Patentable Subject Matter

Prof Merges

1.12.10

Agenda

• Old business: finish yesterday

• Introduction to patents

• Patentable subject matter

John Stuart Mill

• Mill argues that the moral worth of actions is to be judged in terms of the consequences of those actions. In this he contrasts his own view with that of those who appealed to moral intuitions.

The utilitarian perspective

• “The greatest good for the greatest number”

• “Rights” follow only from calculations of collective welfare

• “Natural rights” are “nonsense on stilts” – Jeremy Bentham

– Jeremy Bentham, A Critical Examination of the Declaration of Rights, in Bentham's Political Thought 257, 269 (Bhikhu Parekh ed., 1973).

Utilitarianism applied

• Derek E. Bambauer, Faulty Math: The Economics of Legalizing The Grey Album, 59 Ala. L. Rev. 345 (2008)

• “prevailing utilitarian calculus” for derivative work right in copyright cannot be defended

– Utilitarian talk masks “hidden” normative concerns (labor-desert, personality)

Introduction to the Patent System

• Quick history

• Purpose of system: “to promote the progress of science and the useful arts”

• Importance of claims in understanding how patents work

Consensus: patents are utilitaian

• But: even with this most “practical” branch of IP law, there are elements of natural rights present:

• Adam Mossoff, Rethinking the Development of Patents: An Intellectual History, 1550-1800, 52 HASTINGS L. J. 1255 (2001).

Who is Chakrabarty?• Ananda Chakrabarty, PhD is a

distinguished professor of microbiology and immunology at the University of Illinois College of Medicine. His most notable creation is a biology-based solution for cleaning up toxic spills using the generically engineered Pseudomonas (today classified as Burkholderia cepacia or B. cepacia).

Ananda Chakrabarty

Chakrabarty: Claims

• Process claims

• “Inoculum” including a carrier (combination claim)

• “the bacteria themselves”

Chakrabarty Claims: p. 129

1. A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.

Chakrabarty

• How many different types of claims?

Chakrabarty

• How many different types of claims?

•WHY?

Chakrabarty

• Process claims – never a problem– Why not?

• Process comprising steps of (1) , (2), (3), where (2) involves living subject matter

Combination claims

• “An inoculum” . . .

• Also allowed

• Why?

Combination claims

How did this case get to the Supreme Court?

• What did patent examiner do with claims?

• What is the “Patent Office Board of Appeals”?

• Appeal then to old CCPA (now Federal Circuit)

SUBJECT MATTER

§ 101 Inventions Patentable

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

Subject Matter: Overview

§ 101 Categories

• Process

• Machine

• Manufacture

• Composition of Matter

• Improvements

History of Section 101

• 1793 Act – “authored by Thomas Jefferson” -- ?

• Edward C. Walterscheid, The Use and Abuse of History: The Supreme Court’s Interpretation of Thomas Jefferson’s Influence on the Patent Law, 39 IDEA 195 (1999).

Alexander Hamilton

Section 101 Categories in Chakrabarty

• Manufacture: p. 129

• Composition of Matter

– “chemical union or mechanical mixture”

The now-famous punch-line

• P 130: Legislative history statutory language, 1952 Act

–“Anything under the sun that is made by [humans]”

• Laws of nature

• Physical phenomena

• Abstract ideas

What are the limits?

The Court’s examples of unpatentable things – p. 130

“a new mineral discovered in the earth, or a new plant found in the wild”

Einstein’s “law” (E=mc2)

Newton’s law of gravitation

How is Chakrabarty’s oil-eating bacterium different?

• “His claim is not to a hitherto unknown natural phenomenon, but to a nonnaturally ocurring manufacture or composition of matter – a product of human ingenuity . . .” -- p 130

Contrast (?) with Kalo

• Combining species into convenient plant-root inoculant

• How is this different from Chakrabarty’s invention?

What are the limits?

• “not nature’s handiwork, but his own”

– How does this limit the scope of patent law?

– Is it predictable? Too open-ended?

Counter-arguments

• Plant-specific Acts

• Congress should make IP policy, not the courts

What about plant-specific Acts?

• Implicit argument:– Expressio unius/exclusio alterius?

PPA/PVPA

Chakrabarty Patent

Utility Patents

PPA/PVPA

Chakrabarty Patent

Utility Patents

X

“Expressio Unius/Exclusio Alterius”

All Utility Patents

PPA/PVPA

Chakrabarty Patent

Second argument: Congress ought to make policy

• History of patents on living subject matter

• Comparative Institutional Competence

The Life Sciences and § 101

• A Brief history– Plant-specific acts, 1930 & 1970– Early biotech – 1973-1980– Early animal modification: Ex parte Allen,

1987– Gene patents: 1990-today– Gene therapy: mid-1990s-today– Dolly the sheep: late 1990s– Stem cell research: late 1990s-today

Commoncouragepress.com

Somebody owns your genes. Through the U.S. patent system, corporations and universities have claimed property rights not just on the rice and corn at your dinner table but also on you. Moving beyond patenting and "owning" diseases like staph, tuberculosis, and SARS, one American corporation owns the genetic heritage of the entire population of Iceland. A university has property rights on all human clones-even though human cloning is still being debated in Congress. Another company claims to have invented "junk" DNA. Through its patents, it stakes a claim to the research on 95% of human DNA.

Profits Pending examines the devastating affects of these patents on life, from the blatant theft of cultural resources to slowing down research into deadly diseases. Once used to reward the inventiveness of American scientists and entrepreneurs, the patent system is now being abused to control scientific exploration into human biology and to create monopolies over the world's food sources. Instead of promoting scientific research, patents on life now destroy crucial elements of the scientific method such as the free exchange of ideas between researchers. Profits Pending demonstrates that patents on life may ultimately destroy the biotechnology industry and ultimately hinder the innovation the American economy depends on.

Though we are only at the earliest stage of the establishment of patent monopolies over genes, cell lines, and even organisms, the current struggle over access to AIDS drugs is a harbinger of problems ahead. AIDS drug costs are a clear example of the use of patent monopolies to drive up the price of therapy.

• “Purified and isolated” claims

–§ 101 Issues

–Practical advantages

Natural substance patents

Jokichi Takamine

Jokichi Takamine

Jokichi Takamine was born on November 3, 1854 in Takaoka, Japan. He graduated from the college of science and engineering at the University of Tokyo in 1879. That year the Japanese government selected Takamine as one of 12 scholars to pursue graduate studies in Scotland at Glasgow University and at Anderson College. He returned to Japan in 1883 and joined the department of agriculture and commerce.

Takamine (cont’d)

He worked for the department of agriculture and commerce as chief of the division of chemistry until 1887. At that time he formed his own company, the Tokyo Artificial Fertilizer Company, where he later isolated a starch-digesting enzyme, Takadiastase, from a fungus.

Takimine (cont’d)

In 1894 Takamine moved permanently to United States, settling in New York City. He opened his own private laboratory but allowed Parke, Davis & Company to produce Takadiastase commercially. In 1901 he isolated and purified the hormone adrenalin in his laboratory, becoming the first person to accomplish this for a glandular hormone. --- Am Chem Soc’y, J. Chem Ed Online

Takamine: The Legend

Takamine’s patents

• ‘176 Product patent– Why was this valuable?– Why not a process patent (see

Chakrabarty)

Takamine’s patents (cont’d)

• ‘177 Patent– “Salt” (acid) form of isolated hormone– Usually “salt” is applied to an ionic compound

produced by reacting an acid with a base.– Why not at issue here? Claims were amended

during prosecution.

• How could it have been valid?– Prior art

Judge Hand’s Decision

Hand’s decision

“While it is of course possible logically to call this a purification of the principle, it became for every practical purpose a new thing commercially and therapeutically.”

-- p. 99

Hand’s Pragmatism

• “Practical differences”

Vs.

• “Scholastic distinctions”

P. 136

“But even if it were an extracted product without change, there is no rule that such products are not patentable . . .”

The Life Sciences and § 101

• A Brief history– Plant-specific acts, 1930 & 1970– Early biotech – 1973-1980– Early animal modification: Ex parte Allen, 1987– Gene patents: 1990-today– Gene therapy: mid-1990s-today– Dolly the sheep: late 1990s– Stem cell research: late 1990s-today

Critiques

“Reinventing the double Helix: a novel and nonobvious reconceptualization of the biotechnology patent”

• 55 Stanford Law Review 303 (2002); Demaine, Linda J.; Fellmeth, Aaron Xavier

Demaine and Fellmeth (cont’d) Science, Vol 300, Issue 5624, 1375-1376 , 30 May 2003

The challenge is to craft a test to distinguish products of nature from patentable inventions. A parsimonious solution is a variant of the "substantial transformation test“ (STT) used in customs law, in which a product is considered to have undergone a substantial transformation when it has a "new and distinct name, character, or use.“ Because name is highly mutable, the real focus of the test is a change of character or use.

Recent Commentary• Eileen M. Kane, Splitting the Gene: DNA Patents and the

Genetic Code, 71 Tenn. L. Rev. 707, 707 (2004)

By scientific and historical criteria, the genetic code can be characterized as a law of nature and as an essential component of the public domain in molecular biology. The Article concludes that the patenting of genes results in constructive preemption of the genetic code, a result that is contrary to the Supreme Court‘s [rulings].