Session 8
March 24, 2021
Introduction
In this class, we will discuss some of the tangible benefits that come from scientific discovery and from the transformation of discoveries into practical goods. This leads us to ask how science contributes to the economy and to consider some of the conflicts that occur in the conversion of concepts into practical items of commercial value. We will talk about articles, legal rulings, and books that illustrate problems about ownership (as manifest in patents, licenses, and copyrights) and about financial returns (that can swell the incomes of basic scientists or product developers). But we must also think about the best interests of the public versus the just rewards to owners of intellectual property (IP). The issues about ownership also affect matters of trust in science, and they create “conflicts of interest” that can undermine confidence in scientific work. Ownership can also strongly influence the price of the products of science—notably the cost of drugs produced by the pharmaceutical industry, which takes advantage of the discoveries made by government-supported basic science conducted in government and academic laboratories.
We need to acknowledge, from the outset, that “ownership” can mean several different things to a scientist. It can mean recognition as the first to discover or invent something (“priority”). That can lead to concrete rewards for such accomplishments (e.g. promotion, primacy in a field, or prizes). Or it can mean securing rights to IP, most commonly a patent. How do you place value on these things? And how should credit, priority, leadership, and IP be distributed among contenders?
The Covid-19 connection
During this class, we will discuss some issues of immediate importance during the epidemic of COVID-19, so think about these questions as you read the assigned works:
Should patenting and licensing arrangements be altered or suspended during the pandemic emergency?
If so, how would you decide which kinds of intellectual properties would be designated for those changes? For instance, what kind of role must they have in diagnosis, screening, prevention, or treatment?
Which kinds of changes would be most palatable, realistic, or effective: Prohibitions on patents for certain things? Agreements to avoid profits? Free licensing of IP? See, for example, www.opencovidpledge.org
Background and readings for discussion
In considering recent conflicts about IP, we will depend on several aspects of patent law, as first spelled out in the US Constitution:
Article I, section 8, reads, “Congress shall have power… to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.”
Here are some relevant readings; please read at least one or two, and let Dawn know by email which ones you have read:
(1)Charles R. McManis & Sucheol Noh, “The Impact of the Bayh-Dole Act on Genetic Research and Development: Evaluating the Arguments and Empirical Evidence to Date” (An accessible legal essay that reviews some important aspects of the Bayh-Dole Act of 1980, legislation that strongly influenced how academic institutions pursue ownership of biological findings and products.) https://www.researchgate.net/publication/228298131_The_Impact_of_the_Bayh-Dole_Act_on_Genetic_Research_and_Development_Evaluating_the_Arguments_and_Empirical_Evidence A PDF is on the class website.
(2) An essay by Robert Cook-Deegan, a leading scholar on genetics and the law, about the Supreme Court’s decision on DNA patenting in a case that invalidated the patent held by Myriad Genetics on the BRCA1 gene. Reference #23 has the Court’s decision, an important document (US Supreme Court, American Association of Pathologists v.Myriad).
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4225052/pdf/40142_2014_Article_55.pdf
(Last year, a bipartisan effort was mounted to legislate changes in the criteria for patentability, led by Senators Tillis and Coons. One description of this new conflict is provided as a PDF on the course website. What do you think about this proposal?)
(3) The latest and most intense patenting fight in recent times has been over the gene-editing method often referred to as CRISPR/Cas9. An account of one ruling in 2016, by no means the last, can be found in the NY Times by Andrew Pollack: https://www.nytimes.com/2017/02/15/science/broad-institute-harvard-mit-gene-editing-patent.html
Here is one of many articles about the effects of the CRISPR fight on science: “Pursuit of profit poisons collaboration,” by Jacob S. Sherkow, Nature, April 14, 2016 https://www.ncbi.nlm.nih.gov/pubmed/27075081
(4) One of the thorniest issues in academic science bears on the question of what kinds of information and materials should be openly shared, with or without IP protections. This issue is explored in an important legal discussion by faculty at the University of Michigan Law School: Can Patents Deter Innovation? The Anticommons in Biomedical Research https://science.sciencemag.org/content/280/5364/698
That article has direct bearing on whether genetically modified mice (e.g.”oncomice”) should be subject to patenting or licensing. Some of you who work with such mice might want to think about your position on this topic.
(5) About two years ago, investigative reporters at ProPublica and The New York Times revealed evidence of unacknowledged conflicts of interests at several cancer centers, especially at Memorial Sloan Kettering here in New York City. https://www.nytimes.com/2018/12/31/health/memorial-sloan-kettering-conflicts.html
What do you think about these conflicts? What are their consequences? What do you recommend to avoid or ameliorate them?
(6) The fact that the development of the tools used in health care—especially drugs, but also diagnostics and vaccines—depend on both basic science (usually supported by the government and philanthropy) and applied sciences (usually supported by private industry) complicates the pricing of those tools, again especially drugs. See the essay by Robert Pear about “Paying Twice”: https://www.nytimes.com/2018/05/28/us/politics/drug-prices.html
What do you think should be the guiding principles in establishing drug prices? How can we reduce them? Why are they so high in the USA?
(7) Debate about the invention of the HIV test kit and royalties from its use was among my most difficult problems in my first year as NIH Director. One account of the settlement is here: http://articles.latimes.com/1994-07-12/news/mn-14822_1_hiv-test-kit (Another account of the fight over these royalties, France vs USA, can be found in my memoir, The Art and Politics of Science.)
Optional short readings
Here are some other optional readings about events in this domain that have occurred over the past few years. If any of you choose to read these short articles and want to report on them, please tell Dawn.
Public funding is backing a new immunotherapy treatment, but the bulk of any profits will go to a private company. So, are taxpayers getting a good deal?
An academic provides an inside view of the relationships being forged with corporations, and the accompanying expectations.
(3) https://www.nytimes.com/2017/03/10/opinion/bernie-sanders-trump-should-avoid-a-bad-zika-deal.html
Bernie Sanders and a former head of the NIH square off over the development of a vaccine against Zika virus. How does this play out in the realm of Covid vaccines?
Some interesting, longer, optional readings on these topics
These are not required for class but keep them in mind if you want to read more about ownership of intellectual property, fights over priority in science, and other items related to turning discoveries into fame and profits. Some of these might be starting points for a lively term project! All can be found at Amazon.com
L. Jardine, The Man who Measured London (a compelling biography about Robert Hooke, a remarkable scientist and difficult person who played critical roles in English science, the Royal Society, and the plan for London in the late 17th Century)
R. Skloot, The Immortal Life of Henrietta Lacks (a very popular social history of the origins and politics of the most famous cell line in medical research: HeLa cells)
S. Hall, Invisible Frontiers (an excellent account of the early days of the recombinant DNA industry by a journalist who met with you last month)
A. Kornberg, The Golden Helix (a personal story of the founding of the company DNAX by a Nobel Prize-winning biochemist )
B. Werth, The Billion Dollar Molecule (a highly readable story about the development of a biotech company by superb chemists)
J. Shreeve, The Genome Wars (one of several good accounts of the race to finish the analysis of the human genome and possibly commercialize it)
R. Hoffman and C. Djerassi, Oxygen (a play by two distinguished chemists about an imagined dispute among three great 18th century scientists over priority for the discovery of oxygen; the play is another example of representation of science in the arts and about the larger meaning of the phrase “ownership of science.”
