Posts Tagged ‘DNA’

Divided Panel Finds DNA Molecules Patentable – Cancer Screening Claims Too Abstract

Friday, July 29th, 2011

Today a divided Fed. Cir. panel of Judges Lourie, Moore and Bryson – Lourie writing for the “majority” – reversed the district court judge, in AMP v. Myriad, holding that isolated DNA sequences are patent-eligible subject matter and not natural products. While the majority found that the drug candidate screening claims were not patent-ineligible as natural phenomena and also reversed the district court on this point, the panel found that the diagnostic claims that just recited comparing or analyzing the difference between the sequence of a patient’s BRCA gene(s) and a reference “normal” gene sequence were patent-ineligible as overly “abstract,” e.g., as abstract ideas, and so affirmed the decision below.

Another interesting wrinkle is that the panel decided the merits before they were aware that the only plaintiff who they had ruled had standing, Dr. Harry Ostrer, had left his position and joined Albert Einstein, an august institution, but one that does not offer clinical lab screening assays. More later, after I read past the first 10 pages of this 106 page decision.

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Decision of the EPO Enlarged Board of Appeal – Sexual Crossing and Selection of Plants is Not Patentable Even When Using DNA Markers

Wednesday, May 18th, 2011

The following is a contribution from Verena Simpson PhD of Zacco Denmark A/S.

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The core of the Decision

1. A non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being “essentially biological” within the meaning of Article 53(b) EPC.

2. Such a process does not escape the exclusion of Article 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genome of plants or of subsequently selecting plants.

What triggered the Enlarged Board of Appeal [EBoA] Decision?

The Technical Board of Appeal [TBoA] were faced with the task of deciding whether an opposed patent EP1 069 816 should be maintained in amended form. The claims were directed to “a method of producing Brassica oleracea with elevated levels of glucosinolates” comprising steps of crossing selected wild Brassica oleracea species with broccoli breeding lines; selecting hybrids with elevated of glucosinolate levels; backcrossing the selected line; and finally selecting a broccoli line with elevated of glucosinolate levels, where molecular markers are employed to select the desired hybrids.

The sole question faced by the TBoA (T 83/05) was whether the claimed “method” was excluded from patentability under Art 53b EPC and Rule 26(5) EPC2000.

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Patent System Fosters Eugenics – What Next?

Wednesday, April 27th, 2011

USA TODAY ran a provocative article yesterday (April 26, 2011) on the “dark past” of the respected journal Annals of Human Genetics, in which its editor, Andres Linares did a mea culpa for the role of the journal, founded in 1925 and then called Annals of Eugenics, in promoting racial purity and preventing inferior races and social classes from reproducing. I was startled to find that the patent system was tied into the story as a part of “modern genetics today [that] still suffers from the same blind spots that fostered eugenics.” Along with the evils of “[s]tudies that ascribe genes to explain complex character traits” that are promoted by geneticists, are:

“Scientists seeking patent rights over their patient’s genes, a hotly contested area of current law because of the argument patent rights don’t extend to natural products.”

Apart from the fact that this could have been taken from an ACLU Myriad press release, what does the patent system have to do with eugenics? A better choice for criticism might have been: Scientists seeking to develop therapies for genetic disorders by introducing repaired DNA into a patient’s genome - although the “gene therapies” under trial  today are not experiments in eugenics, any more than is patenting a “healthy” or a “defective” gene. But, to borrow from  David Letterman, I wouldn’t give the patent system’s problems to a monkey on a rock.

Update, Partner and Innovate — AUTM Eastern Regional Meeting

Thursday, April 14th, 2011

I will be on a panel entitled “Kicking the Hornet’s Nest – Patenting Early Stage Technology” at the AUTM Eastern Regional Meeting in Baltimore (May 24th). I will be joined by Esther Kepplinger, Director of Patent Operations at Wilson Sonsini and Dr. Kathryn R. Doyle of the Riverside Law Group. We will cover new developments in patenting DNA, claiming diagnostic methods and what the full-term written description requirement of Ariad v. Lilly means to your patenting strategy. How is isolated DNA different than a gold nugget? How is a diagnostic method like Murphy’s Law? Can you still get a mechanism-of-action claim? Your panel of experts will answer these questions and more.  Y’all come!