Patent Eligibility Relief for the Life Sciences Sector

Several weeks ago, the United States Court of Appeals for the Federal Circuit issued a decision in Rapid Litigation Management LTD v. Cellzdirect, Inc. The patent owner appealed the decision of the district court, which had concluded that claims of U.S. Patent No. 7,604,929 were patent ineligible under the “law of nature” doctrine. The unanimous Federal Circuit panel, which was made up of Chief Judge Prost (writing for the majority), Judge Moore and Judge Stoll, vacated and remanded the case for further proceedings. The Federal Circuit ruled that the ‘929 patent claims in question were not directed to a patent-ineligible concept.

This decision could well mark a significant turning point and give real relief to innovators in the life sciences arena. Up until now, the Federal Circuit has avoided a narrow reading of the Supreme Court’s recent precedents in Mayo v. Prometheus and AMP v. Myriad Genetics. It is difficult to know exactly why that has been the case, but one strong possibility is that the Federal Circuit was looking to the Supreme Court to clarify and narrow the expansive language that they used in Mayo and Myriad.

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Getting to a patent as fast as possible

Russ KrajecPatent attorney Russ Krajec is the CEO and founder of BlueIron, a patent-financing company. Krajec is an angel investor, a registered patent attorney, a former Chief Operating Officer of a venture-backed startup company, and an inventor on more than 30 US patents and applications. Russ started BlueIron because he was frustrated with what he perceives to be a conflict of interest between clients, particularly startups, and patent attorneys.

Every patent attorney knows the problems. We know what the client really should be doing, but the client either doesn’t want to pay for the proper solutions, or cannot afford the proper representation. Wouldn’t it be nice if you could just do what is in the best interest of building the best, strongest patent portfolio possible without having to justify every dime to the client? Enter BlueIron. If you are a startup company and you have patentable technology, rather than calling an angel, you might want to consider calling Krajec, who offers free legal work in exchange for the rights to the patent which he then licenses back to the inventors. The inventors also retain an option to purchase the patent back at any time. The model is much cheaper than angel or VC financing.

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USPTO announces Post-Prosecution Pilot Program

Earlier this month, the United States Patent and Trademark Office published a Notice in the Federal Register announcing a new pilot program for applications that have received a final rejection. The Post-Prosecution Pilot Program will run from July 11, 2016, through January 12, 2017, or until the Patent Office has accepted a total of 1,600 compliant requests, whichever occurs first.

According to the Patent Office, this Post-Prosecution Pilot Program responds to stakeholder input gathered during public forums held in support of the Enhanced Patent Quality Initiative. The goal is to provide another opportunity for applicants and examiners to attempt to resolve disputes without requiring an appeal or the filing of a Request for Continued Examination (RCE).

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SCOTUS refuses to take Sequenom v. Ariosa

On June 27, 2016, the United States Supreme Court denied certiorari to Sequenom, Inc., which will let stand a decision of the United States Court of Appeals for the Federal Circuit that ruled a truly revolutionary medical test to be patent ineligible.

The innovation in question is a test for detecting fetal genetic conditions in early pregnancy that avoided dangerous, invasive testing techniques that are potentially harmful to both the mother and the fetus.

The invention, which was embodied in U.S. Patent No. 6,258,540, claimed certain methods of using cffDNA. The patent teaches technicians to take a maternal blood sample, keep the non-cellular portion (which was “previously discarded as medical waste”), amplify the genetic material that only the inventors had discovered was present, and identify paternally inherited sequences as a means of distinguishing fetal and maternal DNA. The claimed method does not preempt other demonstrated uses of cffDNA.

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The Industry Reacts to Cuozzo Speed Technologies v. Lee

On June 20th, the U.S. Supreme Court handed down a decision in Cuozzo Speed Technologies, LLC v. Lee, which may not have wide-reaching implications on the U.S. patent landscape but will nonetheless be troubling to patent owners. In a unanimous 8-0 decision, the court upheld the ability of the Patent Trial and Appeal Board (PTAB) to apply the broadest reasonable interpretation (BRI) of patent claims during an inter partes review (IPR) proceeding. It also declared that PTAB’s use of the IPR system was not judicially reviewable.

“This is obviously a victory for some who challenge a patent’s validity in IPR proceedings since broadly construed claims are more vulnerable to attack than narrowly construed claims,” remarked Scott Daniels, partner at Westerman Hattori Daniels & Adrian, LLP. “Still, the great majority of IPR decisions do not turn on claim construction and for those cases Cuozzo simply makes no difference.”

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