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DNA Helix

The American Gene Patent Legal FAQ

February 19th, 2009 by Andrew Yates

Disclaimer: I am not a lawyer, and this is not legal advice.

Does the government have the right to exclude others from another’s invention or discovery? Yes.

US Constitution, Article 1, Section 8: Powers of US Congress:

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;

Do genes constitute patentable subject matter? Yes.

Abstract ideas, mathematical formulas, and products of nature are all specifically excluded as patentable subjects by judicial rulings. However, forget for a moment that genes are “information.” Think of DNA as a chemical that can be extracted from a human cell —just like any other chemical —because it is.

In practice, scientists do not simply “observe” the “abstract ideas” of DNA “in nature” with something like a microscope. DNA must first be “processed” for humans to learn anything about it. That processing method and its products constitute patentable subject matter.

The precedent for these biochemical patents is Parke-Davis & Co. v H.K. Mulford & Co. At issue was a patent for purified animal adrenaline. While Judge Learned Hand held that while adrenaline itself was a product of nature, the purified adrenaline was something new and thus a patentable subject matter. Likewise, the DNA of genes as it is observed in cells is a products of nature and does not constitute patentable subject matter. However, under 35 U.S.C § 103a, a “biotechnological process using or resulting in a composition of matter”  (e.g. the processed DNA of genes) does constitute patentable subject matter. For example, a specific method utilizing PCR and defined oligonucleotides is a biotechnological process is a patentable subject.

In fact, genomic patents are specifically qualified in patent law. 35 U.S.C. §103 3:

(A) a process of genetically altering or otherwise inducing a single- or multi-celled organism to-

(i) express an exogenous nucleotide sequence,

(ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or

(iii) express a specific physiological characteristic not naturally associated with said organism;

(B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody;

Granted, the ambiguities between what is “matter” and what is an “abstract idea” and what is “man made” and what is “natural” are an epistemological conundrums that have no axiomatic definitions. There’s no reason that American patent law couldn’t be composed differently or even that it must exist at all. However, this is the current understanding of the law until judicial rulings or legislation declare otherwise.

Note that a patent does not exclude others from looking at a gene or from filing further patents based on existing gene patents. It is merely the right to exclude others from making, using, importing, selling, and offering for sale the patented matter.

Does “life” constitute patentable matter? Yes.

Per Diamond v. Chakrabarty, 447 U.S. 303 (1980)

Title 35 U.S.C. § 101 provides for the issuance of a patent to a person who invents or discovers “any” new and useful “manufacture” or “composition of matter.” Respondent filed a patent application relating to his invention of a human-made, genetically engineered bacterium capable of breaking down crude oil, a property which is possessed by no naturally occurring bacteria. A patent examiner’s rejection of the patent application’s claims for the new bacteria was affirmed by the Patent Office Board of Appeals on the ground that living things are not patentable subject matter under § 101. The Court of Customs and Patent Appeals reversed, concluding that the fact that micro-organisms are alive is without legal significance for purposes of the patent law.

Is isolating a gene itself sufficient utility for a patent? No.

We’ve established that genes constitute patentable matter, but patents must be 1) novel 2) nonobvious and 3) useful. Novel and nonobvious criteria are the same for any other patent, but how are gene patents useful? Hypothetically, the “use” of the patent could be how to read the gene sequence itself, but this use is not within the USPTO’s stated guidelines. Disclosing only the nucleic acid molecular structure (the sequence) of a gene itself is not patentable. The gene plus a specific use is patentable.

Per the USPTO Federal Register:

Thus, an inventor’s discovery of a gene can be the basis for a patent on the genetic composition isolated from its natural state and processed through purifying steps that separate the gene from other molecules naturally associated with it. If a patent application discloses only nucleic acid molecular structure for a newly discovered gene, and no utility for the claimed isolated gene, the claimed invention is not patentable. But when the inventor also discloses how to use the purified gene isolated from its natural state, the application satisfies the ”utility” requirement. That is, where the application discloses a specific, substantial, and credible utility for the claimed isolated and purified gene, the isolated and purified gene composition may be patentable.

Do genomic risk reports and diagnostics constitute “specific, substantial and credible utility?” Yes.

Prophetic uses are allowed as long as they are scientifically validated.

Does utility as the subject of further scientific inquiry constitute “specific, substantial and credible utility?” No.

per Brenner v. Manson.

Held: The requirement that a chemical process be useful is not satisfied by a showing that the compound yielded belongs to a class of compounds which scientists are screening for possible uses.

References

Diamond v. Chakrabarty, 447 U.S. 303 (1980)
http://supreme.justia.com/us/447/303/case.html

An Argument for Narrowing What is Un-Patentable Natural Subject Matter
http://www.law.upenn.edu/blogs/polk/patents/archives/2008/04/an_argument_for.html

US Constitution
http://www.law.cornell.edu/constitution/constitution.articlei.html#section8

Anything Under the Sun Made by Man
http://www.bio.org/speeches/speeches/041101.asp

Patent Laws
http://www.uspto.gov/web/offices/pac/mpep/documents/appxl.htm

35 U.S.C. 100 Definitions. – Patent Laws
http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_100.htm

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices
http://www.uspto.gov/web/offices/com/sol/notices/utilexmguide.pdf

Intellectual Property and Genomics
http://www.genome.gov/19016590

Brenner v. Manson, 383 U.S. 519 (1966)
http://supreme.justia.com/us/383/519/case.html

Answers to the most frequently asked kids’ questions about patents, trademarks and copyrights and the U.S. Patent and Trademark Office.
http://www.uspto.gov/web/offices/ac/ahrpa/opa/kids/kidprimer.html
This is a good one! lol

Patenting Life
http://www.nytimes.com/2007/02/13/opinion/13crichton.html
blah blah blah

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