1. Patent Rights Introduction
California’s Proposition 71 (now known as the California Stem Cell Research
Public and Confidential Matters
• CA Stem Cell Research and Cures Act requires public accountability •
Economic Benefits of Prop 71 to California
Creation of new companies and new jobs
Current Litigations
People's Advocate and National Tax Limitation Foundation v. Independent
Citizen's Oversight Committee
From Stem Cell
and Cures Act) established the California Institute for Regenerative Medicine
(CIRM), which is governed by an Independent Citizen's Oversight Committee
• Confidentiality will be maintained for: • Influx of companies and people
– matters involving information relating to patients or medical subjects • Generation of tax revenue
• A continuation of the suit brought in the California Supreme Court for
(ICOC). ICOC is responsible for: injunctive relief
– matters involving confidential intellectual property whether patentable or not
• Establishing policies regarding intellectual property rights arising from • Investment in long-term health-care improvements • Filed in Superior Court - Alameda County
– records containing or reflecting confidential intellectual property whether
Research Funded •
research funded by CIRM; and
Establishing standards that require all grants and loan awards be subject to
intellectual property agreements that balance the business opportunities of
the State with the need to assure that essential medical research is not
patentable or not
– matters involving prepublication, confidential scientific research or data
– matters concerning appointment, employment, performance,
Stem Cell Research Worldwide
• Has not entered substantive stages of litigation
• Complaint alleges that the California Stem Cell Research and Cures/Bond Act
(“the Act”) is unconstitutional because:
By Proposition 71
compensation or dismissal of institute officers and employees – it mandates the drawing of moneys from the State Treasury for the purpose
unreasonably hindered by the intellectual property agreements. Countries that have a permissive or flexible policy on human embryonic stem cell
research and have banned human reproductive cloning* or benefit of the ICOC, an institution it believes is not under the exclusive
Intellectual property rights and policies have not yet been established by ICOC. management and control of the State
Careful consideration is needed for (1) separating research done using federal • Australia • Hong Kong • Singapore
funds versus state funds, (2) setting ownership of intellectual property, (3) Prop 71 Intellectual Property Clause • Belgium • Hungary • Slovenia
– the Act makes no provision for removal of any member of the ICOC or
working groups
• Brazil • Iceland • South Africa
Judith U. Kim, J.D. and setting standards for technology transfer, and (4) allocating royalties.
Existing federal policies can provide guidelines. For federally-funded
The ICOC shall establish standards that require that all grants and loan awards be
subject to intellectual property agreements that balance the opportunity of the
•
•
Canada
China
•
•
India
Iran
•
•
South Korea
Spain
– the Act contains no criteria on which the ICOC is to base its decisions to
make grants
Paul A. Calvo, Ph.D. inventions, the grantee may elect to retain title to the intellectual property with
only a paid-up nonexclusive license to the federal government to practice the
State of California to benefit from the patents, royalties, and licenses that result
from basic research, therapy development, and clinical trials with the need to
•
•
Czech Republic
Denmark
•
•
Israel
Japan
•
•
Sweden
Switzerland
– the Act provides inadequate guidelines for the adoption of standards by or
for the ICOC
invention. The Californian public's wish to ensure the state's financial benefit assure that essential medical research is not unreasonably hindered by the • Estonia • Latvia • Taiwan – the Act leaves the fashioning of intellectual property agreements totally
from their support of stem cell research must be balanced with the need to intellectual property agreements. • Finland • The Netherlands • Thailand within the discretion of the ICOC
incentivize private entities to join them in investing in stem cell research and • France • New Zealand • United Kingdom
development. Universities and private entities must also consider the • Greece • Russia Californians for Public Accountability and Ethical Science v. California Institute
dominating patents on stem cells and uses thereof, to avoid patent infringement. for Regenerative Medicine
Federal Model - Bayh-Dole *adapted from http://mbbnet.umn.edu/scmap.html
• Filed in Supreme Court of California
The Act is currently facing legal challenges, based on unconstitutionality, in the
California legal system. Other states and countries are carefully monitoring the Federal Model - Stevenson-Wydler Technology Innovation Act and Bayh-Dole Act • Court denied request to “fast-track” the suit
actions of ICOC, as a guide for their own investment in stem cell research. • In 1980, the Stevenson-Wydler Technology Innovation Act and the Bayh-Dole Act U.S. Stem Cell Initiatives • Has not yet been filed in Superior Court
were enacted to promote public benefit from government-funded research.
Subsequently, the Stevenson-Wydler Technology Innovation Act was amended by • The Complaint alleged that the Act:
enactment of the Federal Technology Transfer Act of 1986. Millions of $/year Total Budget – violates constitutional, common law and statutory prohibitions against conflicts
California Institute for Regenerative • Nonprofit organizations and small business firms can elect to retain title to any 400
$27.9 Billion of interest in public officials
– legislates an unlawful revision of the CA constitution because it creates a
Medicine (CIRM) Overview invention developed by a contractor pursuant to a government contract.
350
$350 Adult
Stem
conflict for public officials and their commitment for the public interest
• For the contractor to retain title to the invention, the contractor must: Cells – utilizes contradictory and misleading technical terminology
$300
disclose each invention to the federal agency with “a reasonable time”; 300 – invades the authority of and delegates authority to the Regents of the University
make a written election to retain title within a specified time period; of California
CIRM 250
President - Dr. Zach Hall file a patent application, within any statutory bar date, directed to invention in
Director - Dr. Arlene Chiu which it wishes to retain title; and
Scientific Programs and Review of CIRM
include within the patent application a statement specifying that the invention
200 California Institute for Regenerative
was made with government support and that the government has certain rights 150 Medicine (CIRM) Current Status
ICOC to the invention.
29 Members $100 $100 $100 $100 $100
– UC Deans • The federal government may receive title to any subject invention not disclosed to 100
$75
• CIRM is gearing up for a first round of grants
– Other CA Univ. Deans it within such time.
– Nonprofit CA Research Institutes * ESC
– $45 million in funding for the first 3 years
50 $30 $23-25 – 27 proposals have been submitted by state institutions
– CA Life Science Companies
– Disease Advocates
• The federal government is vested with (1) the right to a paid-up license to practice $24
the invention when the contractor elects to retain title and (2) the right to receive • Ray and Dagmar Dolby recently donated $5 million to help fund CIRM
0
title to the invention in the U.S. or any other country in which the contractor has while the litigations are ongoing
CA IL MA** NY PA WA WI NJ MD
not filed a patent application on the invention prior to any pertinent statutory bar NIH
date. • The Dolby gift will be used to hire legal, scientific and intellectual property
NOTE: CA & NJ are only states that have passed legislation allocating funds – all others are proposed figures. staff needed to proceed with the first grant programs
Scientific and Medical Scientific and Medical Scientific and Medical
Strategists and Advisors specializing in the protection, transfer, • The federal government has march-in rights - if the action is necessary because the *NJ has already committed $150M to build a Stem Cell Research Institute.
Accountability Standards
Working Group
Research Funding
Working Group
Research Facilities
Working Group fund recipient “has not taken . . . effective steps to achieve practical application of **Harvard University has created a Stem Cell Research Institute. • CIRM is also pursuing a $100 million short-term bridge financing plan
and enforcement of Intellectual Property Rights. Co-Chairs which will allow the first grants to be awarded
Robert Klein and Sherry Lansing 36 Members To have 11 Members
the subject invention” or to alleviate health or safety needs.
• The 1987 Executive Order expanded Bayh-Dole to promote commercialization to • There is a proposed constitutional amendment that is intended to amend the
intellectual property and public-oversight provisions of Proposition 71
all contractors “regardless of size.”
Non-U.S. Stem Cell Initiatives Conclusions
Benefits of Adopting a Model Similar • England: proposing a fund for 100 million pounds
• Prop 71 IP policies have yet to be established
California Institute for Regenerative to the Federal Model • Singapore: established a $600 million fund
• To maximize participation by private entities, an IP model similar to that of the
• South Korea: spent $54 million over the past 2 years; no set figures on future federal model should be adopted
Medicine (CIRM) Duties • Maximizes participation in CIRM-funded research dollar output
• Current litigation(s) may need to be resolved before grants can be funded in
• Inventions must be promptly reported to CIRM – the success of Dr. Woo Suk Hwang’s group has prompted the South Korean California
• Award grants and loans for stem cell research
• government to increase the group’s funding to $3 million per year and $24.4
CIRM retains non-exclusive, royalty-free license to CIRM-funded
million in facility assistance • Embryonic Stem Cell Research is moving forward irrespective of the U.S.
• Award grants and loans for other “vital” research opportunities inventions for use by and on behalf of CIRM government’s restrictions
• Establish regulatory standards and oversight bodies for research and • Grantee must diligently develop the invention or CIRM may do so, by • China: no set dollar figure
– By state initiatives
facilities licensing the technology or taking title to the invention • Australia, India and Japan are also considering developing stem cell programs – By other countries