It is an undisputed fact that a quick and accurate diagnosis is an indispensable prerequisite for successful treatment of any health disorder. However, only an event like the outbreak of the Covid-19 pandemic brings the central importance of diagnostics for public health into the political spotlight (Immediately after the outbreak of the pandemic, newspapers and professional magazines have been full of headlines emphasizing the extraordinary importance of diagnostics. Here are just two early examples: Hannah Kuchler, Kiran Stacey, and Katrina Manson, White House Moves to Accelerate Testing, Financial Times of March 14/15, 2020, p. 4, and Seth Berkley, COVID-19 Needs a Manhattan Project, Editorial, 2020 Science 367, 1407.). While patents for therapeutics, necessary for efficient protection of the risky and expensive investments in their research and development, but raising the costs for the healthcare system, are often at the center of public debates, patent protection for diagnostic methods seldom discussed in public. This contribution offers an insight into the diagnostics industry and related regulatory provisions, presents statutory and case law related to patenting of diagnostic methods, and discusses the shortcomings of patent protection as regards the use of test results generated by diagnostic methods protected by patents.

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Protection for Diagnostic Methods and Its Limits Under the European Patent Convention and the German Patent Law

  • Joseph Straus

摘要

It is an undisputed fact that a quick and accurate diagnosis is an indispensable prerequisite for successful treatment of any health disorder. However, only an event like the outbreak of the Covid-19 pandemic brings the central importance of diagnostics for public health into the political spotlight (Immediately after the outbreak of the pandemic, newspapers and professional magazines have been full of headlines emphasizing the extraordinary importance of diagnostics. Here are just two early examples: Hannah Kuchler, Kiran Stacey, and Katrina Manson, White House Moves to Accelerate Testing, Financial Times of March 14/15, 2020, p. 4, and Seth Berkley, COVID-19 Needs a Manhattan Project, Editorial, 2020 Science 367, 1407.). While patents for therapeutics, necessary for efficient protection of the risky and expensive investments in their research and development, but raising the costs for the healthcare system, are often at the center of public debates, patent protection for diagnostic methods seldom discussed in public. This contribution offers an insight into the diagnostics industry and related regulatory provisions, presents statutory and case law related to patenting of diagnostic methods, and discusses the shortcomings of patent protection as regards the use of test results generated by diagnostic methods protected by patents.