open sciencesummit2010

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Gene Patenting: Science and Technology after Myriad

David Koepsell, Delft University of Technology, NL

April 13, 2023 2

The domains…

April 13, 2023 3

The domains…

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Science vs. Engineering

• These two fields have traditionally been inter-related, but each has a unique domain (though they overlap in method and products)

• Science, at its core, is the search for natural truths, natural laws, and physical phenomena

• Engineering involves the application of these laws to productive ends

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The domains…

Law, natural equivalence

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The domains…

Algorithm, incorporates law into artifact(process or product requiring intention)

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Science vs. Engineering

science

engineering

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Diamond v. Chakrabarthy, 447 U.S. 303 (1980)

• “While laws of nature, physical phenomena, and abstract ideas are not patentable, respondent's claim is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter -- a product of human ingenuity ‘having a distinctive name, character [and] use.’ Hartranft v. Wiegmann, 121 U. S. 609, 121 U. S. 615. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U. S. 127, distinguished. Pp. 447 U. S. 308-310.”

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Science vs. Engineering

Laws of nature,physical phenomena,“abstract ideas”

nonnaturally occurring manufacture or composition of matter -- a product of human ingenuity ‘having a distinctive name, character [and] use

April 13, 2023 10

AMP v. Myriad

Claims include: “The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.”

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How did this happen?The “isolated and purified” anomaly• Parke-Davis v. H.K. Mulfor & Co. In Parke-Davis,

Judge Learned Hand considered whether an isolated and purified form of adrenalin was patentable. The adrenalin, as patented in U.S. Patent No. 753,177, was extracted from suprarenal glands as a salt, and then further purified as a base…

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The problem with “isolated and purified”

Is “isolated and purified”

different from naturally-occurring

QuickTime™ and a decompressor

are needed to see this picture.

?

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The theory

Where the utility of the isolated and purified substance deviated greatly from the substance in its natural form, courts have suggested that the novelty requirement is met. This is both because the purified substance does not simply occur in nature, and the extraordinary or unexpected results that are achieved when the substance is isolated or purified is indicative of patentable invention

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The irrational implication…

• Priestley could have patented O2…

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The irrational implication…

• After all, pure, isolated O2 does not occur in nature, and it is extraordinarily useful*

* Patent attorneys have actually made this argument with me… nevermind photosynthesis

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Can we reconcile law and reality?

Yes, consider Priestley’s oxygen

He invented a means of accumulating pure oxygen, by heating mercuric acid. He did not invent molecular, gaseous oxygen. Arguably, acc. to Chakrabarthy and Bilski, O2 is a “physical phenomenon,” not patent-eligible. So give Priestley a process patent, but not on the product

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Can we reconcile law and reality?

• Thus, William Nicholson and Anthony Carlisle’s electrolysis of water in 1800 would not have violated Priestley’s patent and would itself be a patent-eligible process.

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Isolation and purification are inventive, their products often aren’t• As with adrenaline…• As with O2…• As with BRCA 1 & 2…

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Post - Myriad and Bilski

Courts could reasonably finally jettison the conflation of product with process and abandon the “isolated and purified” myth… O2=O2, even while the means of accumulated it in a purified form might be new and inventive.

Similarly, BRCA1 and 2 are natural, not artifactual, and un-susceptible to patent under the dictates of both reason and case law.

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Thank you

• http://davidkoepsell.com