Genetic Technologies v. LabCorp. – Mayo Redux.

September 16th, 2014

It was Mayo redux with a vengeance in the September 23, 2014 decision in Genetic Technologies Ltd. v. Laboratory Corp. of Amer. Holdings et al., Civil Action No. 12-1736-LPS-CJB (D. Del. 2014).  Magistrate Judge Burke released an opinion invalidating claim 1 of Genetic Technologies U.S. Patent No. 7,615,342 as claiming non-patentable subject matter under s. 101 that could have been stenciled from the PTO s.101 Guidelines. Claim 1 was directed to a method to predict potential sprinting, strength or power performance in a human. The claim had an “analyzing step” to look for variations in the ACTN3 gene of the human, a “detecting step” to determine the presence of two 577R alleles at a loci of the ACTN3 protein and (c) a “predicting step” positively associating two copies of the allele with the performance elements.

Citing Mayo v. Prometheus and PerkinElmer v. Intema copiously, the correlation between the alleles and athletic performance was held to be a natural law and the analyzing and detecting steps were the “employment of … routine conventional process[es]” that were not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law. The “predicting step” was dismissed as “’no more than an instruction [to] apply the [natural] law.’ Prometheus, 132 S Ct at 1297.”

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SLW Smashes 101 Rejections

September 12th, 2014

FDA Publishes “Purple Book” for Biologicals/Biosimilars

September 11th, 2014

In a major move to get organized for the oncoming wave of biosimilar applications, the FDA has published a “Purple Book” listing licensed (e.g., approved) biologicals and licensed interchangeable biosimilars. Rather than summarize the contents table of the book, linked here is the publication from BIO’s new Intellectual Property Newsletter that links to the FDA press release from the FDA Blog.

CDER List of Licensed Biological Products

CBER List of Licensed Biological Products

 

Indefiniteness After Nautilus – A Very “Delicate Balance”

September 11th, 2014

In Interval Lighting v. AOL, Inc., Appeal no. 2013-1282, -1283, -1284, -1285 (Fed. Cir. Sept. 10, 2014), the appealed indefiniteness finding by the district court was affirmed by the Fed. Cir. panel. This was not surprising, since the disputed term was that some sort of extraneous information– like an advertisement – would be displayed on a computer screen during use in an “unobtrusive manner.” This term (one of “degree”) was termed “highly subjective” by the panel, that found that “its scope…depends ‘on the predictable vagaries of any one person’s opinion.’”

Interval Lighting’s last hope was to convince the panel that the term “unobtrusive manner” should be defined by reference to a “narrow example” from the specification, such as displaying the image in a limited area of the screen. However, the relied-upon embodiment was disclosed in the following way: “e.g., the information is presented in areas of a display screen that are not used by displayed information associated with the primary interaction with the apparatus.”

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