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Is The Chemical Genus Claim Really “Dead” At The Federal Circuit?: Part I, Christopher M. Holman
Is The Chemical Genus Claim Really “Dead” At The Federal Circuit?: Part I, Christopher M. Holman
Faculty Works
A 2020 law review article entitled The Death of the Genus Claim (“Death”) purports to document a dramatic shift in the Federal Circuit’s interpretation of 35 U.S.C. 112(a)’s enablement and written description requirements, particularly as applied to chemical genus claims. According to the authors of Death, it has become nearly impossible to obtain a chemical genus claim that will be upheld as valid in the face of a challenge for overbreadth under Section 112(a). Death was cited extensively in Amgens’s successful petition for certiorari in Amgen v. Sanofi, a case asking the Supreme Court to overturn the Federal Circuit’s decision …
Technology Changes Drive Legal Changes For Antibody Patents: What Patent Examiners Can Teach Courts About The Written Description And Enablement Requirements., S. Sean Tu, Christopher M. Holman
Technology Changes Drive Legal Changes For Antibody Patents: What Patent Examiners Can Teach Courts About The Written Description And Enablement Requirements., S. Sean Tu, Christopher M. Holman
Faculty Works
Antibody patents form the basis of some of the most valuable biotechnology products on the market. In 2020 alone, the sales of the top three drugs exceed 10 billion dollars. Two of those three drugs are monoclonal antibodies (Humira and Keytruda). In the past, patent law offered broad protection for monoclonal antibodies. As time has progressed, however, courts have narrowed the scope of antibody patents. However, very little research has been done to see how patent examiners are applying the rules of patentability to these valuable antibody patents.
We examine approximately two decades worth of antibody patents to determine how …