USPTO ANNOUNCES CANCER MOONSHOT CHALLENGE

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The USPTO announced a public challenge in support of the National Cancer Moonshot Initiative. The USPTO is asking the public to investigate and leverage the intellectual property data within the USPTO and combine it with other economic and funding data (e.g., SEC filings, FDA reporting, National Science Foundation grants and other funding sources) to “reveal new insights into investments around cancer therapy research and treatments.” Issues that may be explored include the peaks and valleys in the landscape of cancer treatment technologies, insights revealed by correlating R&D spending/funding to breakthrough technologies, and whether trace studies of commercially successful treatments from patent to product would informative.

A workshop will be held on Thursday August 25th, 2016 to assist participants with the challenge. The challenge concludes on September 12th and winners will be announced on September 26th, 2016.

The USPTO hopes that the information gleaned from the challenge will support cancer research and the development of new commercialized therapies. As noted by the office “[t]his will empower the federal government—as well as the medical, research, and data communities—to make more precise funding and policy decisions based on the commercialization lifecycle of the most promising treatments, and maximize U.S. competitiveness in cancer investments.”

 

Ariosa Loses Verinata Patent Challenge

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Fetal diagnostic pioneer Ariosa Diagnostics lost its latest attempt to invalidate competitor Verinata Health’s U.S. Patent No. 8,318,430, “Methods of Fetal Abnormality Detection.” The USPTO’s Patent Trial and Appeal Board (PTAB) concluded that Petitioner Ariosa Diagnostics (Ariosa) failed to demonstrate the unpatentability of challenged claims 1-30. Ariosa Diagnostics, Inc. v. Verinata Health, Inc., IPR2013-0027/-00277 (PTAB Aug. 15, 2016).

U.S. Patent No. 8,318,430

The decision is the latest in a long-running challenge by Petitioner Ariosa seeking two inter partes review of the claims of U.S. Patent No. 8,318,430 (the ‘430 Patent). Ariosa initially sought review of the ‘430 Patent on the basis of three prior art documents:  Shoemaker,[1]  Dhallan,[2]  and  Binladen.[3] After trial and oral argument on the original petitions, the PTAB issued a Final Written Decision concluding that Petitioner Ariosa had failed to demonstrate by a preponderance of the evidence that all claims of the ‘430 Patent were unpatentable over the combined teachings of Shoemaker, Dhallan, and Binladen. Ariosa appealed to the Federal Circuit.[4] In Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359 (Fed. Cir. 2015), the Federal Circuit noted in its review that the PTAB might have erred by failing to consider an additional piece of prior art, namely an Illumina Brochure for the Illumina Genome Analyzer, “‘simply because the brochure had not been identified at the petition stage as one of the pieces of prior art defining a combination for obviousness.'” Decision, page 4, quoting Ariosa at page 1365. The Federal Circuit vacated the PTABs finding of non-obviousness and remanded the case to allow the parties to brief how the PTAB may have overlooked the relevance of the Illumina Brochure.

Patentability of the Claims

On remand the PTAB again determined that Petitioner failed to establish the unpatentability of the ‘430 Patent claims from the combined teachings of the cited references, including the teachings of the Illumina Brochure. Importantly the PTAB stated that:

Petitioner, however, provided no further explanation of the combination in the Petition, such as a reason with rational underpinning as to why the ordinary artisan would have combined the references to arrive at the method of the challenged claims, but only presented a claim chart demonstrating where the limitations of each challenged claim could be found in the prior art.

Decision, page 16.

The decision serves as a cautionary tale to patent challengers to not only map the elements of the claims to the prior art but also to clearly articulate the rationale why the art would be combined by one of skill in the art to arrive at the claimed invention.

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[1] Shoemaker et al., Pub. No. US 2008/0090239 A1, published April 17, 2008 (Shoemaker).

[2] Dhallan, Patent No. US 7,322,277 B2, issued February 19, 2008 (Dhallan).

[3] Jonas Binladen et al., The Use of Coded PCR Primers Enables High-Throughput Sequencing of Multiple Homolog Amplification Products by 454 Parallel Sequencing, 2 PLOS ONE 1-9 (2007) (Binladen).

[4] The procedural history has been abbreviated for the sake of brevity. The appeal was a consolidation of two proceedings initiated by Ariosa at the PTAB.

 

 

Advancing Personalized Medicine Through Cross-sector Collaboration and Innovation

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Since 2013, thought leaders, innovators, and health care specialists have convened for a one day summit to discuss the business of personalized medicine. The Business of Personalized Medicine Summit, explores the economic, legal and regulatory barriers to making personalized medicine a reality for patients everywhere while sharing strategies for success. This year’s Summit – Strategies for Partnering and Collaboration – explores new partnering models across and within the health care and pharmaceutical industries that facilitate the research, development and adoption of personalized or precision medicine. Continue reading this entry

Breakthrough Business Solutions to Advance Personalized or Precision Medicine

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In today’s era of unprecedented opportunities and complexity within personalized medicine, it has become critical innovators in the space to adopt a collaborative approach with outside experts in order to quickly and affordably bring new products and services to market. And, as it turns out, collaboration may also be the key to achieving mainstream clinical adoption. Continue reading this entry

FDA Issues Guidance on Use of Public Human Genetic Variant Databases and Their Use in Personalized Medicine

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Next Generation Sequencing (NGS) permits the analysis of millions of genetic variants at a time and has proven to be invaluable for the development of personalized or precision medicine. Analysis of whole genomes is providing insight into the diagnosis, prediction and treatment of disease, and will continue to do so as more genetic information is collected and analyzed. Continue reading this entry