New Cures for Cancers

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  • Sherry M Knowles

Judicial Advocacy

Congress, the Executive Branch, the Judicial Branch and the people of the United States are bonded by a four-page handwritten document housed in a museum about 2 miles from the U.S. Capitol—the U.S. Constitution. This four-page handwritten document has alone created the best and most successful union of people in the world. Whenever our government strays outside this exquisitely balanced tripartite structure, mischief occurs in the form of damage to our union and our successes. This damage is now occurring to one of the most important factors that made the United States a success---motivation for innovation based on strong patent protection.


The U.S. Constitution created the balance of powers for our government to ensure that no one branch of the government would usurp too much power. Article I, Section 8, Clause 8 grant the exclusive right to create patent law to Congress. Congress used this power to create the statute on what subject matter is eligible for patent protection in the United States, which is now found in 35 U.S.C. Section 101. The U.S. Supreme Court thus only has the power to interpret the literal wording of Congress’ law, and is not authorized to create separate and inconsistent law, regardless whether it agrees. The U.S. Supreme Court has shown disdain for Congress and has ignored its statute and its Congressional legislative history. Instead, it has created its own case law under which the is little or no patent protection left for medical diagnostics and natural product drugs, both used in the fight against cancer. Cancer advocates cannot allow this.


The Supreme Court has done this by reading two words out of Congress’s statute—“or discovers”—and creating judicial exceptions to Congress’ statute without authorization from the Constitution. Personalized diagnostics can be considered applied discoveries of how drugs work. The U.S. Court of Appeals for the Federal Circuit, based on its interpretation of U.S. Supreme Court law, has rejected patent protection for every medical diagnostic patent claim it has reviewed since 2012.


The two cancer drugs that saved my life, Adriamycin and taxol, would never have been developed under the new U.S. Supreme Court test for patent eligibility, and I, along with tens of thousands of other women, would not have survived. We desperately need more personalized diagnostics and natural product-based cancer drugs for the people now suffering from cancer and their families.


Sherry Knowles is the co-author with Anthony Prosser of a law review article titled “Unconstitutional Application of 35 U.S.C. 101 by the U.S. Supreme Court”, published in January 2019, which is the culmination of several years of deep legal research on Congress’ legislative history on patent eligibility in the U.S. We reviewed every Patent Act and amendment from 1790 through 2011, and compared it with Supreme Court case law on patent eligibility during the same period.


The unambiguous conclusion of this extensive research is that the Supreme Court has shown extraordinary judicial activism, has penciled two words out of the federal statute, and has without any legal authorization created its own judicial exceptions to the statutory law, which change its meaning. Its new patent eligibility rubric does not align with the statutory language. It has crossed the line from interpretation to creation of patent law, which violates the Constitutional separation of powers.


The Supreme Court has bootstrapped itself with the self-authorizing doctrine of “statutory stare decisis” to say to Congress “and we will continue our inconsistent interpretations until you stop us.” The Supreme Court’s self-concocted and dangerous statutory stare decisis is not an antidote for unconstitutionality, and is directly harming cancer patients.

The history of the Supreme Court’s application of Congress’ patent eligibility statute is notable.


(i) It interprets Congress’ patent eligibility statute as applying to an invention but not an applied discovery, despite the fact that the word “discovery” is in Congress’ statute.

(ii) It has never carried out its Constitutionally required statutory construction of the first four words of the statute (Whoever invents or discovers).

(iii) Its cases refer to its own inconsistent opinions as precedent, instead of referring to the wording of Congress’ statute as the law as required by the U.S. Constitution.

(iv) It has admitted that its judicial exceptions are not based on the wording of the statute, and that “too broad an interpretation of this exclusionary principle could eviscerate patent law.”

(v) It has stated that “groundbreaking” and “brilliant” discovery does not satisfy the 101 inquiry, even though the word discovers is in Congress’ statute.

(vi) The Court’s opinions have digressed into economic analysis of the appropriate balance between patent protection and freedom to operate, despite not having any power under the Constitution to set patent policy.


Learn the Facts and Get Active!


BRIEF OF AMICI CURIAE SEVEN LAW PROFESSORS IN SUPPORT OF THE PETITION FOR REHEARING EN BANC


ON PETITION FOR REHEARING EN BANC


BRIEF OF FREENOME HOLDINGS INC. AND ACHILLION PHARMACEUTICALS, INC. AS AMICI CURIAE IN SUPPORT OF NEITHER PARTY


THE BIOTECHNOLOGY INNOVATION ORGANIZATION (BIO) AS AMICUS CURIAE IN SUPPORT OF NEITHER PARTY