In about 20 percent to 25 percent of breast cancers, the cancer cells produce too much of a protein known as HER2, making the cancers grow faster, according to WebMD. Many patients are treated with the drug Herceptin, another Genentech drug, and a class of chemotherapy drugs called taxanes to reduce the risk of recurrence.
When those drugs fail to contain the spread, doctors have turned to Kadcyla and other treatments.
In February 2013, South San Francisco-based Genentech received Food and Drug Administration approval for Kadcyla. Made up of two cancer-fighting drugs, the treatment pairs a cell-killing chemotherapy with Herceptin and attacks cancer cells from the inside, according to Genentech’s marketing material. The treatment is designed to cause less harm to healthy cells, although it may still damage healthy cells and cause serious side effects, the company said.
Genentech said it’s treatment is the first HER2-targeted treatment of its kind for metastatic breast cancer. Other drugs for the treatment of mastastic breast cancer include Perjeta, another Genentech drug, and Tykerb, a GlaxoSmithKline treatment.
In it’s lawsuit, Phigenix said Donald received a patent for a method targeting specific genes for treating breast cancer in December 2011. The suit said that between June and September of last year, Donald repeatedly had discussion with Genentech over its alleged violation of his patent.
Phigenix said it has not granted a license or any other rights giving another company or anyone else permission to use its patented inventions. Gutkin, the company’s lawyer, would not say whether Donald’s method is currently in use or seeking FDA approval.
Genentech is also accused of encouraging health care professionals to prescribe and administer Kadcyla in violation of Donald’s patent.
Phigenix’s research includes developing drugs that block cancer causing proteins. The company is also developing diagnostic tests that may detect prostate abnormalities years before pre-malignancy.
Donald received a bachelor’s degree in biology from Florida A&M University and master’s and doctoral degrees in molecular biology from Clark Atlanta University. He also conducted post-doctoral research at Emory University. He has about 100 oncology-related patents, pending patents and patent applications, the company said.