreening
–Improve generic quality
–Automatic substitution
–Insurance reimbursement rules
–Collusive settlements
26
![Page 27: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/27.jpg)
Post-TRIPS Rx Options 3
• Reverse linkage
• Global Orange Book
• Regional drug registration
• Liability rules (Ebay)
• Scope & obviousness
27
![Page 28: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/28.jpg)
Post-TRIPS Rx Options 4
• Reimbursement (Outterson & Kesselheim 2009;
Frank & Newhouse 2008)
• Conditions on clinical trials (HPV)
• Conflicts of interest in medicine &
research
• Conditions on university licenses
(UAEM)
![Page 29: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/29.jpg)
Regime Shifting II
• Patent Failure
• Pharmaceuticals
• ACTA
29
![Page 30: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/30.jpg)
ACTA
• Supplements WTO judicial model
with private enforcement
• Drive for substantive
harmonization
• Secret negotiations – 18th Century
diplomatic model
30
![Page 31: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/31.jpg)
ACTA
• Improperly conflates trademark,
pharmaceutical safety, patent
disputes (Outterson & Smith 2006; Outterson
2009)
• Dutch seizures of losartan & AIDS
medicines
• Goal is to hinder legal parallel trade
& CL in pharmaceuticals
![Page 32: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/32.jpg)
Bottom Line:
• No assurance that global public
health is a priority in ACTA
• Transparency
• Carve out pharmaceuticals &
patents
• Sean Flynn @ American
University - Law
![Page 33: panel 2 - kevin Outterson](https://reader033.fdocuments.us/reader033/viewer/2022051413/5594c30e1a28ab963d8b462e/html5/thumbnails/33.jpg)
Papers at ssrn.com
Kevin Outterson
[email protected] Professor of Law
Boston University School of Law
33