ELITE ​Strategic Services

Patentability of biopharma diagnostics has become nearly impossible under current judicial rulings on section 101, ELITE CEO James Edwards discusses in his March 23 article in Intellectual Asset Management.  The article focuses on the implications of current 101 jurisprudence for the COVID-19 pandemic.

When the medical device tax was in place, #medtech innovators were forced to reduce investments in R&D and eliminate jobs -- both bad for patient care.  This is why ELITE joined a broad coalition urging #repealdevicetax once and for all!

ELITE's James Edwards has teamed up with Gene Quinn, world-class IP attorney and IPWatchdog founder and publisher, to review patent portfolios to improve commercialization. The duo provides "fresh eyes" to help clients make their IP assets more productive. The Quinn-Edwards initiative involves both large and small projects, including focused consultation or narrow research.

The Montana Bar Association's IP Section heard from ELITE's James Edwards and immediate past president of the Licensing Executives Society Brian O'Shaughnessy.  Edwards and O'Shaughnessy discussed the state of the U.S. patent system and legislative proposals in Congress that would bolster areas of patents that courts, recent laws and administrative changes have weakened.  They cited the U.S. Chamber's 2018 GIPC down-ranking of the U.S. patent system to 12 place globally.

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​Section chair Toni Tease moderated the session.  The speakers discussed such matters as the STRONGER Patents Act and recent administrative reforms that PTO Director Andrei Iancu has initiated to improve examiners' application of 101 patentable subject matter and PTAB's claim construction.

ELITE CEO James Edwards got not just a mention, but a photo with Licensing Executives Society CEO Kim Chotkowski, in her column.  Ms. Chotkowski recounted her LES travels in the quarterly newsletter.  She had spoken at an event Edwards organized, featuring MIT engineer-inventor-entrepreneur-Congressman Thomas Massie.

The podcast Invention Stories posted an interview with ELITE's James Edwards about his work with innovators. The popular interview-format podcast explores how Edwards came to invention and patents/IP matters, as well as his advice to inventors looking to patent and commercialize their inventions.

The Congressional Inventions Caucus Advisory Committee, of which ELITE's James Edwards is a member, has announced a special inventors' expo and panel program for Wednesday, March 14, titled "How to Evaluate Disruptive Inventions."  The event runs from 4 p.m. to 7 p.m. in 902 Hart Senate Office Building.  It's open to the public, bur RSVP is required.

A panel at the Licensing Executives Society Spring Meeting included ELITE's James Edwards, discussing the policy outlook for patent licensing.  An expert on IP policy, Edwards shared insights on proposed patent legislation and developments in the courts and at the USPTO.

The health care consulting group Healthcare Solutions Connection has added ELITE founder and CEO James Edwards to HSC's network of experts.  HSC, based in Washington, brings the best of the best experts in all facets of health care around solving the challenges of health care operations for client providers, payors, and early-stage health care innovators.

Edwards applies his expertise in health and innovation policy, as well as digital health and entrepreneurship, to HSC's projects.  "I'm thrilled to have this opportunity to work with Carrie Nixon, Carson Porter, and the HSC team," Edwards said.  They've assembled an impressive team, put together a cutting-edge consulting model, and emulated the Navy SEALs to meet health care clients' needs."

Fraud and abuse laws like those barring antikickback and doctor self-referral pose barriers to new care delivery and payment models envisioned in health reforms.  ELITE's James Edwards discusses this situation in a recent analysis piece.

Invention and commercialization pros from near Clemson University, QVC, Edison Nation, and beyond gathered to discuss the practical steps involved in going from idea to commercial product and the critical role of intellectual property for making this happen.  ELITE's James Edwards, who organized the event, served as moderator.

Following the federal court ruling in the off-label promotion case involving Amarin, ELITE's Edwards authored a white paper analyzing the issue.  He finds this legal development a step toward rebalance between sharing new medical information and appropriate regulatory requirements.

ELITE Strategic Services CEO James Edwards discussed the prospects of several key health policies for 2015 at the January meeting of Health Tech Net in Washington, D.C.  He discussed topics such as the 21st Century Cures initiative, patent legislation, and FDA's regulation of mobile health. This was part of HTN's monthly program on a panel Edwards helped organize.

James Edwards, CEO of ELITE, discussed federal funding options for biomedical business R&D. Speaking at SC BIO's annual conference, Edwards talked about NIH opportunities and strategies for seeking funds through such vehicles as SBIRs, STTRs, and grants.

DeLegge Medical and ELITE Strategic Services formed a strategic alliance to help life sciences companies reduce their regulatory risk.