Patents as Governance for Human Genome Editing Presented by: Prof. Sherkow Date: December 1, 2021 History of DNA - 1953 – discovery of the molecular structure of DNA • - 1980s - recombinant DNA revolution • - - Can decode, but can do little to "edit" Clumsy; not programmable 2012 - CRISPR! • Naturally occurring adaptive immune system in bacteria (long a puzzle) • Target and cleave precise location in a genome ~20bp • Programmable (nucleic acid directed) Šikšnys • Worked out minimal components from adaptive immune system and biochemical pathways • Effected through RNP Genome Editing Technologies - CRISPR - ZFNS - TALENS - Mega nucleases - Vectors - ...subject to IP disputes! - Uptake turns on IP landscape for these technologies What are Patents - Patents: • Protect inventions • Must be applied for and meet statutory requirements • Right to *exclude*- not use • Country-by-country Patents as Governance - Patents Can Be a Governance Instrument - What gets patented (and therefore excludable) - - - • Technically feasible • Commercial consequence • Competitive strategy • Subject matter/moral utility* Who can use patented applications • Commercial v. non-commercial • Research tool v. development Conditions on use • Ethical restrictions • Reporting Cost of use Moral Utility: Ordre Public Exception (EPC) - EPC art. 53(a): no patents on heritable human genome editing • No one should *own* immoral technology... • But removing it from privatization makes it tough to police! - Shifts patenting (and research) to more permissive regimes - No viable US analog • Moral utility mostly dead Licensing Regimes - Licensing as Instruments of Patent Governance • Government licenses (gov't can license to others) • Compulsory licenses (gov't mandates others can use) • March-in rights (gov't takes away right to exclude) • Government use rights (gov't can use) • Subject matter restrictions (limits on what can be patented) • Private governance  Ethical licensing restrictions (with Guerrini et al. 2017) Democratic Concerns - Democratic Concerns with Patent Governance (with Naomi Scheinerman) - Licensing power is inequitably distributed and anti-democratic • Few real remedies for consolidation  Case for government rights or march-in rights • Risk of scientific elitism  But no evidence elitism is ethically suboptimal (at least relative to more democratic measures) - - Public representative conflicts over private governance • More smoke than fire (threats = action, on yielding votes) • "Greasy wheel" syndrome • Technically complex Rebuffs democratic engagement • Post hoc • Artificially limited choices • Framing the narrative Other Options - Enforceable Domestic Governance Beyond Patents - FDA/MHRA premarket approval - Private law - - • Torts • Contracts Funding agencies and review boards • NIH/WELLCOME • ICER/NICE Raw politics Outstanding Questions - What is the relationship, if any, between dignity concerns and private law governance regimes? • - What empirical evidence do we have that moral utility is "working"? • - Can we disentangle from funding? How salient is patent governance globally? • - Typically antipathic; can they be harnessed for good? Is this a "first world problem"? Is private enforcement of ethical restrictions anti-democratic? • Oddly contrasting situation in U.S. re employment discrimination (Sean Farhang)