Breaking the Natural Law: Patentability of Life Science Innovations

• Date: 01 September 2022
• Author: Samoneh C. Kadivar

Published in Landslide, Volume 15, Number 1, 2022. © 2022 by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion

thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the

American Bar Association.

11

BREAKING THE

NATURAL LAW

Patentability of Life Science Innovations

By Samoneh C. Kadivar

To be entitled to a patent, an invention must

satisfy a number of statutory requirements,

including the patent eligibility requirement

under 35 U.S.C. § 101. Section 101 of the Patent

Act states that an inventor can patent “any new

and useful process, machine, manufacture, or

composition of matter, or any new and useful

improvement thereof.”

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This provision is subject

to three judicial exceptions: abstract ideas, laws

of nature, and natural phenomena. If patent

claims are directed to any of these three judi-

cial exceptions without more, then they are not

patent eligible. Courts have rationalized these

three exceptions to prevent tying up basic scien-

tic and technological tools needed for future

innovation. This article looks at how § 101 patent

eligibility has evolved and the implications on patent

eligibility in the life science eld.

Life Science Close Encounters of the

§ 101 Kind

The rst life science case dealing with § 101 was the U.S.

Supreme Court’s decision in Funk Bros. Seed Co. v. Kalo Inocu-

lant Co. in 1948,

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followed in 1980 by Diamond v. Chakrabarty.

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In Funk Bros., the Supreme Court found inventions directed to a

man-made mixture of certain naturally occurring bacterial species

strains patent ineligible.

4

Prior to the inventor’s patent, the general

practice was to make and sell naturally occurring bacterial strains

separately, because when the different bacterial species strains were

mixed, they created an inhibitory effect on each other and lost

efciency in treating crops.5 The inventor discovered that there

are strains of each bacterial species that do not have an inhibitory

effect on each other.

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He thus created a mixture of these naturally

occurring bacterial species strains and patented the mixture.

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The

Supreme Court found that because the mixture of naturally occur-

ring bacteria did not produce a new property of the bacteria, the

invention was directed to a natural phenomenon and thus not

patent eligible.8

By contrast, the Supreme Court in Chakrabarty found that

claims directed to human-made bacterium were patent eligible.9

The Court distinguished the facts over Funk Bros., nding that the

inventor in Chakrabarty did not simply discover a bacteria mixture

like in Funk Bros. but created and genetically engineered the bacte-

ria to break down crude oil, a property that is not possessed by

any naturally occurring bacteria.10

For decades, Funk Bros. was the only Supreme Court decision

that held a life science patent ineligible under § 101. As a result,

§ 101 was infrequently used to challenge the validity of life science

patents. This changed in 2012 with the Supreme Court’s decision

in Mayo Collaborati ve Services v. Prometheus Laboratories, Inc.11

The Mayo v. Prometheus G ame Changer

The invention in Mayo was directed to using thiopurine drugs to

treat autoimmune diseases.12 Patients metabolize the thiopurine

drugs differently, so their doses have to be adjusted accordingly. If

the dose is too high, there are negative side effects, and if the dose

is too low, the drug does not work.13 At the time of the claimed

invention, scientists already knew that the drug metabolite levels

in a patient’s blood were correlated with the likelihood that a

particular dosage of a thiopurine drug could cause harm or prove

ineffective.14 The inventors discovered the threshold level of effec-

tiveness of the thiopurine drug.15

The claims recited a method of optimizing treatment for

immune-mediated gastrointestinal disorders by (1) administer

-

ing a thiopurine drug, (2) determining the resulting metabolite

Samoneh C. Kadivar is a senior associate at Baker Botts in

Austin, Texas. She focuses her practice on intellectual property

litigation and has participated in representing clients before

the International Trade Commission, U.S. district courts, and

the Federal Circuit. She can be reached at samoneh.kadivar@

bakerbotts.com.

Published in Landslide, Volume 15, Number 1, 2022. © 2022 by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion

thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the

American Bar Association.

11