Archive for the ‘Uncategorized’ Category

FDA Releases Outline of Guidance for Developing Tests Based on Human Genetic Variants

Friday, July 8th, 2016

Tfda officehe FDA is charged with regulating “Next Generation Sequencing (NGS) Tests,” and has just released draft guidance on what needs to be regulated. (A copy of the first draft and second draft can be found at the end of this post.) The strategies involve the generation of reliable diagnostic conclusions for patients based on one or, oftentimes, many many mutations that are compared to those of other patients and to reference databases. Under “Scope,” the FDA has stated:

“[T]his paper discusses factors and principles to identify genetic databases that are of sufficient quality to support a regulatory submission…..[T]his paper discusses data quality and database operations as applied to the clinical interpretation of human genetic variants, i.e., for establishing the link between variants and the risk or diagnosis of disease or other states of health.”

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Superman Breyer v. Batman Lourie Battle in the Sequenom Petition for Cert.

Sunday, March 27th, 2016

iStock_000087208111_SmallSince this is an amplification of my last post on the Sequenom petition for cert. in Sequenom v. Ariosa, please go back at read my first post on the petition. I have been arguing for some years that the patent world will never be at rest where diagnostic claims are concerned until the patent eligibility of a simple “If A, then B” claim is addressed by the Fed. Cir. and/or the Supreme Court.

This is the type of claim criticized by Justices Breyer, Souter and Stevens in the “Metabolite Labs dissent” of 2006, when the Court declined to decide the patent-eligibility of a method of detecting a deficiency of cobalamin or folate by assaying a body fluid for an elevated level of homocysteine and correlating the elevated level with a cobalamin or homocysteine deficiency.” Justice Breyer just called the claim a law of nature with a mental step.

Fast forward to 2012 and the Mayo decision (132 S.Ct. 1289), and the Supreme Court invalidated an awkwardly drafted claim that I will re-write here as a method of medical treatment claim:

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Will Copyright Law Put Us on a Path to International Patent Exhaustion?

Tuesday, February 2nd, 2016

This is a guest post from Theresa Stadheim of Schwegman Lundberg & Woessner.

This article was first published by the American Intellectual Property Law (AIPLA) Patent Law Committee in its January 2016 newsletter.  For membership in AIPLA, visit here

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Will Copyright Law Put Us on a Path to International Patent Exhaustion? Lexmark v. Impression Products

Under the doctrine of patent exhaustion, once a patented product is sold in a sale authorized by the patent holder, patent rights in that product are exhausted.  Domestic patent exhaustion (i.e., patent exhaustion upon a domestic sale) is a common law doctrine in the United States, as well as being generally accepted worldwide.  However, the current Lexmark v. Impression Products litigation has raised the issue of whether international sales should also lead to exhaustion of patent rights.

The Lexmark v. Impression Products litigation

Lexmark manufactures printers and toner cartridges used in those printers.  In Lexmark Int’l, Inc. v. Ink Techs. Printer Supplies, LLC, plaintiff Lexmark alleged that it first sold the patented inkjet cartridges at issue outside of the United States, and that these cartridges were later acquired and remanufactured by defendants, including Impression Products, thereby infringing Lexmark’s patent.[i]

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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…)