Posts Tagged ‘biotechnology news’

Labeling GMO’s — Too Late and Too Much

Friday, January 29th, 2016

iStock_000066549553_SmallCommentators arguing that genetically-modified plants (and animals) or “GMO’s” have been prepared by conventional plant breeding, fail to address the central issue driving the debate about the safety of genetically-engineered crops intended for human consumption.  The issue is not whether or not it is safe to continue to crossbreed different varieties of wheat or corn, or any other plant, to yield improved traits.  This is indeed botanical intervention that has been going on for centuries.

In recent years, companies like Pioneer and Monsanto developed the ability to introduce genes that were isolated from non-plant sources, such as bacteria, into corn, soybeans, cotton and other crops.  Such genes impart properties to the “transgenic” plants such as the ability to resist attack by the European corn borer or to be resistant to glyphosphate (“Roundup”), a relatively non-toxic herbicide, so that it can be used to control weeds while not harming the cash crop.  However, such genes are foreign to the host plant.  This has led “green” organizations to oppose their use to produce “Frankenfoods” that raise human health issues, or at least have demanded the such food or food products be labeled as produced from “GMOs,” so that consumers can choose whether or not to consume them. (more…)

Patenting “Natural Products” Down-Under Post-Myriad

Wednesday, December 16th, 2015

iStock_000063710003_SmallAlthough the Australian High Court held that claims to naturally occurring DNA (e.g., BRCA1 nucleic acid) were not patent eligible because they were not a “manner of manufacture,” since the encoded information therein was not “made” by human action, in contrast to the USPTO, the Australian Patent Office issued “Examination Practice” guidelines dealing with the requirements to patent products of nature. The Guidelines generally left their Bergy-like examination standards intact outside of the nucleic acid arena. A copy of those guidelines can be found at the end of this post.

Naturally occurring nucleic acid molecules derived from genetic material or synthesized, including fragments thereof like primers, probes and iRNA, as well as cDNA are not patent-eligible since they “merely replicate the genetic information of a naturally occurring organism.”

More encouraging is the reaffirmation by the Australian PTO that “technical subject matter” including recombinant or isolated proteins, pharmaceuticals, methods of treatment and “applications of computer technology” remain patent-eligible, as do plant and microorganisms. The key factor seems to lie in determining whether or not the substance of the claims was “made” – created or modified by human action – or is “artificial.” Merely “artificial” is a bar, but it appears to include inspecting the claim for replicants – Dolly? — or synthetic versions of naturally occurring materials. While the physical difference between the claim and the material in its natural state is one factor to be weighed, the heartening sentence is that “[i]solation or purification can represent making or modification when the substance of a claim is properly directed to a chemical product.”

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USPTO Report on State of Confirmatory Genetic Testing Comes off the Waffle Iron

Monday, October 12th, 2015

waffle-ironIn 2011—after the Fed. Cir. decision in Myriad upholding claims to BRACA1 and 2 genes—the PTO was tasked by a section of the AIA with providing Congress with a report on the effect of patenting on confirmatory genetic testing. The report has finally been released and, predictably, has little in the way of solid conclusions – especially since hard data in this area has always been wanting. (A copy of the report is available at the end of this post.) For example, addressing the question about the effect of access to confirmatory genetic testing on the quality of medical care, the report “concluded”: “Where evidence was available, it was often not of the magnitude, quality or rigor that scientists generally consider reliable in drawing conclusions.” The report estimated that only 1-5% of patients who were genetically tested, e.g., for mutations relating to a predisposition of a pathology, needed further testing.

Significant to the IP community, the report stated that the decisions in Myriad and Mayo invalidating many of the claims of the patents that were on appeal four years ago, has “dramatically changed” the “patent landscape” and cleared “some hurdles” that may have prevented patients from getting confirmatory  genetic diagnostic testing. Of course, post Myriad, the PTO and, more ambiguously, the Fed. Cir. have taken the position that most diagnostic claims are not patent eligible. That removes a lot of “hurdles” for any organization that wants to copy a diagnostic test that is, or could have been, patented not so long ago.

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Physiology/Medicine Nobels Awarded for Discoveries of “Natural Products”

Thursday, October 8th, 2015

nobelIn re Roslin Institute, a Fed. Cir. panel consisting of Judges Dyk, Moore and Wallach ruled that clones including Dolly the sheep were not patent eligible. Judge Dyk, writing for the panel endorsed the “markedly different” structure requirement for patent eligibility that the PTO had proposed abandoning in December 2004:

“[According to Chakrabarty], discoveries that possess ‘markedly different characteristics from any found in nature,’ are eligible for patent protection. In contrast, any existing organism or new discovered plant found in the wild is not patentable.”

In Ariosa, Judges Renya, Linn and Wallach turned a method of isolation of cffDNA into a “natural product”:

“The method therefore begins and ends with a natural phenomenon. Thus the claims are directed to matter that is naturally occurring….Because the claims at issue are directed to naturally occurring  phenomena, …the practice of the method claims does not result in an inventive concept that transforms the natural phenomenon of cffDNA into a patentable invention.”

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