Laws that Support New Diagnostics and Drugs

Our mission is to help lead judicial and legislative advocacy to create and change laws that motivate new diagnostics, personalized medicines and cancer drugs.  To inspire and influence advocacy, we are committed to educating Americans on what the federal courts are doing to decrease protection for medical innovation, and what Congress needs to do.

Since 2012, following the U.S. Supreme Court decision in Mayo Collaborative Services, et. al., v. Prometheus Laboratories (132 S.Ct. 1289 (2012)), the U.S. Court of Appeals for the Federal Circuit has invalidated every medical diagnostic patent claim to come before the court. This significantly decreases the motivation to create personalized medical diagnostics, because companies, acting rationally, will not invest in a market that they cannot protect.  

Since 2013, following the U.S. Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. 576 (2013)), isolated natural products are no longer eligible for patent protection. Just a few examples of drugs that would not have been protected by patents, and thus never developed into drugs and marketed by companies are cancer drugs Adriamycin (doxorubicin), Taxol (paclitaxel, taxotere and docetaxel), Vincristine and Vinblastine. The majority of women with breast cancer have been and still are treated with doxorubicin and/or taxol or taxotere.  The antibiotics penicillin, tetracycline and streptomycin are also isolated natural products. A study carried out by Sherry Knowles and Prof. Matthew Higgins at Georgia Institute of Technology (now at University of Utah), determined that between 2001 and 2011, over 18 billion doses of natural product-based drugs were administered to Americans. What would America, our communities and our families have done without these 18 billion doses of drugs?

In 2019, the American Cancer Society estimates that 1,762,450 Americans will be newly diagnosed with cancer.  The American Cancer Society estimates that 606,800 Americans will die of cancer. Men have a 39.66% chance of developing cancer in their lifetime and women have a 37.65% chance of getting cancer. Only 67% of people who have cancer will survive for 5 years.