Pcr Patent Wars

8/13/2019 Pcr Patent Wars

1/17


2/17

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


3/17

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


4/17


5/17

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


6/17


7/17

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


8/17


9/17

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


10/17

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


11/17

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%


12/17

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


13/17

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


14/17

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


15/17

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


16/17

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


17/17

Knowledge is important society above and beyondability to generate a profit.

Documents

Pcr Patent Wars