Transcript Intellectual Property - The Washington Campus

Intellectual Property Rights and
Regulations in a Global Economy
Lila Feisee
Managing Director for Intellectual Property
BIO
January 6, 2010
Washington Campus
About BIO
• Trade association with more than 1,200
biotechnology companies, academic institutions,
state biotechnology centers, and related
organizations in all 50 states.
• Vast majority are small, emerging companies with
little revenue and no marketed products
• Health care,
• Agricultural,
• Industrial, and environmental biotechnology
products
“The very first official thing I did in my
administration—and it was on the very first day
of it too—was to start a patent office; for I knew
that a country without a good patent office and
good patent laws was just a crab, And couldn’t
travel any way but sideways or backwards.”-Mark Twain, “A Connecticut Yankee in King
Arthur’s Court” 1889
Today’s Topics
1. Role of biotechnology in the global economy
2. Role of Patents in Biotechnology
3. Challenges and opportunities in IP for Biotech
1. Patent reform and the PTO
2. Gene patents and management of IP arising from
federally funded research
3. Healthcare reform
4. Compulsory licensing/access to technologies
Role of biotech in the Economy
• Jobs for more than 7.5 million people in the United States
• Commercialized more than 300 biotechnology drugs and
diagnostics
• Health products used by more than 325 million people
worldwide;
• Another 400 or so biotechnology products are in the pipeline.
• In the agricultural field
• simultaneously increasing food supplies, reducing
pesticide use, conserving natural resources of land water
and nutrients, and increasing farm income.
• leading the way in creating alternative fuels from
renewable sources without compromising the environment.
The role of Biotech in the economy
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Market capitalization as of April 2008 was $360 billion
U.S. health care biotech revenues from publicly traded companies rose
from $8 billion in 1992 to $58.8 billion in 2006.
U.S. publicly traded biotech companies spent $27.1 billion on research
and development in 2006.
The top five biotech companies invested an average of $170,000 per
employee in R&D in 2007.
Biotechnology attracted more than $24.8 billion in financing in 2007 and
raised more than $100 billion in the five-year span of 2003-2007.
The average annual wage of U.S. bioscience workers was $71,000 in
2006, more than $29,000 greater than the average private-sector
annual wage.
See Battelle report..
http://bio.org/local/battelle2008/State_Bioscience_Initiatives_2008.pdf
Patents and Biotech
• Ideas/research with potential are patented
• DNA, proteins, cells, transgenic plants and animals,
methods of treating and detecting
• Long lead time and hundreds of millions of dollars of
investment
• University research and government funding
• Investor financing and collaborations
• Ancillary benefits of patents: Jobs
• High-skilled workforces have a higher standard of
living
Diligence Categories for Investors
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Management
Intellectual Property
Legal
Technology
• Preclinical work
• Clinical Data
• Regulatory Diligence
• Manufacturing
• Financials
Pillars of Biotechnology’s Growth
• Strong public/private partnerships and innovative
research
• Strong intellectual property protection
• Broad patent eligibility
• Predictability in term length
• Predictability in enforcement
• Stable regulatory environment
• Safety of approved product
• Timeliness of approval
Timeline for biotech therapeutic
Development
Fed
$$$
Invention &
Patent Filing
-6
Marketing
Approval
0
Basic
Research
Patent
Expiration
12
Applied Research
(including clinical
work to obtain
approval)
20
Market
Exclusivity
Period
Industry Use of Patents
• To generate capital
• 90% have no products on the market
• To exclude competitors for a period of time
• 10% with products must protect investment
• As product for licensing
• Universities, mid-size companies
Global Innovation
• 700K patent applications
• 1 million in the next few years
• Increase in total number of licenses over the
past decade
46,576 total licenses/options executed from 1996 – 2006
**based on AUTM data
Challenges and Opportunities
Patent and PTO reform
Challenges and Opportunities
on the IP front
• Patent Reform
• Congress
• Legislation pending
• Expand opportunities to challenge patents (House and
Senate)
• Decrease the value of patents through recalculation of
damages (House)
• Lacks true front-end quality reforms (House and Senate)
• PTO
• New Administration, looking at ways to streamline patent
process
Challenges and opportunities: In
the Courts
• Business method patents: The Federal Circuit, in In Re Bilski, basically
eliminated much-maligned patents on disembodied business methods
• Willful infringement: Under the Federal Circuit’s In re Seagate decision,
willfulness is now a much more circumscribed doctrine that is harder to
establish in litigation.
• Obviousness: In KSR v. Teleflex, the Supreme Court made it easier for the
PTO to reject applications on combination inventions, and for defendants
to prevail on an obviousness defense against asserted patents.
Is Reform Necessary?
• Stream-line patent office processes
• Collaborations with other patent offices
• Bring the PTO into the 21st century with the
right tools and training
Challenges and Opportunities
Healthcare Reform
Biosimilars Legislation
• In healthcare legislation
• Create a pathway for approval of biosimilars
• In both the House and Senate passed bills
• Both bills have biosimilars provision though the
House bill’s patent provisions are a bit better for
our members
• Congressional leaders (Dems) are meeting to
try and reach a deal that will hold in both
chambers.
• January-early February timeframe
FOBs Provisions
• 12 years DE (both House and Senate)
• Senate bill does not allow for additional exclusivity
• House bill allows for 6 months for pediatric exclusivity
• Allows interchangeability based on FDA assessment
(Both House and Senate)
• FDA can set guidances but they’re not required to do
so (Both House and Senate)
• FDA can require analytical data and animal studies or
can waive this requirement (Both House and Senate)
• Distinct naming provision (Generic naming)
• House has unique naming provision, Senate bill does not
• Patent provisions in Senate bill, more restrictive and
burdensome on innovator, unlikely to allow for
resolution of all disputes prior to approval of
biosimilar and also has the potential to create
additional litigation
• BIO is able to support both the House and Senate
versions of the FOBs provisions.
Patent Provisions
• BLA triggers obligation to provide to innovator access to
application (Both House and Senate)
• Identification of relevant patents is the obligation of the
innovator (Both House and Senate)
• Process patents and method of use patents can also be used
in infringement (Both House and Senate)
• The earliest date litigation can ensue is 4 years after licensure
of the innovator product (Both House and Senate)
• Both bills would open a time window for litigation long before
approval of biosimilar.(Both House and Senate)
• No stay of approval (both House and Senate)
• Senate bill more restrictive in who can access
confidential info to biosimilars
• No access to Scientists and individuals who are involved in
prosecution of the relevant patents
• No access to Patent owners who have not exclusively
licensed to the reference product sponsor
• The House bill is more flexible and relies on a
contract-based confidentiality within the FDA.
• Identification of relevant patents- The Senate bill
follows a four step process while the House follows a
2 step process
• Both allow for a back and forth on the referenced patents
• But Senate allows for a negotiation of which patents
should be litigated if no agreement reached there would
be a “list exchange” of patents the two parties view as
relevant and the innovator has 30 days to file suit on all
common listed patents.
• Under either bill the biosimilar applicant can certify
that it will not begin marketing until patent
expiration and parties may license instead of litigate.
• Senate bill provides for essentially two waves of
litigation
• Early wave over the list exchange patents
• Late wave on patents identified but not common to both
lists
• Senate bill does not allow for third party
participation in the preapproval litigation process
• Linkage- Senate requires appellate decision prior to approval
of biosimilar
• House requires district court decision
• Senate provides for DJ action only after biosimilar’s intent to
launch
• House has no DJ provisions
• Senate bill has cause of action when biosimilar certifies that a
patent is invalid or unenforceable
• House has no such cause of action provision
• Senate bill has forfeiture and and penalty for those patents
that could have been included in early wave but not timely
litigated.
• House bill does not have such a provision
Gene Patents and Federally funded
Inventions
• Patents are eroneously equated with high
prices
• Stricter control over federally funded research
• Senator Wyden tried to include “reasonable
pricing clause” in licensing agreements between
federally funded labs and companies (last
healthcare debate)
• Exercise march-in rights to compulsory license
certain types of technologies
• Several hearings on how to manage federally
funded inventions
• ACLU sued Myriad Genetics for its breast cancer test-BRCA gene patented
• Questions quality
• The ability to get a second opinion
• Whether or not genes should even be patented
• SACGHS report on licensing of gene patents
for diagnostics
• Possible legislation to limit licensing of gene
patents– Wasserman Schultz
• Understand the role of IP in developing new
medicines for intractable diseases
• Increase funding of university labs and
research
• Increase funding of university technology
transfer offices
• Use IP incentives to bring companies into the
fold during the “valley of death” stage
Challenges and Opportunities
Global IP
International IP
• Biodiversity treaties
• Access and benefit sharing of genetic and biological
materials
• Mandatory Patent Disclosure requirements for
genetic and biological resources
• World Health Organization
• Access to Medicines
• Compulsory licensing, mandatory licensing, patent
pools
• UN Framework Convention for Climate Change
• Funding of and access to climate change technologies
Patents are the Solution not the
Problem
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Hidden driver of economic recovery
Catalyst for innovation
The impetus for addressing global challenges
A solution to poverty
• The Property Rights Alliance study showed that countries that
protect the physical and intellectual property of their people
enjoy nearly nine times higher GDP per capita than countries
ranking lowest in property rights protections.
• The study, the 2009 International Property Rights Index (IPRI),
compared the protections of physical and intellectual property to
economic stability in 115 countries representing 96 per cent of
the world’s GDP.
• http://www.propertyrightsalliance.org
Thank You
bio.org/ip