CRISPR Nobelists Surrender Their Own European Patents

Lecture 8 CRISPR Nobelists surrender their own European patents: 2 European CRISPR patents to Nobel Laureates Doudna and Charpentier are set to be revoked by the European Patent Office (EPO) cuz the 2 key patents aren't distinct enough to qualify as inventions ● EPO noted that patents fail to mention the short DNA sequences needed to cut the target DNA sequence. The Nobelists’ lawyers asserted these motifs are common knowledge; “even undergraduate students” would know they are needed for CRISPR function. ● Stakeholders: The patents are opposed by strange bedfellows, environmental advocates who oppose genetic engineering, competing pharmaceutical firms and lawyers representing undisclosed clients, and defended by ERS Genomics, the company set up by Charpentier to license her CRISPR patents. ● This is a tactical retreat. With broad patents remaining in the EU, losing these two could have repercussions in other patent courts, even in the US.. “Doudna and Charpentier’s lawyers don’t want anything negative out of the EPO” the EPO’s highly respected views could have “played through to the US.” ● CRISPR–Cas9 patent ownership differs in Europe and the United States. In Europe, the Doudna and Charpentier patents dominate, whereas in the United States, patents from Feng Zheng of the Broad Institute prevail. ● These two parties, and others, have been contesting CRISPR–Cas9 ownership for over a decade. Last year, the South Korea-based ToolGen claims that it invented CRISPR–Cas9 editing before Zheng or Doudna and Charpentier. ● The Patent and licensing situation was already complicated, but these latest developments make it more so. ● Despite CRISPR–Cas9 being overtaken by newer gene-editing tools, patents including Cas9 remain valuable. For instance, base editing, prime editing and technologies underlying large sequence insertions require a Cas9 component. Cas9’s patent outcomes will also affect new-generation gene-editing technologies,” Take Home Messages – Genetic Ownership, Patents ● Patents have become a mechanism to protect investments in product development and intellectual property rights, to ensure that the creators of new products and methods reap the rewards of their investments. ● Patents are anti-competitive, but this is balanced by the public good associated with incentivizing innovation. This balance can be struck by decisions involving the breadth of patents and their duration. ● In 1980, the Supreme Court established that organisms could be patented, the implication was the genes could also be patented. ● Finding genes of interest, patenting them and developing drugs (often using recombinant DNA methods) fueled the rise of the pharmaceutical industry. ● Were these gene patents a good thing? ● With genomics, human genes were patented at an alarming pace (The Venter Patents). Would Celera have existed without the commercial promise of patenting human genes? ● Myriad Genetics won the race to identify the BRCA genes and patent them. ● In 2013 the US Supreme Court ruled (unanimously) that unmodified genes that occur in nature cannot be patented. ● Was this a shift in legal thinking, or a logical consequence of the fact that finding genes is now so easy, it is not worthy of patent. ● CRISPR is a high stakes patent fight, but not unusual when trying to determine the “ownership” of scientific discovery. ● Genome editing is another exponentially growing DNA revolution Careers in Genomes: growing relevance of genomics has changes ● Biomedical Researchers, healthcare professionals, healthcare ecosystems ● Nurse, research scientist, genetic counselor, science historian, data scientist, engineer ● Encounter genomics through healthcare and as a citizen by interactions with professionals who "touch" genomics as part of their jobs ● 27 National Institutes of health ○ National human genome research institute (NHGRI) established in 1989 ■ Now at 660 million/year and 700 staff