C

atherine Klapperich was at home one night recently when she pulled up the news coverage. There, in a room almost 5,000 miles away, was a prototype of a technology she says she and her colleagues developed. But it was being shown off to the cameras by a Turkish scientist, who said that she had invented it.

“Seeing it on TV, it’s so visceral. You click on the link, and I gasped, like, ‘Oh my gosh, how can this be?’” said Klapperich, a biomedical engineer at Boston University. “We didn’t even need to know Turkish to know this was a problem.”

What followed was a dispute — and now a seeming détente — that touched on global intellectual property rights, the glory of discovery, women in science, and how nothing can stay unnoticed for long anymore. It was a scientific soap opera, but one with real consequences.

The ordeal over who actually invented the diagnostic test appears to be headed toward a resolution, with officials at Izmir Katip Celebi University telling BU this month that they “do not claim any rights or interests” on Klapperich’s technology and that they are investigating the matter. But for Klapperich and BU, the coverage set off a scramble to make sense of the situation and then to defend what they maintain is their own research — not the Turkish scientist’s.

That scientist, Melike Karakaya, did spend a year in Klapperich’s lab as a visiting student, but according to Klapperich and others, she did no work on the test.

The events also amounted to a distraction from the work Klapperich is trying to promote: the development of a fast, easy-to-use human papillomavirus test could help detect cervical cancer cases in the developing world. One of Klapperich’s former students, Natalia Rodriguez, whose doctoral thesis focused on the research, is now running a startup called Jane Diagnostics to try to commercialize the test.

“Our concern is that, when you start a small company, you have your IP, you have your scientific capital, and you want to maintain that,” said Klapperich, who is the scientific founder of the company.

In an email to STAT, Karakaya said she never intended to claim the BU test as her own and insisted that her design for an HPV test uses a different approach. She said she is aiming to get her work published.

Karakaya said the Turkish media misrepresented some of what she had said, which may have caused some confusion. She added that the “general nature” of her research — building a paper-based, cheap HPV diagnostic — is similar to Klapperich’s. But she said the Boston researchers have continued to allege she lifted their work even though she has tried to explain the differences to them.

“I do not know why they still make this an issue after my repeated messages to them,” Karakaya wrote.

Turkish News
Melike Karakaya and officials at Izmir Katip Celebi University at a press conference highlighting what Karakaya said was her invention. Screen capture via YouTube
Karakaya speaks to a Turkish news anchor about work she claimed she developed.

 

The story seemed made for TV. A news anchor hailed Karakaya’s discovery as an accomplishment for women in science, adding that it could benefit countless women. The university held a press conference. In interviews, Karakaya explained that she had received a grant to study for a year at BU, where she came up with a paper-based diagnostic test.

“My work is on cancer, particularly on early diagnosis,” she said, according to a Turkish-language interview, part of a burst of media reports in January. “I developed a microfluidic chip that would allow the early diagnosis of cervical cancer.”

Karakaya said she had heard from companies interested in commercializing the test, but that she wanted to work with the Turkish Health Ministry to advance the technology. Officials at Izmir Katip Celebi University, where Karakaya completed her PhD last year and works as a researcher, likened it to an at-home pregnancy test, it was so easy to use.

According to Klapperich, Karakaya arrived at her lab in August 2014.

Newsletters

Sign up for our Morning Rounds newsletter

Please enter a valid email address.

She spent a few weeks that September shadowing Rodriguez, who was at work on the HPV diagnostic, but then was moved to another project, Rodriguez said. She collected no data and was not involved at all in the development of the chip, the Boston researchers said. They published a paper describing their work in early 2016, and Karakaya is not listed as a coauthor.

“Yeah, she worked in the same lab and sat at the same table as Natalia, but she really wasn’t working on Natalia’s project,” Klapperich said. “It just wasn’t even a question. When she was here, it wasn’t like there was some big fight over authorship — that’s why it was so stunning.”

Before the paper was published, in December 2015, BU also applied for a patent on the work. It has not been granted yet, but BU officials said Karakaya is not listed on the application.

“I was more disappointed than anything else,” Rodriguez said. “This was something I spent a lot of years on and lot of time and effort on, and someone I helped. I taught her and I trained her.”

Boston University
A prototype for the HPV diagnostic test in Klapperich’s lab. Josh Reynolds for STAT


Klapperich first learned about the Turkish media coverage on Jan. 26 after receiving a tip from a Turkish-speaking scientist in the United States who had seen the reports about Karakaya. BU soon started reaching out to Turkish media outlets to raise their concerns. On Feb. 8, Michael Pratt, the managing director of BU’s Office of Technology Development, emailed an official at the Turkish university.

“Although Ms. Karakaya worked in Professor Klapperich’s lab as a visiting scholar, she did not contribute to the development of the chip described in this paper,” Pratt wrote. “We are concerned that faulty attribution of this technology to anyone other than the rightful inventors of this technology is scientifically unethical, and could irreparably harm Boston University’s reputation, and that of its faculty.”

Then, early this month, BU received the note that the Turkish university was not declaring Klapperich’s work as its own. BU says it is satisfied with the response.

“We would like to assure you that as management of university we do not claim any rights institutionally about the paper or the patent pending technology you described,” an official at the Turkish university wrote. (The university did not respond to followup questions from STAT.)

Even if the Turkish researchers had tried to pursue a patent, they might not have succeeded. In addition to applying for a US patent, BU had filed a Patent Cooperation Treaty application, which signals to other countries that a technology has been submitted for a patent on a particular date.

The system is in place to prevent the “sort of shenanigans” that BU feared was happening in this case, said Jacob Sherkow, a patent expert at New York Law School.

But if BU does receive a US patent, it will still need to pursue intellectual property protection in other jurisdictions so no one else can manufacture the test.

“Patent rights are territorial, so a US patent would only be enforceable in the United States,” said Tom Cotter, an international patent expert at the University of Minnesota Law School.

Even though the dispute appears to be resolved at the university level, both Klapperich and Karakaya are left with questions. Karakaya said it would not make sense for her to pursue research “that is identical to an already published work” and that she wondered if the Boston researchers were worried about competition.

“I guess that the extra sensitivity in this issue may be due to the rights for commercializing their published work at this time,” she wrote in the email.

Klapperich has no doubts, however, that Karakaya tried taking credit for others’ research. The devices that were shown off at the press conference, Klapperich said, looked like the versions of the prototypes BU researchers had during Karakaya’s time in the lab.

Regardless of what happens, both Rodriguez and Klapperich emphasized that they view the entire episode as an anomaly and that it would not deter them from working with international scientists. Klapperich said the same thing could have happened with a visiting American scientist.

“Because we work in global health and because our work requires that we work with scientists and clinicians outside the United States, we have to stay open to these kinds of collaborations,” Klapperich said. “We can’t let one person shut it down.”

Leave a Reply to Michael Cancel reply

Please enter your name.
Please enter a comment.

  • Dear
    I am search Chadian , working in status nutrition for child in chad with related by food eaten I wont to participle in the conference should help me in this cease again to exchange my experience with others peoples came to others countries had much knowledge and wisdom in this field but I didn’t know who did you use to participle in this conference, please sir can you oriented me to know different process . to applied
    thank so much

  • Can you smell the money to be made here. Current patent rights will have us paying thru the nose forever. Patents need strong regulations regarding expiration dates. And no smoke and mirror tactics to extend patent rights forever. Patents protect but also stifle innovation if they never expire.

Sign up for our Morning Rounds newsletter

Your daily dose of news in health and medicine.