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Biotechnology Patents
Issues, Concerns, and
Unintended Consequences
Do Biotechnology Patents
Stifle Innovation?
‘The Tragedy of the Anticommons’
‘Tragedy of the commons’
– Overuse of commonly owned resources results when there are no
restrictions on use or incentives to conserve
Hardin, G. (1968) Science 162:1243
‘Tragedy of the anticommons’
– Multiple owners of a given resource can result in underuse of that
resource
– So-called “patent thicket” threatens innovation
• High transaction costs
• Significant delays due to multiple negotiations
• Failure to obtain only one of many licenses can derail project
– Biomedical research particularly vulnerable
• DNA, research tools, reagents
Heller, M.A and Eisenberg, R.S. (1998) Science 280:698
‘The Tragedy of the Anticommons’
• Common example- Golden Rice
– Rice expressing pro-Vitamin A-three foreign genes two from
daffodil one from a bacterium to combat vitamin A deficiency, a
serious third world problem
– Technology encompasses 40 patents and contractual obligations
(MTAs) affecting commercial development
• Madey v. Duke impact on academic freedom
– Research exemption does not apply by virtue of non-profit status
– Universities have ‘commercial interests’
• Obtaining government and private grants
• Sports marketing
• Technology Transfer
• “Patent Trolls”- Exert rights in large patent bundles
– Time lost in litigation
– Money lost rather than fighting
‘The Myth of the Anticommons’
• If ‘tragedy of the anticommons” exists, should see:
– Decrease in research & development expenditure
– Fewer innovative therapies tested
• In fact, since 1998 see:
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Research & development expenditures increased 60%
Venture capital funding increased ~200%
Employment increased 21%
Clinical trials increased 37%
T. Buckley (2007) Biotechnology Industry Organization (BIO) White Paper
‘The Myth of the Anticommons’
• Madey v. Duke shows little impact on academic research
– Only 8% of researchers report being aware of third party IP
– Of the 8%, 12% report changing their approach and 16% report a delay of
more than one month
Source: Walsh et al. (2005) Science 309:2002-2003
• However, this simply means academic researchers are routinely
infringing patents.
– Generally, companies are not exerting their patent rights against academic
researchers- not biting the hand that feeds?
– Will university technology transfer/licensing change this benevolence?
• Academic DNA patent licensing practices are diverse and flexible
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Non-exclusive licensing
Retained academic and humanitarian rights
Field restrictions
Patent pools
Source: Pressman et al. (2006) Nat. Biotechnol. 24:31-39
Gene Patenting
Gene Patenting
• Gene patenting has been possible since the Diamond v.
Chakrabarty case
– Claims drawn to “isolated nucleotide sequence” to avoid “product
of nature” rejections
• Both composition and method of use claims are possible
– Compositions
• Isolated nucleotide sequence
• Expression vectors
• Probes
– Methods of use
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Production of therapeutic proteins
Gene therapy
Diagnostics
Transgenic plants and animals
Gene Patenting
The Numbers
• 4,270 patents claiming human DNA sequences
• 63% patents owned by private firms
– e.g., Incyte, Human Genome Sciences, Isis, Amgen, Glaxo,
Millennium, Roche/Genentech, Celera (Applera), Myriad
• Represents 4,382 genes or ~20% of the human
genome
• ~3,000 genes have only a single intellectual property
rights holder
Source: Jensen and Murray (2005)
Science 310:239-240.
Gene Patenting Controversy
Public Awareness
• Public awareness of gene patenting resulted from
several events
– High profile of the Human Genome Project
– Publication of Next, introduction of “Genomic
Research and Accessibility Act” and New York Times
Op-Ed piece by Michael Chrichton
– Legal Activities of Myriad Genetics
• From awareness grew controversy
Gene Patenting Run Amok
• Dramatic increase in the number of DNA sequence patents
filed during Human Genome Project
– Intellectual property “land grab”
• Rush to file resulted in substandard patent applications
claiming:
– DNA fragments
• SNPs
• Domains
– Genes with no known function
• Poor quality applications and public pressure forced a reevaluation of patentability guidelines by USPTO
– New guidelines issued in 2001 to ensure only tangible inventions
receive protection
Gene Patenting Controversy
The Myriad Firestorm
• In 2001 Myriad Genetics begins to exert its patent rights
relating to breast and ovarian cancer susceptibility genes,
BRCA1 and BRCA2
– Testing must occur solely through Myriad or its licensees
– Test $3000
• Opponents contend Myriad position restricts patient access
– High cost
– Not all insurance providers reimburse
– Lack of second opinion opportunity
• Opponents cite this as an example of private profit at
public expense
– Development costs significantly lower than biologics
• Less regulatory hurdles for approval
Gene Patenting Controversy
Summary
• Product of nature
– Where’s the invention?
• Genes must be isolated, altered to be patented
• Ownership
– How can a company own my genes?
• Patents do not convey ownership
• Limits to Access
– Profits versus the public good
Stem Cell Patenting
Stem Cell Patenting
• Stem cell patenting is in a position to be as
controversial as gene patenting
• ‘Perfect storm’ conditions
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Ethical, moral, religious issues
Federal research restrictions
Miracle cure aura
Intense media coverage
Ten year market potential of $4 billion
• Arguments for and against stem cell patenting are
similar to those of gene patenting
Stem Cell Patenting
• Through 2005- Patents covering ‘uses methods or
compositions involving human or animal stem cells’:
– 1,724 granted and 3,711 pending- USPTO
– 421 granted and 560 pending- EPO
– 4,265 published- PCT
Ownership of Granted Stem Cell Patents
Source: Bergman & Graff (2007) Nat. Biotechnol. 25:419-424
Stem Cell Patenting
• Currently, most of the controversial focus on stem
cell patents is on three patents in particular
• “Primate Embryonic Stem Cells”
– US 5,843,780- Primate embryonic cells
– US 6,200,806- Human embryonic stem cells (hES)
– US 7,029,913- Cultures of hES cells
• James A. Thomson, inventor
• Wisconsin Alumni Research Foundation (WARF),
assignee
Follow-On Biologics
Generic Drugs
• Prior to 1984, FDA approval of generic drugs
required the same clinical trials as brand-name
drug
– Duration and costs of trials had a dramatic negative
impact on introduction of generics
• Only 35% of brand-name drugs had generics
• “Drug Price Competition and Patent Term
Restoration Act”-1984 (“Hatch-Waxman Act”)
– Sought to balance patent protection and generic drug
availability
Generic Drugs
• Long clinical trial times required by FDA before approval “eats into”
patent life
– Hatch-Waxman provides for patent extension- 100% approval time and 50% of
trial time; maximum of 5 years
• Hatch-Waxman Abbreviated New Drug Application (NDA)- prove
bioequivalence, not efficacy
– Small molecules easy to demonstrate molecular equivalence
– +/- 20% bioavailability of brand-name
• No generics approved within 5 years of brand-name approval, socalled “data exclusivity”
– NDA data considered trade secret
• “Safe Harbor” provision
– Exempt from infringement if generating data for FDA
• Established process for patent challenge
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Summary: Patent Issues in
Biotechnology
Patents offer inventors a limited monopoly to their inventions in exchange for
sharing the ‘inner workings’ of those inventions with the public
– Provides incentives to inventors
– Stimulates innovation
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Changes in case law that allowed the patenting of biological processes,
components and organisms led to the advent of the biotechnology industry
– Diamond v. Chakrabarty
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The Bayh-Dole Act helped bring university research from the lab to the
marketplace
– A large percentage of university licensing is in the life sciences
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Long development times and high costs of bringing biotech products to market
make patents vital to the biotechnology industry
Biotechnology patents raise many ethical issues for the public
– Patenting of ‘life’
– The public good vs. private profits
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Biotechnology companies and public policy makers must work together to
ensure that patents continue to stimulate innovation and bring new diagnostic,
preventative and therapeutic products to market
– Avoid the ‘anticommons’
– Preserve academic freedom