Intellectual Property Law in 20 Minutes UAEM National Conference Yale 14 Nov 2009.

Intellectual Property Law in 20 Minutes

UAEM National Conference

Yale 14 Nov 2009

Patent Allegories

What patents do

Where

Why

Process or

Product

Patents are legal rights to exclude…A1S1§8

Novel

Useful

Non-obvious

Some patents are asinine

Some patents are amazing

Why do we patent?

• Would you invest in a product that could be freely copied? – Exclusion = Monopoly

• But, without a real market– Exclusion = Deprivation

• Patents incent (32 ARVs!), but not in places without markets (0 TB rx!)

• HIV is exceptional (illuminates + obscures)

Global Agreement on Tariffs & Trade

World Trade Organization in 1994+

Trade-Related Aspects of Intellectual Property Rights (TRIPS)

All patent law is domestic, but there are international floors.

United States20 years to exclude exclude others from using, selling, copying…

Bayh-Dole pathway

Marks and Clerk, 2007 Biotechnology Report. London

Universities Patent

Global

1 Japan Science & Tech Agency 1022

2 University of California 5433 US Government 4434 Genentech Inc. 421

5 University of Texas 277

1 University of California54

32 US Gov't 443

3 University of Texas 277

4 Johns Hopkins University 154

5 Stanford University 148

6 Columbia University 137

7 University of Pennsylvania 133

8 University of Florida 132

9 Duke University 110

10 Wisconsin 102

11 University of Michigan 100

12 MIT 100

13 University of Washington 96

14 Yale University 93

15 University of Minnesota 84

16 New York University 80

17 University of Illinois 79

18 Harvard University 75

Global Biotech Assignees US Not-for-Profit Assignees

Univ. Outputs...reading 1Abacavir – Minnesota

AZT – NCI

FTC/3TC - Emory

Enfurvitide – Duke/UCSF

Darunavir – U Ill Chicago, NIH

Didanosine – NIH

Stavudine – Yale

25 ARVs – no public support

Univ. Outputs…reading 2Universities do 1/6 R+D in US; ½ basic science.

(Nat'l. Sci. Bd. Sci. and Eng. Indicators 2004, at 5-5, 5-8; Mowery et al. “Growth of Patenting and Licensing by US Univ.” 30 Res. Pol'y 99, 101 (2001))

“At least a third of drugs marketed by the major drug companies are now licensed from universities or small biotech companies, and these tend to be the most innovative.” (Angel, Marcia. “The Truth About the Drug Companies. NY Review of Books. Vol. 51. No. 12, p. 4, citing An Industry in Evolution, 3rd ed., Mary Jo Lamberti, ed. CenterWatch, 2001. p. 22.)

15 of the “most important” drugs sold between 1965 and 1992 “were developed using knowledge and techniques from federally funded research.” (Congressional Joint Economic Committee [Senator Connie Mack, chair]. “The benefits of medical research and the role of the NIH.” May 2000.)

Now, we’ve got a molecule…

…Inventor + Lawyer + $$ + USPTO + 3 years…

Twenty – Ishirini – Vingt

How does my goofy government’s decision to grant a monopoly on laser-mediated cat exercise…bind someone in Durban?

Well…

Patent law is domestic.

But, the Uruguay Round requires everyone in the WTO (everyone) implement TRIPS.

India became fully compliant in 2005. Now, it must honor product and process patents (formerly just process). One files multiple applications, to exclude in multiple places.

LDCs (derived by algorithm) have until 2013, but some move toward anti-counterfeiting now

Excluded: Kenya, Nigeria, Namibia, Botswana, South Africa, India, China, Cameroon

Where do we patent?

• UCSF – OECD + Japan• Emory – “India and China are viable

markets”• UT - ?• Gilead – “ZA + India are least

developed”• U U? • In the end, countries with manufacturing

capacity are crucial (multiplier)• Drug-specific

So…

• Patents are value-free rights to exclude someone from using your technology– Most have zero impact; some are powerful

• Patents incent risky investment– But not in weak/failing markets

• Patenting in India has multiplier effect• Universities patent biotech innovations

TDF v. d4tNucleoside reverse transcriptase inhibitor X XSevere Lypodystrophy & hyperlypidemia XSuperior Viral Suppression XPeripheral Neuropathy XOn US list of recc’d therapies 2001 2001On US list of recc’d therapies 2002 2002On US list of recc’d therapies 2003 2003On US list of recc’d therapies 2004 On US list of recc’d therapies 2005 On US list of recc’d therapies 2006On US list of recc’d therapies 2007On US list of recc’d therapies 2008On US list of recc’d therapies 2009Clinton Foundation 2009 LI price/unit $0.28 $0.04

d4t+3tc+NVP

“Second” Lines

• Necessary after 3-5 years, or immediately

• Newer, more complicated to make, more expensive

• Patented in more countries – Boehringer never enforced

NVP

• Demand rising sharply

Gilead’s 13 x 95

• Gilead sells rights to make, sell, use, Tenofovir to 13 generic producers in India

• Registration in >70 countries• Includes ZA, India + 93 others

(excludes Brazil)

Compulsory LicenseLicensing a patent allows someone else to use/make/sell it. When negotiations break down, a government can issue a compulsory license.

South Africa flirted….Thailand completed…Ecuador considers…2001 DOHA DeclarationParagraph 5:

(b) Each Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted. (c) Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.

Kaletra!Every protease inhibitor requires boosting with Ritonavir ([ ]/r)

Abbott makes RitonavirAbbott makes LopinavirGlaxo makes FosemprenavirBMS makes AtazanavirTibotec/JJ makes DarunavirMerck makes Indinavir

Everyone needs ritonavir, so Abbott quadruples the price

Thailand wants some LPV/rThai officials fail to negotiate acceptable price with Abbott

Thai government issues compulsory license in 2007

Abbott withdraws 7 pending applications from Thailand"I'd like to underline that we have to find a right balance for compulsory licensing…We can't be naive about this. There is no perfect solution for accessing drugs in both quality and quantity." WHO Director-General Dr. Margaret Chan

"Compulsory licensing is the only way we could attract them to sit down and talk with us over price reduction…We will continue to talk with them until we reach the point where we can optimize the accessibility of the drugs to the Thai people." Thai Health Minister Mongkol Na Songkhla

So…

• Patents got us Tenofovir, d4t…• Absence of patent assertion got us cheap

d4t • Patent sub-licensing will lead to cheap TDF• You can patent anywhere (but you won’t)• Your patents are like your running shoes –

where are you going, and to do what?• Patent Pools, 9am tomorrow

Hanging Chads

• FTAA, TRIPS+• Gleevac (Novartis CML)