103 · L3 Ethical & Controversial Aspects of Biotech Patenting

Overview — the master logic of biotech patent ethics

The through-line of this lecture is a single fault line: patent law protects inventions, not discoveries. Yet biotechnology exists precisely where that line is hardest to draw — every gene, protein and cell line a company wants to patent was first a discovery in nature. The courts and patent offices of the US, Europe and beyond have spent four decades drawing, erasing and redrawing this boundary case by case, and it still sits in a different place in different jurisdictions.

The lecture moves in three acts. Part 1 traces the foundational dilemma — invention vs. discovery — and the five landmark US cases (Chakrabarty, Moore, OncoMouse, Myriad, Mayo). Part 2 widens the lens to the international framework (TRIPS, Paris, Berne) and a US–EU–China comparison. Part 3 asks why this is ethically controversial, what a biotech entrepreneur should take away, and where the next fights (CRISPR, AI, personalized data) will be.

Invention vs. Discovery — the foundational dilemma

Patent law protects inventions, not discoveries, and the two are defined in opposition:

• Discovery — finding something already in nature (a new mineral, an Amazon plant, the law of gravity, a gene sequence as it exists in your body).
• Invention — creating something new that did not previously exist, or a new and useful application of a discovery; requires human ingenuity or an "inventive step."

The Supreme Court holds that laws of nature, natural phenomena, and abstract ideas are not patentable — they belong to the "storehouse of knowledge of all men, free to all... and reserved exclusively to none." That phrasing anchors the whole "product of nature" doctrine.

Landmark Case 1 — Diamond v. Chakrabarty (U.S. Supreme Court, 1980)

Facts. Ananda Chakrabarty, a genetic engineer at General Electric, developed a new, human-made bacterium that breaks down multiple crude-oil components for spill cleanup; no natural equivalent existed. The examiner rejected the claim to the bacterium, arguing living things were not patentable.

Question. Is a live, human-made microorganism patentable subject matter?

Ruling — 5–4. Yes. The bacterium was not a "product of nature" but a product of human ingenuity with "markedly different characteristics from any found in nature and one having the potential for significant utility." The Court said Congress intended patentable subject matter to "include anything under the sun that is made by man."

Why it matters commercially: Every later biotech-patent victory (OncoMouse, cDNA) is a logical extension of Chakrabarty: a human-made life form is an invention, not a discovery. The 5–4 split shows how close the modern industry came to a different path.

Landmark Case 2 — Moore v. Regents of the University of California (California Supreme Court, 1990)

Facts. John Moore was treated for leukaemia at UCLA. His physician, Dr. David Golde, removed Moore's spleen and other tissues; without Moore's knowledge or consent, Golde used the cells to develop a patented, commercially valuable cell line, the "Mo" cell line. Moore sued for a property right to his cells and a profit share.

Question. Does a patient retain property rights in excised cells, and can they sue for "conversion" (theft of property) if used commercially without consent?

Ruling. Against Moore on property: once tissue is removed, the patient no longer holds a property right, lest a "litigation lottery" hinder socially important research. However, the physicians breached their fiduciary duty and failed to obtain proper informed consent by not disclosing research and financial interests.

Landmark Case 3 — The "OncoMouse" (Harvard College v. Canada, 2002)

Facts. In the 1980s Harvard engineered the "OncoMouse," a mouse carrying an active cancer-promoting gene (oncogene) that made it highly cancer-susceptible — an invaluable research tool. Patent rulings diverged sharply:

• United States (1988). The USPTO granted it, explicitly claiming a "transgenic non-human mammal" — a logical extension of Chakrabarty.
• European Patent Office (EPO). Initially rejected, then granted after a "utilitarian balancing test" weighing animal suffering against potential medical benefit to humanity — the first explicit ethical calculation in patent examination.
• Canada (2002). 5–4 rejection of the mouse itself: a "higher life form" is not a "manufacture" or "composition of matter" under Canadian law; a complex social/ethical issue for Parliament, not courts. (The process of making it remained patentable.)

Significance. Shows deep divisions even among Western nations with similar legal traditions; the definition of a patentable invention varies significantly once ethics enter.

Landmark Case 4 — Association for Molecular Pathology v. Myriad Genetics (U.S. Supreme Court, 2013)

Facts. Myriad Genetics found the location and sequence of BRCA1 and BRCA2; mutations raise breast/ovarian cancer risk. Myriad patented the isolated gene sequences and complementary DNA (cDNA) versions, gaining a monopoly on testing that it enforced aggressively at high cost.

Question. "Are human genes patentable?" Is isolating a DNA segment an act of invention?

Ruling — unanimous. Isolated genomic DNA (gDNA) is NOT patentable: "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated." Myriad found the gene, it did not create or alter its information — a discovery. But cDNA IS patentable: it is not naturally occurring — lab technicians build it from mRNA, removing non-coding introns, yielding a molecule distinct from any in the body.

Real-world impact: Post-Myriad, no US company can monopolise a naturally occurring human gene sequence. This opened genetic testing to competition and forced diagnostic firms to rethink correlation-based protection — the direct lead-in to the Mayo problem.

Landmark Case 5 — Mayo v. Prometheus (U.S. Supreme Court, 2012)

Subject. Patents on methods for dosing thiopurine drugs (autoimmune disease) by measuring blood metabolite levels. Key steps: (1) administer the drug; (2) determine metabolite levels; (3) interpret to adjust dosage.

Ruling — unanimous — not eligible under 35 U.S.C. § 101. The method merely described a natural law (correlation between metabolite levels and drug efficacy/toxicity) plus routine, well-known steps. Justice Breyer's opinion: a claim must do more than state a law of nature and say "apply it" — it needs an inventive concept transforming the natural law into a patent-eligible application.

Implications. Casts doubt on many diagnostic tests relying on natural correlations; raises concerns for biotech and personalized medicine; reinforces that laws of nature, natural phenomena and abstract ideas need inventive transformation.

Part 2 — The international framework (TRIPS / Paris / Berne)

Three major agreements form the global skeleton:

TRIPS detail. Copyright ≥50 years, automatic (no registration), computer programs as literary works. Patents in all fields of technology for ≥20 years, with enforcement and dispute resolution. Requires national treatment and most-favoured-nation, and incorporates Paris Convention Articles 1–12 and Article 19 (binding even on non-parties). Article 27.1: patents available for "any inventions, whether products or processes, in all fields of technology," if new, inventive step, industrial application. Articles 27.2 & 27.3 permit exclusions: ordre public or morality (incl. human/animal/plant life or health); diagnostic, therapeutic and surgical methods; plants and animals other than microorganisms; essentially biological processes for producing plants or animals. Ordre public lets WTO members exclude inventions whose commercial exploitation would violate public order or morality.

Paris Convention (1883, WIPO). Industrial property; establishes national treatment, the right of priority, and independence of patents/trademarks across countries; general minimum standards without uniform substantive law. Berne Convention (1886, WIPO). Literary/artistic works with automatic protection on fixation, minimum life + 50 years (70 in many countries), national treatment, no formalities, and moral rights — authorship and objection to distortion or mutilation.

Comparative analysis — US (USPTO) vs EU (EPO) vs China (CNIPA)

Part 3 — Ethical frameworks & why biotech patenting is controversial

• Commodification of life / human dignity. Patenting genes or animals turns them into commodities, an affront to human dignity or the sanctity of life.
• The patent-holder counterargument. A patent is a temporary, exclusive right to a specific commercial use — needed to recoup R&D — not "ownership" of the gene.
• Social justice & access. Myriad's monopoly priced its test out of reach, worsening disparities — public good vs. commercial interest.
• Stricter eligibility post-Mayo. Natural-law discoveries need a truly inventive concept, raising the bar for naturally-derived biotech.
• Impact on diagnostic innovation. Methods merely applying a known biomarker correlation without novel steps now face rejection.
• The "chilling effect" & patent thicket. One company owning a fundamental gene/tool can block others or force expensive licences, slowing science.
• Benefit sharing & bioprospecting. When genetic material comes from individuals or populations, who shares the profit? A core Moore/bioprospecting question.
• Shift to trade secrets. Some firms keep diagnostic algorithms and data interpretations as trade secrets, limiting disclosure.

Patented Genes: An Ethical Appraisal (issues.org/sagoff/)

The Joint Appeal (18 May 1995). ~200 religious leaders called for a moratorium on patenting human and animal life forms: "We believe that humans and animals are creations of God, not humans, and as such should not be patented as human inventions." Consistent with the precedent that products of nature are not patentable.

Industry response. Biotech argued its critics misunderstand patent law: patents create temporary legal monopolies to encourage useful advances, with no moral or theological implications. As Carl Feldbaum (Biotechnology Industry Organization president) put it: "A patent on a gene does not confer ownership of that gene to the patent holder. It only provides temporary legal protections against attempts by other parties to commercialize the patent holder's discovery or invention."

Two purposes of patent law. (1) A natural property right — John Locke: "Justice gives every man a title to the product of his honest industry." Religious leaders, who hold God as author of nature, take offence when mortals claim to own what divine intelligence produced. (2) A utilitarian incentive — temporary monopolies encouraging socially beneficial investment.

How the conflict was historically avoided. Products of nature were treated as unpatentable because not "novel." In 1928 an appeals court held General Electric could not patent pure tungsten, only its purification method (tungsten is a product of nature). Chakrabarty (1980) changed this: the 5–4 majority allowed patenting hybridised bacteria because "his discovery is not nature's handiwork, but his own" — yet still reiterated that "a new mineral discovered in the earth or a new plant discovered in the wild is not patentable subject matter."

The PTO policy shift. Afterwards the PTO issued patents on products of nature — genes, fragments, cell lines, human proteins. Examples: 1987 — Genetics Institute patented human erythropoietin (EPO), a 165-amino-acid protein stimulating red blood cell production; Scripps Clinic patented human factor VIII:C, a clotting agent extracted from blood. Closing point: gene patents "confer commercial rights, not ownership."

Real-world hook: The 1980s PTO pivot — from "you cannot own a product of nature" to routinely patenting genes and proteins — is the quiet revolution behind today's biotech industry, and the "commercial rights, not ownership" framing is what lets the industry answer its religious critics.

Practical implications for the biotech entrepreneur

• Freedom to Operate (FTO) is complex. A patent does not mean you can commercialise — you may still infringe a broader patent. The lecture's example: the Wuhan Institute's proposed use patent for Remdesivir would still be blocked by Gilead's composition-of-matter patent.
• Global IP strategy is essential. An invention patentable in the EU (an isolated gene with a function) may be rejected in the US; strategy must track where you manufacture, sell and do R&D.
• The Myriad & Mayo legacy (US). Diagnostic startups face a narrower path: show the method is more than observing a natural correlation. Rely more on trade secrets for correlations/data while patenting novel reagents, machines or software.
• Informed consent is non-negotiable. Moore warns: clinical-trial and tissue-use consent must be watertight and transparent about commercial interests.

Future controversies

• CRISPR & gene editing. Who owns an edited gene or organism? What about germline edits passed to future generations? Enormous ethical stakes.
• AI & drug discovery. If an AI discovers a candidate with no human inventive step, who is the inventor and can the output be patented? Patent law is unprepared.
• Personalized medicine & data. As individual genetic data gains value, the Moore/Myriad debates over ownership, privacy and control will intensify.

Key take-away lessons

• The "product of nature" doctrine is a major hurdle. You cannot patent something merely because you found it, however difficult — human ingenuity and a "marked difference" from nature are required.
• Ethics & morality are part of patent law. In much of the world, especially Europe, justify an invention on moral as well as technical grounds (EPC Article 53(a), ordre public).
• Landmark cases have real-world consequences. Chakrabarty, Myriad and OncoMouse decide what a company can protect, where it can operate, and which business models are viable.
• The law is constantly evolving — faster than legislation. Today's landscape will differ in five years; staying informed is strategic necessity.