HRFM Today

Patent Office Holds That New Method for Diagnosing Alzheimer’s Disease Patent Ineligible

In a sign of the continuing difficulty of obtaining patent protection for medical diagnostic methods since the Supreme Court’s 2012 decision in Mayo Collaborative Servs. v. Prometheus Labs., Inc. (see summary here and here), the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (PTO) recently affirmed a patent examiner’s rejection of a patent claiming a method for diagnosing Alzheimer’s disease.  The patent application is owned by Eisai R&D Management Co., Ltd., a subsidiary of the Japanese pharmaceutical company Eisai Co., Ltd. (“Eisai”).  The application claims administering lidocaine, a local anesthetic, to a patient suspected of having Alzheimer’s disease then measuring levels of lidocaine or a metabolite thereof in the patent’s cerebrospinal fluid.  Levels of lidocaine or its metabolite below levels seen in healthy control subjects indicates that the patient has Alzheimer’s disease.

Intellectual Property Owners Association Asks Court to Correct Course on Patent Eligibility

Since the Supreme Court began its recent foray into the issue of patent eligibility over the past few years, lower courts and the PTO have been struggling to adapt, all too often to the unjustified detriment of patentees.  So said the Intellectual Property Owners Association (IPO) in a recent filing with the Court of Appeals for the Federal Circuit, asking the full court to rehear a recent decision and assess patent eligibility more appropriately by regarding claims in their entirety, not as fragmented elements.

Unlike questions of whether an invention warrants a patent because it is sufficiently new or non-obvious, the question of patent eligibility asks whether an invention is even of a type intended for patenting in the first place.  The Supreme Court has said that some inventions are excluded from patenting, or ineligible, because patenting them unduly “preempts” or “ties up” such things as abstract ideas, natural phenomena, or laws of nature that should remain free for all people’s use.  Some of its more recent rulings have been applied expansively by lower courts to exclude from patenting previously eligible inventions that apply natural phenomena, natural laws, etc., that were previously considered patent eligible.  One example is Ariosa v. Sequenom, a case currently on appeal to the Federal Circuit (consolidated Case Nos. 14-1139, -1144), where a three-member panel of the court found the patent at issue invalid for ineligibility.  The patentee has asked the full court to rehear the case on the grounds that the panel, as have the PTO and many other courts in recent years, over-extended the Supreme Court’s exclusions from patenting and the patent regime would be further damaged if the panel’s decision stands.  In a brief written by HRFM attorney Teige Sheehan, Ph.D., IPO supports the patentee’s request for rehearing and urges the full Federal Circuit to correct this over-extension and provide guidance for a more limited application of the patent-ineligibility doctrine the better comports with the Supreme Court’s guidance.

The inventors here discovered that the blood of a pregnant woman contains genetic material from the fetus she is carrying.  Building on this discovery, they patented a method for prenatal screening using a blood test, significantly safer than previous methods, like amniocentesis, which pose health risks to the fetus.  Although the Federal Circuit panel agreed that the new test “revolutionized prenatal care,” it held that it was ineligible for patenting because the presence of fetal genes in pregnant women’s blood was a natural phenomenon and the patent claims did not include sufficiently more than this ineligible subject matter to be valid.  IPO argues that the panel erred in its eligibility assessment by inappropriately breaking the claimed method down into its individual parts, rather than analyze the claims as a whole as the Supreme Court requires, thereby “miss[ing] the forest for the trees.”  It also argued that the panel inappropriately disregarded evidence submitted by the patentee that other groups had made use of the existence of fetal genes in pregnant women’s blood with methods that did not infringe the patent, meaning the claims did not “unduly preempt” the natural phenomenon.  If the Federal Circuit grants the request that the full bench rehear the appeal, it may invite further briefing to advise it on how to more appropriately apply Supreme Court precedent in assessing patent eligibility.

By Teige Sheehan, Ph.D.