Law Commons^™

Is The Chemical Genus Claim Really “Dead” At The Federal Circuit?: Part I, Christopher M. Holman

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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

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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 …

Recent Pto Guidance Charts A New Course Through The Patent Eligibility Quagmire, Christopher M. Holman

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In a span of four years, 2010-2014, the U.S. Supreme Court issued four decisions that have dramatically altered patent eligibility jurisprudence: Bilski, Mayo, Myriad, and Alice. Ever since Bilski was decided, the PTO has struggled to apply the new patent eligibility jurisprudence in a consistent and predictable manner. The two part framework for assessing patent eligibility, as set for in Alice and Mayo, is stated at a high level of abstraction, and the Supreme Court has given little concrete guidance as to how it is to be applied beyond the specific claims at issue in its precedent. At times, the …

A Biotechnology-Centric Look At Fee Shifting In Patent Litigation Post-Octane Fitness, Christopher M. Holman

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The U.S. Supreme Court’s 2014 decision in Limelight Networks v. Akamai Technologies decision (Akamai III), in conjunction with the Federal Circuit’s stance on divided infringement claims, effectively undermined the value of method claims, particularly in the realm of pharmaceuticals, diagnostics, and other biotechnology related innovation, by limiting the ability of patentees to establish liability in cases where steps of the claimed method are performed by multiple parties. On remand, the en banc Federal Circuit in Akamai Technologies v. Limelight Networks (Akamai IV) sought to address the problem by expanding the definition of direct infringement under 271(a) to encompass more scenarios …

Eli Lilly V. Teva: Generic Companies Infringe Under Akamai Iv In Case Of Divided Infringement, Christopher M. Holman

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The U.S. Supreme Court’s 2014 decision in Limelight Networks v. Akamai Technologies decision (Akamai III), in conjunction with the Federal Circuit’s stance on divided infringement claims, effectively undermined the value of method claims, particularly in the realm of pharmaceuticals, diagnostics, and other biotechnology related innovation, by limiting the ability of patentees to establish liability in cases where steps of the claimed method are performed by multiple parties. On remand, the en banc Federal Circuit in Akamai Technologies v. Limelight Networks (Akamai IV) sought to address the problem by expanding the definition of direct infringement under 271(a) to encompass more scenarios …

The Mayo Framework Is Bad For Your Health, Christopher M. Holman

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This Article begins by providing a brief historical retrospective of the development of the patent eligibility doctrine, and then delves into the related questions of: (1) what are the Supreme Court’s policy objectives for the recent reinvigoration of the patent eligibility doctrine; and (2) has it achieved those objectives? The article then discusses three important out-standing questions regarding the application of the new test for patent eligibility: (1) what constitutes a natural phenomenon; (2) what constitutes an inventive step; and (3) what, if any, role does preemption play in the analysis? The article then provides four examples of recent lower …

Copyright For Engineered Dna: An Idea Whose Time Has Come, Christopher M. Holman

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The rapidly emerging field of synthetic biology has tremendous potential to address some of the most compelling challenges facing our planet, by providing clean renewable energy, nutritionally-enhanced and environmentally friendly agricultural products, and revolutionary new life-saving cures. However, leaders in the synthetic biology movement have voiced concern that biotechnology's current patent-centric approach to intellectual property is in many ways ill-suited to meet the challenge of synthetic biology, threatening to impede follow-on innovation and open access technology. For years, copyright and patent protection for computer software have existed side-by-side, the two forms of intellectual property complementing one another. Numerous academic commentators …

Recent Developments Affecting The Enforcement, Procurement, And Licensing Of Research Tool Patents, Joshua D. Sarnoff, Christopher M. Holman

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A vigorous discussion exists regarding the need to provide exclusive patent rights as incentives to invent and to disclose so-called "research tools," whether such exclusive rights should apply to all uses and users of patented research tools, and whether exclusive rights to prohibit all uses of research tools would unduly discourage sequential invention. This article summarizes recent developments under U.S. patent laws of particular relevance to the debate over the patenting of research tools, and provides some insights into the practices of various academic sciences, industries, and government agencies regarding the treatment of these important inventions. The article provides a …

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 …

Do Reverse Payment Settlements Violate The Antitrust Laws, Christopher M. Holman

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The term "reverse payment" has been used as shorthand to characterize a variety of diverse agreements between patent owners and alleged infringers that involve a transfer of consideration from the patent owner to the alleged infringer. Reverse payment settlements are particularly associated with drug patent challenges mounted by generic drug companies under the Hatch-Waxman Act. Many, including the Federal Trade Commission, would characterize these agreements as antitrust violations. However, courts have generally declined to find these agreements in violation of the antitrust laws based solely on the presence of a reverse payment.

This article begins in Section II with an …

Biotechnology's Prescription For Patent Reform, Christopher M. Holman

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On June 8, 2005, Congressman Lamar Smith introduced H.R. 2795, the Patent Reform Act of 2005, aimed at improving the quality and certainty of issued patents, simplifying the patent procurement process, harmonizing U.S. law with international practice, and reining in abusive patent enforcement practices. Congress has set the legislation aside for the time being, but will likely revisit the issue again shortly. The biotechnology industry, one of the fastest growing sectors in the United States economy, strongly opposes many of the proposed reforms. This paper considers the Congressional testimonies of the Biotechnology Industry Organization ("BIO") and other representatives of biotechnology's …