Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
Sept. 30 — Patent examiner rejections for claims to naturally occurring materials have increased dramatically as result of Supreme Court decisions, conference panelists said Sept. 29.
And lower courts have rigidly followed the higher court's rulings in invalidating existing patents, even though that wasn't what the high court intended, said Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff, Chicago.
“The court intended to draw the outer boundary and leave it to lower courts to figure the rest out. But that is not what is happening,” Noonan said. “As a result, there is uncertainty across the board about the eligibility and enforceability of certain types of claims in issued patents, in pending patent applications and in claims arising from university research.”
The resulting uncertainty companies developing biologics and personalized medicine approaches are facing makes their efforts more difficult and can discourage investment that is essential to the development process, panelists said.
The session, titled “How Diagnostics Can be Developed in a Post- Mayo World,” was part of the BIO IP & Diagnostics Symposium in Alexandria, Va.
The panelists cited Supreme Court decisions in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 2012 BL 66018, 132 S.Ct. 1289 (2012 BL 66018) and Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 2013 BL 155804, 133 S.Ct. 2107. Mayo held that claims for methods for administering a drug are patent ineligible as laws of nature unless there is an “inventive step” and Myriad that composition claims for isolated DNA are patent ineligible because they recite the judicial exception to patent eligibility of products of nature.
Bernard Chao, associate professor of law at the University of Denver, said, “It looked like a ton of existing and pending patents would be no longer eligible after Mayo and Myriad.” He described how he tried to determine if this was true by using a data set of patent examiner rejections of appropriate PTO categories that would cover patents related to naturally occurring materials.
According to the analysis, 15.9 percent of these patent applications were rejected based on Section 101 patent eligibility provisions pre- Mayo and 86.4 percent were rejected under Section 101 post- Mayo. Chao said that the PTO category that covers methods for measuring or testing processes involving enzymes or micro-organisms had the most Section 101 rejections—50 percent—and the least success in overcoming the rejections, while the category covering recombinant enzymes and toxins and miscellaneous recombinant proteins had the least rejections and the most success at overcoming them.
“There's still a lot we don't know, and the research is ongoing. But what we're seeing is that Section 101 rejections have increased, sometimes dramatically, but not evenly across all [categories],” Chao said.
Noonan said that diagnostic methods claims are particularly vulnerable to being considered an abstract idea, which is a judicial exception to patent eligibility. The product is almost always information.
“The Supreme Court continues to evidence skepticism regarding the Federal Circuit's rulings and decisions by the Patent and Trademark Office. The practical effect of this is that no precedent is relevant to the court except its own. There is continued evidence of the court's disdain for patent law minutiae, also known as the law itself.”
The Supreme Court continues to search for the right balance, seemingly convinced that patents can both harm innovation and promote innovation, Noonan said.
“The court continues to fail to give deference to PTO expertise, which is contrary to administrative law precepts, and extends the court's penchant for deciding patent policy. There is, after all, no basis for judicial exceptions to patent eligibility except the court's precedent,” he said.
Noonan concluded, “In order to assist our clients, the life sciences industry and the patent community, we must continue to determine what the effect of these decisions on diagnostic method patents has been, what the effect has been on innovation and commercialization of diagnostic methods, and how we can go forward.”
Michael Flavin, managing director of Flavin Ventures, a life sciences-focused venture capital firm, said that biologics, personalized medicine and drug-diagnostic combinations have taken control of the life sciences horizon. “Consequently, issues concerning naturally occurring substances will become even more pronounced. A CEO in the biotech space can pray that Congress will clarify this mess, file application in the [European Union] where it seems less complicated and, finally, work with expert patent counsel trained in biotechnology.”
Flavin advised companies that want to patent claims for naturally occurring substances and methods for diagnosis in the U.S. to:
“When you're going out with fund-raising, the venture capital community will be questioning you on your patent portfolio, retain its own patent counsel and drill down on your patent claims. Many investors won't invest in this space right now because there's not enough clarity on what will happen in future litigation, legislation and regulation,” Flavin said.
He added, “Put a bunch of scientists together and you will be amazed at what they come up with. Have the R&D team assist in the preparation of patent application. The patent attorney will benefit from hearing scientists' ideas on how to craft patent claims and specifications.”
To contact the reporter on this story: John T. Aquino in Washington at email@example.com
To contact the editor responsible for this story: Randy Kubetin at firstname.lastname@example.org
Some of Chao's analysis of post-Mayo Section 101 rejections is at http://patentlyo.com/media/2016/04/Chao.2016.PersonalizedMedicine.pdf.
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)