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Is Lilly Written Description Paper Tiger?: Comprehensive Assessment Of The Impact Of Eli Lilly And Its Progeny In The Courts And Pto, Christopher M. Holman Jan 2007

Is Lilly Written Description Paper Tiger?: Comprehensive Assessment Of The Impact Of Eli Lilly And Its Progeny In The Courts And Pto, Christopher M. Holman

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In University of California v. Eli Lilly, decided by the Federal Circuit in 1997, the court established for the first time a new form of patent law's written description requirement, apparently targeted specifically at biotechnology. To this day, the conventional wisdom is that the so-called Lilly written description requirement (LWD) exists as a biotechnology-specific super-enablement requirement, substantially more stringent than the enablement requirement (the conventional standard for patentability), and standing as an impediment to effective patent protection for biotechnology inventions. My objective in writing this article was to test this conventional wisdom, by conducting a comprehensive search for all LWD …


Protein Similarity Score: Simplified Version Of The Blast Score As Superior Alternative To Percent Identity For Claiming Genuses Of Related Protein Sequences, Christopher M. Holman Jan 2004

Protein Similarity Score: Simplified Version Of The Blast Score As Superior Alternative To Percent Identity For Claiming Genuses Of Related Protein Sequences, Christopher M. Holman

Faculty Works

Recombinant proteins form the basis for most of the products of biotechnology, including drugs, diagnostics, research reagents, genetically modified organisms and industrial enzymes. However, the nature of proteins and the rules of patentability conspire to make it difficult to achieve adequate patent protection for novel proteins and the polynucleotides that encode them. Narrow patent claims limited to protein sequences sharing a high degree of structural identity can generally be designed around by introducing structural changes in the claimed protein, thereby avoiding the patent without substantially altering the protein's function. However, inventors are generally restricted in their ability to broadly claim …