Genetics and Patent Law

Lecture 7 Who owns your genes? Genetics and Patent Law Early Patent History: ●​ Ancient Greece: some evidence of rights to "creators" for a year ●​ 1300s Britain: "letter patent" of monopolies political patronage (granted by king) ●​ 1421 Florence: first invention patent ●​ 1474 Venice: first patent law (established a process to grant exclusive rights for 10 years in its territory in return for public disclosure ●​ 1624 English Parliament: passed the Statute of Monopolies -> not to create a new right but rein in king's power to grant monopolities as income source and poltiical patronage. Invention patents to promote the collective good, replacing monarchic with law ●​ U.S. Constitution: the progress of science and arts, by securing for limited times to inventors the exclusive right to their discoveries”. Congress passed a patent statute based on this authorization, and Thomas Jefferson was the first Commissioner of Patents Modern Patents: ●​ Patents are compromises that grant monopolies and protect intellectual property -> acculumate innovation cost to realize its benefits ●​ All patents are anti-competitive -> innovations not open to free market until period is over ○​ Thus is inherently gray -> trying to promote innovations without supressing competition ○​ Ex. High drug costs due to many years of development. Nobody is going to do this if their intellectual property immediately becomes a public good. Drug companies are reluctant to develop drugs for rare diseases as they are very expensive What is Patentable and What for? ●​ An invention must be patentable subject matter ●​ The U.S. definition is “any new and useful process machine, manufacture, or composition of matter, ●​ or any new and useful improvement thereof”. ●​ An invention must also meet three criteria for patentability: (a) novelty, (b) nonobviousness, and (c) utility. ●​ A patent must describe an invention in sufficient detail that a “person having ordinary skill in the art” will be able to make and use of it without “undue experimentation.” History of Genetic Patents: June 1980: Diamond v. Chakrabarty: able to patent genetically modified living organisms ●​ The U.S. patent office denied General Electric’ patent for a bacterium selectively bred to metabolize petrochemicals and digest oil spills as you can't patent a life form, but the Supreme Court said yes. Thus, case was public national discussion abt recombinant DNA and biohazard fears from splicing genes into living organisms, but also a promise of biotechnology in gene cloning. So Supreme Court decided that products and organisms made by recombinant DNA technology were patentable ○​ Caused the General Secretaries of 3 Largest U.S. religious denominations to sign a President letter (Jimmy Carter) raising question concerns abt who shall determine how human good is best served enginnered and how to control these, who will benefit, and the fundaental nature of human life, dignity, and worth Erythropoietin (Epo) is a poster child of a valuable gene patent ●​ Epo, a hormone produced in the kidney, protects red blood cells against destruction and stimulates the stem cell of the bone marrow to increase their production ●​ Treats anemia associated with kidney disease, diabetes, cancers ●​ multibillion-dollar therapeutic protein that was central to the rise of Amgen (business model of sequencing genes encoding protein therapeutics, gained notoriety by E. Coli producing indigo dye) ○​ Synthetic Ego made by recombinant DNA tech, licensed to Amgen ●​ Epo research: drug EPOGEN (human ego produced by CHO cells grown in culture (Chinese Hamster Ovary) -> large 660mil/year revenue (total of 25 bil 1987-2011) ○​ case highlights the high stakes of these patents and legal wrangling over patents ●​ 1987 - "The Genetics Institute": patent on isolating (not producing) protein ○​ Amgen: similar patent DNA sequence production commercially ■​ Thus, neither could proceed without infringing on others patent ■​ 8 years later: fine The Genetic Institute for infringement -> Amgen stock up 12% ○​ Protein modifications and production are constantly on Amgen's turf -> court decides if it is a violation of the patent or not ○​ Recombnant Ego protein protein expired in 2015 The Venter Patents: prior to DNA large-scale sequencing, sequencing DNA was difficult and costly until automated sequencing ●​ Craig Venter (NIH founder Celera): sequenced coding sequences (ESTs) and identified potential drug targets (instead of isolating genes of interest then sequencing them ○​ Funded by drug companies looking for early access to human genes to targgets ○​ NIH didn't fund nor private companies since it didn't advance their business Myriad Genetics CEO Claims He Owns Your Genes 2013 Supreme Court decision on BRCA ●​ BRCA is the poster child for debates on the issue of genetic patents ●​ Mary Clare King (scientist and Human Rights Activist) found a linkage between BRCA1 ​ (on chromosome 17) that is associated with 5-10% of breast cancer cases ●​ Race to clone and sequence the gene (won by Myriad Genomics -> became sole source for BRCA testing in the U.S., which caused lots of legal action) ○​ So if you wanted to know your own genotype at this locus, you had to pay Myriad ○​ Through 2013, Myriad did 1 mil BRCA tests and got 2.8 billion ●​ Health Professional organizations and the ACLU challenged these patents ○​ Used Myriad and BRCA as a test case of genetic patents based on the high profile nature of this disease and gene. Intend to set a precedent to apply to other genes ●​ Supreme Court rules that can't patent DNA sequence but can patent analytical techniques for studying it (ex. Synthetic DNA if modififed the way they operate from their natural state) ●​ Opinion: Can't patent naturally occurring DNA sequence because it is difficult to study ○​ Growth of genomics could have affected this issue in 1970 ●​ DT Interpretation: Before it was ‘Kind of a Big Deal’ to isolate and identify genes. It was a major research enterprise, and the resources put into that effort were perhaps more deserving of patent protection, or put another way, patent protection was necessary ●​ What changed scientifically? Legally? Scientifically, we can isolate human genes in everyone for little cost or effort Titanic Clash over CRISPR patent turns ugly ●​ 2012: CRISPR disputes where Cas9 cut strands of DNA specfici sites ●​ March 2013: Jennifer Doudna and Emmanuelle Chrpentier filed a patent ●​ Oct 2013: Feng Zhag filed a patent and was granted in April 2014, rewrded additional patents on the tech when Doudna patent was pending ●​ April 2015: Berkeley team intereferrered to determine which team was first to invent the technique ○​ Both sides showed evidence -> Zhang used Doudna info to guide theirs ○​ Whether he application to human cells was as invention under patent law. Did Dr. Zheng advance the field beyond an “ordinary skill in the art” Zhang won