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HHS Bid to Service Mark 'Precision Medicine Initiative' Raises Questions

NEW YORK (GenomeWeb) – The US Department of Health & Human Services has applied to service mark the Precision Medicine Initiative moniker, raising questions as to how it plans to enforce the mark and what it hopes to gain from it.

Under two applications (see here and here) filed by HHS, the government body seeks to service mark the term "Precision Medicine Initiative" as the name for the registry that will house the deidentified genomic data of 1 million volunteers, as well as the name for the overarching research program launched by the President in January. A service mark is similar to a trademark, except the former brands a service and the latter distinguishes a product.

Kathy Hudson, NIH deputy director for science, outreach, and policy, told GenomeWeb this week that HHS is applying for the service marks in order to protect taxpayers' interests and prevent groups that would use the term to give the impression that they're part of the government initiative when they're not. "You could imagine someone saying that this is part of the Precision Medicine Initiative, and we're selling you this gizmo," Hudson reflected. "Well, if it's not a part of the initiative, you can't do that."

Treatments tailored to a person's molecular characteristics have been widely known as "personalized medicines" for more than a decade. Since President Obama announced the Precision Medicine Initiative on Jan. 30, the term "precision medicine" has exploded into common parlance and is becoming particularly popular among researchers and industry players. Most drug developers say they're making precision medicines, and diagnostic firms advertise tests that identify patients who should get them. In addition, a number of medical conferences focused on "precision medicine" have popped up, and across the nation universities have opened centers and institutes paying homage to the term in their banner.

Hudson characterized the Precision Medicine Initiative as a high-priority project for the President and the NIH that will require a substantial investment and continue over many years. "So, we want it to be understood that when people are representing themselves as part of the initiative that they are truly a part of the Precision Medicine Initiative," she said.

The filing date for the application to service mark the initiative's name is Jan. 30, the same date as Obama's White House speech announcing the Precision Medicine Initiative. The HHS cites Jan. 30 as the term's "first use anywhere" date and the "first use in commerce" date.

Of course, the President announced the Precision Medicine Initiative during the State of the Union Address on Jan. 20. And well before he uttered the three words, the National Research Council published a report in 2011, entitled "Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease," in which the reasons for using "precision" over "personalized" medicine as a term are laid out. The White House initiative – and the program's moniker – were likely inspired by ideas in this report.

"It's hard to imagine no one ever used those three words together before Obama, although I bet the HHS general counsel's office or the White House did a quick Google search before the State of the Union speech by the president," said Robert Cook-Deegan, research professor at Duke Sanford School of Public Policy.

From personalized to precision

According to Google Trends data (see graph below), historically, "personalized medicine" is the term people usually search for, but there was a marked spike in the popularity of "precision medicine" as a search term right after the President made his speech at the White House announcing the $215 million plan.

Well before the President's speech, genomics expert Geoffrey Ginsburg at Duke University noted the shift in terminology from "personalized" to "precision" medicine, and the university even changed the name of its Center for Personalized Medicine to the Center for Personalized and Precision Medicine. Ginsburg who headed up the center from 2010 to 2014 explained in a note posted on the group's website back in 2013 that although it was launched as the Center for Personalized Medicine, the meaning of the word "personalized" has evolved with the growing interest in so-called patient-centered healthcare – where the focus is on increasing patient involvement in care decisions.

"With the rise of diverse molecular/sequencing and digital [health] technologies and the recognition of molecular heterogeneity of individuals, the term 'precision medicine' is being used more and more to reflect the evolution of the field," Ginsburg wrote. The Duke center changed its name to include the terms "personalized" and "precision" in an effort to reflect the group's commitment to both ideas.

Last year, Duke decided to transition its Institute for Genome Sciences & Policy into smaller units. Amid this change, IGSP's Center for Genomic Medicine and the Center for Personalized and Precision Medicine came together and is now called Duke Center for Applied Genomics and Precision Medicine. "My view is that as the fields evolve we need to evolve as well," Ginsburg, who heads up this new center, told GenomeWeb over e-mail.

HHS's two service mark applications for the "precision medicine initiative" comes amid this terminology transition, while "precision medicine" is still a relatively young term. According to posted documents, the applications don't yet have an assigned examiner. While HHS awaits a determination, Hudson wouldn't say whether the government has had to negotiate with certain groups to discourage them from dubbing their projects "precision medicine initiative."

After Nature reporter Erika Check Hayden published an article recently with the headline "California unveils 'precision-medicine' project," she tweeted that while reporting the piece she had learned that the US government had applied to mark the phrase "precision medicine initiative." Launched by Governor Jerry Brown with $3 million in start-up funding, the two-year effort is dubbed the California Initiative for Advancing Precision Medicine. All three words – precision, medicine, and initiative – are in the title of the California effort, but not in the sequence that would be covered by the marks for which HHS has applied.

Hudson acknowledged that HHS has encountered situations where groups who aren't part of a government-backed project are conducting programs under the same marked name. "Generally, when that has happened conversations with the organizations result in a happy outcome where they agree to not pursue use of the name that looks like our [service] mark, or they stop using the name that is our [service] mark," she said. But Hudson declined to provide specific examples, saying she wasn't free to share the government's negotiations with entities potentially infringing HHS marks.

This isn't the first time the government has service or trademarked the name of one of its programs or offerings. Justia, the legal information site, lists numerous marks attributed to HHS, and some of them are well known to the personalized/precision medicine field. For example, the USPTO has accepted HHS' application to mark ClinSeq (an effort investigating whole-genome sequencing to study human health), and registed HHS's mark for GTR (the catalog of tests also known as the Genetic Testing Registry), as well as a mark for PharmGKB (a resource on how genetic factors influence drug response). 

"We [service] mark stuff all the time," Hudson said, citing another application for The BRAIN Initiative. "That is not to say that then we don't let anyone use it, but it just means that then we control the use of it. That means that we can make sure that people use it in a good and beneficial way for protecting the project and not misuse it in a way that suggests that the initiative is doing something it's not."

The current status of HHS's application to register the mark for The BRAIN Initiative – another Obama pet project to develop technologies to advance an understanding of the brain and neurological diseases – reads "Final Refusal – Mailed." But an NIH spokesperson said that the application is still pending at USPTO. Meanwhile, the status of another application from the President and Fellows of Harvard College to register a mark for the HARVARD Brain Initiative – differentiated from the government effort by an illustration of the brain and the word Harvard – suggests that the group is planning to file an opposition. The lawyer handling the application declined to discuss the status of this application with GenomeWeb.

For the public?

At a recent meeting hosted by the Personalized Medicine Coalition, Hudson discussed the Precision Medicine Initiative and mentioned the service mark applications. Mary Williams, executive director at the Association for Molecular Pathology, heard about HHS's plans in this regard from a colleague who attended that meeting and was surprised. She was left wondering what HHS plans to do with the mark and what it has to gain from it.

For Williams, the idea of the federal government service marking the name of a tax-payer funded initiative doesn't sit well on a philosophical level. When the government patents or trademarks (or service marks) something, it should be to facilitate public use and access, not to hinder it, she believes. AMP was among the plaintiffs in AMP v. Myriad, in which the Supreme Court two years ago determined that isolated gene sequences were patent ineligible – a decision that was lauded by NIH Director Francis Collins.

AMP often uses images and educational materials produced by the government to inform its members. "If the federal government was to copyright their images and education materials, and no one could use it, what would that mean?" she posited. "Maybe [HHS] would say this is a completely different thing."

Countering these types of criticisms, Hudson said that HHS intends to service mark the term "precision medicine initiative" in order to protect its use in the public's interest. For example, when NIH starts recruiting volunteers into the research cohort, "then people who are participating … can proudly say that they are part of the Precision Medicine Initiative cohort," Hudson said. "So, that is giving it to the people. We're not going to restrict use of the term for the purposes of representing what the government is doing."

Despite the fact that so many groups are eagerly paying lip service to the President's initiative, Amy Miller, executive VP of the Personalized Medicine Coalition, told GenomeWeb that her group will not be jumping on the "precision medicine" bandwagon. The organization, which represents a broad swath of the life sciences sector, conducted focus groups in 2013 that revealed average Americans' preference for the term "personalized medicine," even though few had heard of it.

Focus group participants seemed to particularly like it when "personalized medicine" was defined in a way that suggested they'd have more control over their healthcare options and that care would be preventative. Participants, however, had more negative reactions to the term "precision medicine," which they found too clinical or said sounded like "a term used by marketers," according to Miller.

"We are sticking with Personalized Medicine Coalition and we are going to continue to use the phrase personalized medicine," she said. "Precision medicine makes me think of a scalpel and exact science. But there's still art here. We have great diagnostics, but we also still look at the clinical picture of the patient. We also still look at [patients'] preferences."