In view of recent U.S. Supreme Court (Supreme Court) decisions including Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo), the U.S. Patent and Trademark Office (U.S. PTO) on March 4, 2014, issued a guidance for evaluating subject matter eligibility under 35 U.S.C. § 101 (Guidance). The Guidance superseded the June 13, 2013, memorandum issued on the day the Myriaddecision was issued. Interestingly, the Guidance was issued without public notice or opportunity for the public to comment.

The Guidance is divided into four sections. Part I discusses the three-part test for determining subject matter eligibility. Part II explains how to determine whether a claim as a whole is “significantly different.” This portion of the Guidance provides a list of 12 factors – six that weigh toward eligibility (namely, finding a significant difference) and six that weigh toward ineligibility (namely, a finding of no significant difference). Part III provides seven examples explaining the factors. Part IV provides a new form paragraph for Examiners to use when rejecting claims in accordance with the guidance.

Many in the patent community have expressed concern regarding the Guidance. Comments have ranged from practitioners being “horrified” by the Guidance to others suggesting that perhaps the Guidance violates international trade agreements. Kevin Noonan, in a March 18, 2014 post on Patent Docs, nicely summed up what I think many in the patent community are thinking when he stated:

It is perhaps not a surprise that the Office issued these Guidelines in view of the hostility to patents evinced almost weekly by the Obama administration. Whether the result of undue influence from companies themselves hostile to patenting due to the impact patents can have on their industries, or from academics having their own reasons for taking an anti-patent stance, or simply because administration officials believe that patents make drugs and other products more expensive, it has consistently been the case that in its public statements and policy initiatives the Executive Branch has acted in ways not supportive of patenting and frequently seemingly naïve about the issues and the effects of the positions that have been taken (recall the “magic microscope,” for example). Former Director Kappos seemed to be a buffer between the Office and the rest of the administration in this regard, consistent with his broad experience. His absence (and the consequences of not naming a permanent Director since Mr. Kappos left) is evident in the substance of these Guidelines.

It is important to remember that the Guidance does not have the force of law and is simply a tool that the U.S. PTO will use to administer the law based on it current understanding (correct or incorrect) of Supreme Court case law. The Federal Circuit has stated that such guidance/guidelines are not binding on the Court. For example, readers will recall that in 2001 the U.S. PTO issued guidelines for reviewing patent applications for compliance with the written description requirement {Guidelines for Examination of Patent Applications under the 35 U.S.C. 112, ¶1 “Written Description” Requirement (Guidelines)}. The Federal Circuit specifically mentioned these Guidelines in Enzo Biochem, Inc. v. Gen-Probe Inc. stating that “The PTO has issued Guidelines governing its internal practice for addressing that issue. The Guidelines, like the Manual of Patent Examining Procedure (MPEP), are not binding on this court, but may be given judicial notice to the extent they do not conflict with the statute.”

In view of the significance of the Guidance, we at the BRIC Wall thought it would be informative to compare the requirements for evaluating patent eligible subject matter in the U.S. with that of the BRIC and other countries. Specifically, in an upcoming series of posts, we will review subject matter eligibility not only in the U.S., but also in Australia, Brazil, Canada, China, Europe, Japan, India, Russia and South Africa. In addition, we will examine the subject matter eligibility in each of these countries of four of the seven examples provided in the Guidance. Finally, we will also analyze claim one of U.S. Patent Nos. 6,573,103 (Antenatal Screening for Down’s Syndrome) and 6,355,623 (the claim discussed in Mayo).