Gabriel Ben-Dor Stanford-Brown iGEM 2012 September 2012 AT A GLANCE Ethics of Gene Patenting: Moral, Legal, and Practical Perspectives Moral Issues Patenting Genes is like “Owning” Something Human For • The human genome is part of a “common humanity.” Patenting genes violates that humanity. • An individual’s genome is a personal sacred thing. To profiteer off the nuance differences (e.g. mutation) between one human and another would be a violation of the personal nature of genes. • A patent grants the owner the right to exclude everyone else from access or usage (to a gene lets say); no one else being allowed to use something without your permission can be analogous to “owning” Against • In reality, gene patents do not apply to genetic material as it natural occurs in our body. Thus, human sanctity is maintained. • A patent only prevents others from using your ideas. It does not grant ownership. Monopoly on a Medical Treatment/Service For • Being able to patent genetic material is what leads to development of treatments in the first place; patented ideas secure investors • Laws of supply and demand dictate fair price for consumers Against • Limits options for patients • Can lead to overpricing of medical treatments Fear of Global Injustice For • A patent owner could deny or make it expensive/difficult for • Laws of supply and demand dictate fair price for consumers Against • All people should have equal access to knowledge and use derived from gene research • Third world countries, serving minimal risk of competition, that would benefit immensely could be denied Legal Issues “Sufficiently Isolated or Transformed” Sufficient • Isolated and/or manipulated genes are a product of human ingenuity • Isolating genes changes the original structure of DNA and turns it into a similar but new structure. In other words, through purification, genes and their function can become something new practically. Insufficient • Genes, whether isolated or manipulated, as essentially just information and that is where their value stems from. These life instructions should not be controlled. • Synthetic biologists find many patents involve procedures that standard in the industry. A gene is not that different in our out of the body (e.g. Is a PCR and adding biobrick cut sites really enough?) The Non-obviousness Requirement Sentiments that threshold to meet this requirement is too low • What a Federal Appeals Court and the average synthetic biology consider to be obvious may not correspond; a scientist could consider patented parts to be quite customary and expected. • Gene patents some may argue can be considered to have more “discovery” like character than “invention.” The Utility Requirement: The Specificity of the Claimed Use Sentiments of Insufficiently Specified • Many patent claims are too general. • Patent holder may simply want to cover every possibility they could use. • “Current available forms” is not being stretched Practical Issues Benefits of Patents: Motivation and Innovation • Private Ownership of IP attracts and boosts investment • Owner gets credibility • Can generate revenue for licensing • Foundational Patents and Fear of Litigation • Far reaching patents increase fear of litigation • Firms could buy as many gene patents as possible in a low key fashion, suddenly emerging as the holder when large investments are at stake Patent Thickets For • “there are a number of companies [with] some degree of patent protection, it would seem unlikely that one group…would be able to hold a ‘monopoly’ on anything.” Against • It could be argued that patenting more than is intended or able to immediately work on makes research on patented items unavailable for the rest of the scientific community • Thicket owners could be forced to eventually share licensing and royalties. This cross-licensing is sub-optimal and caps incentives. • if genes are to be patented, it should be done so as specific composite parts. Weighing Different Solutions Completely Open Source For • Research is accelerated by the public sharing of ideas and creations Against • Hinder an investor’s incentive to help develop research into the product Copyleft For • The inventor/writer can get credit and legal benefits without restricting any use • Cheap Against • Only covers original works of expression. Would not be able to apply to syn bio • Could lower incentives for IP; requiring to have free licensing may cause investors to have to fear competition and might be less inclined to invest Patentleft For • Can apply to genes more so that copyleft • The inventor/writer can get credit and legal benefits without restricting any use Against • More expensive than copyleft • Could lower incentives for IP; requiring to have free licensing may cause investors to have to fear competition and might be less inclined to invest Patent Non-Assertion Model For • Enables synthetic biology to grow without hindering IP investment interest Against • More nuanced patent agreement: nuance requires better lawyers, and better lawyers often equate a greater financial expense for an individual synthetic biologist .