Deputy for Patent Exam Policy: The Devil is in the Details

We argue, hour by hour, day by day, about large issues of morality and ethics and discuss how to make our nation “green”. We discuss large high-level issues like “should we have a public option for healthcare?”, but we give less attention to the details regarding what such an option might look like. Similarly, in the patent system, the public often argues large issues like the patent eligibility of business methods, computer related inventions, and genes, but gives less attention to the establishment of consistent standards for determining which patents will issue and what innovations will be buttressed by the exclusivity incentives that come with those patents. It is time to focus on the details, and a good place to start is with the hiring of a new Deputy Commissioner for Patent Examination Policy (DCPEP).

Undersecretary of Commerce for Intellectual Property and Patent Office Director David Kappos will soon select a new DCPEP. The importance and influence that this person will bring to the future of innovation should not be underestimated. In the past, this person was selected from a pool of career executives having little practical interaction with the private sector. Perhaps it is time that a candidate is selected from the not-so-small pool of individuals who not only understand the workings of the USPTO, but who also understand the needs of private enterprise. Perhaps instead of focusing on the candidates with law degrees, it is time to focus on individuals with policy skills.

Patent examination policy is a rubber–meets-the-road position. It is here that the laws passed by the Congress, the edicts issued by the White House, and the (sometimes not so) subtle legal interpretations of the courts converge. It is from this office that practical real-world policy emerges. It is here that patent examiners receive their examination marching orders and it is from here that the interpretation of the laws, edicts, and interpretations are converted into changes that ultimately find their way into the patent examiners’ bible: the Manual of Patent Examining Procedure (MPEP).

The MPEP, more than anything else, controls what will be patented and why. The MPEP is where patent examiners find refuge when management or applicants agree or disagree with their decisions. The MPEP is also the only source of information that the public can reasonably rely upon when they disagree with the patent office.

Anecdotally, it was reported that a CAFC Judge asked former DCPEP Stephen Kunin, who had more authority over patent policy: the CAFC or the USPTO? The reported reply from Mr. Kunin was, “The USPTO, of course. We [the USPTO] see and decide hundreds of thousands of legal fact patterns each year. The CAFC only sees a handful. Unless Congress intervenes (a rare and unlikely event), it is the USPTO that decides whether or not to implement the findings of a court decision by providing patent examination guidelines and ultimately revisions to the MPEP.”

While the Undersecretary and the Commissioner for Patents are the bosses, they are busy deciding high level issues and rely upon the expertise and staff of the DCPEP to adapt to changing legal, political, and social dynamics. It is the DCPEP who influences things like whether the separate written description requirement discussed in the famous UC California v. Eli Lilly case should be adapted to a broad policy framework or considered to be limited to its facts. It is the DCPEP who responds to small issues like what a computer related invention comprises and what is takes for a business method to cross the patent eligibility threshold.

The DCPEP and their staff help provide fodder for public outrage and debate areas such as stem cell and gene patenting even while quietly and methodically shaping the policies by which these things are judged. Similar to the town hall meetings about health care coverage, the debates on patent eligibility are often loud, boisterous, and perhaps most importantly, take up TV news time and column space in newspapers and blogs. The debates about the standards upon which patents are issued on genes, stem cells, computer implemented inventions, informatics, chaos theory, and Frisbees™, however, receive little attention.

The overarching patent eligibility policies are hotly debated in many areas, such as the current debate in the HHS Secretary’s Advisory Group on Genetics, Health, and Society (SACGHS) on whether or not gene patents help or hinder medical innovation. The USPTO policy staff, on the other hand, decide relatively quietly, what standards will be used for deciding when to issue patents on this contentious subject matter. A few vocal patent attorneys and small public interest groups may opine as to the merits of particular patent examination standards, but their voices often fade to background noise when presented in the same fora as the debates on patent eligibility.

The eligibility debates are important; however, these issues carry huge momentum. Lawmakers and judges may take generations to find answers to eligibility issues. In the meantime, bureaucrats at the USPTO must continue to determine when and under what circumstances to issue patents. Therefore, this treatise focuses on more pragmatic aspects of public policy that need to be decided today. The answer as to whether to patent the components of our common genetic heritage is important. It has also been decided in black letter law for over a generation. This does not mean that we should not continue to debate the question. Right now, however, we need to ensure that balanced and consistent patent policies for issuing patents on things like cloud computing, genetic testing, and new educational methods are developed and maintained. Right now, as we face a potential flu pandemic, it is critical that balanced standards be maintained for what it takes for a vaccine to be patented and preserve our private sector innovation infrastructure even while we debate the role of the private sector in healthcare.

The ongoing fundamental social debates, while the foundation of our Republic, serve to distract the public from the subtle actions of law and policy makers. Time is a precious commodity and we, the members of society, only have so much to dedicate to outrage. We rely upon our political representatives and professional bureaucrats to take care of the details.

Unfortunately, for better or worse, the devil is in the details. If we are going to adapt the limits of Moore’s law on computing power to the potential of the $1000 genome sequence for personalized medicine, we need innovation. If we are going to have innovation in a time of increasing federal deficits, impending inflation, and shrinking job pools, we need public sector investment. If the Founding Fathers were correct when they agreed to include patents in the US Constitution even before they could agree on a bill of rights, then we need a robust patent system based upon past success rather than current politics. (Harmonization is a topic for another day.)

So, do not underestimate the position and power of the Deputy Commissioner for Patent Examination Policy. The USPTO used to be considered a backwater agency and the DCPEP was a minor prince in that small kingdom. Those days are long gone. The DCPEP is one of the most important offices within the USPTO. It is time that rather than populating this position with someone politically favorable, this individual is selected for their ability to recognize and balance the needs of innovation, understand the limitations of the examination system, and appreciate the private sector’s role in the future of innovation.

About the Author

Brian R. Stanton, Ph.D., is a consultant on management, intellectual property (IP), and business infrastructure policy matters. Most recently, he was the Director of the Division of Policy at the National Institutes of Health’s (NIH) Office of Technology Transfer. Dr. Stanton was responsible for IP and technology transfer policy for NIH and the U.S. Public Health Service (PHS). While at NIH, he led a revision of the US PHS’s technology transfer policy manual and co-authored numerous licensing policy documents including the Organization for Economic and Cooperative Development’s (OECD) guidelines for the licensing of genetic inventions. Prior to NIH, Dr. Stanton spent over a decade at the US Patent and Trademark Office (USPTO) where, among other things, he co-authored policy documents including the USPTO’s Utility and Written Description Examination Guidelines and helped develop uniform patentability standards for the biotechnology and pharmaceutical industries and assisted the public in addressing difficult patent, trademark, technology transfer and development issues. Dr. Stanton continues to serve as an advisor to numerous governmental and NGO bodies including the IPR Task force of the HHS Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS), Health Canada, the World Health Organization (WHO) and the OECD.