• Sherry M Knowles

Legislative Advocacy

Updated: Oct 10, 2019

The simple facts:

  • The U.S. Constitution grants Congress the sole right to create patent law (Art. I, Section 8, Clause 8).

  • Congress has repeatedly passed laws on what subject matter is eligible for patenting in the United States since 1790 (only three years after ratification of the Constitution).

  • In well over 20 repeated passages of the law, Congress has insisted that both inventions and applied discoveries are patent eligible, even over dissent.

  • The U.S. Supreme Court has held through a series of cases that inventions, but not applied discoveries, are eligible for patent protection in the U.S.

  • The U.S. Supreme Court has created “judicial exceptions” to Congress’ statute, that result in the statute meaning its exact opposite.

  • The U.S. Supreme Court’s case law excluding applied discoveries from patent eligible subject matter has resulted in NO patent protection for personal medicine diagnostics since 2012.

  • The U.S. Supreme Court’s case law excluding applied discoveries from patent eligible subject matter has resulted in NO patent protection for isolated natural product drugs, which have formed the core of anti-cancer therapy for years. Basic research on new isolated natural products has gone to a full stop because of the Supreme Court cases.

  • Personal diagnostics and drugs based on natural products are still patent eligible in Europe, China, Japan, South Korea and other foreign countries, which means the U.S. is falling behind globally.

  • Since the Constitution grants Congress the sole right to create patent law, and the U.S. Supreme Court’s case law is inconsistent with Congress’ law, then the U.S. Supreme Court’s law is unconstitutional.

  • The U.S. Supreme Court’s law is harming present and future cancer patients and their families and friends.

  • The U.S. Supreme Court’s law should be fixed by having Congress pass a new statute overriding the U.S. Supreme Court’s law which would return the United States to a prominent position in full motivation for cancer and other medical research.

What has Congress done about this?

  • The Senate Judiciary Committee has reactivated its Subcommittee on Intellectual Property in part to address these issues.

  • The Judiciary Subcommittee on IP consists of:

  1. Thom Tillis, NC (Chairman)

  2. Chris Coons, DE (Ranking Member)

  • Majority Members;

  1. Marsha Blackburn, TN

  2. Ben Sasse, NE

  3. Lindsey Graham, SC

  4. Mike Lee, UT

  5. Chuck Grassley, IA

  6. Mike Crapo, ID

  • Minority Members:

  1. Patrick Leahy, VT

  2. Mazi Hirono, HI

  3. Kamala Harris, CA

  4. Sheldon Whitehouse, RI

  5. Dick Durbin, IL

  6. Richard Blumenthal, CT

  • The IP Subcommittee held Hearings over three days from 45 witnesses (June 4, 5 and 11, 2019) on the issue of The State of Patent Eligibility in the U.S.

  • The Subcommittee is now considering amendments to the patent eligibility statute.

Additional Readings:


Written Testimony of Sherry M. Knowles Principal, Knowles Intellectual Property Strategies, LLC Before the United States Senate Committee on the Judiciary Subcommittee on Intellectual Property on “the State of Patent Eligibility in America, Part I”


Attachment 1 to Written Testimony


Attachment 2 to Written Testimony


Attachment 3 to Written Testimony


Attachment 4 to Written Testimony


Attachment 5 to Written Testimony


Supplemental Written Testimony of Sherry M. Knowles Principal, Knowles Intellectual Property Strategies, LLC in Response to Questions from Senator Blumenthal Committee on the Judiciary Subcommittee on Intellectual Property on “The State of Patent Eligibility in America, Part I”


Supplemental Written Testimony of Sherry M. Knowles Principal, Knowles Intellectual Property Strategies, LLC in Response to Questions from Senator Hirono Committee on the Judiciary Subcommittee on Intellectual Property on “the State of Patent Eligibility in America, Part I”


Prepared Statement of Philip S. Johnson, Chief Intellectual Property Counsel, Johnson & Johnson On Behalf of the Coalition for 21st Century Patent Reform Before the

United States Senate Committee on the Judiciary On “Patent Reform in the 111th Congress: Legislation and Recent Court Decisions”


Supplemental Statement of JUDGE PAUL R. MICHEL (Ret.) former Chief Judge United States Court of Appeals for the Federal Circuit Before the Subcommittee on Courts, Intellectual Property, and the Internet COMMITTEE ON THE JUDICIARY United States House of Representatives “The Impact of Bad Patents on American Businesses”


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