At the request of Senators Thom Tillis (R-NC), Marie Hirono (D-HI), Tom Cotton (R-AR) and Chris Coons (D-DE), the US Patent & Trademark Office (USPTO) is undertaking a study on the current state of patent eligibility jurisprudence in the United States and how the current jurisprudence has impacted investment and innovation, particularly in critical technologies like quantum computing, artificial intelligence, precision medicine, diagnostic methods and pharmaceutical treatments. On July 9, 2021, the USPTO issued a Federal Register Notice seeking public input on these matters to assist in preparing the study. The deadline for submitting written comments is September 7, 2021.

The Federal Register Notice included 13 concerns on which comments were requested:

1. Explain how the current state of patent eligibility jurisprudence affects the conduct of business in your technology areas, and identify your technology areas.

2. Explain what impacts you have experienced as a result of the current state of patent eligibility jurisprudence in the United States. Include impacts on as many of the following areas as you can, identifying concrete examples and supporting facts when possible:

   1. patent prosecution strategy and portfolio management;

   2. patent enforcement and litigation;

   3. patent counseling and opinions;

   4. research and development;

   5. employment;

   6. procurement;

   7. marketing;

   8. ability to obtain financing from investors or financial institutions;

   9. investment strategy;

   10. licensing of patents and patent applications;

   11. product development;

   12. sales, including downstream and upstream sales;

   13. innovation and

   14. competition.

3. Explain how the current state of patent eligibility jurisprudence in the United States impacts particular technological fields, including investment and innovation in any of the following technological areas:

   1. quantum computing;

   2. artificial intelligence;

   3. precision medicine;

   4. diagnostic methods;

   5. pharmaceutical treatments and

   6. other computer-related inventions (e.g., software, business methods, computer security, databases and data structures, computer networking, and graphical user interfaces).

4. Explain how your experiences with the application of subject matter eligibility requirements in other jurisdictions, including China, Japan, Korea, and Europe, differ from your experiences in the United States.

5. Identify instances where you have been denied patent protection for an invention in the United States solely on the basis of patent subject matter ineligibility, but obtained protection for the same invention in a foreign jurisdiction, or vice versa. Provide specific examples, such as the technologies and jurisdictions involved, and the reason the invention was held ineligible in the United States or other jurisdiction.

6. Explain whether the state of patent eligibility jurisprudence in the United States has caused you to modify or shift investment, research and development activities, or jobs from the United States to other jurisdictions, or to the United States from other jurisdictions. Identify the relevant modifications and their associated impacts.

7. Explain whether the state of patent eligibility jurisprudence in the United States has caused you to change business strategies for protecting your intellectual property (e.g., shifting from patents to trade secrets, or vice versa). Identify the changes and their associated impacts.

8. Explain whether you have changed your behavior with regard to filing, purchasing, licensing, selling, or maintaining patent applications and patents in the United States as a result of the current state of patent eligibility jurisprudence in the United States. Describe how you changed your behavior.

9. Explain how the status of patent eligibility jurisprudence in the United States has affected any litigation for patent infringement in the United States in which you been involved as a party, as legal counsel, or as another participant (e.g., an expert witness). Explain whether this jurisprudence has affected the cost or duration of such litigation, the ability to defend against claims of patent infringement, the certainty/uncertainty of litigation outcomes, or the likelihood of settlement.

10. Identify how the current state of patent eligibility jurisprudence in the United States impacts the global strength of U.S. intellectual property.

11. Identify how the current state of patent eligibility jurisprudence in the United States impacts the U.S. economy as a whole.

12. Identify how the current state of subject matter eligibility jurisprudence in the United States impacts the global strength of U.S. intellectual property and the U.S. economy in any of the following areas, providing concrete examples and supporting facts when possible:

    1. quantum computing;

    2. artificial intelligence;

    3. precision medicine;

    4. diagnostic methods;

    5. pharmaceutical treatments and

    6. other computer-related inventions (e.g., software, business methods, computer security, databases and data structures, computer networking, and graphical user interfaces).

13. Identify how the current state of patent eligibility jurisprudence in the United States affects the public. For example, does the jurisprudence affect, either positively or negatively, the availability, effectiveness, or cost of personalized medicine, diagnostics, pharmaceutical treatments, software, or computer-implemented inventions?

Further information about the Patent Eligibility Jurisprudence Study can be obtained here.