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Full-Text Articles in Intellectual Property Law
Supreme Court Asked To Consider Role Of Post-Filing Evidence In Assessing Obviousness Of Pharmaceutical Inventions, Christopher M. Holman
Supreme Court Asked To Consider Role Of Post-Filing Evidence In Assessing Obviousness Of Pharmaceutical Inventions, Christopher M. Holman
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On January 20, 2015, Bristol-Myers Squibb petitioned for certiorari in Bristol-Myers Squibb v. Teva Pharmaceutical, asking whether an assessment of obviousness should "consider post-filing evidence showing the actual differences between a patented invention and the prior art." The district court had found patent claims directed towards Entacavir (an anti-hepatitis drug) obvious in view of structural similarity between the drug and a prior art compound, in spite of the fact that the prior art compound was highly toxic and therefore not a viable candidate for use as a human drug. A Federal Circuit panel affirmed the district court's decision to disregard …
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
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
Faculty Works
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 …