Gottlieb’s Departure Should Not Siderail Reforms to 510(k) Pathway

The unexpected resignation of Dr. Scott Gottlieb from the Food and Drug Administration last week gave the life sciences industry pause. Gottlieb has been an agile leader, who proved himself to be ready and willing to help the agency evolve as the health care sector becomes more technology-centric. It is reported that he issues more than 200 guidances a year, many aimed at easing the way for new technologies including digital therapeutics, gene therapies and wearable medical devices. His two-year … Continued

Steady as She Goes: Medtech Venture Investment Q3 2018

Venture investment in the medical device sector has held remarkably steady over the course of 2018 according to the PwC/CB Insights Healthcare MoneyTree report. According to the report, medical device companies took in $750 million in venture investment in Q3, 2018, nearly the same amount as in Q1 and Q2 ($772 million and $780 respectively). That is consistent with investment in the sector in 2017 which averaged $771 million a quarter. However, investment in the sector was bumpier in 2017, ranging from a … Continued

United States Issues Patent Number 10,000,000

This week the United States Patent and Trademark Office (USPTO) issued U.S. patent number 10 million. More than just a number, patent 10 million celebrates the rich history and strength of the American intellectual property system dating back to the first U.S. patent, signed 228 years ago by George Washington on July 31, 1790, and issued to Samuel Hopkins for a process of making potash, an ingredient used in fertilizer. “Innovation has been the lifeblood of this country since its … Continued

EPO Revokes the Broad Institute’s CRISPR Patent

The European Patent Office (EPO) has revoked a foundational CRISPR-Cas9 patent granted in Europe to the Broad Institute of Cambridge Massachusetts. The patent at issue was filed in December 2013, but cites U.S. patent applications dating back to December 2012 in order to show its claims predate a patent filing by the University of California, Berkeley. The EPO’s decision was based on the fact that Broad’s 2012 and 2013 U.S. patent filings include Luciano Marraffini of Rockefeller University as an … Continued

Top 5 Intellectual Property (IP) Developments in 2017

  As we start the New Year, here’s a look back at the most significant intellectual property law developments in 2017 affecting medical device companies. It was a record-breaking year for the number of patent cases (seven) being considered by the U.S. Supreme Court. Here are the five most noteworthy updates for the past year: One: TC Heartland v. Kraft Food. The Supreme Court overturned decades of legal precedent in this decision about where infringement litigation can be filed. The … Continued

Brazil Planning to Automatically Grant Patent Applications to Reduce Backlog

Currently the proposed regulation is in a public consultation phase and no new rules are yet in force.  If the currently proposed regulation is enacted, the following requirements would need to be met in order for an original patent application to be automatically issued: A request for national phase entry of a PCT application would need to occur before the date of publication of the future regulation; The application would need to have been published or early publication requested up to thirty … Continued

Supreme Court Curtails Forum Shopping in Patent Litigation

June 9, 2017 – In a decision largely seen as beneficial to technology and medical device companies, the Supreme Court recently restricted the ability of companies to sue for patent infringement in plaintiff-friendly jurisdictions of their choosing.  Prior to the Court’s May 22 decision in TC Heartland v. Kraft Foods, a patent holder could sue an alleged infringer in essentially any federal district court.  Over the past 25 years, many patent holders have chosen to file suit in the very small … Continued

American Diabetes Association Healthtech Showcase

Join me and over 400 Bay Area venture capitalists, angel investors and business leaders to network and check out the latest innovative technology coming from Silicon Valley healthtech companies. Proceeds from the event will go to the American Diabetes Association. Once again, the centerpiece of the Leaders Forum will be the HealthTech Showcase, where 50 of the most fundable early stage healthtech companies will present their technologies. Supporters of the event will have the opportunity to mingle with the Showcase … Continued

Method Patents Become Stronger

The U.S. Supreme Court held earlier this year in Commil USA v. Cisco Systems that a mistaken but good faith belief that a patent is invalid is not a defense to a claim of induced infringement.  This ruling is particularly important for medical device companies since liability for infringement of medical method patents must often be found through a theory of inducement rather than by direct infringement. Medical device companies often pursue both apparatus claims and method claims when filing … Continued

U.S. Supreme Court Rules on Induced Patent Infringement

In the past several months, the U.S. Supreme Court has decided major patent law issues in six cases – a remarkable number that makes up almost 10% of the Court’s current docket. These include a case on what constitutes patentable subject matter case (Alice v. CLS Bank), claim definiteness (Nautilus v. Biosig Instruments), when attorney fees may properly be awarded to a prevailing party (Octane Fitness v. Icon Health, Highmark v. Allcare), the burden of proof in non-infringement declaratory judgment … Continued

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