Posts Tagged ‘biotechnology appeal’

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.

10-1406

Supreme Court Grants Cert. In Caraco

Monday, June 27th, 2011

Today (June 27, 2010), the Supreme Court granted cert. in yet another patent appeal, Caraco Pharm. Labs., Ltd., v. Novo Nordisk, (Supreme Ct. 10-844). Earlier this month, I did an extensive post on the decision below, in which the Fed. Cir. denied Caraco’s counterclaim seeking to strike the broad “use code” that Novo had put on its drug, Prandin (U-968). Even though Caraco would market the generic for a narrower use, the broad use code effectively prevented Caraco from “carving out” the still-patented use(s) from its labeling, thus effectively keeping it off the market.

I took a chance by posting on this one because the Solicitor General’s office recommended review and there was a strong dissent below. However, when the appeal started getting some attention in the press – though the issues were often mischaracterized – it began to look more likely that cert. would be granted. I am not so sure that the Fed. Cir.’s recent streak of affirmances will be left intact.

Appeals Court Overturns Stem Cell Ban

Monday, May 2nd, 2011

On April 29th, in Sherley v. Sebelius, the U.S. Court of Appeals for the D.C. Cir., (a copy is available at the end of this post) overturned the injunction imposed by the district court, which had blocked the implementation of the 2009 NIH Guidelines on finding research using human embryonic stem cells. 74 Fed. Reg. 32170(2009). The Guidelines, in turn, had been formulated to implement President Obama’s  executive order 13505 that lifted President Bush’s executive order banning such funding. The suit, brought by two researchers working with adult stem cells, argued that the Guidelines were in conflict with the 1996 Dickey-Wicker Act, which banned funding for both research that would create human embryos for research purposes or would destroy human embryos. For more background, see my post of Sept. 1, 2010.

The Court found that preliminary injunction was improperly granted “because Dickey-Wicker is ambiguous and the NIH seems reasonably to have concluded that, although [D-W] bars funding for the destructive act of deriving an ESC from an embryo, it does not prohibit funding a research project in which an ESC will be used.”  In other words, if some other unfunded entity disassembles an unwanted embryo obtained with informed consent of the donor from an in vitro fertilization clinic and provides the ESCs to a researcher, the researcher can obtain federal funding to study them. Since establishing the Guidelines, the NIH has approved additional ESC lines for federal funding. While this is good news for researchers working with embryonic stem cell lines approved under the NIH Guidelines, the underlying suit will continue to threaten the administration’s more liberal view of stem cell research.

Sherley – 4-29-11 Documents and Order

ACLU Files Its Brief in Myriad – Argues DNA Is A Blueprint Without a Name

Friday, January 28th, 2011

On November 30, 2010, the ACLU filed its brief at the Federal Circuit in AMP et al. v. USPTO and Myriad Genetics, Inc. et al. If you have been reading my posts on this suit, you are by now probably tired of reading the same positions repeated over and over by various brief writers and commentators. (My most recent post was on Myriad’s brief, filed October 22d.) There have been more than ten amicus briefs filed for both sides. The Myriad supporters argue that cases like “the adrenaline decision,” Bergy and Chakrabarty indicate that man-made compositions should be broadly patentable, including ones isolated and purified from natural sources that are structurally and functionally distinct from the “native” forms. The ACLU and its supporters cite Funk Bros., American Fruit Growers and the odd 1931 In re Marden CCPA decisions as support that this view would permit patents on gold nuggets panned from a stream or a fallen leaf (see pages 14 and 46 of the ACLU brief for a re-run of this argument) and that DNA is likewise unchanged by isolation from the genome.

However, it is interesting to see how far the ACLU will reach to support its nearly metaphysical argument that DNA is pure information. At pages 42-43, it ratchets up its arguments to the point of scientific absurdity:

“The [Myriad] claims acknowledge that, unlike other chemicals, DNA stores specific information – as dictated by the order of nucleotides – that serves as the blueprint for all of the proteins, cells, and organs that make up the human body. While chemical molecules like water can be described as H2O, HOH, or OH2 because they consist of any two hydrogen atoms and an oxygen atom, DNA is not described according to the sugars and phosphates of its backbone, but by its nucleotide sequence. Because this blueprint is the defining characteristic of DNA and remains the same before and after isolation, isolated DNA has neither a distinctive name, character, and use from naturally-occurring DNA nor markedly different characteristics.”

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