U.S. Government and USPTO Urges Federal Circuit to Dismiss Stem Cell Appeal

On January 17, 2014, the United States government and the United States Patent and Trademark Office (collectively “the government”) responded to the Federal Circuit’s December 4, 2013 order inviting them to address whether Consumer Watchdog (“CW”) has Article III standing to pursue its appeal of the USPTO’s affirmation of the patentability of Wisconsin Alumni Research Foundation’s (“WARF”) human embryonic stem cell patent (U.S. Patent No. 7,029,913, the “’913 Patent”). The government argues that because CW fails to identify any concrete or particularized interest in the patentability of the ’913 Patent, it lacks standing to appeal to the federal court. The government notes that CW neither suggests that it is an actual or prospective competitor or licensee of WARF, nor does it assert any concrete interest in the invention of the ’913 Patent. The government also asks the court to provide guidance on whether appeals from the USPTO’s post-grant proceedings are governed by the same Article III inquiry that governs the availability of declaratory judgment relief in the federal district courts. Continue reading this entry

Six Hot Opportunities in Genomic Medicine

Advances in DNA sequencing technology and the interpretation of the acquired data have fueled advances in genomics and its application in the delivery of personalized healthcare. Illumina recently announced a new milestone that will move the industry in ways that are yet to be realized, or even envisioned – a DNA sequencing super computer (HiSeqX) designed to process 20,000 genomes per year at a cost of $1,000 each. It is reported that the current cost to sequence a human genome is about $10,000. Illumina’s a high-speed, relatively low cost HiSeqX sequencer is expected to remove barriers to wide spread genomic data collection by lowering the cost and increasing the speed of sequencing, which in turn will allow even more sophisticated analysis and the application of that information to treat and prevent disease. Continue reading this entry

Supreme Court to Review Divided Infringement

The U.S. Supreme Court has agreed to review a Federal Circuit decision that could impact the enforcement of patents covering certain technologies relevant to the personalized medicine industry, e.g., patented diagnostic methods and digital health. On January 10, 2014, the Court granted certiorari in Limelight Networks v. Akamai Technologies (12-786), to review the issue of whether a party can be found to have induced another to infringe a patent claim when neither one could have been found to directly infringe the claim. In the decision on appeal, the Federal Circuit held that infringement can be found under 35 U.S.C. § 271(b) if a party induced others to act with him or induced others to perform all elements of the claim. In its en banc opinion, the Federal Court overruled its prior precedent that held that for a single party to be liable for induced infringement, a single entity must perform all elements of the claim. See BMC Resources, Inc. v. Paymentech, L.P., 498 F.3d 1373 (Fed. Cir. 2007). The Federal Circuit reasoned that a party who knowingly induces others to engage in acts that jointly practice the steps of a patented method – and those others perform those steps – has had precisely the same impact on the patentee as the party who induces the same infringement by a single infringer. Continue reading this entry

Task Force Recommendation for BRCA-Related Genetic Testing

The U.S. Preventive Services Task Force (“USPSTF”) recently issued a report regarding the effectiveness of BRCA1/BRCA2 genetic tests for women and within the report, issued recommendations for preventive screening for women with and without confirmed familial history of breast, ovarian, tubal, or peritoneal cancer (“BRCA-related cancers”). Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer in Women: U.S. Preventive Services Task Force Recommendation Statement (“Report”). In addition to providing detailed, reasoned recommendations to the public, the Report reviewed the effectiveness of various interventions for women who are mutation carriers and identified research needs and gaps to improve clinical care. Continue reading this entry

United States and PTO Invited to Stem Cell Party

Last week Consumer Watchdog (“CW”) and Wisconsin Alumni Research Foundation (“WARF”) squared off at the Federal Circuit over CW’s appeal of the  inter partes reexamination of WARF’s U.S. Patent No.  7,029,913 (the ’913 Patent, entitled “Primate Embryonic Stem Cells”). Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 13-1377 (Fed. Cir. 2013).  CW’s appeal challenges the patent-eligibility of in vitro cultured human embryonic stem cells (hESCs) claimed in the ’913 Patent. Continue reading this entry