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GROUP 32 ABHIMANYU ANCHA 129278042 PARICHIT DEV 129278107 SORABH GAMBHIR 129278108
INTRODUCTION
Polymerase Chain Reaction (PCR), molecular biology technique: small amount of DNA to be amplified exponentially Discovered, Developed, and Patented in industry settings Patents on biological tools could impede their dissemination and use PCR was protected with robust patent rights and heavily licensed PCR managed to disseminate IPR not prevented PCR from its widely use Initial period od secrecy in initial in house development phase
The strategy was patent first, then publish, now the focus shifted to commercialization
COMMERCIALIZATION
Strategic partnership with other cooperation: Others expertise for further development of the technology
December 1985, Cetrus (49%) enters joint venture with Perkins-Elmer (51%) to develop diagnostics instruments and reagents for use with PCR February 1986, Cetus enters with agreement with Kodak to develop invitro PCR diagnostics 28 July 1987, Patent #4683202 Process for amplifying nucleic acid sequence Patent #4683195 Process for amplifying and detecting and for cloning nucleic acid sequence Issued to Cetus
COMMERCIALIZATION
PCR diagnostics market was booming; more than 50 different organizations approached Cetrus for licensing PCR for diagnostic purposes
ROCHE-CETUS PARTNERSHIP
ROCHE CETUS
DuPont VS Cetus
In August 1989, Du Pont filed a case on Cetus, alleging core PCR patents were not novel
Process had been previously described in 1970 Cited work on Repair Replication by Dr. Gobind Khorana at MIT
On August 23, 1990, USPTO announced to uphold the validity of both patents
Repair Replication papers too indefinite and uncertain to have made PCR an obvious process
PCR LICENSING
To expand and commercialize, Roche formed a new subsidiary, Roche Molecular Systems to handle manufacturing and licensing od PCR rights Cetus had implemented agreements(RTLAs) the reach through licensing
Users pay royalties to Cetus on any invention or marketable product created by PCR This plan was met with harsh criticism
ROCHE VS PROMEGA
On 27 October 1992, Roche filed suit against Promega which covers nTaq polymerase use in the PCR reaction In 1990, Promega and Cetus entered into license, which granted the right to manufacture and sell the Taq polymerase for non PCR users Promega paid $30,000 up front costs and 10 % royalties of sales Roche claimed that Promega violated the agreement by manufacturing products that aimed customers to use them for PCR On 16 May 1995, Roche provide the court a list of 200 individuals, institutions using for PCR Roche said that they are suing the inducer, not suing the many parties that have been induced
ROCHE VS PROMEGA
The two arguments were made 1) invalidity 2) inequitable conduct Invalidity: Taq polymerase has been isolated by Chien and colleagues at University of Cincinnati Re-petitioned that enzyme isolated by Chien was fragments of enzyme Promega presented that Cetus did not perform side by side control experiments between the Taq enzyme and polymerase isolated by Chien Inequitable Conduct: Cetus intentionally deceiving UPSTO had obtained the patent by
In May 2004, the patent was invalidated and Roche could not recoup damages for breech of contract
LEARNING
Complications can arise from earlier patents
Their validity can be challenged and patent rejected
Even with easy licensing terms, their can be parties that flout the norm
Knowledge