1. 10th Annual Niro Lecture: Society, Social Contract and the Patent Office Professor Peter Drahos Centre for Governance of Knowledge and Development The Australian National University, Canberra DePaul Center, Chicago 15 March 2007

2. Current governance of the European patent system insider governance European patent system Patent Attorneys EPO Big business users governance

3. Separation of powers approach to governance European patent system Target concentrations of power Transparency balance External audit process Transparency registers

4. Traditional models of governance State Law Food safety Pharmaceuticals Aviation etc

5. Modern networked governance model Public or private actor State Public or private actor

6. WTO’s Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) Japanese multinationals with large IP portfolios United States multinationals with large IP portfolios World Trade Organization TRIPS European multinationals with large IP portfolios USTR

7. Doha Declaration on TRIPS and Public Health NGOs eg MSF Oxfam Public health advocates Civil society activists Developing country governments Developed country governments

8. A transparency balance: existing model Patent Office Policy Committees Advisory Committee PO staff Big users, patent attorneys PO acts as a secretariat for Review/Inquiry filtering effect

9. Patent Office Policy Committees Advisory Committee PO staff Big users, patent attorneys Users of patented technologies Scientists Open source A transparency balance: membership and appointment to committees transparent

10. Patent quality: an external audit check litigation opposition Granted patents (100%) EPAC EP Companies Scientists Health NGOs Software organizations EPO internal audit process

11. ‘even experts have trouble making accurate searches’ Generic drug company enters patent system here Patent granted

12. Transparency Registers Generic drug company enters patent system here Island of certainty Patent granted

13. Concentrations of power that compromise patent quality Patent Office Examiners Senior Managers Large numbers of applications Patent attorneys Output targets A separation of powers approach would increase the independence of examiners consistent with the goal of improving quality

14. Greenpeace: Patents on Life Campaign Launched in 2001, the Patents on Life Campaign monitors patents on life; broad species patents; biopiracy; fair trade; patents; and the World Trade Organization and human patenting. Launched in 2001, the Patents on Life Campaign monitors patents on life; broad species patents; biopiracy; fair trade; patents; and the World Trade Organization and human patenting. In August 2005 Greenpeace revealed Monsanto’s application for global pig patent In August 2005 Greenpeace revealed Monsanto’s application for global pig patent ‘Filed at the World Intellectual Property Organization (WIPO) in Geneva (2) the patent application staked a claim on pig rights in more than 160 countries, including the UK, Germany, the US, Russia, Brazil, Australia, China and India. If granted, US-based Monsanto will be in a position to prevent breeders and farmers from breeding pigs with certain characteristics or methods of breeding, or force them to pay royalties. The patents cover methods of conventional breeding and also the screening for naturally occurring genetic conditions that can make pigs grow faster.’ ‘Filed at the World Intellectual Property Organization (WIPO) in Geneva (2) the patent application staked a claim on pig rights in more than 160 countries, including the UK, Germany, the US, Russia, Brazil, Australia, China and India. If granted, US-based Monsanto will be in a position to prevent breeders and farmers from breeding pigs with certain characteristics or methods of breeding, or force them to pay royalties. The patents cover methods of conventional breeding and also the screening for naturally occurring genetic conditions that can make pigs grow faster.’ Further information: http://www.greenpeace.org/international/press/reports/greenpeace-patents-on-life-in

15. Electronic Frontier Foundation (EFF): Patent Busting Project Patent Busting Project is intended to take on illegitimate patents that suppress non- commercial and small business innovation or limit free expression online. Patent Busting Project is intended to take on illegitimate patents that suppress non- commercial and small business innovation or limit free expression online. The Project has two components: The Project has two components: A. Documenting the Damage by: (1) Identifying the worst offending patents; (2) Documenting the prior art that shows their invalidity; and (3) Chronicling the negative impact they have had on online publishers and innovators. B. Challenging the patents: Once it has identified some of the worst offenders, EFF will begin filing challenges to each in the form of a “re-examination request” to the USPTO. These requests create a forum to affirmatively invalidate patents rather than forcing technology users to await the threat of suit. Under this procedure, EFF can choose particularly egregious patents, submit the prior art it has collected, and argue that the patent should be revoked. EFF will collaborate with members of the software and Internet communities as well as legal clinics and pro bono cooperating attorneys to help in these efforts. Further information: http://www.eff.org/patent/

16. Alternative Law Forum (ALF): The Mailbox Project Following India’s membership to the WTO (and TRIPS) in 1995, India was required to open a ‘mailbox’ which would allow companies to deposit applications for patents covering pharmaceutical products. However, the mailbox remained ‘closed’ until the recent enactment of the Patents (Amendment) Act 2005. Following India’s membership to the WTO (and TRIPS) in 1995, India was required to open a ‘mailbox’ which would allow companies to deposit applications for patents covering pharmaceutical products. However, the mailbox remained ‘closed’ until the recent enactment of the Patents (Amendment) Act 2005. Under the new Act, the Patent Office was required to publish the applications deposited in the ‘mailbox’ so as to provide some transparency to the general public, but more importantly to allow any interested parties to be able to identify relevant applications for pre-grant and post grant oppositions. Under the new Act, the Patent Office was required to publish the applications deposited in the ‘mailbox’ so as to provide some transparency to the general public, but more importantly to allow any interested parties to be able to identify relevant applications for pre-grant and post grant oppositions. The Mailbox Project makes the existing information in patent applications more user friendly and complete in terms of a searchable database. ALF add information such as the nature of the disease, drug type, the chemical entity(ies) that each application relates to and the related priority document for the Indian application. The Mailbox Project makes the existing information in patent applications more user friendly and complete in terms of a searchable database. ALF add information such as the nature of the disease, drug type, the chemical entity(ies) that each application relates to and the related priority document for the Indian application. The database has the ability to: The database has the ability to: search for drugs applied for in the ‘mailbox’search for drugs applied for in the ‘mailbox’ identify the disease to which the invention claimed in the patent application relatesidentify the disease to which the invention claimed in the patent application relates identify the applicant/company for the patentidentify the applicant/company for the patent link the searcher to the priority application (where claimed) or a related patentlink the searcher to the priority application (where claimed) or a related patent Further information: http://www.altlawforum.org/MAIL%20BOX

17. Public Patent Foundation (PubPat) Representing the public’s interests in the patent system PubPat is a not-for-profit legal services organization that represents the public's interests against the harms caused by the patent system, particularly the harms caused by undeserved patents and unsound patent policy. PUBPAT provides the general public and specific persons or entities otherwise deprived of access to the system governing patents with representation, education and advocacy. PubPat is a not-for-profit legal services organization that represents the public's interests against the harms caused by the patent system, particularly the harms caused by undeserved patents and unsound patent policy. PUBPAT provides the general public and specific persons or entities otherwise deprived of access to the system governing patents with representation, education and advocacy. PUBPAT accomplishes its mission through the following activities: PUBPAT accomplishes its mission through the following activities: Protecting the public domainProtecting the public domain Educating and advocatingEducating and advocating Activities include Software Patent WatchActivities include Software Patent Watch Activities include Software Patent Watch, PubPat in Congress, PubPat in Supreme Court, PubPat in the Federal Circuit and free instructions on how to find prior art. Activities include Software Patent Watch, PubPat in Congress, PubPat in Supreme Court, PubPat in the Federal Circuit and free instructions on how to find prior art. Further information: http://www.pubpat.org/

18. International Center for Technology Assessment (CTA): Patent Watch Program CTA's Patent Watch Program seeks to identify pernicious patents granted by the USPTO, encourage grassroots activities against such patents, and initiate and support legal challenges against existing and future pernicious patents. CTA's Patent Watch Program seeks to identify pernicious patents granted by the USPTO, encourage grassroots activities against such patents, and initiate and support legal challenges against existing and future pernicious patents. As a result of the program, CTA has been involved in the following legal action: Withdrawal of U.S. Patent No. US-6,444,872-B1 05/24/2004 The University of Texas withdraws its patent on a beagle whose immune system was compromised to facilitate the dog's use in medical experiments. Inter Partes Reexamination Communication - U.S. Patent No. US-6,444,872-B1 05/19/2004 The U.S. Patent and Trademark Office grants CTA's request that the PTO reexamine the University of Texas' patent on a beagle whose immune system was compromised to facilitate the dog's use in medical experiments. USPTO Reexamination Request - U.S. Patent No. US-6,444,872-B1 02/25/2004 The Patent Watch Program and the American Anti-Vivisection Society file a legal "Request for Reexamination" with the federal Patent and Trademark Office. The action demands that the Office cancel a patent granted to University of Texas researchers on a beagle whose immune system was compromised to facilitate the dog's use in medical experiments. As a result of the program, CTA has been involved in the following legal action: Withdrawal of U.S. Patent No. US-6,444,872-B1 05/24/2004 The University of Texas withdraws its patent on a beagle whose immune system was compromised to facilitate the dog's use in medical experiments. Inter Partes Reexamination Communication - U.S. Patent No. US-6,444,872-B1 05/19/2004 The U.S. Patent and Trademark Office grants CTA's request that the PTO reexamine the University of Texas' patent on a beagle whose immune system was compromised to facilitate the dog's use in medical experiments. USPTO Reexamination Request - U.S. Patent No. US-6,444,872-B1 02/25/2004 The Patent Watch Program and the American Anti-Vivisection Society file a legal "Request for Reexamination" with the federal Patent and Trademark Office. The action demands that the Office cancel a patent granted to University of Texas researchers on a beagle whose immune system was compromised to facilitate the dog's use in medical experiments. Withdrawal of U.S. Patent No. US-6,444,872-B1 Inter Partes Reexamination Communication - U.S. Patent No. US-6,444,872-B1 USPTO Reexamination Request - U.S. Patent No. US-6,444,872-B1 Withdrawal of U.S. Patent No. US-6,444,872-B1 Inter Partes Reexamination Communication - U.S. Patent No. US-6,444,872-B1 USPTO Reexamination Request - U.S. Patent No. US-6,444,872-B1 CTA also issues policy recommendations and publications based on the Patent Watch Project. CTA also issues policy recommendations and publications based on the Patent Watch Project. Further information: http://www.icta.org/patent/index.cfm http://www.icta.org/patent/index.cfm

19. PATENT APPLICATION VPO EPO ACCEPTSVPO US PTO decision VPO REJECTS VPO MAY ACCEPT VPO looks at US PTO ACCEPTS REJECTS ACCEPTS Patent applications in the Vietnamese Patent Office

22. Professor Peter Drahos, Director Centre for Governance of Knowledge and Development Regulatory Institutions Network (RegNet) The Australian National University, Canberra peter.drahos@anu.edu.aucgkd.anu.edu.au