Monday, November 01, 2010

DoJ amicus brief in Myriad says no to patentability of genomic DNA

The conclusion of the Department of Justice amicus brief in the Myriad case says:

For the foregoing reasons, the Court should reverse the district
court’s invalidation of the composition claims that are limited to cDNAs
and similar man-made constructs, but affirm the district court’s
conclusion that the claims encompassing isolated human genomic DNA
are invalid.

DNA isolated from nature is not patentable.

Of interest to LBE was a reference within the brief to work by Hans

Similarly, Hans Dehmelt won the Nobel Prize in physics in 1989
for being the first to isolate a single electron free of the atom, an
accomplishment with useful applications in atomic clocks and other
devices. Dehmelt undoubtedly could have patented his process and
apparatus for isolating an electron in free space, as well as any method
for exploiting the characteristics of electrons thus isolated, assuming
the other requirements of Title 35 were satisfied. But Dehmelt plainly
did not invent the elemental unit of negative charge in the universe.
Nonetheless, on appellants’ theory, Dehmelt could have patented the
isolated electron itself (as a “manufacture”) and thereby arrogated to
himself the exclusive right to conduct experiments in electron quantum
physics for twenty years.6

Footnote 6 states: The Supreme Court in Chakrabarty observed that Newton could
not have patented the law of gravity, 447 U.S. at 309; surely that prize
does not still await the first scientist to isolate the graviton.

[Who wrote this stuff???]

Two grad students of Dehmelt, who later did work on ion traps at
Bell Labs in the 1960s and 1970s, were involved in the Finnegan/Bruker-Franzen matter at the ITC.
The issue of the patent on ion traps (eg, process and apparatus) was very much litigated.
Dehmelt isolated a single electron in the ion trap; whether he "purified" a group of electrons
from other matter might be questioned.

Lithium makes an appearance at page 23 of the amicus brief:

Not until 1818 was lithium,
which has innumerable industrial applications, first isolated in metallic
form by Sir Humphry Davy and W.T. Brande. See Krebs, The History
and Use of Our Earth’s Chemical Elements: A Reference Guide 48 (2d
ed. 2006). That accomplishment marked a significant achievement in
chemistry, but it did not entitle Davy and Brande to claim a patent on
the third element in the periodic table.

Page 24 of the amicus brief has the text:

cf. In re Seaborg,
328 F.2d 996 (CCPA 1964) (upholding patent for element 95,
americium, which does not occur in nature).

One might want to look at the case, because the DoJ brief
misstates what the issue was in Seaborg. What was at issue
in Seaborg was an issue of detectability, not natural occurrence.
Americium had already been made by man, and by nature (in Africa).

The BakerBotts website has text on Seaborg:

The court also distinguished In re Seaborg, 51 C.C.P.A. 1109 (C.C.P.A. 1964).[50] Applicant Seaborg had applied for a patent on an isotope of americium produced by a nuclear reaction.[51] The Patent and Trademark Office ("PTO") had rejected the claims of the application for lack of novelty, stating that prior art reactors inherently produced the americium isotope.[52] The Federal Circuit's predecessor, the Court of Customs and Patent Appeals ("CCPA"), reversed the PTO because the prior art process produced the isotope only in quantities so small as to be undetectable.[53] The court differentiated this situation from the present claim, in which DCL was claimed as forming in detectable amounts in the human body after the ingestion of loratadine.[54]

In the article There's Always Something There to Remind You in IPT, LBE had written in 2003:

Note In re Seaborg, 328 F.2d 996 (CCPA 1964). Applicant argued that a small amount of an unknown, unconcentrated isotope would have been undetectable, and the CCPA concurred. However, what result if a new analytical method were subsequently developed which made that small amount detectable?

[Curiously, Google falsely attributes this article to "R. Smith," not to LBE, the actual author: There's Always Something There to Remind You by R Smith - 2003 - Related articles]

Contemplate text from L. B. Ebert, “Inherent difficulties,” Int. Prop. Today, Nov. 1999: To illustrate one issue in the interpretation of Continental Can, consider the discovery of buckyballs. In 1984, workers at Exxon disclosed the existence of C60, with the formula as determined by mass spectrometric measurement n6 and a way to make said C60. (J. Chem. Phys., 1984, 81, 3322). They did not disclose the correct structure of C60; Professors Smalley and Kroto proposed the structure of C60 to be that of a truncated icosahedron in 1985. This was not known to be correct until after the work of Huffman and Kratschmer in 1990. Now, assuming that the synthesis of Exxon always led to C60 with the icosahedral structure, would a patent claim to C60 in 1990 (with the truncated icosahedral structure) be inherently anticipated by the Exxon work in 1984, even though no one knew the structure in 1984, and in fact could not have proved the structure until 1990? Assuming that one of ordinary skill would recognize the inherent property, albeit at a later date, one might think there would be inherent anticipation. (Of course, a 1990 claim to merely C60 would be explicitly anticipated by the written description and enablement of the 1984 reference.)

There is discussion of the DoJ amicus brief at the PatentHawk blog:
Putting Genes On -->

Hal Wegner on the DOJ getting down with the Funk (i.e., citing Funk Brothers to support its anti-patent position).

A critical underpinning for the decision below is the false concept that Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), has a holding keyed to patent-eligibility under 35 USC § 101, which was perpetuated in Bilski v. Kappos, 130 S. Ct. 3218 (2010). Nothing could be further from the truth. The mistake is perhaps understandable, given the statement by the Supreme Court in Bilski that names "three specific exceptions to § 101's broad patent-eligibility principles", citing in particular Funk v. Kalo. See Bilski , 130 S. Ct. at 3225 (citing Funk v. Kalo, 333 U.S. at 130).

Appellant in its principal brief in Myriad has, however, correctly understood and explained the critical distinction that shows that Funk v. Kalo was focused upon patentability under what today is 35 USC § 103, and not patent-eligibility.

If outlawed, the IPO tallies over 30,000 DNA patents that would meet the grim reaper, a low patent body count by KSR massacre standards.

The Scientist presented some "confused" coverage of the significance of the DoJ amicus brief:

The US government announced on Friday (October 29) that researchers should not be able to patent genes because they are “products of nature.” This decision, which overturns the long-standing policy that genes are eligible for patents, could have a “huge impact on medicine and on the biotechnology industry,” according to the New York Times.

The controversy about whether or not to patent genes arose over a 1998 patent for the breast cancer gene BRCA1. According to a study published last May in the journal Genomics, the patent should never have been granted, since it allowed the patent holder, a biotech company called Myriad Genetics, to establish a US monopoly on genetic testing for breast and ovarian cancer risk. The latest action came in the form of a “friend-of-the-court” brief filed by the Department of Justice, and contradicts the long-time policy of the patent office and the National Institutes of Health.


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