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INTRODUCTION
Polymerase Chain Reaction (PCR), molecular biology tecamount of DNA to be amplified exponentially
Discovered, Developed, and Patented in industry settings
Patents on biological tools could impede their disseminatio
PCR was protected with robust patent rights and heavily lic
PCR managed to disseminate
IPR not prevented PCR from its widely use
Initial period od secrecy in initial in house development pha
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DISCOVERY AND DEVELOPM
Discovery of PCR techniqueKary Mullis, a chemist w
Prize in 1993 for his work on PCR Work in Cetus- synthesizing short segment of DNA
Experimented the denaturation/renaturation propertiequantify the properties of time and temperature on DN
Finally on December16, 1983 : the evidence of amoligonucleotide with polymerase by increasing t
denaturing/renaturing process Contact to Al Halluin, Cetus Chief Patent Councel
Halluin contact to CetusPresident; pursue it but not aimportant things
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DISCOVERY AND DEVELOPME
On 28 March 1985, First PCR process patents filed with U
Now Cetus shifted focus to dissemination of technology
PCR application presented at the meeting of the Amefor Human Genetics
In September 1985, PCR application paper submitted to
The strategy was patent first, then publish, now the focommercialization
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COMMERCIALIZATION
PCR diagnostics market was booming; more thanorganizations approached Cetrus for licensing PCR fpurposes
PCR diagnostic market worth $1.5 billion
November 1988, Cetus created entire division for devPCR
Division focus on business partnerships and licensing pro
Cetus-Kodak partnership was set to expire in Decembewas seeking ways to capitalize to more favourable offsponsors like DuPont, Abbott and Hoffaman-La Roche
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DuPont VS Cetus
In August 1989, Du Pont filed a case on Cetus, alleg
patents were not novel Process had been previously described in 1970
Cited work on RepairReplicationby Dr. Gobind Khor
On August 23, 1990, USPTO announced to uphold tboth patents
Repair Replication papers too indefiniteand uncer
made PCR an obvious process
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PCR OUTGROWS CETUS
Even increased sales from PCR, Cetus finished 1990 with
Cetus negotiated Roche would pay $300 million for soof rights to diagnostic uses of PCR
On 23 July 1991, Chiron Corporation merge withestimated deal $660m
On 11 December 1991, Roche acquired the rights Cetus
Cetus retained the rights to use PCR in the devtherapeutics
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PCR LICENSING
To expand and commercialize, Roche formed a neRoche Molecular Systems to handle manufacturing od PCR rights
Cetus had implemented the reach througagreements(RTLAs)
Users pay royalties to Cetus on any invention or marketcreated by PCR
This plan was met with harsh criticism
Roche announced new, less imposing PCR licensing str
Eliminated the up-front fee i.e., $15000 to non profit and
Reduced the royalties on the sales of PCR based prod9%
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ROCHE VS PROMEGA
On 27 October 1992, Roche filed suit against Promega w
nTaq polymerase use in the PCR reaction In 1990, Promega and Cetus entered into license, wh
the right to manufacture and sell the Taq polymerase users
Promega paid $30,000 up front costs and 10 % royalties o
Roche claimed that Promega violated the agr
manufacturing products that aimed customers to use th On 16 May 1995, Roche provide the court a list of 200
institutions using for PCR
Roche said that they are suing the inducer, not suinparties that have been induced
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ROCHE VS PROMEGA
The two arguments were made 1) invalidity 2)conduct
Invalidity: Taq polymerase has been isolated bycolleagues at University of Cincinnati
Re-petitioned that enzyme isolated by Chien was enzyme
Promega presented that Cetus did not perform side bexperiments between the Taq enzyme and polymeras
Chien Inequitable Conduct: Cetus had obtained the
intentionally deceiving UPSTO
In May 2004, the patent was invalidated and Rochrecoup damages for breech of
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ROCHE VS M.J. RESEARCH
In June 1998, Roche filed suit against M.J., claimiinfringed 3 thermal cycle patents
M.J. willingly selling to customers, who they know thause the machines for PCR
Roche showed their website in which their thermal being adapted for PCR
The jury found that wilfully infringed patents and award
of total amount $19.8 million
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EVALUATING EFFECTS OF IPR
Many argue that patents provide incentives for the cand development of new technologies
Patent protection may have been essential to spdevelopment within Cetus but hinder to use this teresearchers
Most complaints about licensing fee and royalties whicexpensive in some fields
On 28 March 2005, expiration of key PCR process pateto open up new areas of research
Strong patent rights are incompatible with dissemination but in PCR the 3 key reasons that PCR so widespread
Cetus/Roche sextensive use of licensing and business pa
Fair and adaptable licensing strategies
Ease of obtaining licenses
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LEARNING
Complications can arise from earlier patents
Their validity can be challenged and patent rejecte
Even with easy licensing terms, their can be pflout the norm
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Knowledge is important society above and beyondability to generate a profit.