Breast Cancer – Patents
Introduction: Breast cancer is a malignancy that effects women across the world and is most prevalent among various types of cancers. Patents are jurisdiction specific exclusive rights that are sought by innovators across various technological fields. However, patent rights become questionable and debatable when these are sought in respect of pharmaceutical drugs, medical devices, surgical techniques, diagnostic tests, personalized medicines and research tools related to healthcare. Across Western jurisdictions, patents have been sought for artificial plant varieties (hybrid plants, genetically modified plants etc.), animal species created with human intervention (Harvard Oncomouse, Dolly the Sheep etc.), and methods of human treatment. Due to the presence of numerous patents in the field of healthcare, it imminently results in the requirement of large number of licenses to access patented technology, which subsequently leads to increased cost of treatment because of accumulation of royalties (royalty stacking) to be paid to the patent holders. Therefore, in developing countries like India, it becomes highly controversial as to whether to grant such patents to protect Intellectual Property Rights (IPR) or to focus on affordable healthcare by rejecting such patents.
Strategy, Scope and Focus: With a view to discuss implications of patents specifically related to breast cancer, we have researched and analyzed the breast cancer patent landscape in India and US, in light of latest legal developments, with special focus on Trastuzumab (a medicine which treats a form of breast cancer) and US Supreme Court judgement to overturn Myriad Genetics’ patents on the “breast cancer genes - BRCA1 and BRCA2”.
Breast Cancer and Patents
Basics of Patent Rights: As it is well known that patent protection is granted for a limited period of 20 years, wherein the patent holder holds exclusive rights for exploitation of the patented invention. Generally, patents are aimed at encouraging innovations by providing incentives to the patent holders by offering them recognition for their creativity.
Biotechnology Patents: In the field of biotechnology and healthcare, the cost of reparation is crucial, as the research in these fields is highly expensive. The financial investments can only be paid off if the companies can protect results by exclusive rights (patents) and gain the competitive advantage.
Gene Therapy Patents: Historically, there has been a close relation between gene therapy, patents and scientific advancements. Large pharmaceutical companies have invested huge amount of capital in patenting genes, either on their own or by acquiring small biotech companies. For example, Swiss pharmaceutical company Sandoz (subsidiary of Novartis) acquired Genetic Therapy Inc. of Gaithersburg, Md. In 1995, for about $295 million. At that point of time, Genetic Therapy held exclusive license to a patent received by the National Institutes of Health for ex vivo gene therapy (somatic gene therapy), which involves taking cells out of the body, treating them with altered genes and replacing them in the body, with a view to compensate for deficient or defective genes. However, Novartis shut down Genetic Therapy after approximately 8 months because expected results could not be achieved, thereby bringing out the risks involved in such investments.
Patents for Breast Cancer Genes: Although disease-associated genes involve meticulous research and development, patents granted for protecting such innovations are at epicenter of various debates as they may hamper future R & D activities, in addition to leading to cumbersome costs of treatments. These concerns are presently being debated across various jurisdictions with regards to breast cancer genes (BRCA 1 and BRCA 2). In past, patents for these genes have been granted by EPO and USPTO.
Myriad Genetics: Myriad Genetics, Inc. is a molecular diagnostic company based in Salt Lake City, Utah, and holds hundreds of patents worldwide on BRCA 1 and BRCA 2, including the genes and diagnostic methods based on them. Many parties fear that due to such exclusive rights, the research may become impossible to carry out in public laboratories, or will become highly expensive.
Myriad Genetics Breast Cancer Patents: Number of PCT Patents filed by Myriad Genetics (Singly & Jointly) in each IPC
Commercially, Myriad Genetics has become a forerunner in the healthcare industry for diagnostic testing of BRCA1 and BRCA2 gene mutations, which are closely related to breast and ovarian cancer. In recent past, such diagnostic tests created controversy and were heavily debated when Angelina Jolie announced she had been tested positive for the mutations, whereby she voluntarily had a preventative double mastectomy.
Association for Molecular Pathology, et al. v. Myriad Genetics, Inc.: In light of Myriad's wide patent portfolio covering the BR