Posts Tagged ‘patent claims’

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Prometheus Unbound – Are Methods Of Medical Treatment The Next “Targets”?

Tuesday, May 22nd, 2012

In my March post “Unnatural Acts – Patenting Diagnostic Tests Post-Prometheus” I wrote:

“I have been trying to formulate diagnostic claims that would pass muster post-Prometheus and I am having trouble. If a researcher discovers the marker, the researcher should be able to patent it and ANY utility it has, including its use for the diagnosis/prediction of disease. Likewise if the researcher discovers a completely new utility for a known marker – e.g., as an  indicator of Alz Disease, this should meet the patent eligibility requirements of s. 101. However, the correlations that the researcher bases the assay claims on are still ‘natural phenomena’ according to Prometheus. So we patent attorneys are completely cycled back into the loop of [divining] what further steps are necessary to yield a patent-eligible claim for the new diagnostic correlation.”

Last night, a new monster crawled out from under the legal bed we have to lie in after Prometheus. It is not simply that diagnostic claims based on “If ‘a’ then ‘b’” naturally-occurring correlations are of doubtful patent-eligibility; we already know that Justice Breyer will exclude such diagnostic claims, such as the one involved in the “Metabolite Dissent,” the first chance he gets – so long as he can hold the Court together. The new monster is a modern Frankenstein stitched together from the language in Prometheus:

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Posted in Patentable Subject Matter | 2 Comments »

Cordis v. BSC – Therasense at Work

Monday, October 3rd, 2011

Last week the Fed. Cir. affirmed the district court’s finding of no inequitable conduct, due to the failure of the applicant or his attorney to cite a relevant prior art reference in a parent application that yielded the two patents-in-suit. Cordis Corp. v. Boston Scientific Corp., App. No. 2010-1311, -1316 (Fed. Cir. Sept. 28, 2011). (A copy of the decision is found at the end of this post.) In the earlier proceeding the district court, in a bench trial, found that BSC had proved the threshold levels of materiality of the reference and intent regarding nondisclosure by clear and convincing evidence. The court went on to hold that applicant had not purged the fraud (my term) by merely citing the reference in the “child application” in a “normal IDS” and that both patents were unenforceable due to IC (ed. note – remember “the fruit of the poisonous tree”).

On appeal, the Fed. Cir. agreed that the reference was material but remanded for additional, more specific findings on intent to deceive, e.g., whether or not the inventor in fact read the search report or the reference. Cordis Corp. v. Boston Scientific Corp., 188 F. App’x 984, 988 (Fed. Cir 2006). The district court, did not make these findings but, rather, reconsidered the evidence of record and found that the “clear and convincing standard” had not been satisfied regarding deceptive intent. The court based its new finding on its opinion that “the inferences argued by plaintiff are supported by evidence of record and are as reasonable as those inferences argued by defendants.” [641 F. Supp. At 359; citing Scanner Techs. Corp. v. ICOS Vision Sys. Corp., 528 F.3d 1365 (Fed. Cir. 2008)].

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Myriad Petition For Rehearing Denied

Wednesday, September 14th, 2011

On September 13, 2011, the Fed. Cir. panel in AMP v. Myriad denied AMP’s (read ACLU’s) petition for rehearing by the panel. (A copy of the petition can be found at the end of this post.) In challenging the holding that the  claimed isolated DNA molecules are not products of nature, AMP argued that “the language of the patents defines the function, not the structure of the patented genes and gene fragments…the composition claims in the patents are not defined by chemical structure. They are defined by function.” The success of this argument would require the panel to read the term, “[a]n isolated DNA” out of claim 1 of the ‘282 patent:

  1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

Clearly, that was not going to happen, although it appears to be an attempt to riff on dissenter Bryson’s conclusion: “What is claimed in the BRCA genes is the genetic coding material, and that material is the same, structurally and functionally, in both the native gene and the isolated form of the gene.” Slip op. at 13.  However, even “markedly different”  Judge Moore, who presented the best “chemical” analysis of the claims, had no reason to change her views.

AMP’s second argument was hard to follow, but seemed to be based on its opinion that the claimed BRCA1 and 2 gene fragments are inherently present in the body  e.g., in the blood of cancer patients, and so are patent-ineligible natural products. This may be an attempt to reopen the purification vs. isolation argument that held appeal for some of the panel, but arguing that the claimed fragments must arise in vivo “at least some of the time” is not going to carry the day as an inherent anticipation argument, much less as a product of nature argument.

The panel left pending Myriad’s petition for rehearing that challenges AMP et al.’s standing to bring suit, although AMP argued that the American College of Medical Genetics has organizational standing and an additional plaintiff, Ellen Matloff, had conversations about possible infringement with Myriad. AMP may not be in the bottom of the 9th inning yet, but they are in the bottom of the 8th. The panel did such a thorough analysis of the issues that I just don’t see a petition for rehearing en banc getting on base.

 Myriad Petition for Panel Rehearing

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BSC v. J & J – Written Description Requirement Spreads its Wings

Monday, July 11th, 2011

On June 7th, in a Fed. Cir. panel decision written by Judge Moore, the panel affirmed the invalidation of four J&J patents (a copy of these patents is available at the end of this post) for failure to meet the written description requirement of s.112(1). The patents claimed drug eluting stents, used to keep angioplastied arteries from re-closing, or undergoing restenosis. Boston Scientific Corp. v. Johnson & Johnson, App. No. 2010- 1230-1234 (Fed. Cir. June 7, 2011). The stents disclosed in the specifications all released rapamycin, a macrocyclic lactone, but the claims were broader, and used terms like “rapamycin or a macrocyclic lactone analog of rapamycin” or a” macrocyclic triene analog of rapamycin.” However, no such rapamycin analogs were disclosed in the specification.

The “problem” with the summary judgment below, at least as J&J saw it, was that a number of workable rapamycin analogs were known to the art as of the effective filing date of the applications. In fact, BSC was using one of them in its stents. J&J felt it could rely on the court’s holding in Capon v Eshhar, 418 F.3d 1349 (Fed. Cir. 2005) which affirmed that claims to chimeric DNA molecules were adequately supported by the specification in combination with evidence that many examples of useful subunits were known.

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Posted in Written Description Requirements (WDR) | 1 Comment »

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